The use of an embolic protection device (EPD) during TAVR remains infrequent, and the most common factor related to EPD use is TAVR case volume, not TAVR reimbursement by the Centers for Medicare and Medicaid Services (CMS) or its new technology add-on payment, according to a study published in JAMA Cardiology.

Angela Lowenstern, MD, et al., used data from 511 institutions captured in the STS/ACC TVT Registry to identify patients undergoing TAVR from January 2018 to September 2019. The study accounted for both patient and hospital characteristics in analyzing the association between EPD use and CMS reimbursement using multivariable logistic regression models.

Overall, the investigators found that TAVR with an EPD was performed in 7.1% (6,012) of the 84,353 patients (median age, 81 years; 54.8% men). Patient characteristics associated with EPD use included prior stroke, female sex, hemodialysis and shock. Study authors also found higher TAVR volume was associated with greater EPD use (per 25 TAVRs; adjusted odds ratio, 1.15; 95% CI, 1.09-1.21;p<0.001).

While higher CMS reimbursement up to $50,000 per TAVR seemed to indicate a greater likelihood of EPD use, this trend was no longer evident after adjusting for site characteristics. Moreover, there was no significant increase in EPD use following the institution of the CMS new technology add-on payment for CMS TAVR reimbursement.

The study authors acknowledge that "further work is needed to understand the economic drivers that contribute to the association between procedural volume and EPD use and to better understand the optimal design of payment structures for new technologies."

In an accompanying editorial comment, Neel M. Butala, MD, MBA; Andrew S. Oseran, MD, MBA; and Robert W. Yeh, MD, MSc, FACC, emphasize the importance of this research question, stating "updated reimbursement decisions for newly approved devices by CMS often lag behind, resulting in disjointed policy and potentially limiting patient access to these technologies."

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention

Keywords: STS/ACC TVT Registry, National Cardiovascular Data Registries, Aged, 80 and over, Transcatheter Aortic Valve Replacement, Centers for Medicare and Medicaid Services, U.S., Logistic Models, Odds Ratio, Medicare, Embolic Protection Devices, Registries, Renal Dialysis, Stroke, Cardiology, Technology, Hospitals, Policy

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