FM SEPTEMBER 2018 ISSUE - digital edition


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editor’s note

SEPTEMBER AUGUST 2018 2018 / Vol: / Vol. 5 / 5 Issue: / Issue 4 5

Founder & & Editor Editor

CH Unnikrishnan

Executive Editor Editor

S Harachand


Science Editor

Science Editor

Dr Rajanikant Vangala

Dr Rajanikant Vangala

Consulting Editors

Dr Copy Shivanee Editor Shah

Jeetha Sreejiraj D’Silva Eluvangal

Dr Consulting Sumit Ghoshal Editors

Copy Dr Shivanee Editor Shah

Sreejiraj Dr Sumit Ghoshal Eluvangal

Photo Editor Editor


Umesh Goswami


Design Editor


Gopakumar K

Mathewkutty J Mattam


Mathewkutty Advisory Board J Mattam

Dr Devi Shetty

Advisory Board


Dr B


S Ajaikumar


Dr Shashank B S Ajaikumar Joshi

Dr Prof. Shashank Arumugam Joshi S

Dr I Prof. C Varma Arumugam S

Dr N I C K Warrier Verma

Dr Sekar N K Warrier Seshagiri

Dr Sekar Seshagiri

Mr Knowledge Rajesh Partner R Nair


Knowledge Partner

SGRF Business Head


Tushar Kanchan


Tushar Circulation Kanchan & Subscription Manager

Circulation S Sanjeev Nair& Subscription Manager

S Design Sanjeev & Graphics Nair

Editorial Blackboard Offices Kochi



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Lower Parel Parel (W), (W), Mumbai Mumbai 400 013. 400 013.

Dear Doctor,

Dear Doctor


We know



all for





It is always












faith of




of patients




your healing


touch keeps








this noble


that profession. we could In the really hectic carry practice, out our it’s mission quite of natural helping that you you connect might miss with the

new out on world some of of medicine, the latest but developments also helped us in emerging realise that medicine. the Indian this medical era

and of innovation, healthcare medical community science is always is getting open redefined to quality almost information by the day. that Old adds

value technologies to their are noble being profession. replaced by the new in the blink of an eye. Robots

and While artificial our August intelligence edition are dwelt taking upon over the a good emerging part of vistas the procedures, of cancer care

in while the genomics era, and we molecular want to science take you unveil to the the fascinating mysteries world of life further. of ultra

niche We are technologies fortunate to that have democratise such breakthroughs the word as of they non-invasive help specialists procedures like

in you cardiac rise above care the in this expectations issue. This of is important today’s informed as these patient. sophisticated

technologies and devices, which make life better for the practitioner and

the Similarly, patient it is alike, also are a time gaining when wide India currency is witnessing among revolutionary the suave cardiologists

growth in

across healthcare the globe. industry, especially in the private sector, wherein an increasing

number Another of critical doctors area that taking we up discuss multiple in this roles issue of clinician, is a genomic researcher revelation and

that entrepreneur. warrants This serious requires attention expansion of the of community. your focus The to a alarming wider canvas. prevalence In

of this inherited context, heart it becomes diseases important in India how due a to busy endemic professional genetic like mutations you can calls

for keep a rethink pace with of our these diagnostic latest developments and treatment in a approaches quick and easy in cardiology. way.

On the medical education front, we had taken up the controversial

CPS At Future certificate Medicine, scam which in the is August conceived issue. and As crafted several by DNB a team graduates of senior in the

country journalists, have scientists been pleading and doctors, now for our an aim equal is to status help you with do MD just and that. MS, We

Future are equipped Medicine to bring looks you at the the issue latest in from this edition. the science In ‘Straight of care Talk’, from across

Dr the Azad world Moopen, in an interesting a very successful and convenient doctor-entrepreneur way, supplemented and still by an the best

academic of views and enthusiast, analyses laments from the about masters India’s in each dated field. medical We present curriculum. you this

specialised knowledge vehicle that plugs you into the emerging world of

care seamlessly. Come, let’s join hands in this information journey.

CH Unnikrishnan

C H Unnikrishnan

The publishers regret that they cannot accept liability for errors or omissions

contained in in this publication, however caused. The The opinions and and views views contained in

this in this publication are are not not necessarily those those of the of the publishers. Readers are are advised to

seek to seek specialist advice advice before acting on on information contained in in this publication,

which is provided for general use and may not be appropriate for the readers’

particular circumstances. The ownership of trademarks is acknowledged. No part of

this publication or any part of the contents thereof may be reproduced, stored in a

retrieval system or transmitted in any form without the permission of the publishers

in writing. An exemption is hereby granted for extracts used for the purpose of fair


Printed and Published by Ravi Dee Cee, DC Books, D C Kizhakkemuri Edam, Good

Shephered Street, Kottayam, Kerala on behalf of NextGen Science Media Pvt. Ltd,

printed at Spenta Multimedia Pvt, Lower Parel (West), Mumbai-400 013,India and

published at DC Books, D C Kizhakkemuri Edam, Good Shephered Street, Kottayam,


© 2018 NextGen Science Media Pvt. Ltd, RNI Number KERENG/2012/44529 futuremedicineindia FutureMedIndia







Ground-breaking advances in

percutaneous intervention tech

are charting a new course in

cardiovascular medicine

I would suspect

that patients

with low risk will

continue to have

surgery instead

of TAVI unless we

have evidence that,

in long term, TAVI

valves will last as

long as surgery


Dr. T J Collins

Director, Interventional

Cardiology, Ochsner

Clinic, Louisiana, USA.






Despite the fact that genomic

data help measure the risk

precisely, inherited heart

diseases remain largely






DNB doctors are pinning

their hope on the proposed

NMC Bill as SC rejects

the demand seeking

absolute equivalence

to MD/MS degree


Vol 5 Issue 5

September 2018

56 78




Gynaecs are left high and

dry as the ethical debate on

whether to allow

the termination of high-risk

pregnancies post 20 weeks

continues to rage






cardiomyopathy runs

through a family, casting the

shadow of imminent cardiac





Will the recall of Voveran

1 ml injection from the

Indian market affect clinical

management of pain

across specialties? Experts











Dr Azad Moopen

Chairman, Aster DM

Healthcare Group














06 Letters

08 News updates

14 Healthcare

50 Drug approvals

62 Oncology

74 Research snippets

80 Public health

84 Hospital news

86 Diagnostics

88 Devices

92 Events

95 Book review

96 Products

98 Holy grail




₹ 250.00








letters to the editor

Sweet surprise


It is really a sweet surprise to

go through August release of

Future Medicine. I must thank

and congratulate you for this

new endeavor.

Personally I like the

way you are positioning

healthcare industry towards

new technology, latest

diagnostics and it will be

my pleasure to read this

magazine, which adds value

to industry and society.

With regards,

Dr. R B Smarta

Managing Director, Interlink

Marketing Consultancy P. Ltd,




Got the copy of Future

Medicine. Good articles.


Dr Dhanya Abhilash

Vaishnavam, Shornur

Bold interview

Dear Sir,

Read the interview with

Dr Ajaykumar of HCG in

the August edition. Really

interesting views that he

shared in the same. He

was audaciously bold in

expressing his anguish

against some of the existing

practices among the

medical community, which

none dared to speak out.

Congratulations and expect

more such bold interviews,

involving leaders in the


Dinesh Aurora,

New Delhi



Congratulations for the

launch of an excellent

medical news magazine,

which is fairly comparable

with any top brands in the

same space in the West. The

clarity in topics discussed is

par excellence and the look

and feel is exceptional. Wish

you all the best.

Dr Narayanankutty Warrier

Senior Oncologist and

Medical Director,

MVR Cancer Centre and

Research Institute, Kozhikode.

Very informative

Dear Editor

The article appeared on

CPS certificate scam in the

inaugural edition of Future

Medicine actually helped me

take an informed decision

as I was planning to go for

my post graduate diploma. It

also changed my perception

about such institutions. Really

appreciate the way it was


Dr Suresh Kumar



Dear Editor

Got the new edition of Future

Medicine. Very informative

for us doctors as it helps

widening our exposure to the

evolving world of medicine.

Selection of stories are

excellent and the treatment

is also unique. The CPS

certificate scam report was

certainly an eye-opener.

Dr Amrutha C Das


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clinician. It empowers doctors with the most relevant updates,

trends, case studies, expert views, knowledge exchange,

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science. To be relevant in the future of care, subscribe today.


news updates

AP first to make

AD syringes


Andhra Pradesh has

become the first Indian

state to launch auto-disable

syringes for all clinical

purposes and to declare itself

as a ‘Safety Injection Use

State’. The state government

had, in May 2018, passed

an order to use auto-disable

syringes for all clinical

purposes. Subsequently,

the Ministry of Health,

Medical & Family Welfare

launched the programme “AD

Syringes for Patient Safety”

on August 16.

The WHO had begun the

global campaign for the use

of safe injection practice in

early 2015 and chosen India,

Egypt and Uganda as the

focus countries to spearhead

the same. The global health

body had then stated that

the return on investment

(RoI) was 14 dollars for every

dollar invested in injections

safety. The WHO gave a

directive to all member

states and institutions

to go for mandatory use

of SMART auto-disable

safety engineered syringes

in healthcare system by

2020 and urged all donor

institutions to supply only

AD / RUP / SIP syringes

henceforth in their

campaigns, depending

upon local manufacturing

capacity, availability and

affordability. Many countries

including USA, EU, Canada

and Japan have already

adopted Safety Engineered

Syringes (SES).

Vishisht Chikitsa

Ratan Awards


Delhi Medical Association

honoured the leading

medical professionals of

India with its Vishisht Chikitsa

Ratan Award for their

distinguished work in the

India to revise essential medicines list

India’s health ministry has

decided to constitute a

committee for preparing

guidelines for the revision of

the National List of Essential

Medicines (NLEM) and include

medical devices, disposables

and consumables in the list.

The Standing National

Committee on Medicines

(SNCM) will provide the terms

of reference to the committee

to prepare detailed guidelines

and procedures for revision

of NLEM and suggest

additions and deletions to

profession and contribution

to the society.

At a function held at

Maulana Azad Medical

College, New Delhi, Union

Health Minister J P Nadda

conferred the honours to the

outstanding physicians.

the list. It will also suggest

Revision of NLEM 2-15,

Inclusion of Medical Devices,

Medical Disposables, Medical

Consumables and other

products. Presently, among

the devices, only cardiac

stents are included in the


NLEM was last revised in

2015, expanding it to 384

drugs from the then existing

348, including drugs for

critical illnesses like cancer,

HIV and diabetes.

The new committee will

The recipients of the

award include Dr Randeep

Guleria, Director, AIIMS;

Dr Balram Bhargava,

Director, ICMR; Dr Vijay

Trehan, Director and

Professor Cardiology,

GB Pant Hospital; Dr

be headed by the director

general, ICMR. It will have

representations from various

ministries and organizations,

including those of health,

chemicals and fertilisers,

AYUSH, National Institute

of Malaria Research, Vector

Borne Diseases Control

Programme, and other

research bodies like NIPER.

It will also include the Drugs

Controller General and state

health secretaries. The threeyear

committee will update

the list periodically.

Ashok Seth, Cardiologist

and Director, Fortis Escorts

Heart Institute; Dr TS Kler,

Leading Electrophysiologist

and Head Cardiology, PSRI

Hospital; Dr Mohan Nair,

Senior Cardiologist, Holy

Family Hospital; Dr AS Soin,

Liver Transplant Surgeon;

Dr Ajay Kumar, Senior

Gastroenterologist, Fortis

Escorts Heart Institute;Dr NK

Aggarwal, Head, Forensic

Medicine, GTB Hospital; Dr

KK Aggarwal,ex-President,

Indian Medical Association; Dr

Ajay Kumar, Senior Uro and

Nephro Transplant Surgeon,

Patna; Dr SS Aggarwal,

Senior Paediatrician, Jaipur

Rajasthan; Dr Siddharth

Ramji, Dean, Maulana Azad

Medical College and Dr Prem


Aggarwal, Cardiologist.

The Union Health Minister

also conferred Life Time

Achievement Awards to

practicing nanogenerians,

including Dr. J.S. Guleria, Dr

G.P. Seth, Dr. M.G. Abbott and

Dr. M.L. Dang.


expands base

to Karnataka


DocOnline expanded

its base into Karnataka

by starting operations in


The telemedicine startup

will offer online doctor

consultations in Kannada

language, besides English,

Hindi, Telugu and Tamil,

according to a company


The online

healthcare platform

offers unlimited

doctor consultations

for the entire


period, and has

a customer base of about

200,000. DocOnline also

offers tailor-made solutions

to corporates and B2C

customers of Karnataka.

DocOnline delivers

consultation on nonemergency/preventive

healthcare through a digital

technology platform, enabling

interaction to users anywhere

and at any time with certified

and experienced general

physicians via telephone,

video and chat facilities.

Health ministry -

IGNOU tie-up on


The Union Health

Ministry has signed

a memorandum of

understanding (MoU) with

Indira Gandhi National Open

University (IGNOU) to scale

up short-term healthcare

courses through its available


The ministry, together

with IGNOU, will create a pool

of trained personnel in the

healthcare sector and set up a

dedicated cell for developing,

implementing and certifying

the skill-based programmes of

the open varsity.

As per the MoU, the

health ministry will provide

financial assistance to IGNOU

for establishing the structure

and initiating the programmes.

The courses will be started in

a phased manner across the


Initially, four courses

will be launched across the

country; namely, Home Health

Aide, Geriatric Care Assistant,

Phlebotomist and General

Duty Assistant. This will be

followed by the remaining

six skill-based curriculum

as standardised by the

Health Ministry - Diabetes

Educator, Dietetic Aide, EMT-

Basic, Dispensing Optician/

VT and Medical Equipment

Technology Assistant.

The health ministry has

identified IGNOU to scale up

the skill-based courses in

healthcare sector and train

14 lakh people by 2025. The

signing of the MoU is under

the existing framework of

‘Skills for Life, Save a Life’

initiative, under which ten

short-term course curricula

were formally released by

the Ministry in June 2017

in association with Ministry

of Skill Development and

Future Medicine to be a game changer in medical news: Reddy

Dr. Pratap C Reddy launches Future Medicine in New Delhi

Future Medicine, the first-of-its-kind

medical science and news magazine

aimed at clinicians and healthcare

fraternity in India, was launched at the

hands of Dr Pratap C Reddy, founder and

chairman, Apollo Hospitals, at an august

event in New Delhi on July 28.

The magazine, conceived and crafted

by a team of senior journalists, scientific

writers and and doctors, aims to be

an indispensable tool for healthcare

practitioners who wish to keep themselves

abreast of the latest developments in

medical science and research from across

the world.

“Future Medicine is a uniquely

positioned medical science and technology

news magazine for Indian doctors that not

only enriches knowledge about emerging

scientific trends from across the world,

but also provides a great platform for

doctors, researchers and medical students

to discuss and debate the hottest topics of

the day in medical science,” said Dr Reddy.

The magazine will help in driving

greater awareness and provide access to

the very latest information, , something

that is critically missing in our country.

“I am sure this will be a game changer,”

Reddy added.

While unveiling the magazine in

Kochi on 14 of August, Dr Azad Moopen,

Chairman of Aster DM Healthcare Group

and Aster MediCity, Kerala said, “There’s

clearly a space existing for such a media

platform and it will be very helpful in the

Indian medical scenario.”

Future Medicine is owned and

published by NextGen Science Media, a

healthcare-focused startup media venture

that recently raised its first round of

funding from Singapore-based Emerge

Ventures, Kerala-based DC Books and

individual investors. The magazine has

been launched in print and online

formats and will soon be available in

a specially designed mobile app for

the quick reference of doctors on the

consultation table.



This MOU will create

a training and monitoring

network at the district level,

integrating the tertiary,

secondary and primary

health-care institutions. It is

envisioned that this MoU will

take up large-scale training

in a time-bound manner at

an affordable cost and will

be accessible to all citizens of


Centre amends

rules for path


The central government

has notified the Clinical

Establishments (Central

Government) Amendment

Rules, 2018, setting minimum

standards for diagnostic labs.

Based on the scope

of services offered, the

notification classifies

diagnostic labs into three

categories: basic composite

(small), medium and

advanced labs.

Post graduation in

pathology or biochemistry

or medical biology is an

essential qualification for

medium and advanced

labs. As far as small labs

are concerned, there is no

minimum qualification.

The path labs conducting

routine tests biochemistry,

haematology such as basic

medical microbiology and

Manipal doctors identify `pp’

blood phenotype

rare blood group called

A ’pp’ or ’P null’ has been

identified in India by a team

of doctors in Manipal.

The team, led by Dr

Shamee Shastry from the

blood bank of Kasturba

Medical College, Manipal

landed upon the rare blood

group as they were looking

for compatible blood for a

patient who needed urgent


Even after cross

matching with more than

80 units, the doctors could

not find a compatible

blood unit for the patient.

Following extensive


workup, the samples were

referred to International

Blood group Reference

Laboratory (IBGRL), Bristol,

UK for serological testing.

The reference laboratory

helped to confirm that the

patient’s cells had the rare

‘pp’ phenotype.

“The patient had a

very rare ‘P null’ blood

group and anti-PP1Pk

antibody in his blood

that has a potential to

cause acute intravascular

hemolytic reaction in

case of incompatible

blood transfusion,” said

Dr. Shamee Shastry,

professor and the head

of the department of

Immunohematology and

Blood Transfusion in a press


Rare donor registry

will be of great help in

managing such cases. The

antibody is also known to

cause recurrent abortions in

women. Finding compatible

units for such cases is

a near impossible task

without a well-established

rare-donor panel, she


A blood type is

considered rare if it is

found in fewer than 1 in

1,000 people. A person

is said to have rare blood

group when he lacks

high-frequency antigens or

multiple common antigens,

according to the release.

immunology tests like rapid

test (point of care tests)

for infection, urine routine

examination and microscopy,

hanging drop for vibrio

cholerae and the stool for

ova, cyst have been classified

as small-scale labs in the

amended Rules.

For running a small

diagnostic lab, a pathology

degree in medicine or surgery

from a recognised university

is desirable.

No doctor is essential to

run small pathological labs,

as per the new amendment

of the Clinical Establishment

Act, 2010.

The new notification

seems to be contrary to the

Supreme Court order on

December 12, 2017, which

clearly stated that laboratory

reports can be countersigned

only by a registered

medical practitioner with a

postgraduate qualification in


Medium labs are those

that provide additional tests

such as hormone bioassay,

tumour markers, plasma

protein electrophoresis,

coagulation assay, PAP

smear, fine-needle aspiration

cytology (FNAC), sputum

and CSF cytology and

certain microbiology and

immunology tests, including

serological tests for viruses,

bacteria, fungi, parasites and

cultural sensitivity.

Advanced labs, according

to the new rules, handle tests

like coagulation profile, drug

monitoring and toxicology

assay, molecular genetics,

tests for detection of inborn

errors of metabolism,

other haematology tests,

histopathology examination,

molecular genetics, immuno

cytochemistry, biological

fluid cytology, ultrasound or

CT examination, FNAC and

immunohisto-chemistry. Also

included here are culture

sensitivity tests for viruses,

real-time polymerase chain

reaction (RTPCR) tests and

tissue diagnosis test for

infectious diseases.


launches web


DocsApp has introduced

web-based consultation

for the users in tier 3 and 4

cities of India, who may not

be familiar with the concept

of mobile applications.

The online consultation

platform has removed the

necessity of using its mobile

application by providing an

easy-to-use web service.

Doctors across the country

can now be reached via the


web platform.

As the use of the

internet is becoming more

widespread in the semi-urban

parts of India, providing

consultations via the web

will help internet users

access healthcare services

via multiple devices including

mobile, laptops and desktops,

according DocsApp.

Started in 2015, DocsApp

has a user base of over

3.5 million customers

and provides 75,000+

consultations per month. The

app connects patients to

specialist doctors across 19

specialities within 30 minutes

on the app via chat or call.

DocsApp allows patients to

order medicines and lab tests

from home.

DocsApp received the

‘App of the year 2017’ award

from Amazon in the medical


Sanofi Pasteur

launches 4-strain

flu vac in India

Sanofi Pasteur, the vaccine

division of Sanofi,

launched its four-strain

influenza vaccine FluQuadri

in India.

FluQuadri will be India’s

first quadrivalent vaccine to

provide broader protection

against influenza to

population above 3 years of

age, the company said.

The majority of seasonal

influenza vaccines currently

available are trivalent. They

offer protection against two

A strains and one single B

lineage (B/Victoria or B/

Yamagata) of the influenza

virus. However, over recent

flu seasons, co-circulation

of both B lineages has been

consistently observed, making

it difficult for the World

Health Organization (WHO)

to recommend which B strain

should be incorporated in

trivalent influenza vaccines.

Given the change in

epidemiology, quadrivalent

vaccination represent the

next logical step.

India has also seen

circulation of type B influenza

strains. The Integrated

Disease Surveillance Program

(IDSP) annual report of 2017

stated that in the wake of

high number of influenza

deaths and cases in Gujarat,

an expert committee noted

that one of the main reasons

of flu epidemic in Gujarat

Dr Mohan receives Harold Rifkin Award for diabetes care

Dr V Mohan, chairman and

chief of diabetology

at Dr Mohan’s Diabetes

Specialities Centre, has

received the prestigious

Harold Rifkin Distinguished

International Service in the

Cause of Diabetes Award

by the American Diabetes

Association (ADA).

Dr Mohan, who is also

the president and chief of

diabetes research of the

Madras Diabetes Research

Foundation, is the first

Indian doctor to receive this


Dedicated to the memory

of Dr Harold Rifkin, an

internationally recognised

clinician, researcher and

educator in diabetes, the

award is one of the highest

scientific achievement

awards of American

Diabetes Association, given

was that during last year,

the H3N2 and B subtypes

of influenza virus were

circulating, but not H1N1,

leading to a build-up of the

susceptible population.

The WHO includes

quadrivalent influenza

vaccines in its


Philips launches

India’s Future

Health Index

The first edition of India’s

Future Health Index (FHI),

a research-based platform

by Royal Philips to help

determine the readiness of

Dr Mohan

annually to an individual

whose efforts have increased

the awareness of the

burden of diabetes

worldwide to improve the

care and lives of those with


The award recognises

Dr Mohan’s outstanding

countries to address global

health challenges and build

sustainable, fit-for-purpose

national health systems has

been launched.

Lack of access due

to low skilled-physician

density and a low number of

hospital beds impede value

the most, according to FHI.

The study also found that

despite a lower-than-average

data analytics score, Indian

healthcare professionals are

open to the use of futuristic

technology (AI, virtual reality)

in healthcare, even more so

than the general population.

FHI finds that healthcare

professionals could become

key promoters of connected

care technologies as they

consider themselves highly

knowledgeable about

connected care devices

and believe in a future

where everyone owns them

to manage their health,

potentially boosting data

collection and analytics in


service to the cause of

diabetes in India and his

pioneering work in the field

of diabetes.

The award was conferred

on Dr Mohan during the

78th Scientific Sessions

of the American Diabetes

Association at Orlando

during the National Scientific

Achievement Awards

Presentation Ceremony

held on June 25 at WB4

Convention Centre.

Dr Mohan has worked

tirelessly to address the

challenges of diabetes

in India and developing

countries. He has actively

been involved in government

health policy and advocacy

programmes related to

diabetes, and has served as

the president of the Research

Society for the Study of

Diabetes in India.


GSK invests

$300m in



ritish drug giant

GlaxoSmithKline has

committed investment of

USD 300 million in 23andMe

in an exclusive four-year

collaboration to develop

innovative medicines using

human genetics as the basis

for discovery.

The collaboration

will combine the leading

consumer genetics company’s

large-scale genetic resources

and advanced data science

skills with the scientific and

medical knowledge and

commercialisation expertise

of GSK.

With over 5 million

customers, 23andMe offers

those with an interest in

genetics the opportunity

to learn more about their

personal genetic profile.

23andMe customers can

also choose to participate

in research and contribute

their information to a

database, which is now the

world’s largest genetic and

phenotypic resource.

GSK and 23andMe will

focus on translating genetic

and phenotypic data into

R&D activities that will

improve target selection to

allow safer, more effective

‘precision’ medicines to be

discovered. The collaboration

will also support identification

of patient subgroups that

are more likely to respond

to targeted treatments, as

well as helping to allow more

effective identification and

recruitment of patients for

clinical studies, according to


The programme is

expected to leverage

23andMe’s large base of

consented customers who

are aware of their LRRK2

variant status as a result of

23andMe’s FDA-authorised

genetic health reports. GSK

and 23andMe will also target

and rapidly recruit patients

with defined LRRK2 mutations

in order to reach clinical proof

of concept.

PATH and SD Bio

to develop malaria


The international nonprofit

organization PATH

announced a new partnership

with South Korean company

SD Biosensor to support

the development of a new

diagnostic for malaria.

PATH and SD Biosensor

developed a simple, lowcost

device, Standard

G6PD, to guide appropriate

clinical care of patients with

Plasmodium vivax malaria

who also have a hereditary

enzyme deficiency that

can lead to severe

anaemia if the patient

receives treatment with


drugs to cure the infection.

WHO recommends

that patients be tested

for glucose-6-phosphatedehydrogenase


deficiency before the

radical cure is administered.

Currently available rapid

tests for G6PD deficiency do

not adequately determine

the G6PD status of women

who carry the gene for

G6PD deficiency on only one

X chromosome and have

intermediate G6PD activity


Current tests that provide

this level of determination

of G6PD activity in women

are too expensive and

complex for use at the point

of care in low-resource

settings where P. vivax is


To address this gap, PATH

is advancing a portfolio of

novel rapid tests for G6PD

deficiency that are easy to

use and meet specifications

to improve treatment of

patients with P. vivax malaria

and support elimination


SD Biosensor’s Standard

G6PD Test is a handheld

device that delivers results

in two minutes and provides

a quantitative measure of

G6PD activity, including in

heterozygous women. The

test uses a small sample of

blood, which is placed on a

disposable strip and inserted

into the reusable device, a

format similar to a blood

glucose meter that is easy

to use at the point of care

in low-resource settings.

It provides a quantitative

measurement of both G6PD

levels and total haemoglobin,

enabling health workers to

determine if radical cure

with an 8-aminoquinolinebased

drug is appropriate for


Funding to PATH to

support advancement of new

G6PD diagnostic tools has

been provided by

UKAid from the United

Kingdom Department for

International Development

and the Bill & Melinda Gates






The govt readies to roll out its most ambitious scheme to ensure universal

access to good-quality health care services: A Lowdown.


The much awaited and much

debated Ayushman Bharat

scheme of the incumbent central

government is soon going to be a

reality. The scheme aims to provide

comprehensive primary healthcare

to all through 1.5 lakh Health and

Wellness Centres (HCW) and the

National Health Protection

Scheme (NHPS) that offers

cashless, free and entitlementbased

health insurance cover

of Rs. 5 lakhs per annum per

family for most of the secondary

and tertiary inpatient care

needs of poor and economically

deprived sections. It plans to cover

10.5 cr families initially, with rural

beneficiaries comprising more than

80 percent of the total. The debates

around the scheme have covered

a wide range of issues, including

the financial prudence involved

in launching such a scheme, the

adequacy of the allocated budget,

the time of launch, preparedness

for a smooth and efficient

execution, the adequacy of

reimbursement tariffs

and finally, the quality

of care.

