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下腔静脉支架置入术的安全性和疗效的系统评价。

A Systematic Review of the Safety and Efficacy of Inferior Vena Cava Stenting.

机构信息

School of Cardiovascular Medicine and Sciences, King's College London, London, UK.

Department of Vascular Surgery, St Thomas' Hospital, London, UK.

出版信息

Eur J Vasc Endovasc Surg. 2023 Feb;65(2):298-308. doi: 10.1016/j.ejvs.2022.11.006. Epub 2022 Nov 9.

Abstract

OBJECTIVE

Inferior vena cava (IVC) stenting may provide benefit to patients with symptomatic obstruction; however, there are no devices currently licensed for use in the IVC and systematic reviews on the topic are lacking. The aim of this study was to carry out a systematic review of the literature and meta-analysis to investigate the safety and efficacy of IVC stenting in all adult patient groups.

DATA SOURCES

The Medline and Embase databases were searched for studies reporting outcomes for safety and effectiveness of IVC stenting for any indication in series of 10 or more patients.

REVIEW METHODS

A systematic review of the literature was carried out according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

RESULTS

Thirty-three studies were included describing 1 575 patients. Indications for stenting were malignant IVC syndrome (229 patients), thrombotic disease (807 patients), Budd-Chiari syndrome (501 patients), and IVC stenosis post liver transplantation (47 patients). The male:female ratio was 2:1 and the median age ranged from 30 to 61 years. The studies included were not suitable for formal meta-analysis as 30/33 were single centre retrospective studies with no control groups and there was considerable inconsistency in outcome reporting. There was significant risk of bias in 94% of studies. Median reported technical success was 100% (range 78 - 100%), primary patency was 75% (38 - 98%), and secondary patency was 91.5% (77 - 100%). Major complications were pulmonary embolism (three cases), stent migration (12 cases), and major bleeding (15 cases), and there were three deaths in the immediate post-operative period. Most studies reported improvement in clinical symptoms but formal reporting tools were not used consistently.

CONCLUSION

The evidence base for IVC stenting consists of predominantly single centre, retrospective, observational studies that have a high risk of bias. Nonetheless the procedure appears safe with few major adverse events, and studies that reported clinical outcomes demonstrate improvement in symptoms and quality of life. Randomised controlled trials and prospective registry based studies with larger patient numbers and standardised outcome are required to improve the evidence base for this procedure.

摘要

目的

下腔静脉(IVC)支架置入术可能对有症状阻塞的患者有益;然而,目前尚无获准用于 IVC 的设备,并且缺乏关于该主题的系统评价。本研究的目的是对文献进行系统评价和荟萃分析,以调查所有成年患者群体中 IVC 支架置入术的安全性和有效性。

数据来源

检索了 Medline 和 Embase 数据库,以查找报道了 10 例或更多患者系列中 IVC 支架置入术安全性和有效性结果的研究。

审查方法

根据系统评价和荟萃分析的首选报告项目进行了文献系统评价。

结果

共纳入 33 项研究,描述了 1575 例患者。支架置入的适应证为恶性 IVC 综合征(229 例)、血栓性疾病(807 例)、Budd-Chiari 综合征(501 例)和肝移植后 IVC 狭窄(47 例)。男女比例为 2:1,中位年龄为 30 至 61 岁。由于 30/33 项研究为单中心回顾性研究,没有对照组,并且结果报告存在很大差异,因此不适合进行正式的荟萃分析。94%的研究存在显著的偏倚风险。报道的技术成功率中位数为 100%(范围 78%至 100%),原发性通畅率为 75%(38%至 98%),继发性通畅率为 91.5%(77%至 100%)。主要并发症为肺栓塞(3 例)、支架移位(12 例)和大出血(15 例),术后即刻有 3 例死亡。大多数研究报告临床症状改善,但未一致使用正式的报告工具。

结论

IVC 支架置入术的证据主要来自单中心、回顾性、观察性研究,这些研究存在高度偏倚风险。尽管如此,该手术似乎是安全的,不良事件很少,并且报告临床结果的研究表明症状和生活质量有所改善。需要进行随机对照试验和前瞻性注册研究,纳入更多患者并使用标准化结局,以提高该手术的证据基础。

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