Low operator volume was associated with worse 30-day outcomes among patients undergoing TAVR and mitral transcatheter edge-to-edge repair (MTEER), according to a study published Jan. 8 in JAMA Cardiology. These findings, informed by data from the STS/ACC TVT Registry, provide useful insights into the relationship between procedural volumes and outcomes at the operator level in the U.S. as the Centers for Medicare and Medicaid Services (CMS) seeks to revisit TAVR coverage for aortic stenosis.

Dharam J. Kumbhani, MD, SM, FACC, et al., included 358,943 TAVR patients (827 hospitals; 7,524 operators; median annual volume 24 [11–47]) and 51,407 MTEER patients (493 hospitals; 2,483 operators; median annual volume 12 [7–19]), seeking to evaluate the association between operator volume and patient outcomes at 30 days.

After adjustment, results showed that operators performing <15 TAVR procedures per year were associated with a higher rate of 30-day mortality (odds ratio [OR], 1.13; 95% CI, 1.02–1.26; p=0.02) and in-hospital complications (OR, 1.09; 95% CI, 1.03–1.16; p=0.005) vs. operators with more than 37 TAVR procedures per year.

Among MTEER procedures, operators with fewer than seven procedures per year saw higher in-hospital complication rates (OR, 1.31; 95% CI, 1.11–1.56; p=0.002) than those with more than 16 procedures per year, but no difference was found in 30-day mortality (OR, 1.16; 95% CI, 0.96–1.41; p=0.12).

These associations between operator volume and patient outcomes were observed at both low-volume and high-volume centers. Kumbhani and colleagues note that current National Coverage Determinations developed by CMS “specify volume minimums for hospitals but not for individual operators.”

“Our analysis may help inform future policy documents for these procedures,” write the authors. “…The use of real-world data to inform the development of process metrics of quality, such as volume, and direct measurement of quality outcomes will become increasingly important under the recently adopted Transitional Coverage for Emerging Technologies.”