Farivar Behzad S, Abbasi Mohammad N, Dias Agenor P, Kuramochi Yuki, Brier Corey S, Parodi F Ezequiel, Eagleton Matthew J
Department of Vascular Surgery, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Department of Vascular Surgery, Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
J Vasc Surg. 2017 Oct;66(4):1028-1036.e18. doi: 10.1016/j.jvs.2017.02.042. Epub 2017 May 11.
This study evaluated and compared the long-term clinical outcomes of endovascular repair of infrarenal aortoiliac aneurysms (EVAR) vs EVAR with preservation of antegrade internal iliac artery (IIA) perfusion using iliac branched devices (EVAR-IBDs).
From October 1998 to August 2015, patients with infrarenal aortoiliac aneurysmal (AIA) disease at high risk for conventional open surgery were enrolled in a prospective physician-sponsored investigational device exemption trial. Clinical data of 75 patients treated with EVAR-IBD and 255 with standard EVAR were analyzed. Technical success, perioperative outcomes, mortality, device patency, endoleak rates, and reinterventions during a follow-up of 10 years were analyzed.
There were 87 IBDs deployed in 75 patients. Technical success rate was 97%. Mortality at 30 days was 1.3%. Freedom from aneurysm-related mortality at 3, 5, and 10 years was 99%. Freedom from a type I or III endoleak at 3, 5, and 10 years was 99%. Freedom from secondary reinterventions at 3, 5, and 10 years was 86%, 81%, and 81%, respectively. Primary patency of the IBDs at 3, 5, and 10 years was 94%, 94%, and 77%, respectively. Twenty-four percent of patients underwent EVAR for concomitant AIA disease (EVAR-AIA), and 78% were managed by staged IIA embolization before EVAR. No statistically significant difference in freedom from aneurysm-related mortality, limb occlusions, or endoleak rates was identified in patients with EVAR-AIA vs EVAR-IBD (P > .05). There were significantly more secondary reinterventions in the EVAR-AIA group compared with the EVAR-IBD group (hazard ratio, 0.476, 95% confidence interval, 0.226-1.001; P = .045).
EVAR of infrarenal AIAs with preservation of antegrade flow to the IIA using IBDs is feasible with long-term sustained durability. Serious considerations should be given to the use of IBDs in patients with infrarenal AIAs meeting appropriate anatomic criteria.
本研究评估并比较了肾下腹主动脉髂动脉瘤腔内修复术(EVAR)与使用髂支装置保留顺行性髂内动脉(IIA)灌注的EVAR(EVAR - IBD)的长期临床疗效。
从1998年10月至2015年8月,将常规开放手术高风险的肾下腹主动脉髂动脉瘤(AIA)疾病患者纳入一项由医生发起的前瞻性研究器械豁免试验。分析了75例接受EVAR - IBD治疗的患者和255例接受标准EVAR治疗的患者的临床数据。分析了技术成功率、围手术期结局、死亡率、器械通畅率、内漏率以及10年随访期间的再次干预情况。
75例患者共植入87个IBD。技术成功率为97%。30天死亡率为1.3%。3年、5年和10年无动脉瘤相关死亡率分别为99%。3年、5年和10年无I型或III型内漏率分别为99%。3年、5年和10年无二次再次干预率分别为86%、81%和81%。IBD在3年、5年和10年的原发性通畅率分别为94%、94%和77%。24%的患者因合并AIA疾病接受EVAR(EVAR - AIA),78%的患者在EVAR前通过分期IIA栓塞进行治疗。在EVAR - AIA患者与EVAR - IBD患者中,无动脉瘤相关死亡率、肢体闭塞或内漏率方面未发现统计学显著差异(P>.05)。与EVAR - IBD组相比,EVAR - AIA组的二次再次干预明显更多(风险比,0.476,95%置信区间,0.226 - 1.001;P =.045)。
使用IBD保留向IIA的顺行血流进行肾下腹主动脉髂动脉瘤的EVAR是可行的,具有长期持续的耐久性。对于符合适当解剖标准的肾下腹主动脉髂动脉瘤患者,应认真考虑使用IBD。