Timaran Carlos H, Veith Frank J, Rosero Eric B, Modrall J Gregory, Arko Frank R, Clagett G Patrick, Valentine R James
Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, 5909 Harry Hines Boulevard, Dallas, TX 75390-9157, USA.
Arch Surg. 2007 Jun;142(6):520-4; discussion 524-5. doi: 10.1001/archsurg.142.6.520.
A randomized clinical trial from the United Kingdom (EVAR trial 2) comparing endovascular aortic aneurysm repair (EVAR) with no intervention found no advantage for EVAR in patients with high risk. This finding was predominantly caused by the substantial in-hospital mortality after EVAR (9%).
The nationwide in-hospital mortality for patients with the highest risk undergoing EVAR in the United States is lower than that reported in EVAR trial 2.
Population-based, cross-sectional study.
The 2001-2004 Nationwide Inpatient Sample.
The Nationwide Inpatient Sample identified EVAR procedures for nonruptured abdominal aortic aneurysms. Risk stratification was based on comorbidities and the Charlson comorbidity index, a validated predictor of in-hospital mortality after abdominal aortic aneurysms repairs. Weighted univariate and logistic regression analyses were used to determine the association between comorbidity measures and risk-adjusted in-hospital mortality.
During the 4-year period, 65 502 EVARs were performed with an in-hospital mortality of 2.2%. Risk-adjusted in-hospital mortality rates ranged from 1.2% to 3.7%. Stratified analyses, including only elective EVAR procedures, revealed that in-hospital mortality was significantly higher in patients with the most severe comorbidities (1.7%) vs those with lower comorbidity (0.4%; P<.001). Patients with high risk had only a 1.6-fold increased risk of adjusted in-hospital mortality (odds ratio, 1.6; 95% confidence interval, 1.2-2.2) compared with patients with low risk.
The EVAR procedure is currently being performed in the United States with low in-hospital mortality, even in patients with the highest risk. Therefore, EVAR should not be denied to high-risk patients with abdominal aortic aneurysms in the United States on the basis of the level I evidence from the United Kingdom study.
英国的一项随机临床试验(EVAR试验2)比较了血管内主动脉瘤修复术(EVAR)与不进行干预,结果发现对于高危患者,EVAR并无优势。这一发现主要是由于EVAR术后较高的住院死亡率(9%)所致。
在美国,接受EVAR的最高危患者的全国住院死亡率低于EVAR试验2中所报告的死亡率。
基于人群的横断面研究。
2001 - 2004年全国住院患者样本。
全国住院患者样本确定了非破裂性腹主动脉瘤的EVAR手术。风险分层基于合并症和查尔森合并症指数,这是腹主动脉瘤修复术后住院死亡率的有效预测指标。采用加权单因素和逻辑回归分析来确定合并症指标与风险调整后的住院死亡率之间的关联。
在4年期间,共进行了65502例EVAR手术,住院死亡率为2.2%。风险调整后的住院死亡率在1.2%至3.7%之间。仅包括择期EVAR手术的分层分析显示,合并症最严重的患者住院死亡率(1.7%)显著高于合并症较轻的患者(0.4%;P<0.001)。与低危患者相比,高危患者调整后的住院死亡风险仅增加了1.6倍(比值比,1.6;95%置信区间,1.2 - 2.2)。
目前在美国进行EVAR手术的住院死亡率较低,即使是最高危的患者。因此,基于英国研究的一级证据,在美国不应因腹主动脉瘤而拒绝为高危患者进行EVAR手术。