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

Abstract

WHAT THIS PAPER ADDSThis observational prospective multicentre series reports the longest term results of the third generation Anaconda device in infrarenal aortic aneurysms with good data consistency. The endograft provided high technical success. During this five year assessment, secondary interventions were performed in 35 of 176 patients (19.9%) and a significant aneurysm diameter decrease of À13.5% was observed, yet the limb occlusion rate remained high (15 limbs [4.3%] in 14 patients [7.9%]) and was significantly higher when additional leg extensions were implanted. Moreover, distal arterial embolisation occurred in some cases. Finally, implantation outside instructions for use should be avoided as it led to significantly higher rates of migration, surgical conversion, and aneurysm sac expansion.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 Anaconda TM endograft. Methods: From June 2012 to October 2013, 176 consecutive unruptured infrarenal abdominal aortic aneurysms were included (160 male patients, mean age 75.3 AE 8.4 years). Survival, freedom from type Ia endoleak, limb events, and re-interventions were estimated using the KaplaneMeier 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 AE 8.6 mm vs. 42.3 AE 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 ¼ .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.

Incidence and predictive factors for endograft limb patency of the fenestrated Anaconda endograft used for complex endovascular aneurysm repair

“…17 Most of the reported experience with the Anaconda™ endograft comes from secondgeneration devices. 15,16,24,25 Only one reported study has included only third-generation devices 23 and a few studies included mixed populations. 7,13,14,17 Rödel et al included both second-and third-generation grafts and reported an overall occlusion rate of 9.8% over a mean follow-up of 47 months, with no difference in occlusion between second-and third-generation grafts.…”

“…al found an occlusion rate of 7.9% in third-generation Anaconda™ endografts over a median follow-up of 59 months, with 10.7% of patients treated outside the IFU. 23 This was associated with an increased risk of late failure including migration, probably due to lack of adequate sealing. 23 The authors did not relate treatment outside the IFU to limb occlusion.…”

“…[9][10][11][12] Despite a good overall performance, relatively high rates of limb occlusion are seen in both the infrarenal and Fenestrated Anaconda™; up to 14% and 23% respectively. 9,11,[13][14][15][16][17][18][19][20][21][22][23][24][25] The aim of this study was to describe the incidence, risk factors, and outcomes of treatment for limb occlusion, in patients treated for complex AAA with the Fenestrated Anaconda™.…”

Preloaded contralateral gate techniques during endovascular aortic repair for aneurysms and occlusive disease

“…The 5-year results of the French registry report 98.3% technical and 94.9% clinical success, but there have been concerns about a high limb occlusion rate. 7,8 There are unfortunately no large studies comparing gate cannulation with Anaconda TM to traditional methods, and the device is not commercially available in the US.…”

High Long Term Re-Intervention Rates for a Third Generation Stent Graft

“…Midy et al 1 report five year outcomes for the third generation Anaconda stent graft system (Vascutek; Terumo, Paisley, UK) from a post-approval French multicentre prospective observational study.…”