The UTHealth Medical School has been chosen as one of the first 25 sites in the country to investigate the safety and efficacy of Edwards Lifesciences Sapien 3 transcatheter aortic heart valve for patients with severe aortic valve stenosis. The procedure will be done at the Memorial Hermann Heart & Vascular Institute-Texas Medical Center (HVI).
Aortic valve stenosis, which affects approximately 300,000 Americans, is an age-related disease resulting from calcium deposits that cause the valve 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 usually die within two years.
The Sapien transaortic valve replacement (TAVR), delivered via catheter, is an alternative for patients who are high risk for surgery or inoperable. Up to 500 patients will be recruited for the latest version of the Sapien device, which is part of the PARTNER II Trial: Placement of AoRTic TraNscathetER Valves. Principal investigator of the Houston site of the Phase III study is Dr. Richard Smalling, the James D. Woods Distinguished Chair in Cardiovascular Medicine and director of interventional cardiovascular medicine in the Division of Cardiology.
The Sapien 3 valve will be employed in one of three delivery techniques: the transfemoral approach through an incision in the leg, the transapical route between the ribs, or the transaortic approach through a small incision in the chest and aorta. Results will be compared to the results of previous Sapien valves.
“The new device has a smaller profile and design improvements, including a different structure around the bottom of the valve meant to reduce paravalvular leak,” Smalling said. The Sapien 3 valve can be delivered in a smaller catheter, allowing physicians to use it in patients with narrower femoral arteries. UTHealth/HVI is one of just two sites in Texas investigating the new device.
UTHealth/Memorial Hermann Heart & Vascular Institute physicians have performed more than 200 TAVR procedures and they were the first in Houston to implant the first FDA-approved TAVR device (Sapien + Retroflex3) in November 2011. For information, call 713.704.TAVR (8287).
-Deborah Mann Lake, Office of Public Affairs, Media Relations