Abstract：
OBJECTIVE: The 2019 Global Vascular Guidelines recommended open bypass for patients at average risk with greater limb severity and anatomical complexity. However, the outcomes of tibial and pedal bypass (TPB) are inferior to those of above-the-knee surgical revascularization. This may be due to the technical difficulty and need for development of skills to perform TPB. However, there is a limited knowledge on the learning curve in TPB. Thus, the aim of the study is to assess this learning curve in a single-center retrospective analysis.
METHODS: Cases treated with TPB with an autologous vein conduit in patients with chronic limb-threatening ischemia (CLTI) at a Japanese single center from 2009 to 2022 were analyzed retrospectively. The primary endpoint was the learning curve for TPB.
RESULTS: The study included 449 TPB procedures conducted by a single main surgeon in patients with CLTI (median age, 75 years; 309 males; diabetes mellitus, 73%; end stage renal failure with hemodialysis, 44%). The operative time decreased significantly as the number of cases accumulated (p < .001). Using the cumulative sum (CUSUM) operative time, the learning curve was estimated to be phase 1 (initial learning curve) for 134 cases (1-134); phase 2 (competent period) for 179 cases (135-313); and phase 3 (mastery and challenging period) for 136 cases (314-449). The mean follow-up period was 34 ± 31 months. The 1- and 3-year limb salvage rates of 97% and 96% in phase 3 were significantly higher than those in phases 1 and 2 (p < .001, p = .029). Major adverse limb events (MALE) occurred in 117 (26%) patients, and the 1- and 3-year MALE rates of 10% and 17% in phase 3 were significantly lower than those in phases 1 and 2 (p < .001, p = .009).
CONCLUSIONS: In the study, vascular surgeon required a learning curve of 134 TPB cases to Overcoming the learning curve for bypass was associated with improvement of medium-term outcomes for limb salvage and freedom from MALE.
METHODS: Cases treated with TPB with an autologous vein conduit in patients with chronic limb-threatening ischemia (CLTI) at a Japanese single center from 2009 to 2022 were analyzed retrospectively. The primary endpoint was the learning curve for TPB.
RESULTS: The study included 449 TPB procedures conducted by a single main surgeon in patients with CLTI (median age, 75 years; 309 males; diabetes mellitus, 73%; end stage renal failure with hemodialysis, 44%). The operative time decreased significantly as the number of cases accumulated (p < .001). Using the cumulative sum (CUSUM) operative time, the learning curve was estimated to be phase 1 (initial learning curve) for 134 cases (1-134); phase 2 (competent period) for 179 cases (135-313); and phase 3 (mastery and challenging period) for 136 cases (314-449). The mean follow-up period was 34 ± 31 months. The 1- and 3-year limb salvage rates of 97% and 96% in phase 3 were significantly higher than those in phases 1 and 2 (p < .001, p = .029). Major adverse limb events (MALE) occurred in 117 (26%) patients, and the 1- and 3-year MALE rates of 10% and 17% in phase 3 were significantly lower than those in phases 1 and 2 (p < .001, p = .009).
CONCLUSIONS: In the study, vascular surgeon required a learning curve of 134 TPB cases to Overcoming the learning curve for bypass was associated with improvement of medium-term outcomes for limb salvage and freedom from MALE.
摘要：
目的：《2019年全球血管指南》建议对肢体严重程度和解剖复杂性较高的平均风险患者进行开放搭桥手术。然而,胫骨和踏板旁路术(TPB)的结果不如膝关节上方手术血运重建.这可能是由于技术困难和需要开发执行TPB的技能。然而,TPB的学习曲线知识有限。因此，本研究的目的是在单中心回顾性分析中评估这一学习曲线.
方法：回顾性分析2009年至2022年日本单中心慢性威胁肢体缺血（CLTI）患者使用自体静脉导管TPB治疗的病例。主要终点是TPB的学习曲线。
结果：该研究包括由一名主要外科医生对CLTI患者进行的449例TPB手术（中位年龄，75岁；309名男性；糖尿病，73%；终末期肾衰竭伴血液透析，44%）。随着病例数的增加，手术时间显著减少（p<.001）。使用累计总和(CUSUM)手术时间，134例(1-134例)的学习曲线估计为1期(初始学习曲线);179例(135-313例)的2期(胜任期);136例(314-449例)的3期(掌握期和挑战期).平均随访时间为34±31个月。第3阶段的1年和3年保肢率分别为97％和96％，明显高于第1阶段和第2阶段（p<.001，p=.029）。117例（26%）患者发生重大肢体不良事件（MAE），第3阶段的1年和3年的10％和17％的男性犯罪率明显低于第1阶段和第2阶段（p<.001，p=.009）。
结论：在研究中，血管外科医师需要134例TPB病例的学习曲线,以克服旁路的学习曲线与改善保肢和无MAE的中期结局相关.
方法：回顾性分析2009年至2022年日本单中心慢性威胁肢体缺血（CLTI）患者使用自体静脉导管TPB治疗的病例。主要终点是TPB的学习曲线。
结果：该研究包括由一名主要外科医生对CLTI患者进行的449例TPB手术（中位年龄，75岁；309名男性；糖尿病，73%；终末期肾衰竭伴血液透析，44%）。随着病例数的增加，手术时间显著减少（p<.001）。使用累计总和(CUSUM)手术时间，134例(1-134例)的学习曲线估计为1期(初始学习曲线);179例(135-313例)的2期(胜任期);136例(314-449例)的3期(掌握期和挑战期).平均随访时间为34±31个月。第3阶段的1年和3年保肢率分别为97％和96％，明显高于第1阶段和第2阶段（p<.001，p=.029）。117例（26%）患者发生重大肢体不良事件（MAE），第3阶段的1年和3年的10％和17％的男性犯罪率明显低于第1阶段和第2阶段（p<.001，p=.009）。
结论：在研究中，血管外科医师需要134例TPB病例的学习曲线,以克服旁路的学习曲线与改善保肢和无MAE的中期结局相关.
