June 17, 2026Journal of the American College of Cardiology567 citations
Acute and 12-Month Results With Catheter-Based Mitral Valve Leaflet Repair
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Key Result
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).
Key Points
- To assess the safety and effectiveness of the MitraClip device in patients with significant mitral regurgitation at high surgical risk.
- Enrolled patients with severe symptomatic MR and ≥12% surgical mortality risk.
- Compared outcomes with a retrospective comparator group receiving standard care.
- Evaluated 30-day mortality, 12-month survival, and functional outcomes post-procedure.
- MitraClip procedure succeeded in 96% of patients; 12-month survival was 76% in HRS vs. 55% in comparator (p=0.047).
- Significant decrease in left ventricular end-diastolic volume from 172 ml to 140 ml (p=0.001).
- Quality of life improved with physical component score rising from 32.1 to 36.1 (p=0.014) at 12 months.
Study Design
Type
Cohort (n=78)
Structured PICO
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?
P
Population
Patients with severe symptomatic mitral regurgitation and an estimated surgical mortality rate of ≥12%, mean age 77 years, followed for 12 months.
I
Intervention
Percutaneous mitral leaflet repair using the MitraClip device
C
Comparator
Standard care (concurrently screened but not enrolled patients identified retrospectively)
O
Outcome
12-month survivalhard clinical
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.
Main Result
Absolute Event Rate: 76% vs 55%
p-value: p=0.047
Abstract
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).
Expert Takes3 quotes
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“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.”
Patrick Whitlow, Interventional cardiologist, Cleveland ClinicCleveland Clinicauto_pipelineSupportiveView source
Cite This Study
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).