July 1, 2020
Five-Year Results Reported From the French EPI-ANA-01 Registry of Terumo Aortic's Anaconda Endografts in Infrarenal AAA
July 1, 2020—Five-year results of the postapproval French multicenter prospective observational study (EPI-ANA-01) were published by Dominique Midy, MD, et al in European Journal of Vascular and Endovascular Surgery (EJVES; 2020;60:16-25). The study sought to evaluate the technical success and 5-year mortality and secondary intervention rates of the third-generation Anaconda endograft (Terumo Aortic).
The investigators noted that longer-term results with new generation endografts are essential because there has historically been a significant decrease in aneurysm-related survival is observed at long-term follow-up after infrarenal endovascular aneurysm repair (EVAR) compared with open repair.
As summarized in EJVES, the study included 176 consecutive unruptured infrarenal abdominal aortic aneurysms (160 men, mean age 75.3 ± 8.4 years) between from June 2012 to October 2013.
Survival, freedom from type Ia endoleak, limb events, and reinterventions were estimated using the Kaplan–Meier method. Anatomic and clinical characteristics were compared according to the occurrence of migration, conversion, adverse limb events, endoleak, and sac enlargement.
The primary technical rate was 98.3%; the clinical success rate was 94.9%; a hostile neck was identified in 33.9% of patients; and 10.7% of patients were treated outside instructions for use (IFU). The early postoperative (≤ 30 days) mortality rate was 1.7%.
In EJVES, the EPI-ANA-01 investigators reported the following:
- The overall survival rate was 94.9% at 1 year and 65.9% at 5 years (aneurysm-related in four [2.3%] patients).
- The clinical success rate was 90.9% at 1 year and 70.6% at 5 years.
- Secondary interventions were performed in 35 of 176 (19.9%) patients.
- The overall limb occlusion rate was 7.9%.
- The aneurysm sac diameter decreased significantly (from 53.9 ± 8.6 mm at preoperative to 42.3 ± 14.7 mm at 5 years; P < .001).
- Patients treated outside the IFU had significantly higher rates of migration, surgical conversion, and aneurysm sac expansion (P = .03).
The investigators concluded that the Anaconda endograft provides high technical success and satisfactory 5-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 embolization should be observed, advised the EPI-ANA-01 investigators in EJVES.