The HighLife transcatheter mitral valve replacement system: A novel two-component platform.

Abstract

Mitral regurgitation (MR) remains a prevalent and undertreated condition, particularly in patients at high surgical risk or unsuitable for mitral transcatheter edge-to-edge repair (M-TEER). The HighLife (HighLife SAS, Paris, France) transcatheter mitral valve replacement (TMVR) system offers a novel solution with its unique two-component design comprising a subannular ring and a self-expanding bioprosthetic valve. Delivered via a transfemoral arterial and transseptal venous approach, this "valve-in-ring" system enables circumferential anchoring without the need for annular calcification or transapical access. Early clinical experience, including first-in-human and feasibility studies, has demonstrated high technical success, significant MR reduction, and favorable short- and mid-term outcomes. Recent device iterations, such as the large annulus valve and Clarity prosthesis, address prior limitations related to annular size and left ventricular outflow tract (LVOT) obstruction risk, broadening the range of suitable anatomies. Despite its promise, the HighLife system presents challenges including procedural complexity, bleeding risk, and the need for precise imaging and experienced operators. Ongoing clinical trials will be critical to further define its safety, durability, and long-term efficacy. With further evidence, the HighLife system may offer a viable TMVR option for patients previously deemed untreatable by conventional transcatheter or surgical approaches.