Wahlgren Carl Magnus, Malmstedt Jonas
Department of Vascular Surgery, Karolinska University Hospital, Stockholm, Sweden.
J Vasc Surg. 2008 Dec;48(6):1382-8; discussion 1388-9. doi: 10.1016/j.jvs.2008.07.009. Epub 2008 Oct 1.
The management of infrarenal aortic aneurysms in high-risk patients remains a challenge. Endovascular aneurysm repair (EVAR) is associated with superior short-term mortality rates but unclear long-term results and has not been shown to improve survival in patients unfit for open repair (OR). The aim of this population-based study was to evaluate the outcome after elective EVAR compared with OR in a high-risk patient cohort.
Prospectively collected data from January 2000 to December 2006 were retrieved from the Swedish Vascular Registry. The high-risk cohort was defined as age >or=60 years, American Anesthesiologists Association (ASA) class 3 or 4, and at least one cardiac, pulmonary, or renal comorbidity. These criteria were met by 217 of 1000 EVAR patients and 483 of 2831 OR patients. Primary end points were 30-day and 1-year all-cause mortality. Kaplan-Meier curves for survival and multivariate Cox regression analyses were performed.
The crude 30-day and 1-year all-cause mortality rates for EVAR vs OR for the whole treatment group (n = 3831) were 1.8% vs 2.8% and 8.0% vs 7.2%, respectively. In the high-risk cohort (n = 700), EVAR patients were approximately 2 years older and renal insufficiency and diabetes mellitus were more common, and smoking was more prevalent in the OR group. About two-thirds of EVAR procedures were performed at university hospitals and one-half of OR procedures were performed at county hospitals. In the high-risk cohort, there was no difference in mortality at 30-days (EVAR, 4.6% vs OR, 3.3%), but OR had lower 1-year mortality (8.5% vs 15.9%; P = .003). More bleeding complications occurred in the EVAR group, but more pulmonary complications occurred in the OR group; however, there was no difference in cardiac, cerebrovascular, or renal complications. The mean follow-up was 3.4 years. EVAR was associated with increased mortality risk after adjusting for age, ASA class, and comorbidities (hazard ratio, 1.50; 95% confidence interval, 1.07-2.12; P = .02). Kaplan-Meier survival analysis showed a lower mortality rate for patients undergoing OR, which remained during follow-up (P = .001).
Elective OR of aortic aneurysms seems to have a better outcome compared with EVAR in this specific, population-based, high-risk patient cohort after adjusting for covariates. We cannot confirm the benefit of EVAR from previous registry studies with a similar high-risk definition. In clinical practice, OR may be at least as good as EVAR in high-risk patients fit for surgery.
高危患者肾下腹主动脉瘤的治疗仍然是一项挑战。血管内动脉瘤修复术(EVAR)与较低的短期死亡率相关,但长期结果尚不清楚,且尚未证明其能改善不适合开放修复术(OR)患者的生存率。本基于人群的研究旨在评估在高危患者队列中,择期EVAR与OR相比的治疗结果。
从瑞典血管登记处检索2000年1月至2006年12月前瞻性收集的数据。高危队列定义为年龄≥60岁、美国麻醉医师协会(ASA)分级为3或4级,且至少有一种心脏、肺部或肾脏合并症。1000例接受EVAR治疗的患者中有217例、2831例接受OR治疗的患者中有483例符合这些标准。主要终点为30天和1年全因死亡率。进行了生存的Kaplan-Meier曲线分析和多因素Cox回归分析。
整个治疗组(n = 3831)中,EVAR与OR相比,30天和1年全因死亡率的粗率分别为1.8%对2.8%和8.0%对7.2%。在高危队列(n = 700)中,接受EVAR治疗的患者年龄约大2岁,肾功能不全和糖尿病更常见,OR组吸烟更普遍。约三分之二的EVAR手术在大学医院进行,一半的OR手术在县医院进行。在高危队列中,30天时死亡率无差异(EVAR为4.6%,OR为3.3%),但OR组1年死亡率较低(8.5%对15.9%;P = 0.003)。EVAR组出血并发症更多,但OR组肺部并发症更多;然而,心脏、脑血管或肾脏并发症无差异。平均随访时间为3.4年。在调整年龄、ASA分级和合并症后,EVAR与死亡风险增加相关(风险比,1.50;95%置信区间,1.07 - 2.12;P = 0.02)。Kaplan-Meier生存分析显示接受OR治疗的患者死亡率较低,且在随访期间一直如此(P = 0.001)。
在这个特定的、基于人群的高危患者队列中,调整协变量后,择期主动脉瘤开放修复术似乎比EVAR有更好的治疗结果。我们无法从之前具有类似高危定义的登记研究中证实EVAR的益处。在临床实践中,对于适合手术的高危患者,开放修复术可能至少与EVAR一样好。