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Percutaneous Mitral Valve Repair for Mitral Regurgitation in High-Risk Patients: Results of the EVEREST II Study
Study Questions:
What are the 12-month outcomes in high-risk patients treated with the MitraClip (percutaneous mitral valve edge-to-edge repair) device?
Methods:
Symptomatic patients with grades 3 to 4+ mitral regurgitation (MR) originating from and due to A2/P2 malcoaptation, appropriate leaflet geometry felt suitable for the MitraClip device, and a predicted surgical mortality risk ≥12% (based on the Society of Thoracic Surgeons risk calculator, or the estimate of a surgeon coinvestigator) following prespecified protocol criteria, were enrolled in the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy II) High-Risk registry and the REALISM Continued Access Study High-Risk Arm.
Results:
In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001), and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). The annual hospitalization rate for heart failure fell from 0.79% preprocedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%.
Conclusions:
The authors concluded that the percutaneous MitraClip device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort.
Perspective:
The EVEREST II study and its continued access registry included patients with either primary or secondary MR, and found improvement in MR severity, symptoms, and LV dimensions compared to baseline. At 12 months, a majority of patients had at least 2+ MR, an outcome that would not be acceptable with surgical intervention; suggesting that MitraClip is not to MR as transcatheter aortic valve replacement (TAVR) is to aortic stenosis. Despite less-than-surgically-acceptable outcomes, modest improvements in MR severity afforded by this transcatheter device might benefit some patients with severe symptomatic MR who truly are not operative candidates.
Keywords: Registries, Myocardial Infarction, Stroke, Follow-Up Studies, Mitral Valve Insufficiency, Heart Failure, Cardiac Surgical Procedures, Health Surveys
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