First-in-Human Experience with the Edwards SAPIEN M3 System: A Novel Transeptal Transcatheter Mitral Valve Replacement Alternative for the Treatment of Mitral Regurgitation - John Webb

Written by Katrina Mountford, Medical Editor.
19th March 2018

Abstract

Mitral regurgitation (MR) is common and associated with heart failure and a poor prognosis. However, multiple technologies have emerged for transcatheter mitral therapy. Dr Webb’s presentation focussed on the early clinical use of the Edwards SAPIEN M3 System, a novel system for the treatment of MR. The valve’s design features include a knitted PET skirt that aids sealing between native mitral leaflet and dock; 20F eSheath compatibility; and a nitinol dock that facilitates anchoring of the 29 mm SAPIEN M3 valve, allows treatment of a wide range of annulus sizes and encircles the native leaflets.

Findings from the first 10 cases showed that all patients treated with SAPIEN M3 (mean age 74.1 yrs, all NYHA class III or IV) were hemodynamically stable throughout the procedure; all had the device successfully implanted; and none was observed to have left ventricular outflow tract obstruction (LVOTO). There was no conversion to surgery, device embolisation, device migration or Implantation of more than one valve observed. Procedure time and outcomes improved with operator experience, and no mortality was observed at 30 days, an unusual finding in such a procedure.

In conclusion, early data suggest that use of the SAPIEN M3 System is feasible for treating patients with severe MR who are at high risk for mitral valve surgery, and the system warrants further investigation.