As we witness the

start of the scheme

and await the full launch


next month, here are some of the

things that need to be kept in mind:

Estimated budget for NHP

Immediately after the announcement of

the scheme in February, the CEO of Niti

Ayog mentioned a number of Rs 10,000

cr to Rs 11,000 cr as the estimated

cost of servicing NHP, while the CEO of

Ayushman Bharat indicated an amount

of Rs 20,000 cr to Rs 30,000 cr. An

ex-finance minister from the opposition

benches mentioned a number of “not

less than Rs 1.5 lakh crore” in Parliament.

Niti Ayog’s estimate is possible only

if 85 percent of the NHPS provision

happen through public facilities

(essentially valued at the marginal cost

of serving patients, with the fixed cost

of infrastructure, manpower, etc. to be

covered as part of the regular health

budget of the relevant departments).

The Ayog’s estimate also involves some

assumptions which are just not practical

in the short-to-medium term. The

estimate of Rs 1.5 lakh crore is also way

off the mark. As per an Ernst & Young

estimate, making provisions for possible

efficiencies of scale and a reasonable

mix of public-private consumption (50-

50) and plausible hospitalization rate

increase for the target segment, it is

possible to contain expenditure between

Rs 30,000 to Rs 35,000 crore.

Financial prudence

In a country where both the politicians

and the public have put up with

less than 25 percent of the budgets

for government schemes ultimately

reaching the intended beneficiary

and lakhs of crores being scammed

or siphoned off, I can either ignore

or view with sympathy --for the

demonstrated lack of compassion and

the state of schizophrenia -- anyone

who questions the financial prudence

of such a programme. The scheme

meets a serious need of the poor and

underprivileged, whose alternatives are

either to agonisingly suffer the pain

and agony of their self/ kins without







treatment or avail such services with a

consequence of devastating financial

implications, often leading to lifelong


Timing of launch

I have little doubt that the time of

the launch is predominantly guided

by political exigencies. I am sure the

planning and preparation will be better

if the implementation team gets another

year for a full-scale launch. But still, it

will not be perfect. In a country like ours,

with its accompanying complexities of

execution, the cost of certitude beyond

a certain point becomes prohibitive

when you consider that tens of millions

of people are pushed below the poverty

line every year owing to healthcare

costs. For the sheer tangible benefit

to those millions, it will be prudent to

launch with reasonable preparedness,

and correct/optimize the systems as

needed along the way.


It is critical that the planners have

chosen a top-down approach in

designing the programme with respect

to governance standards/processes

and a bottoms-up approach for coming

up with state-specific implementation

plans. While a central template must be

enforced for governance purposes, the

operational success of the programme

will be contingent upon customising

the programme to address the ground

conditions, which vary significantly from

state to state and even within the state.

This includes the availability of relevant

human resource, the maturity of private

providers, public health capability,

morbidity profile and the cost of care.

I am certain, the learned managers of

this programme are fully seized of this

matter, but I have a few other concerns:

HWC: What is of concern to me is that

there has been very little discussion

The number of people

expected to benefit

from the scheme

Each family is

entitled to get a

yearly insurance

cover of

Niti Ayog’s

estimated cost of

servicing NHPs

10.74 ₹5lakh ₹10,000cr



around the HWCs, perhaps because it

offers less glamour, politically speaking.

But they are the very foundation for

achieving the vision that drives the

AB programme, as 80 percent of the

intended beneficiaries are in rural

areas while 80 percent of the primary

care providers in rural India have no

medical qualification (World Bank-CPR

Report, 2003, J.Das, et al.) Unless HWCs

provide the much-needed filter -- as

gatekeepers and referral centers -- via

effective intervention at a preventive and

primary level, the programme will not

achieve its intended vision. This is a very

daunting task, but also a crucial one,

and I would expect the government to

set monthly targets for launching fully

operational HCWs and report on its

progress publicly.

Technology: It is imperative that a

complex programme like this depend

heavily on technology support for

effective execution, be it for process

efficiency, process integrity, fraud

prevention, optimization strategies

or customer feedback. It is unlikely

that the technology capabilities will

be fully deployed before a while, and

importantly, given the rural reach that

is planned. Therefore, it is crucial that

there is a robust plan for the interim and

a sustainable operational ecosystem for







carrying out technology operations in

the future.

Communication: My discussions with

the sections of the targeted population

reveal they have little understanding of

the programme, but I am certain, in an

election year, the establishment will not

miss out on outreach.

Patient safety and dignity

What I am most concerned about is

this: Given the state of public healthcare,

the extent of geographical coverage

needed in higher-tier towns, the

paucity of accredited hospital capacity,

the stretched reimbursement tariffs

underpinned by the general psychology

of low quality-consciousness for a “free”

service, ensuring minimum standards

of care and human dignity to the

beneficiaries will be most challenging.

There should be a carrot and stick

approach to tackle this, with incentives

for performance (like better tariffs,

easier cash-flow etc.) and a serious

penalty for critical non-performance.

Importantly, patient feedback should

be an important tool for assessing

the performance of the providers,

in addition to formal medical audits,

and such feedback should be sought

independently (not by the provider)

after discharge and outside the environs

of the provider. It should also be

available to the general public through a

portal, akin to a TripAdvisor.

Reimbursement tariff

Private sector players have expressed

their distress at the inadequacy of the

proposed tariff under this scheme. It

is understandable, as the estimates

are significantly lower than prevailing

market rates. But their reactions are

also based on an evaluation that

compares the viability of the proposed

tariffs within their prevalent business

model which is not designed for this

kind of mass service. I am certain

that private providers are innovative

enough to realign their model, and

will demonstrate a sense of social

solidarity to respond effectively to

this noble challenge. But what the

government must ensure, and will be

of great value to the providers, is strict

discipline in receivables settlement. I

would even suggest that 80 percent of

the bill should be immediately cleared

upon presentation (can be linked to

performance as well) and the remaining

within 21 days with automatic interest

eligibility for any delay.

Adoption by states

This issue is pretty much settled, with

most states, even the ones from

opposing political dispensations,

having already adopted the scheme.

This was inevitable as it is politically

disadvantageous to oppose the scheme

for its currency with the public and is

economically advantageous to the states

with their own health schemes.

The author has long-standing association

with EY India but the views are strictly






A new proposal aims to bring down hemoglobinopathies

through carrier screening and prenatal diagnosis in India


India’s health ministry has formulated

a draft policy proposing mandatory

genetic screening of all pregnant

women to bring down the prevalence of

genetic disorders like thalassemia and

sickle cell anaemia.

The draft policy, titled ‘For Prevention

and Control of Hemoglobinopathies

– Thalassemia, Sickle Cell Disease and

variant Hemoglobins In India’, also

includes a comprehensive plan for the

treatment and management of these


“This policy encompasses the public

health goals of providing the best

possible evidence-based treatment for

those affected, and reducing the birth

of affected children through carrier

screening and prenatal diagnosis,” the

draft states.

According to estimates, there are

almost 3.6 to 3.9 crore carriers of

ß-thalassemia in India, and about 10,000

to 15,000 babies with ß-thalassemia

major are born each year. For sickle cell

disease, there are about 25 lakh carriers

of the gene (Hemoglobin AS), and about

1.25 lakh patients of sickle cell disease.

A World Health Organization

document on Hemoglobin Disorders

states that most of the affected children

die in early childhood and most of

the survivors have chronic disease.

Worldwide, over 1% of couples are at risk

for haemoglobin disorders, out of whom

most have at least one affected child,

and most of the affected children die in

early childhood.

Gynaecologists across the country

have welcomed the government’s move.

“It is a very good proposal,” said

Dr Nita Thakre, an Ahmedabad-based

gynaecologist who specialises in

high-risk pregnancies. “Screening for

thalassemia and sickle cell anemia

should be among the standard prenatal

tests, along with HIV and HbSAg,” she

said. Dr Thakre said the government

should also ensure that the screening

test is either available for free or is priced

reasonably. Currently, the cost of the test

is approximately Rs 1,200.

While, the proposal targets pregnant

women, doctors feel that carriers

should be identified much earlier. “The

government should work on creating

awareness. As of now, even educated

people are not aware of these disorders

and if they are carriers,” said Dr Thakre.

Ideally, the prenatal tests should be done

to identify the status of both partners






because if 2 people with thalassemia

minor get married, they could have child

who has thalassemia major. “Those who

are found to be carriers need to be

counselled about the implications of the

condition,” she added.

The draft policy also talks of

putting in place advanced facilities for

comprehensive care of patients with

thalassemia and sickle cell anemia.

This includes providing medicines, iron

chelating agents, leukocyte filters and

infusion pumps

free of cost to poor

patients. “The policy

envisages creation of

centres of excellence

in states, which will have

advanced facilities required for

comprehensive care of patients

with thalassemia/sickle cell disease,

including a bone marrow transplant

unit and a prenatal diagnostic centre,”

the draft policy states.

The centres of excellence

will provide technical support for

thalassemia treatment in medical

colleges, tertiary care hospitals, districtlevel

health facilities and primary

health centres, as well as impart

training to health professionals. The

policy recommends the creation of a

hemoglobinopathy unit (clubbed with

hemophilia for logistic purposes) in

government medical colleges/tertiary

care facilities as well as district-level

hospitals to carry out therapy as well as

preventive activities.





Despite the fact that genomic data help measure the risk precisely, inherited

heart diseases remain largely neglected


Cardiovascular disease has been the largest cause of death

in India for several decades. Although high blood pressure

and the buildup of fat inside the artery walls, contributed

by unhealthy diet, smoking, obesity and stress, are still singled

out as key risk factors, recent studies flag a more serious alert

on the genetic side. These studies have proved that around

4.5% of South Asian population are naturally prone to heart

disease. The cause is inherited genetic mutation. Of this group,

at least 10% are carriers of the same mutation from both the

parents and therefore run the risk of sudden cardiac death at a

very young age.

So, think before prescribing a blood thinner and giving a pat

on the patient’s shoulder saying there is a “small congestion”

in the heart. Do a fact check on the medical history of the

patient’s family and you ought to find similar cases there,

either living with the disease or involving death at a young

or middle age. Go a little deeper, as such cases often need a

comprehensive evaluation.

The prevalence of inherited heart diseases have been high

in the country, but unfortunately it hasn’t got much attention

until now. In today’s genomic era, population mapping and

next-generation sequencing technologies are revealing the true

and scary picture. If these studies are to be believed, around 60

million Indians carry a monogenic mutation that is responsible

for serious cardiomyopathies, a frequent cause of sudden heart


MyBPC3-key villain

While at least 200 rare mutations affecting more than 20

different genes have been identified for heart disease, the

mutation associated with the gene MyBPC3 or the sarcomeric

gene is found to be the key factor that causes dilated

cardiomyopathy (DCM) and hypertrophic cardiomyopathy


The MyBPC3 gene that provides instructions for making

cardiac myosin binding protein C (cardiac MyBP-C) is found in

heart muscle cells or sarcomere. This cell structure,

which is the basic unit that helps heart muscle contraction,

are made up of thick and thin filaments. The overlapping thick

and thin filaments attach to each other and release, which

allows the filaments to move relatively to one another so that

muscles can contract with a regular rhythm to pump blood to

the body. MyBP-C also regulates the speed of cardiac muscle


Because individuals who have heritable cardiomyopathies

with MyBP-C defects have a disorganised sarcomeric structure

and late-onset symptoms, MYBPC3 has been identified for

increased risk of heart failure by either hypertrophic or dilated


Earlier studies had identified variant(s) in MyBPC3

associated with increased risk of heart failure by screening

“More than 1.5 billion

people in South Asia are

correctly viewed not as a

single large population,

but as many small

endogamous groups.

Dr K Thangaraj

Senior Principal Scientist, CCMP,


There are multiple challenges here.

First is the low awareness about

inherited heart diseases, the other

two are the cost and general

inertia in approaching these

cases in a comprehensive way,

Dr Hisham Ahmed

Consultant Cardiologist, AIMS Kochi




DNA samples from individuals with cardiomyopathies in India.

This was also established in various other studies with small

and large patient, postmortem cases and controlled healthy

individual groups.

A large-scale case-control study in India 2008, published

in Nature Genetics, had suggested that homozygous deletion

might be associated with a severe and sometimes early-onset

We started the first Cardiac

Risk in Young (CRY) clinic in

India in 2015. And now, we

are looking at novel genetic

variants involved in HCM

pathology specific to India.

Dr KM Cherian

Founder and Chairman,

Frontier Lifeline Hospital, Chennai

form of the disease, although it was found in normal individuals

as well.

In this study, which was done to assess the significance of

the 25-bp deletion by MyBPC mutation, taking 800 cases and

699 controls in two groups comprising 354 individuals with

cardiomyopathies (including 33 postmortem cases and 238

healthy controls matched for ancestry, age, sex and geography)

49 carried 25bp deletion, 46 as heterozygotes and three as

homozygotes. Two out of the three homozygotes died as

children younger than 3 years old owing to cardiomyopathies.

There were also much larger studies and surveys later

to prove the effect of genetic mutation resulting in recessive

diseases, including more focused studies on heart diseases. The

reason for such high prevalence of recessive diseases in the

South Asian population is the existence of a large number of

divided population groups in the form of ethnic communities,

caste groups etc. that marry only within their respective groups.

Hence, even the genetic mutations associated with recessive

diseases are passed on from one generation to the next as

both parents are frequently carriers of the defective version.

“More than 1.5 billion people in South Asia are correctly

viewed not as a single large population, but as many small

endogamous groups. We assembled genome-wide data



Genetics testing and inherited heart diseases

Professional bodies now recommend genetic testing for the management of

patients with genetic disease as well as at-risk members in the family


The last few decades have led

to the identification of the

genetic basis of a large number of

cardiovascular diseases. They include

dilated cardiomyopathy (DCM) and

hypertrophic cardiomyopathy (HCM)

with mutations related to the sarcomere

and structural genes, channelopathies

with mutations in ion channel genes,

arrhythmogenic cardiomyopathy with

mutations in desmosomal genes

and aortopathies with mutations in

genes encoding for connective tissue

elements. As a result, genetic testing

has taken on an important role in

managing families with the inherited

cardiovascular disease. Various

professional bodies have now included

the recommendation of genetic testing

for the management of patients with

the disease as well as at-risk members

in the family.

Why genetic testing in CVD?

1. Diagnostic genetic testing : This can

be performed to establish a specific

genetic diagnosis. For example, the

clinical phenotype may be shared

among different disease entities, each

with their own underlying cause,

prognosis and treatment. In patients

with left ventricular hypertrophy, genetic

testing will help in characterizing it as

sarcomeric HCM or an HCM phenocopy.

2. Predictive Genetic Testing : This is

done in apparently healthy relatives

to determine who has inherited the

causal variant in the family and is at

risk for developing the disease. The

majority of inherited cardiovascular

diseases exhibit autosomal dominant

inheritance pattern, with a 50 %

chance of transmission to the offspring.

This makes an evaluation of at risk




Dilated cardiomyopathy



Long QT syndrome


polymorphic ventricular


Major Genes or Gene

Families Analyzed





Effect on



Sarcomere gene 30 to >60 NA + Yes

Sarcomere and

cytoskeleton genes

(including TTN)

30-40 NA NA Yes

LMNA 90 Yes ++ Yes

Loeys-Dietz syndrome

Familial thoracic

aortic aneurysms and


Vascular Ehlers Danlos




TGFBRl/2, SMAD3, and


ACTA2, MYH11, and


70-90 Yes ++ Yes

20-25 NA ++ Yes

COL3A1 ~95 Yes ++ Yes



healthy family members an important

strategy. The aim of phenotypic and

genotypic family evaluations are to

identify individuals with the previously

unrecognized disease and currently

healthy family members who are at risk

for future disease development.

When to perform genetic testing?

All patients diagnosed with an inherited

Detection rates and clinical utility of diagnostic genetic testing

for selected inherited cardiovascular diseases

60-80 Yes ++ Yes




from over 2,800 individuals from over 260 distinct South

Asian groups. We identified 81 unique groups, 14 of which

had estimated census sizes of more than 1 million, that

descend from founder events,” says Dr K Thangaraj, Senior

Principal Scientist at Centre for Cellular and Molecular Biology,

Hyderabad, who led this large study in 2016.

Less medical attention

Even as the criticality of inherited heart diseases in India

is becoming more and more apparent, the local medical

community is yet to pay the required attention to the issue.

“There are multiple challenges here. While the first and the

most important issue is the low awareness about inherited

heart diseases, the other two are the cost and practical

The mutations

for different

cardiomyopathies have

been identified and

cataloging of mutations

on a phenotypic basis

is underway.

Dr. Shailesh Pande

Senior Medical Geneticist,



cardiovascular condition should

undergo a comprehensive evaluation

which includes a full phenotypic

assessment, a systematic family history

with at least a 3 generation pedigree

chart, genetic counseling and genetic


The typical scenarios in which

genetic testing may be done in

cardiovascular disease is given below :

1. High utility scenario: In this

situation, a definite diagnosis

along with familial inheritance pattern

will increase the pre-test probability

of identification of a disease-causing

variant. This can then be used for

predictive testing in other family


2. Intermediate utility scenario:

Certain inherited cardiovascular

diseases may exist without affected

relatives and may be due to recessive

inheritance, de novo mutations

or reduced penetrance. Genetic

testing in this group may be done

if it will make a difference to the

patient’s management and if other

members of the family would benefit

from predictive testing. It may be a

challenge to determine whether the

identified variant in this scenario is

indeed that disease causing variant,

especially since there is an absence of

a family history of the disease.

3. Low utility scenario: In these clinical

situations, genetic testing has a low

likelihood of a positive genetic test

result and should not be pursued.

For example, investigating a case of

sudden cardiac death in a family with

no living, affected individuals available

for testing and no genetic sample

available from affected descendants.

Another scenario in which genetic

testing is of low utility is when the

Genetic testing not performed or

results negative or inconclusive

(variant not definitively pathogenic

or of unknown significance)

Serial phenotypic evaluation of

at-risk first-degree relatives to

monitor for disease development

Serial phenotypic evaluation of

first-degree relatives of family

members found to be affected

during family evaluation

identified genetic variant is not a

reliable marker for the disease in


We have entered the genomic

era of cardiovascular disease. Genetic

testing constitutes a powerful tool in

the diagnosis of inherited cardiovascular

disease and identification of at-risk

family members. Genetic testing is now

becoming increasingly available and

the cardiovascular physician would

do well to familiarize himself with the

appropriate indications, interpretations

and related complexities of genetic

testing in cardiovascular disease.

Cardiovascular disease gene panels,

as well as whole exome sequencing

Flowchart of Family Evaluation and

Predictive Genetic Testing

Family proband diagnosed with inherited

cardiovascular disease

Diagnostic genetic testing

identified a pathogenic mutation

Predictive genetic testing in at-risk




At risk for disease


Serial phenotypic

evaluation to

monitor for disease




Not at increased

risk for disease


Dismiss from


screening (perform

evaluation if

clinical change


(via next-generation sequencing), have

established themselves as validated

methods of genetic testing. Integrating

the results of genetic testing will

definitely aid in the management and

risk stratification of the patient and

the patient’s family with the inherited

cardiovascular disease.

The author is Assistant

Professor, Project

Lead, Hypertrophic

Cardiomyopathy Registry

& Clinic, AIMS, Kochi.

difficulties in approaching these cases in a comprehensive

way, which is essential, in a traditional hospital set-up,” says Dr

Hisham Ahmed, the consultant cardiologist at Amrita Institute of

Medical Sciences and Research who was instrumental in setting

up the country’s first and only comprehensive hypotrophic

cardiomyopathy unit at Amrita Hospital in Kochi. The center

was set up in collaboration with world renowned HCM specialist

Dr Barry J Maron, with genetic diagnostics support from

Bangalore-based MedGenome.

According to India’s leading cardiac surgeon Dr KM Cherian,

hypertrophic cardiomyopathy (HCM) is one of the most

common inherited cardiomyopathies. The awareness of this

condition in India is limited and specialist clinics to treat this

condition are very few.

“We started the first Cardiac Risk in Young (CRY) clinic in

India in 2015. And now, we are looking at novel genetic variants

involved in HCM pathology specific to India,” Dr Cherian added.

Since it is a critical health issue in India, and at the same

time, less focused, some hospitals have volunteered dedicated

screening and treatment centres for inherited heart diseases,

aided by the advanced genomic tests that have emerged of


“Through CRY, we are providing comprehensive care for the

patients and their families affected by HCM and other forms of

inherited cardiomyopathies free of cost,” says Dr Cherian.

However, there are still very few institutions in India that

have a fully integrated care, including genetic screening, cardiac

imaging, interventional cardiology, cardiac electrophysiology,


heart failure team and specialised doctors who can handle

surgeries such as septal myectomy to treat obstructive

hypertrophic cardiomyopathy.

“There is also a general inertia among cardiac surgeons to

focus on septal myectomy as it is an extensive procedure with

comparatively less outcome,” said Dr Praveen Varma, Professor

and Head of the Department of Cardiovascular & Thoracic

Surgery at Amrita Institute of Medical Sciences and Research.

Genomic support

“We have known for long time that there are people out

there at high risk for disease based just on their overall

genetic variation,” says Dr Sekar Kathiresan, a well-known

physician scientist,a human geneticist and the director of the

Cardiovascular Disease Initiative at the Broad Institute and

The Center for Genomic Medicine at Massachusetts General


“Now, we are able to measure that risk using genomic data

in a meaningful way. From a public health perspective, we need

to identify these higher-risk segments of the population so we

can provide appropriate care,” Dr Kathiresan commented in an

August statement published on the website of Association of

American Universities related to a new test that helps identify

those at risk of five deadly diseases with a genetic component

in the world. Among these diseases were coronary artery

disease, breast cancer and type-2 diabetes.












Jammu Kashmir
















Tamil Nadu


West Bengal


Andhra Pradesh


Now, we are able to measure

that risk using genomic data

in a meaningful way. From

a public health perspective,

we need to identify these

higher-risk segments of

the population so we can

provide appropriate care,”

Dr Sekar Kathiresan

Director, CVD Initiative, Broad

Institute, and The Center for

Genomic Medicine at MGH.

Many of the cardiac disorders run in the family indicating

inherited genetic risk factors. Cardiac disorders can be a part

of syndrome or can be isolated one. Depending upon the

symptoms presentation, appropriate genetic testing can be

suggested. At Metropolis, the test range varies from routine

chromosomal karyotyping, FISH, Microarray to Next generation

sequencing (NGS) depending upon the symptoms and patient

Distribution of

the 25bp deletion

of MYBPC3 and

its frequency in

Indian states






Nort East



“In the era of NGS, mutations on

phenotypic basis are underway and are

expected to lead to new discoveries

that may translate to novel diagnostic,

prognostic and therapeutic targets for the

benefit of the patients,” said Dr. Shailesh

Pande, Senior Medical Geneticist &

Genetic Counsellor, Consultant-HOD, Dept.

of Medical Genetics, Metropolis Healthcare.

The mutations for different

cardiomyopathies have been identified

and cataloging of mutations on a

phenotypic basis is underway. These

efforts are expected to lead to new

discoveries that may translate to novel

diagnostic, prognostic and therapeutic

targets, Dr Pande added.

Meanwhile, new studies have

revealed that the instance of hypertrophic

cardiomayopathy in the world population

is much larger than what was known


“Earlier, the world average of HCM

cases was known to be one in every

500 and that has gone up to one in

every 200 people now. This could

probably be representative data for

India too, or may be it is more,” alerts

Dr Hisham Ahmed.





For a Healthy & Happy Heart

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Cardiac Gene Panel

Global Standards



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with interpretations

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NT-ProBNP | Troponin I | CK-MB | Myoglobin | LDH | CPK-Total & CK-MB | SGOT | Homocysteine

| D-Dimer | HsCRP | Cholesterol-Total | HDL | Non HDL | LDL | VLDL and Triglycerides | Lp(a)

| Apolipoprotein B/A1 ratio | Cardiac Gene Panel (NGS)

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National Accreditations Board For

Testing And Calibration Laboratories

cover story





Ground-breaking advances in percutaneous intervention tech are charting a new

course in cardiovascular medicine


Transcatheter procedures are taking centre-stage in

cardiovascular medicine as a less-invasive alternative

to open heart surgeries that involve splitting open the

rib cage to get access to the vital organ.

Replacement of heart valves via catheterisation leaves

a very small, often unrecognisable, scar at access points,

such as upper thighs, compared to deep sternal wounds in

traditional heart surgeries. Surgical replacement of aortic valve

accounts for about 10-15% of all sternotomy, experts say.

“There’s an explosion of technology happening in

interventional cardiology. Interventionists now have minimally

invasive options for many conventional surgeries, But the

traditional techniques of surgery take time to change,”

observes Dr Praveen Varma PK, Professor and Head of

the Department, Cardiovascular & Thoracic Surgery, Amrita

Institute of Medical Sciences (AIMS), Kochi.

What makes transcatheter procedures even more

attractive is the faster recovery time. The patient can leave

the hospital within just two days instead of a minimum of two

weeks of hospitalization, followed by months-long mandatory

rest, in the case of open surgery.

TAVR - The harbinger of change

Transaortic valve replacement or TAVR is one such procedure

gaining wide currency among cardiologists and patients


TAVR is considered a boon for patients suffering from

severe aortic stenosis (AS) with prohibitive surgical risk. Quite

often, aged patients with severe AS are turned away deeming

unfit for surgical aortic valve replacement (SAVR) citing frailty,

co-morbid conditions or a poorly functioning left ventricle as









Replacement valves

are either mechanial or

biological. A mechanical

valve is manmade

and lasts longer than

biological valves in most

cases, though mechanical

valve also require the

life long use of blood

thinners. Biological valves

are tissue valves that

come from animals, most

often from pigs and cows.

Biological valves lasts 10

to 20 years and usually

do not require long-tem





TAVR has already been established as the preferred

approach in patients facing a higher risk for SAVR,

supported by evidence generated from large, randomised

studies such as Placement of AoRTic TraNscathetER

Valve Trial using Sapien valve (Partner) and the CoreValve

US pivotal trials. Prospective randomised data from the

Partner B cohort studies demonstrated that TAVR is

superior to medical therapy in inoperable patients.

Clinical outcomes from trials in intermediate risk

patients using Sapien 3 valve (Partner IIS3i) indicated

significantly lower death rates. The occurrence of stroke

also fell drastically to 1% at 30 days in comparison with

4.4% in surgery patients over the same period.

Five-year follow-up data from Medtronic’s CoreValve

US pivotal NOTION (Nordic Aortic Valve Intervention Trial)

studies showed similar rates of all-cause mortality and

superior hemodynamic performance for TAVR compared

to surgery.

