Postoperative surveillance and long-term outcome after endovascular aortic aneurysm repair in the Netherlands: study protocol for the retrospective ODYSSEUS study

Abstract

IntroductionStrict imaging surveillance protocols to detect complications following endovascular aneurysm repair (EVAR) are common practice. However, controversy exists as to whether all EVAR patients need intense surveillance. The 2019 European Society for Vascular Surgery guidelines for management of abdominal aortic aneurysm (AAA) suggest that patients may be considered for limited follow-up with imaging if classified as ‘low risk’ for complications based on their initial postoperative imaging. The current study aims to investigate the intervention-free survival and overall survival stratified for patients with and without yearly imaging surveillance.Methods and analysisThe Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient’s medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients.Ethics and disseminationThe study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal.Trial registration numberThe Netherlands Trial Registry, NL6953 (old: NTR28773).

Editor's Choice – Post-operative Surveillance and Long Term Outcome after Endovascular Aortic Aneurysm Repair in Patients with an Initial Post-operative Computed Tomography Angiogram Without Abnormalities: the Multicentre Retrospective ODYSSEUS Study

“…The sample size calculation was based on a superiority design for secondary interventions and non-inferiority for aneurysm related mortality. 18 In patients with a postoperative CTA without abnormalities and to correct for 10% incomplete or missing data, a total of 1 598 (1 438/ 0.9) patients were required to detect a 7% difference for the outcome secondary interventions, and 1 451 (1 306/ 0.9) patients for aneurysm related death with a noninferiority limit of 3%. 18 The ShapiroeWilk test, Q-Q plots, and histograms were used to determine whether continuous data were normally distributed.…”

“…18 In patients with a postoperative CTA without abnormalities and to correct for 10% incomplete or missing data, a total of 1 598 (1 438/ 0.9) patients were required to detect a 7% difference for the outcome secondary interventions, and 1 451 (1 306/ 0.9) patients for aneurysm related death with a noninferiority limit of 3%. 18 The ShapiroeWilk test, Q-Q plots, and histograms were used to determine whether continuous data were normally distributed. Continuous variables were presented as mean and standard deviation (SD) for normally distributed data, or median and interquartile range (IQR) for non-normally distributed data.…”

“…The study was approved by the local Institutional Review Board (W18_102#18.130), registered with The Netherlands Trial Registration (NL6953), and the protocol was published. 18 In accordance with the Dutch Code of Civil Procedure, the opt out procedure was used; by default patient records were used for research, unless the patient objected to participation within four weeks of notification.…”

A Rare Case and Presentation of Traumatic Penetrating Aortic Arch Injury: A Case Report and Literature Review

“…As a result, injuries to the descending thoracic aorta are more amenable to endovascular options due to their location and stability, whereas proximal injuries, such as those to the aortic arch, are rarely candidates because these patients typically require more urgent surgical intervention [35]. In addition, special considerations are required for the endovascular approach: an adequate "seal or landing zone" for the stent graft and lifelong imaging monitoring (30 days, 6 months, and 12 months after repair, then annually if there are no complications) [35,36].…”

A retrospective study of 3D deep learning approach incorporating coordinate information to improve the segmentation of pre- and post-operative abdominal aortic aneurysm

“…EVAR is a procedure of stent-graft implantation inside AAA under endovascular intervention in order to decrease the size of the aortic lumen. Measurement of AAA volume after EVAR is one of the considerations of imaging surveillance for patient follow up ( Geraedts et al, 2020 ). If AAA size continues to increase after EVAR, it indicates a complication called endoleak.…”