An accurate understanding of clinical outcomes and their relation to hospital volume is critical to ensure quality of TAVR programs, according to a perspective article published Jan. 21 in the Journal of the American College of Cardiology.  

Ahead of an anticipated new Centers for Medicare and Medicaid Services (CMS) national coverage determination related to TAVR, Gregory J. Dehmer, MD, MACC, chair of the NCDR Public Reporting Advisory Group; Ralph G. Brindis, MD, MPH, MACC, NCDR senior medical officer and a past president of the ACC; David M. Shahian, MD, FACC, member of the NCDR Science and Quality Oversight Subcommittee; and Michael J. Mack, MD, FACC, member of ACC's Board of Trustees, discuss how the relationship between TAVR procedure volume and outcomes can help in understanding the quality of care provided in specific hospitals.

According to the authors, the use of volume as a quality measure "remains contentious" and the necessary volume needed to "accurately and reliably measure outcomes" is unclear. They note that the recent 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement, includes an overview of the relationship between volume and quality. They add that the document explained that quality assessments have a greater validity for higher-volume centers that can produce statistically significant metrics, and recommended that CMS establish minimal procedure volumes for hospitals that perform TAVR.

Dehmer et al., explain that there was broad agreement among stakeholders at a July 2018 Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting that "facilities and operators engaged in TAVR must accurately track their risk-adjusted clinical outcomes along with their procedural volume and have a robust quality assurance program in place to ensure optimal patient outcomes."

As availability of TAVR procedures increases, the "central focus must be the transparent and accurate evaluation of TAVR clinical outcomes and better understanding of the complexities of the volume-quality relationship," the authors conclude.

According to John D. Carroll, MD, FACC, vice chair of the STS/ACC TVT Registry, "The STS/ACC TVT Registry provides benchmarking and outcomes data that can help participating hospitals measure performance and develop quality improvement programs and can guide policy decisions as TAVR use expands. The Registry will continue to help TAVR teams improve care."

Keywords: Transcatheter Aortic Valve Replacement, Centers for Medicare and Medicaid Services, U.S., Benchmarking, Quality Improvement, Medicaid, Aortic Valve, Medicare, Heart Valve Prosthesis, Registries

< Back to Listings