Rise and rise of TAVR

TAVR has made remarkable progress since it was started

in 2002. The procedure was originally approved for

transcatheter aortic valve replacement as an alternative

option to SAVR for patients with native aortic stenosis

whose risk of death or severe complications from

surgery is high. In 2016, the USFDA expanded the TAVR

indication for Sapien 3 transcatheter heart valve (THV)

to patients who are at intermediate surgical risk of death

or complications. Later, in 2017, the FDA again approved

an expanded use of Sapien 3, made by Edwards

Lifesciences LLC, as a valve-in-valve treatment. Valve-invalve

procedures offer an alternative to repeat surgery

since the replacement valve is inserted inside the failing

surgical bioprosthetic valve through a patient’s blood

vessel or a small cut in a patient’s chest.

In the US, TAVR took a big leap to nearly 40,000

procedures in 2017 from less than 5,000 cases five years

ago. Similarly, the centres registered for doing TAVR

There was one thing common between an 82-year-old

patient on ventilator and dialysis due to cardiogenic

shock, an 81-year-old cancer survivor in and out of the

intensive care unit due to recurrent cardiac decompensation,

a 65-year-old with previous coronary bypass on whom

surgeons had reservations against re-do sternotomy

and a 75-year-old with an aortic arch that reminded one

of calcified rock formations: They all had severe aortic

stenosis (AS), were denied life-saving surgical aortic valve

replacement (SAVR) citing high surgical risk, and they all

walked home after a smooth uncomplicated transcatheter

aortic valve replacement (TAVR

or TAVI).

TAVR can easily be

considered the most disruptive

medical innovation in

cardiovascular medicine after

coronary stents. The ability to

implant a 26 mm transcatheter

valve (THV) through a 6

mm suture-less skin incision,

without damaging the THV

structure is as fancy as it

sounds. Since its first human

use in the year 2002, TAVR has

been extensively scrutinized in

high-quality randomized clinical

Dr. Anoop Agrawal

trials across various patient

scenarios with a common final

conclusion: TAVR performed equal or better compared to

the standard of care. Hemodynamic performance of THV is

superior to a surgical valve. This, added to the fact that the

majority of patients with TAVR don’t require blood thinners,

makes it a very attractive choice. It is gratifying to be able to

offer a therapeutic option to patients with AS who otherwise

are left with no viable alternative if their surgical risk is high.

In the lower-than-extreme-surgical-risk subset, having an

option of minimally invasive therapy that is equal to, or

better than, conventional therapy empowers our patients to

make a well-informed decision.

While TAVR, for reasons mentioned above, may be







favored by many as the default

option for all AS patients, there are

a few obstacles to the widespread

adoption of TAVR. First, although

TAVR has a lower risk profile

compared to SAVR in intermediate

to extreme surgical risk patients;

the same cannot be said with

certainty for low surgical risk

patients. PARTNER 3 is an ongoing

large multi-center trial aimed to

study TAVR performance in low

surgical risk patients. Second, we

should be able to do better on

issues like a para-valvular leak

and the need for pacemaker

implantation. Third, the longevity

of THV has not been extensively

studied yet since early TAVR

implantation was performed on

patients in their 8th or 9th decade

of life.



More than 40,000

implants are being

performed in the United

States annually, and TAVR

volumes have surpassed

SAVR volumes in many

developed countries.

Severe AS




2012 2013 2014 2015 2016























About 4.5 lakh patients

with AS remain

untreated in india.


TAVR has taken the world by storm. Since its commercial

approval, more than 3 lakh implantations have been performed

worldwide. More than 40,000 implants are being performed in

the United States annually, and TAVR volumes have surpassed

SAVR volumes in many developed countries. The TAVR procedure

itself is highly efficient, thus improving the throughput of an

established center. A high volume center can easily perform 4-5

transcatheter aortic valve replacements within the daily working

hours, compared to 2 surgical procedures. Post-procedure care

is also less resource intensive, which allows efficient manpower

management. From a patient’s perspective, TAVR is a delight. The

majority of the patients get extubated on the operating table

itself, spend about 24-36 hours in intensive care, and another

24-48 hours on the general floor, with total hospital stay being

3-4 days. The majority are able to converse and take orally

within a few hours of the procedure and are able to walk the

next day. The skin incision is suture-less, which at times becomes

difficult to spot after a week of the procedure. The need for

physical rehabilitation is minimal since the total bed rest time is

very short, and unlike SAVR, there is no sternal wound to limit

patients’ activity.

The Indian experience with TAVR is restricted to a few centers

currently, with approximately 500 cases performed nationwide

since the first case in the year 2011. This slow start can be

attributed to a few factors. First, there is limited awareness

among both patients as well as physicians. Continued medical

education sessions can address part of this deficit. Second,

the expertise to perform TAVR is restricted to a few centers.

India does not have a training center for TAVR. Majority of the

physicians in India acquire the skill-set via workshops, simulators,

foreign observership, and/or learning on the job with a mentor.

A few physicians with dedicated TAVR training from the United

States or Europe have relocated to India.

Third, TAVR is cost prohibitive to the majority of the people

residing in India currently. A major portion of this cost is related

to THV and its support hardware. The procedure itself adds little

to the overall cost. As with any new device innovation, one can

expect the price of THV to come down in the next few years.

Notably, TAVR typically is not associated with high recurring cost

after the procedure, as the majority of the patients are put on

routine medications and require only general check-ups on follow


The landscape of cardiovascular medicine is changing. TAVR

has evolved to be one indispensable therapeutic option to

patients with AS.

The author is Consultant, Interventional Cardiology, CARE Hospitals,

Banjara Hills, Hyderabad

procedure in the US also grew five-fold during the same


TAVR is widely accepted by interventionists in the US and

a lot of them want to do the procedure, said Dr Tyrone J

Collins, Director of Interventional Cardiology, Ochsner Clinic,

New Orleans, USA. “I think most doctors would be willing to

do TAVR or send their patients for TAVR. But probably, if I had

to guess only 10% are actually doing it. It’s a small number.”

One of the major hurdles that come in the way of rapid

expansion of TAVR in the US is the set of norms set by the US

FDA for hospitals and physicians. The hospitals are required

to have a certain volume of valve surgery performed. And the

surgeons and cardiologists have to work together.

A team of physicians is required to perform the procedure,

Dr Collins added.

Heart Team: A multi-disciplinary approach

The European Union granted CE marking for Medtronics’


CoreValve system way back in 2007. Currently,

TAVR is performed in AS patients who are

at high risk with a logistic EuroScore of

more than 20%, as well as in those who are

contraindicated to surgery.

The recently published European guidelines

on valvular heart disease recognise the

achievements around TAVR. The guidance puts

the multi-disciplinary Heart Team -- comprising

cardiologists, cardiac surgeons, anaesthetists,

elderly specialists and non-medical cardiac

care specialists -- at the centre of the decision

process with regard to the choice of the

surgical/interventional treatment. These Heart

Teams are seen to operate best in Heart Valve

Centres, in which comprehensive diagnostic

and therapeutic options are provided to the

highest standards. The treatment provided in

these centres of excellence can be adjusted

to individual patient needs, which should

consequently improve results.

Unsurprisingly, the US and EU top the

chart for the number of TAVRs performed.

Some estimates show that TAVR outnumbered

surgical valve replacement in the US in 2016.

In India, TAVR is catching up with more

and more cardiologists and cardiac surgeons

coming forward to update themselves with the

new modality of treatment.

“The therapy is gaining momentum

exponentially due to many cardiologists and

surgeons wanting to adopt the therapy. But

expertise in the form of structurally trained

specialists in this therapy are a minority,”

opines Dr A B Gopalamurugan, Director

There was a dearth

of skilled vascular


in India, not

in coronary


But now, since

they are acquiring

peripheral vascular

skills in addition

to coronary skills,

the dearth is

becoming less

and less

Dr. N. N. Khanna,

Chairman of Asia Pacific

Vascular Society

for Cardiac Services, HeartTeam India, SIMS

Hospital, Chennai.

Skill-gap - A concern in India?

The majority of operators in India have not

gone through the training but perform these

procedures with the help of proctors. India

Valves Heart Team started by Heart Valve

Foundation of India, a national forum for

transcatheter valve therapy, is a dedicated

effort to impart structured training in this

discipline, Gopalamurugan explained.

Started in 2017, India Valves Heart Team

is a virtual heart team concept. It is a team

of skilled transcatheter valve therapy experts

on call, who will travel across India helping

physicians adopt the therapy in their own

place. The team can be contracted by any

centre with the amenities to deliver the TAVR

procedures and simultaneously train specialists.

The number of AS requiring valve

replacement is steadily on the rise in India.

Nearly one-third of severe AS cases diagnosed

go untreated.

According to Dr Gopalamurugan, there

are at least a thousand heart centres in India

having the basic infrastructure required for

TAVR, including a catheter laboratory and an

on-site cardiac surgery. But what is lacking

are the protocols, procedures and training

for TAVR sessions.

From coronary to peripheral

Not all the experts in the field, however,

seem to share the view that skill shortage

More transcatheter valves on the way

Thanks to the remarkable

success story of TAVR, trials are

underway to study the feasibility

of other catheter-based devices to

treat valvular heart problems.

In July, Abbott Labs started a

pivotal clinical study in the US for

its Tendyne Transcatheter Mitral

Valve Replacement (TMVR) system

for the treatment of mitral regurgitation

-- a condition characterised

by the backflow of blood caused

by the incomplete closure of the

valve. The study, called SUMMIT,

will enroll up to 1,010 patients at

80 sites in the US, EU and Canada

to evaluate the Tendyne TMVR

system. The device is a tri-leaflet,

bioprosthetic valve stabilized

by a pad and a tether mechanism

to be implanted inside the native


In addition to the US trial, Abbott

is planning a separate feasibility

study of the Tendyne system in

patients with severe mitral annular

calcification (MAC), a condition in

which calcium accumulates along

and beneath the mitral valve’s ringlike

structure that separates the

top and bottom chambers of the

left side of the heart.

Tendyne is currently under

clinical investigation in Europe.

Early data from a global study

showed a 97 percent implant

success rate with no

associated deaths or

strokes, according

to Abbott, which

also recently secured


from the US

FDA for a new

version of its transcatheter-clip-based


valve repairing system







Depending on

patient’s health

and the procedural


recommended by

doctor, the average

TAVR procedure lasts

approximately 1.5

hours. In comparison,

the average open

heart surgery lasts

approximately 4 hours.




Femoral artery is the

preferred and most

widespread access

site for TAVR. The

6mm skin incision is





TAVR is a rapidly evolving

therapeutic modality currently

available for patients with

severe aortic stenosis that are

unsuitable for surgery because

of technical or anatomical

issues or high estimated

surgical risk.



t’s very new and

“Iinvolves repairing

my leaky valve using

a clip device, without

open heart surgery” --

Mitra Clip captured the

world’s attention when

Elizabeth Taylor tweeted

these words in October


The late, veteran

Hollywood actress is one

of the early recipients

of this percutaneous

mitral valve repairing

device developed by

Abbott Labs to treat

degenerative mitral

valve regurgitation in

patients who do not

qualify for open heart


The MitraClip device is a

small metal clip covered

with a polyester fabric

that is implanted in the

mitral valve through a

guided catheter device.

The device stops the

reverse flow of the

blood by clipping

together a small area

of the mitral valve. The

valve continues to open

and close on either

side of the clip. This

allows blood to

flow on both sides

of the clip while

cutting down the

back-flow of blood

into the left atrium.

MitraClip does not

address the mitral

annulus nor the

problems with the

chordae tendinae.



TAVR doesn’t remove the old damanged valves.

It wedges the replacement valve into the aortic valve’s place.









Self-expanding valve

FRAME: Nitinol

LEAFLETS: Porcine pericardium

Balloon-expanded valve

FRAME: Cobalt-chromium stent

LEAFLETS: Bovine pericardium

Mechanical-expanded valve

FRAME: Nitinol

LEAFLETS: Bovine pericardium

Self-expanding valve

FRAME: Nitinol

LEAFLETS: Bovine pericardium









Transfemoral, transapical,

transaortic, subclavian

Partially Repositionable

FDA approval in January 2014

CE, IDE ongoing

Not Repositionable

USFDA approval 2015


CE mark approved, October 2013

FDA ongoing


CE mark approval in December

2013, FDA ongoing

is such a big problem in India today. “There was a dearth

of skilled vascular interventionists in India, not in coronary

interventionists. But now, since they are acquiring peripheral

vascular skills in addition to coronary skills, the dearth is

becoming less and less,” avers Dr. (Prof.) N.N. Khanna,

Coordinator of Cardiology, Cathlab & Vascular Services,

Indraprastha Apollo Hospitals, New Delhi & President of

International Society of Endovascular Specialists (ISEVS -

Indian Chapter).

Pointing out the huge turnout at the 10th Asia Pacific

Vascular Intervention Course (APVIC) that concluded recently

in New Delhi, Dr Khanna said the need for the interventionists

to get themselves acquainted with this technology is felt much

more today than in earlier days.

“Last year, APIC had 1,000 delegates and 50 international

faculties. This year it has gone up to 1,380 delegates and 82

international faculties. As far as the workshops are concerned,

they went from 8 last year to 18 for 10th APVIC,” adds Dr

Khanna, who is also the Chairman of Asia Pacific Vascular


Even though the acceptance level of TAVR is quite good

among Indian clinicians, it is not getting transformed into

practice. Less than 200 cases a year are done in the entire

country, when the need is almost 2 lakh procedures in a year.

The prime reason, according to him, is the cost. In India, a

TAVR procedure can cost around Rs 26 lakhs,whereas surgical

valve replacement costs only Rs 2.5 lakhs. In other words,


The increasing popularity of TAVR has led to the development of

a large variety of valves with varying features.

Company Device Leaflets Approach

Biotronik BioValve Porcine Arterial

Braile Biomedica Inovare Bovine Apical

Colibri Heart/ Venus Medtech Colibri Porcine Arterial

Direct Flow Medical Direct Flow Bovine Arterial

Hansen Medical AorTx Equine Both

HLT Medical Meridian Porcine Arterial

JenaValve Technology JenaValve Porcine Apical

Symetis Acurate neo Porcine Arterial

Symetis Acurate TA Porcine Apical

Thubrikar Aortic Valve, Inc. Optimum TAV Bovine Both

Transcatheter Technologies Trinity Bovine Apical

Venus MedTech Inc. Venus A Tissue Arterial

SOURCE: Vizient, Inc. 2017

TAVR is ten times costlier than SAVR.

The cost factor, however, is likely to improve in the future,

as was seen in the case of coronary stents and angioplasty.

Factors limiting TAVR spread

It is true that less-invasive transcatheter replacements are


‘Most doctors in the US

would be willing to do TAVI’

Dr. Tyrone J Collins is currently Director

of Interventional Cardiology, Ochsner

Clinic, and affiliated with Ochsner

Medical Foundation New Orleans,

Louisiana, USA. Dr. Collins graduated

from Meharry Medical College in 1979

and has been in practice for 39 years.

Dr. Collins also specializes in Cardiology

and Internal Medicine. Excerpts from his

conversation with FM

Do you think TAVR will replace

the conventional open heart valve

replacement surgery? If so, why?

No, I think TAVI (TAVR) will always be

an alternative to surgery for patients

in the US and all over the world. Most

patients get surgery. TAVI is an alternative

for patients at high risk. For moderate

risk patients, they can go for surgery or

TAVI. We really don’t know what is going

to happen for patients at low risk for

surgery. I would suspect that patients

with low risk will continue to have surgery

instead of TAVI unless we have evidence

that, in long term, TAVI valves will last as

long as surgery valves.

Currently, which are the heart valves

that can be replaced by trans-catheter


Right now, the majority of the patients

who undergo TAVI are getting their aortic

valves replaced. The pulmonary valve

can be placed in pediatric patients. The

replacement of other valves like tricuspid

Dr. Tyrone J Collins

and mitral valves is still under investigation.

What is the level of acceptance of TAVI

among the interventionists in the US?

It is widely accepted by the

interventionists in the US. A lot of

interventionists want to do TAVI. But there

are lots of reasons that TAVI is not available

in all the hospitals in the US. I think most

doctors would be willing to do TAVI or send

their patients for TAVI. But probably, if I had

to guess, only 10% are actually doing it. It’s a

small number.

As a procedure, can TAVI be used across

all sorts of patients with valve dysfunction

or is its use limited to patients who are not

fit to undergo an open heart surgery?

Certainly for patients who can undergo

open heart surgery, TAVI is an alternative

for them. TAVI has a spectrum of patients

that can get the valve. We don’t know how

long the TAVI valves last, because we have

not done it long enough to have that data.

Patients who are not at high surgical risk

can certainly have TAVI. We don’t know what

will happen to those who are at low surgical

risk. There are trials going on right now to

gather that information.

What are the possible risks with TAVI


The first thing that can happen with TAVI,

like any other operation, is that you can die.

There is a possibility of stroke; there is a

possibility of needing a pacemaker, bleeding

complications, infections. The usual and

the biggest concerns that we have with

most TAVI patients is whether they will be

needing a pacemaker or not.

TAVI is minimally invasive. It does not

involve anaesthesia or open surgery and

the recovery time is extremely short. Still,

it is yet to be widely available at Indian

hospitals? What could be the possible

reasons according to you?

The biggest drawback, I would anticipate

here in India, is the cost of the valves. A

valve costs probably over 30,000 US dollars

in India. Unless we develop a valve that

is not so expensive, I think its acceptance

worldwide will be low.



An indigenously


transcatheter heart valve

is currently under clinical

investigation in India.

Called MyVal, the balloon

expandable tri-leaflet

aortic valve is made of

bovine pericardial tissue.

Supported by nickelcobalt

alloy frame, MyVal

has a hybrid honeycomb

cell design as a unique

feature. The design

has open cells in the

upper half of the valve

to ensure un-jailing of

coronary ostia, while

closed cells in the lower

half contribute to radial


Developed by the

Vapi-based Meril Life

Sciences Pvt Ltd, MyVal

is designed in various

sizes starting from

20mm to 32mm.

Animal studies

using MyVal have been

completed in a porcine

model at the Skirball

Center for Cardiovascular

Research, New York.

As part of the

ongoing clinical

programme, MyVal

has been, recently,

implemented on a

74-year-old male patient

with severe aortic

stenosis who was at a

high risk of surgery at

GB Pant Hospital, New


The first year data

from the 100-patient

prospective, single arm,

multicentre, open-label

5-year study will be

available by 2018-2019.





Edwards Cardioband Tricuspid

Valve Reconstruction System

for the treatment of tricuspid

regurgitation has received CE

mark recently. The Cardioband

is the first commercially

available transcatheter therapy

for the treatment of tricuspid

heart valve disease, the

company said.

The Cardioband Tricuspid

System is delivered via a

transfemoral approach The

device is designed to reduce

tricuspid regurgitation through

annular reduction. It enables

precise positioning to a

patient’s specific anatomy

and real-time adjustment with

simultaneous confirmation of


The data from the TRI-

REPAIR CE Mark study with the

Cardioband Tricuspid System

demonstrated the device can

be an effective treatment

option for those with tricuspid


Edwards acquired the

Cardioband System from

Valtech Cardio in January 2017.

The Cardioband System is not

approved for commercial sale

in the US.

safer and hassle-free. They involve less trauma and the

patients need lesser time to recover. They also give outcomes

which are similar, if not better, to surgery as shown by

extensive clinical studies.

However, it remains to be seen whether transcatheter

valve replacements, especially TAVR, will become the standard

of care in place of surgery.

One of the major factors limiting the widespread adoption

of TAVR is the lack of data suggesting its feasibility in low-risk

patients. TAVR is currently approved for extremely high-risk

patients with severe AS who are inoperable. There is data

supporting the device’s use in the intermediate risk patient

population. Finally, there is not much clinical information

on the durability of these valves beyond 5 years of implant.

This is, partly, owing to the fact that TAVR is a comparatively

new procedure and most of the implantations are made in

patients who are either in their 80s or 90s. Larger, more

rigorous clinical trials like Partner 3 are currently underway to

gather evidence for the long-term durability of valves.

Likewise, TAVR too is associated with almost all the risk

factors associated with surgical replacement of aortic valves,

including stroke, bleeding complications, infections or even


Studies have estimated that approximately 4% of patients

experience a stroke within 30 days of a TAVR procedure.

Leaders in the field are now trying to bring in adjunctive

offerings to minimize the risks and improve TAVR patient

outcomes. Claret Medical’s neurovascular brain-protection

system Sentinel is an example.

The need for a permanent pacemaker after TAVR is

another major issue the interventionists are trying to tide

over. Irregular heartbeats due to conduction abnormalities

are higher in patients undergoing percutaneous valve

replacement than in surgery.

“The usual and the biggest concern that we have with

most TAVR patients is whether they will be needing a

pacemaker or not,” comments Dr T J Collins.

Permanent pacemaker implantation comes with short and

long-term risks.



Amplatzer Septal

Occluder is a selfexpanding,


device designed for closure

of atrial septal defects.

This minimally invasive

transcatheter closure is

the primary treatment

option for secundum atrial

septal defects (ASD).It is

designed to appose the

septal wall on each side

of the defect and create

a platform for tissue ingrowth

after implantation.

The device has two nitinol

mesh sections which

grasp septal wall on either

side of the defect. Nitinol

and interwoven polyester

promote occlusion and

tissue in-growth. Its selfcentering

waist fills the

defect. The device can

be easily recaptured and

redeployed for optimal


Pivotal trials

using Amplatzer

Septal Occluder

found the closure

rate at 6 months

defined as a shunt

less than or equal to

2 mm without the need for

surgical repair

The Amplatzer, the

first transcatheter septal

occluder on the U.S.

market, got the US FDA

approval 2001.

In October 2013, the

FDA issued a warning

that the device may

cause life-threatening

tissue erosion inside the

heart. The FDA received

more than 100 reports

of erosions associated

with the Amplatzer ASO

between 2002 and 2011.

Medical journals contained

articles reporting tissue

erosion among patients

implanted with this device.

These cases resulted in lifethreatening


that required immediate



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cover story



The Indian drug regulator granted approval to Impella heart pumps in July 2018

for use during high-risk percutaneous coronary intervention

Impella heart pump is a percutaneous

ventricular assist device to temporarily

aid the flow of blood while the patient

is undergoing an elective or urgent highrisk

percutaneous cardiac intervention (PCI)

procedure. This catheter mounted micro-axial

pump works on the principle of Archimedes’

Screw. With each rotation, the screw system

scoops a certain volume of blood from the left

ventricle and ejects it into ascending aorta. A

motor rotates the assembly at high speed leading

up to 5 litres of cardiac output, depending on

the type of Impella device used. The device

can be removed soon after the procedure.

However, it can be left in place if required

even after the procedure until the

functioning of the heart stabilises.

Currently, the device is available as

Impella 2.5, Impella LP 5.0, Impella LD,

Impella CP and Impella RP. All the versions,

except Impella RP, received pre-market

approval by the USFDA in 2016 for short-term

use (

The Indian drug regulator granted

approval to Impella 2.5, Impella 5.0 and

Impella CP in July 2018 for use during high-risk

percutaneous coronary intervention, cardiogenic

shock and other reduced-left-ventricular-function

conditions. The approval gains importance at a time

when India is witnessing an alarming increase in heart

disease cases and a proportionate increase in the number

of deaths due to cardiac ailments.

“Indian hospitals are commonly witnessing patients

with severe coronary artery disease and multiple

co-morbidities. While coronary intervention in such

patients is high risk, these patients have high mortality if

the disease is left untreated,” says Dr Anoop Agrawal,

Consultant Interventionist, CARE Hospitals, Banjara Hills,


Many such patients with complex diseases may benefit

from PCI using Impella heart pump. India has witnessed a

34% rise in death from cardiovascular causes in the past 26

years, he added.

Impella is getting increasingly accepted the world over.

Abiomed Inc, which makes the device, registered a jump of

42% in its worldwide revenues from Impella heart pump in

the fourth quarter of the financial year 2018 compared to

the previous year.

In India, a protected PCI procedure, including

atherectomy with Impella 2.5 support, was performed in

July at Fortis Escorts Heart Institute, New Delhi, probably for

the first time in the country.

According to Dr Agrawal, Impella’s enrollment is currently

limited to centres in Delhi and Jaipur. Apart from lack of

expertise and limited availability, early adoption of the

device could be restricted due to its high cost.

“Impella, as it stands currently, is cost-prohibitive for

the majority of the Indian population,” Dr Agrawal says.

“Impella increases the overall cost of a PCI multi-fold,

which, in a cost-sensitive Indian healthcare market, can

certainly be a point of contention, particularly since Impella

use in high-risk PCI has not conclusively shown to improve


There is a learning curve associated with Impella

implantation and its troubleshooting, particularly among

technicians and nurses.

Impella heart pump is the only percutaneous ventricular

assist device approved for a variety of cardiovascular

scenarios. This breakthrough device can be a powerful

addition to any cardiac catheterization laboratory

armamentarium. Whether it will find its place in Indian

healthcare market will largely depend on cost-effectivity as

well as local availability of device and clinical expertise, Dr

Agrawal pointed out.

The feasibility of Impella for use in ischemia-related

cardiac arrest, especially when cardiac intervention is

needed, is well established. But further clinical studies

are required to prove its routine use in cardiopulmonary

resuscitation (CPR) situations.













Boston Scientific

recently bought

out Claret Medical’s

neurovascular brainprotection


Sentinel to prevent

stroke risk associated

with TAVR in an upfront

deal of $220 million.

Sentinel reduced the

incidence of strokes by

63% within the first 72

hours of the procedure,

capturing debris flowing

toward the brain in

99% of TAVR cases

regardless of the type

of replacement valve,

according to the clinical

trial data provided by

the company.


cover story


Micra device is indicated to patients with high-grade atrioventricular block

Another transcatheter device that is making waves in

interventional cardiology is Micra pacemakers. Micra

is a small, single chamber, leadless transcatheter

pacing system delivered percutaneously directly into the

right ventricle.

The use of the device is indicated to patients with highgrade

atrioventricular (AV) block in the presence or absence

of atrial fibrillation (AF) as an alternative to dual chamber

pacing when atrial lead placement is considered difficult. It

is also approved for use in heart rhythm abnormalities like

bradycardia-tachycardia syndrome or sinus node dysfunction

(sinus bradycardia/sinus pauses).

“In India, the physician response has been enthusiastic

with more than180 implants that have happened across the

country, since launch,” says Abhishek Dubewar, Senior Director

of Cardiac and Vascular Group, Indian Subcontinent, Medtronic.

According to Medtronic data, more than 18,000 patients

across the world have been implanted Micra.

The unique feature of this device is its size. It is 93% smaller

than conventional pacemakers. Micra MC1VR01 is only 25.9 mm

long with a mass of 1.75 gm and an outer diameter of 6.7 mm.

