Babocs Dora, Kanamori Lucas Ruiter, Schmid Bruno Pagnin, Tenorio Emanuel, Maximus Steven, Mendes Bernardo C, Macedo Thanila A, Huang Ying, Oderich Gustavo S
Department of Surgery, Advanced Aortic Research Program at the Baylor College of Medicine, Houston, TX.
Department of Surgery, Advanced Aortic Research Program at the Baylor College of Medicine, Houston, TX; Department of Interventional Radiology, Hospital Israelita Albert Einstein, Sao Paulo, Sao Paulo, Brazil.
J Vasc Surg. 2025 Oct;82(4):1156-1167.e2. doi: 10.1016/j.jvs.2025.05.031. Epub 2025 May 21.
To evaluate the impact of increased clinical experience and changes in practice protocols on the incidence of early major adverse events (MAEs) during fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs).
Clinical outcomes of 847 consecutive patients (72% males; median age, 74 years; interquartile range, 69-79 years) treated by the same operator in two centers were reviewed (2007-2024). Of these, 590 patients were treated under a prospective investigational device exemption study. Changes in practice protocols included routine use of fusion/cone beam computed tomography (2012), therapeutic instead of prophylactic cerebrospinal fluid drainage (CSFD) (2019, Q3) and preferential use of total transfemoral access (2020, Q4). The primary end point was 30-day/in-hospital MAE assessment using learning curve cumulative sum analysis per quartiles of experience. The study period was divided into four quartiles: Q1 (2007-2014), Q2 (2014-2017), Q3 (2017-2020), and Q4 (2020-2024).
There was a significant increase in the proportion of extent I to III TAAA (from 16% to 58%; P < .001), chronic postdissection aneurysms (from 1.9% to 21%; P < .001), symptomatic aneurysms (from 5.2% to 10%; P < .001), heritable thoracic aortic diseases (from 0.5% to 4.2%; P = .011), and prior EVAR (from 8.5% to 51%; P < .001) between Q1 and Q4 experience. Despite the increased aneurysm complexity, MAEs significantly decreased over time and across quartiles (P < .01). The use of fusion/cone beam computed tomography was associated with a significant decrease in total operative time and radiation exposure (P < .001). Overall 30-day mortality was 1.7% (14/847). The incidence of MAEs significantly decreased for CAAAs and extent IV TAAAs (P < .01) and remained stable for extent I to III TAAAs after institution of therapeutic instead of prophylactic CSFD and total transfemoral access. Learning curve cumulative sum analysis indicates that 32 consecutive cases were needed to reach a learning curve and 100 cases to reach plateau, with significantly improved outcomes in the fourth quartile of experience.
FB-EVAR was performed with low mortality (1.7%) in a large cumulative experience. Increased clinical experience and changes in practice protocol associated with significantly improved outcomes of FB-EVAR, despite a significant increase in anatomical and patient complexity. The institution of therapeutic instead of prophylactic CSFD and total transfemoral access had no deleterious effect on outcomes of extent I to III TAAAs but improved outcomes in patients with less extensive aneurysms. Among CAAA patients, 21.2% had therapeutic instead of prophylactic CSFD, and 10.7% had total transfemoral access. For extent IV aneurysms, 47.3% had therapeutic CSFD, and 22.5% had total transfemoral access.
评估临床经验的增加和实践方案的改变对复杂腹主动脉瘤（CAAA）和胸腹主动脉瘤（TAAA）开窗分支型血管腔内主动脉修复术（FB-EVAR）期间早期主要不良事件（MAE）发生率的影响。
回顾了同一术者在两个中心治疗的847例连续患者的临床结果（2007 - 2024年）。这些患者中，72%为男性；中位年龄74岁；四分位间距为69 - 79岁。其中590例患者是在一项前瞻性研究器械豁免研究下接受治疗的。实践方案的改变包括融合/锥形束计算机断层扫描的常规使用（2012年）、治疗性而非预防性脑脊液引流（CSFD）（2019年第三季度）以及优先使用经股动脉入路（2020年第四季度）。主要终点是使用学习曲线累积和分析按经验四分位数评估30天/住院期间的MAE。研究期分为四个四分位数：Q1（2007 - 2014年）、Q2（2014 - 2017年）、Q3（2017 - 2020年）和Q4（2020 - 2024年）。
在Q1和Q4经验期间，I至III型TAAA的比例显著增加（从16%增至58%；P <.001），慢性夹层后动脉瘤的比例显著增加（从1.9%增至21%；P <.001），有症状动脉瘤的比例显著增加（从5.2%增至10%；P <.001），遗传性胸主动脉疾病的比例显著增加（从0.5%增至4.2%；P =.011），以及既往接受过血管腔内主动脉修复术的比例显著增加（从8.5%增至51%；P <.001）。尽管动脉瘤复杂性增加，但MAE随时间推移和跨四分位数显著减少（P <.01）。融合/锥形束计算机断层扫描的使用与总手术时间和辐射暴露的显著减少相关（P <.001）。总体30天死亡率为1.7%（14/847）。对于CAAA和IV型TAAA，MAE的发生率显著降低（P <.01），在采用治疗性而非预防性CSFD和经股动脉入路后，I至III型TAAA的发生率保持稳定。学习曲线累积和分析表明，需要连续32例病例才能达到学习曲线，100例病例才能达到平台期，在经验的第四个四分位数中结果有显著改善。
在大量累积经验中，FB-EVAR的死亡率较低（1.7%）。尽管解剖结构和患者复杂性显著增加，但临床经验的增加和实践方案的改变与FB-EVAR的结果显著改善相关。采用治疗性而非预防性CSFD和经股动脉入路对I至III型TAAA的结果没有有害影响，但改善了动脉瘤范围较小患者的结果。在CAAA患者中，21.2%采用了治疗性而非预防性CSFD，10.7%采用了经股动脉入路。对于IV型动脉瘤，47.3%采用了治疗性CSFD；22.5%采用了经股动脉入路。
