When Mary Ann Bernal's fatigue and shortness of breath were diagnosed as a leaky mitral valve in her heart, the Niles, Illinois, woman volunteered for a trial at NorthShore Evanston Hospital of a new, less invasive way to treat the debilitating and sometimes fatal condition.
Seven years after surgeons implanted a MitraClip in her heart, Bernal is a living testament to the procedure. Back on her feet within weeks, she now plays tennis regularly with her son, walks two miles daily and keeps up with her 7-year-old granddaughter.
Though it doesn't work for everyone, patients like Bernal have had "life-transforming" results from the clip, said Dr. Ted Feldman, a NorthShore University HealthSystem cardiologist and the lead investigator on the clinical trials for the MitraClip, which he called "much safer than open- heart surgery."
The procedure could have widespread application in the treatment of mitral regurgitation, a condition in which the valve — one of four in the heart — does not close completely, causing blood to flow backward and leak into the left atrium. More than 250,000 people in the U.S. are diagnosed each year, with symptoms that include fatigue and shortness of breath. Unchecked, the condition can lead to stroke, heart attack or death.
Open-heart surgery to repair or replace the valve has been the standard treatment for decades, but is too risky for many patients, Feldman said. Developed by Evalve, a San Francisco company acquired last fall by North Chicago-based Abbott Laboratories, the MitraClip is inserted through the femoral vein in the groin and threaded up to the heart, where it holds together the leaflets of the mitral valve to prevent leaking.
In 2003, Feldman performed the country's first MitraClip implant at Evanston Hospital. Since then, hundreds of patients have received the device at 35 sites in the U.S.
While the clip is slightly less effective at reducing leakage than surgery, patients recover much faster — about one week versus six weeks — and experience one-sixth as many serious complications, said Feldman, who reported findings of the completed study to the American College of Cardiology in March.
"Open-heart surgery is not something that everyone completely recovers from," he said.
Approved in Europe two years ago, more than 1,300 patients have had the procedure worldwide. The last step in the approval process in the U.S. is a review by the Food and Drug Administration, which Feldman said is expected to take up to 18 months. During the review period, the FDA has limited the procedures to 20 per month nationwide, creating a backlog stretching into late summer, Feldman said.
One enthusiastic proponent for FDA approval is Arlene Beyna, who also participated in the local trial.
The 67-year-old grandmother from Mount Prospect sought help for what had become chronic fatigue when she could no longer partake in one of her favorite pastimes: shopping.
"I used to park my car and by the time I got to the mall, I'd just be so exhausted I would have to sit down and go back home," Beyna said.
Diagnosed with mitral regurgitation, Beyna's medical history included extensive radiation for Hodgkin's disease in her early 30s and eight spinal surgeries, during one of which she said she went into respiratory arrest and nearly died. Open-heart surgery would have been especially risky.
Since she had the MitraClip in November, Beyna has been able to take care of her grandchildren, tackle once-daunting stairs and, she said, "I can go shopping and I don't have to stop."
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