inside this issue no boundaries for critical care bar in ... · nienaber ca, roselli ee, saﬁ hj,...

Raising the BAR in Lung Transplant 4

CardiacConsult

Stephen G. Ellis, MD

No Boundaries for Critical Care Transport Team 3

Investigational Heart Valve Uses Magnets, Not Stitches 6

First Implant of Combination Aortic-Mitral Allograft Heart Valve 7

New TAA Stents Under Investigation 12

Inside This Issue

An Update for Physicians from Cleveland Clinic Heart and Vascular Institute | Fall 2008 | Vol. XVIII No. 3

Christopher Bajzer, MD Sean Lyden, MD

A. Marc Gillinov, MD

| Cardiac Consult | Fall 08 | Cleveland Clinic’s toll-free physician referral number is 800.553.5056

Medical Editors

Managing Editor

Marketing

Art Director

Photographers

clevelandclinic.org/heart

Visit clevelandclinic.org/heart | Cardiac Consult | Fall 08 |

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.


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.

| Cardiac Consult | Fall 08 | Visit clevelandclinic.org/heart

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.

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 Massachu-setts General Hospital in Boston. As an Amer-ican 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 resi-dent in Thoracic and Cardiovascular Surgery in 2005. His specialty interests include aortic valve and aortic root surgery, minimally inva-sive cardiac surgery, re-operative heart surgery and percutaneous valve replacement.

New Cardiothoracic Surgeons Join Cleveland ClinicCleveland 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.

Dr. Soltesz earned his medical degree at Harvard Medical School, along with a mas-ter’s degree in public health. He completed his residency in general surgery and cardio-thoracic surgery at Brigham and Women’s Hospital in Boston. There, he was awarded the Manic Research Fellowship for NIH-funded 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 replace-ment and re-operative heart surgery.

Ravi Nair, MD, Named Associate Director of Sones Cardiac Catheterization Laboratories

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.


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 TherapiesA 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.

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.


Racing Hearts Spur Search for Better Monitoring Technology

One in every two Americans has at least one chronic health condition. As a result, many are going online to help manage their health.

Cleveland Clinic Collaborates With Google to Enhance Patients’ Healthcare Experience



Cleveland Clinic to Launch Stem Cell Studies for High-Risk Heart Patients

From the Cover


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 pow-

erful immunosuppressive drugs), as well

as overcoming potential ethical issues.

Although stem cells reside in small num-

bers 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 aspirate-

derived 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

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 am-

mation 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 en-

rolling patients with Acute MI and other

stem cell studies are planned. If the re-

sults 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 se-

vere 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.

Infl uencing Stem Cells to Continue Healing Hearts

After a person suffers a heart attack, the body sends out a distress signal directing the pa-tient’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 pa-tient’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 tech-nologies now being developed by AcelleRX Therapeutics, which in-fl 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.

This summer, Cleveland Clinic Heart & Vascular Institute launched new stem cell clinical trials that may help challenging, high-risk heart patients.

We are currently accepting physician and patient-based referrals for Late Time. Contact Linda Clarke at 216.445.6567.


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.

Open Surgery vs. Endovascular Stent Grafting for Descending Thoracic Aortic Aneurysms


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 evalu-ate 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 endo-vascular prosthesis in high-risk surgical patients. Separate trial arms exist for the treatment of ascending aortic aneurysms and dissections, symp-tomatic 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 com-mercially 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.

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.

Subjects must be ages 18 to 65 and considered a candidate for elec-tive surgical repair of the TAA (i.e., low-to-moderate risk at the time of implant), have a descending thoracic aneurysm that is a maxi-mum 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 an-eurysms 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).


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.

Unraveling Heart Hormone Mystery Could Mean Treatments for Life-Threatening Hypertensive Disorders


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.

Clinical AchievementsIncreasing 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 dilata-

tion, 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 collabo-

ration with Biomedical Engineer-

ing, former Cleveland Clinic heart

surgeon Michael Banbury, MD,

and CC Innovations, has devel-

oped 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.

CME Calendar

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.

DrConnectEstablishing your own DrConnect account is as easy as 1, 2, 3.

1)

2)

3)

Special Assistance for Out-of-State Patients

The Cleveland Clinic’s Medical Concierge program is a complimen-tary 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 reser-vations for hotel or housing accommodations; and arrange leisure activities. For more information: call 800.223.2273, ext. 55580, visit clevelandclinic.org/services, or email [email protected].

inside this issue no boundaries for critical care bar in ... · nienaber ca, roselli ee, saﬁ hj,...

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