The Structural Heart Program team at McGovern Medical School is among the first in the country to investigate the safety and effectiveness of Edwards Lifesciences Sapien 3 transcatheter aortic heart valve in low surgical risk patients who suffer from severe aortic valve disease. The procedure is being performed at Memorial Hermann Heart & Vascular Institute-Texas Medical Center (HVI).
Principal investigators of the Houston site of the randomized PARTNER 3 study are Richard W. Smalling, M.D., Ph.D., the James D. Woods Distinguished Chair in Cardiovascular Medicine and director of interventional cardiovascular medicine, and Tom C. Nguyen, M.D., assistant professor and director of minimally invasive valve surgery. Both are attending physicians at HVI.
Aortic valve stenosis, which affects approximately 300,000 Americans, is an age-related disease resulting from calcium deposits in the valve that cause it to narrow and stiffen. As it becomes harder to pump the blood to the rest of the body, the heart weakens. Patients experience fainting, chest pain, heart failure, irregular heart rhythms, and cardiac arrest. Without treatment, patients with severe aortic stenosis usually die within two years.
Transcatheter aortic valve replacement (TAVR) for the diseased valve is a less invasive procedure than conventional open heart surgery. TAVR is currently approved by the U.S. Food and Drug Administration for patients who are high risk or inoperable. There has been some promising data on intermediate risk patients, Nguyen said. In the randomized clinical trial, researchers are now testing whether TAVR or open heart surgery is the best option for low-risk patients with severe aortic stenosis. The UTHealth/Memorial Hermann HVI site is one of a limited number across the country selected to participate in the study. It is the only site in Houston.
“We have a unique comprehensive and collaborative approach for the treatment of valve disease with an internationally recognized team of surgeons and cardiologists. Each patient is carefully examined by our dedicated valve team and discussed at our multi-disciplinary valve conference, including cardiac surgeons, interventional cardiologists, cardiac anesthesiologists, interventional echocardiographers, and other professionals,” Nguyen said. “We put patients first and believe this provides a thoughtful and unbiased approach to determining the best care for patients.”
UTHealth/Memorial Hermann HVI physicians have performed more than 1,000 TAVR procedures and were the first in Houston to implant the first FDA-approved TAVR device (Sapien + Retroflex3) in November 2011 and one of the first in the country to perform this procedure with patients who were partially awake. For information, please call 713.500.UTCV (8828).