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).
reintervention. Type 1a endoleak was seen in 17.6% of cases, type 1b in 4.0% and type 2 in 2.0%. Migration of the aortic stent was seen in 15.6% of cases and rupture in 6.0%. Aneurysm-related and all-cause mortality are 5.0% and 26.1% respectively. Adherence to IFU is associated with significantly fewer cases of type 1a endoleak (P¼0.003) and aneurysm-related death (P¼0.023). Conclusion -Results with this device have not borne out the initial optimism regarding near-universal morphological applicability. Experience has shown that morphological considerations remain of great importance, as evidenced by the better results when adherent to IFU. This device has allowed the treatment of patients who may not have been treatable using conventional devices.
dead vs alive patients also in the open repair(p¼0.003) and endovascular treatment subset (P¼0.039). The use of a ROC curve allowed to identify a cutoff point of pH of 7.22, able to distinguish subsets of patients at different risk, with a mortality rate of 85.7% in the pH group 7.22 compared to 45.1% in that with pH > 7.22 (p< 0.001). The multivariate logistic regression model showed that age (p¼0.005, OR¼1.10, 95% CI 1.03-1.18), creatinine 2.05 (p¼0.010, OR¼11.82, 95% CI 1.81-77.07), ph 7.22 (p¼0.014, OR¼8.43, 95% CI 1.54-46.26), open instead of endovascular repair (p¼0.030, OR¼4.04, 95% CI 1.14-14.32) and cardiopulmonary resuscitation (p¼0.028, OR¼31.25, 95% CI 1.46-670.41) were independent predictors of death. Using these five variables, a new score was created (Bicocca Aneurysm Score), allowing to stratify patients at different risk of death. The upper cohort had a perioperative mortality of 100%. Conclusion: The Bicocca Aneurysm Score predicted the 30day mortality in patients who underwent surgical and endovascular treatment for a rAAA. Further studies are required to validate the score.
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