First Woman to Have Non-Surgical Heart Repair Feels Lucky

Mary Ann Bernal, 70, of Niles, is the first woman in the United States to have her heart’s mitral valve repaired with a new device that can be positioned without surgery.  On Jan 28, 2004, Mary Ann underwent an experimental procedure in which her valve was repaired with a tiny metallic clip that was fed via catheter through a small groin incision.  The clip is being tested in a Phase I clinical trial led by Ted Feldman, MD, Director of Evanston Hospital’s Cardiac Catheterization Lab.  NorthShore University HealthSystem is one of only 7 centers nationwide that are taking part in the study.

When she first had heart trouble, tests showed that Mary Ann’s mitral valve was not closing properly, creating a condition known as mitral regurgitation.  She was told that eventually, her heart’s decreased pumping capacity would lead to heart failure. The only way to avoid this fate, her doctor said, was to have major open-heart surgery to repair the valve.

Her cardiologist evaluated her heart again last December when Mary Ann felt that she didn’t have as much energy while exercising.  “He said, ‘Your heart was bad before. Now it’s terrible,’” she recalls.  Mary Ann remembered seeing a news item about a non-surgical mitral valve repair and asked to be considered for it.  She was happy to learn that Evanston Hospital was one of only seven centers nationwide who are offering the procedure.  She had a series of tests and was elated to learn that she was selected as a candidate for the study.

“I talked to Dr. Feldman and after hearing him, I didn’t give it a second thought. The procedure went well. I only stayed in the hospital for one night. Within a week, I was back to my normal routine and I feel wonderful,” Mary Ann says, who has returned to exercising.

“I just feel glad that I was chosen for the study and I didn’t have to go through surgery. It was like I won the Lottery,” she adds.

To be eligible for the investigational procedure, candidates must have moderate to severe or severe mitral regurgitation and be experiencing symptoms (fatigue, chest pain, shortness of breath); or, lacking these symptoms, they must have a weakened left ventricle (heart muscle).  

Chronic mitral regurgitation is a progressive disorder that affects approximately 4 million people in the United States.  Approximately 250,000 patients develop significant mitral regurgitation annually in the US. Those with significant mitral regurgitation eventually become so weakened by the condition that they require open-heart surgery with cardiopulmonary bypass. Approximately 50,000 people a year have open, arrested-heart mitral valve surgery.

For information about this study, known as the Evalve trial, phone 847.570.2366.

Read more about current clinical trials

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