Alexander Vanmaele , Vinamr Rastogi , José Oliveira-Pinto , Sander ten Raa , Marie Josee E. van Rijn , Frederico Bastos Gonçalves , Jorg L. de Bruin , Hence J.M. Verhagen
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Patients were categorised by adherence to instructions for use (IFU), adequate seal, and absence of endoleak (method A1), and without high risk features (method A2) on the first post-operative CTA. Additionally, these patients were dichotomised based on aneurysm sac shrinkage at one year (> 5 mm maximum diameter reduction, method B). Outcomes were graft related adverse events and all cause death. Negative predictive value (NPV) was used to compare risk classifications.</div></div><div><h3>Results</h3><div>Of 422 eligible patients, 297 underwent the required imaging for classification: 140 (47.1%) and 109 (36.7%) patients were classified as low risk based on methods A1 and A2, respectively, while 147 (49.5%) were assumed low risk based on method B. The five year cumulative incidence of adverse events in low risk patients according to method A1 was 14.7% (95% confidence interval [CI] 8.5 – 20.9%), similar to method A2 (16.1%, 95% CI 8.8 – 23.4%) and method B (15.4%, 95% CI 9.3 – 21.5%). The five year median NPV for adverse events for method A1 was 85.2% (95% CI 79.7 – 90.8%), comparable with method A2 (83.8%, 95% CI 76.9 – 90.3%; <em>p</em> = .37) and method B (84.7%, 95% CI 79.4 – 89.5%; <em>p</em> = .87). Significantly higher NPVs were found by combining method A1 or A2 with method B, with median values ≥ 95% up to four years after EVAR. The five year NPV for death did not differ between methods (five year NPV<sub>method A1</sub>, 81.7%, 95% CI 76.6 – 86.5%).</div></div><div><h3>Conclusion</h3><div>Refraining from imaging in the first five years after EVAR in patients treated within IFU and with a favourable post-operative CTA would have failed to detect important complications at an early stage. It is proposed to combine the post-operative CTA with sac shrinkage at one year in order to stratify post-EVAR surveillance. No benefit was found in considering the high risk features suggested in the European Society for Vascular Surgery (ESVS) guidelines.</div></div>","PeriodicalId":55160,"journal":{"name":"European Journal of Vascular and Endovascular Surgery","volume":"69 5","pages":"Pages 744-754"},"PeriodicalIF":6.8000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Single Centre Evaluation of the Proposal of the European Society for Vascular Surgery Abdominal Aortic Aneurysm Guidelines to Stratify Surveillance after Endovascular Aortic Aneurysm Repair\",\"authors\":\"Alexander Vanmaele , Vinamr Rastogi , José Oliveira-Pinto , Sander ten Raa , Marie Josee E. van Rijn , Frederico Bastos Gonçalves , Jorg L. de Bruin , Hence J.M. Verhagen\",\"doi\":\"10.1016/j.ejvs.2025.01.042\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>The aim of this study was to evaluate and compare methods that identify patients at low risk of developing complications after endovascular aortic aneurysm repair (EVAR) and who would thus not require surveillance in the first post-operative years.</div></div><div><h3>Methods</h3><div>This was a retrospective, single centre, cohort study including all patients after elective infrarenal EVAR with both immediate post-operative and one year computed tomography angiography (CTA) imaging. Patients were categorised by adherence to instructions for use (IFU), adequate seal, and absence of endoleak (method A1), and without high risk features (method A2) on the first post-operative CTA. Additionally, these patients were dichotomised based on aneurysm sac shrinkage at one year (> 5 mm maximum diameter reduction, method B). Outcomes were graft related adverse events and all cause death. Negative predictive value (NPV) was used to compare risk classifications.</div></div><div><h3>Results</h3><div>Of 422 eligible patients, 297 underwent the required imaging for classification: 140 (47.1%) and 109 (36.7%) patients were classified as low risk based on methods A1 and A2, respectively, while 147 (49.5%) were assumed low risk based on method B. The five year cumulative incidence of adverse events in low risk patients according to method A1 was 14.7% (95% confidence interval [CI] 8.5 – 20.9%), similar to method A2 (16.1%, 95% CI 8.8 – 23.4%) and method B (15.4%, 95% CI 9.3 – 21.5%). The five year median NPV for adverse events for method A1 was 85.2% (95% CI 79.7 – 90.8%), comparable with method A2 (83.8%, 95% CI 76.9 – 90.3%; <em>p</em> = .37) and method B (84.7%, 95% CI 79.4 – 89.5%; <em>p</em> = .87). Significantly higher NPVs were found by combining method A1 or A2 with method B, with median values ≥ 95% up to four years after EVAR. The five year NPV for death did not differ between methods (five year NPV<sub>method A1</sub>, 81.7%, 95% CI 76.6 – 86.5%).