Stephen G. Ellis, MD - Cleveland Clinic

Inside This Issue
Stephen G. Ellis, MD
No Boundaries
for Critical Care
Transport Team 3
Raising the
BAR in Lung
Transplant 4
Investigational
Heart Valve Uses
Magnets, Not
Stitches 6
First Implant of
Combination Aortic-
Mitral Allograft
Heart Valve 7
Cardiac
Consult
An Update for Physicians from Cleveland Clinic Heart and Vascular Institute | Fall 2008 | Vol. XVIII No. 3
New TAA
Stents Under
Investigation 12

Christopher Bajzer, MD Sean Lyden, MD
A. Marc Gillinov, MD
Medical Editors
Managing Editor
Marketing
Art Director
Photographers
clevelandclinic.org/heart
Page 2 | Cardiac Consult | Fall 08 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

No Boundaries for Critical Care Transport Team
On July 4, 2008, a teenage boy in Tennessee was hit full in the chest
with a projectile from a fi reworks mortar. He was admitted to his local
hospital with severe cardiac contusion. Over the course of the next week,
the boy’s condition deteriorated. He eventually went into cardiogenic
shock and fl ash pulmonary edema. To the Tennessee doctors, he looked
like a candidate for a left-ventricular assist device or heart transplant.
In any case, they knew he needed to get to Cleveland Clinic Heart &
Vascular Institute, fast.
Visit clevelandclinic.org/heart | Cardiac Consult | Fall 08 | Page 3

Raising the BAR in Lung Transplant
Currently, bronchial healing problems affect up to 15 to 20 percent of lung transplant patients after surgery.
Complications include the non-healing and dehiscence of the airway anastomosis. Bronchiolitis obliterans syndrome
with loss of lung function observed in many of the patients within a few years might also be related to the health of
the airways. A new lung transplantation technique being tested at Cleveland Clinic Heart & Vascular Institute appears
to reduce the incidence of bronchial healing problems. The technique is called bronchial arterial revascularization,
or BAR, and it represents a major departure from current practice.
Page 4 | Cardiac Consult | Fall 08 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

Ravi Nair, MD, Named Associate Director of
Sones Cardiac Catheterization Laboratories
Ravi N. Nair, MD, has been appointed to the Department of Cardiovascular
Medicine in the Cleveland Clinic Heart & Vascular Institute. He will serve
as associate director of the Sones Cardiac Catheterization Laboratories and
professor of medicine at the Lerner College of Medicine of Case Western
Reserve University.
New Cardiothoracic Surgeons Join Cleveland Clinic
Cleveland Clinic is pleased to announce the appointment of Douglas Johnston, MD, and Edward Soltesz, MD, MPH,
to the Department of Thoracic and Cardiovascular Surgery of the Heart & Vascular Institute. Both of these outstanding
surgeons completed advanced training in the department.
Visit clevelandclinic.org/heart
Dr. Johnston earned his medical degree at
Harvard Medical School, where he was an
HMS National Scholar. He completed his
internship and surgical residency at Massachusetts
General Hospital in Boston. As an American
College of Surgeons Resident Research
Scholar, he completed a Research Fellowship
in transplantation immunology, supported by
an NIH National Research Fellowship Award.
Dr. Johnston joined Cleveland Clinic as a resident
in Thoracic and Cardiovascular Surgery
in 2005. His specialty interests include aortic
valve and aortic root surgery, minimally invasive
cardiac surgery, re-operative heart surgery
and percutaneous valve replacement.
Dr. Soltesz earned his medical degree at
Harvard Medical School, along with a master’s
degree in public health. He completed
his residency in general surgery and cardiothoracic
surgery at Brigham and Women’s
Hospital in Boston. There, he was awarded
the Manic Research Fellowship for NIHfunded
research on cardiothoracic imaging.
At Cleveland Clinic, Dr. Soltesz completed an
additional fellowship in complex aortic and
endovascular surgery. His specialty interests
include minimally invasive cardiac surgery,
valve repair and replacement, endovascular
aortic surgery, percutaneous valve replacement
and re-operative heart surgery.
| Cardiac Consult | Fall 08 | Page 5

