Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy

Ioanna Kosmidou; JoAnn Lindenfeld; William T. Abraham; Saibal Kar; D. Scott Lim; Jacob M. Mishell; Brian Whisenant; Robert Kipperman; Konstantinos Dean Boudoulas; Björn Redfors; Bahira Shahim; Zixuan Zhang; Michael J. Mack; Gregg W. Stone

doi:10.1161/circheartfailure.120.007293

November 1, 2020Circulation Heart Failure

Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchronization Therapy

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Why the study?

Whether the benefits of the MitraClip plus GDMT extend to heart failure patients with secondary mitral regurgitation and previously implanted CRT was unknown.

Does transcatheter mitral valve repair (TMVr) with MitraClip reduce death or heart failure hospitalization in heart failure patients with moderate-severe or severe secondary mitral regurgitation, regardless of prior cardiac resynchronization therapy (CRT)?

Structured PICO

Does transcatheter mitral valve repair (TMVr) with MitraClip reduce death or heart failure hospitalization in heart failure patients with moderate-severe or severe secondary mitral regurgitation, regardless of prior cardiac resynchronization therapy (CRT)?

P

Population

614 patients with heart failure and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of guideline-directed medical therapy (224 with prior CRT, 390 without CRT).

I

Intervention

Transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT)

C

Comparator

Guideline-directed medical therapy (GDMT) only

O

Outcome

Composite of death or heart failure hospitalization at 2 yearscomposite

Implication

TMVr with MitraClip reduces the composite of death or heart failure hospitalization at 2 years in patients with heart failure and severe secondary mitral regurgitation, with consistent benefits regardless of prior CRT implantation.

Abstract

Background: In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT. Methods: Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use. Results: Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%, P =0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42–0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39–0.69]; adjusted P interaction =0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted P interaction =0.14) and HF hospitalization (adjusted P interaction =0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity. Conclusions: In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01626079.