1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study

JACC Cardiovasc Interv. 2023 Dec 11;16(23):2854-2865. doi: 10.1016/j.jcin.2023.09.003. Epub 2023 Nov 22.

Abstract

Background: A significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to-edge repair because of high surgical risk or inappropriate mitral valve anatomy.

Objectives: The aim of this study was to evaluate the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR and high surgical risk.

Methods: This prospective, multicenter, nonrandomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR during 1-year follow-up. Echocardiographic data were assessed at an independent core laboratory.

Results: A total of 30 patients (mean age 75.6 years, 27% women, median Society of Thoracic Surgeons score 5.5%) with severe MR (90% with secondary MR, median left ventricular ejection fraction 43%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system was implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, 5 patients (17%) had died. None of the patients who underwent implantation required mitral valve reintervention. All patients who underwent implantation had no or trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract obstruction (mean gradient 2.0 mm Hg).

Conclusions: The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention. Additional patient outcomes and longer follow-up are needed to confirm these findings. (Expanded Study of the HighLife 28mm Trans-Septal Trans-Catheter Mitral Valve in Patients With Moderate-Severe or Severe Mitral Regurgitation and at High Surgical Risk; NCT04029363).

Keywords: HighLife; mitral regurgitation; mitral valve replacement; transseptal.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Cardiac Catheterization
  • Feasibility Studies
  • Female
  • Heart Valve Prosthesis Implantation*
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Mitral Valve / diagnostic imaging
  • Mitral Valve / surgery
  • Mitral Valve Insufficiency* / diagnostic imaging
  • Mitral Valve Insufficiency* / surgery
  • Prospective Studies
  • Stroke Volume
  • Treatment Outcome
  • Ventricular Function, Left

Associated data

  • ClinicalTrials.gov/NCT04029363