Extended Use of Percutaneous Edge-to-Edge Mitral Valve Repair Beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) Criteria

• DOI: 10.1016/j.jcin.2014.07.024
• Publication Date: 2014-12-10T21:47:42Z
• Authors: Guilherme F. Atti...; Yohei Ohno; Davide Capodanno; Stefano Cannata; Fabio Dipasqua; Sebastiano Immé; Sarah Mangiafico; Marco Barbanti; Margherita Ministeri; Anna Cageggi; Anna Maria Pistritto; Sandra Giaquinta; Silvia Farruggio; Marta Chiarandà; Giuseppe Ronsivalle; Audrey Schnell; Salvatore Scandura; Corrado Tamburino; Piera Capranzano; Carmelo Grasso
• Keywords: Male; Time Factors; Kaplan-Meier Estimate; EVEREST; Severity of Illness Index; 03 medical and health sciences; 0302 clinical medicine; Predictive Value of Tests; Risk Factors; GRASP; MitraClip; Humans; percutaneous mitral valve repair; Prospective Studies; Registries; Cardiac Surgical Procedures; Aged; Aged, 80 and over; edge-to-edge mitral valve repair; Hemodynamics; Mitral Valve Insufficiency; Recovery of Function; Middle Aged; 3. Good health; Case-Control Studies; Feasibility Studies; Mitral Valve; Female; mitral regurgitation; Cardiology and Cardiovascular Medicine

This study sought to compare, in high-risk patients with 3+ to 4+ mitral regurgitation (MR) dichotomized by baseline echocardiographic features, acute, 30-day, and 12-month outcomes following percutaneous mitral valve repair using the MitraClip.The feasibility and mid-term outcomes after MitraClip implantation in patients with echocardiographic features different from the EVEREST (Endovascular Valve Edge-to-Edge Repair) I and II trials have been scarcely studied.Clinical and echocardiographic outcomes through 12-month follow-up of consecutive patients who underwent MitraClip implantation were obtained from an ongoing prospective registry. Two different groups, divided according to baseline echocardiographic criteria (investigational group [EVERESTOFF] and control group [EVERESTON]), were compared.Seventy-eight patients were included in EVERESTOFF and 93 patients in EVERESTON groups. Important and comparable acute reductions in MR and no clip-related complications were revealed. The primary safety endpoint at 30 days was comparable between groups (2.6% vs. 6.5%, respectively, p = 0.204); in addition, MR reduction was mostly sustained, whereas equivalent improvement in New York Heart Association functional class were demonstrated. Kaplan-Meier freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 12 months was demonstrated in 71.4% and 76.2%, respectively, in the EVERESTOFF and EVERESTON groups (log rank p = 0.378). Significant improvements in ejection fraction and reduction in left ventricle volumes were demonstrated in both groups over time, but the baseline between-group differences were sustained.MitraClip implantation in patients with expanded baseline echocardiographic features, compared with the control group, was associated with similar rates of safety and efficacy through 12-month follow-up. Further validation of our findings is warranted.