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Breakthrough Procedure that Replaces Heart Valve

Heart Replacement Clinical Trial

Return to Heart Health Updates

Media Contact: Betty Olt
(516) 465-2645
bolt@nshs.edu

MANHASSET, NY – Participating in a national clinical trial to evaluate an alternative treatment option to replace a heart valve without open-heart surgery, cardiologists at North Shore University Hospital (NSUH) recently performed the new, less-invasive procedure on a Long Island patient who was considered high risk for the conventional surgery.

NSUH is among 40 hospitals in the nation and one of five in the New York metropolitan area selected for the Medtronic CoreValve US Clinical Trial, a study that will evaluate an investigational heart valve procedure for patients with severe aortic stenosis, or a narrowing of the heart valve.

Approximately 100,000 Americans, most of them over the age of 70, are diagnosed with aortic stenosis each year, but because of age or other serious medical conditions, are considered high risk or inoperable for open-heart surgery.

Edward Bialobzeski, an 84-year-old retired New York City police officer from Seaford, was the first patient at NSUH to receive the implant, known as the Medtronic CoreValve® system, to repair his damaged heart valve.

An avid fisherman and boater, Mr. Bialobzeski always enjoyed an active lifestyle and stayed in shape with regular walks at the Jones Beach boardwalk with his wife Dorothy. In the last few years, Mr. Bialobzeski experienced fatigue and shortness of breath with physical activity. His long-time cardiologist, Alan Scheinbach, DO, of North Seaford’s Massapequa Heart Group, diagnosed Mr. Bialobzeski with aortic stenosis. Because of a complex coronary artery bypass surgery he underwent 17 years earlier, Mr. Bialobzeski was a high risk for conventional aortic valve replacement surgery.

About a year ago, Dr. Scheinbach learned about the CoreValve clinical trial in which NSUH was planning to participate. Once the study was underway this spring at the hospital, Dr. Scheinbach referred Mr. Bialobzesk to Stanley Katz, MD, chief of cardiovascular services at NSUH, senior vice president of cardiovascular services at the North Shore-LIJ Health System and a primary investigator of the study.

“North Shore University Hospital is participating in the CoreValve US Clinical Trial to help evaluate the safety and effectiveness of this novel therapy for people who are in significant need of aortic valve replacement, but currently have few or no treatment options,” said Dr. Katz.

“Because open-heart surgery is currently the only available treatment option for these patients and because the risk of surgery can be significant for many patients, the medical community is enthusiastic about the less-invasive option for these patients,” said Alan Hartman, MD, North Shore-LIJ’s chairman of cardiothoracic surgery and the study’s other primary investigator. Rick Esposito, MD, a cardiac surgeon, and Bruce Rutkin, MD, an interventional cardiologists at NSUH, are co-investigators of the study.

In the US, the CoreValve System will not be commercially available until the successful completion of the clinical trial and approval by the US Food and Drug Administration (FDA). The Core Valve System is available in 40 countries and throughout Europe.

Similar to a technique to implant stents in clogged arteries, the CoreValve procedure involves physicians guiding a catheter, or thin tube, with a prosthetic valve through an opening in the patient’s femoral artery in the thigh to reach the heart. The prosthetic valve is placed in the aortic valve, where it expands with in the diseased aortic valve. The procedure is completed without open-heart surgery or surgical removal of the existing valve.

Aortic stenosis occurs when the aortic valve does not properly open and close, usually due to a build up of calcium, which restricts blood flow from the heart to the rest of the body. The reduced blood flow increases pressure within the heart, causing the heart to weaken and function poorly. Symptoms of the disease can include: fatigue, dizziness, chest pain or pressure, heart murmur, shortness of breath during activity, heart palpitations and fainting. When aortic stenosis becomes severe and symptoms develop, it is life-threatening.

“Aortic stenosis can cause a decline of functional capacity and people become less physically active, as in Mr. Bialobzeski’s case,” said Dr. Rutkin. “After the minimally invasive aortic procedure, Mr. Bialobzeski’s recovery was excellent. By the second day he was walking unassisted and he was discharged after four days in the hospital.”

As part of the clinical trial Mr. Bialobzesk’s recovery will be closely monitored by physicians at NSUH and his community cardiologist.

Noticing a difference in his condition when leaving the hospital, Mr. Bialobzeski said his “breathing was easier.” He said he is looking forward to logging many more miles on the Jones Beach boardwalk with his wife and enjoying time with his family, including two daughters, five grandchildren and his two-year old great-granddaughter. Grateful for the opportunity to participate in the clinical trial, Mr. Bialobzesk is also looking ahead to September, when he and his wife will celebrate their 60th wedding anniversary.

For more information about the Medtronic CoreValve US Clinical Trial visit:  www.aorticstenosistrial.com, or contact Diane Delliliune, RN, research coordinator, NSUH’s Department of Cardiology at (516) 562-2345.

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