Vascular Surgery Department, University General Hospital of Alexandroupolis, Demokritus University of Thrace, Alexandroupolis, Greece.
J Vasc Surg. 2011 Sep;54(3):616-27. doi: 10.1016/j.jvs.2011.03.235. Epub 2011 Jul 29.
To evaluate and compare the outcome after endovascular abdominal aortic aneurysm repair (EVAR) with the newly released Endurant endograft system in patients with different aortoiliac anatomic characteristics.
We conducted a prospective observational study assigning patients with infrarenal abdominal aortic aneurysm (AAA) treated with the Endurant endoprosthesis from February 2009 to March 2010. Two groups were studied, according to the presence of a friendly (group I [GI] = 43) or hostile (group II [GII] = 34) infrarenal aortoiliac anatomy. Hostile profile was defined as any (or combination) of the following measurements: 5 mm ≤ proximal neck length (Lpr) ≤ 12 mm, 60° < proximal neck angle (A°pr) ≤ 90° and 60° < any iliac axis angle (A°iliac) ≤ 90°. Primary end points included technical and clinical success, freedom from early or late secondary interventions, any type of endoleak, and aneurysm-related death. All outcome measures were calculated using the Kaplan-Meier method and the log rank test was applied for comparisons between the groups.
The mean comorbid severity scoring was higher in GII (P = .018). The mean follow-up period in GI and GII was 12.9 ± 3.9 months (± SD, range: 6.4-19.8) and 12.4 ± 4 months (range: 4.2-19.6), respectively. Two unplanned conversions to aortouniiliac configurations were required in GI. The technical success rate in GI and GII was 95.4% and 100%, respectively. The requirement for intentional occlusion of the internal iliac artery, the requirement for cross-limb technique, the necessity of troubleshooting techniques, the procedure and radiation times, the frequency of postimplantation syndrome, and mean hospital stay were significantly higher in GII (P = .028, P = .013, P = .005, P = .037, P < .001, P = .032, P = .021, respectively). Two patients of GI died in the early postoperative period (one aneurysm but not device-related death), whereas no deaths in GII were recorded, yielding an overall 30-day mortality rate of 2.3%. No type I/III endoleaks were recorded up to the end of the study. Freedom from any type of endoleak, early or late secondary interventions, and aneurysm-related death at 12 months were found in 93.2%, 87.1%, and 93.3% of GI patients; respective values for GII were 86% (P = .21), 93.4% (P = .066), and 93.4%. The clinical success rate was 82.1% and 100% at 12 months for GI and GII, respectively.
Early (12 months) results suggest similar clinical performance of the Endurant stent graft system in endovascular treatment of AAAs with friendly and hostile anatomies, however, demonstrating more intra- and perioperative adversities for the last group. Larger prospective studies or even randomized trials comparing different new generation graft models are required to evaluate the comparable long-term results and possible expansion of EVAR indications for this specific endograft in adverse anatomies.
评估并比较使用新型 Endurant 覆膜支架系统治疗不同腹主动脉瘤解剖结构患者的血管内治疗效果。
前瞻性观察研究,2009 年 2 月至 2010 年 3 月期间对使用 Endurant 覆膜支架治疗的 43 例髂动脉瘤患者(I 组)和 34 例髂动脉瘤患者(II 组)进行研究。根据髂总动脉的友好型(组 I [GI])或敌对型(组 II [GII])解剖结构,分为两组。敌对型定义为任何(或组合)以下测量值:近端颈长度(Lpr)5mm≤Lpr≤12mm,近端颈角(A°pr)60°<A°pr<90°,任何髂轴角(A°iliac)60°<A°iliac<90°。主要终点包括技术和临床成功率、无早期或晚期继发性干预、任何类型的内漏和与动脉瘤相关的死亡率。所有的结果测量都采用 Kaplan-Meier 法计算,并用对数秩检验比较两组之间的差异。
GII 组的平均合并症严重程度评分更高(P=0.018)。GI 组和 GII 组的平均随访时间分别为 12.9±3.9 个月(±SD,范围:6.4-19.8)和 12.4±4 个月(范围:4.2-19.6)。GI 组中有 2 例需要转换为腹主动脉髂动脉构型。GI 组和 GII 组的技术成功率分别为 95.4%和 100%。GII 组需要计划性闭塞髂内动脉、需要交叉肢体技术、需要解决技术问题、需要手术和放射时间、需要植入后综合征的频率和平均住院时间显著更高(P=0.028、P=0.013、P=0.005、P=0.037、P<0.001、P=0.032、P=0.021)。GI 组有 2 例患者在术后早期死亡(1 例与动脉瘤但与器械无关的死亡),而 GII 组无死亡记录,总的 30 天死亡率为 2.3%。研究结束时未发现任何类型的 I/III 型内漏。GI 组在 12 个月时的无任何类型内漏、早期或晚期继发性干预和与动脉瘤相关的死亡率分别为 93.2%、87.1%和 93.3%;GII 组分别为 86%(P=0.21)、93.4%(P=0.066)和 93.4%。GI 组和 GII 组的临床成功率分别为 82.1%和 100%。
早期(12 个月)结果表明,新型 Endurant 覆膜支架系统在治疗友好型和敌对型腹主动脉瘤方面具有相似的临床效果,但最后一组患者的术中及围手术期并发症更多。需要更大规模的前瞻性研究甚至随机试验来比较不同新一代支架模型的长期可比结果,并可能扩大该特定支架在不利解剖结构中的血管内治疗适应证。