March 30, 2009 - Twelve-month data from the high-risk registry arm of the EVEREST II study shows that percutaneous mitral valve repair using the MitraClip system in symptomatic high-risk surgical patients with functional mitral regurgitation (FMR) improves patient clinical status and left ventricular function.
The data of the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) study was presented at the 58th Annual Scientific Session of the American College of Cardiology (ACC) i2 Summit Scientific Sessions in Orlando, FL.
Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston North Shore Hospital, Evanston, IL and co-principal investigator of the EVEREST trials presented the data.
"The high-risk registry data in the functional MR patients demonstrate that these patients benefit substantially from the MitraClip therapy," said Dr. Feldman. "By expanding the options available to these patients, clinical practice will change for the better when this therapy is available in the U.S."
The FMR high-risk registry cohort was composed of 46 symptomatic patients with grade 3 or 4 MR and at least a 12 percent predicted risk of surgical mortality. Mortality risk was determined by either the Society of Thoracic Surgery Mortality Risk Model, or by a cardiac surgeon's determination that one or more specifically defined risk factors resulted in a predicted mortality risk of at least 12 percent. The average age was 73 years and most patients had several co-morbidities.
At 12 months, 73 percent of patients with matched data were in NYHA functional class I or II, compared to only 9 percent at baseline. This improvement in functional class was accompanied by improved LV function. The rate of hospitalization for heart failure in the year after treatment with the MitraClip system was significantly (p=0.02) lower than the rate in the year prior to treatment.
Percutaneous mitral repair with Evalve's MitraClip device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR.
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