The HighLife TMVR System: CRM, 2026 Review Highlights 90 Percent Success in Mitral Regurgitation

These findings were published in early 2026 in Cardiovascular Revascularization Medicine.

The Clinical Challenge of Mitral Regurgitation

Mitral Regurgitation (MR) remains a prevalent and often undertreated valvular condition, particularly for patients unsuitable for conventional surgery or Mitral Transcatheter Edge-to-Edge Repair (M-TEER). While M-TEER is established, many patients with complex anatomy or poor leaflet coaptation require complete valve replacement. Transcatheter Mitral Valve Replacement (TMVR) addresses these needs but faces technical hurdles, such as achieving stable anchoring in a dynamic, non-calcified annulus and avoiding Left Ventricular Outflow Tract (LVOT) obstruction. The HighLife system (HighLife SAS, Paris, France) introduces a unique design to mitigate these risks.

Review Overview and Mechanism

The review analyzed a multicenter feasibility trial involving 30 high-surgical-risk participants with symptomatic ≥3+ Mitral Regurgitation (MR) over two years at 14 international centers, utilizing a HighLife platform consisting of two primary components: a subannular polymer ring and a self-expanding bioprosthetic valve. The ring is delivered via a retrograde transfemoral arterial approach and positioned around the native leaflets to provide a stable, circumferential anchoring base. Subsequently, the bovine pericardium valve is delivered through a transseptal venous approach and deployed within the ring. This "valve-in-ring" interaction avoids the need for direct annular fixation or radial force, adapting to various patient anatomies while facilitating native leaflet "jailing" to enhance sealing.

Key Clinical Findings of the Review Include:

• High Procedural Success: Investigations reported that technical success was achieved in 90% of the feasibility study participants and 88% of the expanded 52-patient cohort, with 100% of the latter group surviving the immediate procedure.

• Effective Regurgitation Control: The analysis confirmed that Mitral Regurgitation (MR) was eliminated or reduced to trace levels in 88% of patients at discharge, with more than 80% of the expanded study group maintaining these results at one year.

• Superior Outflow Safety: Evaluation showed that no patients experienced Left Ventricular Outflow Tract (LVOT) obstruction, with mean gradients of 2.0 mmHg being significantly lower than the 10.3 mmHg and 8.2 mmHg reported for the Intrepid and EVOQUE systems, respectively.

• Functional Status Improvement: Results indicated that 82% of treated patients reached New York Heart Association (NYHA) functional class I or II by the two-year follow-up, representing a substantial improvement from the 50% who were in classes III or IV at baseline.

• Procedural Risk Profile: Findings reported a 13.5% rate of life-threatening bleeding and a similar 30-day mortality rate in the expanded trial, highlighting the importance of managing procedural risks in this high-surgical-risk population.

Clinical Relevance and Future Innovations

For cardiac teams, the HighLife system offers a promising alternative, specifically for those with Functional Mitral Regurgitation (FMR) or Primary Mitral Regurgitation (PMR) who lack other options. Its design leads to exceptionally low mean LVOT gradients of 2.0 mmHg, significantly lower than other TMVR platforms. New iterations, such as the Large Annulus Valve (LAV) for sizes up to 53 mm and the Clarity prosthesis for higher obstruction risks, continue to broaden patient eligibility. While the procedure involves a learning curve and risks like life-threatening bleeding (13.5% in expanded trials), meticulous imaging via computed tomography (CT) and transesophageal echocardiography (TEE) remains essential for procedural success.

Reference

Penteris M, Lampropoulos K. The HighLife transcatheter mitral valve replacement system: A novel two-component platform. Cardiovascular Revascularization Medicine. 2026;83:90–95.