Kong Li Sheng, MacMillan Douglas, Kasirajan Karthik, Milner Ross, Dodson Thomas F, Salam Atef A, Smith Robert B, Chaikof Elliot L
Department of Surgery, Division of Vascular Surgery and Endovascular Therapy, Emory University School of Medicine, Atlanta, GA, USA.
J Vasc Surg. 2005 Oct;42(4):631-8. doi: 10.1016/j.jvs.2005.05.056.
Reports continue to document the occurrence of major adverse events after endovascular aortic aneurysm repair. Although many of these problems can be successfully managed through endovascular salvage, operative conversion with explantation of the endoprosthesis remains necessary in some patients. We report herein a review of all patients initially enrolled in multicenter US clinical trials of the Excluder endograft who underwent secondary conversion to open surgical repair.
Clinical data and relevant medical records of patients enrolled in phase I and II multicenter US clinical trials of the Excluder endograft were retrospectively reviewed for adverse events and further narrowed to those patients who underwent secondary operative conversion. Hospital records, operative and anesthesia reports, and all imaging studies were analyzed at initial implantation and at the time of subsequent open surgical repair.
Late open conversion was performed in 16 (2.7%) of the 594 patients enrolled in the Excluder clinical trials. Presumed endotension accounted for 8 of 16 of secondary conversions. In two of these patients, however, an endoleak was identified at the time of open surgical repair. Of the remaining eight patients, two underwent conversion for device infection, five for persistent endoleak, and one for aneurysm rupture. The overall 30-day mortality was 6.25% (1/16), with one death occurring in a patient with a ruptured aneurysm. Of patients who underwent conversion because of endotension, the maximal abdominal aortic aneurysm diameter (mean +/- SD) at the time of initial implantation and subsequent graft removal was 61 +/- 11 mm and 70 +/- 10 mm, respectively. The mean time to open conversion for treatment of endotension was 37 +/- 12 months (range, 20-50 months; median, 42 months). Freedom from conversion was 98.6% and 96.7% at 24 and 48 months, respectively.
Endotension in the absence of a demonstrable endoleak has been a major indication for late surgical conversion in patients treated with the Excluder endograft. Given the potential presence of an undetected endoleak and the possible effects of progressive sac enlargement on long-term device stability, continued close surveillance of patients with assumed endotension is required. Should changes in device design eliminate endotension, a further reduction in the already low incidence of late open conversion of the Excluder endograft can be anticipated.
报告持续记录了腹主动脉瘤腔内修复术后严重不良事件的发生情况。尽管其中许多问题可通过腔内挽救成功处理，但在某些患者中仍有必要进行手术转换并取出腔内移植物。我们在此报告了对所有最初纳入美国Excluder腔内移植物多中心临床试验且接受二次转换为开放手术修复的患者的回顾。
回顾性分析了参与美国Excluder腔内移植物I期和II期多中心临床试验患者的临床数据和相关病历，以查找不良事件，并进一步筛选出接受二次手术转换的患者。分析了初始植入时以及随后开放手术修复时的医院记录、手术和麻醉报告以及所有影像学检查。
在参与Excluder临床试验的594例患者中，有16例（2.7%）进行了晚期开放转换。推测的内张力是16例二次转换中的8例原因。然而，在其中2例患者中，开放手术修复时发现了内漏。在其余8例患者中，2例因器械感染进行了转换，5例因持续性内漏进行了转换，1例因动脉瘤破裂进行了转换。总体30天死亡率为6.25%（1/16），1例死亡发生在动脉瘤破裂患者中。因内张力进行转换的患者，初始植入时和随后取出移植物时的最大腹主动脉瘤直径（均值±标准差）分别为61±11mm和70±10mm。因内张力接受开放转换治疗的平均时间为37±12个月（范围为20 - 50个月；中位数为42个月）。在24个月和48个月时，无需转换的比例分别为98.6%和96.7%。
在无明显内漏的情况下，内张力一直是接受Excluder腔内移植物治疗患者晚期手术转换的主要指征。鉴于可能存在未检测到的内漏以及瘤腔逐渐扩大对长期器械稳定性的潜在影响，需要对假定存在内张力的患者持续进行密切监测。如果器械设计的改变消除了内张力，可以预期Excluder腔内移植物本就较低的晚期开放转换发生率会进一步降低。
