Enzen 试验:对治疗肾下主动脉髂动脉瘤的 EVAR 内膜假体 Zenith 和 Endurant 在疗效、内漏和再介入方面的分析。

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2024-08-26 DOI:10.1177/15266028241270895
Rafael de Athayde Soares, Matheus Veras Viana Portela, Kaline Amaro, Ana Izabel Nasser, Keityane de Lima Pedrosa, Roberto Sacilotto
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引用次数: 0

摘要

目的:本文的主要目的是分析使用 Endurant II(美敦力)和 Zenith Flex(库克)内膜移植物进行腹主动脉髂动脉瘤(AAA)血管内修复(EVAR)的患者因动脉瘤并发症引起的内漏、再介入和死亡的结果:这是一项前瞻性连续队列研究,研究对象是在2019年1月至2022年12月期间接受EVAR手术的AAA患者。对两组患者进行了评估:Endurant组(使用Endurant II进行EVAR的患者)和Zenith组(使用Zenith Flex进行EVAR的患者):共有156名患者接受了评估。结果:共评估了 156 名患者,其中 Zenith 组(67 名患者,42.9%)和 Endurant 组(89 名患者,57.1%)。围手术期死亡率为 5.1%,8 名患者(6 名患者为 Zenith 组,2 名患者为 Endurant 组,P=0.054)。有 28 名患者(17.9%)需要紧急修复动脉瘤(扩张或破裂),各组之间没有差异。后期内漏有36例(23.1%),Zenith组(23例,34.3%)的发生率高于Endurant组(13例,14.6%,P=0.002),其中大部分是II型内漏(21例,13.4%)。有12例I型内漏,Zenith组(13.4%)的发生率也高于Endurant组(3.4%,P=0.002)。此外,在肢体移植物闭塞(LGO)方面,有九名患者(5.8%),Zenith 组(9%)的发病率高于 Endurant 组(3.4%,P=0.045)。在720天的卡普兰-梅耶总生存率中,Zenith组为82.3%,Endurant组为89.1%,两组间无统计学意义(P=0.09)。在720天的Kaplan-Meier中,Zenith组的无再干预率为82.8%,Endurant组为93.2%(P=0.001):在本研究中,Zenith 内膜移植物的内漏发生率、动脉瘤相关死亡率、LGO 和再干预率均高于 Endurant II 内膜移植物。线性回归分析表明,内漏的存在、内膜移植物设备的类型(Zenith 移植物)和肢体移植物闭塞与较高的再介入率有关:临床影响:在本研究中,与使用 Endurant II 内植物的患者相比,Zenith 内植物的内漏发生率、动脉瘤相关死亡率、肢体移植物闭塞率和再干预率均较高。这篇文章的主要影响和创新之处在于为评估和选择最适合 EVAR 中 AAA 患者的内膜移植物提供了机会。
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The Enzen Trial: Analysis of EVAR Endoprosthesis Zenith and Endurant for Infrarenal Aortoiliac Aneurysms Regarding Outcomes, Endoleaks, and Reinterventions.

Objective: The main objective of this paper is to analyze the outcomes regarding endoleaks, reinterventions, and death related to aneurysm complications in patients submitted to endovascular repair (EVAR) for abdominal aortoiliac aneurysm (AAA) using Endurant II (Medtronic) and Zenith Flex (Cook) endografts.

Methods: This was a prospective, consecutive cohort study of patients with AAA who underwent EVAR between January 2019 and December 2022. Two groups of patients were evaluated: Group Endurant (patients submitted to EVAR with the use of Endurant II) and Group Zenith (patients submitted to EVAR with the use of Zenith Flex).

Results: A total of 156 patients were evaluated. Group Zenith (67 patients, 42.9%) and Group Endurant (89 patients, 57.1%). The perioperative mortality was 5.1%, eight patients (six patients Group Zenith, and two patients Group Endurant, p=0.054). There were 28 patients (17.9%) submitted to urgent repair of the aneurysm (expansion or rupture), with no differences among the groups. There were 36 cases (23.1%) of later endoleak, with a higher incidence in Zenith group (23 patients, 34.3%) than Endurant group (13 patients, 14.6%, p=0.002), most of them Type II endoleak (21 patients, 13.4%). There were 12 cases of Type I endoleak, also with a higher prevalence in Zenith group (13.4%) than Endurant group (3.4%, p=0.002). Moreover, regarding limb graft occlusion (LGO), there were nine patients (5.8%), with a higher prevalence in Zenith group (9%) than Endurant group (3.4%, p=0.045). The overall survival in a Kaplan-Meier at 720 days was 82.3% in the Zenith group and 89.1% in the Endurant group, with no statistical significance among the groups (p=0.09). The freedom from reintervention rates in a Kaplan-Meier at 720 days was 82.8% in the Zenith group and 93.2% in the Endurant group (p=0.001).

Conclusion: In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, LGO and reinterventions than patients submitted to Endurant II endografts. The linear regression analysis showed that the presence of endoleaks, type of endograft device (Zenith graft) and limb graft occlusion were related to higher reintervention rates.

Clinical impact: In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, limb graft occlusions and reinterventions than patients submitted to Endurant II endografts. The main impact and the innovation that this article provides is an opportunity to evaluate and choose the best endograft suitable for the patient with AAA during EVAR.

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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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