Influence of experience on procedure steps, safety, and functional results in edge to edge mitral valve repair-a single center study.

ABSTRACT

OBJECTIVES: We sought to determine the effects of experience on the Mitraclip® procedure steps as well as procedure safety and functional results. BACKGROUND: MR has proven deleterious in heart failure. Mitraclip® therapy evolved an important option in patients with severely reduced left ventricular function (LVEF). METHODS: Between 2011 and 2016, 126 consecutive patients were grouped in three groups and investigated in a prospective observational study. We evaluated the duration of procedural steps, safety endpoints, and functional results. RESULTS: The median logistic EuroScore was 32% (7-40%). Ninety-five percent of patients were in NYHA-stage ≥III and 51% had a LVEF <30%. Groups were homogeneous as to their baseline NYHA status and right heart catheterization data. Echocardiography data are comparable, albeit with a decreasing effective regurgitant orifice area (0.44 ± 0.21 group I vs. 0.34 ± 0.22 group III, P = 0.02). Frailty was less frequent and baseline 6 min walking test results improved from group I to group III. Duration of a first clip placement decreased from 106 ± 50 to 50 ± 21 min (P < 0.001). Total procedure time decreased from 221 ± 70 to 144 ± 68 (P < 0.001). The number of clips implanted increased from 66 to 79 (P = 0.02). MitraClip® implantation was effective in either group but the combined safety endpoint was reached less frequent in group III (P = 0.01). There was no difference in MACCE rate, 30 day- or intrahospital-mortality between groups. CONCLUSION: Safety and duration of procedure steps improved substantially with experience. MR reduction was sustained from the beginning without further improvement. Patient selection is a key factor for success. © 2016 Wiley Periodicals, Inc.