Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial)
| Autor: | Elixène Jean-Baptiste, Patrick Feugier, Coralie Cruzel, Gabrielle Sarlon-Bartoli, Thierry Reix, Eric Steinmetz, Xavier Chaufour, Bertrand Chavent, Lucie Salomon du Mont, Meghann Ejargue, Blandine Maurel, Rafaelle Spear, Dominique Midy, Fabien Thaveau, Pascal Desgranges, Eugenio Rosset, Réda Hassen-Khodja, Pascale Bureau, Mireille Ravoux, Catherine Bozzetto, Marie-Antoinette Sevestre-Pietri, Béatrice Terriat, Claire Favier, Maryse Degeilh, Claire Le Hello, Jean-Pierre Favre, Simon Rinckenbach, Anca Loppinet, Yann Goueffic, Jérôme Connault, Yves Alimi, Pierre Barthélémy, Jean-Luc Magne, Christophe Seinturier, Marie-Luce Choukroun, Olivier Rouyer, Liliane Bitton, Jean-Pierre Becquemin |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Aortography Time Factors Computed Tomography Angiography medicine.medical_treatment Computed tomography Diagnostic accuracy 030204 cardiovascular system & hematology 030230 surgery Likelihood ratios in diagnostic testing Endovascular aneurysm repair 03 medical and health sciences Blood Vessel Prosthesis Implantation 0302 clinical medicine Postoperative Complications Predictive Value of Tests Color duplex ultrasound Multidetector Computed Tomography medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Ultrasonography Doppler Color Prospective cohort study Aged Aged 80 and over medicine.diagnostic_test business.industry Endovascular Procedures Reproducibility of Results medicine.disease Abdominal aortic aneurysm Treatment Outcome Retreatment Female Radiology France Cardiology and Cardiovascular Medicine business Aortic Aneurysm Abdominal |
| Zdroj: | Circulation. Cardiovascular imaging. 13(6) |
| ISSN: | 1942-0080 |
| Popis: | Background Color-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. Methods Between 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. Results This 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. Conclusions DUS 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. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01230203. |
| Databáze: | OpenAIRE |
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