EVEREST II High-Risk Registry Reported for MitraClip

May 6, 2010—Saibal Kar, MD, presented data from the Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) High-Risk registry at the Society for Cardiovascular Angiography and Interventions (SCAI) 33rd annual scientific sessions in San Diego. EVEREST II is studying the safety and effectiveness of the MitraClip valve repair system (Evalve, Inc, Menlo Park, CA; acquired in 2009 by Abbott Vascular, Santa Clara, CA). The High-Risk registry results 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, stated the SCAI. The MitraClip is an investigational device that has not yet been approved by the US Food and Drug Administration.

“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,” commented Dr. Kar. “Patients who couldn’t walk across a room without being short of breath are now able to walk up a flight of stairs, go shopping, and exercise.”

According to SCAI, for the High-Risk registry arm of EVEREST II, investigators enrolled 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 average age of patients was 77 years. All patients had congestive heart failure, and 90% were in New York Heart Association (NYHA) class 3 or 4. Approximately 60% of patients had previously undergone cardiac surgery, 85% had coronary artery disease, 35% had chronic lung disease, and 23% had moderate-to-severe kidney failure. According to the Society of Thoracic Surgeons risk score, the average predicted risk of surgery-related death was 18.2%.

Placement of the MitraClip was successful in 96% of patients, with no procedural deaths. Within the first 30 days, the mortality rate was 7.7%, which was significantly lower than the predicted 18.2% surgical mortality rate (P = .008) and not significantly different from the 8.3% mortality rate in a matched control group who were treated with medication alone. At 30-day follow-up, 75% of survivors were in NYHA class 1 or 2. Survival at 1 year was 75% compared to 55% in the medication-only control group.

At 1 year, 74% of survivors who were treated with the MitraClip were still in NYHA class 1 or 2, 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. The investigators concluded that treatment with the MitraClip valve repair system can be performed safely in high-risk patients and provides long-lasting relief of symptoms.