Acute and 12-Month Results Published From the EVEREST II High-Risk Study

January 10, 2012—Acute and 12-month results from the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High-Risk Study (HRS) were published by Patrick L. Whitlow, MD, et al in the Journal of the American College of Cardiology (2012;59:130–139).

EVEREST II assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, CA) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality. The investigators concluded that the MitraClip device reduced MR in a majority of patients who were deemed to be at high risk for surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months.

According to the investigators, patients with severe MR (3 to 4+) at high risk for surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. In the study, patients with severe symptomatic MR and an estimated surgical mortality rate of 12% were enrolled. A comparator group of patients who were screened concurrently but not enrolled (instead treated by standard care) were identified retrospectively and consented to be compared in terms of survival rates.

As detailed in the Journal of the American College of Cardiology, 78 patients underwent the MitraClip procedure. The mean age of the patients was 77 years, > 50% had previous cardiac surgery, 46 had functional MR, and 32 had degenerative MR. MitraClip devices were successfully placed in 96% of patients. The protocol-predicted surgical mortality rates in the HRS and concurrent comparator groups were 18.2% and 17.4%, respectively, and the Society of Thoracic Surgeons calculator estimated mortality rates were 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS group and 8.3% in the comparator group (P = NS). The 12-month survival rate was 76% in the HRS group and 55% in the concurrent comparator group (P = .047).

The investigators reported that in surviving patients with matched baseline and 12-month data, 78% had an MR grade of 2+. Left ventricular end-diastolic volume improved from 172 to 140 mL, and end-systolic volume improved from 82 to 73 mL (both P = .001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (P < .0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [P = .014], and the mental component score increased from 45.5 to 48.7 [P = .065]) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (P = .034).

Zoltan G. Turi, MD, and Michael Rosenbloom, MD, discuss the implications of the EVEREST II findings in a commentary, “An Option for the High-Comorbidity Patient With Mitral Regurgitation,” in the Journal of the American College of Cardiology (2012;59:140–142).