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

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

Better option for high-risk patients

In the nationwide partner (Placement of AoRTic traNscathetER) trial, Lasala and his Washington University colleagues are able to replace aortic valves percutaneously (through the skin) for the first time. 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 Once in position, the valve is inflated in the aorta, and the balloon and catheter are withdrawn.

This procedure offers new hope for older patients with faulty aortic valves who previously had no treatment options due to their age or other existing problems.“This has the potential to replace the open procedure for high-risk patients,” says Ralph Damiano Jr., MD, chief of cardiac surgery at Barnes-Jewish Hospital and Washington University.

Damiano and Lasala serve as co-principal investigators of the partner trial at the university. Other physicians conducting the study include cardiac surgeons and interventional cardiologist Alan Zajarias, MD. Zajarias spent six months in France training with the procedure’s developer, Alain Cribier, MD.

About 100,000 elderly Americans receive new aortic valves each year. Another 30,000 need a replacement valve but can’t get it because the replacement method – open-heart surgery – is too risky for them. “Unfortunately, older people have a difficult time tolerating an open-heart surgical procedure,” Lasala says.

Percutaneous Procedure benefits all patients

In a traditional procedure, surgeons open a patient’s chest and stop the heart to remove the old valve and put 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 nonbeating heart.

Lasala says performing the procedure percutaneously has two benefits, “One, it can treat people who are not good candidates for surgery, and two, it can minimize the risks of death and other problems associated with an operation even if you are a candidate.”
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