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Jason Merrill
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ST. LOUIS – A recommendation by a U.S. Food and Drug Administration advisory panel could soon lead to open-heart surgery without the “open.”

On July 20, the FDA advisory panel voted 9 to 0, with one abstention, that the benefits of an aortic heart valve inserted into the body through transcatheter means outweighed its risks for patients who can't undergo traditional valve replacement surgery. On a separate question, the panel voted 7-3 that the valve was reasonably safe.

Typically, the FDA follows the advice of advisory panels and many expect the procedure to be approved in the coming months.

Since January 2008, the Barnes-Jewish Hospital and Washington University School Heart and Vascular Center has performed transcatheter aortic valve implantation (TAVI) as one of 23 centers in a national trial that could revolutionize how some heart patients are treated. Recently, physicians at the heart and vascular center performed their 100th TAVI case.

“It’s an effective way of treatment for patients who otherwise would remain untreated,” says Alan Zajarias, MD, Washington University interventional cardiologist at Barnes-Jewish. “This is a phenomenal thing for patients who were not able to do their daily routine due to aortic stenosis. If they were not surgical candidates previously, we can now do something to help them live longer and feel better.”

In the nationwide PARTNER (Placement of AoRTic traNscathetER valves) trial, Dr. Zajarias and his Washington University colleagues are for the first time able to replace aortic valves percutaneously. Instead of opening a patient's chest, physicians thread a catheter, mounted with a compressed replacement valve on a tiny balloon, through an incision in a vein in the groin. Once in position, a stent-like valve is inflated in the aorta and the balloon and catheter are withdrawn.

The device called the SAPIEN valve, developed by Edwards Lifesciences, consists of a heart valve made of cow heart tissue attached to a collapsible mesh stent.

"This has the potential to supplant the open procedure for high-risk patients," says Ralph J. Damiano Jr., MD, chief of cardiac surgery at Barnes-Jewish Hospital and Washington University School of Medicine, who with John Lasala, MD, PhD, serves as co-principal investigator of the trial at the university. Other physicians conducting the trial are Hersh Maniar, MD, cardiac surgeon and Dr. Zajarias, who spent six months in France training with the procedure’s developer, Professor Alain Cribier, MD, chief of cardiology at the University Hospital in Rouen, France.

Overall, some 100,000 elderly Americans receive new aortic valves each year. 30,000 more are in need of a replacement valve but can't get it because the method of replacement – open-heart surgery – might kill them.

“Unfortunately, older people have a difficult time tolerating an open-heart surgical procedure,” says Dr. Lasala.

In a traditional procedure, surgeons open a patient’s chest and must halt the heart to extract the old valve and stitch in a new one while the patient is kept alive on a heart-lung bypass machine. This allows surgeons to circulate blood through the patient’s body and operate on a non-beating heart.

Dr. Zajarias says it’s important to note the FDA panel decision only applies to those patients who are not good surgical candidates.

“We are hoping within the next couple of months those who are considered high risk surgical candidates but can still have surgery that the FDA will give a decision if they can be candidates as well,” he says. “Surgery is still the treatment of choice for those who are surgical candidates.”