Transcatheter Mitral Valve Replacement with the Transseptal EVOQUE System

ABSTRACT Background Transseptal transcatheter mitral valve replacement (TMVR) may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair. Objectives To examine the initial experience with a novel transseptal TMVR system. Methods Patients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were ≥ moderate MR, New York Heart Association (NYHA) Class ≥ 2, and high/prohibitive surgical risk. Primary outcome was technical success defined by Mitral Valve Academic Research Consortium criteria. Results Fourteen patients were treated, all with ≥ moderate-severe MR. Median age was 84 years, and median STS 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 thirteen patients (92.9%) and one patient was converted to surgery. At 30 days there was one non-cardiovascular mortality (7.1%), two strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent PVL closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with PVL closure, MR was ≤ mild in all implanted patients at 30 days with no MR in ten (83.3%). Mean mitral gradient was 5.8mmHg (median). Functional class improved to NYHA Class ≤2 in nine patients (81.8%). Conclusions This 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.