The bipolar device has a nominal pacing cathode with a

steroid eluting electrode and minimum pacing anode. Two of

its four nitinol tines have 15 times the holding force necessary

to hold the device in place. The three-axis accelerometer in

Micra adjusts the heart rate automatically by sensing changes

in the body related to activity level. It has a proximal retrieval

feature as well to enable recovery of the device in critical


Since the device is placed in the heart via a vein in the leg,

it leaves no scar of a chest incision, or the bump that results

from conventional pacemakers. Micra is completely selfcontained

within the heart.

Data from a clinical study in 719 implanted patients with

average follow-up of 4.4 months showed that Micra provides

the same benefits as a traditional pacemaker to increase the

heart rate and help relieve the symptoms of bradycardia.

Primary, prespecified safety, effectiveness and long-term

performance studies have found that Micra implantations have

63% fewer major complications than traditional pacemakers.

“The advantage of Micra pacemaker is it eliminates

potential infections from the implantation site or from the

lead wires, as in conventional pacemakers,” says Dr Hisham

Ahamed, Consultant Interventional Cardiolgist, AIMS, Kochi.

However, a limiting factor with Micra is that it is a single

chamber pacemaker, pointed out Dr Ahamed. But trials are

ongoing using an experimental device which can work in

tandem with Micra while remaining in the adjacent chamber of

the heart.

The advantage of

Micra pacemaker

is it eliminates


infections from the

implantation site or

from the lead wires,

as in conventional


Dr Hisham Ahamed

Consultant Interventional

Cardiolgist, AIMS, Kochi.


fewer major


than traditional




success rate






infection rate

*SOURCE: Medtronic


cover story



In your view, what are the most important technologies

of late that has really revolutionized interventional

cardiology across the world?

Traditionally, surgical replacement was the gold standard

therapy for severe aortic and mitral valve diseases. But

with increasing survival, these conditions have become

more common in the elderly population with multiple other

comorbidities. Such patients are considered to be high

risk and inoperable. Catheter-based therapies have emerged

as a low-risk alternative for these patients with unmet clinical


Besides transcatheter aortic valve replacement (TAVR), the

other procedures that are rapidly upcoming are transcatheter

mitral valve repair/replacement (TMVR), transcatheter

pulmonary and tricuspid valve replacement (TPVR / TTVR), left

atrial appendage closure for stroke prevention and pulmonary

artery denervation for pulmonary hypertension.

The emergence of 3D and 4D imaging now allows

physicians to better visualize anatomical structures and

morphological anomalies and plan their surgery / transcatheter

therapies with more precision and less complications.

Personalised medicine, by way of genetic testing for

cardiomyopathy, is another major advancement.

World renowned cardiac

surgeon, Dr K M Cherian performed

India’s first successful coronary

artery bypass surgery in 1975.

Considered a pioneer in Indian

cardiac surgery, Dr Cherian made

his imprint by performing the first

heart-lung transplant, the first

paediatric transplant and the first

TMR (laser heart surgery) and

so on. The Founder Chairman

of Frontier Lifeline Hospital and

Frontier Mediville, Dr Cherian, who

was the first Indian to become the

President of the World Congress

of Thoracic Cardiac Surgeons and

the first member of the American

Association of Thoracic Surgery from

India, says that the key challenge

here to access new technologies and

devices is the cost. Edited excerpts

from an interview with FM.

How updated are Indian medical and healthcare

fraternity to leverage these advancements for the

benefit of the patients here?

The major limitation is the availability of access to newer

technologies/devices and the cost, as most of them are

currently imported and not made in India.

Current status of your key research projects aiming at

developing bioprosthetic valves using shark skin and the

light-weight artificial heart?

Left ventricular assist devices (LVAD) are used worldwide in

developed countries. The cost of these devices are prohibitively

high in India. It comes to around Rs.65 to 80 lakhs. We, in

collaboration with our Russian counterparts, are developing an

assist device called ‘Sputnik Heart’ which will be available at a

marginal / affordable cost to help patients with unmet clinical


Our team is undertaking preliminary research, looking at

the feasibility of using shark skin for bioprosthetic valves’ fabric.

The currently available bioprosthetic valves, which are made of

bovine or porcine pericardium, have a high failure rates after 8

to 10 years, especially in young patients due to calcification and

degeneration. There is good evidence to show shark skin has

good tensile strength and very low calcification and this might

be the best substitute to produce bioprosthetic valves.





Transcatheter heart valve therapy, a transformational life-saving procedure,

should be made available to all in need.


Transcatheter heart valves are

emerging as one of the rapidly

growing device markets globally.

Transcatheter Aortic Valve


Since the first Transcatheter Aortic Valve

Replacement (TAVR) in 2002 by Prof

Alain Cribier in Hospital Charles Nicolle at

the University of Rouen, the procedure

is now approved in more than 50

countries and more than 100,000

have been performed worldwide. The

majority have involved Edwards Sapien

and Medtronic Corevalve. In India, only

400+ procedures have been done

since the first trans-apical TAVR was

carried out by a team led by Dr Prashant

Vaijyanath andDr K M Cherian at Frontier

Lifeline Hospital, Chennai in 2010. This

is well below its potential. Globally, the

prevalence of AS is 2% in those over 65

years and 12% in those over 75 years.

Extrapolating this to the population of

India (about 1.3 billion), approximately









70 million will be over 65, out of which

around 300,000 will be eligible, and

require, TAVR for inoperable and severe


Transcatheter Pulmonary Valve

Replacement (TPVR)

With the growing population of adult

congenital heart disease patients, there

is the need for a less-invasive option for

replacing a narrowed RV to PA conduit

or significant restenosis or regurgitation

of a pulmonary artery conduit. Since the

first report of percutaneous pulmonary

valve replacement by Philip Bonheoffer

in 2000, more than 10,000 procedures

have been done worldwide, with the

majority using the Melody valve. But less

than 10 implants have been done in

India. With more and more congenital

heart disease patients who live to their


Transcatheter heart valve (THV) replacement has been

emerged as a life-saving alternative








high cost of

15 to 20


per valve




any health





low cost



Lack of





by international


for India (like

Melody valve)

Lack of

awareness: Low

referral rate

from primary/





made low cost




to cap the

THV device

prices (like the

coronary stent )


by central

and state





audit and


for THV



by the


bodies like CSI)



among primary

and secondary



conference /





THV procedures are expected to double from

the current numbers by 2021







Contributing factors

for THV spread





advances in




2021 2021 & BEYOND


adulthood needing RV to PA conduit

replacement for restenosis as well as

children who have already undergone

multiple heart surgeries developing

leaking or narrowed pulmonary valve,

there is a large group of patients who

will benefit from the less-invasive lifesaving

procedure. Despite this, large

players like Medtronic are not offering

their TPVR programmes in India, nor

are commercially available dedicated

transcatheter pulmonary valves available

in India.

Valve in Valve (THV)


Valve-in-valve transcatheter valve

replacement for a failed surgical

bioprosthetic valve (ViV) has emerged

as a low risk alternative for this category

of high risk re-do surgery patients. More

than 10,000 procedures have been

performed worldwide. Here too, India

is lagging behind with less than 20 ViV

done in total. One of the first ViVs in

India was implanted by a team led by

Dr Rajaram Anantharaman at Frontier

Lifeline Hospital. This is not due to a

dearth of patients. There is a large group

of young patients with rheumatic valve

disease (which is still prevalent in India)

who received surgical bioprosthetic valve

that are now failing, and require their

second or third surgery before they are

40 to 50 years old. They are among

those who can benefit the most from

low-risk ViV implants.

Low-cost heart valves

for Indian patients

Dr K M Cherian Heart Foundation has

been developing low-cost affordable

device solutions in the first SEZ in India

at Frontier Medivelle, Chennai. Some of

the them include decellularized bovine

and porcine pericardial patches and

bovine jugular vein conduits, which have

already helped a large group of patients

in need. A low-cost bioprosthetic valve is

also being developed in association with

Georgia Tech, USA, which is currently

in phase III study. Most recently, the

foundation is developing a low-cost

SOURCE: Edwards Lifesciences

Medtronic’s Melody TPVR

transcatheter valve for both aortic and

pulmonary positions in collaboration

with CSIR-NAL, who are pioneers in

developing nitinol-based self-expanding

devices. Let us hope that Prime Minister

Narendra Modi’s initiative of ‘Make in

India’, along with the government’s

new policies on devices, will help in

developing indigenous devices at

affordable cost to overcome the current

low implant rates via such life-saving

therapies for such no-option patients.

The author is Senior

Consultant Interventional

Cardiologist and Lead for

TAVR, Heart Transplant

and Cardiomyopathy C.R.Y

Clinic,Frontier Lifeline

Hospital, Dr K M Cherian

Heart Foundation, Chennai





DNB doctors are pinning their hope on the proposed NMC Bill as the SC rejects

the demand seeking absolute equivalence to MD/MS degree

With the union government

going ahead with its plan to

introduce the National Medical

Commission (NMC) bill to implement

drastic changes to medical education

in India -- including the replacement

of the Medical Council of India (MCI)

-- the demand for making Diplomate

of National Board (DNB) equivalent

to Doctor of Medicine (MD) has been


DNB is awarded by the National

Board of Examinations (NBE), an

autonomous body under the Ministry of

Health and Family Welfare, while MD/

MS degrees are offered by universities

affiliated to MCI.

The Association of National Board

Accredited Institutions (ANBAI), which

formed the All India DNB Alumni

Association in June this year to raise

the voice of DNB graduates, is at the

forefront of raising the demand. The

body recently submitted a Charter of

Demands to the PMO and Union Health

Minister J. P. Nadda on behalf of DNB

graduates in the country. The decision

to submit the Charter of Demands was

taken at the inaugural meeting of the All

India DNB Alumni Association, which was

held in Hyderabad in June.

When ANBAI officials met J.P.

Nadda with the demand of DNB-

MD equivalency in May this year, the

minister reportedly assured them









that DNB graduates would be given

equivalency to MD degree as per the

2012 Government of India (GOI) gazette

notification. “Government of India has

categorically said that DNB and MD are

equivalent. But some people are still

not ready to give equivalency, which is

against law. The government has agreed

to implement it stringently once they

introduce the new bill,” said Dr. Sunil

Sharma, Joint Secretary, ANBAI.

Follow the law: DNBs

The 2012 GOI gazette notified DNB

equivalence to MD for all those who have

undergone DNB training in institutions

which run MCI-recognized postgraduate

degree courses in a given subject and

those who have undergone training

in multi-specialty teaching hospitals

with at least 500 beds. The notification

proposed one additional year of senior

residency or equivalent training or

research job in an MCI-recognized

hospital or institution for others for

equivalency. But the gazette notification

issued by MCI in 2017 proposed DNB

equivalence only for those candidates

who have undergone training in

institutions which run MCI-recognized

postgraduate degree courses. The

National Board of Examinations regulates


almost 7,000 post graduate medical

seats, mainly in private hospitals.

When contacted, Dr. Alexander

Thomas, President, ANBAI, said, “The

GOI 2012 gazette notification stated that

both DNB and MD are equivalent. We

are asking the government to follow the


However, the Parliamentary Standing

Committee on Health and Family

Welfare recommended that ‘the DNB

qualification awarded by NBE shall be

equal in all respects to the postgraduate

degrees awarded by MCI, except in

relation to teaching in medical colleges.’

But ANBAI has been demanding

equivalence as per 2012 notification.

Dr. Sunil Sharma further said that by

establishing DNB-MD equivalency and

allowing DNB graduates to teach, more

specialist doctors can be created and

this in turn will contribute to the buildup

of healthcare sector in the country.

In a related development, another

representative body of DNB doctors

have filed an appeal to the Delhi High

Court seeking equivalence. ”The Delhi

High Court has already admitted our

case and the next hearing is slated

for October,” says Dr Jateen Ukrani,

President, Association of DNB Doctors.

The association is also lobbying with

the government simultaneously,

he added.

Eligibility rules are

binding: MCI

Medical Council of India (MCI),

on the other hand, makes it

clear that the revised norms

are not against DNBs teaching provided

they have secured the qualification

from a medical college where “teaching

and learning taking place for the same.”

Explaining the rationale for the

additional stipulation, MCI points to

the governing teachers’ eligibility

qualification regulation that prescribes

requirements for full-time teachers in

medical colleges.

“The stipulated conditions are

prescribed to evoke parity from the

point of view of the material fact

that what is incorporated in regular

MD/MS courses of three years duration

Eligibility for teaching--

The bone of contention

including the pedagogical skills which

are gained by the regular learners by

teaching the undergraduate students

in a medical college is missing with

reference to the DNB learners in places

other than medical colleges.,” according

to a response issued by Dr Jayshree

Mehta, President, MCI.

Since the eligibility so prescribed in

the regulation is binding in nature and

mandatory in character, they “are not

open for any waiver, condonation of

concession of any type.”

Setting and monitoring the

standards of medical education through

The ongoing controversy on DNB equivalence started

when the Medical Council of India (MCI) revised its

Minimum Qualifications for Teachers in Medical Institutions

Regulations in June 2017. The requirement now is that

doctors who have completed their DNB from institutions

not recognised by MCI, such as private hospitals,

need to complete three years of junior

residency and two years of senior residency, if

they wish to qualify for the post of an assistant

professor in a teaching institute. It implies that DNB doctors

need an additional five years of service experience if they

want to have a career in a medical college.

DNB doctors found the new norm a major impediment

to find a teaching job soon after qualifying for the diploma.

The new standards also cast doubts on the eligibility of

those DNB members who are already working as faculty.

DNB doctors maintain that teaching is an integral

aspect of their curriculum and the MCI has acted unilaterally

without consulting them or the health

ministry. The Ministry of Health has made it

clear that DNB is equivalent to MD/MS through

notifications. However, the MCI is continuing with its

policy, they allege.


the medical colleges in the country are

well under its ambit and jurisdiction of

the MCI as per the statutory mandate

vested with the regulatory body.

Single PG authority: Solution?

The raging debate hit a wall with the

Indian Supreme Court quashing a writ

petition seeking DNB-MD/MS parity filed

by Sankalp Association of DNB Doctors.

Experts propose the merger of DNB

with MD/MS/ MCh/DM as the only way

out to sort this issue out permanently

as India is the only country in the world

having parallel systems of PG degrees.

In the west also, medical education

is not restricted to medical colleges

and non-medical college hospitals also

contribute to the PG seats in huge

numbers, and they do not discriminate

between the degrees with separate


However, the clause proposing a

single post graduate degree from the

National Medical Commission (NMC) Bill

was dropped when the bill was tabled

in the Lok Sabha. The merger of the

Post-Graduation Board and the National

Board of Examination (NBE) was one of

the proposals in the draft version of the

NMC Bill, which was intended to overhaul

medical education in India by replacing

MCI. The PG Board, under the MCI,

awards MD/ MS degree to MBBS doctors,

while the NBE, under the Union Health

and Family Welfare ministry, awards DNB

(Diplomate of National Board).

Meanwhile, the Indian Medical

Association (IMA) has endorsed the

demands of DNB students and the DNB

Association for complete equivalence

and common nomenclature for Indian

PG students. In a letter to the Union

health minister, IMA said ”There has

been a long-pending demand of the

DNB students to have one authority and

hence merge the DNB course with the

MCI in a ”One Nation One Degree” policy...

This will also remove the dichotomy in

medical education with two parallel,

vertical institutions performing the same


Want of uniform training

There appears to be no major dissent

amongst the medical fraternity on DNB


The Government of India

notification dated 11th June 2012

states the bed requirement for

teaching units


post graduate

broad specialty


post graduate

super specialty

The Delhi High

Court has already

admitted our

case and the next

hearing is slated for


Dr Jateen Ukrani

President, Association of

DNB Doctors

holders’ demand for on-par status.”We

don’t consider our DNB colleagues

inferior or superior to us. There are

many DNBs in our association. We

don’t discriminate against them,” says

an ENT surgeon from Chennai. ”Still,

I can say the difference between a

specialist trained in a medical college

and a DNB is huge,” he adds, preferring


Currently, DNB training is not

uniform across the country. Most of the

students get away with theory marks.

They won’t get sufficient practical

exposure. After DNB, one year of

experience is required in a Medical

Council of India-recognised higher

learning centre. Sometimes, DNBs are

trained in some district or corporate

hospital. Theoretically, they may be


However, the majority of

hospitals are not equipped to offer a

comprehensive training programme for

PG students. The MCI has set certain

conditions, such as the number of outpatients

and in-patients for hospitals

attached to medical colleges offering

postgraduate qualifications. But that

stipulation is not there in DNB centres.

Some of the DNB training centres

may be smaller, but training and skillsets

vary in medical colleges as well,

and not just in DNB training centres,

others argue.

In another recent development,

the Post Graduate Committee of the

MCI rejected the proposal sent by

Devendra Fadnavis, Chief Minister,

Maharashtra, to the Health Ministry

for flexible conditions for starting

DNB courses in government medical

colleges. Fadnavis had proposed

simultaneous running of DNB courses

along with MD and MS courses

in government medical colleges

against extra faculty, if available. The

committee, after detailed discussion,

rejected the proposal citing that

PG seats require other facilities

like a certain number of beds and

infrastructure, apart from faculty. MCI

stated that if an institution has extra

faculty and all other facilities, they can

add more number of MD/MS seats

rather than requesting for DNB.


clinical trials



The study demonstrates 70% of patients with HER2 negative breast cancer

did not really benefit from chemotherapy

Senior oncologists in India

have strongly endorsed the

breakthrough finding of the Trial

Assigning Individualized Options for

Treatment (TAILORx) conducted by

United States National Cancer Institute

(NCI) and ECOG-ACRIN Cancer Research


The findings of the study,

which were published in the New

England Journal of Medicine in June,

demonstrated that the ‘Oncotype

DX Breast Recurrence Score’ test

definitively identified zero benefit from

chemotherapy in 70% of women with

early-stage breast cancer. It also found

that among the 30% who benefited,

chemotherapy could be life-saving.

“The study will have a practicechanging

impact on the medical

community with regard to prescribing

chemotherapy to breast cancer

patients. The Oncotype Dx test can

identify low-risk patients who may

safely avoid chemotherapy as well as

the high-risk patient who will benefit

by chemotherapy. Such personalized

treatment has the potential to decrease

the overall use of chemotherapy in

breast cancer,” remarked Dr. Vinay

Deshmane, surgical oncologist at P D

Hinduja Hospital and Breach Candy

Hospital, Mumbai.

The TAILORx study, the largest

ever breast cancer treatment trial,

was supported by the United States

National Cancer Institute (NCI), part of

the National Institutes of Health, and

designed and led by the ECOG-ACRIN

Cancer Research Group.

Breast cancer is the most common

cancer among women in India and

accounts for 27% of all cancers in

women. The incidence rate of 25.8 per

100,000 is lower in India than in some

developed countries, but the mortality

rate (12.7 per 100,000) is comparable

to that in western countries. Data on

incidence rates of breast cancer from

six major cancer registries in India show

that the annual percentage increase in

the incidence of breast cancer has been

in the 0.46 to 2.56% range.

The majority of breast cancer

patients diagnosed worldwide have

hormone-positive, HER2-negative,

node-negative cancer. The TAILORx

study definitively established that

chemotherapy may be spared in about

70 percent of these patients, including

all women older than 50 with Breast

Recurrence Score® results of 0 to 25 and

all women age 50 or younger

with Breast Recurrence Score results of

0 to 15.

Importantly, 30 percent of earlystage

breast cancer patients will

derive benefit from chemotherapy,

including women of any age with

Breast Recurrence Score results of 26

to 100, and in women younger than

50, where a modest (2 percent) benefit

from chemotherapy was observed with

Breast Recurrence Score results of 16

to 20, which gradually grew as scores

The study will

have a practice

changing impact

on the medical

community related

to prescribing


to breast cancer


Dr Vinay Deshmane

Surgical oncologist at

Breach Candy Hospital,




Breast cancer is the most common cancer in women in India and accounts for 27% of all cancers in women.

The study enrolled

10,253 women aged

18-75 years of age

with tumours from

1.1 to 5.0 cm in size

(or 0.6-1.0 cm and

intermediate or high

grade tumours).


The women

were divided into

different arms based

on their recurrence

score, as evaluated

using the Oncotype

DX 21-gene

expression assay,

which provides

a Recurrence

Score (RS) that

has been found

to be prognostic

for distant

recurrence, and

for low recurrence

with endocrine

therapy alone if

low (RS = 0 to 10),

and predictive of


benefit if high (RS =

26 or higher).

A total of 6711

evaluable women

had a mid-range

recurrence score of

11 to 25 and were

randomised to

receive endocrine

therapy alone, or

to the standard

treatment arm to

receive endocrine

therapy plus


Breast cancer has

ranked number

one cancer among

Indian females with

age adjusted rate

as high as 25.8 per

100,000 women

and mortality

12.7 per 100,000


OncoType DX not available

in India and samples

analysed in the US costs

about Rs 3 lakh.


Prevalence of HR

positive, HER2

negative and node

negative breast

cancers is around

25% total breast

cancer population

in India.

increased up to and above 25. This

important finding reveals a new level of

precision of chemotherapy benefit for

younger patients that only the Oncotype

DX® test can provide.

“The TAILORx findings can spare

thousands of women from getting

toxic chemotherapy treatment that

really wouldn’t benefit them. By

identifying the right patients who

can benefit from chemotherapy,

and sparing chemotherapy and its

toxic side effects in those who will

not benefit from it, the personalized

treatment approach is a breakthrough

advancement in the medical fraternity.

As the sole commercial representative

in India for Genomic Health, we hope

to bring changes in the standard of

care in India,” said Prasad Vaidya, CEO,

Medilinks Inc.

However, there are oncology

experts who do not fully support the

generalisation of the study finding and

its impact, especially in countries like


“Although the findings of TAILORx

trial gives an insight for judging low risk

patients and help avoid the pain and

toxicity of chemo for them, the situation

in India is not exactly comparable with


findings can

spare thousands

of women from

getting toxic


treatment that

really wouldn’t

benefit them.

Prasad Vaidya

CEO, Medilinks Inc

the West, where very early testing

(mammography etc.) for breast.cancer is

quite common. But, that is not the case

in India, where majority of patients come

for treatment at an advanced stage and

if a situation arises like the patient needs

chemotherapy even after doing a costly

Oncotype DX test (as it’s not available

here) it is a double whammy,” said Dr

Narayanankutty Warrier, Medical Director

at MVR Cancer Centre and Research

Institute, Kozhikode.

The trial enrolled 10,273 women

with breast cancer from 6 countries

across the globe. It used the Oncotype

DX Breast Recurrence Score test

that assesses the expression of 21

genes associated with breast cancer

recurrence. The score is used to assign

women with early-stage, HR- positive,

HER2-negative, axillary lymph node–

negative breast cancer to the most

appropriate and effective post-operative


TAILORx participants with Breast

Recurrence Score results from 0 to 10

were treated with endocrine therapy

alone, based on prior results from the

NSABP B-20 study, which showed no

opportunity for chemotherapy benefit.

TAILORx participants with Breast


Recurrence Score results from 26 to 100

were treated with chemotherapy plus

endocrine therapy based on the prior

results from the NSABP B-20 study,

which showed an absolute benefit of

chemotherapy greater than 20 percent.

To more precisely define the effect

of chemotherapy for women considered

to be at intermediate risk for recurrence,

6,711 women with Oncotype DX Breast

Recurrence Score results of 11 to 25,

the primary study group in TAILORx,

were randomized to receive endocrine

therapy with or without chemotherapy.

These randomized patients comprised

two-thirds of all patients enrolled in

TAILORx and were followed by the

investigators for approximately nine

years on average.

Dr. Mandar Nadkarni, Oncosurgeon

at Kokilaben Dhirubhai Ambani

Hospital,Mumbai, commented, “This

is a landmark study in the field of

breast cancer management. Results

of the study will have a major impact

on practising physicians and breast

cancer patients. Previously, the majority

of breast cancer patients all over the

world were recommended to receive

chemotherapy after surgery with lots

of side effects, affecting the quality of

life of patients. For long, doctors and

patients both have wished to have

a reliable tool that will help identify

patients who need chemotherapy

and spare the others who would not

benefit much by this treatment, thereby

individualizing patient therapy instead of

generalising it.’’

Dr. Suresh Advani, renowned

Oncologist and Padma Bhushan

recipient, concluded: “Today,

personalized medicine has allowed us to

avoid chemotherapy for certain group of

patients. We can select the people who

don’t need chemo and administer it to

only those who need it.”

Currently, MammaTyper is the only

test performed for measuring breast

cancer gene expression in order to

predict Oncotype DX-type results within

India. This test offered by Mumbai-based

diagnostics lab Metropolis Healthcare

at its Global Reference Laboratory in

Mumbai. Since other players in this

space get the test conducted abroad

It may not be a fair

comparison in India,

where majority of

patients come for

treatment at an advanced

stage and if a situation

arises like the patient

needs chemotherapy

even after doing a costly

Oncotype DX test it is a

double whammy.

Dr Narayanankutty


Medical Director, MVR Cancer

Centre and Research Institute,


MammaTyper is

a cost-effective

method to identify

low-risk patients at

the current set-up in


Dr Kirti Chadha

Vice President,


(Europe or the US) by sending out the

samples, it often adds to the cost and

time consumed for the results.

According to Dr Kirti Chadha, Vice

President, Oncomet - the Integrated

Oncopathology division of Metropolis

Healthcare, MammaTyper, which is a

CE-IVD marked assay, does subtyping for

prognosis of breast cancer suggesting

that endocrine therapy may be

adequate for patients with a low risk

of relapse. “Thus, it is a cost-effective

method to identify low-risk patients

at the current set-up in India,”

she added.

MammaTyper, which is offered by

Metropolis in India through a technology

collaboration with BioNTech Diagnostics

GmbH, Germany, allows precise,

quantitative measurement of the mRNA

expression of the ERBB2 (HER2), ESR1

(ER), PGR (PR) and MKI67 (proliferation

marker Ki-67) biomarkers, which in turn

facilitates molecular subtyping of tumor

tissue according to St. Gallen guidelines,

according to leading oncologists.

They agree that this test provides

molecular stratification of breast cancer,

information which is required for the

selection of effective therapy tailored

to each patient. Since quantitative

measurement of the expression levels

of the four St. Gallen biomarkers is a

much better predictor of Oncotype DX

Recurrence Score (RS) results than using

traditional IHC or FISH methods. It also

helps physicians avoid over treating

certain patient groups, thus sparing

patients from additional rounds of

debilitating chemotherapy, says Dr N K

Warrier, Medical Director at MVR Cancer

Centre & Research Institute, Kozhikode.

According to the Union health

ministry, breast cancer ranks as the

number one cancer among Indian

females with rate as high as 25.8 per

100,000 women and mortality of

12.7 per 100,000 women. For women

diagnosed during 2010-14, five-year

survival for breast cancer is now 89.5%

in Australia and 90.2% in the USA, but

international differences remain very

wide, with levels as low as 66.1% in

India according to the study titled Global

surveillance of trends in cancer survival




the next generation of electrochemotherapy

The IQWave TM represents the next generation of electrochemotherapy with its effective and flexible treatment

capabilities. It has been developed to achieve positive clinical outcomes on a level that was not possible in the past.

