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Institutional Learning Curve for MitraClip
Study Questions:
What is the relation between institutional experience and procedural results of transcatheter mitral valve repair (TMVR)?
Methods:
The investigators stratified MitraClip procedures from the Society of Thoracic Surgeons/ American College of Cardiology TVT (Transcatheter Valve Therapy) Registry into tertiles on the basis of site-specific case sequence (1-18, 19-51, and 52-482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable. Restricted cubic splines were used to explore potential nonlinear relationships between case volume and outcomes.
Results:
MitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤+1 residual mitral regurgitation [MR] without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p < 0.001), whereas procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or need for cardiac surgery) also increased across tertiles of case experience, but the differences were smaller (91.2%, 91.2%; and 92.9%; p = 0.006). In the learning-curve analysis, visual inflection points for procedural time, procedural success, and procedural complications were evident after about 50 cases, with continued improvements observed up to 200 cases.
Conclusions:
The authors concluded that for TMVR with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications.
Perspective:
This analysis of the US commercial TMVR experience with the MitraClip reports that clinical outcomes, including procedural success, procedure duration, and procedural complications, improved with increasing institutional case experience. Furthermore, the impact of institutional experience was especially evident on the endpoint of optimal MR reduction with a threshold of >50 cases related to improvement in outcomes. These data emphasize the importance of increasing site case experience as well as close multidisciplinary collaboration for the treatment of patients with MR with appropriate patient selection, which is relevant to long-term clinical success and involves collaboration between invasive and noninvasive cardiologists along with other specialists managing patients’ comorbid conditions. Additional studies are indicated to understand the impact of site and operator experience on longer-term outcomes following TMVR with the MitraClip.
Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease, Mitral Regurgitation
Keywords: Cardiac Surgical Procedures, Heart Valve Diseases, Learning Curve, Mitral Valve Insufficiency, Outcome and Process Assessment, Health Care, Secondary Prevention, STS/ACC TVT Registry
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