Inside This Issue Benico Barzilai ... - Cleveland Clinic · Thoracic and Cardiovascular Surgery...

Legacy and Innovation: A Major Heart Convocation p4

CardiacConsult

Benico Barzilai, MD: New Head of Clinical Cardiology p3

Pathobiology and Therapeutics of Ischemia Reperfusion Injury p6

Percutaneous Therapies in the Spotlight p14

A New Era of Treatments for Aortic Aneurysms p18

Inside This Issue

Heart and Vascular News from Cleveland Clinic | Fall 2009 | Vol. XVIV No. 3

Featured Article

Introducing our Newest Centers- p8

Dear Colleagues,

Cleveland Clinic is celebrating its 15th straight year of being ranked No. 1 in

America for heart care in U.S.News & World Report’s annual “America’s Best

Hospitals” survey. We thank you, our referring physicians from around the world,

for making this possible. You honor us with your confidence and trust. Our goal

is to give you and your patients excellent service and restore each patient to your

care with the best possible outcome. You inspire us to get better every year.

We were thrilled that so many of our readers were able to attend The Treatment

of Cardiovascular Disease: Legacy and Innovation, at Cleveland Clinic in June.

More than 1,200 people attended this sold-out event, which included presenta-

tions by the leading heart and vascular specialists of our day. We all learned a

great deal from the give-and-take of these discussions, and are inspired by the

promise of future breakthroughs in the treatment of cardiovascular disease.

(See the photo-essay on Legacy and Innovation on page 4-5 of this issue.)

The future is the focus of several other articles in this issue of Cardiac Consult. Hot

topics include endovascular technology (p. 18), percutaneous therapies (p. 14) and

the ongoing investigation of stem cells and their therapeutic deployment for heart

disease (p.20). We also introduce our newest centers – providing multidisciplinary

care for the aorta, pericarditis, advanced ischemic heart disease, thrombosis and

hemostatis, and syncope (p.8) as well a discussion using genetic testing to identify

common cardiovascular diseases for better medical management (p.16).

We hope you enjoy these articles showcasing the latest developments in cardiac

and vascular care. Please feel free to contact us if you have any comments, ques-

tions or suggestions about this publication or our institute. And again, we thank

you for helping to make the Sydell and Arnold Miller Family Heart & Vascular

Institute the No. 1 heart program in America.

Sincerely,

Christopher Bajzer, MD Sean Lyden, MDAssociate Director, Peripheral Intervention Staff Surgeon, Interventional Cardiology Vascular Surgery

A. Marc Gillinov, MDThe Judith Dion Pyle Chair in Heart Valve ResearchThoracic and Cardiovascular Surgery

| Cardiac Consult | Fall 09 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

Cardiac Consult offers updates on state-of-the-art diagnostic and management techniques from Cleveland Clinic heart and vascular specialists. Please direct correspondence to:

Medical Editors

Christopher Bajzer, MDA. Marc Gillinov, MD Sean Lyden, MD [email protected]@[email protected]

Managing Editor

Ann Bungo

Art Director

Michael Viars

Marketing Manager

Megan Frankel

Marketing Associate

Jason Lansdale

Illustration

Mark Sabo

Photographers

Ken BaehrBenjamin Benschneider Don Gerda Russell Lee Willie McAllister Tom Merce Reen Nemeth Steve Travarca Paul Warchol

clevelandclinic.org/heart offers informa-tion on new procedures and services, clini-cal trials, and upcoming CME symposia, as well as recent issues of Cardiac Consult.

The Sydell and Arnold Miller Family Heart & Vascular Institute, ranked No. 1 in the nation for cardiac care by U.S.News & World Report every year since 1995, accommodates nearly 300,000 patient visits each year in world-class facilities. Staff are committed to researching and applying state-of-the-art diagnostic and management techniques. Cleveland Clinic is a not-for-profit, multispecialty academic medical center.

Cardiac Consult is written for physicians and should be relied upon for medical education purposes only. It does not provide a complete overview of the topics covered, and should not replace the inde-pendent judgment of a physician about the appropriateness or risks of a procedure for a given patient.

© The Cleveland Clinic Foundation 2009

Visit clevelandclinic.org/heart | Cardiac Consult | Fall 09 |

Benico Barzilai, MD: New Head of Clinical Cardiology

“We are extremely pleased to have such an established and

highly respected leader in the field of clinical cardiology join our

team,” says Steven Nissen, MD, Chairman of Cardiovascular

Medicine. “Clinical cardiology is a critically important section

of cardiovascular medicine, providing care for a wide range of

patients with conditions varying from the very common to rare

forms of heart disease – including those that have been identi-

fied as untreatable at other facilities.”

Dr. Barzilai recalls how he arrived at the field of clinical cardi-

ology. “I majored in biomedical engineering at Case Western

Reserve University, but found I was more attracted to the

physiology of the heart and the circulatory system than the

electronics I was studying,” he says. “When I was an intern

in the Coronary Care Unit at Washington University School of

Medicine in St. Louis, I found myself staying up all night trying

to take care of all of the sick patients. I was mesmerized by

the experience and have never looked back.”

In his new position, Dr. Barzilai has set an important goal.

“As the Section Head of Clinical Cardiology, I hope to make the

section the portal by which many patients come to Cleveland

Clinic,” he explains. “Many patients have very complicated

medical histories, and it is unclear the contribution of the heart

to the patients’ complaints. I look to the talented clinicians

in our section to define the extent of heart disease in these

patients and come up with a rational treatment plan.”

Dr. Barzilai adds that, “In keeping with Cleveland Clinic’s mis-

sion, I also feel it’s important to continue to study the role of

new medicine and new techniques for our patients.”

Prior to his appointment to the Cleveland Clinic staff in

2009, Dr. Barzilai had been a long-time member of the staff

at Barnes-Jewish Hospital-Washington University School of

Medicine in St. Louis, Mo. Most recently, he was Director of

the Vascular Heart Disease Clinic at Barnes-Jewish Hospital

and Professor of Medicine there, positions he has held since

2006. Since 1992, he also has served as Director of the

Adult Cardiology Fellowship Training Program. He earned

the Neville Award for Clinical Excellence in 2005.

A native of Chicago, Dr. Barzilai is a 1978 graduate of the Uni-

versity of Illinois School of Medicine. He served his internship

and residency at Barnes-Jewish Hospital-Washington Univer-

sity School of Medicine, followed by a fellowship in cardiology

there, which he completed in 1984. He has held an academic

appointment at the Washington University School of Medicine

since 1984.

Dr. Barzilai has a long-standing interest in coronary artery

disease and valvular disease. The Center for Treatment of Val-

vular Heart Disease at Barnes-Jewish Hospital was established

under his leadership. He has published extensively in leading

journals, including the Journal of the American College of

Cardiology, Chest and Annals of Thoracic Surgery, on topics

including ultrasonic tissue characterization with real-time

integrated backscatter, quantitative ultrasonic characterization

of the nature of atherosclerotic plaques in the human aorta,

effects of myocardial contraction on ultrasonic backscatter be-

fore and after ischemia and changes in myocardial backscatter

throughout the cardiac cycle.

Contact Dr. Barzilai at 216.444.3410 or [email protected].

