Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR.
Patients with severe symptomatic MR and an estimated surgical mortality rate of ?2 % were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care.
Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50 % had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96 % of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2 % and 17.4 % , respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2 % and 14.9 % , respectively. The 30-day procedure-related mortality rate was 7.7 % in the HRS and 8.3 % in the comparator group (p = NS). The 12-month survival rate was 76 % in the HRS and 55 % in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78 % had an MR grade of ?+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89 % to class I/II in 74 % (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 [p = 0.014] and the mental component score from 45.5 to 48.7 [p = 0.065]) 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 = 0.034).
The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System [EVEREST II]; )