Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
Department of Vascular Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
J Vasc Surg. 2024 Jul;80(1):138-150.e8. doi: 10.1016/j.jvs.2024.02.026. Epub 2024 Feb 28.
With the recent expansion of the Centers for Medicare and Medicaid Services coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. Because approximately 30% of perioperative strokes/deaths post-CAS occur after discharge, appropriate thresholds for in-hospital event rates have been suggested to be <4% for symptomatic and <2% for asymptomatic patients. This study evaluates the tfCAS learning curve using Vascular Quality Initiative (VQI) data.
We identified VQI patients who underwent tfCAS between 2005 and 2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. The primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/myocardial infarction (MI), 30-day mortality, in-hospital stroke/transient ischemic attack (stroke/TIA), and access site complications. The relationship between outcomes and procedure counts was analyzed using the Cochran-Armitage test and a generalized linear model with restricted cubic splines. Our results were then validated using a generalized estimating equations model to account for the variability between physicians.
We analyzed 43,147 procedures by 2476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2%-1.7%), in-hospital stroke/death/MI (5.8%-1.7%), 30-day mortality (4.6%-2.8%), in-hospital stroke/TIA (5.0%-1.1%), and access site complications (4.1%-1.1%) as physician experience increased (all P values < .05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1%-1.6%), in-hospital stroke/death/MI (2.6%-1.6%), 30-day mortality (1.7%-0.4%), and in-hospital stroke/TIA (2.8%-1.6%) with increasing physician experience (all P values <.05). The in-hospital stroke/death rate remained above 2% until 13 procedures.
In-hospital stroke/death and 30-day mortality rates after tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. Nevertheless, a substantially high rate of in-hospital stroke/death was found in physicians' first 25 procedures. With the recent Centers for Medicare and Medicaid Services coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased postoperative complications.
随着医疗保险和医疗补助服务中心（Centers for Medicare and Medicaid Services）覆盖范围的扩大，股动脉颈动脉支架置入术（transfemoral carotid artery stenting，tfCAS）预计将在颈动脉疾病的治疗中发挥更大的作用。现有的关于 tfCAS 学习曲线的研究主要是在十多年前进行的，可能无法充分描述当前医生经验对结果的影响。由于大约 30%的颈动脉支架置入术（carotid artery stenting，CAS）后围手术期卒中/死亡发生在出院后，因此建议适当的住院期间事件发生率阈值为：症状性患者<4%，无症状患者<2%。本研究使用血管质量倡议（Vascular Quality Initiative，VQI）数据评估 tfCAS 的学习曲线。
我们确定了 2005 年至 2023 年期间接受 tfCAS 的 VQI 患者。每位医生的手术按时间顺序分为 12 组，从手术例数 1-25 到 351+。主要结局是住院期间卒中/死亡发生率；次要结局包括住院期间卒中/死亡/心肌梗死（myocardial infarction，MI）、30 天死亡率、住院期间卒中/短暂性脑缺血发作（transient ischemic attack，TIA）和入路部位并发症。使用 Cochran-Armitage 检验和具有限制立方样条的广义线性模型分析结局与手术例数之间的关系。我们的结果随后使用广义估计方程模型进行验证，以考虑医生之间的变异性。
我们分析了 2476 名医生的 43147 例手术。在症状性患者中，随着医生经验的增加，住院期间卒中/死亡（手术例数 1-25 到 351+：5.2%-1.7%）、住院期间卒中/死亡/MI（5.8%-1.7%）、30 天死亡率（4.6%-2.8%）、住院期间卒中/TIA（5.0%-1.1%）和入路部位并发症（4.1%-1.1%）的发生率降低（所有 P 值均<.05）。住院期间卒中/死亡发生率仍高于 4%，直到 235 例手术。同样，在无症状患者中，随着医生经验的增加，住院期间卒中/死亡（2.1%-1.6%）、住院期间卒中/死亡/MI（2.6%-1.6%）、30 天死亡率（1.7%-0.4%）和住院期间卒中/TIA（2.8%-1.6%）的发生率降低（所有 P 值均<.05）。住院期间卒中/死亡发生率仍高于 2%，直到 13 例手术。
tfCAS 后住院期间卒中/死亡和 30 天死亡率随着医生经验的增加而降低，这表明存在与以往报道一致的较长学习曲线。鉴于医生的早期病例可能未包含在 VQI 中，因此学习曲线可能被低估了。尽管如此，在医生的前 25 例手术中仍发现了相当高的住院期间卒中/死亡发生率。随着医疗保险和医疗补助服务中心最近对 tfCAS 覆盖范围的扩大，大量医生将进入学习曲线的早期阶段，可能导致术后并发症增加。