Benico Barzilai, MD, a well-regarded leader in cardio-vascular disease and treatment, has been named Section Head of Clinical Cardiology in the Robert and Suzanne Tomsich Family Department of Cardiovascular Medicine of the Miller Family Heart & Vascular Institute.


A Major Heart Convocation

In 1956, F. Mason Sones,

MD, discovered moving

cine-coronary angiography.

In 1967, Rene Favaloro,

MD, performed the world’s first

published coronary artery bypass.

In 2009, more than 1,200

heart care professionals gathered

to honor these milestones.

The Treatment of Cardiovascular Disease: Legacy and Innovation, a comprehensive international symposium, June 3-5, at Cleveland Clinic was a remarkable event. It was a reunion of legendary names in cardiovascular care, and a chance for heart specialists from around the world to measure the state of the art in cardiothoracic surgery, cardiovascular medicine, vascular surgery and their related disciplines. Attendees from across the United States and nearly 50 countries packed the auditoriums and conference rooms for presentations on topics ranging from Plaque Regression to the Heart-Brain Connection. Faculty included members of the Sydell and Arnold Miller Heart & Vascular Institute at Cleveland Clinic, and 47 distinguished guests from Johns Hopkins Medicine, Mayo Clinic, Masschusetts General Hospital and other leading centers.

Delos M. Cosgrove, MD, president and CEO of Cleveland Clinic, welcomed the group to the opening session. Bruce Lytle, MD, chairman of the Miller Family Heart & Vascular Institute at Cleveland Clinic, introduced keynote speaker Floyd D. Loop, MD, retired chairman and CEO of Cleveland Clinic and a former cardiac surgeon.

and

| Cardiac Consult | Fall 09 | Visit clevelandclinic.org/heart

(1) Morning Plenaries were held in the Cleveland Clinic Bank of America Conference Center. Many of the ses-sions were standing room only.

(2) Attendees from across the United States and nearly 50 countries could attend any of 35 different sessions on topics ranging from the management of lower extremity arterial disease, to heart-brain medicine.

(3) Joseph Sabik, MD, chairman of Thoracic and Cardiovascular Surgery, describes the newest techniques in coronary surgery, with a discussion comparing minimally invasive and conventional surgical outcomes.

(4) There was an abundance of exhi-bitors. Attendees learned about new products and devices, and some got a chance to try out a surgical robot.

(5) Leslie Cho, MD, director of the Women’s Cardiovascular Center, makes a point about prevention at a plenery moderated by Michael Modic, MD, chairman of the Neurological Institute, and including Michael Lauer, MD, of the NHLBI, Mario Garcia, MD, of New York’s Mt. Sinai Medical Center, and (far right) Stephen Nicholls, PhD.

(6) In the evening, attendees gathered for cocktails and conversation on the rooftop pavilion of the new Sydell and Arnold Miller Family Pavilion.

(7) Among the legends of cardiac sur-gery on hand were (left to right) former (1989-2004) CEO Floyd D. Loop, MD, Fawzy Estafanous, MD, the father of cardiac anesthesiology, and President and CEO Delos M. Cosgrove, MD.

(8) As the sun set on the last day of the conference, visiting cardiologist James Sechler, MD, said “There’s never been anything like it.”

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Examining the Pathobiology and Therapeutics of Ischemia Reperfusion Injury

Kenneth McCurry, MD, who recently joined Cleveland Clinic’s Department of Thoracic and Cardiovascular Surgery after serving as Director of the Lung and Heart-Lung Transplantation Program and Surgical Director of the Cardiac Transplant Program at the University of Pittsburgh Medical Center, is looking for answers to these questions in hopes of developing techniques, strategies, pharmacological agents or other approaches to try and protect the heart or lungs during the transplant process.

In his lab, Dr. McCurry is examining several therapeutic agents that might have a protective effect in heart and lung transplant models.

“One of the agents I’ve been studying in recent years is carbon monoxide,” Dr. McCurry says. “While it is toxic in higher doses, it is quite protective for ischemia reperfusion injury in lower doses.”

In previous studies, Dr. McCurry and colleagues found that carbon monoxide provides protection against oxidative stress via anti-inflammatory and cytoprotective actions as well as that a carbon monoxide-saturated preservation solution protects lung grafts from ischemia-reperfusion injury. He expects to report additional findings later this year.

A second agent Dr. McCurry has more recently begun examining is nitrite, a common anion in the body. “Nitrite is a metabolite of nitric oxide that appears to have a very significant protective effect against ischemia reperfusion injury,” he says.

“We are working to develop a delivery system for nitrite to a point where it can potentially be clinically evaluated in a clinical trial in lung transplantation.”

Dr. McCurry has been collaborating on this work with Mark T. Gladwin, MD, Director of the Hemostasis and Vascular Biology Research Institute at the University of Pittsburgh Medical Center, and hopes to secure funding for a multicenter study of nitrites in pulmonary and cardiac transplantation.

On the clinical research side, Dr. McCurry has recently focused on alternative immunosuppressive strategies for both heart and lung recipients, but lung recipients, in particular, because they suffer from amongst the worst outcomes of all organ transplants.

Together with John Fung, MD, PhD, Chairman of General Surgery and Hepato-Pancreato-Biliary and Transplant Surgery at Cleveland Clinic, Dr. McCurry hopes to begin studying a novel immunosuppressive strategy to better un-derstand the immunologic responses of the lungs and liver. To achieve this, Dr. McCurry is the Principal Investigator or a multi-institutional grant that is pending review at the National Institutes of Health.

“We’re interested in trying to understand the relationship of various parts of the immune system and how they each respond to different immunosuppressant strategies,” he says.

Also in the works, Dr. McCurry will be the chair of the data safety and monitoring board for a pivotal trial involving TransMedics, Inc. Organ Care System, a heart preservation device designed to keep the heart beating while being trans-ported from the donor to the recipient. He also is supplying input to the company for developing a similar device for lungs, which is currently being evaluated in Europe.

Contact Dr. McCurry at 216.445.9303 or [email protected].

Ischemia reperfusion injury not only causes acute problems within a day or two of heart and lung transplantation, it also can make organs more susceptible to rejection and decrease long-term survival rates. What hasn’t been fully explained is what causes that process. What are the triggers? What exacerbates it?


BriefIn

New Generation Heart Assist Device

Cleveland Clinic continues to offer the newest mechanical

circulatory assist devices available to support patients with

advanced heart failure. Cleveland Clinic surgeons have

implanted over 500 devices to date, including 48 device

implants in 2008.

Cleveland Clinic is currently

participating in a clinical trial

for the miniaturized, full-output

HeartWare™ Ventricular Assist

System for bridge-to-transplant ap-

plications. This device is designed

to be implanted in the pericardial

space, avoiding the abdominal

surgery generally required to implant other assist devices.

This less invasive implantation technique is expected to

lead to relatively short surgery time and faster recovery.

Improved Safety with New Chest Tube Drainage Design

Preventing the obstruction of surgical drainage tubes

inserted after heart, lung and trauma surgery has important

implications for both patient safety and comfort. Cleveland

Clinic researchers are collaborating in the development

of chest tube drainage systems that feature proprietary

drainage tubes and clearing mechanisms. These drainage

systems will help clinicians manage bleeding and clogging

in a safer fashion, as well as increase patient comfort and

improve patient outcomes.