Magnets Could Save Stitch in Time
for Some Heart Valve Patients
Researchers are investigating a replaceable heart valve that uses magnets
rather than stitches to keep the valve in the proper position, an innovation that
could mean shorter surgeries, less time for patients on bypass machines, and
reduced risk of complications after repeat replacement of prosthetic valves.
Page 6 | Cardiac Consult | Fall 08 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

First Implant of Combination Aortic-Mitral
Allograft Heart Valve at Cleveland Clinic
The implantation of the first combination aortic-mitral
allograft heart valve, developed by CryoLife, was
performed in May by Jose Navia, MD, a cardiac surgeon
with the Cleveland Clinic Heart & Vascular Institute.
Role of Blood Vessel Protein Could
Be Key to Anti-Clotting Therapies
A protein normally associated with the development of blood vessels might also
render platelets more active and make people more susceptible to dangerous blood
clots. This discovery could lead to new therapies against unwanted blood clotting.
Visit clevelandclinic.org/heart
| Cardiac Consult | Fall 08 | Page 7

Racing Hearts Spur Search for Better Monitoring Technology
If patients complain about the inconveniences of ambulatory heart monitoring (sticky electrodes, bulky devices, etc.),
imagine how race car drivers feel. Driving 200 mph is not exactly conducive to impediments. But because their hearts
are pounding from the exertion, monitoring can be quite useful to their medical care.
Page 8 | Cardiac Consult | Fall 08 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

Cleveland Clinic Collaborates With Google
to Enhance Patients’ Healthcare Experience
One in every two Americans has at least one chronic
health condition. As a result, many are going online
to help manage their health.
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| Cardiac Consult | Fall 08 | Page 9

From the Cover
Cleveland Clinic to Launch Stem Cell
Studies for High-Risk Heart Patients
Page 10 | Cardiac Consult | Fall 08 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

This summer, Cleveland Clinic Heart & Vascular Institute launched new
stem cell clinical trials that may help challenging, high-risk heart patients.
In August 2008, we began enrolling
patients in two studies testing a high-risk
patient’s own stem cells to see if they can
improve heart muscle function.
Utilizing a patient’s own stem cells
eliminates the problem of rejection (such
as after a heart transplant requiring powerful
immunosuppressive drugs), as well
as overcoming potential ethical issues.
Although stem cells reside in small numbers
in many organs in the body, they are
present in the largest number in the bone
marrow and in fat tissue. Harvesting such
cells can be done with relatively light
sedation and local anesthesia.
“These exciting, new studies will test
therapies that may potentially bring
hope to patients with limited treatment
options,” explains Stephen G. Ellis, MD,
Section Head, Invasive and Interventional
Cardiology, Cleveland Clinic Heart &
Vascular Institute.
These studies, part of a fi ve-center
NIH-sponsored consortium, will
recruit patients over one to two years.
They include:
TIME – This fi rst study will examine
whether or not bone marrow aspiratederived
stem cells are better given at
three or seven days after heart attack
to improve heart muscle function.
The 204-patient REPAIR-AMI study
suggested greater improvement in
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ejection fraction and reduction in the
composite endpoint of death, reinfarction
or heart failure when stem cells were
given via the intracoronary route fi ve
to 10 days after infarction compared to
earlier (possibly due to the acute infl ammation
seen early after heart attack).
This NIH-funded study seeks to confi rm
or refute this important fi nding. Patients
have to have had a large anterior MI for
study entry and patients are randomized
2:1 two stem cells versus placebo.
LATE TIME – This study will test whether
similarly derived stem cells help heart
muscle function if they are given two to
three weeks after heart attack. Patients
have to have had a large anterior MI for
study entry and patients are randomized
2:1 two stem cells versus placebo.
A third trial using cells from a healthy
donor from Athersys Inc. is currently enrolling
patients with Acute MI and other
stem cell studies are planned. If the results
suggest benefi t, they will likely lead
to larger randomized trials to determine
whether or not such stem cells improve
patient longevity and freedom from severe
symptoms with an acceptable safety
profi le, says Dr. Ellis, who is the primary
investigator for the studies.
“Potential FDA approval for such
approaches is, therefore, a number
of years away, at best,” he notes.
We are currently accepting physician and patient-based referrals for Late Time.
Contact Linda Clarke at 216.445.6567.
Infl uencing Stem Cells to
Continue Healing Hearts
After a person suffers a heart
attack, the body sends out a
distress signal directing the patient’s
own as-yet undefi ned stem
cells to go to the heart. There
they “differentiate” into heart
tissue cells and start to repair the
damage. The trouble is, after a
short period of time, this homing
signal ends and the body stops
repairing itself. Is there a way to
keep that signal on — or even to
turn it back on later — so a patient’s
heart heals more naturally,
effi ciently and quickly?
Marc Penn, MD, PhD, Stem
Cell Biology and Regenerative
Medicine and Cleveland Clinic’s
Department of Cardiovascular
Medicine, discovered technologies
now being developed by
AcelleRX Therapeutics, which infl
uence a patient’s own stem cells
to travel to the site of the injured
heart tissue. The stem cells then
continue the tissue healing.
AcelleRX Therapeutics is building
its team with a goal to support
a Phase I clinical trial to treat
chronic heart failure patients
within the next 12 to 18 months.
| Cardiac Consult | Fall 08 | Page 11

