Context: Although the efficacy of carotid stenting has been established in clinical trials, outcomes of the procedure based on operator experience are less certain in clinical practice.
Objective: To assess association between outcomes and 2 measures of operator experience: annual volume and experience at the time of the procedure among new operators who first performed carotid stenting after a national coverage decision by the Centers for Medicare & Medicaid Services (CMS).
Design, setting, and patients: Observational study using administrative data on fee-for-service Medicare beneficiaries aged 65 years or older undergoing carotid stenting between 2005 and 2007.
Main outcome measure: Thirty-day mortality stratified by very low, low, medium, and high annual operator volumes (<6, 6-11, 12-23, and ≥24 procedures per year, respectively) and treatment early vs late during a new operator's experience (1st to 11th procedure and 12th procedure or higher).
Results: During the study period, 24,701 procedures were performed by 2339 operators. Of these, 11,846 were performed by 1792 new operators who first performed carotid stenting after the CMS national coverage decision. Overall, 30-day mortality was 1.9% (n = 461) and rate of failure to use an embolic protection device was 4.8% (n = 1173). The median annual operator volume among Medicare beneficiaries was 3.0 per year (interquartile range, 1.4-6.5) and 11.6% of operators performed 12 or more procedures per year during the study period. Observed 30-day mortality was higher among patients treated by operators with lower annual volumes (2.5% [95% CI, 2.1%-2.9%], 1.9% [95% CI, 1.6%-2.3%], 1.6% [95% CI, 1.3%-1.9%], and 1.4% [95% CI, 1.1%-1.7%] across the 4 categories; P < .001) and among patients treated early (2.3%; 95% CI, 2.0%-2.7%) vs late (1.4%; 95% CI, 1.1%-1.9%; P < .001) during a new operator's experience. After multivariable adjustment, patients treated by very low-volume operators had a higher risk of 30-day mortality compared with patients treated by high-volume operators (adjusted odds ratio, 1.9; 95% CI, 1.4-2.7; P < .001). Similarly, we found a higher risk of 30-day mortality in patients treated early vs late during a new operator's experience (adjusted odds ratio, 1.7; 95% CI, 1.2-2.4; P = .001).
Conclusion: Among older patients undergoing carotid stenting, lower annual operator volume and early experience are associated with increased 30-day mortality.