Artificial Chordae for Mitral Valve Repair

A novel system for repairing or replacing mitral valve chor-

dae is currently being investigated. The PreChord System

consists of premeasured artificial chordae and a measuring/

attachment device that mechanically attaches the new

chordae with one simple maneuver — thereby reducing

surgeon and patient time in the operating room.

Transcathether Valve Delivery System

One of the challenges of transcatheter valve procedures is

the ability compress the tissue valve for ease of delivery.

A novel valve delivery is being investigated in which tissue

valves are processed, sterilized, crimped and preloaded

into a catheter based delivery system. The proprietary stent

design allows the valve to be crimped easily and secure

attachment to the annulus of the valve being replaced.

Sharing Knowledge: Cleveland Clinic Surgeons

Bring MIS Know-How Abroad

Two Cleveland Clinic surgeons recently spent time abroad

teaching minimally invasive heart surgery techniques so

that more patients can benefit from less pain, quicker

recoveries, fewer complications and shorter hospital stays.

Joseph F. Sabik, MD, Chairman of Thoracic and Cardio-

vascular Surgery, spent five days in India in June 2009

to perform the country’s first minimally invasive CABG

procedure. He operated at four different hospitals during

his stay, teaching the minimally invasive technique, which

costs the same as the open procedure, to surgeons there.

Cardiac Surgeon Tomislav Mihaljevic, MD, pictured above,

also spent time earlier this year in Singapore teaching robotic

mitral valve surgery to surgeons there.


Introducing Our Newest CentersSpecial Feature:


The institute model allows patients to better access the care they need through such specialized, multidisciplinary, disease-specific centers that integrate the expertise of cardiologists, interventional cardiologists, cardiothoracic surgeons, cardiac imaging specialists, electrophysiologists, vascular surgeons and others, into the comprehensive care of a single disease.

“This organization will allow us to bring a focused approach to these very difficult-to-manage patients,” says Bruce Lytle, MD, Chairman of the Miller Family Heart & Vascular Institute at Cleveland Clinic. “In addition, it will allow us to be more pro-active in the development of novel therapies and help provide a unified approach to patient care. We believe we will be able to provide patients with a one-stop approach to these difficult management problems and better therapies.”

These new centers join the ranks of our existing centers, including the Center for Atrial Fibrillation, Kaufman Center for Heart Failure, Center for Cardiac Electrophysiology and Pacing, Center for Preventive Cardiology and Rehabilitation, Center for Cardiovascular Imaging, Vascular Medicine Center and Women’s Cardiovascular Center.

Here is a closer look at each of the newly formed centers:

Aorta Center

Led by Lars Svensson, MD, PhD, the Cleveland Clinic Aorta Center is one of the largest aorta surgery practices in the United States.

The collaborative physician practice among heart and vascular surgeons, cardiologists, radiologists, and other medical special-ists allows for thorough evaluation, follow-up and treatments to meet the needs of each patient.

The Aorta Center’s surgeons have considerable experience and expertise in performing complex aortic operations, with just under 1,000 aorta procedures performed in 2008. These include ascending aorta, aortic arch, descending aorta, thoracoabdominal repairs and thoracic aorta endovascular stent graft procedures, all of which are performed by a mul-tidisciplinary team. During the last 10 years, 21 percent of open great vessel procedures performed at Cleveland Clinic were for life-threatening acute aortic dissections.

This year, five new centers – for aorta, pericardial diseases, advanced ischemic heart disease, hemostasis and thrombosis, and syncope and autonomic disorders – have been established within the Sydell and Arnold Miller Heart & Vascular Institute at Cleveland Clinic to care for patients with these complex disorders.


Center for the Diagnosis and Treatment of Pericardial Diseases

The Center for the Diagnosis and Treatment of Pericardial Diseases is a multidisciplinary specialty treatment group dedicated to the diagnosis and treatment of pericardial diseases – whether acute, chronic or recurrent.

Under the leadership of Allan Klein, MD, Director of Cardio-vascular Imaging Research and a staff cardiologist in the Sec-tion of Cardiovascular Imaging, the multidisciplinary center includes cardiologists, surgeons, rheumatologists, oncologists and infectious disease specialists to care for patients with a wide spectrum of pericardial diseases, including all types of pericarditis, pericardial cyst, pericardial tamponade, pericar-dial constriction, pericardial abscess and pericardial tumors.

Services offered include the latest imaging techniques, such as tissue Doppler imaging, color M-Mode Doppler, transesopha-geal echocardiography, MR and CT help to distinguish the specific type of pericarditis, detect complications of pericarditis and determine the best treatment. In some cases, specialized cardiac catheterization hemodynamic measurements with dual chamber catheters and respirometer are needed to pinpoint the diagnosis and target treatment. The center also offers surgical procedures for pericardial disease including pericardiectomy, percutaneous balloon pericardiotomy, pericardial window, and video-assisted thoracoscopic surgery (VATS).

Center for Advanced Ischemic Heart Disease

Headed by Wael A. Jaber, MD, Section of Cardiovascular Imaging, the Center for Advanced Ischemic Heart Disease brings a multi-disciplinary approach to the diagnosis and treatment of patients who have severe ischemic coronary heart disease and for whom the therapeutic options locally are limited.

The center consists of specialists from interventional cardiology, cardiothoracic surgery, cardiac imaging, electrophysiology, dietary management, risk factor control, anginal management, pain management, stem cell therapy and pharmacy.

The Center for Advanced Ischemic Heart Disease includes an outpatient clinic and regular meetings for the multi-disciplin-ary discussion of individual patients. The center will bring a focused approach to these difficult-to-manage patients and allow us to guide the managment of these patients to improve their symptoms and impact their prognosis.


Hemostasis and Thrombosis Center

Headed by John R. Bartholomew, MD, FACC, Section Head of Vascular Medicine, and Andrew E. Schade, MD, PhD, Depart-ment of Clinical Pathology, the Hemostasis and Thrombosis Center focuses on the prevention, diagnosis and acute and chronic management of patients with these conditions.

The multidisciplinary center includes specialists from the Miller Family Heart & Vascular Institute, Taussig Cancer Institute, Laboratory Medicine, Pediatrics, Genetics, Internal Medicine, Interventional Radiology, Cardiovascular and Vas-cular Surgery, Pharmacy and Lerner Research Institute who have a particular interest in these disorders.

The center effectively consolidates this expertise, as the un-derlying causes of bleeding and thrombotic conditions are not always known or identifiable. However, certain condi-tions attributed to both conditions are classified as heredi-tary states while others are acquired. In addition to physician visits, the center will coordinate important laboratory tests, ultrasound studies of the venous and arterial systems, pulse volume recordings, CT and MRI imaging, magnetic reso-nance venous and CT angiography, conventional angiogra-phy and pharmacy services.

Center for Syncope and Autonomic Disorders

The Center for Syncope and Autonomic Disorders, led by Fredrick Jaeger, DO, Director of the Cardiac Arrhythmia Monitoring Lab, Cardiovascular Medicine, was created to provide accurate diagnosis and appropriate treatment for patients with these disorders.

The multidisciplinary center includes specialists from elec-trophysiology and pacing, autonomic cardiologists, adult and pediatric autonomic neurologists, physical therapy, and others, who have extensive experience in treating patients with syncope or other neurogenic disorders, such as postural orthostatic tachycardia syndrome (POTS), progressive orthostatic hypoten-sion (POH) and other dysautonomia conditions.

