School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Mechanical and Biomedical Engineering, National University of Ireland Galway, Galway, Ireland.
Cochrane Database Syst Rev. 2021 Dec 14;12(12):CD012992. doi: 10.1002/14651858.CD012992.pub2.
Type B aortic dissection can lead to serious and life-threatening complications such as aortic rupture, stroke, renal failure, and paraplegia, all of which require intervention. Traditionally, these complications have been treated with open surgery. Recently however, endovascular repair has been proposed as an alternative.
To assess the effectiveness and safety of thoracic aortic endovascular repair versus open surgical repair for treatment of complicated chronic Type B aortic dissection (CBAD).
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and AMED databases, as well as the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers, to 2 August 2021. We searched references of relevant articles retrieved through the electronic search for additional citations.
We considered all randomised controlled trials (RCTs) and controlled clinical trials (CCTs) assessing the effects of thoracic aortic endovascular repair (TEVAR) versus open surgical repair (OSR) for treatment of complicated chronic Type B aortic dissection (CBAD). Outcomes of interest were mortality (all-cause, dissection-related), neurological sequelae (stroke, spinal cord ischaemia/paresis-paralysis, vertebral insufficiency), morphological outcomes (false lumen thrombosis, progression of dissection, aortic diameters), acute renal failure, ischaemic symptoms (visceral ischaemia, limb ischaemia), re-intervention, and health-related quality of life.
Two review authors independently screened all titles and abstracts identified by the searches to identify those that met the inclusion criteria. From title and abstract screening, we did not identify any trials (RCTs or CCTs) that required full-text assessment. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of evidence using GRADE.
We did not identify any trials (RCTs or CCTs) that met the inclusion criteria for this review.
AUTHORS' CONCLUSIONS: Due to lack of RCTs or CCTs investigating the effectiveness and safety of TEVAR compared to OSR for patients with complicated CBAD, we are unable to provide any evidence to inform decision-making on the optimal intervention for these patients. High-quality RCTs or CCTs addressing this objective are necessary. However, conducting such studies will be challenging for this life-threatening disease.
B 型主动脉夹层可导致严重且危及生命的并发症,如主动脉破裂、中风、肾衰竭和截瘫,所有这些都需要干预。传统上,这些并发症采用开放手术治疗。然而,最近提出了血管内修复作为替代方法。
评估胸主动脉血管内修复与开放手术修复治疗复杂慢性 B 型主动脉夹层(CBAD)的有效性和安全性。
Cochrane 血管信息专家检索了 Cochrane 血管专业登记册、Cochrane 对照试验中心注册库(CENTRAL)、MEDLINE、Embase、CINAHL、AMED 数据库,以及世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov 试验注册库,检索时间截至 2021 年 8 月 2 日。我们检索了通过电子检索获得的相关文章的参考文献,以查找其他引文。
我们考虑了所有评估胸主动脉血管内修复(TEVAR)与开放手术修复(OSR)治疗复杂慢性 B 型主动脉夹层(CBAD)效果的随机对照试验(RCT)和对照临床试验(CCT)。感兴趣的结局为死亡率(全因、夹层相关)、神经后遗症(中风、脊髓缺血/瘫痪-麻痹、椎体不足)、形态学结局(假腔血栓形成、夹层进展、主动脉直径)、急性肾衰竭、缺血症状(内脏缺血、肢体缺血)、再次干预和健康相关生活质量。
两名综述作者独立筛选所有通过检索确定的标题和摘要,以确定符合纳入标准的研究。从标题和摘要筛选中,我们没有发现任何需要全文评估的试验(RCT 或 CCT)。我们计划按照 Cochrane 干预系统评价手册中描述的建议进行数据收集和分析。我们计划使用 GRADE 评估证据的确定性。
我们没有发现任何符合本综述纳入标准的试验(RCT 或 CCT)。
由于缺乏比较 TEVAR 与 OSR 治疗复杂 CBAD 患者的有效性和安全性的 RCT 或 CCT,我们无法提供任何证据来为这些患者的最佳干预措施提供信息。需要高质量的 RCT 或 CCT 来解决这个问题。然而,对于这种危及生命的疾病,开展此类研究将具有挑战性。