Study Supports Abbott Vascular's MitraClip for High-Surgical-Risk Patients

March 10, 2010—Olaf Franzen, MD, et al have published results from a study for the MitraClip (Abbott Vascular, Santa Clara, CA). The findings were published online ahead of print in the European Heart Journal. The investigators sought to assess acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical- risk patients with an emphasis on adverse valve morphology and severe left ventricular dysfunction, as well as assess the feasibility of catheter-based mitral valve repair using the MitraClip system in high-surgical risk patients with mitral regurgitation (MR) > grade 3+. The investigators concluded that mitral valve repair using the MitraClip system was shown to be feasible in patients at high surgical risk primarily determined by an adverse mitral valve morphology and/or severe left ventricular (LV) dysfunction.

As detailed in the European Heart Journal, MitraClip therapy was performed in 51 consecutive patients (aged 73 ± 10 years; 34 [67%] men) with symptomatic functional (n = 35 [69%]) or organic MR (n = 16 [31%]). Mean logistic EuroSCORE was 29% ± 22%; Society of Thoracic Surgeons score was 15 ± 11. LV ejection fraction was 36% ± 17%. In 35 patients (69%), adverse mitral valve morphology and/or severe LV dysfunction were present. MitraClip implantation was successful in 49 patients (96%). Most patients (n = 34/49 [69%]) were treated with a single clip, whereas 14 patients (29%) received two clips and one patient received three clips. Mean device and fluoroscopy times were 105 ± 65 min and 44 ± 28 min, respectively. Procedure-related reduction in MR severity was one grade in 16 patients (31%), two grades in 24 patients (47%), and three grades in nine patients (18%). Fortyfour of the 49 successfully treated patients (90%) showed clinical improvement at discharge (NYHA functional class > III in 48 patients [98%] before and 16 patients [33%] after the procedure [P < .0001]). There were no procedure-related major adverse events and no in-hospital mortality.