Our team uses a full range of diagnostic tests including the head upright tilt test and hemodynamic, blood volume and autonomic reflex testing to evaluate patients. The center offers a wide spec-trum of treatments, including lifestyle modification, medication, pacemaker implantation and investigational therapies.

For more information

To refer patients for evaluation at any of our centers, call 216.444.6697 or 800.659.7822.


Initial event, October 2006:

A 73 year-old male widower with a remote history of smoking, hypertension, paroxysmal atrial

fibrillation and obesity presented to a local emergency room in Mississippi with severe back pain

and diaphoresis. Computed tomography (CT) demonstrated a distal (type B) aortic dissection.

He was treated with blood pressure control and discharged to home.

Referral to Cleveland Clinic, July 2007:

Follow-up imaging reportedly demonstrated aneurysmal growth of his aorta and he was recom-

mended to undergo surgical repair with a risk of death or paraplegia of greater than 30 percent.

Patient seeks a second opinion at Cleveland Clinic and is seen by cardiologist Ajay Bhargava, MD,

cardiovascular surgeon Eric Roselli, MD, and undergoes CT scan under the direction of cardiovas-

cular imaging specialist Paul Schoenhagen, MD. The CT scan of his chest, abdomen and pelvis

are performed using an individualized acquisition protocol with timing of contrast optimized to

visualize the diseased aorta and to minimize the dose of radiation exposure. It is determined that

his aortic aneurysm and dissection are not big enough at this time to warrant intervention. His

medication regimen is adjusted to better control his hypertension and dyslipidemia. He receives

council on weight loss and is instructed to avoid heavy lifting. Patient gets remarried.

Continued follow-up care, July 2007 – July 2008:

Repeated imaging studies performed at six-month intervals demonstrate significant aortic growth

despite well-controlled hypertension. Preoperative work-up includes cardiac catheterization with

interventional cardiologist Russell Raymond, DO, echocardiography, brain MRI and pulmonary

function studies, which demonstrate moderate chronic obstructive pulmonary disease that increases

his risk for open thoracoabdominal aortic aneurysm repair. Due to the complexities of his aortic dis-

section and the flow characteristics to his visceral and renal arteries, he is not a candidate for total

endovascular repair of his thoracoabdominal aorta either. Dr. Roselli recommends a staged hybrid

approach to replace his entire aorta using both endovascular and open surgical techniques.

First stage endovascular repair, August 15, 2008:

Dr. Roselli and the endovascular surgical team, including dedicated vascular anesthesia, nurs-

ing and radiologic technologists, perform thoracic stent-graft repair of the distal aortic arch and

descending thoracic aortic aneurysm to the level of the diaphragm through a small groin inci-

sion. Patient tolerates this well and is discharged to home on postoperative day 4.

Postoperative recovery from first-stage repair:

After six weeks, patient begins cardiac rehabilitation. He continues this exercise regimen at home

and loses an additional 25 pounds, but develops persistent atrial fibrillation for which he is evalu-

ated and treated medically by electrophysiologist Thomas Callahan, MD. After his routine three-

month postoperative visit and repeat aortic imaging with Dr. Roselli, they schedule his second

stage completion repair. He is in better shape now than when he first presented.

After surviving the acute event, patients with aortic dissection have a chronic disease and are managed by cardiologists, surgeons and imaging specialists at the Cleveland Clinic Aortic Center. Together, they tailor a treatment plan that in-cludes medical management, regularly scheduled aortic imaging, and careful timing of endovascular intervention and/or open surgical repair to eliminate the risk of aortic rupture and death while optimizing the patient’s quality of life.

Eric Roselli, MD

Case Study: Aortic Dissection


Second stage open completion repair, January 6, 2009:

Dr. Roselli and his cardiovascular surgical team, including cardiothoracic anesthesia, nursing and

perfusionists, perform total abdominal aortic repair from the level of the diaphragm to the iliac

arteries, with separate reconstruction of the visceral and renal arteries through a left flank incision

without disrupting the chest cavity using partial cardiopulmonary bypass support. Patient required

no blood transfusions for this procedure. After two days in the intensive care unit and seven in the

stepdown unit, he is discharged to home.

Follow-up, February and April 2009:

After six weeks and a visit with cardiology, he is cleared to once again begin stage 2 cardiac

rehabilitation. At three months, repeat aortic imaging demonstrates an intact repair of the entire

thoracoabdominal aorta with a stable stent-graft proximally and patent branch vessels distally.

(See Figure 1 above) He is still in atrial fibrillation and cleared for its definitive treatment.

Atrial fibrillation ablation, April 14, 2009:

Patient undergoes percutaneous ablation of his atrial fibrillation with Dr. Callahan and is now in

sinus rhythm. He will continue to follow his rhythm maintenance with Dr. Callahan and will have

regularly scheduled visits and aortic imaging with Drs. Roselli and Bhargava. The newlyweds are

planning a summer vacation.

This case is an excellent example of how the Aorta Center’s comprehensive multidisciplinary

approach enables patients to live longer and better quality lives. Contact Dr. Roselli at

216.444.0995 or [email protected].

First stage stentgraft repair

Second stage open repair

Figure (1)


An interview with Samir Kapadia, MD, Director of Cleveland Clinic’s Cardiac Cath Lab and an interventional cardiologist in the Robert and Suzanne Tomsich Department of Cardiovascular Medicine.

Q: Why are percutaneous treatments for aortic valve stenosis such an attractive

potential option?

A: Aortic stenosis is the most common valvular condition, affecting about 4 percent of

people who are 75 years of age. However, only one third of these patients who present

with severe aortic stenosis undergo aortic valve replacement because many of them are

considered too high-risk for standard valve replacement. Yet, the literature shows that if

we do not correct the aortic stenosis in these patients, the mortality is extremely high –

as high as almost 50 percent per year for symptomatic patients.

Clearly, something must be done. Yet, we are not able to do it with surgery. Many of these

patients are inoperable because they are older and have systemic problems, like lung prob-

lems, strokes, weak hearts, kidney problems or calcification, which makes it difficult to put

them on cardiopulmonary bypass.

This is why finding a minimally invasive way to replace the aortic valve, without stopping

the heart, could make such a big difference in these patients. First, there is a tremendous

need. Second, the current therapies are not able to fulfill this need of this growing older

population with a lot of co-morbidities. Third, recovery is another issue.

If you look at the surgical outcomes in these patients, there are quite a few patients who

do not die from the surgery, but do not end up with a functional lifestyle either – they are

in nursing homes for a long recovery, which takes a big toll on them. These are the reasons

why a lot of referring physicians don’t even send many aortic valve stenosis patients to

conventional surgery. It is also why it is so exciting and so important to have percutaneous

procedures for the aortic valve.

Q: What is the difference between minimally invasive surgery and percutaneous

or transcatheter valve replacement?

A: This is an extremely important question. The difference between the two is that percu-

taneous and transcatheter procedures are done in a beating heart without cardiopulmonary

bypass. This is a major advancement. Most of the time, the percutaneous or transcatheter

procedures are done without even vascular cut down. If it’s done with a transfermoral

approach, you cannot even see the incision.

Q: What are the complications associated with these percutaneous and transcatheter

procedures?

