Impact of COAPT trial exclusion criteria in real-world patients undergoing transcatheter mitral valve repair

Int J Cardiol. 2020 Oct 1:316:189-194. doi: 10.1016/j.ijcard.2020.05.061. Epub 2020 May 26.

Abstract

Background: The generalizability of the COAPT trial results on the benefit of TMVR in patients with secondary mitral regurgitation is unclear.

Methods: Functional and long-term clinical outcome were examined in 122 consecutive patients with secondary mitral regurgitation and reduced ejection fraction undergoing TMVR. "COAPT-like" patients were defined according to principal COAPT inclusion/exclusion criteria if all of the following was fulfilled: symptomatic mitral regurgitation grade 3+ or more according to American guidelines; left ventricular ejection fraction ≥ 20%, left ventricular end-systolic dimension ≤ 70 mm, estimated pulmonary artery systolic pressure ≤ 70 mmHg, mitral valve orifice area ≥ 4 cm2, no prior mitral valve procedure, no right sided congestive heart failure, no COPD requiring home oxygen therapy and NYHA class less than IVb.

Results: 51% of 122 patients (mean age 74 ± 10 years, 76% male) showed COAPT-like characteristics. COAPT-like patients showed a significantly lower hazard for the composite endpoint of mortality and heart failure hospitalization (HR 0.51, 95%CI 0.30-0.89, p = .017) during a mean follow-up of 16 ± 6 months, with an estimated 1-year event rate of 20% vs 43%, respectively. The improvement in functional outcomes 6 min walking distance (76 ± 136 m vs. 31 ± 90 m), Minnesota Living with Heart Failure Questionnaire (-6 ± 19 vs. -10 ± 23) and Short Form 36 physical component score (3.8 ± 10 vs. 5.5 ± 11) was similar in COAPT-like and the other patients.

Conclusion: In this first real world cohort half of the patients undergoing TMVR showed COAPT-like characteristics and these patients showed a substantially better clinical outcome. The mid-term functional benefit was similar in COAPT-like and other patients.

Keywords: COAPT; MitraClip; Patient selection; Secondary mitral regurgitation.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Female
  • Heart Valve Prosthesis Implantation*
  • Humans
  • Male
  • Middle Aged
  • Minnesota
  • Mitral Valve / diagnostic imaging
  • Mitral Valve / surgery
  • Mitral Valve Insufficiency* / diagnostic imaging
  • Mitral Valve Insufficiency* / surgery
  • Stroke Volume
  • Treatment Outcome
  • Ventricular Function, Left