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SCAI Presents MitraClip Study Results

A new catheter-based procedure is providing relief to patients who suffer from shortness of breath and fluid overload as the result of a severely leaky heart valve, but who are too sick for open-chest surgery, according to a study presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 33rd Annual Scientific Sessions.

Data from the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) High Risk Registry showed that, in patients who are not healthy enough to undergo surgery to repair a leaky mitral valve, use of the MitraClip valve repair system is safe and, in the majority of patients, effective in relieving symptoms that limit the ability to engage in day-to-day activities. There has never been a treatment option for this high-risk group of patients in the past.

The MitraClip is an investigational device that has not yet been approved by the FDA. During the procedure, the device is mounted on a catheter and advanced into the heart via a vein in the groin. The entire procedure is done on a beating heart using x- ray and ultrasound to guide the procedure.

For the study, interventional cardiologists recruited 78 patients with severe mitral regurgitation (classified as moderate-to-severe, or severe) who were considered to be at very high risk for surgery.

The placement of the MitraClip was successful in 96% of patients, with no procedural deaths. At one year, 74% of survivors who were treated with the MitraClip were still in New York Heart Association (NYHA) class I or II and average heart function was improved by several measures. In addition, there was a 45% reduction in readmissions to the hospital for congestive heart failure. None of the patients in the study developed more severe symptoms, worse mitral regurgitation or underwent surgery within that time period.

Researchers concluded that treatment with the MitraClip valve repair system can be performed safely in high-risk patients and provides long-lasting relief of symptoms.

Saibal Kar, director of interventional cardiac research at the Heart Institute, Cedars Sinai Medical Center, Los Angeles, said: “The MitraClip system is a first-in-class treatment and a remarkable innovation the beginning of a very exciting era for treating valvular disease with minimally invasive devices.”