Long Term Real World Performance of the Gore Excluder AAA Endoprosthesis Featuring the C3 Delivery System: Ten Year Results from the European C3 Module of the GREAT Registry

IF 8.5 1区医学 Q1 PERIPHERAL VASCULAR DISEASE

European Journal of Vascular and Endovascular Surgery Pub Date : 2026-10-01 Epub Date: 2025-11-28 DOI:10.1016/j.ejvs.2025.11.044

Moritz S. Bischoff, Eric Verhoeven, Athanasios Katsargyris, Dittmar Böckler

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Bischoff, Eric Verhoeven, Athanasios Katsargyris, Dittmar Böckler","doi":"10.1016/j.ejvs.2025.11.044","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to report the ten year data for patients treated with the Gore Excluder AAA Endoprosthesis featuring the C3 Delivery System for infrarenal aortic disease, as recorded in the European C3 module of the Gore Global Registry for Endovascular Aortic Treatment.</div></div><div>This study aimed to report the ten year data for patients treated with the Gore Excluder AAA Endoprosthesis featuring the C3 Delivery System for infrarenal aortic disease, as recorded in the European C3 module of the Gore Global Registry for Endovascular Aortic Treatment.</div><div><h3>Methods</h3><div>The European C3 module included patients from 13 centres who underwent endovascular aortic aneurysm repair between August 2010 and December 2012. Outcomes were assessed using descriptive statistics and Kaplan–Meier survival analysis with 95% confidence intervals (CIs).</div></div><div>The European C3 module included patients from 13 centres who underwent endovascular aortic aneurysm repair between August 2010 and December 2012. Outcomes were assessed using descriptive statistics and Kaplan–Meier survival analysis with 95% confidence intervals (CIs).</div><div><h3>Results</h3><div>At module closure, 396 patients (87.1% men; mean age ± standard deviation 73.9 ± 7.8 years) were available for analysis, with a mean follow up duration ± standard deviation of 6.4 ± 3.2 years. Of these, 94.4% underwent elective endovascular aortic aneurysm repair for infrarenal aortic aneurysm, and 16.9% (67 of 396) were treated outside the instructions for use. At ten years, the all cause mortality rate was 46.0% with 182 deaths: five aortic related, 120 non-aortic related, and 57 of unknown cause. Freedom from aortic related death was 98.6% (95% CI 96.7 – 99.4%). Freedom from any re-intervention and device related re-intervention was 77.3% (95% CI 71.8 – 81.8%) and 80.6% (95% CI 75.3 – 84.9%), respectively. Freedom from type 1 endoleak was 95.4% (95% CI 92.3 – 97.5%), with type 2 endoleaks accounting for 82% (41 of 50) of all endoleaks. Structural complications were rare: two cases of migration (0.5%), one case of compression (0.3%), and no cases of device fractures. Nine patients (2.3%) required conversion, and secondary rupture occurred in three cases (0.8%).</div></div><div>At module closure, 396 patients (87.1% men; mean age ± standard deviation 73.9 ± 7.8 years) were available for analysis, with a mean follow up duration ± standard deviation of 6.4 ± 3.2 years. Of these, 94.4% underwent elective endovascular aortic aneurysm repair for infrarenal aortic aneurysm, and 16.9% (67 of 396) were treated outside the instructions for use. 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引用次数: 0

Abstract

Objective

This study aimed to report the ten year data for patients treated with the Gore Excluder AAA Endoprosthesis featuring the C3 Delivery System for infrarenal aortic disease, as recorded in the European C3 module of the Gore Global Registry for Endovascular Aortic Treatment.

Methods

The European C3 module included patients from 13 centres who underwent endovascular aortic aneurysm repair between August 2010 and December 2012. Outcomes were assessed using descriptive statistics and Kaplan–Meier survival analysis with 95% confidence intervals (CIs).

