Key result
Increased operator experience with the MitraClip procedure significantly reduced total procedure time from 221 to 144 minutes (P<0.001) and improved the combined safety endpoint (P=0.01).
Why the study?
Does operator experience improve procedure duration, safety, and functional results in patients undergoing edge-to-edge mitral valve repair?
Observational (n=126)
No
Does operator experience improve procedure duration, safety, and functional results in patients undergoing edge-to-edge mitral valve repair?
p-value: p=<0.001
Increased operator experience in edge-to-edge mitral valve repair significantly reduces procedure time and improves safety outcomes.
Supports shorter MitraClip procedures with experience; hypothesis-generating for volume standards in structural interventions.
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.
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Hamm et al. (2016) conducted an observational in Mitral regurgitation (n=126). Operator experience vs. Less experience (earlier cases) was evaluated on Duration of procedural steps, safety endpoints, and functional results (p=<0.001). Increased operator experience with the MitraClip procedure significantly reduced total procedure time from 221 to 144 minutes (P<0.001) and improved the combined safety endpoint (P=0.01).
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