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内脏动脉区覆膜支架腔内隔绝术后失败的分支型和开窗型主动脉瘤腔内修复术的结果。

Results of fenestrated and branched endovascular aortic aneurysm repair after failed infrarenal endovascular aortic aneurysm repair.

机构信息

Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, Mass.

Division of Vascular and Endovascular Surgery, University of Alabama at Birmingham, Birmingham, Ala.

出版信息

J Vasc Surg. 2020 Sep;72(3):849-858. doi: 10.1016/j.jvs.2019.11.026. Epub 2020 Mar 3.

Abstract

OBJECTIVE

Failure of infrarenal endovascular aneurysm repair (EVAR) due to loss of proximal seal is increasingly common. Open surgical conversion can be challenging and has been associated with significant morbidity and mortality. The aim of this study was to evaluate the use of fenestrated-branched EVAR (F/BEVAR) for the treatment of patients with prior EVAR failure.

METHODS

Consecutive patients enrolled as part of the Aortic Research Consortium in six prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/BEVAR between 2012 and 2018 were included in this study. The cohort was stratified according to whether the F/BEVAR procedure was performed after EVAR failure. Demographics, operative details, perioperative complications, and length of stay were compared between groups. Postprocedural survival, type I or type III endoleak, target artery patency, target artery instability, and reintervention rates were calculated using Kaplan-Meier method and compared between groups.

RESULTS

A total of 893 patients underwent F/BEVAR; 161 (18%) were treated after failed EVAR and 732 (82%) were treated without prior EVAR. Patients with failed EVAR were more often men (84% vs 66%; P < .01) with larger aneurysms (6.9 cm vs 6.4 cm; P < .01). There were no differences in aneurysm extent (P = .20) between groups; for the entire cohort, there were 19% juxtarenal, 9.2% suprarenal, and 72% thoracoabdominal aneurysms. The average number of targeted arteries per patient was 3.6 in both groups. The procedural technical success (99% vs 97%; P = .15) did not differ between groups, but radiation dose (4750 vs 2920 mGy; P = .02), dose-area product (154,572 vs 82,842 mGy·cm; P < .01), and operative time (5.2 vs 4.6 hours; P < .01) were significantly higher in the failed EVAR group. Median intensive care unit length of stay (2.9 days) and total length of stay (6.3 days) did not differ between groups. The 30-day mortality rate (failed EVAR, 2.5%; no EVAR, 1.1%; P = .25) and 30-day major adverse event rates did not differ between groups. Kaplan-Meier estimates of freedom from type I or type III endoleak (91.9% vs 92.5%; P = .65), target artery patency (97.3% vs 97.0%; P = .91), freedom from target artery instability (86.3% vs 88.8%; P = .53), and freedom from reintervention at 1 year (84.7% vs 88.7%; P = .10) did not differ between the failed EVAR and no EVAR groups, respectively. One-year survival was decreased in the failed EVAR group (86.3% vs 91.9%; P = .02), but this effect did not persist on multivariable analysis (hazard ratio, 1.52; 95% confidence interval, 0.88-2.62; P = .14).

CONCLUSIONS

In this multicenter study, F/BEVAR was safe and effective in patients with prior failed EVAR, with nearly identical outcomes to those of patients without prior EVAR. However, differences in procedural metrics indicate higher level of technical challenge in performing F/BEVAR in patients with prior failed EVAR.

摘要

目的

腹主动脉瘤腔内修复术(EVAR)后近端密封失效导致的失败越来越常见。开放手术转换可能具有挑战性,并且与显著的发病率和死亡率相关。本研究的目的是评估在先前 EVAR 失败的患者中使用分支型腔内修复术(F/BEVAR)的效果。

方法

连续纳入作为评估 2012 年至 2018 年期间 F/BEVAR 的六个前瞻性、非随机、医生赞助的研究性器械豁免研究的 Aortic Research Consortium 的患者,纳入本研究。根据 F/BEVAR 手术是否在 EVAR 失败后进行,对队列进行分层。比较两组之间的人口统计学、手术细节、围手术期并发症和住院时间。使用 Kaplan-Meier 方法计算术后生存率、I 型或 III 型内漏、靶动脉通畅率、靶动脉不稳定率和再介入率,并进行组间比较。

结果

共有 893 例患者接受了 F/BEVAR;161 例(18%)在 EVAR 失败后接受治疗,732 例(82%)在没有先前 EVAR 的情况下接受治疗。EVAR 失败的患者更常见为男性(84%比 66%;P<.01),且动脉瘤更大(6.9cm 比 6.4cm;P<.01)。两组之间动脉瘤的范围没有差异(P=0.20);对于整个队列,有 19%的近肾动脉瘤、9.2%的肾上动脉瘤和 72%的胸腹主动脉瘤。两组患者的平均靶动脉数为 3.6 个。手术技术成功率(99%比 97%;P=0.15)在两组之间没有差异,但辐射剂量(4750 比 2920mGy;P=0.02)、剂量面积乘积(154572 比 82842mGy·cm;P<.01)和手术时间(5.2 比 4.6 小时;P<.01)在 EVAR 失败组中显著更高。两组之间重症监护病房住院时间中位数(2.9 天)和总住院时间(6.3 天)无差异。30 天死亡率(EVAR 失败组,2.5%;无 EVAR 组,1.1%;P=0.25)和 30 天主要不良事件发生率在两组之间无差异。Kaplan-Meier 估计的 I 型或 III 型内漏无(91.9%比 92.5%;P=0.65)、靶动脉通畅率(97.3%比 97.0%;P=0.91)、靶动脉不稳定率(86.3%比 88.8%;P=0.53)和 1 年无再介入率(84.7%比 88.7%;P=0.10)在 EVAR 失败组和无 EVAR 组之间无差异。EVAR 失败组的 1 年生存率降低(86.3%比 91.9%;P=0.02),但多变量分析表明这种影响并不持续(风险比,1.52;95%置信区间,0.88-2.62;P=0.14)。

结论

在这项多中心研究中,F/BEVAR 在先前 EVAR 失败的患者中是安全有效的,其结果与没有先前 EVAR 的患者几乎相同。然而,手术指标的差异表明,在先前 EVAR 失败的患者中进行 F/BEVAR 具有更高的技术挑战性。

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