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.

Assessment of fenestrated Anaconda stent graft design by numerical simulation: Results of a European prospective multicenter study.

OBJECTIVE: A crucial step in designing fenestrated stent grafts for treatment of complex aortic abdominal aneurysms is the accurate positioning of the fenestrations. The deployment of a fenestrated stent graft prototype in a patient-specific rigid aortic model can be used for design verification in vitro, but is time and human resources consuming. Numerical simulation (NS) of fenestrated stent graft deployment using the finite element analysis has recently been developed; the aim of this study was to compare the accuracy of fenestration positioning by NS and in vitro. METHODS: All consecutive cases of complex aortic abdominal aneurysm treated with the Fenestrated Anaconda (Terumo Aortic) in six European centers were included in a prospective, observational study. To compare fenestration positioning, the distance from the center of the fenestration to the proximal end of the stent graft (L) and the angular distance from the 0° position (C) were measured and compared between in vitro testing (L1, C1) and NS (L2, C2). The primary hypothesis was that ΔL (|L2 - L1|) and ΔC (|C2 - C1|) would be 2.5 or less mm in more than 80% of the cases. The duration of both processes was also compared. RESULTS: Between May 2018 and January 2019, 50 patients with complex aortic abdominal aneurysms received a fenestrated stent graft with a total of 176 fenestrations. The ΔL and ΔC was 2.5 mm or less for 173 (98%) and 174 (99%) fenestrations, respectively. The NS process duration was significantly shorter than the in vitro (2.1 days [range, 1.0-5.2 days] vs 20.6 days [range, 9-82 days]; P < .001). CONCLUSIONS: Positioning of fenestrations using NS is as accurate as in vitro and could significantly decrease delivery time of fenestrated stent grafts.

Five Year Results of the French EPI-ANA-01 Registry of AnacondaTM Endografts in the Treatment of Infrarenal Abdominal Aortic Aneurysms.

OBJECTIVE: A significant decrease in aneurysm related survival is observed at long term follow up after infrarenal endovascular aneurysm repair (EVAR) compared with open repair. Therefore, longer term results with new generation endografts are essential. The aim of this post-approval French multicentre prospective observational study (EPI-ANA-01) was to evaluate the technical success and five year mortality and secondary intervention rates of the third generation AnacondaTM endograft. METHODS: From June 2012 to October 2013, 176 consecutive unruptured infrarenal abdominal aortic aneurysms were included (160 male patients, mean age 75.3 ± 8.4 years). Survival, freedom from type Ia endoleak, limb events, and re-interventions were estimated using the Kaplan-Meier method. Anatomical and clinical characteristics were compared according to the occurrence of migration, conversion, adverse limb events, endoleak, and sac enlargement. RESULTS: The primary technical and clinical success rates were 98.3% and 94.9%, respectively. A hostile neck was identified in 33.9% of patients and 10.7% were treated outside instructions for use (IFU). An early post-operative (≤30 days) mortality rate of 1.7% was observed. At one and five years, respectively, the overall survival rate was 94.9% and 65.9% (aneurysm related in four patients [2.3%]) and the clinical success rate was 90.9% and 70.6%. Secondary interventions were performed in 35 of 176 patients (19.9%). The overall limb occlusion rate was 7.9% and the aneurysm sac diameter decreased significantly (pre-operative diameter 53.9 ± 8.6 mm vs. 42.3 ± 14.7 mm at five years; p < .001). Patients treated outside the instructions for use (IFU) had significantly higher rates of migration, surgical conversion, and aneurysm sac expansion (p = .03). CONCLUSION: The Anaconda endograft provides high technical success and satisfactory five year aneurysm exclusion and clinical success rates. However, implantation outside the IFU should be avoided, as it leads to significantly worse outcomes, and caution over the risk of limb occlusion and distal embolisation should be observed.

Results of the French Multicentric Study of ANACONDA™ Fenestrated Endografts in the Treatment of Complex Aortic Pathologies (EFEFA Registry).

BACKGROUND: Most of the experience on fenestrated endovascular aneurysm repair involves the custom-made Zenith® endograft (Cook). The fenestrated Anaconda® endograft (Vascutek) was introduced with the potential advantages of complete repositioning and lack of stent material on the main aortic body for more versatility. However, few data are available. Our objective was to assess its mid-term results in the treatment of complex aortic aneurysms. METHODS: Consecutive patients treated with the custom-made fenestrated Anaconda endograft in France and the Principality of Monaco, from December 2010 to October 2015, were included. RESULTS: Eighty-six patients were included over 16 centers (82 men, mean age 73.4 ± 8.1 years, 16 (18.6%) symptomatic aneurysms). The repositioning system was used in 68 cases (79.1%). Two hundred ninety-two visceral/renal vessels were targeted, with a mean number of 3.4 ± 0.6 target vessels/patient and a successful reconstruction in 99.3% of the cases (290/292 vessels). Perioperative technical success was achieved in 86.0% (74/86 patients). In-hospital and 30-day mortality rates were 3.5% (3 patients) and 7.0% (6 patients), respectively. At 12 and 24 months, estimated overall survival rate was 88.3% and 85.2%, target vessel's patency rate was 97.2% and 96.3%, and freedom from aneurysm-related reintervention rate was 96.3% and 88.0%, respectively. At 24 months, there were 7 type II endoleaks (12.7%) and a significant reduction in aneurysm maximum transverse diameter in 70.4%. Five limb occlusions occurred at 1-year and 1 at 2-year follow-up (7.0%). CONCLUSIONS: The fenestrated Anaconda stent-graft system offers acceptable technical success rates, mid-term efficacy, and durability with respect to aneurysm sac regression, target vessel patency, overall mortality, and reintervention rates. Long-term results are still awaited, until then, the rate of graft limb occlusion is of concern and should be further investigated, especially in case of particularly complex aortic anatomies.