IRCCS Istituto Ortopedico Galeazzi, Unit of Clinical Epidemiology, Milan, Italy.
National Centre for Healthcare Research and Pharmacoepidemiology, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
World J Emerg Surg. 2021 Aug 12;16(1):41. doi: 10.1186/s13017-021-00386-9.
Multiple studies regarding the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in patients with non-compressible torso injuries and uncontrolled haemorrhagic shock were recently published. To date, the clinical evidence of the efficacy of REBOA is still debated. We aimed to conduct a systematic review assessing the clinical efficacy and safety of REBOA in patients with major trauma and uncontrolled haemorrhagic shock.
We systematically searched MEDLINE (PubMed), EMBASE and CENTRAL up to June 2020. All randomized controlled trials and observational studies that investigated the use of REBOA compared to resuscitative thoracotomy (RT) with/without REBOA or no-REBOA were eligible. We followed the PRISMA and MOOSE guidelines. Two authors independently extracted data and appraised the risk of bias of included studies. Effect sizes were pooled in a meta-analysis using random-effects models. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Primary outcomes were mortality, volume of infused blood components, health-related quality of life, time to haemorrhage control and any adverse effects. Secondary outcomes were improvement in haemodynamic status and failure/success of REBOA technique.
We included 11 studies (5866 participants) ranging from fair to good quality. REBOA was associated with lower mortality when compared to RT (aOR 0.38; 95% CI 0.20-0.74), whereas no difference was observed when REBOA was compared to no-REBOA (aOR 1.40; 95% CI 0.79-2.46). No significant difference in health-related quality of life between REBOA and RT (p = 0.766). The most commonly reported complications were amputation, haematoma and pseudoaneurysm. Sparse data and heterogeneity of reporting for all other outcomes prevented any estimate.
Our findings on overall mortality suggest a positive effect of REBOA among non-compressible torso injuries when compared to RT but no differences compared to no-REBOA. Variability in indications and patient characteristics prevents any conclusion deserving further investigation. REBOA should be promoted in specific training programs in an experimental setting in order to test its effectiveness and a randomized trial should be planned.
最近发表了多项关于使用主动脉腔内球囊阻断复苏术(REBOA)治疗非可压缩性胸外伤和无法控制的失血性休克患者的研究。迄今为止,REBOA 的临床疗效仍存在争议。我们旨在进行一项系统评价,评估 REBOA 在大出血性休克合并严重创伤患者中的临床疗效和安全性。
我们系统地检索了 MEDLINE(PubMed)、EMBASE 和 CENTRAL 数据库,检索时间截至 2020 年 6 月。所有纳入的研究均为比较 REBOA 与开胸手术(RT)联合/不联合 REBOA 或不使用 REBOA 治疗效果的随机对照试验和观察性研究。我们遵循 PRISMA 和 MOOSE 指南。两名作者独立提取数据并评估纳入研究的偏倚风险。使用随机效应模型对合并数据进行荟萃分析。使用推荐评估、制定与评价(GRADE)方法评估证据质量。主要结局指标为死亡率、输注血液成分的量、健康相关生活质量、出血控制时间和任何不良反应。次要结局指标为血流动力学状态的改善和 REBOA 技术的失败/成功。
我们纳入了 11 项研究(5866 名参与者),研究质量从低到高不等。与 RT 相比,REBOA 降低了死亡率(OR 0.38;95%CI 0.20-0.74),而与不使用 REBOA 相比,REBOA 没有降低死亡率(OR 1.40;95%CI 0.79-2.46)。REBOA 与 RT 之间在健康相关生活质量方面没有差异(p = 0.766)。最常见的并发症是截肢、血肿和假性动脉瘤。由于所有其他结局的报告数据稀疏且存在异质性,因此无法进行任何估计。
我们关于总体死亡率的研究结果表明,与 RT 相比,REBOA 对非可压缩性胸外伤患者有积极作用,但与不使用 REBOA 相比无差异。不同的适应证和患者特征限制了任何结论的确立,需要进一步研究。REBOA 应在特定的培训计划中在实验环境下进行推广,以测试其有效性,并应计划进行随机试验。