FM SEPTEMBER 2018 ISSUE - digital edition

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
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
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
valve.
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
approval
from the US
FDA for a new
version of its transcatheter-clip-based
mitral
valve repairing system
MitraClip.
28 / FUTURE MEDICINE / SEPTEMBER 2018