Cardiologists and cardiovascular surgeons at The University of Texas Health Science Center at Houston (UTHealth) and Memorial Hermann Heart & Vascular Institute (HVI) are the first in Houston to implant the artificial heart valve recently approved by the Food and Drug Administration (FDA), as well as a newer, smaller version that is part of a clinical trial.
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. George Cumberledge, 86, of Livingston, received the FDA-approved Sapien + Retroflex3, the first ever transcatheter aortic valve on Nov. 17.
"Mr. Cumberledge had prior open-heart surgery and suffered from congestive heart disease for the past two years so he was not a candidate for open surgery," said Dr. Colin Barker, M.D., assistant professor of cardiology at UTHealth/HVI. "We were able to offer him the approved device and he's ready to go home 36 hours later."
That same day, Houstonian Martha Frazier, 88, received the Sapien XT + NovaFlex, the next-generation valve that is currently part of a multi-site trial comparing this newer, smaller valve to the current one.
"In the case of Mrs. Frazier, we took someone with severe disease who was a nonsurgical patient and now we've cured her," Barker said. "We are the only site in Houston with the option of using an alternative smaller device and it was necessary in this procedure. Otherwise, it would not have been successful."
UTHealth Medical School/HVI is one of just two sites in the state to test the FDA-approved valve against the newer version. The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves will recruit 600 patients, who will be followed for at least five years. Principal investigator of the Houston site of the Phase III study is Richard K. 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.
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.
"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."
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. The newer version is smaller and therefore easier to deploy in smaller arteries. 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 with UTHealth/HVI surgeons including 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 UTHealth/HVI Heart Valve 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."
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