Potent treatment

The IQWave TM system enhances the effects of the chemotherapeutic

substance by opening up small pores in the

tumour cells, allowing the injected chemotherapeutic

substance direct access to the DNA of the targeted cells.

Combined with the coagulation effect created by the high

voltage electric field the cancer cells go into rapid necrosis.

Since electrochemotherapy normally can be performed under

local anaesthesia and light sedation, it is rather painless as well

time efficient. A complete treatment only takes 15 - 25 mins.


The current protocol for electrochemotherapy was established

in 2006 by the ESOPE* study. The current indications for

treatment with electrochemotherapy are.

• Head and neck squamous cell carcinoma

• Malignant melanoma

• Basal cell carcinoma

• Adenocarcinoma of the breast and salivary gland

• Hypernephroma

• Kaposi sarcoma

• Transitional cell carcinoma

*European Standard Operating Procedures of Electrochemotherapy


Scandinavian ChemoTech AB, Baltzarsgatan 25, 211 36 Malmö, Sweden. Email : | M +91-7977791436 •

drug approvals

First siRNA drug to

treat nerve disease

Alnylam Pharmaceuticals, Inc

announced that the US FDA

approved patisiran (Onpattro)

infusion for the treatment of

polyneuropathy caused by

hereditary transthyretin-mediated

amyloidosis (hATTR) in adult


This is the first FDA-approved

treatment for patients with

polyneuropathy caused by hATTR,

a rare, debilitating and often fatal

genetic disease characterized by

the buildup of abnormal amyloid

protein in peripheral nerves, the

heart, and other organs.

It is also the first FDA approval

of a new class of drugs called small

interfering ribonucleic acid (siRNA)


siRNAs work by silencing a

portion of the RNA involved in

causing the disease.

Patisiran encases the siRNA

into a lipid nanoparticle to deliver

the drug directly into the liver, in an

infusion treatment, to alter or halt

the production of disease-causing


Patisiran is designed to

interfere with RNA production

of an abnormal form of protein

transthyretin (TTR). By preventing

the production of TTR, the drug

can help reduce the accumulation

of amyloid deposits in peripheral

nerves, improving symptoms and

helping patients better manage the


Tagrisso to treat

NSCLC in India

The Drug Controller General

of India granted import

and market permission

for osimertinib (Tagrisso)

tablet with 40 mg and 80

mg strengths as a firstline

treatment for EGFRm

advanced non-small cell lung

cancer (NSCLC).

The receipt of this

permission paves the way

for the launch of osimertinib

in India, said AstraZeneca

Pharma India Limited .

Osimertinib is indicated

for the first-line treatment of

patients with locally advanced

or metastatic non-small cell

lung cancer whose tumours

have epidermal growth factor

receptor (EGFR) exon 19

deletions or exon 21 (L858R)

substitution mutations.

Osimertinib is already

approved and available for

the treatment of patients

with metastatic EGFR T790M

mutation-positive NSCLC, as

detected by an appropriate

test, whose disease has

progressed on or after EGFR

tyrosine kinase inhibitor (TKI)


In 2017, osimertinib

was granted ‘Breakthrough

Therapy’ status and ‘Priority

Review’ designations by the

US FDA in 1st line treatment


New treatment

regimen for

Eylea in EU

The European Commission

has approved a new

treatment approach for

aflibercept (Eylea) to enable

clinicians to combine proactive

treatment with early extension

of the injection interval for

patients with neovascular agerelated

macular degeneration


The new regimen allows

clinicians already in the first

year of treatment to extend

patients’ individual injection

intervals based on visual and/

or anatomic outcomes.

The new approach is

based on results from the

ALTAIR study, in which, after

52 weeks, 57% of the patients

had their next regularly

scheduled Eylea injection at an

interval of 12 weeks or more.

Treatment intervals up to 16

weeks between injections

have been studied.

Patients participating

in the study gained an

average of up to 9.0 letters,

including 50% of participants

who gained 10 or more

letters of vision at week

52, as measured on the

Early Treatment Diabetic

Retinopathy Study (ETDRS)

eye chart. These results were

largely maintained during the

second year, demonstrating

the sustainability of this

proactive approach.

Eylea has been approved

in the majority of countries

to treat patients with five

indications: neovascular AMD

(wet AMD), visual impairment

due to diabetic macular


edema (DME), retinal vein

occlusion (RVO; branch RVO

or central RVO) and myopic

choroidal neovascularization.


elagolix for



The US FDA gave clearance

to elagolix (Orilissa), an

oral gonadotropin-releasing

hormone (GnRH) antagonist

for women with severe

endometriosis pain.

This nonpeptide small

molecule drug inhibits

endogenous GnRH signaling

by binding competitively to

GnRH receptors in the pituitary

gland. The administration

of the drug results in dosedependent

suppression of

luteinizing hormone (LH) and

follicle-stimulating hormone

(FSH), leading to decreased

blood concentrations of

ovarian sex hormones,

estradiol and progesterone

Approved under priority

review, Orilissa is the first

oral treatment for the

management of moderate to

severe pain associated with

endometriosis in over

a decade and is expected

to be available in the U.S.

retail pharmacies in early

August 2018.


pain is often managed with

medicines such as oral

contraceptives, NSAIDs,

opioids and hormonal

therapies, which can work for

some women, but very few are

specifically indicated for the

treatment of endometriosis.

In more extensive cases,

surgical interventions are often

pursued, and may not be

curative for all individuals.

The approval is supported

by data from two replicate

studies in the largest

endometriosis Phase 3 study

programme conducted to

date, which evaluated nearly

1,700 women with moderate

to severe endometriosis

pain, announced AbbVie and

Neurocrine Biosciences in a

press release.

The recommended

duration of use for Orilissa is

up to 24 months for the 150

mg once-daily dose and up

to six months for the 200 mg

twice daily dose, as it causes a

dose-dependent decrease in

bone mineral density (BMD).



injectable for


The USFDA has approved

Perseris, a once-monthly

subcutaneous risperidonecontaining,


injectable for the treatment of

schizophrenia in adults.

Clinically relevant levels

were reached after the first

injection of Perseris without

use of a loading dose or any

supplemental oral risperidone,

according to Indivior PLC, the

maker of the drug.

Risperidone is a wellestablished

treatment for

schizophrenia, and uses

the extended-release

delivery system to form a

subcutaneous depot that

provides sustained levels of

risperidone over one month.

Initial peak risperidone plasma

levels occur within 4 to 6

hours of dosing and are due

to an initial release of the drug

during the depot formation


The efficacy of Perseris

was evaluated in a pivotal

Phase 3 randomized, doubleblind,


8-week study of 354 patients.

The safety of Perseris

was evaluated in 814 adults

Reusable contraceptive ring

for yearlong use

The US Food and

Drug Administration

approved segesterone

acetate and ethinyl

estradiol vaginal system

(Annovera), the first

vaginal ring contraceptive

that can be used for an

entire year.

Annovera is a

combined hormonal

contraceptive for women

of reproductive age used

to prevent pregnancy. The

donut-shaped reusable

ring is non-biodegradable,

a flexible vaginal system

that is placed in the vagina

for three weeks followed

by one week out of the

vagina, at which time

women may experience

a withdrawal bleed. This

schedule is repeated every

four weeks for one year

(thirteen 28-day menstrual


Annovera is washed

and stored in a compact

case for the seven days

not in use. It does not

require refrigeration

prior to dispensing and

can withstand storage

with schizophrenia. A total

of 322 patients were treated

with Perseris for at least six

months, with 234 of those

treated for at least 12 months.

The systemic safety profile of

the drug was consistent with

the known safety profile of

oral risperidone.

The most common

temperatures up to 30°C


The efficacy and safety

of Annovera were studied

in three, open-label clinical

trials with healthy women

ranging from 18 to 40

years of age. Based on the

results, about two to four

women out of 100 women

may get pregnant during

the first year they use


Annovera carries a

boxed warning relating

to cigarette smoking and

serious cardiovascular

events. Women over 35

who smoke should not

use Annovera. Cigarette

smoking increases the risk

of serious cardiovascular

events from hormonal

contraceptive use.

The marketing

approval of Annovera

was granted to The

Population Council, Inc.

The Population Council,

through its distribution

partner TherapeuticsMD,

currently expects to make

Annovera fully available in

late 2019 or early 2020.


systemic adverse reactions

in the pivotal Phase 3 trial

were increased weight,

sedation/somnolence and

musculoskeletal pain.


to treat 2 non-




(Poteligeo) injection

for the treatment of adult

patients with relapsed or

refractory mycosis fungoides

(MF) or Sézary syndrome (SS)

has been approved for sale in

the US.

This approval provides

a new treatment option for

patients with MF and is the

first FDA approval of a drug

specifically for SS.

Developed by Kyowa Kirin,

Inc., mogamulizumab-kpkc is

a monoclonal antibody that

binds to a protein (called CC

chemokine receptor type 4 or

CCR4) found on some cancer


The approval was based

on a clinical trial of 372

patients with relapsed MF

or SS who received either

mogamulizumab-kpkc or a

type of chemotherapy called

vorinostat. Progressionfree

survival was longer for

patients taking Poteligeo

(median 7.6 months)

compared to patients taking


The FDA granted


application Priority Review

and Breakthrough Therapy

designation. It also received

Orphan Drug designation.

FDA panel backs


for pneumonia

The Antimicrobials Drug

Advisory Committee of

the USFDA voted in favour of

the approval of omadacycline

for the treatment of acute

bacterial skin structure

infections and communityacquired

bacterial pneumonia,

Paratek Pharmaceuticals, Inc.


Omadacycline is a

modernized tetracycline being

developed as a once-daily

IV and oral, broad spectrum

antibiotic for the treatment of

serious community-acquired


is specifically designed

to overcome tetracycline

resistance and exhibits activity

across a broad spectrum of

bacteria, including Grampositive,


anaerobes, atypical bacteria,

and other drug-resistant


The advisory committee

considered data from

the omadacycline global

development programme,

which included three

completed Phase 3 studies

evaluating the safety and

efficacy of the IV and oral

formulations of omadacycline

for the treatment of acute

bacterial skin and skin

structure infections (ABSSSI),

and community-acquired

bacterial pneumonia

(CABP). In all three studies,

omadacycline met all primary

and secondary efficacy

outcomes designated by the

FDA and was generally safe

and well-tolerated.

Under a research

agreement with the U.S.

Department of Defense,

omadacycline is also being

studied against pathogenic

agents causing infectious

diseases of public health

and biodefense importance,

including plague and anthrax.

Radio drug

Azedra for

adrenal tumours

Iobenguane I 131

(Azedra) injection for the

treatment of patients with

pheochromocytoma or

paraganglioma has been

approved for sale in US.

Azedra is the first US FDA

approved drug for adults

and adolescents of age

12 and older with the rare

adrenal tumours that cannot

be surgically removed, have

spread beyond the original

tumour site and require

systemic anticancer therapy.

The efficacy of Azedra

was shown in a single-arm,

open-label, clinical trial in 68

patients, which measured

the number of patients who

experienced a 50 percent

or greater reduction of all

antihypertensive medications

lasting for at least six months.

A radioactive therapeutic

agent, Azedra includes a

warning about radiation

exposure to patients and

family members, which should

be minimized while the

patient is receiving Azedra.

The risk of radiation exposure

is greater in pediatric patients.

Azedra, manufactured by

Progenics Pharmaceuticals

Inc, received Orphan Drug


Tafenoquine for radical cure of P. vivax malaria

The US FDA granted approval for

single-dose tafenoquine (Krintafel)

for the radical cure of Plasmodium vivax

malaria in patients aged 16 years and

older, GSK and Medicines for Malaria

Venture (MMV) said.

Tafenoquine is the first new

treatment for P. vivax malaria in over 60


Tafenoquine is an 8-aminoquinoline

derivative with activity against all

stages of the P. vivax lifecycle, including


It was first synthesised by scientists

at the Walter Reed Army Institute of

Research in 1978.

In 2008, GSK entered into a

collaboration with the not-for-profit drug

research partnership, MMV, to develop

tafenoquine as an anti-relapse medicine

for patients infected with P. vivax.

The approval was based on efficacy

and safety data from a comprehensive

global clinical development P. vivax

radical cure programme designed

in agreement with the FDA. Thirteen

studies in healthy volunteers and

patients directly supported the

programme. The primary evidence for

the clinical efficacy and safety of the

300mg single-dose, to which more

than 800 subjects were exposed,

was provided by three randomised,

double-blind studies: DETECTIVE Part

1 and Part 2 (TAF112582) and GATHER





SEP 30 th - OCT 2 nd , 2018



The 2018 NextGen Genomics, Biology, Bioinformatics and Technologies (NGBT) Conference

is an international meeting organized by SciGenom Research Foundation (SGRF), a

not-for-profit organization working to promote Science, Research & Education. The

conference will also focus on convergence of clinical and genomic technologies for better

healthcare outcomes.

Key topics include:

Clinical genomics

Cell free DNA

Exome Sequencing

Genome sequencing

Human genomics

Liquid Biopsy

Medical Genomics

Non-Invasive testing



Protein engineering

Protein structure

RNA-Seq Sequencing

SNP Analysis

Whole Genome Sequencin

Live and Let Live:

Snakebite Cure


Oct 1 st 2018, Jaipur, India

Genomics Project Grants

Student Meeting Scholarships

Travel Awards

20 keynote lectures; 50+ talks

1000 delegates; 200+ posters

Vendor Exhibition


Sponsors Knowledge Partner & Poster prize sponsors Media Partners

Ms. Lakshmi V | M: +91-9591506568 / Mr. Srijith VM | M: +91- 9497118365 | |




Stem Cell Therapy:

A Risky Resource?

Patients should be warned about dangers of unapproved,

unproven therapies offered by unscrupulous clinicians


Writer is a consultant

on clinical research &

development from


Stem cells, the foundation of every

organ and tissue in human beings,

have evolved as a novel therapy since

the first bone marrow transplantation

of 1957. Stem cells are defined by two


They can self-renew, i.e., make copies of


They can differentiate, i.e., develop into

more specialized cells

Some of the common types of stem cells

are: 1) Embryonic stem cells, which are called

pluripotent, as they can generate every cell

type in a fully formed body except those

of the placenta and the umbilical cord. 2)

Tissue-specific stem cells are those that can

generate cells for specific tissues or organs,

e.g., hematopoietic cells 3) Mesenchymal

stem cells isolated from stroma - the

connective tissue that surrounds other tissues

and organs 4) Induced pluripotent stem

cells engineered in the lab by converting

tissue-specific cells into cells that behave like

embryonic stem cells.

Autologous stem cell transplantation is

a procedure in which blood-forming stem

cells are removed, stored, and later given

back to the same person. Allogeneic stem

cell transplantation is a procedure in which

a person receives blood-forming stem cells

from a genetically similar, but not identical,


Stem cell therapy has the potential

to repair, restore, replace and regenerate

cells, leading to a wide range of potential

applications – bone marrow transplant,

Alzheimer’s, Parkinson’s, spinal injury,

muscular dystrophy, amyotrophic lateral

sclerosis, stroke, myocardial infarction, cancer,

macular degeneration retinitis pigmentosa,

diabetes mellitus, osteoarthritis, rheumatoid

arthritis, chronic wound healing, Crohn’s

disease etc.. Although 10 stem cell treatments

have been approved by international

regulatory authorities, only bone marrow

transplantation is widely used.

Most stem cell research is still

experimental with limited clinical success

because of uncertainty about its benefits

and risks. Small, uncontrolled, and a few

well-controlled clinical trials have not

demonstrated effectiveness of stem cell

therapy in well-researched indications such

as heart failure and graft-versus-host disease.

Recently, PreSERVE-AMI, the largest US clinical

trial of bone-marrow cells for heart-attack

patients, failed to show any benefits.

Safety of stem cell therapy is a major

concern, as there are chances of serious

adverse events, e.g. infection, immune

reaction and tumours. Among the serious

adverse events associated with stem

cell treatment are – paraplegia caused

by development of a glioproliferative

lesion, tumours and renal failure leading

to nephrectomy and worsening of vision

and blindness in macular degeneration.

Adverse effects may be more common

than discussed in literature, as such events

are not reported when stem cell therapy is

tried outside a clinical trial, e.g. on individual

patients in a clinic. In view of such safety

concerns, US Food and Drug Administration

issued a warning cautioning patients about

the dangers of unapproved and unproven

therapies offered by unscrupulous clinicians.

Indian guidance for stem cell therapies

mandates that organizations - hospitals,

clinics, companies, research institutes,

university departments, and cell banking

centres – involved in the collection, isolation

storage, manufacturing, quality control,

preclinical studies and clinical trials of stem

cell therapy require approval from regulatory

authorities International regulators require

robust evidence of safety and efficacy to

ensure that this emerging field can fulfill its

promise to patients.



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medico legal


Gynaecs are left high and dry as the ethical debate on whether to allow

the termination of high-risk pregnancies post 20 weeks continues to rage


As per the Medical Termination of

Pregnancy (MTP) Act, 1971, abortion

is illegal after the 20th week of

gestation, but allowed in exceptional

cases to immediately save the life of the

mother. In 2008, Nikita Mehta was in

her 23rd week of pregnancy when her

foetus was diagnosed with a congenital

heart anomaly. In an attempt to obtain

permission for abortion as a special

case, Dr. Nikhil Datar, her gynaecologist,

approached the Mumbai High Court

requesting for permission to abort Nikita’s

then 26-week old foetus. The Mumbai High

Court did not grant this permission, sticking

to the laws set in 1971. While Nikita had

a miscarriage, the ethical dilemma of

aborting a foetus post 20 weeks,

or allowing a child with congenital

anomalies to be born, continues

to rage.

Nikita’s may have been the

first case to be contested in

the courts. However, there are

many such cases when abortion

may be needed, either for a

minor rape victim who may

not even be eligible to be a

mother, or to protect the child

from a life-long abnormality.

Many of these abnormalities are

now commonly detected between 20

and 24 weeks, which is too late for legal

abortion. While the law was set at a time

when there were no ultrasounds, genetic

testing, or any other means to determine

whether the child will be born abnormal,

today, with the technology having

progressed by leaps and bounds, isn’t it

time to modify the 20-week cap?

Why 20 weeks, you may ask? Is it

because there is an increased risk to the


mother’s life beyond 20 weeks? This isn’t

true as reports from the Royal College of

Obstetrics and Gynaecology (RCOG) show

that the risk to the mother’s life remains

the same whether at late termination of

pregnancy or at delivery. Countries such as

the UK have laws that allow abortion up

to 24 weeks. However, RCOG reports that

‘abortion must not result in the birth of a

living child’ as the subsequent death of

the child would be considered as murder.

As the gestation period increases, so does

the probability of a child being born alive

at abortion. In other countries, intrauterine

foeticide is generally used in cases of

abortion post 24 weeks to avoid live births.

The main ethical concern, that of the right

to live for the child, remains. Does the

mother, or even the law have the right to

terminate this life?

Of major interest to gynaecologists

and the Indian population overall was the

breakthrough judgement in 2016, when

Supreme Court allowed a rape victim

to abort her 24-week-old foetus

that was diagnosed as having

anencephaly. Since this first

case, there have been 33

cases that have received

High Court permission for abortion post

20 weeks. These cases include child rape

victims or women with severe foetal

abnormalities; the most recent one being

granted at 31 weeks to a 13-year-old rape


Several of these cases are being

handled by Dr. Nikhil Datar, who is

extremely passionate about this cause.

“How can you disallow a woman her

right? Currently there is a complete









mismatch. While diagnostics have

significantly improved over the years,

therapeutics have not improved, and the

law has not changed at all since 1971.

You can now diagnose a disorder, but

there is no treatment, and unfortunately

no termination is allowed either. Such a

mismatch in progress increases the anxiety

levels for pregnant woman. A screening

test stating a 1:50 chance of Downs

syndrome is enough for the mother to

want to abort the foetus early on without

waiting for a confirmatory diagnosis lest

it be too late to abort later. This results

in many terminations of even normal

babies simply because of an absurd,

arbitrary law set at a time when no such

diagnoses were possible”.

He undertakes such cases probono

with the help of the Human

Rights Law Network (HRLN) and

other specialist doctors who can

provide a detailed medical

report explaining the

abnormality and the reasons

why abortion should be

granted. Advocate Colin

Gonsalves and Advocate

Sneha Mukherjee of HRLN

have been instrumental

in getting these cases to court in a timely


“I believe that when the law came

into force in 1971, the 20 week limit must

have seemed reasonable depending upon

the medical advancements made by then.

However, we are in 2018 and with the

medical advance today, it is possible to

do a medical termination at any stage

during the pregnancy. The Shantilal

Shah Committee report, based on which

the Act was drafted, emphasized the

unnecessary waste of a mother’s health

and life because of a restrictive law

and we believe that 50 years later, we

argue our cause on the same ground.

The right of the woman to her agency,

her body and the right to choose to

live with dignity and personal integrity

is unconditional,” says Advocate Sneha,

emphasising that the laws need to be

changed as it is safe to perform

abortions with the medical advancements

of today.

The Courts are also increasingly

sympathetic to the plight of these women

and are taking immediate action involving

a local government hospital for a second

opinion. Within 72 hours, an independent

report is sent to the court and if the

abnormality is confirmed, permission is

granted. The entire process takes about

8 days, which is extremely timely for law


While the law courts need to be

approached for every case that exceeds

20 weeks of gestation, there is a means

of obtaining permission for abortion in

exceptional cases where the foetus is

diagnosed with a congenital abnormality

or in case of child rape victims. However,

these women must go through the

cumbersome process to request

permission to medically terminate their

pregnancies. The medico-legal issues

involved in the process led the Ministry

of Health to a draft an amendment to

the MTP Act in 2014. The amendment

provided for abortions up to 24 weeks

under special circumstances, such as risk

to the life or mental status of the mother

or child and in cases of rape. However,

this amendment bill has been pending

with the Parliament for the last five years,

while the quest for justice for these

pregnant women continues.


straight talk




One of the serious concerns

in the Indian healthcare scenario

at present is the absence of a

compulsory continued medical

education (CME) system for doctors

to update themselves with the fastevolving

changes in medical science.

It is high time the government put

in place a strong law that restricts

the practice of doctors who do not

undergo a certain period/number of

well-designed and recognised CME

programmes every year. The Medical

Council, or any other competent

health authority, should have the

powers to make doctors comply

with this law, says Dr Azad Moopen,

Chairman, Aster DM Healthcare

Group, who built one of the largest

hospital networks in India and the

Middle East countries. Moopen, a

successful doctor-entrepreneur who

strongly believes that a fully updated

medical education system and a

medical fraternity abreast with the

latest knowledge is an essential part

of quality healthcare, engages

in Straight Talk with


SUMIT GHOSHAL, Edited excerpts.

India is seeing an increasing trend of individual doctors

taking up multiple roles as clinician, researcher and

entrepreneur as they chase bigger growth trajectories in

life. You have been a very successful doctor-entrepreneur.

What is the key advice that you can give to the aspiring

entrepreneurs who want to set up hospital chains or

corporate hospitals?

Entrepreneurship needs a completely different skill-set.

The professional skills of a doctor may not always help one

to be successful as an entrepreneur. One very important

thing that these aspiring doctor-entrepreneurs must do is

a preparation, preferably for at least five years, by taking

a sabbatical to learn the different aspects of the business

before jumping into their own venture. This includes a deep

study on market opportunities in multiple geographies, as

it could be a multi- or single-speciality hospital, or even

creating a completely different model to cater to a need that

exists. Another important requirement is to get trained in

management. Would-be entrepreneurs should do a 2- to

3-year internship at a large hospital or a course in a reputed

institute on the management of finance, HR, technology and

so on. This will help them avoid many mistakes that a maiden

entrepreneur could potentially make. They may think that it

can be managed, but the fact remains that a professional

approach is required in all these aspects. Frankly speaking,

I haven’t done this . I learnt it by committing mistakes, and

from my experience, I can say that they can avoid most of

those mistakes with this preparation. The third important

thing is the access to funding, where you have to have good

people or institutions who are on the same wavelength of

thoughts to support you. It is also important that, at the same

time, one should also look at access to capital from a bank

or an institution. But, one thing that they should make sure is

that the leveraging of loans should be at a respectable level,

because the debt:equity position for the hospital business

cannot be compared with that of other businesses. A hospital

will take at least 5 to 10 years to establish its brand and gain

patient trust, and it is easy for one to get into a debt-trap if

they can’t hold on until that time.

You mentioned that updating the skill-set and

knowledge are the most important elements in a quality


Dr Azad Moopen

Photo: Prakash Elamakkara/FM

healthcare system. But, what needs to be

done to ensure this in a country like India,

where the medical curriculum is not quite

updated and the CME is poor?

It is an important question from the

professional point of view. For this, there

should be strict measures from the

regulatory side to ensure quality of education

and regular updating of doctors’ skill-set. The

government should bring in a requirement

that doctors have to fulfill a certain number

of well-designed and recognised CME hours

in a year. Some doctors who completes

their graduation or post graduation 20 or

30 years ago may not have done much to

update their skills as the regulation does not

make it mandatory over here. In the West,

and even the GCC, it is compulsory that

doctors must earn their specified CME credits

in their respective fields for getting their

And once you

graduate, you are

free to practice

lifelong with that

degree, unless you

voluntarily take an

initiative to study

and update further.

licenses renewed. In India, another serious

concern is the dated medical curriculum.

Sad to say that most of what is in Indian

medical curriculum is still the same that

I studied 40 years ago, despite the fast

changes that happened in the field of

medicine. And once you graduate, you are

free to practice lifelong with that degree,

unless you voluntarily take an initiative to

study and update further. There should be a

thorough revision in the medical curriculum

in India. For instance, there are many things

that is essential in the profession today

— such as medical ethics, dealing with

patients‘ relatives, taking the consent of the

patients for even touching them — that are

not taught in Indian medical colleges, unlike

in the West. Also, I feel that the government

should provide much more support and

funding for new research in hospitals, an


the patient back to the original doctor for

follow-ups. That’s how it should be as

it is a long-term relationship which will

ultimately prove beneficial for the patient

as well.

aspect that is often neglected in this country.

Why do we not see a robust patient-reference culture

among Indian doctors or hospitals as it exists in developed

markets, especially in the private healthcare set-up?

The main issue here is that the individual doctors often do

not want to lose patients. There are two key reasons for this.

One is the financial loss, and the other is the ego that doesn’t

allow them to admit that someone else is a better expert or

is better equipped. References to other doctors or hospitals is

not a big issue in a government funded set-up as the doctors

are not concerned about revenue. In fact, they can leave the

risk to someone else by referring high-risk cases to another

doctor. There are also issues with the receiving doctors or

hospitals in the referral context. They do not often report back

to the referring doctor with case progress or additional details

on the investigation. So the referring doctor loses confidence

as well as the patient. Referring complicated or improperly

diagnosed cases to an expert doctor or a hospital is a

well-appreciated and appropriate culture in the healthcare

system and good for the doctor. I am sure this culture will

gradually emerge in India too as the system gets evolved

with better awareness. For example, we at Aster have, from

the beginning, implemented a policy to reach back to the

referring doctor with the feedback on additional investigation,

case progress with our expertise etc., and also referring

Do you think Indian patients are, in

some way, deprived of better medical

treatment because of less updated

doctors and slow adaptation of better

technologies by hospitals? Does the

existing revenue level at Indian hospitals

create a constraint?

