NEW YORK (Reuters Health) – For patients with significant mitral valve regurgitation who are not considered candidates for surgery, catheter-based mitral leaflet repair with the MitraClip device (Abbott Vascular) may be a good option, based on findings reported in the January 19th issue of the Journal of the American College of Cardiology.

“MitraClip device placement in this selected high-risk group is feasible, effective in reducing symptoms and improving clinical status, and relatively safe in patients who otherwise have no safe option to reduce MR (mitral regurgitation),” the authors conclude.

Dr. Patrick L. Whitlow, with the Cleveland Clinic, Ohio and colleagues explain that up to a half of patients with severe symptomatic mitral regurgitation may receive only medical management because surgical risks are deemed prohibitive.

To assess the benefit of endovascular treatment using the MitraClip device in such high-risk subjects, the team conducted a prospective, single-arm study with 78 patients with mitral regurgitation grade 3+ to 4+ and an estimated surgical mortality risk of at least 12%.

The procedure involves advancing the device via the left atrium into the mitral valve so that the MitraClip can be deployed to coapt the mitral leaflets across the regurgitant orifice.  This was accomplished in 96% of the patients in the current study.

Outcomes in these patients were compared to a retrospectively recruited group of 36 patients who were screened for the study but not enrolled and who were managed with standard care.

Procedure-related mortality at 30 days was 7.7% in the MitraClip group, while 30-day mortality in the comparison group was not significantly different at 8.6%, the report indicates.  At 12 months, survival was 76% among patients who underwent percutaneous mitral repair and 55% in the comparison group.

Among surviving patients in the MitraClip group, mitral regurgitation grade improved to less than 2+ in 78% of them at 12 months, the authors found.  Furthermore, there were significant reductions in LV end-diastolic volume (from 172 to 140 mL) and end-systolic volume (from 82 to 73 mL).

In the year before the procedure, the hospitalization rate for heart failure was 42%; it was 16% in the 12 months following discharge after the MitraClip procedure, Dr. Whitlow and colleagues report.

“Favorable LV remodeling demonstrates that the degree of reduction in MR obtained with the MitraClip device is hemodynamically important” they conclude, but add, “Long-term follow-up is ongoing and needed to confirm whether the benefits observed at 12 months are sustained.”

SOURCE:

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

J Am Coll Cardiol 2012;59:130-139.