New valve lets some patients take heart

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Patients who are diagnosed with aortic stenosis, a narrowing and stiffening of the aortic valve in the heart, have for years faced a dire prognosis: either undergo risky open heart surgery, or face a two-year mortality rate of over 50 percent. But now a new artificial heart valve that can be inserted without any major surgery may allow old or frail patients to obtain the life-extending benefits of valve replacement without the risk of extensive surgery.

Aortic stenosis is a deterioration of the heart s aortic valve, blocking blood flow to the entire body, which causes the heart to work harder to pump blood and leads to serious symptoms, including heart failure, arrythmia, blood clots, fainting, and sudden death. While about 300,000 patients are diagnosed with the condition each year in the U.S., only about 50,000 are actually able to undergo life-saving open heart surgery to replace the valve. That s because thousands of patients are either too old or too sick to have a good chance of surviving the operation.

To help these patients who would otherwise have few options, the Sapien heart valve (manufactured by Edwards Lifesciences) has just been approved by the Food and Drug Administration for use by such patients. This heart valve is threaded into the correct position by way of the femoral artery, a major artery that runs from the aorta to the leg. In a study of over 300 patients, 70 percent of those who received the valve were still alive after one year, as opposed to only 50 percent of those who received comfort care or non-surgical treatment, such as medication.

While this procedure itself is rife with potential for serious complications, including internal bleeding or stroke, ACSH's Dr. Gilbert Ross still considers it to be an important option for those with aortic stenosis, since many are ineligible for open heart surgery. Symptomatic aortic stenosis is a lethal disease with a dire prognosis, he says. Given the very low survival rate of those who don t receive a valve replacement, the risk of going without treatment is a much more significant concern than the possibility of complications.