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Barnes-Jewish and Washington University perform first percutaneous valve replacement

January 17, 2008, ST. LOUIS – Some call it open-heart surgery without the "open."

Barnes-Jewish Hospital and Washington University School of Medicine are now one of 15 sites in the United States participating in a clinical trial that could revolutionize how some heart patients are treated.

"This might reshape the whole approach surgeons and cardiologists take toward treating aortic valves," says John Lasala, MD, PhD, director of the cardiac catheterization lab at Barnes-Jewish and Washington University. "This could be gigantic, depending on the outcome of the trial."

In the nationwide PARTNER (Placement of AoRTic traNscathetER valves) trial, Dr. Lasala 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 an artery 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 Once in position, a stent-like valve is inflated in the aorta and the balloon and catheter are withdrawn.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 Dr. Lasala, serves as co-principal investigator of the PARTNER trial at the university. Other physicians conducting the trial are Nader Moazami, MD, chief of heart transplant and Alan Zajarias, MD, assistant professor of medicine 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.

"This will be a major trend in over the next decade," says Prof. Cribier.

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. Lasala says performing the procedure percutaneously has two benefits.

"One, it can treat people who are not a good candidate for surgery and two, it can minimize the mortality and morbidity associated with an operation even if you are a candidate," says Dr. Lasala.

The first candidate treated at Barnes-Jewish Hospital is Mary Ann Cahalin, 78, of Florissant, MO. Infection after a previous bypass rendered her inoperable for future open-heart surgery. When she was diagnosed with a leaky aortic valve in 2007, her family was hopeful she would be eligible for the percutaneous procedure. "There was no other option," says Ann Davis, Cahalin''s daughter.

Cahalin, a Girl Scout volunteer of 42 years, had been unable to participate in scout training she had been performing until the leaky valve slowed her down. Now, she plans to get back to her work with the scouts. One day after the procedure, Cahalin says she was pain free.

"No pain at all," says Cahalin. "Preparing me for the procedure took longer than the procedure itself." In fact, the January 15 procedure on Cahalin from start to finish took under two hours.

"We think it has widespread universal application and we hope to be a center of excellence to lead that charge," says Dr. Lasala.

Offering guidance during the first case was Prof. Cribier who, in addition to developing the procedure, performed the world''s first transcatheter valve replacement in April 2002.

After the new aortic valve was deployed in Cahalin, Prof. Cribier praised the team in the Barnes-Jewish Hospital cath lab procedure room, "Phenomenal job, just phenomenal."

Cahalin''s husband Jim agrees, "This is as close to a miracle as we can get."

The PARTNER trial is randomized and not available to all patients. Learn more about PARTNER trial guidelines. For more information about the PARTNER trial at Washington University School of Medicine and Barnes-Jewish Hospital, call 314-747-4452 or 314-747-4547.