Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center/Case Western Reserve University, Cleveland, Ohio.
Division of Vascular Surgery, Cardiothoracic and Vascular Surgeons, Austin, Tex.
J Vasc Surg. 2019 Aug;70(2):516-521. doi: 10.1016/j.jvs.2018.10.115. Epub 2019 Feb 2.
In the pivotal U.S. Food and Drug Administration approval trial, ROADSTER, transcarotid artery revascularization (TCAR) using the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical Inc, Sunnyvale, Calif) was shown to have one of the lowest reported complication rates, not only for carotid artery stent placement, but also for any carotid intervention, including endarterectomy. The number of cases required for a surgeon to gain the proficiency to realize these outcomes has not been studied. Our objective was to determine the learning curve for vascular surgeons performing the TCAR procedure. We examined the effect of surgeon procedural experience on intraoperative data and postoperative outcome.
This retrospective review analyzed data from a prospectively maintained database of 188 consecutive patients from three large academic centers who underwent TCAR. Procedures were ordered chronologically for each surgeon and grouped into bins of five. Operative times and flow reversal times were analyzed by analysis of variance. Results led to comparison of surgeons' early experience (cases 1-15) with their later experience (cases 16-50). The primary outcome was postoperative stroke and death.
The mean procedural time for all cases was 75.0 ± 23.8 minutes. When the procedural time of cases 1 through 15 (mean, 79.0 ± 28.3 minutes) were compared with cases 16 through 50 (mean, 71.8 ± 19.0 minutes), a significant difference was noted (P = .02). The mean flow reversal time was 10.6 ± 6.8 minutes. When flow reversal times were compared using analysis of variance testing, cases 1 through 15 were statistically similar and cases 11 through 50 were also similar, but the two groups differed from each other (P < .001). For flow reversal, cases 1 through 15 had mean reversal times of 13.3 ± 8.8 minutes compared with 8.5 ± 3.5 minutes for cases 16 through 50 (P < .001). Postoperative stroke rates were similar in the 1 through 15 and 16 through 50 case groups (2.4% vs 1.0%; P = .59), as were death rates (0.0% vs 1.0%; P > .99). The combined stroke/death rates were also comparable at 2.4% in the early cohort vs 1.9% in the late cohort (P > .99).
There seems to be a relatively short learning curve for the TCAR procedure. After 15 cases, surgeons are able to reduce procedural decrease by 10% (from 79.0 to 71.8 minutes), and flow reversal times by an average of 40% (from 13.3 to 8.5 minutes). More important, the rates of stroke and death do not differ between early and late experience with TCAR. The TCAR procedure may be quickly and safely adopted by vascular surgeons for carotid intervention.
在美国食品和药物管理局的关键批准试验 ROADSTER 中，使用 ENROUTE 经颈动脉血管重建（TCAR）系统（Silk Road Medical Inc，加利福尼亚州森尼韦尔）的经颈动脉血管重建术显示出报告的并发症发生率最低之一，不仅对于颈动脉支架置入术，而且对于任何颈动脉介入术，包括内膜切除术。外科医生需要完成多少例手术才能获得实现这些结果的熟练程度尚未研究。我们的目的是确定进行 TCAR 手术的血管外科医生的学习曲线。我们研究了外科医生手术经验对内窥镜数据和术后结果的影响。
本回顾性分析从三个大型学术中心的前瞻性维护数据库中连续 188 例连续患者的数据，这些患者均接受了 TCAR 治疗。手术按照每位外科医生的时间顺序进行，并分为五组。使用方差分析分析手术时间和血流逆转时间。结果导致比较外科医生早期经验（病例 1-15）与后期经验（病例 16-50）。主要结局是术后中风和死亡。
所有病例的平均手术时间为 75.0 ± 23.8 分钟。当比较病例 1 至 15 的手术时间（平均 79.0 ± 28.3 分钟）与病例 16 至 50 的手术时间（平均 71.8 ± 19.0 分钟）时，发现有显著差异（P =.02）。平均血流反转时间为 10.6 ± 6.8 分钟。当使用方差分析测试比较血流反转时间时，病例 1 至 15 统计学上相似，病例 11 至 50 也相似，但两组彼此不同（P <.001）。对于血流反转，病例 1 至 15 的平均反转时间为 13.3 ± 8.8 分钟，而病例 16 至 50 的平均反转时间为 8.5 ± 3.5 分钟（P <.001）。1 至 15 例和 16 至 50 例的术后中风发生率相似（2.4%比 1.0%；P =.59），死亡率也相似（0.0%比 1.0%；P >.99）。早期队列的中风/死亡率综合发生率也相当，为 2.4%，晚期队列为 1.9%（P >.99）。
TCAR 手术似乎有一个相对较短的学习曲线。在 15 例之后，外科医生能够将手术时间降低 10%（从 79.0 分钟降至 71.8 分钟），血流反转时间平均降低 40%（从 13.3 分钟降至 8.5 分钟）。更重要的是，TCAR 早期和晚期经验的中风和死亡率没有差异。TCAR 手术可能会被血管外科医生迅速且安全地采用用于颈动脉介入术。
