Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Modena, Italy.
Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Modena, Italy.
J Vasc Surg. 2018 Apr;67(4):1005-1016. doi: 10.1016/j.jvs.2017.08.068. Epub 2017 Oct 31.
The objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (TAAAs) treated with the first commercially available "off-the-shelf" multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach.
A multicenter, nonrandomized, retrospective study was conducted of TAAA patients grouped by urgent/emergent and elective treatment with multibranched endograft for endovascular aneurysm repair at 13 Italian centers from November 2012 to August 2016. Urgent/emergent repair was classified as rupture in 16%, impending rupture in 9%, pain in 53%, or a maximum TAAA diameter ≥80 mm in 22%. Study end points were technical success, mortality, spinal cord ischemia, target visceral vessel (TVV) patency, and procedure-related reinterventions at 30 days and at follow-up.
Seventy-three patients (274 TVVs) were enrolled. Treatment was performed in elective (n = 41 [56%]) or urgent/emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n = 43 [59%]) approach. Technical success was 92%. Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction. Spinal cord ischemia was recorded in two patients (3%; elective group). The primary patency of TVVs was 99% (three renal branch occlusions). Procedure-related reinterventions were required in five cases (7%). At least one adverse event from any cause ≤30 days was registered in 42% (n = 31). At a median follow-up of 18 months (range, 1-43 months), eight (11%) deaths (elective vs urgent/emergent, 2% vs 22%; P = .018), three (1%) cases of branch occlusion or stenosis, and five (7%) reinterventions were recorded. A survival of 88% (standard error [SE], 4%), 86% (SE, 4%), and 82% (SE, 5%) was evidenced at 12, 24, and 36 months, respectively. Urgent/emergent repair and female gender were identified as independent risk factors for all-cause mortality (P < .001 and P = .015, respectively), and the staged approach was identified as protective (P = .026). Freedom from reintervention was 86% (SE, 4%) and 83% (SE, 5%) at 12 and 24 months.
The first off-the-shelf multibranched endograft seems safe in both urgent/emergent and elective settings. The staged surgical approach appears to positively influence overall survival. This unique device and its operators will usher in a new treatment paradigm for TAAA repair.
本研究旨在评估首例市售“现货”分支型腹主动脉瘤腔内修复用移植物治疗急/急诊和择期胸腹主动脉瘤（TAAA）患者的即刻和中期结果，采用单步或分期手术方法。
2012 年 11 月至 2016 年 8 月，13 家意大利中心进行了一项多中心、非随机、回顾性研究，根据分支型腹主动脉瘤腔内修复术对 TAAA 患者进行分组，分为急/急诊治疗（16%破裂，9%即将破裂，53%疼痛，22%最大 TAAA 直径≥80mm）和择期治疗。研究终点为 30 天和随访时的技术成功率、死亡率、脊髓缺血、靶内脏血管（TVV）通畅性和与手术相关的再介入。
共纳入 73 例（274 个 TVV）患者。根据单步（n=30[41%]）或分期（n=43[59%]）方法，治疗为择期（n=41[56%]）或急/急诊（n=32[44%]）。技术成功率为 92%。30 天内死亡率为 4%（3 例急/急诊患者死于心肌梗死）。2 例（3%；择期组）出现脊髓缺血。TVV 的一级通畅率为 99%（3 例肾支闭塞）。5 例（7%）需要与手术相关的再介入。至少有 1 例任何原因≤30 天的不良事件发生在 42%（n=31）的患者中。在中位随访 18 个月（范围 1-43 个月）时，记录到 8 例（11%）死亡（择期 vs 急/急诊，2% vs 22%；P=0.018）、3 例分支闭塞或狭窄和 5 例再介入。12、24 和 36 个月时的生存率分别为 88%（标准误差[SE]，4%）、86%（SE，4%）和 82%（SE，5%）。急/急诊修复和女性被确定为全因死亡率的独立危险因素（P<0.001 和 P=0.015），分期方法被确定为保护因素（P=0.026）。12 和 24 个月时的无再介入率分别为 86%（SE，4%）和 83%（SE，5%）。
首例市售分支型腹主动脉瘤腔内修复用移植物在急/急诊和择期治疗中均安全。分期手术方法似乎对总体生存率有积极影响。这种独特的器械及其操作者将为 TAAA 修复带来新的治疗模式。