Vascular complications can occur when the procedure is performed from the groin or the

apex. The stroke rate is about 3 to 4 percent for both approaches. Another complication is

that the valve can move and embolize, requiring bypass surgery to retrieve it, if it is not in

the right place. This has happened in roughly 1 to 4 percent of cases.

The function of the replacement valves replaced by percutaneous or transcatheter procedures

are very similar to the surgically implanted valve and some patients have experienced minor

aortic regurgitation.

Samir Kapadia, MD

Percutaneous Therapies in the Spotlight


Q: Can you give us an update on the status of the PARTNER trial?

A: Certainly. There are currently at least 10 different companies developing aortic

valves. The only one that is available in the United States, currently under study protocol

(PARTNER Trial), is the Edwards SAPIEN transcatheter heart valve. Both the SAPIEN and

CoreValve’s CoreValve ReValving System have been approved for use in Europe.

In North America, enrollment in the multicenter Placement of Aortic Transcatheter Valves

(PARTNER) trial is about two-thirds of the way complete.

Enrollment in the second arm of the trial, which included patients deemed inoperable

who were randomized to receive either the Edwards SAPIEN transcatheter heart valve

or appropriate medical therapy, was completed in late 2008. Additional patients who

are deemed inoperable, however, are now being enrolled in a similar, separate random-

ized registry. Enrollment continues in the first arm. If enrollment continues according to

schedule, we will probably finish at the end of 2009 or beginning of 2010. We antici-

pate the results in the first part of 2011.

Q: What were the results of the previous feasibility study with the SAPIEN valve?

A: Prior to PARTNER, there was a feasibility study called Transcatheter Endovascular

Implantation of Valves (REVIVAL) that was conducted at four centers, including Cleveland

Clinic. Patients who were inoperable underwent valve replacement using the SAPIEN valve.

Findings suggest that patients did wonderfully, when compared to the predicted mortality.

The mean Society of Thoracic Surgeons (STS) score for these patients was 12.8 while the

mortality rate was 9 percent. When the patients referred to Cleveland Clinic for this study

were analyzed, it was seen that symptomatic patients with severe aortic stenosis have high

mortality if timely aortic valve replacement is not feasible. We found 20 percent of patients

referred for percutaneous aortic valve replacement underwent surgical valve replacement

with good outcomes while patients undergoing ballooning aortic valvuloplasty alone or no

intervention had unfavorable outcomes.

Q: Are there any other advances in percutaneous technology that you see on the horizon?

A: Percutaneous technology is one that is undeniably evolving. While percutaneous

therapies show great promise, there are changes underway to improve upon the limitations

of existing valves, such as making them smaller in diameter and repositionable, to make

them even more applicable. A number of such valves are already under development and

being tested in humans in Europe and South America.

We also shouldn’t limit our discussion of percutaneous technology to the aortic valve.

Similar advances in the mitral valve, tricuspid valve and pulmonary valve are in various

stages of development and could improve care for a much larger patient population.

Q: What advantages does Cleveland Clinic have in performing these procedures?

A: Here at Cleveland Clinic, we utilize a team approach that includes interventional cardi-

ologists, cardiovascular surgeons, cardiovascular imaging specialists and cardiac anaes-

thesiologists. This type of collaboration is essential for the success of this novel procedure.

Dr. E. Murat Tuzcu (interventional cardiologist) and Dr. Lars Svensson, (cardiac surgeon)

are the Co-Principle investigators in the PARTNER Trial. This team approach makes our

program stronger than any other program in the country.

Dr. Kapadia is Director of Cleveland Clinic’s Cardiac Cath Lab and has a special interest in

coronary, structural heart disease-related cardiac interventions as well as carotid and periph-

eral interventions. Dr. Kapadia has been involved as principal investigator or co-investigator

in numerous clinical trials related to percutaneous replacement of aortic valve, percutaneous

mitral valve repair, carotid stenting and PFO closure, to name a few. He has been invited to

present results of his research at national and international symposia and conferences.

Contact him at 216.444.6731 or [email protected].

Cleveland Clinic has been par-

ticipating in a feasibility study

(PARTNER - Placement of AoRTic

traNscathetER valves) to deter-

mine if the transcatheter approach

to AVR is a viable non-surgical

treatment option for high-risk

patients who are too ill to undergo

surgical aortic valve replacement.

This prospective randomized

clinical trial has two separate

treatment arms. The surgical arm

of the trial focuses on high-risk

patients who are candidates for

conventional open-heart sur-

gery. Those patients were evenly

randomized to receive either the

Edwards SAPIEN transcatheter

heart valve or surgical valve re-

placement. The medical manage-

ment arm of the trial focuses on

patients who are considered too

high-risk for conventional open-

heart surgery. Those patients were

evenly randomized to receive

either the Edwards SAPIEN trans-

catheter heart valve or appropriate

medical therapy.

The goal of the percutaneous valve

is to provide a less invasive thera-

peutic solution for these patients.

For transfemoral procedures, a

small groin incision is needed.

Transapical valve implantations

are done through a small chest

incision. Neither approach requires

cardiopulmonary bypass. These

procedures do require close collabo-

ration among cardiologists, cardiac

surgeons, imaging specialists, anes-

thesiologists and their teams.

The primary endpoint of the study

is mortality at one year; secondary

endpoints are valve performance

and quality-of-life indicators. The

aim for enrollment in the trial is

1,040 patients and it is expected to

be completed in 2010.

About the PARTNER Study


Genetic TestingHow Identifying Common Cardiovascular Disorders Helps Direct Medical Management

Discoveries made over the past decade are enabling physicians to take a more proactive role in the battle against hypertrophic cardiomyopathy (HCM) and a number of connective tissue disorders.

Today, nearly 500 patients are seen each year for genetic test-ing for cardiovascular disorders at Cleveland Clinic’s Center for Personalized Genetic Healthcare. Clinical geneticist Rocio Moran, MD, believes that number could be greater.

“There is a significant population of patients who never get referred to a genetic provider for one reason or another,” says Dr. Moran. Patients who present with a strong family history or symptoms suggestive of a genetically transmitted disease need to be considered for genetic testing and counseling.

B E N E F I T S O F T E S T I N G

There are numerous benefits to patients undergoing newly available genetic tests – the most prominent being that they can help direct medical management.

Dr. Moran uses connective tissue disorders to illustrate the advantages of using genetic testing to confirm a suspected diagnosis of Marfan, Loeys-Dietz or Ehlers-Danlos syndromes:

“Aortic diseases may have similar features, but it is important to understand underlying genetic causes because there can be distinct management differences.”

“For example, a patient with Loeys-Dietz syndrome with an aortic aneurysm could be a candidate for surgery at a smaller diameter than a patient with Marfan syndrome.”

Another significant difference is that patients with Marfan syndrome have aneurysms within the aorta, but those with Loeys-Dietz syndrome can have aneurysms anywhere along the arterial tree, Dr. Moran says. This means patients whose testing confirms Marfan syndrome are scanned only within the aorta while those with Loeys-Dietz syndrome are imaged along the entire arterial tree.

Genetic testing also can detect misdiagnosis. Dr. Moran says she often sees patients who believe they have a benign type of Ehlers-Danlos syndrome who actually have Loeys-Dietz syndrome. “Differentiating between them can have signifi-cant management differences,” she notes.

