By Meg Tirrell March 14 (Bloomberg) — Abbott Laboratories ’ MitraClip cardiac clamp safely repaired leaking heart valves in a study, potentially providing a less invasive alternative to open-heart surgery. Among the 279 participants in the research, 9.6 percent of those treated with the MitraClip had a major stroke, heart attack, repeat operation, other major adverse event or died within 30 days, compared with 57 percent in the surgery group, the study showed. The results, presented today at the American College of Cardiology meeting in Atlanta, were from the third and final round of tests generally required for U.S. approval. The MitraClip, gained last year in Abbott’s $320 million purchase of Evalve Inc. , is already sold in Europe, and Abbott has submitted an application with the Food & Drug Administration, the Abbott Park, Illinois-based company said in a statement today. This clip “will usher in a whole new field of interventional cardiology,” said Gregg Stone , head of cardiovascular research at Columbia University Medical Center in New York, in a March 4 telephone interview. The MitraClip may transform valve repair in the same way balloon angioplasty changed procedures to clear blocked arteries, Stone said. Both introduce an alternative to open-heart surgery that’s a “much simpler, safer procedure” and get patients out of the hospital and on their feet faster, he said. Mitral Valve Defect The MitraClip is inserted with a catheter through a leg vessel to correct mitral regurgitation , which occurs when the mitral valve doesn’t close properly causing blood to flow backward, according to a statement from Abbott. The condition, which can lead to heart failure, affects more than 8 million people in the U.S. and Europe. The defect is currently managed with drugs or repaired with surgery, the statement said. For decades, patients with severe mitral regurgitation underwent a procedure called the double orifice technique, in which a surgeon sews together two sides of the mitral valve, leaving the ends open and ensuring blood flows in the proper direction. The MitraClip procedure mimics that surgery without the intensive operation, inserting the clip through a catheter in the leg and clamping the two sides of the valve shut. Patients typically spend about a week in the hospital after open-heart surgery, and the total recovery period can take at least six weeks, said Ted Feldman , director of the Cardiac Catheterization Laboratory at NorthShore University HealthSystem in Evanston, Illinois, and a principal investigator of the trial. Frail and Elderly For the frail and elderly, who may be discharged to a rehabilitation facility, “recovery can take several months,” he said. That compares with a hospital stay of about two and a half days, with “no real additional recovery period” at home for the clip procedure. The trial, dubbed Everest II , was designed to see whether the MitraClip would be safer than open-heart surgery and “non- inferior” in terms of effectiveness, said John Capek , Abbott’s executive vice president of medical devices, in a March 10 telephone interview. The device met the study’s goal for effectiveness, measured as freedom from death, mitral valve surgery or repeat procedures at 12 months, as well as a decrease to a certain level in mitral regurgitation. Patients with the device had a success rate of 72.4 percent, compared with 87.8 percent for those who had surgery, results showed. The difference in clinical success rates was within the study’s specified margin to determine non-inferiority, according to Feldman. Safety Profile “The catheter-based system exhibited a highly favorable safety profile, while providing meaningful and sustained clinical benefits,” Feldman said in a statement. “The therapy has the potential to transform the lives of thousands of patients, and enable some to go from bed rest to a more active lifestyle.” The results also show that patients treated with the MitraClip still have the option for surgery afterward if needed, said Donald Glower , a professor of surgery at the Duke University School of Medicine in Durham, North Carolina, and a co-principal investigator of the trial. Abbott anticipates receiving regulatory approval next year, Capek said. The company’s shares fell $1.02, or 1.8 percent, to $54.52 on March 12 in New York Stock Exchange composite trading. They have gained 17 percent in the past 12 months. To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net .
Continue reading here:
Abbott MitraClip Valve Clamp Offers Safe Alternative to Open-Heart Surgery
