Surgeons implant first transcatheter artificial heart valve in Houston

Posted on Thursday, February 2nd, 2012

Cardiologists and cardiovascular surgeons at the Medical School 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,” says Colin Barker, M.D., UT Physicians cardiologist. “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,” Dr. Barker says. “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 Smalling, M.D., Ph.D., UT Physicians cardiologist and director of interventional cardiovascular medicine in the Division of Cardiovascular Medicine.

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,” Dr. Barker says. “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, Dr. Barker says.

“Surgeons and cardiologists are part of a whole team unified for this one disease process,” Dr. Barker says. “There is very little sedation, and in experienced hands, it takes about 45 minutes.”

For the procedures, Drs. Barker and Smalling team with UTHealth/HVI surgeons including Hazim Safi, M.D., UT Physicians cardiothoracic surgeon; and Anthony Estrera, M.D., UT Physicians cardiothoracic surgeon 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,” Dr. Estrera says. “By the time they get out of the hospital, they are already feeling better.”

For more information, call 713.704.8287.

— Deborah Mann Lake, Office of Advancement, Media Relations

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