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接受开窗/分支腔内动脉瘤修复术的患者,术前功能状态可预测 2 年死亡率。

Preoperative functional status predicts 2-year mortality in patients undergoing fenestrated/branched endovascular aneurysm repair.

机构信息

Division of Vascular and Endovascular Surgery, Department of Surgery, University of California, San Francisco, Calif.

UMassMemorial Center for Complex Aortic Disease, University of Massachusetts Medical School, Worcester, Mass.

出版信息

J Vasc Surg. 2021 Aug;74(2):383-395. doi: 10.1016/j.jvs.2020.12.098. Epub 2021 Feb 4.

DOI:10.1016/j.jvs.2020.12.098
PMID:33548435
Abstract

BACKGROUND

Fenestrated/branched endovascular aneurysm repair (F/BEVAR) is a minimally invasive alternative for patients at high risk of open repair of complex aortic aneurysms. Nearly all investigative study protocols evaluating F/BEVAR have required a predicted life expectancy of >2 years for study inclusion. However, accurate risk models for predicting 2-year survival in this patient population are lacking. We sought to identify the preoperative predictors of 2-year survival for patients undergoing F/BEVAR.

METHODS

The prospectively collected data for all consecutive F/BEVAR procedures, performed in an institutional review board-approved registry and/or a physician-sponsored investigational device exemption (IDE) trial (IDE no. G130210), were reviewed (November 2010 to February 2019). We assessed 44 preoperative patient characteristics, including comorbidities, preoperative functional status, aneurysm morphologies, and repair techniques. Preoperative functional status was defined as totally dependent (any impairment in activities of daily living or residing in a skilled nursing facility), partially dependent (any impairment in instrumental activities of daily living), or independent (no impairment in activities of daily living or instrumental activities of daily living). Using the results of univariate analysis (P < .2), a Cox proportional hazards model was constructed to identify the independent predictors of 2-year all-cause mortality.

RESULTS

For the 256 consecutive patients who had undergone F/BEVAR (6 common iliac [2.3%], 94 juxtarenal [41%], 35 pararenal [14%], 119 thoracoabdominal [47%], and 2 arch [0.8%] aneurysms), the 2-year mortality was 18%. On Cox modeling, the only independent preoperative predictor contributing to 2-year mortality was functional status (totally dependent: hazard ratio [HR], 5.4; 95% confidence interval [CI], 1.8-16; P = .0024; partially dependent: HR, 4.5; 95% CI, 2.4-8.7; P < .0000019). A history of an implanted anti-arrhythmic device was protective (HR, 0.4; 95% CI, 0.2-0.99; P = .0495). Factors such as age, congestive heart failure, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, aneurysm extent, and previous aortic surgery, were not significant. The 2-year mortality for the independent (n = 176; 69%), partially dependent (n = 69; 27%), and totally dependent (n = 10; 3.9%) groups was 11%, 33%, and 40%, respectively.

CONCLUSIONS

For patients undergoing F/BEVAR, decreased preoperative functional status was the strongest predictor of 2-year mortality, with totally dependent patients experiencing poor survival. The traditional risk factors were not independently significant, perhaps reflecting the high prevalence of severe chronic illness in these high-risk patients participating in an IDE trial. For the independent patients, the 2-year F/BEVAR survival rate was 89%, equivalent to patient survival after infrarenal EVAR. Therefore, for independent patients, it would be reasonable to expand the indication for F/BEVAR to low-risk patients.

摘要

背景

对于复杂主动脉瘤高危患者,开窗/分支腔内血管修复术(F/BEVAR)是一种微创替代方案。几乎所有评估 F/BEVAR 的研究方案都要求研究纳入患者的预期寿命>2 年。然而,对于这一患者群体,预测 2 年生存率的准确风险模型仍缺乏。我们旨在确定接受 F/BEVAR 治疗的患者 2 年生存率的术前预测因素。

方法

对在机构审查委员会批准的登记处和/或医生赞助的研究性器械豁免(IDE)试验中进行的所有连续的 F/BEVAR 手术的前瞻性收集数据进行了回顾性分析(2010 年 11 月至 2019 年 2 月)。我们评估了 44 项术前患者特征,包括合并症、术前功能状态、动脉瘤形态和修复技术。术前功能状态定义为完全依赖(日常生活活动或居住在熟练护理机构中的任何功能损害)、部分依赖(日常生活活动或工具性日常生活活动中的任何功能损害)或独立(日常生活活动或工具性日常生活活动中无功能损害)。使用单变量分析(P<.2)的结果,构建 Cox 比例风险模型,以确定 2 年全因死亡率的独立预测因素。

结果

在接受 F/BEVAR 治疗的 256 例连续患者中(6 例为常见髂动脉瘤[2.3%]、94 例为肾下动脉瘤[41%]、35 例为肾周动脉瘤[14%]、119 例胸腹主动脉瘤[47%]和 2 例主动脉弓动脉瘤[0.8%]),2 年死亡率为 18%。在 Cox 模型中,唯一独立的术前预测因素是功能状态(完全依赖:风险比[HR],5.4;95%置信区间[CI],1.8-16;P=.0024;部分依赖:HR,4.5;95%CI,2.4-8.7;P<.0000019)。植入抗心律失常装置史具有保护作用(HR,0.4;95%CI,0.2-0.99;P=0.0495)。年龄、充血性心力衰竭、慢性肾脏病、糖尿病、慢性阻塞性肺疾病、动脉瘤程度和既往主动脉手术等因素无统计学意义。独立组(n=176;69%)、部分依赖组(n=69;27%)和完全依赖组(n=10;3.9%)的 2 年死亡率分别为 11%、33%和 40%。

结论

对于接受 F/BEVAR 治疗的患者,术前功能状态下降是 2 年死亡率的最强预测因素,完全依赖的患者生存率较差。传统的危险因素并不独立显著,这可能反映了在 IDE 试验中参与的这些高危患者中严重慢性疾病的高患病率。对于独立患者,2 年 F/BEVAR 生存率为 89%,与肾下 EVAR 后患者的生存率相当。因此,对于独立患者,将 F/BEVAR 的适应证扩大到低危患者是合理的。

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