An innovative artificial heart valve is being put to the test this week, as a panel of cardiologists deliberate with the FDA about the matter. It is the first artificial value that can be implanted without major surgery
This is a device that would replace the aortic valve- one of the four valves in the heart- in people who have aortic stenosis. This is a condition in which the valve opening narrows and makes it more difficult for blood to pass from the heart to the largest artery in the heart, the aorta. This can lead to heart failure, blood clots, and sudden death. The FDA says about 300,000 Americans have this condition and about half of them die within two years.
For this condition, people who are strong enough will undergo open-heart surgery. This involves opening the chest, stopping the heart temporarily, cutting out the old valve, and replacing it with a new one. As one can imagine, it is an extremely risky procedure.
This new artificial heart value can be inserted without any major operation and is, therefore, very promising. It is called the Sapien heart valve and can be inserted through a small incision in the groin and up through a major artery, or it can be inserted through an incision between the ribs. The valve is then wedged into the aortic opening by an inflatable balloon, replacing the natural heart valve.
The Sapien valve was approved in November for patients who aren’t healthy enough to undergo open-heart surgery. The FDA is now considering expanding use for people who are healthier but still face serious risks from open-heart surgery, such as the elderly or people with diabetes. The FDA has asked a panel of experts, mostly cardiologists, to take a final vote on whether the benefits outweigh the risks for these patients.
In a study submitted to the FDA by the company that makes the valve, (Edwards Lifesciences Corp) twenty four percent of people who had it implanted through the artery died after one year, and twenty two percent of people died who had it inserted through the ribs. Meanwhile, people who underwent open-heart surgery had a one-year death rate of twenty seven percent. The numbers were close enough to meet the study’s goal of showing that the valve was at least as effective as surgery.
Unfortunately, problems have come to light for the Sapien valve as well. The panel is taking a closer look at the risk-benefit ratio. There is a higher risk of valve leakage, as well as possibility of a stroke within one month after the procedure.
What causes valve stenosis? Calcium build-up with age can cause the valve to stiffen. Smoking, high cholesterol, and being male also increase the risk. In addition, people can have heart valve damage from cardiac birth defects or an infection from rheumatic fever. At first, there are no symptoms of cardiac valve stenosis. As the valve becomes narrower with time, patients can develop chest pain, dizziness, shortness of breath or an irregular heartbeat.
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