WASHINGTON - The first artificial heart valve designed to be implanted without major surgery appears to help patients who are too frail to undergo chest-opening surgery, according to federal health reviewers.
Edwards Lifesciences’ device can be threaded into place through an artery. Cardiologists hope this approach could offer a new option for patients who aren’t healthy enough for open-heart surgery.
The Food and Drug Administration said 20 percent more patients who received the valve were living after one year than patients who received traditional medical care. Scientists also said patients receiving the device had higher rates of stroke and bleeding in the brain.
The agency will ask a panel of heart doctors to weigh in on these risks at a meeting tomorrow, though the agency is not required to follow the advice.
Some 300,000 Americans have a diseased aortic heart valve, forcing the heart to work harder to squeeze blood through. Eventually the condition can lead to heart failure, blood clots, and sudden death. More than 50,000 people a year undergo open-heart surgery to replace the valve, and thousands more are turned away, deemed too old or ill.
Edwards will make the case for its device based on a study that showed nearly 70 percent of patients with the valve survived at least a year, compared with 50 percent of those without it. FDA reviewers point out little is known about survival after two years.
Patients who receive heart valves through open-heart surgery have been documented to live for decades.