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主动脉腔内球囊阻断复苏治疗增加死亡率,仅通过强烈的未测量混杂因素缓解:使用国家创伤数据库的扩展分析。

Increased mortality with resuscitative endovascular balloon occlusion of the aorta only mitigated by strong unmeasured confounding: An expanded analysis using the National Trauma Data Bank.

出版信息

J Trauma Acute Care Surg. 2021 Nov 1;91(5):790-797. doi: 10.1097/TA.0000000000003265.

DOI:10.1097/TA.0000000000003265
PMID:33951027
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8547242/
Abstract

BACKGROUND

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is being increasingly adopted to manage noncompressible torso hemorrhage, but a recent analysis of the 2015 to 2016 Trauma Quality Improvement Project (TQIP) data set showed that placement of REBOA was associated with higher rates of death, lower extremity amputation, and acute kidney injury (AKI). We expand this analysis by including the 2017 data set, quantifying the potential role of residual confounding, and distinguishing between traumatic and ischemic lower extremity amputation.

METHODS

This retrospective study used the 2015 to 2017 TQIP database and included patients older than 18 years, with signs of life on arrival, who had no aortic injury and were not transferred. Resuscitative endovascular balloon occlusions of the aorta placed after 2 hours were excluded. We adjusted for baseline variables using propensity scores with inverse probability of treatment weighting. A sensitivity analysis was then conducted to determine the strength of an unmeasured confounder (e.g., unmeasured shock severity/response to resuscitation) that could explain the effect on mortality. Finally, lower extremity injury patterns of patients undergoing REBOA were inspected to distinguish amputation indicated for traumatic injury from complications of REBOA placement.

RESULTS

Of 1,392,482 patients meeting the inclusion criteria, 187 underwent REBOA. After inverse probability of treatment weighting, all covariates were balanced. The risk difference for mortality was 0.21 (0.14-0.29) and for AKI was 0.041 (-0.007 to 0.089). For the mortality effect to be explained by an unmeasured confounder, it would need to be stronger than any observed in terms of its relationship with mortality and with REBOA placement. Eleven REBOA patients underwent lower extremity amputation; however, they all suffered severe traumatic injury to the lower extremity.

CONCLUSION

There is no evidence in the TQIP data set to suggest that REBOA causes amputation, and the evidence for its effect on AKI is considerably weaker than previously reported. The increased mortality effect of REBOA is confirmed and could only be nullified by a potent confounder.

LEVEL OF EVIDENCE

Therapeutic/care management, level IV.

摘要

背景

复苏性血管内球囊阻断主动脉术(REBOA)越来越多地被用于治疗非压缩性躯干出血,但对 2015 年至 2016 年创伤质量改进计划(TQIP)数据集的最近分析显示,REBOA 的放置与更高的死亡率、下肢截肢率和急性肾损伤(AKI)有关。我们通过纳入 2017 年数据集来扩展这一分析,量化了残余混杂的潜在作用,并区分外伤性和缺血性下肢截肢。

方法

本回顾性研究使用了 2015 年至 2017 年 TQIP 数据库,纳入年龄大于 18 岁、到达时生命体征稳定、无主动脉损伤且未转院的患者。排除 2 小时后放置的复苏性血管内球囊阻断主动脉术。我们使用逆概率治疗加权法对基线变量进行了调整。然后进行敏感性分析,以确定一个未测量的混杂因素(例如,未测量的休克严重程度/对复苏的反应)的强度,该因素可能会影响死亡率。最后,检查接受 REBOA 治疗的患者下肢损伤模式,以区分因创伤性损伤而截肢和因 REBOA 放置并发症而截肢。

结果

在符合纳入标准的 1392482 名患者中,有 187 名接受了 REBOA。经过逆概率治疗加权后,所有协变量均得到平衡。死亡率的风险差异为 0.21(0.14-0.29),AKI 的风险差异为 0.041(-0.007 至 0.089)。要使未测量的混杂因素解释死亡率的差异,该因素必须比观察到的与死亡率和 REBOA 放置的关系更强。有 11 名 REBOA 患者接受了下肢截肢,但他们都遭受了下肢严重的创伤性损伤。

结论

在 TQIP 数据集中没有证据表明 REBOA 会导致截肢,而且其对 AKI 的影响的证据比之前报道的要弱得多。REBOA 增加的死亡率效应得到了证实,只有通过一个强有力的混杂因素才能使其无效。

证据水平

治疗/护理管理,IV 级。

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