Multicenter Evaluation of an Edge-to-Edge Repair System in High-Risk Patients With Degenerative Mitral Regurgitation.

Background: Transcatheter edge-to-edge repair (TEER) has become an effective alternative for treating degenerative mitral regurgitation (DMR) in patients at high surgical risk. The SQ-Kyrin-M TEER system (SQ-Kyrin-M system) is a novel TEER device developed in China. This study aimed to evaluate the feasibility, safety, and 12-month clinical efficacy of the SQ-Kyrin-M system in patients with high-risk degenerative mitral regurgitation. Methods: In this prospective, multicenter, single-arm study (ClinicalTrials.gov: NCT06467110), 120 patients with symptomatic DMR (grade ≥3+) had the device implanted. The primary endpoint was the clinical success rate at 12 months. Secondary endpoints included technical, device, and procedural success rate; New York Heart Association (NYHA) class improvement; Kansas City Cardiomyopathy Questionnaire (KCCQ) score change; and mitral regurgitation (MR) reduction. Safety endpoints encompassed all-cause mortality, cardiovascular mortality, and major adverse event rate. Results: A total of 120 patients received the TEER procedure across 25 participating sites in China; the mean age was 71.9 years, and the mean Society of Thoracic Surgeons (STS) risk score was 9.3. At 12 months, the Kaplan-Meier estimates were 82.5% for clinical success, 7.6% for all-cause mortality, and 10.8% for major adverse events; MR ≤2+ and MR ≤1+ were achieved in 91.7 and 70.4% of the patients, respectively; 88.9% of patients were in NYHA class I or II; and KCCQ score had improved by 18.9 points. Favorable left ventricular remodeling was observed with sustained reductions in left ventricular end-diastolic and end-systolic volumes. Conclusions: This study demonstrates that the SQ-Kyrin-M system is a safe and effective therapeutic option for DMR patients.