HOUSTON – (Nov. 16, 2011) – Cardiologists and cardiovascular surgeons at The University of Texas Health Science Center at Houston (UTHealth) and Memorial Hermann Heart & Vascular Institute (HVI) will be the first in Houston to implant an artificial heart valve that has just been approved by the Food and Drug Administration (FDA).
The Sapien heart valve made by Edwards Lifesciences is implanted through a catheter as an alternative to open heart surgery for patients with inoperable aortic valve stenosis disease. The surgery for the device, the first ever transcatheter aortic valve, is scheduled for mid-November, said Dr. Colin Barker, M.D., assistant professor of cardiology at UTHealth/HVI.
“With the aging population, the potential impact of this procedure is enormous,” Barker said. “The quality of life metrics are incredible. People can go from dependence to independence. I estimate about 20 percent of my patients will be candidates for this valve replacement.”
At the same time, UTHealth Medical School/HVI will be the only site in Houston and one of just two sites in the state to test the FDA-approved valve against a newer version. The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves will recruit 600 patients through December 2017 and follow them for at least five years. The Houston site of the Phase III study is led by Richard W. Smalling, M.D., Ph.D., James D. Woods Distinguished Chair in Cardiovascular Medicine and Director of Interventional Cardiovascular Medicine in the Division of Cardiology at UTHealth and HVI.
According to the FDA, aortic valve stenosis is an age-related disease caused by calcium deposits in the valve that cause it to narrow and stiffen. As it becomes harder to pump the blood out 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. It affects approximately 300,000 Americans.
The Sapien valve, made of bovine tissue and stainless steel, is about the width of a pencil when it is deployed through a catheter in the femoral artery in the groin. Once it arrives at the correct spot, the new valve is released, replacing the diseased one. Patients generally stay in the hospital for an average of three days, compared to seven days with open heart surgery, Barker said.
“Surgeons and cardiologists are part of a whole team unified for this one disease process,” Barker said. “There is very little sedation and in experienced hands, it takes about 45 minutes.’
For the procedures, Barker and Smalling team up with UT/HVI surgeons led by Hazim J. Safi, M.D., professor and chair of the Department of Cardiothoracic and Vascular Surgery; and Anthony L. Estrera, M.D., professor and Chief of Cardiac Surgery at Memorial Hermann-Texas Medical Center.
The heart team also includes a cardiac anesthesiologist, echocardiologist, critical care experts and research nurses.
“This could add years to the life of patients,” Estrera said. “By the time they get out of the hospital, they are already feeling better.”
For more information, call 713 704-8287 (TAVR).
Deborah Mann Lake
Media Hotline: 713-500-3030