Service de Chirurgie Vasculaire, INSERM U1065, CHU de Nice, Université Côte D’Azur, Nice, France (E.J.-B., R.H.-K.).Service de Chirurgie Vasculaire, CHU Edouard Herriot, Université Claude Bernard Lyon1, Lyon, France (P.F.).Délégation à la Recherche Clinique et à l’innovation, CHU de Nice, Université Côte D’Azur, Nice, France (C.C.).C2VN, APHM, CHU Timone, Service de Chirurgie Vasculaire, Aix Marseille Université, Marseille, France (G.S.-B.).Service de Chirurgie Vasculaire, CHU Amiens-Picardie, Université de Picardie Jules Verne, Amiens, France (T.R.).Service de Chirurgie Vasculaire, CHU Dijon-Bourgogne, Université de Bourgogne, Dijon, France (E.S.).Service de Chirurgie Vasculaire et angiologie, CHU de Toulouse, Université Paul Sabatier, Toulouse, France (X.C.).Service de Chirurgie Cardio-Vasculaire, CHU de Saint-Etienne, Université Jean Monnet, Saint-Etienne, France (B.C.).Service de Chirurgie Vasculaire et Endovasculaire, CHU de Besançon, Université de Franche-Comté, Besançon, France (L.S.d.M.).AP-HM, Department of Vascular Surgery, University Hospital Nord, Aix-Marseille Université, Marseille, France (M.E.).CHU Nantes, l’institut du thorax, service de chirurgie vasculaire, Inserm-UN UMR-957, Nantes, France (B.M.).Service de Chirurgie Vasculaire, CHU de Grenoble, Université Grenoble-Alpes, Grenoble, France (R.S.).Service de Chirurgie Vasculaire, CHU de Bordeaux, Bordeaux, France (D.M.).Service de Chirurgie Vasculaire, CHU de Strasbourg, Strasbourg, France (F.T.).Service de Chirurgie Vasculaire, CHU Henri Mondor, Créteil, France (P.D.).Service de Chirurgie Vasculaire, CHU de Clermont-Ferrand, Université d’Auvergne, Clermont-Ferrand, France (E.R.).Angiology and Vascular Laboratory, CHU de LyonAngiology and Vascular Laboratory, CHU de Clermont-FerrandAngiology and Vascular Laboratory, CHU de NiceAngiology and Vascular Laboratory, CHU d’AmiensAngiology and Vascular Laboratory, CHU de DijonVascular Surgery, CHU de DijonAngiology and Vascular Laboratory, CHU de ToulouseAngiology and Vascular Laboratory, CHU de Saint-ÉtienneVascular Surgery, CHU de Saint-ÉtienneVascular Surgery, CHU de BesançonAngiology and Vascular Laboratory, CHU de BesançonVascular Surgery, CHU de NantesAngiology and Vascular Laboratory, CHU de NantesVascular Surgery: AP-HM Hôpital NordAngiology and Vascular Laboratory, AP-HM Hôpital NordVascular Surgery, CHU de GrenobleAngiology and Vascular Laboratory, CHU de GrenobleAngiology and Vascular Laboratory, CHU de BordeauxAngiology and Vascular Laboratory, CHU de StrasbourgAngiology and Vascular Laboratory, AP-HP CHU de CréteilVascular Surgery, AP-HP CHU de Créteil
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BackgroundColor-duplex ultrasonography (DUS) could be an alternative to computed tomography-aortography (CTA) in the lifelong surveillance of patients after endovascular aneurysm repair (EVAR), but there is currently no level 1 evidence. The aim of this study was to assess the diagnostic accuracy of DUS as an alternative to CTA for the follow-up of post-EVAR patients.MethodsBetween December 16, 2010, and June 12, 2015, we conducted a prospective, blinded, diagnostic-accuracy study, in 15 French university hospitals where EVAR was commonly performed. Participants were followed up using both DUS and CTA in a mutually blinded setup until the end of the study or until any major aneurysm-related morphological abnormality requiring reintervention or an amendment to the follow-up policy was revealed by CTA. Database was locked on October 2, 2017. Our main outcome measures were sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratios of DUS against reference standard CTA. CIs are binomial 95% CI.ResultsThis study recruited prospectively 659 post-EVAR patients of whom 539 (82%) were eligible for further analysis. Following the baseline inclusion visit, 940 additional follow-up visits were performed in the 539 patients. Major aneurysm-related morphological abnormalities were revealed by CTA in 103 patients (17.2/100 person-years [95% CI, 13.9–20.5]). DUS accurately identified 40 patients where a major aneurysm-related morphological abnormality was present (sensitivity, 39% [95% CI, 29–48]) and 403 of 436 patients with negative CTA (specificity, 92% [95% CI, 90–95]). The negative predictive value and positive predictive value of DUS were 92% (95% CI, 90–95) and 39% (95% CI, 27–50), respectively. The positive likelihood ratio was 4.87 (95% CI, 2.9–9.6). DUS sensitivity reached 73% (95% CI, 51–96) in patients requiring an effective reintervention.ConclusionsDUS had an overall low sensitivity in the follow-up of patients after EVAR, but its performance improved meaningfully when the subset of patients requiring effective reinterventions was considered.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT01230203.