This could be true in the rural and semiurban

areas, because the doctors don’t get

much opportunity for re-skilling themselves.

There is the need for a more structured

CME programme that covers a majority of

doctors. Technology upgradation in Indian

hospitals is quite fast and advanced. In our

own hospitals, for example, we have PET,

Robotic Surgery, facilities for

Molecular Diagnosis, etc. In fact, the Gulf

countries are a little behind in this respect.

On the revenue front, the hospitals in

metro cities do not face much of problem.

However, the situation is very different in

the Tier-II and Tier-III towns. In the latter,

the investors are not quite willing to allocate

funds for new technology. But things

can improve if the government is able to

provide some financial incentives to people

who want to set up hospitals in non-metro


As a doctor-entrepreneur, what are the

other key challenges that you see in the

Indian healthcare system? Do you think

the big proposals like Ayushman Bharat

can find some solution to resolve them?

The main challenge or lacunae in

the Indian healthcare system is the low

spending by the government. It does not

even match the 5-6 % of the GDP which we

see in the emerging markets. In developed

countries, it is close to 10%; the highest

being in the US where it is almost 16%.

The other issue is the low penetration of

medical insurance. As a result, the Indian

masses are not able to avail of good

healthcare facilities. However, we hope

these issues will get resolved to a great

extent if the government could successfully

implement the health coverage as proposed

in Ayushman Bharat, and things could

change for the better.





The varying nature of tumours

arising out of the buccal region

calls for separate staging and

treatment approaches


Squamous cell carcinoma of the oral

cavity accounts for about 3.8% of

all cancers worldwide. While it is

the sixth commonest cancer in the

world, it is one of the most common

entities in the Indian subcontinent and


The presence of multiple sub-sites

within the mouth is a peculiarity. Though

these sub-sites are anatomically placed

together, the cancers in these areas

behave differently. Oral tongue and

buccal mucosa are the two commonly

involved sub-sites in cancer.

Buccal cancers include those arising

from the buccal mucosa and those

afflicting upper or lower gingivobuccal

areas. Oral tongue is the commonest site

for mouth cancers in western literature,

whereas in Asian countries, buccal

cancers are more prevalent.

So much so that it is the most

common type of cancer found in men in


Anatomically, the sub-site is different

in that it is closely related to the bony

boundaries of the oral cavity, the

mandible and the maxillary alveolus. It

has a thin, layered structure compared

to the muscular tongue. Being in contact

with the muscles of mastication, the

buccal mucosa sub-site has a critical

relationship with the masticator space

and the infratemporal fossa. Advanced

tumours also tend to invade the skin.

Though squamous cell carcinoma

is the most common pathology among

the cancers of oral cavity, they seem

to have a diverse etiology. The use of

smokeless tobacco, betel quid chewing

and areca nut preparations are causative

in buccal mucosal cancers, while smoking



and alcohol seem to be the reason for

tongue cancers. Studies from India and

western literature have noted that buccal

cancer patients are older and present for

treatment at more advanced stages. Oral

submucous fibrosis -- a unique, chronic,

insidious disease affecting the oral cavity

-- creates a predisposition to buccal

cancers. It is characterized by varying

intensity of fibro-elastic changes resulting

in progressive trismus. It has been

suggested that chewing of areca nut and

other factors like nutritional deficiency

contributes to

the pathogenesis of this condition.

Patients with this condition are at

least nineteen times more at risk to

develop oral cancer than healthy


Molecular differences

Buccal tumours of the Indian

subcontinent and other south-east

Asian countries may be different from

the western disease in the spectrum

of molecular changes. An earlier study

has shown the involvement of the

ras oncogenes, like that of loss of

heterozygosity (H-ras) and amplification

(K and N-ras are more common in

the eastern tumours). Similarly, p53

mutations are infrequent in the Indian

subcontinent tumours. Other changes

like overexpression of Cyclin D1, high

accumulation of STAT-3 are also

reported. The Indian project team of the

International Cancer Genome Consortium

have reported many pathways that

are enriched for genomic alterations

specific to gingiva-buccal cancers. Exome

sequencing and other data showed (a)

significantly and recurrently mutated

genes (b) new genes with recurrent

amplifications or homozygous deletions

(c) existence of molecular subtypes

with distinctive mutational profiles (d)

high proportion of C>G transversions

(e) enrichment of alterations of

pathways specific to gingivo-buccal

oral cancer. Recurrently mutated genes

were validated using the data from an

independent set of 30 gingivo-buccal


Metastatic tendency

Gingivo-buccal cancers have less

propensity to metastasize. While 70%

of the cancers of the tongue tend to

metastasize, only less than half of the

buccal cancers are seen to do so.

Staging and implications

on treatment

The eighth edition of the American











Joint Committee on Cancer (AJCC) has

introduced significant changes in this area,

mainly based on the evidence

from the western literature that have more

relevance to those countries. The staging

system applies more to tongue cancers.

Advanced cancers of the oral cavity

(tumour stage T4) are subdivided into T4a

and T4b, with treatment and prognostic

implications. T4b cancers are generally

very advanced tumours which are often

treated with palliative intent only. But there

is recent evidence, including studies from

India, which show that a sub-group of

these patients with limited spread (infranotch)

may do better. These cancers may

be considered for down-staging to T4a,

based on data.

Though the series by Gupta et al in

their research article titled “Do we need

a different staging system for tongue and

gingivobuccal complex squamous cell

cancers?”, published in Oral Oncology

concluded that there is no need for a

separate staging system, recent reports

from India indicate the need for one.



Surveillance, Epidemiology and

End Results database showed

a 5- year survival rate of

tongue cancer and for cancers

of the gum and other parts

of the mouth (excluding lips,

oropharynx, and tonsil.)





Occurrence of cancers affecting lip and

oral cavity age standardised rate per

100,000, all ages







10.6 9.1







7.1 5.4




4.3 2








10.1 3






6.4 1.5

5.8 1.9 13










Compartmental resection of buccal

cancers, a newer concept in the surgical

management of buccal cancers, ensures

better clearance of the disease and is

postulated to result in better oncological



Gupta et al reported that overall survival

for gingivo-buccal cancers in their series

of about 1500 oral cavity cancers was

significantly poorer than oral tongue

cancers. Another study on a cohort of

advanced gingivo-buccal cancers, led by Dr

KA Pathak, found that patients with pT3/

T4 disease and margin-positive disease

had poorer outcomes. An analysis of the

Surveillance, Epidemiology and End Results

(SEER) database showed a 5- year survival

rate of 65% for tongue cancer and 59.1%

for cancers of the gum and other parts

of the mouth (excluding lips, oropharynx,

and tonsil.) Patients with carcinoma of the

gingivo-buccal sulcus, palate and lip had

significantly better locoregional control (68

vs 57%, p=0.005) and disease-free survival

(64% vs 52%, p=0.001) compared to

patients with squamous carcinoma of the

tongue and floor of mouth, according to a

Mumbai study.

In short, gingivo-buccal cancers seem

to be a different disease in etiology,

clinicopathology and outcomes. Early

findings from cancer genome studies open

new avenues for biological characterization

and exploration of new treatment

strategies. There is a need for a separate

staging system to prognosticate, treat and

report the outcomes of these tumours.

The author is Professor,

Department of Head

and Neck Surgery and

Oncology Amrita Institute

of Medical Sciences,

Kochi, India



the catalyst

Knowledge of good


It is imperative for us to seek good health and prevent

sickness, both at institutional and individual level


Partner, Healthcare


Ernst & Young India.


had mentioned in my previous column

that healthcare (not sick care) must be

the focus of both policy and public. As I

prepare to write this column, intending to

focus on the theme of self-accountability

for a healthy life, I am reminded of an

interesting experience that was shared

by the promoter of one of the largest

healthcare chains in India. His company had

come out with a scheme for a free annual

health check-up for all its employees. When

they reviewed the utilization of the facility

after almost nine months, less than 15

percent had availed of it and this perplexed

the management. It was assumed that

health matters dearly to all. Upon instituting

a quick study to understand the reason

for the poor take-up, the most frequent

response was lack of time and the

overwhelming feedback for making it a

success was to additionally offer a half-day

paid leave for the employee to take the


I must say that I was not truly surprised

by this attitude and neither is it uniquely

relevant to health. I think it’s more a result of

a psychology where management of crisis

perhaps gets celebrated more than the

prevention of crisis. Again I am reminded

of an interesting article by Swaminathan S

Anklesaria Iyer, almost a decade back, where

he had tried to analyse the reason why so

many Indians had risen to the very top in

global corporations during that period. His

hypothesis was that it could be that our

risk response skills-- that is honed from

very early stages living in an environment

where the system does not assure an

objective experience -- that have come to

be a very differentiating skill in the global

context characterised by high volatility and

uncertainty. The moot point here is that,

irrespective of the reasons for our general

psychology of discriminating against proactive

risk management, it will be highly undesirable

and unfortunate if this trait continues to

manifest in matters of health.

The twin problem of a very high

communicable, and a high and rapidlygrowing

non-communicable disease burden

puts India at a unique disadvantage.

Consequently, it is imperative for us that

there is sincere focus, both at an institutional

and individual level, to seek good health

and prevent sickness. The factors that

critically contribute to shaping the health

of a community can be classified into two

categories: Macro factors, such as nutrition,

pre and postnatal care, immunization,

sanitation and pollution, and micro factors,

such as personal hygiene (physical and

mental) and physical activity. The macro

factors need institutional/state intervention,

and are typically beyond an individual’s

control. I intend to focus on the micro factors

for which an individual is fully accountable:

Physical Hygiene: A. Our body is nothing

but the food/drinks we eat. Eating right is half

the thing done, your body will always tell you

what and how much is right if you care to

listen, and keep in mind that “what makes you

crave is not your friend” because nature loves

freedom and not slavery. Personally, I have

found the book, “The Wellness Sense” by Om

Swami, an informative source in this regard.

B. For minor ailments, minimise the use of


modern medicine, which are a concoction of

synthetic chemicals and not a friend of the

body. In fact, we have the unique advantage

of a rich tradition of home remedies,

naturopathy and AYUSH, which should

be our first recourse. Please view Padma

Bhushan Dr. B.M.Hegde’s videos on YouTube

to get a perspective on modern drugs. C.

Periodic internal cleansing of the body, per

season or at least once a year. There are

different methods prescribed in naturopathy

and yogic traditions, and the same can

be understood and adopted as per

individual comfort after expert consultation.

An alternative that I have personally found

very useful is 2-3 day (consecutive) fruit fast

during every season change.

Mental Hygiene: It is mental hygiene

that results in a healthy mind, which in turn

is an essential prerequisite, nay, the very

bedrock, of a healthy body. It is of particular

significance if we have to prevent the menace

of non-communicable disease. Without

mental hygiene, attempts to achieve physical

hygiene is futile. Inversely, physical hygiene

habits grow organically as your mental

hygiene evolves. Unfortunately, this is much

less understood and often neglected. Mental

hygiene essentially stems from a Steady Mind,

something everyone craves for but only a few

achieve in today’s world. It is indeed a great

tragedy that India is one of the rare countries

that has a very rich Yogic tradition, wisdom,

knowledge and practices pertaining to this

esoteric area, but has neglected this priceless

treasure. I suggest only one practice to start








this journey of achieving a Steady Mind:

Pranayama, specifically Anulom-Vilom. Learn

the technique from a qualified expert and

practice it for half an hour a day and witness

the change for yourself.

Physical Activity: There is no dearth of

information available to all on this subject,

but personally, I feel a simple and cheap, but

very effective, way is to target 10,000 steps a

day doing whatever one is comfortable with.

Technology in the form of wearables are a

great ally in this pursuit. A still better way is to

target 30 mins of Surya Namaskar every day.

Before I conclude, I must clarify that I am

neither a medical doctor nor an expert in Yoga

or naturopathy, but have been a keen seeker

of knowledge for good health. What I have

shared in this column is what I have personally

experienced and found beneficial.

The author has long-standing association with

EY India but the views are strictly personal.


case reports



Cardiac evaluation to rule out arrythmias shall be considered for children

having doubtful epilepsy, show case studies

Typical epileptic seizures can vary from brief to long

periods of vigorous shaking. However, epileptic seizures

may also be associated with sudden unconsciousness

and/or rolling of the eyes. Here is the story of a young girl who

suffered from on-and-off headaches and had fainting spells

associated with rolled up eyes and bladder incontinence. Her

EEG and MRI were normal, and she was initially diagnosed

with generalized idiopathic and probably myoclonic epilepsy.

However, anti-epileptic drugs were not effective for her

and even after several different treatment regimens, she

continued to have identical episodes every 5-6 months. She

was eventually brought to a senior paediatric neurologist, Dr.

K. N. Shah, at Lilawati Hospital & Research Centre in Mumbai.

Upon probing into her family history, her parents talked

about another child who also had similar episodes from the

age of 5 years. This child had been similarly diagnosed with

idiopathic and myoclonic epilepsy, and was on anti-epileptic

drugs without benefit. Unfortunately, she died at 11 years of

age during one such episode. Her parents

were desperate to not lose another child, “We

don’t want this daughter to die too. Please do

something. We are not interested in whether

this is epilepsy or not.”

Based on the history of the sudden

death of her sister, and failure to control

her episodes with anti-epileptic drugs, the

neurologist speculated whether it could be

due to cardiac arrhythmia. In children, cardiac

arrhythmia can lead to neurocardiogenic

syncope that resembles epilepsy. She was then

referred to a cardiologist, Dr. Amit Vora, for a

cardiac evaluation where ECG, 2D echo, head

tilt test, stress test, and 48-h Holter monitoring

was done. While ECG, 2D echo, head tilt and

stress tests were normal, the Holter monitoring

showed multiple, rapid polymorphic ventricular

tachycardia episodes, suggestive of cardiac

arrhythmia. In order to prevent sudden death

like her brother, a cardiac pacemaker was put

in and for the last 7 years, the child has had

no repeat episodes. In cases of a family history

of juvenile sudden death, cardiac arrhythmias

may be caused due to mutations in the genes

for cellular transmembrane ion channels.

Genetic diagnosis can be made with nextgeneration

sequencing (NGS). However, in this

case, the patient could not afford the test and

the mutations were not verified.

More recently, Dr. Shah encountered

another similar case. Eleven-year old Geeta

(name changed) in Sholapur had similar

episodes of fainting. Her twin sister, Seema,

had also been having such episodes and

had been diagnosed with epilepsy. However,

during one such episode, Seema dropped

dead while playing in front of her family

members. Now, Geeta also started having

the same episodes. MRI and EEG were done


in Sholapur and were normal.

She was then sent for cardiac

evaluation where her ECG, 2D

echo, head tilt test, and Holter

monitoring was done. ECG,

2D echo and head tilt were

normal. Holter monitoring was

done over a long period and

even a 19-day monitoring did

not show any cardiac issues.

Since no conclusions were

drawn, she was referred to

Dr. Amit Vora in Mumbai for

further evaluation. A stress test

was done and showed few










abnormal beats. She then came to Dr. Shah at Lilawati hospital

where epilepsy was ruled out and NGS was proposed. Geeta’s

family was able to afford the genetic testing and a blood

sample was sent for NGS. Results showed a mutated ryanodine

receptor 2 (RYR2), compatible with cardiac arrhythmia. Geeta

was then started on a beta-blocker, propranolol, and is doing

well for the past 2 years.

Neurocardiogenic syncope or vasovagal syncope is a

transient loss of consciousness or fainting spell often mimicking

epilepsy and may be caused due to cardiac arrhythmias.

Catecholaminergic polymorphic ventricular tachycardia (CPVT)

is a rare cause of such recurrent syncope. CPVT can have high

mortality rates if not diagnosed appropriately and can cause

sudden death as seen in the siblings of both the patients

eventually referred to Dr. Shah. CPVT often

occurs in childhood. Several mutations have

been associated with such arrhythmias,

including RYR2 and calsequestring-2 (CASQ2),

although these mutations occur only in about

60% of CPVT cases. If mutations are found in

the child, NGS should also be proposed to the

parents as they are likely to be carrying the

same mutation which may result in causing

similar episodes for the parents as well.

Sometimes, as in Geeta’s case, parents can test

negative for RYR2 implying de novo mutations

in the child.

Management in such cases can be

achieved with drugs such as -blockers and

a agonists, or with pacemaker implantation.

Appropriate diagnosis is the key to a

successful treatment. Once diagnosed with

mutations in RYR2 or CASQ2, even in the

absence of any symptoms, prophylactic

pacemakers can be considered to avoid

sudden death. In any case, cardiac

arrhythmias should be considered for any

child with doubtful epilepsy and with a

history of sudden deaths in close family




case reports


How PCR proved crucial in pinning down an evasive MRSA infection

An 8-year old male child presented to Rainbow

Children’s Hospital, Vijaywada, with on and off

fever for the past three months. His parents

also mentioned that he had had 2 episodes of seizures

and complained of shortness of breath over the last 2

weeks. The patient then underwent a two-dimensional

echocardiography (2D ECHO) to monitor the heart and

great vessels and to determine if there are any anomalies

in the appearance of the valves or the functioning of the

heart muscles. 2D ECHO showed a heavy vegetation in both

mitral and tricuspid valves, suggesting infective endocarditis

Infective endocarditis can be caused by a myriad of agents

that could be bacterial, fungal, or even viral. A biopsy was

done and sent for routine microbial culture to determine

the causative agent. As another alternative, to help reach

a quicker diagnosis, the doctors decided to confer with

the diagnostic team at a diagnostics lab in Mumbai, for

molecular diagnostic testing. The lab suggested that the

biopsy sample be sent to them for their

infective endocarditis panel testing. Thus,

a portion of the biopsy was also sent to

the lab. The infective endocarditis panel

consists of various strains that are routinely

implicated in endocarditis, including the

usual suspects Streptococcus, Enterococcus,

and Staphylococcus. Thus,if the sample

has any of these strains present, the panel

test will pick out the causative pathogen.

Interestingly, while the microbial culture

tests came back negative, results from

the genetic lab came back positive for

Staphylococcus aureus.

Staphylococcus aureus is known to

cause many diseases including sepsis

and endocarditis. Antibiotics are the most

effective treatment for such infections.


However, due to inappropriate

antibiotic usage over the years,

antibiotic resistant strains are

now rampant, and doctors

need to ensure prescribing

the correct antibiotic

treatment for effectively

treating Staphylococcus

aureus infections. Correct

antibiotic treatment is

typically identified using

antibiotic sensitivity assays,

in which, small wafers

containing antibiotics are

placed onto a culture plate

on which the bacteria are already growing.









Antibiotics that prevent the growth of the bacteria on the

plate are then chosen as the treatment of choice. In the case

of this patient, since the microbial cultures were negative, no

culture plates were available and carrying out an antibiotic

sensitivity assay was not possible. The molecular diagnostic

lab came to the rescue again and use done of their innovative

in-house developed PCR-based assays to detect antibiotic

resistance. PCR or polymerase chain reaction is a molecular

biology technique used to amplify a particular DNA sequence

from a single copy to millions of copies.

Antibiotic resistance is conferred due

to the presence of certain genes. There

are many different genes that can confer

antibiotic resistance, including those for

beta-lactamases which break down betalactam

present in many antibiotics such as

penicillin and cephalosporin. An antibiotic

resistance assay uses this information and

has created a panel that looks for the

presence of specific antibiotic resistance

genes in the DNA from the sample. It

screens for all classes of beta-lactamases,

in addition to genes that confer methicillin

and vancomycin resistance. Results from

this assay indicated that the Staphylococcus

aureus infection was caused by a methicillinresistant

strain and the causative agent

was diagnosed as methicillin-resistant

Staphylococcus aureus (MRSA).This strain

is also resistant to other known antibiotics

such as amoxicillin, penicillin, and oxacillin.

The patient was therefore put on an

alternative antibiotic therapy– vancomycin,

in combination with ceftriaxone–which

proved to be effective for the patient who

recovered well.

In this case, not only was molecular

testing extremely important to identify

the causative agent, it also helped in

charting out the effective treatment route.

According to Dr. Aparna Kotekar, HOD

Molecular Department, iGenetic Diagnostics,

Mumbai, while about 20-30% results come

positive via microbial culture testing, about

50-60% can be identified via PCR-based

assays due to their high sensitivity. The

results for molecular testing also come

back much quicker than microbial cultures

and should especially be used when time

is of major concern. Of course, the major

drawback of using molecular testing is the

cost, which may currently not be affordable

for many. However, as better and newer

technology becomes available,diagnostic

labs are constantly trying to make this

testing more economical. Currently, they also

offer smaller panels instead of their wide

screening panels when the doctors

are relatively sure of the probable

causative agent. This can considerably drop

the prices and make diagnostic testing

more affordable.



case reports


Hypertrophic cardiomyopathy runs through a family, casting the shadow of

imminent cardiac arrest


32-year-old man, Nikhil (name changed), brought

his 2 sons to the one-of-its-kind Hypertrophic

Cardiomyopathy Centre at Amrita Institute of Medical

Sciences (AIMS), Kochi, to be screened for hypertrophic

cardiomyopathy (HCM). While Nikhil’s boys, aged 6 and 2,

had no obvious symptoms, he himself had been an HCM

patient since his teen years and had come to ascertain

the fate of his children. The HCM history went beyond

Nikhil; his mother also had been diagnosed with the same

condition, and at the age of 28, had sadly collapsed while

working and died of sudden cardiac arrest.

Nikhil, the only son, had undergone ECG and echo

studies at VSM Hospital, Mavelikkara, and was diagnosed

with HCM. During a follow-up examination, it was observed

that his condition had worsened

considerably, and by age 17,

his myocardial thickness had

increased to such an extent

that there were overt signs

of obstructive hypertrophic

cardiomyopathy that could

no longer be controlled by

medication. Nikhil underwent

a septal myectomy at Amrita Institute of

Medical Sciences. “It was probably the very

first septal myectomy done at Amrita”, says

Dr. Hisham Ahamed, Associate Professor of

Cardiology, AIMS, Kochi. Dr. Ahamed, along

with Dr. Praveen Varma, Clinical Professor

and Head, Department of Cardiovascular

and Thoracic Surgery at AIMS, have

been instrumental in setting up the first

hypertrophic cardiomyopathy unit in the

country at Amrita.

HCM is an autosomal dominant,

inherited disease, earlier thought to afflict

1 in every 500 individuals. The disease

is caused due to mutations in proteins

important for the structure of the cardiac

muscles and the subsequent thickening

of the heart muscle, especially of the

septum between the ventricles. With the

advent of genetics, it has been possible to

accurately diagnose the condition and it

now appears that the actual prevalence of

this condition is closer to 1 in 200. While


many people with HCM have

no or minor symptoms and

live normal lives; for some, MUTATIONS IN MYH7 ARE

the condition can progress THOUGHT TO ACCOUNT

aggressively and even result FOR AROUND 35% OF

in sudden cardiac death as


seen for Nikhil’s mother. With


these alarming prevalence

rates, it is very important CASES AND RESULT IN

to accurately diagnose THE THICKENING OF THE

and treat such individuals CARDIAC MUSCLES.

to prevent sudden death.

One such avenue to treat

HCM patients is to develop

focused centers such as the

Hypertrophic Cardiomyopathy Center at Amrita Hospital

where a comprehensive team is dedicated to screening,

diagnosing, treating, and following up such patients.

Now, after 15 years, Nikhil came back to have his children

screened. ECG and echo were done for Nikhil and his 2 sons.

As it turns out, while his 6-year-old son showed no features

of hypertrophic cardiomyopathy via ECG and echo, his

2-year-old son showed substantial thickening of the

myocardial wall. However, there was no obstruction and

HCM symptoms had not set in. Due to the familial history

of sudden cardiac death, Nikhil and his son fall under a

high-risk group which warrants genotyping to identify the

causative mutation and to screen for the same mutation in

other first degree relatives in the family. Next-generation

sequencing using a cardiomyopathy panel was done and

showed that both Nikhil and his 2-year-old son carried

a mutation in the MYH7 gene. MYH7 encodes a protein

called myosin

heavy chain 7, that is vital for muscle

contraction. Mutations in MYH7 are thought

to account for around 35% of familial

hypertrophic cardiomyopathy cases and

result in the thickening of the cardiac

muscles. For Nikhil and his son, the mutation

was found to be Arg719Gln (cytogenetic

location: 14q11.2), which is known for its

aggressive traits. Genetic testing confirmed

that both Nikhil and his son are in a

high-risk group for sudden cardiac death

and would need to be strictly followed-up.

For Nikhil’s 2-year-old son, serial echo will

be done, and his condition will be closely

monitored. Once he is older, cardiac MRI will

also be done to monitor his condition.

Nikhil also underwent a follow-up echo.

His latest echo showed severe thickening

of the myocardial wall of around 3 cms.

Considering the aggressive mutation and

the history of sudden cardiac death in the

family, Dr. Ahamed’s team has suggested

placing an implantable cardioverter

defibrillator (ICD). While Nikhil awaits this

procedure, the HCM team is considering a

cardiac MRI to assess the degree of scar

tissue formation in the heart.



esearch snippets

Effects of maternal

weight on


of children

Chao Li et al identified the effect of

low maternal pre-pregnancy weight

on malnutrition status (underweight and

thinness) and the verbal comprehension

ability of children at school age. The

positive effect of average gestational

weight gain on decreasing occurrence of

underweight was also identified.

The study finds a negative effect of

low maternal weight at pre-pregnancy

on nutritional status (underweight and

thinness) and verbal comprehension

in early school-aged children. Average

gestational weight gain was found to be

positively associated with a decrease in

prevalence of underweight children but

not with the intellectual development of


The study findings reinforce the

importance of encouraging women in

poor areas to achieve healthy gestational

weight gain and weight before pregnancy

on further physical and intellectual

development of children.

Secondary carbamate

linker can facilitate

dopamine release

Nikki A. Thiele et al report the finding

of a study to achieve the sustained

release of dopamine in the brain for the

symptomatic treatment of Parkinson’s

disease. Researchers conjugated

dopamine with l-tyrosine, an l-type amino

acid transporter 1 (LAT1)-targeting vector,

using a secondary carbamate linker. The

resulting prodrug, dopa-CBT, inhibited

the uptake of the LAT1 substrate [14C]-

l-leucine in LAT1-expressing MCF-7 cells

with an IC50 value of 28 µM, which was

3.5-times lower than that of the gold

standard for dopamine replacement

therapy, l-dopa (IC50 ca. 100 µM).

