Hospitals and operators performing a higher volume of TAVR procedures may have lower 30-day mortality rates that persist one year into a hospital's experience with TAVR, according to a study published April 3 in the New England Journal of Medicine.

Sreekanth Vemulapalli, MD, et al., used data from the STS/ACC TVT Registry to look at 99,256 patients undergoing transfemoral TAVR at 554 sites by 2,935 operators. The authors examined the association between hospital and operator procedural volume and 30-day mortality rates for TAVR procedures to assess whether a volume-outcomes association persists six months and one year after a hospital begins performing TAVR.

Results showed that the primary outcome of risk-adjusted 30-day mortality was higher at hospitals in the lowest-volume quartile than in the highest-volume quartile (3.19 percent vs. 2.66 percent). There was a 19.45 percent reduction in adjusted 30-day mortality between hospitals in the lowest-volume quartile, which performed a mean of 27 procedures annually, and the highest-volume quartile, which performed a mean of 143 annual procedures. The inverse volume-mortality relationship continued after excluding data from the first six months of TAVR experience at each hospital (3.19 percent in the lowest-volume quartile vs. 2.63 percent in the highest-volume quartile) and the first 12 months of TAVR performance (3.10 percent in the lowest-volume quartile vs. 2.61 in the highest-volume quartile).

In addition, patients were more likely to experience major vascular or major bleeding complications at hospitals in the lowest-volume quartile (10.03 percent) vs. the highest-volume quartile (8.21 percent). There were no other associations between annual procedural volumes and the 30-day composite of complications or individual components.

According to the researchers, the study shows "persistent hospital and operator volume-mortality relationships" even six months and one year after hospitals begin performing TAVR, suggesting that the "volume-mortality association is not simply related to operator learning or reasonable hospital start-up time."

"These findings suggest a clear relationship between the volume of TAVR procedures and death at 30 days, both at the hospital level and at the individual operator level, and should be factored into the Center for Medicare and Medicaid Services' (CMS) revised national coverage determination related to TAVR until a validated quality outcome metric can be established," said Michael J. Mack, MD, FACC, co-author of the study. "This relationship held true even after eliminating the first 12 months, meaning this is not just a 'learning curve.'"

The authors note that some have suggested a transition from procedural volume to direct quality metrics, but the proposed updated national coverage determination, released March 26 by CMS references that possibility only as a future revision. The proposed NCD "may not have the intended effect" without external certification or accreditation, they conclude.

Keywords: Medicaid, Transcatheter Aortic Valve Replacement, Centers for Medicare and Medicaid Services, U.S., Learning Curve, Medicare, Accreditation, Hospitals, Certification, Angiography, STS/ACC TVT Registry, National Cardiovascular Data Registries

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