Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, ahead of a meeting this week to consider broadening its use.
Last summer Edwards Lifesciences Corp. won approval for its first-of-a-kind Sapien heart valve, which can be threaded into place through one of the body's major arteries. The valve is currently available for patients who aren't healthy enough to undergo the more invasive open-heart surgery which has been used to replace the valve for decades.
Now the Food and Drug Administration is considering expanding the device to patients who are healthier, but still face serious risks from chest-opening surgery. Many such patients are in their 80s and have complicating medical factors like diabetes.
In an online review posted Monday, FDA reviewers said the heart valve compared favorably to surgery after one year, with patients living about the same amount of time. In Edwards' study submitted to the agency, 24 percent of patients implanted with the heart valve through their artery died after one year, compared with 27 percent of those who had undergone surgery. Patients who had the valve inserted through an incision between the ribs had a death rate of 22 percent after one year. The numbers were close enough to meet the study's goal of showing that the valve was at least as effective as surgery.
However, reviewers said patients who got the Sapien valve had a higher rate of stroke in the month after the procedure. Additionally, more than half of patients had leaking from the aortic heart valve, a potentially dangerous condition in which blood flows backward into the heart's ventricle chamber.
The FDA will ask a panel of outside advisers to weigh in on these risks at a meeting Wednesday. The expert panel will vote on whether Sapien's benefits outweigh its risks.