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.