Key result
MitraClip associated with ~21% higher absolute 12-month survival vs standard care in high-risk patients.
Why the study?
Patients with severe mitral regurgitation at high risk of surgery may benefit from percutaneous mitral leaflet repair as a potentially safer approach to reduce MR.
Does percutaneous mitral leaflet repair with the MitraClip device improve survival and clinical outcomes compared to standard care in patients with severe symptomatic MR at high risk of surgical mortality?
Cohort (n=78)
Does percutaneous mitral leaflet repair with the MitraClip device improve survival and clinical outcomes compared to standard care in patients with severe symptomatic MR at high risk of surgical mortality?
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“I would say these data are very encouraging. This will be the initial group the MitraClip is used in, as they have no other alternative. In Europe, where the device is already approved, it is this group of patients in whom it is predominantly being used.”
“It will be interesting to see whether these data are strong enough for U.S. approval for this high-surgical-risk group.”
“We also see device iteration making it simpler to achieve similar results, but, of course, it was not 100%. In the complex cases, [MR reduction to mild or less] was closer to 80%. But still, these are spectacular results with low mortality and a low complication rate.”
In patients with severe mitral regurgitation at high surgical risk, percutaneous repair with the MitraClip device improved 12-month survival compared to standard care, while also reducing MR severity, improving symptoms, and promoting reverse left ventricular remodeling.
OBJECTIVES: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. BACKGROUND: 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. METHODS: Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% 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. RESULTS: 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 ≤2+. 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). CONCLUSIONS: 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]; NCT00209274).
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Whitlow et al. (2012) conducted a cohort in Severe symptomatic mitral regurgitation at high surgical risk (n=78). MitraClip device vs. Standard care was evaluated on 12-month survival rate (p=0.047). Catheter-based mitral valve repair using the MitraClip device yielded a 12-month survival rate of 76% compared to 55% with standard care in patients at high surgical risk (p=0.047).
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