TVT Registry Analysis Shows Relationship of Hospitals' Procedural Volume and Outcomes for TAVR

April 5, 2019—An analysis of data from the Transcatheter Valve Therapy registry regarding procedural volumes and outcomes of transcatheter aortic valve replacement (TAVR) from 2015 through 2017 was published by Sreekanth Vemulapalli, MD, et al online ahead of print in The New England Journal of Medicine (NEJM).

As stated in NEJM, the investigators sought to develop a better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes to inform policy decisions. The background of the study is that the Centers for Medicare and Medicaid Services mandated procedural volume requirements as a condition of reimbursement for TAVR when it was introduced in the United States.

The investigators concluded that an inverse volume–mortality association was observed for transfemoral TAVR procedures from 2015 through 2017, with mortality at 30 days higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume.

According to the investigators, 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.

The investigators reported that 96,256 (84.7%) of 113,662 TAVR procedures performed at 555 hospitals by 2,960 operators involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality.

Findings included:

• Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile than at hospitals in the highest-volume quartile: 3.19% (95% confidence interval [CI], 2.78–3.67) versus 2.66% (95% CI, 2.48–2.85); odds ratio, 1.21; P = .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, 8.63–30.26).
• 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: 3.1% versus 2.61%; odds ratio, 1.19; 95% CI, 1.01–1.4.