Transcatheter edge-to-edge repair for secondary mitral regurgitation with third-generation devices in heart failure patients - results from the Global EXPAND Post-Market study

Eur J Heart Fail. 2023 Mar;25(3):411-421. doi: 10.1002/ejhf.2770. Epub 2023 Jan 16.

Abstract

Aims: Mitral valve transcatheter edge-to-edge repair is a guideline-recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis was to report contemporary real-world outcomes in SMR patients treated with third-generation MitraClip systems.

Methods and results: EXPAND is a prospective, multicentre, international, single-arm study with 1041 patients treated for mitral regurgitation (MR) with MitraClip NTR/XTR, with 30-day and 1-year follow-up. All echocardiograms were analysed by an independent echocardiographic core lab. Study outcomes included procedural outcomes, durability of MR reduction, and major adverse events including all-cause mortality and heart failure hospitalizations (HFH). A subgroup of 413 symptomatic patients (age 74.7 ± 10.1 years, 58% male) with severe SMR were included. MR reduction to MR ≤ 1+ and MR ≤ 2+ was achieved in 93.0% and 98.5% of patients, respectively, which was sustained at 1-year follow-up. All-cause mortality was 17.7% at 1-year- follow-up, and the combined endpoint of all-cause mortality or first HFH occurred in 34% of patients. This combined endpoint was significantly less frequently observed in MR ≤ 1+ patients (Kaplan-Maier estimates: 29.7% vs. 69.6% for MR ≤ 1+ vs. MR ≥ 2 +; p < 0.0001). New York Heart Association (NYHA) functional class improved significantly from baseline (NYHA ≤ II: 17%) to 1-year follow-up (NYHA ≤ II: 78%) (p < 0.0001). While MR reduction was comparable between NTR-only vs. XTR-only treated patients, less XTR clips were required for achieving MR reduction.

Conclusions: Under real-world conditions, optimal sustained MR reduction to MR ≤ 1+ was achieved in a high percentage of patients with third-generation MitraClip, which translated into symptomatic improvement and low event rates. These results appear to be comparable with recent randomized clinical trials.

Keywords: Heart failure; MitraClip; Mitral regurgitation; Mitral valve transcatheter edge-to-edge repair; Secondary mitral regurgitation; Transcatheter mitral valve repair.

Publication types

  • Comment

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization
  • Female
  • Heart Failure*
  • Heart Valve Prosthesis Implantation* / methods
  • Humans
  • Male
  • Middle Aged
  • Mitral Valve / diagnostic imaging
  • Mitral Valve / surgery
  • Mitral Valve Insufficiency* / surgery
  • Prospective Studies
  • Treatment Outcome