Centre Hospitalier Universitaire Henri Mondor, Department of Vascular Surgery, Créteil, France.
Centre Hospitalier Universitaire Henri Mondor, Medical Imaging Service, Interventional and Therapeutic Vascular and Oncologic Radiology Unit, Créteil, France.
Eur J Vasc Endovasc Surg. 2021 Aug;62(2):204-213. doi: 10.1016/j.ejvs.2021.03.010. Epub 2021 May 14.
The aim was to describe initial outcomes of physician modified stent grafts using antegrade laser fenestrations and image fusion guidance (LEVAR) and company manufactured custom made (CM) stent grafts for the treatment of complex abdominal aortic aneurysms (CAAAs), thoraco-abdominal aortic aneurysms (TAAAs) and type I endoleaks (T1ELs).
This was a retrospective single centre study. All LEVAR and Zenith (Cook) CM stent graft procedures between 1 January 2012 and 31 December 2018 were reviewed. Endpoints included intra-operative adverse events (IOAEs), in hospital mortality, re-interventions, target vessel patency, and 12 month outcomes (overall survival, freedom from re-intervention, target vessel patency). Outcomes at 12 months were estimated using the Kaplan-Meier method.
A hundred patients were identified and included in the study. All patients were deemed unfit for open repair. The cohort included 22 LEVAR and 78 CM stent grafts. LEVAR cases included painful aneurysms (n = 5), > 65 mm aneurysms (n = 10), anatomical constrains and/or presence of previous renal stents (n = 7) or cases declined by the manufacturer planning centre (n = 2). IOAEs were recorded in 41% of cases (n = 9) in the LEVAR group vs. 10% (n = 8, p = .002) in the CM group. The in hospital mortality rate in the LEVAR group was 9% (n = 2) vs. 4% (n = 3, p = .30) in the CM group. The median follow up duration was 22 months (7 - 38) in the LEVAR group and 28 months (11 - 78) in the CM group. The estimate of overall survival at one year was 91% in both groups. The freedom from re-intervention rate at one year was 58% in the LEVAR group vs. 87% in the CM group. The target vessel patency rates at one year were 95% in both groups.
In high risk patients deemed unfit for open repair, LEVAR may provide satisfactory 12 month overall survival and target vessel patency rates, though reported IOAE, mortality, and re-interventions rates were high thus requiring close and extensive follow up.
描述使用顺行激光开窗和图像融合引导（LEVAR）及公司制造的定制（CM）支架治疗复杂腹主动脉瘤（CAAA）、胸腹主动脉瘤（TAAA）和 1 型内漏（T1EL）的医生改良支架移植物的初始结果。
这是一项回顾性单中心研究。回顾了 2012 年 1 月 1 日至 2018 年 12 月 31 日期间所有 LEVAR 和 Zenith（库克）CM 支架移植物的手术。终点包括术中不良事件（IOAE）、住院死亡率、再干预、靶血管通畅率和 12 个月结果（总生存率、无再干预生存率、靶血管通畅率）。使用 Kaplan-Meier 方法估计 12 个月的结果。
确定了 100 名患者并纳入了研究。所有患者均被认为不适合开放修复。该队列包括 22 例 LEVAR 和 78 例 CM 支架移植物。LEVAR 病例包括疼痛性动脉瘤（n=5）、直径>65mm 的动脉瘤（n=10）、解剖限制和/或存在先前的肾支架（n=7）或制造商规划中心拒绝的病例（n=2）。LEVAR 组有 41%（n=9）的病例发生 IOAE，而 CM 组有 10%（n=8，p=0.002）。LEVAR 组的住院死亡率为 9%（n=2），CM 组为 4%（n=3，p=0.30）。LEVAR 组的中位随访时间为 22 个月（7-38），CM 组为 28 个月（11-78）。两组一年总体生存率估计值均为 91%。LEVAR 组一年无再干预率为 58%，CM 组为 87%。两组一年靶血管通畅率均为 95%。
在不适合开放修复的高危患者中，LEVAR 可能提供令人满意的 12 个月总生存率和靶血管通畅率，但报告的 IOAE、死亡率和再干预率较高，因此需要密切和广泛的随访。
