Outcomes of a transapical edge-to-edge repair system in secondary mitral regurgitation.

Abstract

Objectives: The ValveClamp system (Hanyu Medical Technology) is a novel transcatheter edge-to-edge repair (TEER) system designed for ease of operation; however, there is a lack of data on its application in secondary mitral regurgitation (SMR). The authors report the mid-term outcomes of TEER using the ValveClamp system in SMR.

Methods: The study prospectively analyzed consecutive severe SMR patients who underwent transapical ValveClamp implantation at 10 Chinese centers. The enrolled patients were categorized into atrial SMR (aSMR) and ventricular SMR (vSMR) groups. Clinical and echocardiographic outcomes were evaluated at baseline and at follow-up.

Results: A total of 19 aSMR and 24 vSMR patients were enrolled. Technical success was achieved in 100% of the patients and the overall 30-day device success rate was 88.37%. At 1 year, sustained MR reduction to less than or equal to 1+ was achieved in 76.47% of aSMR cases and 77.27% of vSMR cases, and positive reverse left cardiac remodeling was observed. The estimated overall 1-year survival and HF rehospitalization rates for aSMR and vSMR were 83.33% and 83.59%, respectively (log rank P = .98), and improvement of New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups. In multivariable logistic analysis, a lower leaflet-to-annulus index (LAI) (odds ratio [OR], 0.021; 95% CI, 0.001-0.042; P = .02) and a narrow MR jet type (OR, 12.029; 95% CI, 1.530-94.592-0.990; P = .02) were independently associated with a higher incidence of a residual MR of at least 2+ at 3 months after TEER.

Conclusions: TEER using the ValveClamp system is a safe and feasible therapeutic option for patients with SMR regardless of MR etiology. A lower LAI and a narrow MR jet type were independent predictors of residual MR at follow-up.