Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Yale University School of Medicine, New Haven, CT.
Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Yale University School of Medicine, New Haven, CT.
Ann Vasc Surg. 2022 Oct;86:328-337. doi: 10.1016/j.avsg.2022.04.042. Epub 2022 May 16.
The purpose of this study is to elucidate the role of the AFX2 platform in the endovascular treatment of aortic pathology.
All procedures by a single surgeon resulting in implantation of a bifurcated unibody stent graft were reviewed retrospectively. Indications for selection of the AFX2 endograft in each case were evaluated. Aortic anatomy was determined via review of pre-operative computed tomography (CT) scans. Cumulative event probabilities for endoleak, reintervention, and mortality were estimated. Patient and procedural details were described using mean, standard deviation, medians, and interquartile range (IQR). Kaplan-Meier survival analysis estimated freedom from mortality and reintervention. Cumulative incidence probabilities were calculated as one minus the Kaplan-Meier estimator.
Between March 2018 and December 2020, the author (NN) used 142 aortic endografts in 142 patients. Of these, 46 (32.4%) were AFX2 endografts and the remaining were modular bifurcated devices, predominantly Medtronic Endurant II and Terumo Treo. No AFX-Strata or AFX-Duraply devices were placed. Amongst the patients who received an AFX2, mean age was 71.3 +/- 9.8 years with 84.8% male. Median operative time was 116 (86-166) min, with contrast dose of 79 (41-120) milliliters and fluoroscopy time of 12 (8.6-18) min. Overall, 78.3% (n = 36) of AFX2 devices were placed in aortas with maximum true lumen diameter <5.0 cm. Median postoperative follow-up was 1.7 years (IQR 1.0-2.4 years), with a maximum follow-up of 3.6 years. There was 1 patient lost to follow-up at 5 months. The 2-year incidence of type II endoleak, reintervention, and all-cause mortality was 12.7% (95% confidence interval CI, 0-29.6%), 2.2% (95% CI, 0-6.3%), and 11.3% (95% CI, 0.1-2.1.2%), respectively. There were no type I or III endoleaks.
The AFX2 endograft plays a safe and effective role in treatment of infrarenal aortic pathologies that may be otherwise more technically challenging for traditional modular, bifurcated devices.
本研究旨在阐明 AFX2 平台在主动脉病变血管内治疗中的作用。
回顾性分析了由一位外科医生进行的所有导致分叉一体式支架移植物植入的手术。评估了每种情况下选择 AFX2 内脏移植物的适应证。通过术前计算机断层扫描(CT)扫描确定主动脉解剖结构。估计内漏、再干预和死亡率的累积事件概率。使用平均值、标准差、中位数和四分位距(IQR)描述患者和手术细节。Kaplan-Meier 生存分析估计死亡率和再干预的无风险。累积发生率概率为 1 减去 Kaplan-Meier 估计值。
2018 年 3 月至 2020 年 12 月,作者(NN)在 142 名患者中使用了 142 个主动脉内脏移植物。其中,46 个(32.4%)为 AFX2 内脏移植物,其余为模块化分叉装置,主要为美敦力 Endurant II 和泰尔茂 Treo。未放置 AFX-Strata 或 AFX-Duraply 装置。在接受 AFX2 治疗的患者中,平均年龄为 71.3 +/- 9.8 岁,84.8%为男性。中位手术时间为 116(86-166)分钟,造影剂剂量为 79(41-120)毫升,透视时间为 12(8.6-18)分钟。总体而言,78.3%(n=36)的 AFX2 装置放置在最大真腔直径<5.0cm 的主动脉中。中位术后随访时间为 1.7 年(IQR 1.0-2.4 年),最长随访时间为 3.6 年。有 1 例患者在 5 个月时失访。2 年的 II 型内漏、再干预和全因死亡率分别为 12.7%(95%置信区间,0-29.6%)、2.2%(95%置信区间,0-6.3%)和 11.3%(95%置信区间,0.1-2.1.2%)。无 I 型或 III 型内漏。
AFX2 内脏移植物在治疗可能对传统模块化分叉装置更具技术挑战性的肾下主动脉病变方面发挥了安全有效的作用。