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

JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):74-82. doi: 10.1016/j.jcin.2014.07.024. Epub 2014 Dec 10.

Abstract

Objectives: 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.

Keywords: EVEREST; GRASP; MitraClip; edge-to-edge mitral valve repair; mitral regurgitation; percutaneous mitral valve repair.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • 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