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GREAT 注册研究中经皮入路与开放入路患者结局比较。

Outcomes of Open Versus Percutaneous Access for Patients Enrolled in the GREAT Registry.

机构信息

Department of Graduate Medical Education - General Surgery, Baylor University Medical Center, Dallas, TX.

Department of Graduate Medical Education - Vascular Surgery, Baylor University Medical Center, Dallas, TX.

出版信息

Ann Vasc Surg. 2021 Jan;70:370-377. doi: 10.1016/j.avsg.2020.06.033. Epub 2020 Jun 27.

DOI:10.1016/j.avsg.2020.06.033
PMID:32603847
Abstract

BACKGROUND

Arterial access and device delivery in endovascular aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have evolved from open femoral or iliac artery exposure to selective percutaneous arterial access. Although regional application of percutaneous access for these 2 procedures varies widely, the use of this technique continues to increase. Currently, differences in the use of percutaneous access between EVAR and TEVAR have not been well explored. The Gore Global Registry for Endovascular Aortic Treatment (GREAT) registry collected relevant data for evaluation of these issues and the comparative results between open and percutaneous approaches in regard to complication rates and length of stay (LOS).

METHODS

This study was performed via a retrospective review of patients from the GREAT registry (Clinicaltrials.gov no. NCT01658787). The primary variable of this study was access site complications including postoperative hematoma, vessel dissection, and pseudoaneurysm. Patients were categorized by abdominal (EVAR) and thoracic (TEVAR) aortic procedures using percutaneous-only, cutdown-only, and combined vascular access techniques for a total of 6 groups. Standard statistical methodology was used to perform single-variable and multivariable analysis of a variety of covariates including LOS, geographical location of procedure, procedural success rate, and access sheath size.

RESULTS

Of 4,781 patients from the GREAT registry, 3,837 (80.3%) underwent EVAR and 944 (19.7%) underwent TEVAR with percutaneous-only access techniques being used in 2,017 (42.2%) and cutdown-only in 2,446 (51.2%). There was variable application of percutaneous access by geographic region with Australia and New Zealand using this technique more frequently and Brazil using percutaneous access the least. No significant difference in the rate of access site complications was detected between the 6 groups of patients in the study; however, significantly lower rates of access site complications were associated with percutaneous-only compared with both cutdown-only and combined techniques (P = 0.03). In addition, associated with significantly higher rates of access site complications was longer LOS (P < 0.01). Average LOS was 5.2 days and was higher in the TEVAR group (10.1 days) than that in EVAR (4.0 days, P < 0.05). Increased sheath size does not appear to increase the risk of access site complication.

CONCLUSIONS

There was no significant difference found in the complication rate between percutaneous and cutdown access techniques. This analysis demonstrates that percutaneous-only access is safe, has low complication rates, and has lower LOS compared with open access or combined access techniques.

摘要

背景

在血管内主动脉修复术(EVAR)和胸主动脉血管内修复术(TEVAR)中,动脉入路和器械输送已从开放性股动脉或髂动脉暴露转变为选择性经皮动脉入路。尽管这两种手术的经皮入路的区域应用差异很大,但该技术的使用仍在继续增加。目前,EVAR 和 TEVAR 之间经皮入路的使用差异尚未得到充分探讨。戈尔全球血管内主动脉治疗登记处(GREAT)登记处收集了相关数据,用于评估这些问题以及开放入路和经皮入路在并发症发生率和住院时间(LOS)方面的比较结果。

方法

本研究通过对 GREAT 登记处(Clinicaltrials.gov 编号:NCT01658787)患者进行回顾性分析。本研究的主要变量是入路部位并发症,包括术后血肿、血管夹层和假性动脉瘤。根据腹主动脉(EVAR)和胸主动脉(TEVAR)手术,患者采用经皮入路、切开入路和联合血管入路技术,共分为 6 组。采用单变量和多变量分析方法,对 LOS、手术地理位置、手术成功率和鞘管大小等多种混杂因素进行了标准统计学分析。

结果

在 GREAT 登记处的 4781 例患者中,3837 例(80.3%)接受了 EVAR 治疗,944 例(19.7%)接受了 TEVAR 治疗。其中 2017 例(42.2%)采用经皮入路,2446 例(51.2%)采用切开入路。经皮入路的应用因地理位置而异,澳大利亚和新西兰使用该技术更为频繁,而巴西使用经皮入路最少。研究中 6 组患者的入路部位并发症发生率无显著差异;然而,与切开入路和联合入路技术相比,经皮入路的并发症发生率明显更低(P=0.03)。此外,较长的 LOS 与较高的入路部位并发症发生率显著相关(P<0.01)。平均 LOS 为 5.2 天,TEVAR 组(10.1 天)高于 EVAR 组(4.0 天,P<0.05)。鞘管尺寸的增加似乎不会增加入路部位并发症的风险。

结论

经皮入路和切开入路技术的并发症发生率无显著差异。本分析表明,与开放性入路或联合入路技术相比,经皮入路仅具有安全性、较低的并发症发生率和较短的 LOS。

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