American College of Cardiology Foundation

12/10/2019 | Press release | Distributed by Public on 12/10/2019 15:48

Operator Experience and Transcatheter Mitral Valve Repair

Study Questions:

Is there a relationship between operator experience and procedural results of transcatheter edge-to-edge mitral valve repair (TMVr) for mitral regurgitation (MR)?

Methods:

Data from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) registry for adult patients undergoing an initial procedure between November 2013 and March 2018 were analyzed, with operator case volume as a continuous and categorical (1-25, 26-50, and >50) variable. Patients were excluded if there was a prior transcatheter mitral valve intervention, concomitant transcatheter aortic valve replacement, or cardiogenic shock within 24 hours prior to the procedure. Optimal procedural success was defined as post-implant residual MR grade ≤1+ without mortality or need for cardiac surgery; acceptable MR reduction was defined as post-implant residual MR grade ≤2+ without mortality or need for cardiac surgery. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables.

Results:

All TMVr procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p < 0.001), whereas procedural time and procedural complications decreased. Acceptable procedural success also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p < 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed through 200 cases.

Conclusions:

For edge-to-edge TMVr procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving ≤1+ residual MR.

Perspective:

Edge-to-edge TMVr is a complex procedure that requires a specific skillset for both the operator and the echocardiographer. In keeping with most if not all cardiac and noncardiac procedures, this study suggests that higher operator procedural volumes are associated with better outcomes. The study is an observational review of data from the STS/ACC TVT registry, so confounders could exist. As examples, the proportion of patients with functional as opposed to degenerative MR increased with increasing operator experience, and it is unknown whether procedural success and complication rates are different between these two populations; and more experienced operators were more likely to use >1 clip per case, and the presence of post-procedure residual or iatrogenic mitral stenosis was not assessed.

Clinical Topics:Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation

Keywords:Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Heart Valve Diseases, Heart Valve Prosthesis, Iatrogenic Disease, Mitral Valve Insufficiency, Mitral Valve Stenosis, Outcome Assessment (Health Care), Shock, Cardiogenic, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement


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