Open Surgery vs. Endovascular Stent Grafting
for Descending Thoracic Aortic Aneurysms
Catastrophic rupture is often the first symptom of descending thoracic aortic aneurysms. Most aortic aneurysms
are asymptomatic up until shortly before rupture is imminent. Open surgery is the gold standard treatment
for aneurysms of the descending thoracic aorta, performed through a left thoracotomy or median sternotomy
depending on the location of the aneurysm.
For further reading:
Svensson LG, Kouchoukos NT, Miller DC, Bavaria JE, Coselli JS, Curi MA, Eggebrecht H, Elefteriades JA, Erbel R, Gleason TG, Lytle BW, Mitchell RS,
Nienaber CA, Roselli EE, Safi HJ, Shemin RJ, Sicard GA, Sundt TM, Szeto WY, Wheatley GH. Report From The Society of Thoracic Surgeons
Endovascular Surgery Task Force: Expert Consensus Document on the Treatment of Descending Thoracic Aortic Disease Using Endovascular Stent-Grafts.
3rd Annals of Thoracic Surgery, 2008 Jan;85(1 Suppl):S1-41.
Page 12 | Cardiac Consult | Fall 08 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

New Thoracic Aortic Aneurysm
Stents Under Investigation
Cleveland Clinic is participating in a number of clinical trials of stent grafts for use in patients with thoracic aortic aneurysms
(TAAs). These devices, says Cleveland Clinic vascular surgeon Matthew Eagleton, MD, may allow surgeons to treat more
TAA patients with stent grafts than previously possible. “These devices may prove effective in a wider patient population,
for instance, in those with aortas of larger diameters than can be treated with any stent grafts currently available,” he says.
The following trials are now enrolling patients:
Phase II Study of the Relay Thoracic Stent-Graft – The purpose of this
multi-center study, led at Cleveland Clinic by Dr. Eagleton, is to evaluate
the safety and efficacy of the Relay Thoracic Stent-Graft system,
manufactured by Bolton Medical, to treat TAAs.
Efficacy will be evaluated by the device-related adverse event rate of
endovascular repair (via Relay Thoracic Stent-Graft) through one year.
Safety will be evaluated by comparing major adverse events through one
year in subjects treated with the Relay Thoracic Stent-Graft to those who
underwent surgical repair. Subjects must be diagnosed with descending
thoracic aortic aneurysms, at least 18 years old and have anatomy that
can accommodate the device.
Endovascular Exclusion of Thoracic Aortic Aneurysms – This Phase I
study, led by Principal Investigator Roy K. Greenberg, MD, is assessing the
role of descending thoracic aortic aneurysm exclusion using a novel endovascular
prosthesis in high-risk surgical patients. Separate trial arms exist
for the treatment of ascending aortic aneurysms and dissections, symptomatic
or ruptured aneurysms, and aneurysms that involve branches in
the aortic arch (such as the carotid artery) or the abdomen (celiac artery).
Endovascular Exclusion of AAA Utilizing Fenestrated and Branched
Stent Grafts – This early evaluation of patients, led by Principal
Investigator Dr. Greenberg, is evaluating the role of the novel device to
abdominal and thoracoabdominal aortic aneurysms. The evaluation is
being conducted with subjects that would be expected to be at high
risk for undergoing open surgical repair.
More than 450 patients have been enrolled since 2001, and long-term
follow-up data is one of the primary goals for assessment. Candidates
include patients that are not suitable for endovascular repair with commercially
available infrarenal or thoracic devices. Customized devices
in this trial are used to incorporate the visceral (intestinal and kidney)
arteries or supra-aortic trunk vessels (subclavian, carotid or innominate
arteries) into the repair.
Valor II: The Valiant Thoracic Stent Graft System Clinical Study – This
study, led by site Primary Investigator Sean Lyden, MD, is investigating a
