Author + information
- Received July 13, 2018
- Revision received September 26, 2018
- Accepted October 16, 2018
- Published online January 7, 2019.
- Arash Salemi, MDa,
- Art Sedrakyan, MD, PhDb,
- Jialin Mao, MD, MSb,
- Adham Elmously, MDa,
- Harindra Wijeysundera, MD, PhDc,
- Derrick Y. Tam, MDc,
- Antonino Di Franco, MDa,
- Simon Redwood, MDd,
- Leonard N. Girardi, MDa,
- Stephen E. Fremes, MD, MScc and
- Mario Gaudino, MDa,∗ ()
- aDepartment of Cardiothoracic Surgery, Weill Cornell Medical College, New York, New York
- bDepartment of Healthcare Policy and Research, Weill Cornell Medical College, New York, New York
- cSchulich Heart Centre, Sunnybrook Health Science, University of Toronto, Toronto, Ontario, Canada
- dBHF Centre of Excellence, Cardiovascular Department, King’s College St. Thomas’ Hospital, London, United Kingdom
- ↵∗Address for correspondence:
Dr. Mario Gaudino, Weill Cornell Medicine, Department of Cardiothoracic Surgery, 525 East 68th Street, New York, New York 10065.
Objectives The aim of this study was to assess the impact of individual operator experience on transfemoral transcatheter aortic valve replacement (TAVR) outcomes.
Background TAVR volume-outcome relationships have not been evaluated at the individual operator level.
Methods New York Statewide Planning and Research Cooperative System data from 8,771 transfemoral TAVR procedures performed by 207 operators between 2012 and 2016 were analyzed. Operator volume was defined as the number of TAVR procedures performed during 1 year prior to the index procedure. Hierarchical and restrictive cubic spline regression models were used to evaluate the impact of individual operator experience on risk-adjusted in-hospital outcomes. The primary outcome was a composite of in-hospital mortality, stroke, and/or acute myocardial infarction. Secondary outcomes were the individual components of the primary outcome.
Results After adjusting for hospital and physician characteristics, patients undergoing TAVR performed by high-volume physicians (≥80/year) had a significantly lower risk for death, stroke, or acute myocardial infarction (odds ratio: 0.59; 95% confidence interval: 0.37 to 0.93) compared with those treated by low-volume physicians (<24/year). Being treated by operators who performed 200 procedures during the prior year was associated with significantly lower risks for post-procedural stroke (odds ratio: 0.41; 95% confidence interval: 0.17 to 0.97) and composite events (odds ratio: 0.45; 95% confidence interval: 0.26 to 0.78). This relationship was nonlinear, and a sensitivity analysis excluding the first 10, 20, and 30 procedures for each operator mitigated the effect of the initial learning curve.
Conclusions Increased TAVR experience of operators is associated with improved risk-adjusted in-hospital outcomes. These results have potentially important implications for individual training and hospital programs in TAVR.
This study was funded in part by the U.S. Food and Drug Administration through grant U01FD005478. The funder had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 13, 2018.
- Revision received September 26, 2018.
- Accepted October 16, 2018.
- 2019 American College of Cardiology Foundation