Department of Vascular Surgery, Ospedale Civile di Baggiovara, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Modena, Italy.
J Endovasc Ther. 2024 Oct;31(5):901-909. doi: 10.1177/15266028231161489. Epub 2023 Mar 24.
To analyze the learning curve for thoracic endovascular aortic repair (TEVAR) in a single center over a period of 25 years.
In total, 390 consecutive standard TEVAR procedures undertaken between 1996 and 2021 were included in a retrospective, observational, single-center study. Cumulative sum charts were elaborated for the entire center experience (primary outcome) as well as for the first and second implanting physicians. Data on procedural variables (contrast volume, operative and fluoroscopy time), 30-day major adverse events (MAEs) and clinical success, and endoleak and reintervention rates were secondary outcomes and subdivided into 4 quartiles of experience (Q1-Q4) or presented as first 2 versus latest 2 quartiles (Q1-Q2 vs Q3-Q4).
The mean follow-up was 4.3±4.0 years. The center's learning curve was achieved after 75 procedures, and it was similar for the first implanting physician. The surgeon coming thereafter had a significantly shorter curve (10 TEVARs). Comparing Q1-Q2 with Q3-Q4, 30-day MAEs (16.1 vs 11.3%, p=0.164), 30-day mortality (11.4% vs 3.6%, p=0.003), and intraoperative additional maneuvers (21.5% vs 13.3%, p=0.033) were reduced along with an improvement in clinical success (85.9% vs 90.3%, p=0.190). From Q1 to Q4, operative time (139.8±65.5 to 76.7±43.7 min, p=0.001), fluoroscopy time (15.1±8.8 to 7.1±5.1 min, p<0.001), and contrast volume (244.0±112.1 to 104.3±46.1 mL, p<0.001) showed a considerable reduction. Late endoleak and aortic-related mortality declined significantly from Q1-Q2 to Q3-Q4 (24.1% to 15.5%, p=0.033 and 18.6% vs 8.2%, p=0.006, respectively). Operative time (p=0.021), contrast volume (p=0.016), and fluoroscopy time (p=0.004) were independent risk factors for endoleak, causing a 1.3-fold risk increase for both each 60 minutes of additional operative time (p=0.021) and every 100 mL of additional contrast medium (p=0.016). Each 10-minute increase in fluoroscopy time determined a 1.4-fold risk increment (p=0.004).
The learning curve shortened significantly over time with non-negligible clinical outcome improvements, suggesting that specific endovascular training is mandatory to become an effective TEVAR performer.
For the first time in literature, the standard TEVAR's learning curve has been evaluated at a single vascular surgery center over a period of 25 years. The learning curve for the center and the first physician historically undertaking TEVAR was achieved at the 75th treated patient. The learning curve of the surgeons coming thereafter was significantly shorter (10 cases). This quarter-century demonstrated that intraoperative learning-related variables were associated with long-term clinical outcomes and all have improved over time. Centers approaching TEVAR for the first time and training program providers could use these data to aim to offer better clinical outcomes.
分析一个中心在 25 年内进行胸主动脉腔内修复术(TEVAR)的学习曲线。
共纳入 1996 年至 2021 年间连续进行的 390 例标准 TEVAR 手术,进行回顾性、观察性、单中心研究。为整个中心的经验(主要结局)以及第一和第二植入医生分别制定了累积和图。手术变量(对比剂体积、手术和透视时间)、30 天主要不良事件(MAE)和临床成功率以及内漏和再干预率的次要结局,并分为经验的 4 个四分位数(Q1-Q4)或分为前 2 个和后 2 个四分位数(Q1-Q2 与 Q3-Q4)呈现。
平均随访时间为 4.3±4.0 年。中心的学习曲线在 75 例手术后达到,第一植入医生的学习曲线也相似。此后进行手术的医生的曲线明显缩短(10 例 TEVAR)。与 Q1-Q2 相比,Q3-Q4 的 30 天 MAE(16.1% 与 11.3%,p=0.164)、30 天死亡率(11.4% 与 3.6%,p=0.003)和术中额外操作(21.5% 与 13.3%,p=0.033)减少,临床成功率(85.9% 与 90.3%,p=0.190)提高。从 Q1 到 Q4,手术时间(139.8±65.5 至 76.7±43.7 min,p=0.001)、透视时间(15.1±8.8 至 7.1±5.1 min,p<0.001)和对比剂用量(244.0±112.1 至 104.3±46.1 mL,p<0.001)均显著减少。晚期内漏和主动脉相关死亡率从 Q1-Q2 到 Q3-Q4 显著下降(24.1% 至 15.5%,p=0.033 和 18.6% 与 8.2%,p=0.006)。手术时间(p=0.021)、对比剂用量(p=0.016)和透视时间(p=0.004)是内漏的独立危险因素,每增加 60 分钟手术时间风险增加 1.3 倍(p=0.021),每增加 100 毫升对比剂风险增加 1.3 倍(p=0.016)。透视时间每增加 10 分钟,风险增加 1.4 倍(p=0.004)。
随着显著的临床结果改善,学习曲线在时间上显著缩短,这表明特定的血管内培训对于成为有效的 TEVAR 执行者是必要的。
这是首次在文献中评估单个血管外科中心在 25 年内进行标准 TEVAR 的学习曲线。中心和历史上首次进行 TEVAR 的第一医生的学习曲线在第 75 例治疗患者中达到。此后进行手术的医生的学习曲线明显缩短(10 例)。这 25 年证明,与手术相关的术中学习变量与长期临床结果相关,并且随着时间的推移所有这些变量都有所改善。首次接触 TEVAR 的中心和培训项目提供商可以使用这些数据来提供更好的临床结果。