The study found out that drugs can

be targeted into the brain via l-type

amino acid transporter 1 (LAT1). In the

study, the secondary carbamate linker

of the prodrug facilitated slow release

of dopamine. Prodrug also released

l-tyrosine, a precursor of endogenous

dopamine. Thus, the study concluded

that this prodrug can serve as a potential

dual carrier of dopamine into the brain.

Bioorganic & Medicinal Chemistry Letters Volume

28, Issue 17, Pages 2856-2860, September 2018

Scientific Reports volume 8, 12014, August 2018.

Sheldin complex promotes DNA end-joining

in BRCA1-null cells

Dev H et al came up with a finding

that Shieldin complex promotes DNA

end-joining and counters homologous

recombination in BRCA1-null cells. The

study states that BRCA1 deficiencies

cause breast, ovarian, prostate and

other cancers, and render tumours

hypersensitive to poly(ADP-ribose)

polymerase (PARP) inhibitors.

The study established that Shieldin

acts as the downstream effector of

53BP1/RIF1/MAD2L2 to promote DNA

double-strand break (DSB) end-joining

by restricting DSB resection and to

counteract homologous recombination

by antagonizing BRCA2/RAD51 loading

in BRCA1-deficient cells. Notably, Shieldin

inactivation further sensitizes BRCA1-

deficient cells to cisplatin, suggesting how

defining the SHLD1/2 status of BRCA1-

deficient tumours might aid patient

stratification and yield new treatment


Highlighting this potential, the study

document reduced SHLD1/2 expression in

human breast cancers displaying intrinsic

or acquired PARP-inhibitor resistance.

Nature Cell Biology, Volume 20, pages954–965,

July 2018. DOI:10.1038/s41556-018-0140-1

MOT is a reliable

assessment for

activity in Parkinson’s


line Beyle et al have found that the

Multiple Object Test (MOT), especially

frequency of omission errors, is a

promising tool to rate Parkinson’s disease

(PD) patients objectively and might help


Average salt consumption safe for heart

Andrew Mente et al reports

that contrary to current

recommendations on salt intake,

average salt consumption, which is

around two and a half tea spoons

per day, is safe for the heart.

The latest research indicated

that for the vast majority of

individuals, sodium consumption

does not increase health risks

except for those who eat more than

five grams a day, the equivalent of

2.5 teaspoons of salt. Since fewer

than five per cent of individuals in

developed countries exceed this

level, the research may position salt

rather differently in future.

The international study

also shows that even for those

individuals who exceed the average

intake, there is good news. Any

health risk of sodium intake is

virtually eliminated if people

improve their diet quality by adding

fruits, vegetables, dairy foods,

potatoes, and other potassium rich


The research is conducted

by scientists of the Population

Health Research Institute (PHRI) of

McMaster University and Hamilton

Health Sciences, along with their

research colleagues from 21


The Lancet, 2018; 392 (10146): P496-

506, August 2018 DOI 10.1016/S0140-


to identify patients with a high risk for

having mild cognitive impairment or


Impairment in activity of daily

living (ADL) function is the most

crucial characteristic to differentiate

between mild cognitive impairment and

early stage dementia. In Parkinson’s

disease (PD), both motor and cognitive

impairment have the potential to affect

patients ADL function.

The study, aimed at evaluating the

worsening of cognitive-driven ADLs by

using the performance-based MOT test,

revealed a high Inter-rater Reliability (IRR)

for total processing time and number

of errors, confirming that the MOT is a

reliable assessment for ADL impairment

in PD.

PLOS One August


Role of gas exchange

variables in CPET and

management of HFrEF

Jonathan Wagner et al examined the

role of Cardiopulmonary Exercise

Testing (CPET) and its most commonly

used ventilatory gas exchange variables

for the purpose of risk stratification and

management of HFrEF (Heart Failure with

Reduced Ejection Fraction).

Researchers evaluated five widely

studied gas exchange variables from

CPET in HFrEF patients based on nine

previously used systematic criteria for

biomarkers. They found out that although

some CPET variables met more criteria

than others, evidence supporting the

clinical assessment of variables beyond

peak V . O2 (oxygen uptake) is wellestablished.

A multi-variable approach

also including the V . E-V . CO2 (V . E –

ventilation; V . CO2-carbon dioxide output)

slope and EOV (exercise oscillatory

ventilation) is therefore recommended.

American Heart Journal, Volume 202, Pages 116-

126. August 2018, DOI:


AI-aided diagnosis

for non-neoplastic

rectosigmoid polyps

Yuichi Mori et al have evaluated

the performance of real-time

computer-aided diagnosis (CAD) with

endocytoscopes. The study reveals

that the real-time CAD can achieve

the performance level required for

a diagnose-and-leave strategy for

diminutive, non-neoplastic rectosigmoid


CAD for colonoscopy may help

endoscopists distinguish neoplastic

polyps (adenomas) requiring resection

from non-neoplastic polyps not requiring

resection, potentially reducing cost.

The single-group, open-label,

prospective study was conducted in

791 consecutive patients undergoing

colonoscopy and 23 endoscopists at the

University hospital with real-time use of

CAD during colonoscopy.

Annals of Internal Medicine, August 2018. DOI:


Physical exercise

linked to mental

health burden


ammi R Chekroud et al reports a

study conducted among 1.2 million

Americans that individuals who exercised

had 43.2% fewer days of poor mental

health than individuals who did not

exercise, but were otherwise matched for

several physical and sociodemographic


The largest associations were seen

for popular team sports (22.3% lower),

cycling (21.6% lower), and aerobic and

gym activities (20.1% lower), as well as

durations of 45 min and frequencies of


three to five times per week.

The study also indicates that

more exercise was not always better.

Differences as a function of exercise

were large relative to other demographic

variables such as education and income.

Lancet Psychiatry, PIIS2215-

0366(18)30227August 2018. DOI:https://doi.



interaction induces

procoagulant activity

Christoph Klatt et al report the

results of a study that indicate

RBCs are essential for hemostasis and

arterial as well as venous thrombosis.

FasL-FasR–mediated cell-cell contact

between platelets and RBCs mediates PS

externalization on the RBC membrane

critical for platelet activation and

adhesion upon thrombus formation.

Thus, interfering with the FasL-FasR

interaction might be an innovative and

promising approach for a completely

novel antithrombotic strategy.

The Journal of Clinical Investigation, July 2018

Labour induction

vs expectant


William A. Grobman MD et al

evaluated the consequences of

induction of labour at 39 weeks

among low-risk nulliparous women,

and arrived at a conclusion that doing

so did not result in a significantly lower

frequency of a composite adverse

perinatal outcome, but it did result in

a significantly lower frequency of

cesarean delivery.

Before this study, the perinatal

and maternal consequences of

induction of labor at 39 weeks among

low-risk nulliparous women was


The multicentre trial randomly

assigned a total of 3062 women to

labor induction, and 3044 to expectant

management. The frequency of cesarean

delivery was found significantly lower

in the induction group than in the

expectant-management group.

New England Journal of Medicine 379:513-523

August 2018 DOI: 10.1056/NEJMoa1800566

Alcohol abstention may increase

risk of dementia

Séverine Sabia, et al in a study

“Alcohol consumption and risk

of dementia: 23-year follow-up of

Whitehall II cohort study” revealed

the risk of dementia was increased in

people who abstained from alcohol

in midlife or consumed >14 units/

week. In several countries, guidelines

define thresholds for harmful alcohol

consumption much higher than 14

units/week. The present findings

encourage the downward revision of

such guidelines to promote cognitive

health at older ages.

The study stresses upon the fact

that the number of people living

with dementia is expected to triple

by 2050 and in the absence of a

cure, prevention is key. The study

highlighted that both long-term

alcohol abstinence and excessive

alcohol consumption may increase

the risk of dementia.

BMJ, 362,k2927, August 2018


Low doses of 3


help achieve target BP

Ruth Webster et al report the findings

of the study conducted to assess

whether a low-dose triple combination

anti-hypertensive medication would

achieve better blood pressure (BP)

control vs usual care. They concluded

that treatment with low doses of 3 antihypertensive

drugs led to an increased

proportion of patients achieving their

target BP goal as compared to usual


The study used once-daily, fixed-dose

triple combination pill containing 20 mg

of telmisartan, 2.5 mg of amlodipine,

and 12.5 mg of chlorthalidone therapy as


The study concluded that among

patients with mild to moderate

hypertension, use of such medication as

initial therapy or to replace monotherapy

may be an effective way to improve BP


JAMA. 2018;320(6):566-579, August 2018.


—Compiled by Atiya Nishat


clinical practice



Will the recall of Voveran 1 ml injection from the Indian market affect clinical

management of pain across specialties? Experts comment


The Drug Controller General of India

(DCGI) banned the production of

the painkiller injectable diclofenac

sodium 75 mg/ml sold under the

brand name Voveran on July 4, 2018.

The regulator ordered therecall of the

product based on concerns raised by an

expert panel constituted by the health

ministry for the purpose.

In its recommendation, the

committee said that Transcutol-P as

an excipient in parenteral formulation

needs to be tested for its toxicity

independently in order to establish its

safety; since it is reportedly not an inert


"No evidence has been presented

before the Committee that it can be

used in parenteral formulations even

including Indian Pharmacopoeia,

especially on parenteral preparation for

human use," it says.

"Likewise, the data in a cumulative

form is indicative of its toxicity, which

entails a detailed study on its toxicity

and safety profile in line with the

observations given above. Whether

the same could be permitted for use

especially in the parenteral formulation

has to be decided by drug regulatory

authority as per provisions of drug

regulations on excipients to be used in

the parenteral form particularly those

which are reportedly not inert, as in the

present case," it said.

Subsequent to the report, the

regulator issued an order to the drug

licensing authorities in

Dehradun, Uttarakhand,

and Daman and Diu to

cancel the manufacturing

licence granted to Themis

Medicare for diclofenac

sodium injection 75 mg/

ml using theexcipient


Voveran 1ml, which

was sold in India at a

price of around Rs 129 a

pack (according to Apollo

Pharmacy website),

comprises non-steroidal


drug (NSAID) diclofenac sodium, to

reduce pain and inflammation. The

intramuscular injection has been

useful in treating a number of painful

conditions, including attacks of gout,

flare-ups, joint pain and back pain,

pain from kidney stone and pain from

injuries, making it an important part of

the arsenal across specialties dealing

with painful conditions.

Troikaa, one of the rival companies

producing diclofenac injection, has, in

a lawsuit, alleged that the excipient

Transcutol P could affect the health of

the patient, and thus do not benefit the

treatment per se.


As per a court directive, the

allegation on the safety and tolerability

of diethylene glycol monoethyl ether

(Transcutol-P) in diclofenac injection

has been considered by various expert

committees. The third and the latest

was by the expert committee which

submitted the recommendations in

December, 2017, and was headed by

Girish Sahni, who was then secretary of

Department of Scientific and Industrial

Research, Ministry of Science and


Novartis sells the drug under the

brand Voveran, while Themis Medicare,

which does contract manufacturing for

Novartis, sells it under Aquadol.Troikaa’s

diclofenac injection is branded Dynapar

AQ in the market.

The dispute of Gujarat-based

Troikaa Pharmaceuticals Ltd against the

painkiller injectable has entered a new

phase with the Indian drug regulator

ordering the withdrawal of the medicine

from the market.

For Novartis, the drug reportedly

contributed around Rs 250 crore of


“Diclofenac 1 ml injection forms

a small part of the larger Novartis

portfolio,” says a Novartis spokesperson.

While the dispute, which dates back

to 2015 when Troikaa approached the

authorities, may continue in the courts in

the future, the reaction from the medical

fraternity to the ban has been mixed.

Doctors are of diverse views about

the non-availability of the drug, which

was one of the less painful options in

the low-dose category.

For several years now, the drug has

been used to manage moderate pain

in rheumatoid arthritis and orthopaedic

treatments. Many physicians consider it

as the best option for treating moderate

pain regardless of the side effects which

any other painkiller drug might also


Will the ban have any significant

impact on pain management now?

Many say no, with good reason.

“The ban on Voveran is not going to

affect pain management at all, because

there are plenty of other options,” says

Dr Charu Singh, Professor & Head,

Anaesthesiology and Palliative Medicine,

Novartis says Transcutol P

well within the limit

spokesperson for Novartis India,

A which sells diclofenac 1 ml injection

under the brand name Voveran, gave

the following statement:

With respect to Transcutol P; based

on solubility studies performed by

Themis, Transcutol P is an extremely

efficient solvent for diclofenac and

present in the Diclofenac 1 ml injection

within safety limits.

It is important to understand that

Diclofenac 75 mg is recommended

twice daily and should not be given

for more than 2 days. Permissible

Daily Exposure (PDE) in animal studies

for intramuscular/intravenous routes

ranges from 434 mg/day to 784 mg/

day. Each 1 ml of diclofenac injection

contains 200 mg of Transcutol P,

keeping it well within the safety


Novel data provides evidence that

the toxicity previously associated with

high levels of impurities in Transcutol in

non-clinical studies is no longer valid.

It is specifically designed for






AIMS, Kochi. “We don't use diclofenac

injection for pain relief in our clinic.

NSAIDS, as a class of drugs, can cause

severe gastric side effects, besides

renal toxicity. So when we want to use

an NSAID, we prefer the ones having

lesser side-effects, such as ibuprofen or


If one needs an NSAID, the rule is

to have it at the lowest possible dose

at the lowest number of times. Smaller

doses and shorter durations, that is the

use by the parenteral route. Current

pharmaceutical grade Transcutol P is

>99.8% pure. Gattefosse, the global

supplier of Transcutol P, has all the

required safety/toxicology data for

this. Transcutol P is also used in the

parenteral route in the CIS countries

and Korea.

Transcutol P is listed in the Indian

Pharmacopeia (IP) 2018, which does

not restrict its parenteral use. Also,

the British Pharmacopeia and the

European Pharmacopeia do not restrict

the use of Transcutol P in parenteral

formulations and Transcutol P is listed

in the Handbook of Pharmaceutical

Excipients, 7th edition, Washington DC,

for parenteral use. No global regulator

anywhere in the world has called

for the withdrawal of any parenteral

formulation containing Transcutol P.

thumb rule when it comes to NSAIDS,

she added.

Five years back, Voveran was one

of the most frequently used pain

management medicine in its segment

and a ban would have meant a serious

challenge to the doctors. However, in

the past three to four years, several

alternatives emerged. They also have

certain advantages, like less pain to

the patients and the ability to be used

intravenously, said an orthopedist from

Thiruvananthapuram, Kerala.

"Now, there are alternatives such as

tramadol injection, paracetamol injection

and others, which are more effective

and can be provided as an infusion," he


"We have not been using Voveran

for at least five years. We have

alternatives from the same non-steroidal

anti-inflammatory drug class to treat

pain," said the chief medical officer of a

hospital in Chennai.


public health



The world body plans to update the list every year to ensure basic minimum

range of lab facilities in the public health system


Several years ago, the World

Health Organisation (WHO)

published its List of Essential

Medicines, which most countries,

including India, adopted and modified

to create their own National List of

Essential Medicines (NLEM).

After lengthy deliberations that

began in March 2017, the WHO

has taken the initiative further and

published a model list which it has

named the Essential Diagnostics List

(EDL). The list has separate sections

for primary and secondary healthcare

establishments, and sub-sections for

disease-specific laboratory tests.

Thus, the general list in the primary

care section mentions commonly used

laboratory tests such as haemoglobin

estimation and WBC count, clinical

chemistry and immune-assays

including HbA1c and blood lactate

levels, while due emphasis is also given

to microbiology (blood and urine).








In the disease-specific sub-section

are tests for HIV, hepatitis-B antigen,

antibodies to HCV as well as various

species of Plasmodium and a whole

range of tests to diagnose TB.

The highlights of the second

section of the list are the tests which

should be available in healthcare

facilities with a good clinical laboratory

at hand. Here the clinical chemistry

list incorporates AST-ALT, alkaline

phosphatase, serum pH value and

blood gases along with BUN-creatinine

and several others.

“The disease-specific IVDs (in vitro

diagnostic tests) were selected from

WHO evidence-based guidelines,

which are referred to in the EDL with

links to the respective documents. An

additional factor considered by WHO


was the availability of evidence from

the WHO pre-qualification of in vitro

diagnostics programme or from other

WHO IVD assessment processes, as

applicable, which further support

the choice of certain diagnostic

test categories. Links to relevant

documents are provided in the EDL by

type of test,” the WHO document says.

In addition to the listing of the

individual laboratory tests, the WHO

document also provides a number

of supporting documents that

offer guidelines on how the tests

should be conducted. Although the

accompanying chart mentions the

testing devices and instruments

pre-qualified by the WHO, the two

processes – inclusion in EDL and prequalification

are totally independent

of each other. Pre-qualification by

the WHO is a requirement for those

vendors who would like to sell

healthcare devices, medicines and

other materials for WHO-funded health


“In order to effectively use the EDL

and adapt it to national needs, WHO

recognizes that member states will









need to consider a variety of factors.

These include, among others: local

demographics and burden of disease;

local disease elimination priorities; local

availability of treatments; training and

experience of available personnel; local

unmet needs and testing gaps; supply

chain and transport links; quality

assurance capacity; financial resources;

information technology capabilities and

environmental factors,” the document


The 35-page document announcing

the EDL was prepared by a Strategic

Advisory Group of Experts (SAGE)

after wide ranging consultations with

healthcare authorities across the world.

The draft document prepared by

SAGE was then published on the WHO

website in late 2017, and comments

were invited from stakeholders.

Finally, there was a four-day

symposium held at the WHO global

headquarters in Geneva from April 16

to 20, 2018, including an open session

held on the last day, after which the

EDL was published in mid-May.

While this is the first time the WHO

has examined the topic of laboratory

tests that support therapeutic

decisions in hospitals and clinics, the

intention is to make this an annual

exercise. The criteria for selection of

SAGE members for 2019 have already

been announced on the WHO website,

and applications have been invited

by the EDL secretariat. During the

next few years, the EDL is likely to be

expanded and rationalized, as more

and more countries adopt the model

list and their experiences are added to

the global database.

Whether the EDL would serve

the interests of the Indian public or

not will depend largely on how the

WHO recommendations are used. The

primary purpose behind the entire

exercise is to ensure that a basic

minimum range of laboratory facilities

are available in the public health

system. This is supposed to happen

through a tiered system of local and

regional reference laboratories. But in

India, the entire diagnostics industry

is highly fragmented and poorly

regulated (from the standpoint of

quality). Hence any effort to create

a countrywide network of pathology

laboratories is likely to face huge


Besides, if the NLEM experience

is anything to go by, the EDL could

also be an instrument for imposing

price control on the ubiquitous private

healthcare sector. This would ultimately

impact the manufacturers and

suppliers of diagnostic kits, needles,

syringes and other devices, possibly to

the detriment of all.


hospital news

Microsoft and Apollo launch

AI-powered CVD risk score

As part of Microsoft’s AI Network

for Healthcare initiative, Microsoft

India and Apollo Hospitals has

launched the first-ever AI-powered

Cardiovascular Disease Risk Score

API (application program interface),

designed specifically to predict

the risk of the disease in

the Indian population.

Doctors across

the Apollo network

of hospitals will now

be able to leverage

this AI-powered

API to predict the

risk of CVD and drive

preventive cardiac care

across the country.

Built on Microsoft

Azure, this API aims to determine

a more accurate CVD risk score for

the Indian population. It has been

developed using a combination of

applied AI and clinical expertise


trains citizens

on emergency


on a large sample of retrospective

data on health checks and coronary

events. The scoring considers risk

contributors including lifestyle

attributes such as diet, tobacco

and smoking preferences and

physical activity as well as

psychological stress and

anxiety as reflected via

the rate of respiration,

hypertension and

systolic and diastolic

blood pressure. The

score categorizes risk

into high, moderate

and minimal and

also provides insights

on the top modifiable

risk contributors, thereby

assisting physicians to consult

patients in a more holistic way,

while providing insights to patients

for lifestyle modification and timely



leneagles Hospitals India has launched ‘I am emergency

ready’ campaign to help minimize the risk factor during

medical emergencies by training citizens to administer

immediate care.

This programme will be conducted across four

metropolitan cities such as Mumbai, Chennai, Bengaluru and

Hyderabad at 9 hospitals of Gleneagles Global Hospitals and

Continental Hospitals.

‘I am emergency ready’ will educate local citizens

to handle different types of emergency situations be it

accidents, stroke, cardiac arrest, trauma etc.

Gleneagles Hospitals also plans to conduct BLS training

for individuals, corporates, everyday people like auto drive.

Pristine Organics in

pact with Aster CMI

on ketogenic diet

Pristine Organics, a Bangalorebased

nutraceutical company, has

joined hands with Aster CMI Hospital

to offer ketogenic dietary therapies

(KDTs) to children suffering from


KDTs are non-pharmacologic

treatments for intractable childhood

epilepsy. Ketogenic diets are high in

fat, has moderate protein and low

carbohydrate, which helps to control

seizures in children.

Pristine Organics has developed a

special ketogenic diet - MetaNutrition

KETO - which follows a 3:1 ketogenic

formula- suitable for children with

epilepsy. This product will be used by

the specialists at Aster CMI Hospital,

Neukids Centre.

The typical ‘classic’ ketogenic diet

provides 3 to 4 grams of fat for every

1 gram of carbohydrate and protein.

The planned diet involves special

ingredients to be weighed and

prepared according to the instruction

and counseling provided by the

dietitian with minimal deviation

expected from the patient.

Cytecare starts stereotactic radiosurgery centre

Cytecare Cancer Hospital and Brains

Neuro Spine Centre have set up

an advanced Neuro-Onco Centre to

provide stereotactic radiosurgery (SRS)

in Bengaluru.

The non-invasive SRS treats

the tumour without affecting the

normal tissues and blood vessels of

the brain. The only limitation is the

size of the tumour which should be

less than 3 cms. It can even treat

multiple tumours if they are within

the size limits at different locations in

the brain.

The total dosage required to

control the tumour is determined

using the data derived from MR

imaging and delivered by a team

of neurosurgeons, radiotherapists,

radiation physicists and at times an


The advantage is that the entire

required dosage can be delivered

to a tumour in a single day and

the treatment gets over in a few






By incorporating molecular diagnostics into decision-making when treating

infections, we may be able to stem the tide of chronic antibiotic overuse


THE DISCOVERY of antibiotics was a

significant milestone in healthcare

that resulted in a reduction in

morbidity and mortality caused by

bacterial infections. Ironically, better

access to antibiotics has resulted in

its overuse and misuse, leading to

development of resistance to these

antibiotics. Considering that infectious

diseases account for 20-25% of all

deaths in India, it is really a matter of

concern that our armamentarium of

antibiotics against infections is soon

going to become obsolete.

As per a recent report in the

Proceedings of the National Academy of

Sciences (2018), antibiotic usage more

than doubled in India in 15 years (2000

– 2015). Not only are antibiotics freely

available without prescriptions in India

but even when prescribed, an estimated

50-60% of these prescriptions are

unnecessary. The problem is not

limited to India. A large study in the

US published in 2013 showed that out

of 40 million people given antibiotics

for respiratory conditions, 27 million

did not really need it. In our country,

low healthcare spending, prevalence

of counterfeit antibiotics with suboptimal

dosing, and a high frequency of

incomplete antibiotic course (especially

among the lower income group where

antibiotics are used for symptomatic

relief instead of microbial eradication)

make the situation worse. In a majority

of cases, infections are empirically

treated in the absence of information

about the identity of the infectious

agent and antibiotic resistance in the

pathogen. This is a chronic problem

especially in critical care settings

where multiple high level antibiotics

are used. In a study conducted by

iGenetic Diagnostics in MUmbai, it was

found that while only 28% of patients

admitted in ICUs with CNS infections

had bacterial infections, almost all were

being empirically treated with high level

antibiotics. Long-term indiscriminate use

of antibiotics can also result in increased

invasive fungal infections as well as

increased morbidity due to drug

toxicity issues.

Exposure of microorganisms to

antibiotics results in drug-resistance.

These drugs kill susceptible pathogens,

and allow antibiotic-resistant ones

to proliferate. Broadspectrum

antimicrobials increase the selective

pressure on bacteria and result in the

emergence of multi-drug resistant

pathogens. Drug resistance develops

either by acquisition of genes that are

responsible for inactivating antibiotic

molecules or by target gene mutation.

The former is especially dangerous

as it can spread quickly by horizontal

gene transfer. Thus, antimicrobials

become ineffective leading to

persistent infections, and ultimately

result in the spread of these resistant

microbes in the community. As per the

World Health Organization’s (WHO’s)

“Antimicrobial Resistance- Global

Report on Surveillance” of 2014, the

incidence of resistance in common

pathogens like E. coli, K. pneumoniae

and S. aureus was about 50%. This

is quite alarming considering that no

new antibiotics have been developed

in the last 4 decades. Thus, AMR has

become a global health crisis which

could render even common infections


untreatable with existing antibiotics.

Evidence-based use of antibiotics

and de-escalation can go a long way in

curtailing the spread of AMR. For this,

detection of the pathogen and antibiotic

resistance patterns are absolutely critical.

Traditionally, this is done by microbial

culture and sensitivity which can easily

take around 72 hours for bacteria and

longer for fungi. Besides, microbiological

methods show false negativity in

patients pre-treated with antimicrobials,

and have low sensitivity for slow

growing, intracellular and fastidious

microbes. Additionally, most routine labs

cannot culture viruses and hence rely

only on serological tests for diagnosing

viral infections. These tests suffer from

low sensitivity and specificity.

Molecular methods overcome

the limitations of microbiological and

serological methods reducing the time

to results in identifying pathogens and

antibiotic resistance. In India, most

labs that do molecular diagnostics rely

on point-of-care (POC) devices that

currently suffer from low detection

limits, low specificity and detect

a limited range of organisms and

antibiotic resistance markers. This often

results in false negatives, erroneous

polymicrobial reports and low rates

of detection of both pathogens and

antimicrobial resistance. iGenetic

Diagnostics, which conducted the AMR

India study, have of late developed

highly sensitive molecular diagnostic

assays that quickly and accurately

pin-point the cause of infections and

antibiotic resistance. Using multiplexed

PCR assays, it can diagnose over a

100 pathogens including a variety of

bacteria, fungi, viruses and parasites

as well as antibiotic resistance within

8 hours. The assays are extensively

validated, highly specific, cover a wider

range of syndromes, detect many more

pathogens and according to clinicians, it

has detection limits that are far superior

to other molecular diagnostic tests

available in the market. In addition to

multiplexing the PCR assays to reduce

costs, this test also allow customization

of these diagnostic panels making them


iGenetic’s internal data shows that








the detection rates with comprehensive

syndromic evaluation panel is between

50-60% while cases where only single

or a limited number of pathogens were

ordered have abysmal detection rates

of about 12-15%. This shows that we

need a drastic change in our approach

to combating infections. In today’s

age where we are not geographically

limited, we need to consider a wider

array of pathogens. By incorporating

molecular diagnostics into decisionmaking

when treating infections, we

may be able to stem the tide of chronic

antibiotic overuse leading to antibiotic

resistance. This starts with educating

all stakeholders of the importance of

spending time and resources on rapid

diagnostics in the short-term to get

long-term benefits of conservation of

life-saving antibiotics.

