Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System

ObjectivesThe aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system.BackgroundTransseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair.MethodsPatients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria.ResultsFourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%).ConclusionsThis first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes.