Early Results Presented for Edwards' Sapien M3 System to Treat Mitral Regurgitation

March 5, 2018—John Webb, MD, presented "encouraging" findings from the early experience with the Sapien M3 system (Edwards Lifesciences) for the treatment of mitral regurgitation at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.

According to CRT, the findings showed that 10 patients treated with Sapien M3 were hemodynamically stable throughout the procedure and all had the device successfully implanted. No patients were observed to have left ventricular outflow tract obstruction (LVOTO) and no mortality was observed at 30 days. The investigators also found that procedure time and outcomes improved with operator experience.

In the CRT report, Dr. Webb said that the experience of patients being hemodynamically stable throughout the procedure is "much different than most transapical procedures." There was no LVOTO, he noted, "because the anterior mitral valve leaflets are pulled together by the dock system." He added, the lack of mortality at 30 days "is very unusual for a system like this."

"Early data suggest that use of the Sapien M3 system is feasible for treating patients with severe mitral regurgitation who are at high risk for mitral valve surgery and warrant further investigation," concluded Dr. Webb, who is Director of Interventional Cardiology at St. Paul's Hospital in Vancouver, British Columbia.