Procedural volume and outcomes for transcatheter aortic-valve replacement

Sreekanth Vemulapalli, John D. Carroll, Michael J. Mack, Zhuokai Li, David Dai, Andrzej S. Kosinski, Dharam J Kumbhani, Carlos E. Ruiz, Vinod H. Thourani, George Hanzel, Thomas G. Gleason, Howard C. Herrmann, Ralph G. Brindis, Joseph E. Bavaria

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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.

Original languageEnglish (US)
Pages (from-to)2541-2550
Number of pages10
JournalNew England Journal of Medicine
Volume380
Issue number26
DOIs
StatePublished - Jun 27 2019

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Mortality
Confidence Intervals
Low-Volume Hospitals
High-Volume Hospitals
Odds Ratio
Centers for Medicare and Medicaid Services (U.S.)
Transcatheter Aortic Valve Replacement
Registries
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Vemulapalli, S., Carroll, J. D., Mack, M. J., Li, Z., Dai, D., Kosinski, A. S., ... Bavaria, J. E. (2019). Procedural volume and outcomes for transcatheter aortic-valve replacement. New England Journal of Medicine, 380(26), 2541-2550. https://doi.org/10.1056/NEJMsa1901109

Procedural volume and outcomes for transcatheter aortic-valve replacement. / Vemulapalli, Sreekanth; Carroll, John D.; Mack, Michael J.; Li, Zhuokai; Dai, David; Kosinski, Andrzej S.; Kumbhani, Dharam J; Ruiz, Carlos E.; Thourani, Vinod H.; Hanzel, George; Gleason, Thomas G.; Herrmann, Howard C.; Brindis, Ralph G.; Bavaria, Joseph E.

In: New England Journal of Medicine, Vol. 380, No. 26, 27.06.2019, p. 2541-2550.

Research output: Contribution to journalArticle

Vemulapalli, S, Carroll, JD, Mack, MJ, Li, Z, Dai, D, Kosinski, AS, Kumbhani, DJ, Ruiz, CE, Thourani, VH, Hanzel, G, Gleason, TG, Herrmann, HC, Brindis, RG & Bavaria, JE 2019, 'Procedural volume and outcomes for transcatheter aortic-valve replacement', New England Journal of Medicine, vol. 380, no. 26, pp. 2541-2550. https://doi.org/10.1056/NEJMsa1901109
Vemulapalli S, Carroll JD, Mack MJ, Li Z, Dai D, Kosinski AS et al. Procedural volume and outcomes for transcatheter aortic-valve replacement. New England Journal of Medicine. 2019 Jun 27;380(26):2541-2550. https://doi.org/10.1056/NEJMsa1901109
Vemulapalli, Sreekanth ; Carroll, John D. ; Mack, Michael J. ; Li, Zhuokai ; Dai, David ; Kosinski, Andrzej S. ; Kumbhani, Dharam J ; Ruiz, Carlos E. ; Thourani, Vinod H. ; Hanzel, George ; Gleason, Thomas G. ; Herrmann, Howard C. ; Brindis, Ralph G. ; Bavaria, Joseph E. / Procedural volume and outcomes for transcatheter aortic-valve replacement. In: New England Journal of Medicine. 2019 ; Vol. 380, No. 26. pp. 2541-2550.
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AU - Vemulapalli, Sreekanth

AU - Carroll, John D.

AU - Mack, Michael J.

AU - Li, Zhuokai

AU - Dai, David

AU - Kosinski, Andrzej S.

AU - Kumbhani, Dharam J

AU - Ruiz, Carlos E.

AU - Thourani, Vinod H.

AU - Hanzel, George

AU - Gleason, Thomas G.

AU - Herrmann, Howard C.

AU - Brindis, Ralph G.

AU - Bavaria, Joseph E.

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N2 - 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.

AB - 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.

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