A study conducted at the Jawaharlal

Institute of Postgraduate Medical

Education and Research (JIPMER),

Puducherry, India, showed that

molecular diagnostics reduced deaths

due to neonatal sepsis from 18% to 3%

along with decreasing the number of

antibiotics used per patient. This shows

that molecular diagnostics enables

evidence-based antibiotic use rather

than empirical antibiotic treatment with

broad-spectrum, high-level antibiotics.

These tests can be used effectively for

antibiotic stewardship programmes

aimed at reducing the spread of

antibiotic resistance. They also serve to

decrease healthcare costs by lowering

consumption of expensive 3rd-line

drugs, cut ICU/hospital stay and result

in better patient outcomes including

reduced morbidity and mortality.

The author is Director,

Molecular Genetics,

iGenetic Diagnostics Pvt

Ltd, Mumbai.



WebCardio to be rolled out

pan India by Dec

Kochi-based GadgEon Smart Systems

Pvt Ltd will launch its wireless multiday

holter, WebCardio, across India by

December. The IoT-based wireless holter

can continuously record ECG up to three

days. This innovative solution developed

by GadgEon using a biosensor platform

has already gone through clinical validation

and currently launched only in selected


“We are currently present in Kerala and

a few cities in other states. As the product

is well received in these markets, we are

planning to take it nationwide in another 3

to 4 months,” said Hariprasad V Nair, Chief

Executive Officer, GadgEon Systems Inc,

the US-based parent of GadgEon Smart


Explaining the advantages of

WebCardio, Aravind Ravikumar, Director-

Healthcare & Biomedical, GadgEon Smart

Systems, said that the nurse or technician

can view the ECG waveform after affixing

the ECG patch on patient, by wirelessly

pairing it with a companion mobile App.

This helps technician to ascertain the

quality of ECG before starting the holter

recording process. Once recording is

initiated, the patient can go

home and continue with their

normal activities. While,

its “Pay per Use model”

allows smaller clinics and

individual doctors to add

Holter monitoring to their

practice without any

capital investment.

“For the hospitals,

that already has

holter recorder,


would help

augmenting the

capacity without

any additional

Hariprasad V Nair and

Aravind Ravikumar

investment.” he


Zephyr Valve to

treat severe


Zephyr Endobronchial

Valve to treat breathing

difficulty associated with severe

emphysema received clearance in

the US.

The device is a less-invasive

treatment option for people

with emphysema who have

severe symptoms that have not

improved from taking medicines.

Zephyr Valves are similar in

size to pencil erasers. Doctors

can place them into the diseased

areas of the lung airways during

a procedure using a flexible

bronchoscope in a hospital


The design of the device is

intended to prevent air from

entering the damaged parts of

the lung and to allow trapped

air and fluids to escape. During

inhalation, the valves close,

preventing air from entering the

damaged part of the lung. During

Magnetic device for guiding sentinel node biopsies

The Magtrace and Sentimag

magnetic localization system

for guiding lymph node biopsies

in patients with breast cancer

undergoing mastectomy has received

marketing approval in the US.

The device uses magnetic

detection during sentinel

lymph node biopsy

procedures to identify

specific lymph nodes,

known as sentinel lymph

nodes, for surgical removal.

Testing the sentinel lymph

nodes indicates whether

the cancer has spread from

the breast.

The Sentimag System comprises a

sensitive magnetic sensing probe and

a base unit designed to detect small

amounts of Magtrace, the magnetic

tracer drug that is injected into breast


The Magtrace particles travel to

lymph nodes and become physically

trapped in them, facilitating

magnetic detection of the lymph


Following the injection of

Magtrace, the Sentimag probe is

applied to the patients’ skin in

areas closest to the tumour site

containing the lymph nodes.

The sensing of the magnetic

particles is indicated by changes in

audio and visual alerts from the base

unit, enabling the surgeon to move

the hand-held probe around the area

of the lymph nodes, and locate the

sentinel lymph node or nodes.

Currently, a sentinel lymph node

biopsy is performed after injection

of radioactive materials and/or blue

dye. This magnetic system will offer

an option for patients undergoing

mastectomy for their sentinel lymph

biopsy procedure that does not

require the injection of radioactive


The device is manufactured by

Endomagnetics Inc.


exhalation, the valves open,

letting out the trapped air,

relieving the pressure.

The Zephyr Valve device

is contraindicated for patients

with active lung infections;

those who are allergic to

nitinol, nickel, titanium or

silicone; active smokers and

those who are not able to

tolerate the bronchoscopic


Pulmonx’s Zephyr

Valve device was granted

Breakthrough Device

designation by USFDA.

60mm stapler for

da Vinci system

Intuitive Surgical’s fully

wristed 60mm stapler for

use with its da Vinci robotic

system received US FDA


The device, called

SureForm 60, is a singlepatient-use

60mm stapler

that offers 120 degrees of fully

wristed articulation.

Surgeons control SureForm

60 through the da Vinci

surgeon console, creating

an immediate connection

between clinical decisionmaking

and instrument action.

The da Vinci surgical

systems are designed to help

surgeons perform minimally

invasive surgery. Da Vinci

systems offer surgeons

high-definition 3D vision, a

magnified view, and robotic

Software for self-monitoring

of blood glucose


reaMed Advisor Pro, an artificial intelligence (AI)-

based diabetes treatment decision support software

has been granted De Novo approval by USFDA.

Advisor Pro is indicated to assist healthcare

providers in the management of people with type

1 diabetes who use insulin pumps and continuous

glucose monitoring (CGM).

DreaMed Advisor Pro is a cloud-based digital

solution generating insulin delivery recommendations

by analysing information from CGM, self-monitoring

blood glucose (SMBG), and insulin pump data.

Applying event-driven adaptive learning, Advisor

Pro refines its understanding for each individual and

sends recommendations to the healthcare provider

on how to optimize a patient’s insulin pump settings

for basal rate, carbohydrate ratio (CR) and correction

factor (CF).

and computer assistance.

Combining da Vinci’s

tremor filtration with SureForm

60’s tip stability and 120

degrees of articulation in all

directions may help provide

surgeons with precise stapler

manipulation and placement.

SureForm 60 uses

SmartFire technology—

integrated software that

optimizes stapler and staple

line performance. SmartFire

measures tissue compression

before and during staple

firing, making automatic

adjustments to the firing

process as staples are formed

and the transection is made.

SmartFire makes more than

1,000 measurements per

second, helping to ensure a

more consistent staple line,

while helping prevent tissue

damage, across a range of

tissue thicknesses.

SureForm 60 has general,

thoracic, gynecologic, urologic,

and pediatric indications. It is

compatible with the da Vinci

Xi and X surgical systems.

Normandy VBR

spine supporting


Normandy VBR

System, a cervical and

thoracolumbar expandable

corpectomy cage, will soon

be available for patients in

the US.

The Normandy VBR

System is an adjustable

height, vertebral body

replacement device that is

implanted into the vertebral

body space to provide

structural stability in skeletally

mature patients following

corpectomy or vertebrectomy.

The system comprises

spacers of various sizes

and options, to fit the

anatomical needs of a wide

variety of patients. The

device can be adjusted to

the required height after


The device is mechanically

locked at the required height

by means of a locking screw.

Each spacer has an axial hole

to allow autograft or allograft

to be packed inside each

spacer. Protrusions on the

superior and inferior surfaces

grip the endplates of the

adjacent vertebrae to resist


Components are

manufactured from titanium

alloy (Ti-6AL-4V) per ASTM


The Normandy VBR

System, made by Zavation,

is indicated for use in the

cervical spine (C2-C7) and

thoracolumbar spine (T1-

L5) in skeletally mature

patients for partial or total

replacement of a diseased

vertebral body due to tumour,

osteomyelitis, trauma or

for reconstruction following

corpectomy performed to

achieve decompression of the


spinal cord and neural tissues

in degenerative disorders.

Vascular access

devices for


The U.S. Food and Drug

Administration permitted

marketing of two catheterbased

devices, the Ellipsys

Vascular Access System and

the everlinQ endoAVF System,

to make connections to veins

and arteries for hemodialysis


The catheters are

designed to create what’s

called an arteriovenous (AV)

fistula in patients with chronic

kidney disease who need


The devices are designed

to create AV fistulas

percutaneously. A catheter is

inserted into a blood vessel in

the arm and is guided to the

site of the planned AV fistula.

The devices then deliver

energy to form a connection

between an upper forearm

artery and an adjacent vein.

The Ellipsys Vascular Access

System uses one catheter,

while the everlinQ

Eversense continuous glucose

monitoring system

Senseonics Holdings, Inc received

premarket approval for Eversense

Continuous Glucose Monitoring (CGM)

System to target people with

diabetes in the United States.

The CGM system features

an implantable glucose

sensor and provide longterm

continuous monitoring

for up to three months.

The Eversense System

consists of a fluorescencebased

sensor, a smart

transmitter worn over the sensor

to facilitate data communication, and a

mobile app for displaying glucose values,

trends and alerts. The sensor, which is

inserted subcutaneously in the upper

arm by a physician via a brief in-office

procedure, lasts up to three months,

thereby eliminating the need for patients

to self-administer the weekly or biweekly

sensor insertions required by traditional

CGM systems.

The system’s smart transmitter

interprets glucose data from the

sensor and sends it to the

system’s mobile application

via Bluetooth. It also

provides on-body vibratory

alerts for discretion

and added safety. The

transmitter can be removed

and recharged without

discarding the sensor.

The Eversense application

was based on the previously-reported

results of the PRECISE II U.S. pivotal trial

in which Eversense was studied in 90

adults with type 1 or type 2 diabetes

at eight clinical centres in the US to

demonstrate the system’s safety and

effectiveness over 90 days of continuous


endoAVF System uses two.

Before patients can start,

dialysis patients need to have

an AV fistula created. An AV

fistula is traditionally made

by surgically joining an artery

and a vein under the skin in

the arm. After some time, the

mature vein can then receive

the two needles used for

each hemodialysis session.

Surgically created AV fistulas

typically take several months

to heal, and for the vein to

mature before being usable

for hemodialysis.

The Ellipsys Vascular

Access System and everlinQ

endoAVF System were

reviewed through the De Novo

premarket review pathway, a

regulatory pathway for some

low-to-moderate-risk devices

of a new type.



Monsoon Rheumatology Summit turns

spotlight on scleroderma and SpA

India has already put its footprint on the world map of rheumatology, say experts

The first edition of Monsoon

Rheumatology Summit turned out

to be a big-time opportunity for the

clinicians in the field to gather the latest

information about the two most hotlydebated

subjects in rheumatology today:

scleroderma and spondyloarthropathy


An initiative of the Kerala chapter of

the Indian Rheumatology Association (IRA),

the three-day event comprising interactive

sessions and an international symposium

concluded on 22nd of July at Kochi, Kerala.

“Advances in scleroderma are of great

relevance to Indian rheumatologists,

though the disease is more common in

the west, currently. Spondyloarthropathy

is so important a subject that hardly a

day passes without a case of SpA in the

rheumatologist’s clinic,” said Dr Debashish

Danda, President, IRA, while inaugurating

the international symposium.

By choosing scleroderma and

spondyloarthropathy as theme subjects,

the organisers gave the summit a clear

focus and direction. India has already

put its footprint on the world map of

rheumatology, Dr Danda added.

Scleroderma, which commonly affects

women between the ages of 30 and 50,

is a group of autoimmune diseases that

often results in changes to the skin, blood

vessels, muscles and internal organs.

Statistics show that 35% to 40% of the

patients die within 5 years of scleroderma

disease. More than 4 lakh people are

suffering from this condition in India.

Spondyloarthritis attacks the spine. It

can also involve the skin, intestines and

the eyes. Seen more in men, the disease

should be identified and treated in the

initial stage. The IRA estimates that there

are more than 1 crore spondyloarthritis

patients in India.

International faculty on scleroderma

sessions in the meet included Dr. Dinesh

Khanna of University of Michigan, Prof.

Christopher Denton, Institute of Immunity

The response to this

first-time summit is so

overwhelming that we are

looking at organising the

event every alternate year.

Dr Padmanabha Shenoy

Founder of Center for

Rheumatism Excellence, Kochi

and Transplantation, Royal Free Hospital,

UK and Dr. Mohit Kapoor, University Health

Network, Toronto, Canada.

Among the spondyloarthropathy

experts who attended the conference

were Dr. Nigil Haroon, University of Toronto,

Prof. Georg Schett, Director of Department

of Internal Medicine at University of

Erlangen-Nuremberg, Germany, and Prof.

Ranjeny Thomas, University of Queensland

Diamantia Institute, Australia.

The aim of the Global Monsoon

Rheumatology Summit was to integrate

the initiatives to find remedies for

scleroderma and spondyloarthritis, said Dr

Padmanabha Shenoy, founder of Center

for Rheumatism Excellence (Dr. Shenoy’s

CARE), Kochi.

“This is the first time the meet is

being conducted. The response is so

overwhelming that we are looking at

organising the event every alternate

year,” said Dr Shenoy, who is also the

Rheumatologist Ambassador of Asia

Pacific League of Associations for


The summit also aims to to provide an

opportunity to the attendees to update

themselves on the latest developments

in the field as well as translate them to

clinical practice, he explained.

Over 300 rheumatologists from

India as well as the US, Canada, UK,

Singapore, Europe and GCC participated

in the summit.



Incidence of peripheral vascular

disease is very high in India: APVIC-X

Three-day session highlights the need for better-trained

clinicians to diagnose and treat PVD

Dr N. N. Khanna

The tenth edition of Asia Pacific

Vascular Intervention Congress

(APVIC-X) was held at The Taj

Palace Hotel, New Delhi from 29th

June to 1st July, 2018.

Organised by Asia Pacific Vascular

Society, the three-day meet was

conducted with a Fellows Course and

an Interventional Course dedicated

to Peripheral Vascular Interventions,

new techniques in the cardiovascular

field, live case transmission from

various centres and case-based


“Earlier, we were only targeting

the heart. Of course, we were saving

patients from heart attacks; but we

were losing patients to stroke and

we were having amputations and

renal failure. That is when we thought







that we have to look for disease in

other vascular beds, not just the

heart,” said Dr N. N. Khanna, Chairman

of Asia Pacific Vascular Society,

commenting on the relevance of the


The Fellows Course at the

event comprised of a wide range

of workshops, including simulation

-based training, hands- on workshops

on Duplex scanning, carotid, renal, iliac

and femoral stenting, closure devices,

endovenous laser therapy and venous


The APVIC-X also organised a

special session on “How to Write a

Good Manuscript” for acceptance into

American / Indexed Journals.

India has the highest incidence of

peripheral vascular disease, pointed

out Dr Khanna. PVD is not confined to

the leg, but is everywhere in the body,

he added. “Wherever blood vessels are

there, there is PVD.”

Most of the doctors in the field

in India are not adequately trained

to diagnose or treat PVDs. However,

their interest in learning peripheral

interventions has substantially

increased over these years.

Last year, 1,000 delegates and 50

international faculty participated in the

event. This year, it went up to 1,380

delegates and 82 international faculty.

The workshop base was also

expanded to 18 from just 8-10 in

APVIC-IX to cover the entire range

of vascular interventions, explained Dr

Khanna, who is also President

of International Society of

Endovascular Specialists (ISEVS -

Indian Chapter).

There used to be a shortage of

skilled vascular interventionists in India,

but not in coronary interventions.

Training programmes like APVIC

are making the paucity visible less

and less by equipping specialists

with peripheral vascular skills. Such

conferences have become more

sought after, with APVIC itself

emerging as the biggest vascular

course in South Asia, he added.



Upcoming conferences



1 - 2

3rd American College of

Physicians Indian Chapter


Lucknow, Uttar Pradesh



Regional meeting of

International Society for

Gynecologic Endoscopy


Pune, Maharashtra



All India Association for

Advancing Research in

Obesity Conference






Skull Base Surgery

Society of India (SBSSI)

Neurovascon 2018

Chennai, Tamil Nadu




Joint Annual meeting

of 18th Asian Oceanic

Society of Paediatric

Radiology (AOSPR) and

16th Indian Society of

Paediatric Radiology





Antifungal Resistance in

Candida and Aspergillus:

from Clinic to Clinical





Premier B2B Medical

Equipment Show 2018

New Delhi



IASTEM -463rd

International Conference

on Medical, Biological and

Pharmaceutical Sciences

Pune, Maharashtra


IASTEM -467th

International Conference

on Medical, Biological and

Pharmaceutical Sciences




ISER- 445th International

Conference on Science,

Health and Medicine





5- 7

42nd Annual Conference

of Indian Society for

Surgery of the Hand


Coimbatore, Tamil Nadu



Conference of the Indian

Society for the Study of


Bangalore, Karnataka



11 - 14

44th Annual Conference

of International Society

for Pediatric and

Adolescent Diabetes


Hyderabad, Telangana



Academics World 470th

International Conference

on Recent Advances

in Medical and Health


New Delhi


25 - 27

International Diabetes

Federation (IDF) Diabetes

Complications Congress


Hyderabad, Telangana



IASTEM -485th

International Conference

on Medical, Biological and

Pharmaceutical Sciences





Telemedicon 2018 - 14th

International Conference

of Telemedicine Society

of India

Amravati, Andhra




AOCMF Seminar -

Advances in Sleep Apnea

and Orthognathic

Chennai, Tamil Nadu




Respiratory Drug Delivery

(RDD) Asia Conference


Kochi, Kerala




15th International Child

Neurology Congress

Mumbai, Maharashtra



46th IPS National

Conference Mangalore


Mangalore, Karnataka




American Society of

Nuclear Cardiology

(ASNC) Society of Nuclear


Chandigarh, Chandigarh


30-Dec 4

19th Congress of the

International Society for

Burn Injuries (ISBI)

Gurugram, Delhi

The announced dates of the conferences may change


ook review





The Future of Medicine Is

in Your Hands

By Eric Topol

364 pp. Basic Books.

Technology is all around us. Some of

it is even starting to look a bit unreal.

Eric Topol, in his book “The Patient

Will See You Now - The Future of Medicine

Is in Your Hands”, talks about a soon-to-be

real world in which a patient, empowered

by technology, has a greater say in the

decisions pertaining to his health, or even

takes complete charge of his own medical


Unquestionably, smartphones, big data,

ubiquitous computing and the infinite

possibilities of the digital age signal a

change -- to emancipate the patient from

the bondage of paternalism which has

been ruling theme of medical profession for

thousands of years. The traditional, godlike

persona of the physician, or “the doctor

knows best” model, has been encouraged

throughout history, based on the simple

assumption that the healer possesses “a

body of knowledge and skills unavailable to

his patient.”

It remains a fact that there does exist a

knowledge gap between a doctor, who has

been extensively trained, and the individuals

without a medical background. This

knowledge chasm will continue to remain,

even after information and data becomes

accessible to all. But the question is about

shared decisions. The patient seldom has a

say in diagnostic and treatment decisions,

even though he or she has all the right to.

The great leveling force, information

technology, has now demolished the walls.

It has enabled open platforms, open access

and open science. And the time has come

for open medicine.

Topol sets the agenda for the transition

from autocratic to semi-autonomous


He envisions the day when smartphones

perform blood tests, while medical scans and

bloodstream-embedded biosensors pick up

genomic signals, and MRI scanners come “as

thin as a dime”.

The days are not far off when biosensors

that monitor the patient’s vitals, his









compliance with medications and even his

gait at home settings obviating the need for


A cardiologist and tech enthusiast,

Topol clearly sees the democratisation of

medicine on the threshold. He pictures it

as the emancipation of medicine to “a new

data science, with each individual capable

of calling the shots”, and the emancipation

of the patient from the shackles of

authoritarianism -- all guided by a powerful,

common smartphone pathway.






Chemotherapy —D-EECT


IQWave enhances traditional

chemotherapy with tumour-adapted

electric field and more controlled

distribution of it. This improves the

coverage of the electrical currents and

thereby improves the therapeutic effect.

Using the IQWave Probe, the physician

have choice of treating different size

of tumour affected area. This unique

technology makes it possible to treat

tumours that are hard to reach with

traditional electrochemotherapy

treatment - such as oral tumours and

tumours located at the root of the tongue,

among others. Thanks to its integrated

tumour-specific data base, the treating

doctors will be able to exchange data on

treated tumours. IQWave has a laptop

size design for ease of transport and


Unique treatment benefits

A train of 8 dynamic high voltage pulses

of 5kHz with a duration of 100µsec is

applied on the tumour cell.

The treatment is multi-dimensional,

which means that the pulses will travel

horizontally, vertically and diagonally

during the same treatment cycle, optimally

covering the tumour.

IQWave with only four electrodes

can minimise the risk of untreated

surfaces. Electrodes position can be

arranged to achieve two configurations –

12mm and 8 mm, depending on

size of treatment area.

Outcome of D-EECT

Rearrangement of the membrane

phospholipid bilayer occurs on the applied

area with the formation of hydrophilic

pores allowing the cytotoxic drug enter

into the nucleus and attack DNA.

Reversible effect called vascular lock leads

to capturing cytotoxic drug.

Exposure of tumour cells to the pulses

of electrical fields in itself can cause

apoptosis by electroporation.

In some cases, D-EECT (Dynamic-

ElectroEnhanced Chemotherapy)also

creates immunological effect by activating

the immune-system.

IQWave - Applications

ChemoTech’s IQWave, has treated

several cutaneous and subcutaneous

cancers regardless of tumour histology in

the areas of head and neck, breast, oral and

skin, among others. The focus is primarily

palliative, but the effect of the treatment

can also in some cases be curative.

An interesting article from Dr. Shramana

Banerjee on electrochemotherapy

treatment in breast cancer says

“Electrochemotherapy provides an

alternative treatment for patients that

have irradiated skin and an option

when all other therapies have failed.

One of the most promising aspects of

electrochemotherapy is its unique ability

to selectively kill tumour cells without

harming normal surrounding tissue as is

targeted by the application directly over

the lesions to be treated. Drug resistant

tumour cells in combination with

electrochemotherapy will allow cytotoxic

action potentiated up to 700 folds.

Electrochemotherapy may also be used

in adjunct to other forms of established

treatment such as radiotherapy; although

hypoxia causes radio-resistance,

electrochemotherapy agents have also

radio sensitizing effects that are further

amplified during electrochemotherapy.

This advantage may be utilized in the

development of combined therapeutic

treatment planning.”

Fast and effective treatment

IQWave has a significant advantage

of treating patients on outpatient

basis as the entire treatment including

preparation takes only about

45 minutes, - the patient stay in

hospital is less.

This is a sponsored article. FM editorial holds no responsibility for the information therein.



WebCardio – Multiday,

Disposable, Wireless Holter

Monitoring Solution for ECG


WebCardio is a Wireless, Disposable,

Multiday Holter monitor that can

continuously record ECG up to three

days. It can be used for detection and

quantification of Cardiac Arrhythmias

including Tachycardia, Bradycardia,

Pauses, Conduction delays and blocks,

Ventricular and Supraventricular beats

and runs, and Atrial fibrillation.

The WebCardio solution developed

by GadgEon using LifeSignals’ USFDA

cleared Biosensor Platform, has gone

through clinical validation and

commercially launched in selected cities.

The WebCardio solution consists of

a body worn disposable ECG patch,

a companion mobile App and cloud

based Rhythm interpretation and

report generation service. The nurse or

technician can view the ECG waveform

after affixing the ECG patch on the

patient, by wirelessly pairing it with

a companion mobile App. This helps

technician to ascertain the quality of

ECG before starting the Holter recording

process. Once recording is initiated, the

patient can go home and continue with

their normal activities. The ECG Patch

shall continuously acquire and store the

data in its memory. The stored ECG data

is automatically transferred wirelessly

to the already paired mobile app at a

periodic interval. This data is then pushed

to the cloud server from the Mobile

App, when cellular network is available.

The patch can be worn by the patient

up to 72 hours as prescribed by the


Once the complete ECG data is

available in the server, a team of qualified

cardiac technicians analyzes the ECG

and creates the report using USFDA

approved Holter analysis software.

Reports and the full disclosure ECG

are then made available online to the

doctor. The report shall optionally be

emailed to the clinical personnel.

The WebCardio “Pay per Use model”

allows smaller clinics and individual

doctors to add Holter monitoring to their

practice without any capital investment.

For the hospitals, that already has

Holter recorder, WebCardio solution

would help to augment the capacity

without any additional capital

investment and also helps to provide

extended Holter monitoring service of up

to 72 hours.

WebCardio solution improves the

productivity and reduces the workload of

hospital personnel (nurse, technician) as

ECG patch can be easily administered on a

patient compared to a traditional multiple

lead Holter recorders. Further, the analysis

and report generation is available as

service from WebCardio. The small size

and compact design of ECG patch helps

the patient to continue with normal

daily activity, resulting in improving the

diagnostic yield with better compliance

and long-term monitoring. The cloud

based wireless solution of WebCardio also

helps the patient by reducing the

hassles and costs related to multiple visits

to hospital.

WebCardio will soon add more features

to evolve into a comprehensive Remote

patient monitoring solution including near

real time monitoring services and support

for multiple vital parameters. It will

also have variants to support various

inhospital use cases. With Machine

learning and AI capabilities integrated,

WebCardio will deliver advanced

diagnostic decision support system,

which enables predictive and proactive

healthcare services. Riding on the

current mobile revolution, WebCardio

also helps to meet telemedicine needs to

rural segment.

This is a sponsored article. FM editorial holds no responsibility for the information therein.





Founder and Chairman, Apollo Group of Hospitals

Doctors always enjoyed a credible position

in the community as people listen to them

with love and respect. But now, it is time for

them to take on the additional role of mentors of

the society to bring in the much needed change

and groom the people to stay healthy. This is an

urgent need now, as the entire world and India in

particular, is under the serious threat of a rapidly

advancing ‘tsunami’ called non-communicable

diseases (NCDs).

There are young people dying of heart attack,

cancer and diabetes. India has already become the

world capital of diabetes. Cardiovascular disease is

the largest cause of death in India. Cancer is fast

spreading across age groups. But, the fact remains

that all these diseases are preventable.

What is immediately needed is a strong

awareness among the public about how these

diseases can be prevented, and the responsibility

for that lies with the doctors, including myself. In

other words, we are the best people who can take

this initiative effectively to drive society to a healthy


This has happened in the developed world

sometime ago and that is the reason they could

control the vast spread of NCDs among the youth.

So, the time has come in our part of the world to

raise an army against NCDs, and the doctors should

be the Commandant Generals of that army.

I am doing this in my village, and I could mobilise

a team of doctors to actually motivate people to

stay healthy and avoid being a victim of life-style

diseases. The doctors have got the power to make

people practice what they say -- provided they

are sincere enough to bring the change -- instead

of getting them trapped in complex treatments,

economic loss and finally, premature death.

So it’s the duty of the new-age doctor to

wear the helmet that says: “Yes, I can make a


— As told to CH Unnikrishnan



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