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

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.

Author information

1
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.
2
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Cardiology, Tokai University School of Medicine, Isehara, Japan.
3
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.
4
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
5
Harrington Heart and Vascular Institute, University Hospitals, Case Medical Center, Cleveland, Ohio.
6
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: melfat75@gmail.com.

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

PMID:
25499300
DOI:
10.1016/j.jcin.2014.07.024
[Indexed for MEDLINE]
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