1-Year Outcomes After Transcatheter Edge-to-Edge Repair in Degenerative MR Stratified by Extent of Cardiac Damage.

BACKGROUND

The impact of extramitral cardiac damage (EMCD) in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) for degenerative mitral regurgitation (DMR) is unknown.

OBJECTIVES

The aim of this study was to understand M-TEER outcomes stratified by the extent of EMCD.

METHODS

One-year outcomes from the randomized CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) trial (NCT03706833) in prohibitive surgical risk patients with 3+ or 4+ DMR were analyzed by baseline EMCD stages (stage 0, no EMCD; stage 1, left ventricular remodeling; stage 2, left atrial remodeling; stage 3, pulmonary hypertension and/or tricuspid regurgitation; stage 4, right ventricular dysfunction).

RESULTS

The analysis included 211 patients: 53.1% in stages 0, 1, and 2 (n = 112), 13.3% in stage 3 (n = 28), and 33.6% in stage 4 (n = 71). Stages 0, 1, and 2 were combined because there were few patients in stage 0 (n = 3) and stage 1 (n = 1). At baseline, patients with more advanced cardiac damage had more comorbidities, lower functional and quality-of-life measures, and greater mitral regurgitation severity. One-year rates of clinical events among all stages were comparable for major adverse events (P = 0.343) and all-cause mortality (P = 0.644) and significantly different for heart failure hospitalization (P = 0.012). Patients in all stages achieved comparable echocardiographic and quality-of-life improvements at 1 year, including mitral regurgitation ≤1+ (P = 0.474), left ventricular diastolic (P = 0.619) and systolic (P = 0.676) volumes, and Kansas City Cardiomyopathy Questionnaire score (P = 0.335), with significant improvements from baseline (P < 0.05 vs baseline for all).

CONCLUSIONS

Results from the CLASP IID trial demonstrate benefit of M-TEER in DMR patients across all EMCD stages, including stage 4, with low major adverse events and all-cause mortality and comparable significant improvements in echocardiographic and quality-of-life outcomes at 1 year.