Results

At module closure, 396 patients (87.1% men; mean age ± standard deviation 73.9 ± 7.8 years) were available for analysis, with a mean follow up duration ± standard deviation of 6.4 ± 3.2 years. Of these, 94.4% underwent elective endovascular aortic aneurysm repair for infrarenal aortic aneurysm, and 16.9% (67 of 396) were treated outside the instructions for use. At ten years, the all cause mortality rate was 46.0% with 182 deaths: five aortic related, 120 non-aortic related, and 57 of unknown cause. Freedom from aortic related death was 98.6% (95% CI 96.7 – 99.4%). Freedom from any re-intervention and device related re-intervention was 77.3% (95% CI 71.8 – 81.8%) and 80.6% (95% CI 75.3 – 84.9%), respectively. Freedom from type 1 endoleak was 95.4% (95% CI 92.3 – 97.5%), with type 2 endoleaks accounting for 82% (41 of 50) of all endoleaks. Structural complications were rare: two cases of migration (0.5%), one case of compression (0.3%), and no cases of device fractures. Nine patients (2.3%) required conversion, and secondary rupture occurred in three cases (0.8%).

Conclusion

The Gore C3 Excluder shows long term safety and durability for infrarenal aortic disease, with low rates of aortic related death and major aortic events. These findings support its effectiveness in a real world setting. However, surveillance adherence remains challenging in daily practice.

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具有C3输送系统的Gore排他AAA内假体的长期真实世界性能：来自GREAT注册中心欧洲C3模块的10年结果

目的：本研究旨在报告10年的数据，这些数据记录在Gore血管内主动脉治疗全球注册的欧洲C3模块中，使用Gore Excluder AAA腔内假体治疗具有C3递送系统的肾下主动脉疾病患者。方法：欧洲C3模块包括来自13个中心的2010年8月至2012年12月期间接受血管内动脉瘤修复的患者。结果评估采用描述性统计和Kaplan-Meier生存分析，95%置信区间（ci）。结果：模块关闭时，396例患者（87.1%男性，平均年龄±标准差73.9±7.8岁）可用于分析，平均随访时间±标准差6.4±3.2年。其中，94.4%的患者接受了选择性血管内动脉瘤修复术治疗肾下动脉瘤，16.9%的患者（396例中的67例）在使用说明书之外接受了治疗。10年后，全因死亡率为46.0%，182人死亡：5人与主动脉相关，120人与非主动脉相关，57人死因不明。无主动脉相关死亡率为98.6% （95% CI 96.7 - 99.4%）。再干预和器械相关再干预的自由度分别为77.3% （95% CI 71.8 - 81.8%）和80.6% （95% CI 75.3 - 84.9%）。1型内漏的发生率为95.4% (95% CI 92.3 - 97.5%)， 2型内漏占所有内漏的82%（50例中的41例）。结构并发症罕见：2例移位（0.5%），1例压迫（0.3%），无器械骨折。9例（2.3%）患者需要转换，3例（0.8%）发生继发性破裂。结论：Gore C3排除剂治疗肾下主动脉疾病具有长期的安全性和持久性，主动脉相关死亡率和主要主动脉事件发生率低。这些发现支持了它在现实世界中的有效性。然而，在日常实践中，监测依从性仍然具有挑战性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Vascular and Endovascular Surgery 医学-外科

CiteScore

6.80

自引率

15.80%

发文量

471

审稿时长

66 days

期刊介绍： The European Journal of Vascular and Endovascular Surgery is aimed primarily at vascular surgeons dealing with patients with arterial, venous and lymphatic diseases. Contributions are included on the diagnosis, investigation and management of these vascular disorders. Papers that consider the technical aspects of vascular surgery are encouraged, and the journal includes invited state-of-the-art articles. Reflecting the increasing importance of endovascular techniques in the management of vascular diseases and the value of closer collaboration between the vascular surgeon and the vascular radiologist, the journal has now extended its scope to encompass the growing number of contributions from this exciting field. Articles describing endovascular method and their critical evaluation are included, as well as reports on the emerging technology associated with this field.