Additionally, genetic testing can help patients clarify their risk pre-symptomatically versus symptomatically. For instance, an individual whose parent had HCM may put them at in-creased risk for sudden cardiac death. These individuals have traditionally been monitored by periodic echocardiograms because there was no definitive way of knowing which side of the 50/50 chance to inherit the disease they fell on without genetic testing. Hence, testing can clarify this risk and prevent unnecessary screening and worry for those not carrying the spe-cific genetic mutations. “Genetic mutations for cardiomyopa-thies are no longer something that we read in journals or learn about from research laboratories,” says W.H. Wilson Tang, MD, a Cleveland Clinic cardiologist with joint appointments in the Genomic Medicine Institute, and Department of Cell Biology at the Lerner Research Institute. “In the past, clinicians would have had to wait until the patient developed signs and symp-toms or significant cardiac abnormalities before we recognize the condition and attempt to intervene. With clinical genetic testing now available, vulnerable individuals can be identi-fied and their families appropriately counseled, and we can start to explore the ability to prevent disease in this high-risk population. On the flip side, we do not need to monitor family members who do not carry the mutation and are not going to develop the disease themselves. This can be a relief.”


L I M I T A T I O N S O F T E S T I N G

Although genetic testing can be a useful tool in many cases, it does have limits – which patients should be educated about in advance.

One limitation is that the results of genetic testing are not always straightforward, for example, when variants of unknown clinical significance are identified. In these cases, additional information is necessary to be able to interpret and utilize the information for clinical decision making. Cleveland Clinic genetic counselor, Christina Rigelsky, MS, explains, “It’s easy for a patient, or even non-geneticist physicians, to believe that anything identified is the cause of their medical problem but that is not always the case.” In these situations, genetics professionals can help evalu-ate the variant and work collaboratively with the laboratory and managing physician to provide families with the most appropri-ate recommendations. Ms. Rigelsky believes this is one of the reasons genetic counseling should always precede genetic testing so patients know that the testing is not always black and white.

“Education before genetic testing can alleviate a lot of misconcep-tions and stress after testing is complete,” she states.

Another factor to be kept in mind is that some patients with a genetic abnormality never manifest the disease. In these cases, appropriate care may not be clear. Rather, careful follow-up and evaluation are warranted. “We still do not understand why some mutation carriers present with severe diseases while oth-ers may have minimal or no manifestations,” Dr. Moran says.

One barrier thus far to genetic testing has been its expense. While testing often comes with a hefty price tag, Dr. Moran says she be-lieves it’s a common misconception in the physician community that genetic testing is not covered by insurance. In many cases it is.

T H E N E X T F R O N T I E R

Right now, it isn’t known if the natural course of diseases can be altered through early identification. However, this discus-sion is one that cardiologists and cardiac surgeons are becom-ing increasingly involved in.

“While many patients and their physicians have taken for granted that the causes and consequences of their conditions are hardwired into their genes and therefore may not be affected by knowledge of genetic information, it is clear that the power of clinical genetic testing is the potential ability to identify patients before they mani-fest a disease and study the impact of interventions. As a result, some diseases or their consequences, such as sudden cardiac death or transplantation, may some day be avoidable,” says Dr. Tang.

I N T H E P I P E L I N E

At Cleveland Clinic, the genetics of cardiovascular diseases continue to be explored from many angles from novel discover-ies to clinical applications – one day perhaps leading to new genetic tests for additional conditions:

• Coronary artery disease – Since the discovery of the first gene linked to heart attack and coronary artery disease from the GeneQuest study in 2003 by Qing Wang, PhD, and colleagues at the Lerner Research Institute, the Cleveland Clinic Gene-Bank study led by Stanley Hazen, MD, PhD, has supported two Specialized Center for Clinically Oriented Research (SCCOR) grants from the National Institutes of Health (NIH) – a $17 million grant to understand the genetic influence on the risks of developing coronary artery disease (led by Edward Plow, PhD), and a $13.5 million grant to study the molecular causes of blood clots including genetic determinants (led by Roy Silverstein, MD). Several novel mechanisms into the develop-ment of atherosclerotic coronary artery disease have already been identified, and there is ongoing research to translate this knowledge into clinical practice. Also in collaboration with the NIH, Stephen Ellis, MD, is leading an effort to validate genes already identified by the NIH CardioGene study to predict restenosis following percutaneous coronary intervention.

• Atrial fibrillation – Mina Chung, MD, and Jonathan Smith, PhD, were recently awarded more than $2.6 million from the NIH to conduct a five-year genome-wide study to identify genetic variants of atrial fibrillation (AF). The team is conduct-ing the genome-wide analysis using single-nucleotide polymor-phisms (SNP) microarrays in patients with and without lone AF. Recently, Dr. Wang identified a specific mutation of the NUP155 gene that was associated with the development of AF from a large family with this condition.

• Cardiomyopathies – Dr. Tang is conducting prospective stud-ies to determine what factors may determine long-term disease progression in patients with inherited cardiomyopathies, includ-ing a recent research grant award to study the manifestations of a specific MYBPC3 mutation in the Amish community. In collaboration with Christine Moravec, MD, in Cleveland Clinic’s Kaufman Center for Heart Failure, Dr. Tang is leading an effort in a consortium of academic centers to link genetic findings specific to cardiomyopathies to the understanding of pathogenic mecha-nisms and the development of detectable biomarkers.

Researchers face many challenges in this complex field, but they are excited about its impact on the future of patient care.

“While the possibilities are endless, the pressing need is to help family members carrying inherited gene mutations to delay or even prevent their disease from developing,” says Dr. Tang.

“There is still much to learn, and we owe it to our patients to continue to search for answers.”

To refer a patient with aortic diseases, connective tissue disorders, or other diseases with a genetic component to the Center for Personalized Genetic Healthcare, call 216.444.9249. To refer a patient for evaluation of cardiomyopathies to the Cardiomyopathy Program at the Cleveland Clinic, call 216.444.2121.


Continuing advances in endovascular technology have created a new era of aortic aneurysm treatments. Endovascular stent-grafts are now used to treat the majority of aneurysm cases performed each year at Cleveland Clinic. As imaging technology and experi-ence advance, we are finding that endovascular repair of aneu-rysms can produce similar results to open surgical techniques, even in patients who are older and have more comorbidities.

“The real advantage is that we can offer high-risk patients with comorbidities an endovascular option that significantly improves their chances of survival over conventional open surgery,” says Eric Roselli, MD, staff surgeon in Cleveland Clinic’s Department of Thoracic and Cardiovascular Surgery.

A N E V O L V I N G T E C H N O L O G Y

In the late 1990s, Cleveland Clinic became one of the first major medical centers in the nation to treat aortic aneurysms with endovascular stent repair. Until recently, endovascular procedures were primarily used to treat abdominal aortic aneurysms (AAA). Today, surgeons in our Aorta Center increasingly use elective endovascular treatment for descending, thoracoabdominal and abdominal aortic aneurysm repairs.

In 2008, more than 1,000 aneurysms were treated at Cleveland Clinic. The Aorta Center brings together experts in Cardiothoracic Surgery, Vascular Surgery, Radiology and other consulting departments to carefully weigh the advantages and disadvantages of endovascular repair against conventional surgery for each patient.

“Endovascular surgery has a lower incidence of acute morbidity and mortality, and offers faster recovery than open conventional surgery,” explains Matt Eagleton, MD, staff surgeon in Cleveland Clinic’s Department of Vascular Surgery. “But leakage of the stent graft and its migration are possible.”

