Aortic Valve Stenosis Treated with Two Hour Procedure

Kathleen Blanchard's picture
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Findings from the PARTNER trial shows patients with aortic valve stenosis could be treated successfully with a two hour procedure akin to a cardiac catheterization, using a flexible catheter inserted through the femoral artery to deploy a new heart valve. The procedure eliminates the need for open heart surgery that is risky for elders with aortic valve disease, but is not yet approved in the United States by the FDA.

"This is exciting because it does save lives and is a major medical paradigm shift," said D. Craig Miller, MD, the Thelma and Henry Doelger Professor of Cardiovascular Surgery at the Stanford University School of Medicine and one of the manuscript's principal authors. "These patients were really sick with a fatal problem, and now they're feeling better and staying out of the hospital. Before, there was nothing we could really offer them."

Aortic stenosis is a narrowing of the heart valve that prevents the backflow of blood into the upper chamber of the heart. When blood flow is restricted through the diseased valve it leads to congestive heart failure. Symptoms are shortness of breath, fatigue, edema and inability to perform activities of daily living.

TAVI - transcatheter aortic-valve implantation - combined with medical therapy, lead to a 20 percent reduction in deaths from aortic stenosis –findings that the researchers call “dramatic”. According to William Fearon, MD, associate professor of cardiovascular medicine at Stanford, who also participated in the study, “The effect was so powerful that by just treating five people you can save one life. But beyond just the survival benefit, the improvement in the patients' quality of life based on their symptoms and their ability to exercise is dramatic."

The study included 358 patients with aortic stenosis who were debilitated from the disease and unable to undergo open heart surgery for valve replacement. Twenty one institutions participated in the trial, with 80 of the patients enrolled at Stanford Medical Center University. According to information from the trial, 14 of the patients were severely ill. One 76 year old woman, Jana Pausa of Atherton, California also had lung disease, making open heart surgery an unsuitable option for treatment.

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Pausa said just getting dressed was a chore. “Before the surgery, I used a walker. Sleeping was difficult because I didn't feel like I could breathe. I had no energy. When I woke up out of surgery, I immediately felt the difference. I could breathe - for sure it saved my life."

The procedure that takes about two hours involves insertion of a catheter into the femoral artery. The valve is deployed at the end of the catheter that is a flexible tube. When the catheter reaches the diseased valve, a balloon on the end of the catheter is inflated, expanding the valve and restoring blood flow throughout the body.

Aortic Valve Stenosis Treatment Comes with a Price

The price of the valve, manufactured and marketed by Edwards Lifesciences Corp., based in Irvine, California is $20,000; made from stainless steel and cow pericardium. For the study, the Edwards SAPIEN valve was used.

The new treatment was also associated with higher rates of stroke, vascular complications and bleeding because of the size of the catheter used to insert the device that is implanted directly into the beating heart.

After one year 50.7 percent of patients receiving standard medical therapy died, compared to 30.7 percent of patients who had received the percutaneous valve replacement. Further studies are needed to test the durability of TAVI valves and whether the new procedure to treat aortic valve stenosis might be an option for younger patients able to undergo open heart surgery.

NEJM

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