大型多中心注册研究的腹主动脉瘤腔内修复术 10 年结果。
Ten-year results of endovascular abdominal aortic aneurysm repair from a large multicenter registry.
机构信息
Permanente Medical Group, South San Francisco, CA, USA.
出版信息
J Vasc Surg. 2013 Aug;58(2):324-32. doi: 10.1016/j.jvs.2013.01.051. Epub 2013 May 14.
OBJECTIVE
To assess outcomes after endovascular abdominal aortic aneurysm repair (EVAR) in an integrated health care system.
METHODS
Between 2000 and 2010, 1736 patients underwent EVAR at 17 centers. Demographic data, comorbidities, and outcomes of interest were collected. EVAR in patients presenting with ruptured or symptomatic aneurysms was categorized as urgent; otherwise, it was considered elective. Primary outcomes were mortality and aneurysm-related mortality (ARM). Secondary outcomes were change in aneurysm sac size, endoleak status, major adverse events, and reintervention.
RESULTS
Overall, the median age was 76 years (interquartile range, 70-81 years), 86% were male, and 82% were Caucasian. Most cases (93.8%) were elective, but urgent use of EVAR increased from 4% in the first 5 years to 7.3% in the last 5 years of the study period. Mean aneurysm size was 5.8 cm. Patients were followed for an average of 3 years (range, 1-11 years); 8% were lost to follow-up. Intraoperatively, 4.5% of patients required adjunctive maneuvers for endoleak, fixation, or flow-limiting issues. The 30-day mortality rate was 1.2%, and the perioperative morbidity rate was 6.6%. Intraoperative type I and II endoleaks were uncommon (2.3% and 9.3%, respectively). Life-table analysis at 5 years demonstrated excellent overall survival (66%) and freedom from ARM (97%). Postoperative endoleak was seen in 30% of patients and was associated with an increase in sac size over time. Finally, the total reintervention rate was 15%, including 91 instances (5%) of revisional EVAR. The overall major adverse event rate was 7.9% and decreased significantly from 12.3% in the first 5 years to 5.6% in the second 5 years of the study period (P < .001). Overall ARM was worse in patients with postoperative endoleak (4.1% vs 1.8%; P < .01) or in those who underwent reintervention (7.6% vs 1.6%; P < .001).
CONCLUSIONS
Results from a contemporary EVAR registry in an integrated health care system demonstrate favorable perioperative outcomes and excellent clinical efficacy. However, postoperative endoleak and the need for reintervention continue to be challenging problems for patients after EVAR.
目的
评估综合医疗体系中血管内腹主动脉瘤修复（EVAR）的治疗结果。
方法
在 2000 年至 2010 年间，1736 名患者在 17 个中心接受了 EVAR 治疗。收集了人口统计学数据、合并症和感兴趣的治疗结果。将因破裂或有症状的动脉瘤而进行的 EVAR 归入紧急情况，否则归类为择期手术。主要治疗结果是死亡率和与动脉瘤相关的死亡率（ARM）。次要治疗结果是动脉瘤囊大小、内漏情况、主要不良事件和再干预情况的变化。
结果
总体而言，患者的中位年龄为 76 岁（四分位距，70-81 岁），86%为男性，82%为白种人。大多数病例（93.8%）为择期手术，但紧急使用 EVAR 的比例从研究期间前 5 年的 4%增加到后 5 年的 7.3%。平均动脉瘤大小为 5.8cm。患者平均随访 3 年（范围，1-11 年），8%的患者失访。术中，4.5%的患者需要辅助操作来治疗内漏、固定或血流受限问题。30 天死亡率为 1.2%，围手术期发病率为 6.6%。术中 I 型和 II 型内漏少见（分别为 2.3%和 9.3%）。5 年生存分析显示，总体生存率为 66%，无 ARM 生存率为 97%。30%的患者术后出现内漏，并随着时间的推移，瘤囊逐渐增大。最后，总再干预率为 15%，包括 91 例（5%）再次 EVAR 手术。总体主要不良事件发生率为 7.9%，在研究期间前 5 年从 12.3%显著下降到后 5 年的 5.6%（P<.001）。与术后无内漏（4.1%比 1.8%；P<.01）或未行再干预的患者相比，有术后内漏或需要再干预的患者 ARM 更差（7.6%比 1.6%；P<.001）。
结论
综合医疗体系中 EVAR 注册的最新结果显示，该治疗方案具有良好的围手术期治疗结果和出色的临床疗效。然而，术后内漏和需要再次干预仍然是 EVAR 后患者面临的挑战。
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