stent graft manufactured by Medtronic Endovascular that can be placed
in the aorta to exclude the weakened part of the artery wall and restore
blood flow. Information will be collected on the performance of the
device for five years.
The study’s primary outcome measures: Successful aneurysm treatment
at 12-month follow-up is the absence of both 1) aneurysm growth that
is > or = to 5 cm at the 12-month visit relative to the one-month visit,
and 2) Type I and/or Type III endoleak where a secondary procedure was
performed or recommended.
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Subjects must be ages 18 to 65 and considered a candidate for elective
surgical repair of the TAA (i.e., low-to-moderate risk at the time
of implant), have a descending thoracic aneurysm that is a maximum
diameter of 5 cm or larger or > 2 times the diameter of the
non-aneurysmal thoracic aorta, with anatomy meeting the protocol
parameters, and a thoracic aortic lesion confirmed, at a minimum,
by diagnostic contrast enhanced CT with optional 3-D reconstruction,
and/or contrast-enhanced magnetic resonance angiogram obtained
within the previous four months prior to screening. The multi-center
trial looks to enroll 125 patients.
STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair
with the Zenith TX2 Endovascular Graft – This multi-center trial, led at
Cleveland Clinic by Dr. Lyden, is studying the safety and effectiveness of
the Zenith ® TX2 TAA Endovascular Graft in the treatment of TAAs.
The Zenith TX2 is a reinforced fabric tube that is sized to the length
of the aorta that needs to be covered to seal off the aneurysm. The
graft is made of a polyester material like that used in open surgical
repair. Standard surgical suture is used to sew the graft material to a
frame of self-expanding stainless steel stents, which provide support.
Instead of making a large incision in the chest, the physician makes a
small incision near each hip to insert and guide the graft into place in
the aorta, relieving pressure on the aneurysm and helping to reduce
the risk of rupture.
The primary hypothesis for effectiveness is that patients treated with the
Zenith TX2 will have equivalent 30-day rupture-free survival compared
to the surgical control. A secondary hypothesis is treated subjects will
have equivalent or fewer complications compared to the surgical control
through 30 days following implant. Subjects must be diagnosed with aneurysms
of the descending thoracic aorta, candidates for either surgery
or endovascular repair and be at least 18 years old.
Evaluation of the GORE TAG Endoprosthesis-45 mm for the Primary
Treatment of the Descending Thoracic Aorta – This study, led by site
Primary Investigator Dr. Eagleton, is investigating the use of a stent
graft to treat thoracic aortic aneurysms in which the aorta above and
below the aneurysm extends up to 42 mm in diameter. The trial will
enroll a total of 35 patients, and outcomes will be assessed for up to
five years after enrollment.
To learn more: Members of the departments of Vascular Surgery and
Thoracic and Cardiovascular Surgery can evaluate each individual
patient to determine which trial, and which graft, best suits his/her
needs. For more information, or if you would like to refer a patient,
please call 216.444.4508 (vascular surgery) or 216.445.9288
(cardiothoracic surgery).
| Cardiac Consult | Fall 08 | Page 13

Unraveling Heart Hormone Mystery Could Mean
Treatments for Life-Threatening Hypertensive Disorders
More than 20 years ago, researchers discovered a hormone in the cells that
make up heart tissue that is essential to regulating blood pressure. It remained
unclear, however, what was responsible for activating the hormone.
Page 14 | Cardiac Consult | Fall 08 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

