NewYork-Presbyterian/Columbia Participates in Trial for New Device Designed to Repair Heart Valve Leakage
The trial will evaluate a minimally invasive approach to heart valve repair
Mar 28, 2016
NewYork-Presbyterian/Columbia is one of four centers in the country participating in a clinical trial to assess a potentially groundbreaking procedure that uses a new device to treat faulty/leaky heart valves, specifically tricuspid regurgitation. The hospital was the first in the United States to successfully perform the procedure.
Tricuspid regurgitation, or TR, is a condition where the heart’s tricuspid valve does not close properly, causing blood to leak – or flow backward – into the right upper heart atrium. This can lead to heart enlargement or heart failure. The new device enables physicians to repair the heart valve via a catheter, requiring only a small incision. Traditionally, tricuspid heart valve repair has required open heart surgery.
“Tricuspid regurgitation is a serious yet under-treated cardiac condition that affects an estimated 1.6 million Americans,” says Dr. Rebecca Hahn, director of interventional echocardiography at NewYork-Presbyterian/Columbia University Medical Center and principal investigator for the trial. “The new system is transforming how we tackle valve repair in heart patients and shows amazing promise as a solution to treating these conditions, as it is minimally invasive and significantly reduces recovery time.”
Dr. Hahn, a world-renowned expert in the field of cardiac imaging, is the first imaging specialist to be appointed as a principal investigator in an interventional cardiology trial. Dr. Hahn developed the imaging protocol for this procedure, championing the technique for visualizing the tricuspid valve using transesophageal echocardiography (TEE), ultrasound and x-rays.
The procedure begins with a catheter inserted through two small incisions in the neck area. The catheter is guided into the tricuspid valve, which is between the right atrium and the right ventricle. The device, manufactured by Mitralign, Inc., is then introduced through the catheter to the annulus of tricuspid valve and releases sutures that can be pulled together to reduce the size of the valve and in turn, solve the leakage.
TR typically impacts individuals who are more than 60 years old and is often detected when the patient is being treated for another condition, like aortic or mitral valve disease. Thus, the condition may go unacknowledged until it becomes too severe to be safely treated. Open heart surgery for valve repair has up to an estimated 35 percent mortality rate in the operating room and requires a 5-7 day recovery period.
“The average recovery time for this new procedure is just 2-4 days, as it doesn’t require open heart surgery,” said Dr. Hahn. “It could represent the best option for patients requiring tricuspid repair, and it may one day become the standard of care.”
NewYork-Presbyterian/Columbia University Medical Center doctors also involved in the trial are Dr. Susheel K. Kodali, co-director of the Heart Valve Center, Dr. Isaac George, surgical director of transcatheter cardiovascular therapies and Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy. If the trial finds that the device and procedure are safe and effective, it will likely be tested at a greater number of institutions across the country.
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Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. For more information, visit cumc.columbia.edu or columbiadoctors.org.