Use of the transseptal Evoque transmitral valve replacement (TMVR) system (Edwards Lifesciences) has been shown to be feasible in a first-in-human experience, a hotline session at PCR e-Course 2020 (25-27 June) has been told. The findings, presented by John Webb (St Paul’s Hospital, Vancouver, Canada), were also simultaneously published in JACC: Cardiovascular Interventions. Webb told the online audience that further clinical studies are required to establish safety and clinical outcomes.
Transcatheter technologies for mitral valve repair are expanding, but not all anatomies are suitable and residual mitral regurgitation (MR) is common. TMVR represents an alternative to repair, with a transseptal approach having potential advantages compared to transapical TMVR—it may offer a less invasive option than surgery for MR, with greater efficacy and fewer anatomic limitations than transcatheter repair.
This study sought to examine the initial experience with a novel transseptal TMVR system., Evoque. The Evoque valve is a novel self-expanding nitinol valve with bovine pericardial leaflets delivered via a transseptal approach. Webb described it as a “device that is unique in terms of its anchorage”.
Patients were treated with the 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. Webb characterised participants as a “high-risk inoperable cohort with multiple comorbidities”. The primary outcome was technical success defined by Mitral Valve Academic Research Consortium criteria.
In all, 14 patients were treated, all with ≥moderate to severe MR. Mean age was 79 years, and median Society of Thoracic Surgeons (STS) score was 4.6%. MR was degenerative in four (28.6%) cases, functional in three (21.4%) and mixed in seven (50%). Technical success was achieved in 13 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 rehospitalisations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the two patients with PVL closure, MR was ≤ mild in all implanted patients at 30 days with no MR in 10 (83.3%). Mean mitral gradient was 5.8mmHg (median). Functional class improved to NYHA Class ≤2 in nine patients (81.8%).
Webb said: “This first-in-man experience was very favourable. [NYHA] functional class improved dramatically. … mitral insufficiency reduced fairly dramatically … and left ventricular function fell slightly.” He indicated that the ongoing early feasibility study will further investigate the safety and efficacy of the Evoque system.