Clinical Achievements
Increasing Success with Aortic Valve Repair
Aortic valve repair, pioneered
at Cleveland Clinic by Delos M.
Cosgrove, MD, has been difficult
to achieve. However, with newer
modifications of the Cosgrove
Technique, surgeons in the Heart
& Vascular Institute have been
experiencing increasing success
in repairing leaky aortic valves
with different pathologies. For
patients with aneurysms and good, but leaking, aortic
valves, the “David” reimplantation procedure has
proved to be a highly successful means of preserving
the patient’s own valve. Lars Svensson, MD, PhD,
of the Heart & Vascular Institute, has found that for
patients with leaking valves and aortic root dilatation,
95 percent of cases can be repaired. In 2007,
47 valve-sparing operations were performed. Today
Heart & Vascular Institute surgeons repair or preserve
two-thirds of leaking bicuspid aortic valves, and they
preserve nearly half of leaking tricuspid aortic valves,
surpassing outcomes at other centers.
Pre-Formed Artificial Chordae for Mitral Valve Repair
A. Marc Gillinov, MD, in collaboration
with Biomedical Engineering,
former Cleveland Clinic heart
surgeon Michael Banbury, MD,
and CC Innovations, has developed
a system that simplifies
the intraoperative creation and attachment of artificial
chordae for valve repair. Called PreChords, the system
provides prepackaged, premeasured chords, plus a
fixation device that eliminates the need for suturing
inside the ventricle.
First U.S. Use of Robotics for Catheter Navigation
The Electrophysiology
Laboratories in the Heart
& Vascular Institute,
under Director Walid
Saliba, MD, was first
in the U.S. to install and use a new robotic system
designed to facilitate navigation of intracardiac
catheters into hard-to-reach areas within the heart’s
atria, improving accuracy and stability.
Visit clevelandclinic.org/heart
CME Calendar
Physicians are welcome to attend the following upcoming symposia:
Cardiovascular CT Training Program 2008
Sept. 19-26
Cleveland Clinic Main Campus
Cleveland, Ohio
Cardio-Renal Summit
Oct. 4
Ritz Carlton
Cleveland, Ohio
Blood Management Summit
Oct. 13
InterContinental Hotel and Bank of America Conference Center
Cleveland, Ohio
21st Century Treatment of Heart Failure: Synchronizing
Surgical and Medical Therapies for Better Outcomes
Oct. 16-18
InterContinental Hotel and Bank of America Conference Center
Cleveland, Ohio
Platelet Response in Acute Coronary Syndrome
Oct. 18
Cleveland Clinic Administrative Campus
Beachwood, Ohio
Cardiovascular CT Training Program
Oct. 24-31
Cleveland Clinic Main Campus
Cleveland, Ohio
Pulmonary Hypertension Summit 2008
Nov. 8
InterContinental Hotel and Bank of America Conference Center
Cleveland, Ohio
Cardiovascular CT Training Program
Nov. 14-21
Cleveland Clinic Main Campus
Cleveland, Ohio
New Horizons in Cardiovascular Treatments
Cleveland Clinic Outreaching China
Dec. 11-13
Shanghai International Convention Center, Shanghai, China
Diastology & New Echo Technologies Summit Featuring:
Contrast Echo Mini Symposium
Feb. 4-7, 2009
Hyatt Regency Bonaventure Conference Center & Spa
Fort Lauderdale, Fla.
Cardiovascular Care: Legacy and Innovation
June 3-5, 2009
Cleveland Clinic
Cleveland, Ohio
For more information about the above events, call the Cleveland
Clinic Department of Continuing Education at 216.444.5696
or 800.762.8173, or visit clevelandclinicmeded.com.
| Cardiac Consult | Fall 08 | Page 15

DrConnect
Referrals
To refer cardiology patients, please call
216.444.6697 or 800.553.5056.
To refer surgical patients, call 877.843.2781.
New patients, in most cases, can be seen by
a cardiologist within one week of calling for an
appointment. Most patients requiring surgery
also can be accommodated within one week.
Special Assistance
for Out-of-State Patients
Establishing your own
DrConnect account is as
easy as 1, 2, 3.
1)
2)
3)
The Cleveland Clinic’s Medical Concierge program is a complimentary
service for patients who travel to Cleveland Clinic from outside
Ohio. Our patient care representatives facilitate and coordinate the
scheduling of multiple medical appointments; provide access to
discounts on airline tickets and hotels, when available; make reservations
for hotel or housing accommodations; and arrange leisure
activities. For more information: call 800.223.2273, ext. 55580,
visit clevelandclinic.org/services, or email medicalconcierge@ccf.org.