Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry

• Published in: JACC. Cardiovascular interventions Vol. 8; no. 1 Pt A; pp. 74 - 82
• Main Authors: Attizzani, Guilherme F, Ohno, Yohei, Capodanno, Davide, Cannata, Stefano, Dipasqua, Fabio, Immé, Sebastiano, Mangiafico, Sarah, Barbanti, Marco, Ministeri, Margherita, Cageggi, Anna, Pistritto, Anna Maria, Giaquinta, Sandra, Farruggio, Silvia, Chiarandà, Marta, Ronsivalle, Giuseppe, Schnell, Audrey, Scandura, Salvatore, Tamburino, Corrado, Capranzano, Piera, Grasso, Carmelo
• Format: Journal Article
• Language: English
• Published: United States 01-01-2015
• Subjects: Aged; Aged, 80 and over; Cardiac Surgical Procedures - adverse effects; Cardiac Surgical Procedures - instrumentation; Cardiac Surgical Procedures - mortality; Case-Control Studies; Feasibility Studies; Female; Hemodynamics; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Mitral Valve - diagnostic imaging; Mitral Valve - physiopathology; Mitral Valve - surgery; Mitral Valve Insufficiency - diagnostic imaging; Mitral Valve Insufficiency - mortality; Mitral Valve Insufficiency - physiopathology; Mitral Valve Insufficiency - surgery; Predictive Value of Tests; Prospective Studies; Recovery of Function; Registries; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome; Ultrasonography; Ventricular Function, Left; edge-to-edge mitral valve repair; EVEREST; MitraClip; mitral regurgitation; percutaneous mitral valve repair; GRASP
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2014.07.024

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.