Management strategies and prognosis of patients ineligible for transcatheter mitral valve replacement

Cardiovasc Revasc Med. 2024 Jul:64:1-4. doi: 10.1016/j.carrev.2024.02.002. Epub 2024 Feb 10.

Abstract

Background: Transcatheter mitral valve replacement (TMVR) faces anatomical challenges, currently limiting widespread adoption.

Objectives: To describe the natural history and prognosis of patients ineligible for various TMVR devices.

Methods: During a 4-year period (2019-2023) 3 TMVR devices (SAPIEN M3, Intrepid and Alta Valve) became available at a single institution (The Christ Hospital, Cincinnati, OH) in the setting of pivotal clinical trials or early feasibility study. Consenting patients who were deemed ineligible ≥1 of these trials were prospectively studied to capture anatomical reasons for ineligibility, cross-over to alternative mitral valve therapies (surgery or high-risk mitral transcatheter edge to edge repair [M-TEER]), and clinical events.

Results: A total of 61 patients (out of 71 consenting patients or 85.9 %) were deemed ineligible for TMVR during the study period. The mean age was 79.2 ± 8.8 years, 65.6 % were female, with elevated surgical risk (median STS 4.3, IQR: 2.7-7.3). The 2 most common anatomical reasons for ineligibility were increased risk of left ventricular outflow tract obstruction (LVOTO) (n = 24, 39.3 %) and annular size (n = 29, 47.5 %). During follow-up (median 277 [162-555] days) there were 7 deaths (11.5 %) and 12 (19.7 %) hospitalizations for heart failure. Management strategies included high-risk M-TEER in 11 patients (1 death [9.0 %], 0 HF hospitalizations [0 %]), surgery in 9 patients (0 deaths, 1 HF hospitalizations [11.1 %]), and medical management in 41 patients (6 deaths [14.6 %], 11 HF hospitalizations [26.8 %]) (p = 0.715 for mortality and p = 0.093 for HF hospitalizations). Residual MR ≥ moderate was 0 %, 50 %, and 100 % for surgery, M-TEER and medical treatment, respectively (p < 0.001).

Conclusions: One third of patients deemed ineligible for TMVR are candidates for high-risk M-TEER or surgery with acceptable morbidity and mortality. Our results have practical implications for patient management.

Keywords: Mitral regurgitation; Mitral valve repair; Mitral valve surgery; Transcatheter edge-to-edge repair; Transcatheter mitral valve replacement.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / instrumentation
  • Cardiac Catheterization* / mortality
  • Clinical Decision-Making
  • Eligibility Determination*
  • Female
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Heart Valve Prosthesis Implantation* / instrumentation
  • Heart Valve Prosthesis Implantation* / mortality
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Mitral Valve Insufficiency* / diagnostic imaging
  • Mitral Valve Insufficiency* / mortality
  • Mitral Valve Insufficiency* / physiopathology
  • Mitral Valve Insufficiency* / surgery
  • Mitral Valve* / diagnostic imaging
  • Mitral Valve* / physiopathology
  • Mitral Valve* / surgery
  • Patient Selection*
  • Prospective Studies
  • Prosthesis Design
  • Recovery of Function
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome