One-Year Outcomes of Novel Transcatheter Edge-to-Edge Mitral Repair System in Patients With Functional Mitral Regurgitation.

Abstract

Background: Transcatheter edge-to-edge repair (TEER) improves outcomes in patients with heart failure and moderate-to-severe functional mitral regurgitation (FMR) who remain symptomatic despite the use of maximal doses of guideline-directed medical therapy (GDMT). The SQ-Kyrin-M system is a novel TEER device designed for FMR treatment.

Aims: This multicenter, prospective, single-arm study (ClinicalTrials.gov number: NCT05988450) evaluates the safety and efficacy of the SQ-Kyrin-M system in severe symptomatic FMR.

Methods: A total of 125 eligible patients (mean age 65.5 ± 8.1 years) with heart failure and moderate-to-severe or severe FMR who remained symptomatic despite the use of maximal doses of GDMT were involved in the analysis. The primary endpoint was the composite rate of all-cause mortality and heart failure hospitalization at 1 year post-intervention. Independent assessments were conducted by an echocardiography core laboratory (ECL) and a clinical events committee (CEC).

Results: At 1 year, the primary endpoint rate was 16.0% (20/125), and the composite major adverse event rate was 10.4%. Mitral regurgitation was reduced to ≤ 2+ in 94.2% of patients, with significant left ventricular reverse remodeling (LVEDV reduction: 33.8 ± 55.4 mL, p < 0.001). Patient-reported outcomes improved significantly, with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores increasing by 15.9 ± 18.8 points (p < 0.001) and 6-minute walk distance (6MWD) improving by 46.7 ± 90.7 m (p < 0.001). The proportion of patients in New York Heart Association (NYHA) class I/II increased from 30.4% to 84.4% (p < 0.001).

Conclusions: The SQ-Kyrin-M transcatheter mitral valve repair system bolsters the evidence supporting the safety and efficacy of TEER interventions for FMR patients.