</div></div><div><h3>Conclusion</h3><div>Refraining from imaging in the first five years after EVAR in patients treated within IFU and with a favourable post-operative CTA would have failed to detect important complications at an early stage. It is proposed to combine the post-operative CTA with sac shrinkage at one year in order to stratify post-EVAR surveillance. No benefit was found in considering the high risk features suggested in the European Society for Vascular Surgery (ESVS) guidelines.</div></div>\",\"PeriodicalId\":55160,\"journal\":{\"name\":\"European Journal of Vascular and Endovascular Surgery\",\"volume\":\"69 5\",\"pages\":\"Pages 744-754\"},\"PeriodicalIF\":6.8000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Vascular and Endovascular Surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1078588425001133\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/3 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Vascular and Endovascular Surgery","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1078588425001133","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/3 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0
摘要
目的:本研究的目的是评估和比较识别血管内动脉瘤修复(EVAR)术后并发症风险低的患者的方法,从而在术后第一年不需要监测。方法:这是一项回顾性、单中心、队列研究,包括所有接受选择性肾下EVAR术后立即和一年ct血管造影(CTA)成像的患者。患者根据遵守使用说明书(IFU),足够的密封,没有内漏(A1方法),以及在第一次术后CTA上没有高风险特征(A2方法)进行分类。此外,这些患者根据一年后动脉瘤囊收缩情况(方法B,最大直径缩小0.5 mm)进行分类。结果是移植物相关不良事件和全因死亡。负预测值(NPV)用于比较风险分类。结果:422名符合条件的患者,297年接受了分类所需的成像:140(47.1%)和109年(36.7%)患者分为低风险基于方法A1和A2,分别在147年(49.5%)认为低风险基于方法B五年累计的不良事件发生率低风险病人根据方法A1为14.6%(95%可信区间[CI] 8.5 - 20.9%),类似于方法A2(16.1%, 95%置信区间8.8 - 23.4%)和方法B(15.4%, 95%置信区间9.3 - 21.5%)。方法A1不良事件的5年中位NPV为85.2% (95% CI 79.7 - 90.8%),与方法A2相当(83.8%,95% CI 76.9 - 90.3%);p = .37)和B方法(84.7%,95% CI 79.4 - 89.5%;P = .87)。将方法A1或A2与方法B联合使用,发现npv显著升高,EVAR后4年的中位值≥95%。两种方法的5年NPV无差异(5年NPV法A1, 81.7%, 95% CI 76.6 - 86.5%)。结论:在IFU治疗的EVAR患者术后前5年不进行影像学检查,且术后CTA良好,将无法在早期发现重要的并发症。建议将术后一年的CTA和囊腔收缩结合起来进行evar后的分层监测。考虑到欧洲血管外科学会(ESVS)指南中建议的高风险特征,没有发现任何益处。
Single Centre Evaluation of the Proposal of the European Society for Vascular Surgery Abdominal Aortic Aneurysm Guidelines to Stratify Surveillance after Endovascular Aortic Aneurysm Repair
Objective
The aim of this study was to evaluate and compare methods that identify patients at low risk of developing complications after endovascular aortic aneurysm repair (EVAR) and who would thus not require surveillance in the first post-operative years.
Methods
This was a retrospective, single centre, cohort study including all patients after elective infrarenal EVAR with both immediate post-operative and one year computed tomography angiography (CTA) imaging. Patients were categorised by adherence to instructions for use (IFU), adequate seal, and absence of endoleak (method A1), and without high risk features (method A2) on the first post-operative CTA. Additionally, these patients were dichotomised based on aneurysm sac shrinkage at one year (> 5 mm maximum diameter reduction, method B). Outcomes were graft related adverse events and all cause death. Negative predictive value (NPV) was used to compare risk classifications.
Results
Of 422 eligible patients, 297 underwent the required imaging for classification: 140 (47.1%) and 109 (36.7%) patients were classified as low risk based on methods A1 and A2, respectively, while 147 (49.5%) were assumed low risk based on method B. The five year cumulative incidence of adverse events in low risk patients according to method A1 was 14.7% (95% confidence interval [CI] 8.5 – 20.9%), similar to method A2 (16.1%, 95% CI 8.8 – 23.4%) and method B (15.4%, 95% CI 9.3 – 21.5%). The five year median NPV for adverse events for method A1 was 85.2% (95% CI 79.7 – 90.8%), comparable with method A2 (83.8%, 95% CI 76.9 – 90.3%; p = .37) and method B (84.7%, 95% CI 79.4 – 89.5%; p = .87). Significantly higher NPVs were found by combining method A1 or A2 with method B, with median values ≥ 95% up to four years after EVAR. The five year NPV for death did not differ between methods (five year NPVmethod A1, 81.7%, 95% CI 76.6 – 86.5%).
Conclusion
Refraining from imaging in the first five years after EVAR in patients treated within IFU and with a favourable post-operative CTA would have failed to detect important complications at an early stage. It is proposed to combine the post-operative CTA with sac shrinkage at one year in order to stratify post-EVAR surveillance. No benefit was found in considering the high risk features suggested in the European Society for Vascular Surgery (ESVS) guidelines.
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.