C O M P A R A B L E R E S U L T S

A 2008 Cleveland Clinic study published in Circulation compared the results of 352 patients who had endovascular aneurysm repair of descending or thoracoabdominal aortic aneurysms (TAA) with those of 372 patients who had open repair, focusing on mortality and spinal cord injury. Results showed similar prevalence of paraplegia and 30-day and 12-month mortality, regardless of repair technique. The highest risk for death and spinal cord injury was most closely correlated with the extent of the aneurysm, regardless of repair technique; patients with type II TAAA had the highest risk, and patients who had aneurysms confined to the thoracic aorta had the lowest risk.

“After treating hundreds of patients, our early outcomes research suggests endografting is equivalent to, if not better than, conventional open surgery in high-risk patients,” says Vascular Surgery Chairman Daniel Clair, MD.

A New Era of Treatments for Aortic Aneurysms

2008 Aorta Surgery Volume

610Open Ascending Aorta and

Aortic Arch Repairs

100 Open Descending Aorta and

Thoracoabdominal Repairs

96Open Abdominal Aortic

Aneursym Repairs

182Endovascular Descending Aorta

and Thoracoabdominal Repairs

149Endovascular Abdominal Aortic

Aneurysm Repairs


H Y B R I D R E P A I R S

In select patients, traditional operative techniques to repair lesions involving the aortic arch are potentially dangerous, while purely endo-vascular approaches are limited by the presence of vessels supplying the brain. Hybrid approaches – utilizing a combination of conventional open surgery and endovascular stent graft techniques – are valuable in treating these complex aneurysms.

The hybrid approaches, Dr. Roselli says, offer the durability of open surgery and the many advantages of less-invasive endovascular repair. New hybrid open/endovascular operating suites in the Sydell and Arnold Miller Family Pavilion at Cleveland Clinic allow both stages of these procedures to be completed in one setting.

While endovascular and hybrid options are increasingly the procedure of choice, there are some instances – such as in emergent settings, when aneurysms form in awkward places, or in aortas too twisted to allow a cath-eter to pass – in which open surgery remains the only alternative, he notes.

N E W E R D E S I G N S , M O R E C O M P L E X A N E U R Y S M S

One of the strengths of the Cleveland Clinic Aorta Center is its research trials that continuously evaluate the efficacy of stent grafts designed and developed by Cleveland Clinic surgeons and physicians. In addition, Cleveland Clinic participates in national research trials that evaluate commercial stent grafts.

These research efforts may allow surgeons to treat more patients with stent grafts than previously possible, Dr. Eagleton says.

Recent advances have made thoracoabdominal vessels and arch aneu-rysms involving the brachiocephalic vessels, as well as the juxtarenal and suprarenal vessels, now amenable to endovascular therapy. More-over, fenestrated and branched endografts also have been developed at Cleveland Clinic for treating complicated aneurysms that are adjacent to or incorporate visceral vessels.

Members of our Aorta Center can evaluate your patients to determine whether an endovascular, hybrid or open approach best suits their needs. For more information, or to refer a patient to Cleveland Clinic Aorta Center, please call 216.444.3500 or 877.8HEART1.

Critical Care Transport

Cleveland Clinic’s Acute Aortic Treatment Center provides rapid

transport, treatment and follow-up for patients with aortic dissection

and impending aneurysm rupture. The Center’s multidisciplinary

treatment team includes vascular and cardiothoracic physicians

and surgeons with expertise in aortic emergencies.

Call 877.379.CODE to expedite the transfer of patients with

acute aortic syndromes.


Cleveland Clinic is conducting research trials to determine

how to modify or enhance stem cells’ essential molecular

signals to enable them to heal muscles of the heart dam-

aged by MIs and chronic heart failure.

“The work that has guided Cleveland Clinic’s cardiovascular

cell research is the central concept that stem cell-based repair

of the heart tries to occur after AMI, but it is clinically inef-

ficient not due to the lack of stem cells, but due to the lack of

molecular signals that orchestrate this critical process,” says

Marc S. Penn, MD, PhD, Department of Stem Cell Biology

and Regenerative Medicine and the Robert and Suzanne

Tomsich Department of Cardiovascular Medicine. “Through

our research we are figuring out what those molecular signals

are, so we can induce cell repair. This is what differentiates

our research from others in the growing cardiovascular stem

cell research field.”

In January 2010, Dr. Penn expects to launch a new

Phase I clinical trial to determine the safety and efficacy

of stromal derived factor-1 (SDF-1) proprietary technol-

ogy developed by Cleveland Clinic. In preclinical studies,

animals that were injected with genes that express SDF-1

protein showed definite improvement in cardiac function

over those animals that were given control genes.

Dr. Penn says the goal of this new gene therapy is to

stimulate the recruitment of the patient’s stem cells to repair

the damaged heart tissue and to induce angiogenesis.

This trial is rather unique because most research involves

harvesting stem cells from patients and delivering them

directly into the heart via minimally invasive procedures

and specially designed catheters.

HealingStemCells

Following an acute myocardial infarction (AMI), the body automatically recruits stem cells from the bone marrow to repair damaged heart tissue. The problem, however, is the molecular signals that recruit the new stem cells stay on for only a short period. Consequently, damage to the myocardium is never repaired, which weakens its functionality and leads to chronic heart failure.


Cleveland Clinic also enrolled the first AMI patient who was

treated with a multipotent adult progenitor cell developed by

Cleveland-based biotech firm Athersys Inc. The first cohort of

the Phase I clinical trial thus far suggests the Athersys Multi-

Stem cell was administered safely and was well tolerated by

the patients. This Phase I trial is continuing to recruit patients.

In preclinical AMI models, MultiStem has shown the potential

to improve heart function. The MultiStem cells are derived from

bone marrow of qualified donors.

“MultiStem is being developed as an off-the-shelf product so

that it can be administered in the catherization lab at any hos-

pital while the patient is undergoing a stent procedure to open

the artery,” says Dr. Penn. “A Cricket Micro-Infusion Catheter, a

proprietary device developed by Mercatormed Systems, enables

physicians to rapidly and efficiently deliver the MultiStem cells

in to the damaged region of the heart.”

Cleveland Clinic’s Department of Stem Cell Biology and Regen-

erative Medicine also is a key clinical site for national stem cell

trials currently recruiting patients including trials being run by

the National Institutes of Health Cardiovascular Cell Therapy

Research Network. They include:

• IMPACT-DCM: Led at Cleveland Clinic by Nicholas Smedira,

MD, Cardiothoracic Surgery, this Phase II trial will examine

intramyocardial delivery of autologous bone marrow cells

in ischemic and non-ischemic patients with chronic heart

failure due to dilated cardimyopathy (DCM). Patients ran-

domized into the treatment group of the IMPACT-DCM trial

are treated with Cardiac Repair Cells (CRCs), an autologous,

mixed-cell product (Aastrom Biosciences) containing expand-

ed populations of stem and early progenitor cells produced

from a small sample of the patient’s own bone marrow. The

CRCs are injected into the heart muscle through minimally

invasive surgery. The IMPACT-DCM trial will determine the

safety and tolerability of CRCs compared to standard-of-care

in patients with DCM.

