Center for Healthcare Outcomes and Policy, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
JAMA. 2011 Sep 28;306(12):1338-43. doi: 10.1001/jama.2011.1357.
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.
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.
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).
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).
Among older patients undergoing carotid stenting, lower annual operator volume and early experience are associated with increased 30-day mortality.
尽管颈动脉支架置入术的疗效已在临床试验中得到证实，但在临床实践中，基于术者经验的手术结果仍不确定。
评估在新术者中，2 种术者经验衡量指标（年手术量和术者经验）与结局之间的关系，这些新术者是在医疗保险和医疗补助服务中心（CMS）的国家覆盖决定之后首次进行颈动脉支架置入术。
设计、地点和患者：利用接受颈动脉支架置入术的 65 岁及以上 Medicare 按服务付费受益人的行政数据，进行回顾性观察性研究，手术时间为 2005 年至 2007 年。
根据非常低、低、中、高年度术者手术量（分别为<6、6-11、12-23 和≥24 例/年）和新术者经验中早期（第 1 至 11 例）与晚期（第 12 例或更高）治疗分层的 30 天死亡率。
在研究期间，2339 名术者进行了 24701 例手术。其中，1792 名新术者进行了 11846 例手术，他们是在 CMS 国家覆盖决定之后首次进行颈动脉支架置入术。总体而言，30 天死亡率为 1.9%（n=461），未使用栓塞保护装置的失败率为 4.8%（n=1173）。 Medicare 受益人的中位年术者手术量为 3.0 例（四分位距，1.4-6.5），11.6%的术者在研究期间每年进行 12 例或更多手术。观察到 30 天死亡率在年手术量较低的术者（2.5%[95%CI，2.1%-2.9%]、1.9%[95%CI，1.6%-2.3%]、1.6%[95%CI，1.3%-1.9%]和 1.4%[95%CI，1.1%-1.7%]；P<0.001）和新术者经验早期（2.3%；95%CI，2.0%-2.7%）治疗的患者中较高，而在晚期（1.4%；95%CI，1.1%-1.9%；P<0.001）治疗的患者中较低。在多变量调整后，与高手术量术者相比，低手术量术者的 30 天死亡率风险更高（校正比值比，1.9；95%CI，1.4-2.7；P<0.001）。同样，我们发现新术者经验中早期治疗的患者与晚期治疗的患者相比，30 天死亡率风险更高（校正比值比，1.7；95%CI，1.2-2.4；P=0.001）。
在接受颈动脉支架置入术的老年患者中，较低的年度术者手术量和早期经验与 30 天死亡率增加相关。
