FDA approves ‘game changing’ procedure at Barnes-Jewish Hospital
Posted By: Jason Merrill 
Date Posted: November 21st, 2011 Category: Breakthroughs, Health Care
Approval by the U.S. Food and Drug Administration of a procedure described as a “game changer” by physicians — transcatheter aortic valve replacement — now allows cardiac specialists at Barnes-Jewish Hospital to perform open-heart surgery without the “open” for patients previously unable to have surgery.
In the procedure — approved by the FDA Nov. 2 — physicians 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 Once in position, a stent-like valve is inflated in the aorta and the balloon and catheter are withdrawn.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 Washington University and Barnes-Jewish Heart & Vascular Center was one of only 23 centers nationally to participate in the nationwide PARTNER (Placement of AoRTic traNscathetER valves) trial leading to the FDA’s approval.
Using X-ray guidance, Alan Zajarias, MD; John Lasala, MD, PhD; and Hersh Maniar, MD, replace a patient’s aortic valve by running a catheter through a single incision in the patient’s leg, rather than opening the patient’s chest in a procedure newly approved by the FDA. | Photo by Tim Mudrovic
“It’s an effective way of providing treatment for patients who otherwise would remain untreated,” says Alan Zajarias, MD, WUSM interventional cardiologist at BJH. “This is a phenomenal thing for patients who weren’t able to do their daily routine due to aortic stenosis. If they weren’t surgical candidates previously, we can now do something to help them live longer and feel better.”
The device, called the SAPIEN valve, was developed by Edwards Lifesciences. It 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 Damiano Jr., MD, chief of cardiac surgery at BJH and WUSM, 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,” Dr. Lasala says.
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 patients who aren’t good surgical candidates.
“We are hoping within the next couple of months, for 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.”
Visit http://bjhne.ws/TAVRforBJCToday for more information. Watch a video on the procedure below: