Fenestrated Endovascular Aortic Repair of Complex Aneurysm Using the Anaconda Fenestrated Device: 1-Year Results From the French Multicenter Registry

Purpose: This study aims to assess the safety and efficacy of the fenestrated Anaconda device for the treatment of complex aortic aneurysms over 1 year in daily clinical practice. Materials and Methods: All patients who received the graft between October 2019 and October 2020 were prospectively enrolled in an observational, multicenter national registry. The primary endpoint was the aneurysm-related 1-year mortality rate. Secondary endpoints included all-cause mortality, technical success, device-related adverse events (AEs) and major complications, secondary reinterventions, endoleaks, target vessel (TV) outcomes, and a center-volume analysis comparing mortality and secondary reintervention rate between expert centers (>15 F/BEVAR per year) and nonexpert centers (<= 15 F/BEVAR per year). Results: Ninety-seven patients from 28 centers were treated. Aneurysms types included juxta-renal and short neck (84.6%), pararenal (5.2%), paravisceral (3.1%), and type IV thoracoabdominal (2.5%). Configurations with 1, 2, 3, and 4 fenestrations were used in 2, 12, 18, and 65 cases, respectively, totaling 350 TVs. Technical success was 98.0%, with 1 type Ic and 1 type IIIc endoleak. Mean follow-up was 468 days. Ten patients died, with 8 deaths (8.2%) due to non-aortic causes and 2 deaths (2.1%) from unknown causes. The estimated 1-year survival rate was 92.7% (95% CI: 87.8-98.1%). The reintervention rate at 30 days was 11.3% and the estimated reintervention rate at 1 year was 21.6% (95% CI: 12.7-29.6%). No type Ia endoleak occurred during follow-up. Three type III endoleaks occurred and required reintervention. Three TV occlusion occurred, yielding a 1-year TVI-free rate of 92.4% (95% CI: 89.4-99.3). No device-related major complication was recorded, and 3 device-related AEs occurred: 1 limb migration, 1 limb kinking and 1 limb thrombosis. There was no statistically significant difference in mortality and survival without reintervention between expert and nonexpert centers (Log rank p=0.52 and p=0.16, respectively). Conclusion: The fenestrated Anaconda device demonstrated acceptable early and at 1-year safety and efficacy for treating primarily juxta-renal and short-neck aortic aneurysms, in centers with varying levels of experience. Clinical Impact The Anaconda Fenestrated, as the second commercially available custom-made device for complex endovascular aortic surgery, might adress some anatomical challenges. Following market authorization, this registry presents the 1-year outcomes of real-world device usage in a large number of centers, including small clinics. The results indicate that the device provided adequate efficacy and safety for treating mostly juxta-renal and short neck aneurysms, with notable improvement in technical success rate compared to older reports.