• MARVEL: This Phase II/III trial will assess safety and efficacy

of MyoCell (Bioheart) autologus clinical cell therapy into myo-

cardium post myocardial infarction to determine if adult stem

cells can improve heart function. After autologous myoblasts

are harvested from a patient’s skeletal muscle tissue, they are

isolated and expanded in culture in a closed system. When a

sufficient number of cells are estimated, they are taken from

culture, packaged in a suspension and injected directly into the

myocardium via the femoral artery.

• TIME: The trial, led by site PI Stephen G. Ellis, MD, Cardiovas-

cular Medicine, will provide stem cell infusions to patients three

days or seven days after they receive percutaneous coronary

intervention (PCI) for AMI. The study will evaluate the safety

and effectiveness of placing bone marrow derived stem cells into

the myocardium to improve its function following an AMI after

successful revascularization. What’s more, the study will help

determine the best time to deliver the stem cells after MI.

• Late TIME: Also led by Dr. Ellis, this trial is similar to the

TIME study. The only difference is that patients will receive

their own bone marrow derived stem cells two to three weeks

following AMI and PCI. For some patients, delaying the delivery

of stem cells two to three weeks after AMI may be better than

initiating treatment during the acute phase.

• FOCUS: This trial will assess the effectiveness of bone marrow

derived stem cell treatment for adults with chronic heart failure

due to a history of myocardial infarction. Some patients with

this condition, especially those with substantial scar tissue on

the myocardium’s wall, or patients with a particular heart struc-

ture, may not be eligible to receive standard treatments of coro-

nary artery bypass grafting or coronary angioplasty and stent

placement. The trial, led by Dr. Ellis, will evaluate whether bone

marrow derived stem cells may be an effective way to achieve

therapeutic angiogenesis and improvement in heart function.

To refer your patients to participate in one of these trials or for

additional information, please call the Department of Stem Cell

Biology and Regenerative Medicine at 866.289.6911.

Research focuses on unlocking mysteries of molecular signals to make adult stem cells heal hearts


Cleveland Clinic Children’s Hospital Welcomes New Pediatric Cardiologists

Cleveland Clinic Children’s Hospital is expanding the staff of pediatric cardiologists in the Center for Pediatric and Congenital Heart Disease.

Kenneth Zahka, MD, Fran Erenberg, MD, Alex Golden, MD, and Ernest Siwik, MD, joined the Department of Pediatric Cardiology in July.

This distinguished group expands the largest and most experienced team of pediatric cardiologists and cardiothoracic surgeons in northern Ohio and provides access for ap-pointments at convenient locations throughout the community. The staff sees patients at Cleveland Clinic’s main campus, Fairview Hospital, Hillcrest Hospital, Marymount Hospital, and at offices in Beachwood, Strongsville, Parma, Westlake, Medina, Lorain, Ashtabula and other facilities in the region.

Marshall Jacobs, MD, internationally recognized surgeon and investigator, has also joined the team as Director of Clinical Research. Dr. Jacobs has had a distinguished career in pediatric surgery while serving on the staffs at Children’s Hospital of Phila-delphia and St. Christopher’s Hospital for Children, Philadelphia, Pa.

Staff expertise in congenital heart repairs, cardiac transplantation, and the diagnosis and treatment of other complex heart conditions ensures that patients and families will receive the very best care available. Cleveland Clinic Children’s Hospital was recently ranked among the top hospitals for pediatric heart and heart surgery (the only ranked program in northern Ohio) in the U.S.News & World Report’s edition of America’s Best Children’s Hospital.

CME CalendarMedical professionals are invited to attend the following upcoming symposia:

Congenital Heart Disease in the

Adult: The Second Annual Ronald

and Helen Ross Symposium

Oct. 9

The Intercontinental Hotel &

Bank of America Conference Center

Cleveland, Ohio

2009 Heart-Brain Summit

Oct. 15-16

Sheraton Chicago Hotel & Towers

Chicago, Illinois

Cardiovascular CT

Training Program 2009

Nov. 13-20

Cleveland Clinic Main Campus

Cleveland, Ohio

Heart-Brain Summit 2010

September 2010

Ruvo Brain Institute

Las Vegas, Nevada

21st Century Treatment

of Heart Failure 2010

October 2010

The Intercontinental Hotel &

Bank of America Conference Center

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 ccfcme.org.Outcomes Data AvailableOur Outcomes books contain clinical outcomes data and information on

volumes, innovations, research and publications. To view Outcomes books for

many Cleveland Clinic institutes, visit clevelandclinic.org/quality/outcomes.

Heart & Vascular Institute

2008Outcomes

Visit clevelandclinic.org/heart | Cardiac Consult | Fall 09 |

DrConnect Make Your Next Report Electronic

DrConnect is an Internet-based service developed to provide our community physician colleagues real-time electronic medical record information about the treatment their patients receive at Cleveland Clinic.

After establishing a DrConnect account with a secure log-in name and password, referring physicians may identify office personnel to receive security rights, allowing DrConnect patient updates to be immediately integrated into a busy medical practice’s daily activities and workflow.

A single daily email notification containing the DrConnect Web address (URL) gives you one-click access to all newly released patient-related information, which is presented in easy-to-navigate “What’s New” screens for quick access and effective case and time management.

Establishing your own DrConnect account is easy. 1) Log onto drconnect.clevelandclinic.org. 2) Click on the OnLine Signup button. 3) Simply fill out your physician participant information, including choosing a secure password, and submit.

Medical Concierge Complimentary assistance for out-of-state patients

and families 800.223.2273, ext. 55580, or email

[email protected]

Global Patient ServicesComplimentary assistance for national and international

patients and families 001.216.444.8184 or visit

clevelandclinic.org/ic

HVI ReferralsTo refer cardiology patients, please call 216.444.6697 or 800.553.5056.

To refer surgical patients, call 877.843.2781.

Same-day Visits Now AvailableThe Miller Family Heart & Vascular Institute has begun offering same-day appointments

for new patients and follow-up visits. Patients who want or need to be seen immediately

will be scheduled with a HVI Cardiovascular Medicine staff member.

All same-day visits will be coordinated through our appointment office. To arrange a

same-day visit, call 216.444.6697 or 800.659.7822.

C L E V E L A N D C L I N I C A C C E S S G U I D E

The Cleveland Clinic Foundation9500 Euclid Avenue/AC311Cleveland, OH 44195

CardiacConsult

Cleveland Clinic Heart Care Ranked No. 1 for the 15th Consecutive Year by U.S.News & World ReportFor the fifteenth consecutive year, Cleveland Clinic has been

ranked No. 1 in the nation for heart care, according to the 2009

U.S.News & World Report “America’s Best Hospitals” survey.

The survey, released in July,

recognized Cleveland Clinic as

one of the nation’s best hospitals

overall, ranking Cleveland Clinic

as No. 4 in the country.

Twelve Cleveland Clinic programs

were listed among the Top 10 in

the United States, including seven

in the Top 5. Digestive disorders, urology and rheumatology were

ranked among the Top 2 programs in the country, and cancer

ranked No. 1 in Ohio. For details, visit, clevelandclinic.org.

Save the Date! Sheik Khalfia Medical City Conference: The Treatment of Cardiovascular DiseaseJanuary 25 – 27, 2010 | Dubai, United Arab Emirates | arabhealthonline.com/congress

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