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Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement
Abstract
BACKGROUND: During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions. METHODS: We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital. RESULTS: Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40). CONCLUSIONS: An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.).
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Metadata
- Authors
- Vemulapalli, S., Carroll, J. D., Mack, M. J., Li, Z., Dai, D., Kosinski, A. S., Kumbhani, D. J., Ruiz, C. E., Thourani, V. H., Hanzel, G., Gleason, T. G., Herrmann, H. C., Brindis, R. G., & Bavaria, J. E.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-06-27
- Volume
- 380
- Issue
- 26
- Pages
- 2541-2550
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2933621115
- Cited by
- 382
- References
- 17
- FWCI
- 36.35
- Type
- journal article
- Language
- en
- Open access
- closed
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- Vemulapalli, S., Carroll, J. D., Mack, M. J., Li, Z., Dai, D., Kosinski, A. S., Kumbhani, D. J., Ruiz, C. E., Thourani, V. H., Hanzel, G., Gleason, T. G., Herrmann, H. C., Brindis, R. G., & Bavaria, J. E. (2019). Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. New England Journal of Medicine. https://doi.org/10.1056/nejmsa1901109
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