Transcatheter Edge-to-Edge Repair in COAPT-Ineligible Patients: Incidence and Predictors of 2-Year Good Outcome

Can J Cardiol. 2022 Mar;38(3):320-329. doi: 10.1016/j.cjca.2021.12.003. Epub 2021 Dec 16.

Abstract

Background: COAPT-trial entry criteria are useful to identify patients with better outcomes after transcatheter edge-to-edge repair (TEER). However, up to one-half of real-world patients with secondary mitral regurgitation (SMR) undergoing TEER do not meet these highly selective criteria and no study has formally investigated them. The aim of this study was to evaluate the predictors of good outcome after TEER in COAPT-ineligible patients.

Methods: All consecutive patients with SMR and heart failure (HF) treated with MitraClip at 3 European centres were retrospectively screened. The presence of at least 1 COAPT exclusion criterion was used to define a COAPT-ineligible profile, allowing the inclusion in the study population. Freedom from all-cause death or HF hospitalisation was evaluated at 2-year follow-up (primary end point).

Results: A total of 305 patients (47%) had a COAPT-ineligible profile. An overall 58% rate of all-cause death or HF hospitalisation was detected at 2 years. Patients with a single COAPT exclusion criterion experienced fewer adverse events than those with multiple criteria (55% vs 69%). At multivariable Cox regression analysis, New York Heart Association functional class II, younger age (< 75 years), lower serum creatinine (< 2 mg/dL), lower left ventricular end-diastolic volume (< 240 mL), and the absence of hemodynamic instability, atrial fibrillation, and chronic obstructive pulmonary disease were independently associated with good outcome.

Conclusions: In this real-world series of patients with SMR undergoing TEER, a COAPT-ineligible profile was common. The presence of only 1 COAPT exclusion criterion or the absence of hemodynamic instability were associated with the most favourable outcomes.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / methods
  • Cardiac Catheterization* / statistics & numerical data
  • Echocardiography / methods
  • Eligibility Determination / methods*
  • Equipment Design
  • Female
  • Heart Failure* / diagnosis
  • Heart Failure* / mortality
  • Heart Failure* / physiopathology
  • Heart Failure* / therapy
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation* / methods
  • Heart Valve Prosthesis Implantation* / statistics & numerical data
  • Humans
  • Male
  • Mitral Valve Insufficiency* / diagnosis
  • Mitral Valve Insufficiency* / epidemiology
  • Mitral Valve Insufficiency* / etiology
  • Mitral Valve Insufficiency* / surgery
  • Mitral Valve* / diagnostic imaging
  • Mitral Valve* / surgery
  • Outcome Assessment, Health Care
  • Patient Selection
  • Severity of Illness Index
  • Stroke Volume