Citation: New England Journal of Medicine. 380(26):2541-2550, 2019 06 27..Journal: The New England journal of medicine.Published: ; 2019ISSN: 0028-4793.Full author list: 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.UI/PMID: 30946551.Subject(s): Aged | Aged, 80 and over | Aortic Valve/su [Surgery] | *Aortic Valve Stenosis/su [Surgery] | Centers for Medicare and Medicaid Services (U.S.) | Female | Hospital Mortality | *Hospitals, High-Volume/sn [Statistics & Numerical Data] | *Hospitals, Low-Volume/sn [Statistics & Numerical Data] | Humans | Insurance, Health, Reimbursement/st [Standards] | Male | Retrospective Studies | Transcatheter Aortic Valve Replacement/mt [Methods] | *Transcatheter Aortic Valve Replacement/mo [Mortality] | Transcatheter Aortic Valve Replacement/sn [Statistics & Numerical Data] | Treatment Outcome | United States/ep [Epidemiology]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | Research Support, Non-U.S. Gov'tOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1056/NEJMsa1901109 (Click here)Abbreviated citation: N Engl J Med. 380(26):2541-2550, 2019 06 27.Local Holdings: Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present.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.Abstract: 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.Abstract: 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).Abstract: 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.).Abstract: Copyright (c) 2019 Massachusetts Medical Society.