Acute and 12-Month Results With Catheter-Based Mitral Valve Leaflet Repair: The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study

Study Questions:

What are the short-term and 1-year outcomes of patients undergoing catheter-based mitral valve leaflet repair?

Methods:

The authors reported the outcome of 78 patients with severe symptomatic mitral regurgitation (MR) and an estimated surgical mortality rate of >12%, who were enrolled in a single-arm study of the MitraClip device. The comparator group was comprised of patients who were screened concurrently, but not enrolled, and who consented to follow-up and were treated by standard care.

Results:

The average age of the treated patients was 77 years. The etiology of MR was degenerative in 32 and functional in 46 patients. MitraClip devices were successfully placed in 96% of patients. MR was reduced to ≤2+ in 56 patients (72%). Protocol-predicted surgical mortality rate in the study arm 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. There was no difference in the 30-day mortality rate (7.7% in the MitraClip arm vs. 8.3% in the comparator group). The 12-month survival rate was significantly greater in the MitraClip arm (76% vs. 55%, p = 0.047). MitraClip was associated with an improvement in New York Heart Association functional class from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001) and significant reduction in end-systolic (82-73 ml) and end-diastolic left ventricular (172-140 ml) volume.

Conclusions:

The MitraClip is associated with an improvement in MR and reduction in symptoms in patients with severe MR who are high risk for surgical repair.

Perspective:

This study adds to the growing evidence supporting a role for catheter-based treatment of MR. The successful and durable reduction of MR was associated with favorable reversal of remodeling, as well as an improvement in functional class. There has been paucity of randomized data evaluating treatment of MR, and the logical next step in the evaluation of this therapy should be a randomized trial to evaluate the role of surgery, medical therapy, and the MitraClip among patients with MR.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging, Mitral Regurgitation

Keywords: Follow-Up Studies, Coronary Angiography, Mitral Valve Prolapse, Survival Rate, Mitral Valve Insufficiency, Catheters, Cardiac Surgical Procedures, Angioplasty, New York, Heart Ventricles


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