FDA favors innovative heart valve for the frail

By MATTHEW PERRONE , AP Health Writer

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.

The posted its review Monday of a highly anticipated heart valve from Edwards Lifesciences that can be threaded into place through one of the body's major arteries. Cardiologists hope this approach could offer a new option for patients who aren't healthy enough to undergo the more invasive open-heart , which has been used to replace valves for decades.

FDA says 20 percent more patients who received Edwards' valve were living after one year than patients who received traditional medical care. However, 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 Wednesday, though the agency is not required to follow the group's advice.

Edwards will eventually seek to market its valve for patients who are healthy enough for open-heart surgery. But because the valve is an , it was initially studied for patients with no other options.

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 , 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 to survive the operation.

The surgery involves sawing the patient's breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place.

Edwards' Sapien valve, which is already available in Europe, is threaded through a leg artery up to the heart and then propped open and wedged into the aortic opening, replacing the natural heart valve.

Edwards will make the case for approving its device based on a study that showed nearly 70 percent of patients with the valve survived at least a year, compared with only 50 percent of those without it. However, FDA reviewers point out that little is known about patient survival after two years and longer-term safety studies are still needed. By contrast, patients who receive through open-heart surgery have been documented to live for decades.

FDA raises concerns that neurological side effects were more than three times higher among patients with the Sapien valve than for patients in the control group. Fourteen percent of patients with the valve experienced stroke, hemorrhaging or other brain-related problems. That compared to just 4.5 percent of patients who did not receive the valve. The FDA says these problems were actually probably underreported, since patients were assessed by a cardiology team rather than doctors specializing in brain injury.

Regulators suggest the stroke risk should be further analyzed in a follow-up study - even if the valve is approved. Edwards has proposed giving patients in that study a regimen of blood thinners to help reduce stroke risk.

If approved, Edwards is expected to charge about $30,000 for the valve, though hospital fees could bring the total cost of surgery closer to $70,000. Standard heart valve replacement costs upward of $50,000, mostly from surgical and hospitalization fees.

Shares of Irvine, Calif.-based Edwards Lifesciences Corp. rose 39 cents to $89.33 in morning trading.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Heart valves implanted without open-heart surgery

Jan 07, 2009

An innovative approach for implanting a new aortic heart valve without open-heart surgery is being offered to patients at NewYork-Presbyterian Hospital/Columbia University Medical Center. Known as the PARTNER (Placement of ...

Study backs new heart valve without cracking chest

Sep 22, 2010

(AP) -- Thousands of older Americans who need new heart valves but are too frail to survive the surgery might soon get a chance at an easier option - a way to thread in an artificial aortic valve without ...

Recommended for you

Most seniors eligible for statin Rx under new guidelines

Nov 25, 2014

(HealthDay)—Most older Americans qualify for treatment with statins under new guidelines for the treatment of blood cholesterol released late last year by the American College of Cardiology and the American ...

Asymptomatic atherosclerosis linked to cognitive impairment

Nov 25, 2014

In a study of nearly 2,000 adults, researchers found that a buildup of plaque in the body's major arteries was associated with mild cognitive impairment. Results of the study conducted at the University of Texas (UT) Southwestern ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.