Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip ^® and lessons learned after the first 75 consecutive patients

Abstract

AimsMitral valve regurgitation plays a significant role in the aetiology and course of heart failure. We investigated the impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip. Methods and resultsOutcomes of the first 75 consecutive patients treated with MitraClip at our centre were stratified by subsequent treatment periods (25 patients each). Median total procedure time and device time decreased from 180 and 105 min in period 1 to 95 and 55 min in period 3 (P , 0.005 each). There was an excess of total safety events in period 1 (n ¼ 16) that decreased in periods 2 and 3 (n ¼ 6 and 3, P ¼ 0.0003). Acute procedural success [APS; clip successfully placed and mitral regurgitation (MR) grade ≤2+ at discharge] was 80% in periods 1 and 2, but 92% in period 3 (P ¼ 0.46). At 6 months, improvement in durability and completeness of mitral valve repair was evident: 89.4% of patients in period 3 and 65.0% in period 1 had MR ≤2+ at 6 months (P ¼ 0.03). Within 30 days, no patient sustained myocardial infarction or stroke, and mortality was 2.7% for all patients without significant differences regarding periods. Furthermore, while treatment period did not affect mid-term survival and hospitalization for heart failure, failure of APS, STS (Society of Thoracic Surgeons) score ≥15%, and overt right heart failure at baseline predicted increased mortality. ConclusionMitraClip showed a learning curve regarding mid-term durability and completeness of mitral valve repair, and APS predicted mortality. Recently published studies should be interpreted in consideration of these findings.--

Acute Changes of Mitral Valve Geometry During Interventional Edge-to-Edge Repair With the MitraClip System Are Associated With Midterm Outcomes in Patients With Functional Valve Disease

“…Of note, recent studies described a significant relapse of moderate-to-severe MR, despite good intraprocedural MR reduction in ≤20% of patients, which was not related to immediate or late clip detachment. 18,19 The presented results confirm the fact that TMVR with the MitraClip system acutely influences the MV annular anatomy in patients with FMR. After assessment of dynamic changes on MV geometry, only the AP diameter remained unchanged or stable during the heart cycle after clip implantation, suggesting a constrained influence of the clip on the mitral annulus.…”

AVJ-514 Trial ― Baseline Characteristics and 30-Day Outcomes Following MitraClip^® Treatment in a Japanese Cohort ―

“…Schillinger et al described an institutional learning curve that became evident in decreasing procedural times and safety events over time, accompanied with increased durability and completeness of MV repair over time. 22 APS was achieved in 86.7% of the present patients. Non-APS in 4 patients was related to MR >2+ at discharge.…”

Real-World Experience of MitraClip for Treatment of Severe Mitral Regurgitation

“…Therefore, the effect of the learning curve of the whole heart team, not only the primary operators, would impact on the clinical outcome in terms of MR reduction and complication rates. 14 Despite the absence of complete reduction of MR in both the functional and degenerative subgroups, together with the lack of significant improvement in LVEF and reduction in pulmonary arterial pressure, significant improvement in symptoms, in terms of reduction in NYHA class, was observed in patients with successful procedure. This phenomenon was also observed in other similar studies.…”