Photo Credit: Pavel Muravev
The following is a summary of “Transcatheter Edge-to-Edge Repair in COAPT-Ineligible Patients With Functional Mitral Regurgitation,” published in the January 2024 issue of Cardiology by Chhatriwalla et al.
The US approval of mitral valve transcatheter edge-to-edge repair (MTEER) for functional mitral regurgitation (FMR) treatment stemmed from findings in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial.
Researchers conducted a retrospective study to assess the outcomes of MTEER in FMR patients ineligible for the COAPT trial.
They categorized MTEER procedures performed for FMR in the TVT (Transcatheter Valve Therapy) Registry (January 1, 2013, and April 30, 2020) as “trial-ineligible” if they exhibited any of the following: cardiogenic shock, inotropic support, left ventricular ejection fraction <20%, left ventricular end-systolic dimension >7 cm, home oxygen use, or severe tricuspid regurgitation. Comparisons between the trial-ineligible and trial-eligible groups were conducted over one year using multivariable models. The primary endpoint was 1-year death or heart failure hospitalization (HFH).
The results showed that of 6,675 patients who underwent MTEER for FMR, 3,721 (55.7%) were trial-eligible, while 2,954 (44.3%) were trial-ineligible. Trial-ineligible patients had a lower rate of technical procedural success (86.9% vs 92.6%; P<0.001) and experienced more frequent in-hospital complications (11.8% vs 5.7%; P<0.001) compared to trial-eligible patients. At 30 days, a clinically significant improvement in health status was observed in 78.9% and 77.0% of patients in the trial-ineligible and trial-eligible groups, respectively. Trial-ineligible patients had a higher risk of 1-year death or heart failure hospitalization (HR: 1.73; 95% CI: 1.57-1.91; P<0.001).
Investigators concluded that MTEER patients in the TVT Registry show similar short-term improvement but higher long-term mortality, suggesting a potential need for alternative approaches for those ineligible for COAPT trial.