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采用医生改良的血管内移植物与公司制造的器械行开窗型血管内主动脉瘤修复术。

Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices.

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 Massachusetts Medical School, Worcester, Mass.

出版信息

J Vasc Surg. 2018 Jun;67(6):1673-1683. doi: 10.1016/j.jvs.2017.10.055. Epub 2017 Dec 8.


DOI:10.1016/j.jvs.2017.10.055
PMID:29224942
Abstract

OBJECTIVE: Fenestrated endografts are customized, patient-specific endovascular devices with potential to reduce morbidity and mortality of complex aortic aneurysm repair. With approval from the U.S. Food and Drug Administration, our center began performing fenestrated endovascular aneurysm repair through a physician-sponsored investigational device exemption (IDE #G130210), using both physician-modified endografts (PMEGs) and company-manufactured devices (CMDs). Because these techniques are associated with specific advantages and disadvantages, we sought to investigate differences in outcomes between PMEG and CMD cases. METHODS: A single-institution retrospective review of all fenestrated endovascular aneurysm repairs was performed. The cohort was analyzed by device type (PMEG or CMD) after matching of cases on the basis of (1) number of target vessels intended for treatment, (2) extent of aneurysm, (3) aneurysm diameter, (4) device configuration, and (5) date of operation. Outcomes of ruptures, common iliac artery aneurysms, and aortic arch aneurysms were excluded. Demographics, operative details, perioperative complications, length of stay, and reinterventions were compared. For patients with >1 year of follow-up time, survival, type I or type III endoleak rate, target artery patency, and reintervention rate were estimated using the Kaplan-Meier method. RESULTS: Between November 30, 2010, and July 30, 2016, 82 patients were identified and matched. The cohort included 41 PMEG and 41 CMD patients who underwent repair of 38 juxtarenal (PMEG, 17; CMD, 21; P = .38), 14 pararenal (PMEG, 6; CMD, 8; P = .56), and 30 thoracoabdominal type I to type IV (PMEG, 18; CMD, 12; P = .17) aneurysms. There were significant differences in presentation requiring urgent aneurysm repair (PMEG, 9; CMD, 0; P = .002), total fluoroscopy time (PMEG, 76 minutes; CMD, 61 minutes; P = .02), volume of contrast material used (PMEG, 88 mL; CMD, 70 mL; P = .02), in-operating room to out-of-operating room time (PMEG, 391 minutes; CMD, 319 minutes; P = .001), incision to surgery end time (PMEG, 276 minutes; CMD, 224 minutes; P = .002), and 1-year reintervention rate (PMEG, 37%; CMD, 13%; log-rank P = .04). No differences in perioperative complications, overall length of stay, type I or type III endoleak, or survival were observed between PMEG and CMD. For the entire cohort including both PMEG and CMD, the overall rate of any 30-day postoperative complication was 39%, and the Kaplan-Meier estimate of survival at 1 year was 86%. CONCLUSIONS: In this single-institution experience of fenestrated endovascular aneurysm repair, the primary differences between PMEG and CMD related only to operative metrics and the need for postoperative reinterventions. No statistically significant advantage was found for one approach over the other; we therefore cannot conclude that one approach is better than the other. Both remain viable options that may compare favorably with open repair of complex aortic aneurysms. Further studies are necessary to determine whether this relative equivalence represents a type II error or lack of long-term durability data or whether true equivalence between PMEG and CMD approaches exists.

摘要

目的:开窗式血管内移植物是一种定制的、针对患者个体的血管内设备,具有降低复杂主动脉瘤修复手术发病率和死亡率的潜力。在美国食品和药物管理局(FDA)批准后,我们中心开始通过医师赞助的研究性器械豁免(IDE#G130210)进行开窗式血管内动脉瘤修复,同时使用医师改良的移植物(PMEG)和公司制造的装置(CMD)。由于这些技术具有特定的优缺点,我们试图研究 PMEG 和 CMD 病例之间的结果差异。

方法:对所有开窗式血管内动脉瘤修复的单中心回顾性研究。在根据以下 5 个标准对病例进行匹配后,对病例进行了设备类型(PMEG 或 CMD)分析:(1)计划治疗的目标血管数量;(2)动脉瘤的范围;(3)动脉瘤直径;(4)设备配置;(5)手术日期。排除破裂、髂总动脉瘤和主动脉弓动脉瘤。比较了人口统计学资料、手术细节、围手术期并发症、住院时间和再次干预。对于随访时间超过 1 年的患者,使用 Kaplan-Meier 方法估计生存率、I 型或 III 型内漏率、目标动脉通畅率和再次干预率。

结果:在 2010 年 11 月 30 日至 2016 年 7 月 30 日期间,共确定并匹配了 82 名患者。该队列包括 41 名接受 PMEG 和 41 名接受 CMD 修复的患者,其中 38 例为肾下型(PMEG,17 例;CMD,21 例;P=0.38),14 例为肾周型(PMEG,6 例;CMD,8 例;P=0.56),30 例为胸腹主动脉 I 至 IV 型(PMEG,18 例;CMD,12 例;P=0.17)动脉瘤。在需要紧急动脉瘤修复的表现(PMEG,9 例;CMD,0 例;P=0.002)、总透视时间(PMEG,76 分钟;CMD,61 分钟;P=0.02)、造影剂用量(PMEG,88 毫升;CMD,70 毫升;P=0.02)、手术室到手术室外时间(PMEG,391 分钟;CMD,319 分钟;P=0.001)、切口到手术结束时间(PMEG,276 分钟;CMD,224 分钟;P=0.002)以及 1 年再干预率(PMEG,37%;CMD,13%;对数秩 P=0.04)方面,PMEG 和 CMD 之间存在显著差异。在围手术期并发症、总住院时间、I 型或 III 型内漏或生存率方面,PMEG 和 CMD 之间没有差异。对于包括 PMEG 和 CMD 在内的整个队列,任何 30 天术后并发症的总体发生率为 39%,1 年的生存率估计值为 86%。

结论:在这项单中心的开窗式血管内动脉瘤修复经验中,PMEG 和 CMD 之间的主要区别仅与手术指标和术后再次干预的需求有关。在这两种方法中,没有一种方法在统计学上具有明显的优势;因此,我们不能得出一种方法优于另一种方法的结论。这两种方法仍然是可行的选择,可能与复杂主动脉瘤的开放修复相比具有优势。需要进一步的研究来确定这种相对等同是否代表了 II 型错误或缺乏长期耐久性数据,或者 PMEG 和 CMD 方法之间是否存在真正的等同性。

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