Abstract
IMPORTANCE: Recent evidence suggests that hospital-level associations between procedural volume and outcomes for transcatheter aortic valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (MTEER) may be plateauing. Less is known about the operator volumes-outcomes association in the contemporary era.
OBJECTIVE: To determine whether an operator-level volume-outcomes association exists for TAVR and MTEER in the contemporary era.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study examined data from patients undergoing TAVR or MTEER between January 2020 and December 2023 included in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry, a national all-comers real-world registry. Consecutive patients undergoing TAVR for aortic stenosis or MTEER for mitral regurgitation were included. Data analysis was performed from October 2024 to December 2025.
EXPOSURE: TAVR or MTEER.
MAIN OUTCOMES AND MEASURES: The primary outcome measures were (1) 30-day all-cause mortality, (2) a 30-day composite outcome, and (3) in-hospital procedural complications following TAVR or MTEER. Data from the STS/ACC TVT Registry were analyzed for patients undergoing TAVR or MTEER between 2020 and 2023. The primary analysis assessed the association between operator volume and 30-day outcomes using a 2-level random-effects logistic regression model. The interaction between operator and hospital volumes and the association between TAVR and MTEER outcomes were also evaluated.
RESULTS: A total of 358 943 patients underwent TAVR at 827 hospitals (7524 operators; median [IQR] annual volume, 24 [11-47]), and 51 407 patients underwent MTEER at 493 hospitals (2483 operators; median [IQR] annual volume, 12 [7-19]). For TAVR, median (IQR) patient age was 79.0 (73.0-85.0) years, and 152 186 patients (42.4%) were female; for MTEER, median (IQR) patient age was 79.0 (71.0-84.0) years, and 23 402 patients (45.5%) were female. Low-volume operators demonstrated inferior process of care measures compared with high-volume operators. In adjusted analyses, a higher risk of 30-day mortality (odds ratio [OR], 1.13; 95% CI, 1.02-1.26; P = .02) and in-hospital complications (OR, 1.09; 95% CI, 1.03-1.16; P = .005) was observed for low-volume TAVR operators (<15/y) compared with high-volume operators (>37/y). For MTEER, in-hospital complications (OR, 1.31; 95% CI, 1.11-1.56; P = .002) were higher for low-volume operators (<8/y) compared with high-volume operators (>16/y), while 30-day mortality was not different (OR, 1.16; 95% CI, 0.96-1.41; P = .12). Associations were consistent across hospital volume strata. Operator-level outcomes for TAVR and MTEER were not correlated.
CONCLUSIONS AND RELEVANCE: In this cohort study, results from a large, contemporary US registry demonstrate a persistent inverse association between operator volume and patient outcomes for both TAVR and MTEER. These findings may help inform future policies aimed at ensuring optimal outcomes.