title: 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.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Harrington Heart and Vascular Institute, University Hospitals, Case Medical Center, Cleveland, Ohio; Interventional Cardiology Department, Pitangueiras Hospital, Jundiai, São Paulo, Brazil.
authors.forename: Guilherme F
authors.initials: GF
authors.lastname: Attizzani
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Cardiology, Tokai University School of Medicine, Isehara, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Ohno
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Cardiology, Tokai University School of Medicine, Isehara, Japan; Excellence Through Newest Advances (ETNA) Foundation, Catania, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Cannata
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Dipasqua
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Immé
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Sarah
authors.initials: S
authors.lastname: Mangiafico
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Margherita
authors.initials: M
authors.lastname: Ministeri
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Cageggi
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Pistritto
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Sandra
authors.initials: S
authors.lastname: Giaquinta
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Farruggio
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Chiarandà
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ronsivalle
authors.affiliation: Harrington Heart and Vascular Institute, University Hospitals, Case Medical Center, Cleveland, Ohio.
authors.forename: Audrey
authors.initials: A
authors.lastname: Schnell
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Scandura
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Cardiology, Tokai University School of Medicine, Isehara, Japan; Excellence Through Newest Advances (ETNA) Foundation, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Piera
authors.initials: P
authors.lastname: Capranzano
authors.affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: melfat75@gmail.com.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Grasso
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016022:Case-Control Studies; D005240:Feasibility Studies; D005260:Female; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D020127:Recovery of Function; D012042:Registries; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D016277:Ventricular Function, Left
keywords: EVEREST; GRASP; MitraClip; edge-to-edge mitral valve repair; mitral regurgitation; percutaneous mitral valve repair