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A Systematic Review on the Safety and Efficacy of Percutaneous Edge-to-Edge Mitral Valve Repair With the MitraClip System for High Surgical Risk Candidates
Study Questions:
What is the safety and efficacy of the MitraClip system for high surgical risk candidates with severe organic or functional mitral regurgitation (MR)?
Methods:
Six electronic databases were searched for original studies published from January 2000 to March 2013. Two reviewers independently appraised studies, using a standard form, and extracted data on methodology, quality criteria, and outcome measures. All data were extracted and tabulated from the relevant articles’ texts, tables, and figures; and checked by another reviewer.
Results:
Overall, 111 publications were identified. After applying selection criteria and removing serial publications with accumulating number of patients or increased length of follow-up, 12 publications with the most complete data sets were included for quality appraisal and data extraction. All 12 studies were prospective observational studies. Immediate procedural success ranged from 72-100%; 30-day mortality ranged from 0-7.8%. There was a significant improvement in hemodynamic profile and functional status after implantation. One-year survival ranged from 75-90%. No long-term outcomes have been reported for high surgical risk patients.
Conclusions:
The authors concluded that MitraClip implantation is an option in managing selected high surgical risk patients with severe MR, and that current evidence suggests that MitraClip can be implanted with reproducible safety and feasibility profiles in this subgroup of patients.
Perspective:
MitraClip implantation seeks to percutaneously establish an isolated ‘edge-to-edge’ repair of the mitral valve, most widely associated with the surgeon Ottavio Alfieri (the ‘Alfieri stitch’). It probably cannot be expected to resolve MR to the degree associated with mitral valve replacement or a good mitral valve repair. It might find a useful niche among patients with legitimately severe MR who remain severely symptomatic despite optimal medical therapy, and who have prohibitive risks for surgical intervention. MitraClip seems unlikely to play an equivalent role among patients with MR to transcatheter aortic valve replacement (TAVR) among patients with severe symptomatic aortic stenosis.
Keywords: Outcome Assessment, Health Care, Heart Valve Prosthesis, Follow-Up Studies, Serial Publications, Mitral Valve Insufficiency, Cardiac Surgical Procedures, Hemodynamics
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