TY - JOUR
T1 - Five Year Results of the French EPI-ANA-01 Registry of AnacondaTM Endografts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
AU - EPI-ANA-01 Research Group
AU - Midy, Dominique
AU - Bastrot, Louis
AU - Belhomme, Denis
AU - Faroy, Francis
AU - Frisch, Nicolas
AU - Bouillanne, Pierre Jean
AU - Delaunay, Thierry
AU - Aguilar, Paul
AU - Francis-Oliviero, Florence
AU - Caradu, Caroline
AU - Hoehne, Marcel
AU - Gheysens, Benoît
AU - Gardet, Emmanuel
AU - Maillard, Phiippe
AU - Chakfe, Nabil
AU - Mugnier, Bruno
AU - Rossi, Antoine
AU - Malikov, Sergueï
AU - El Douaihy, Mehrez
AU - Grognet, Aude
AU - Nicolini, Philippe
AU - Moumouni, Yssifou
AU - Magne, Jean Luc
AU - Gayet, Patrice
AU - Calen, Serge
N1 - Copyright © 2020. Published by Elsevier B.V.
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
KW - Abdominal aortic aneurysm
KW - Anaconda stent graft
KW - Angulation
KW - Endovascular aortic repair
KW - Instructions for use
KW - Limb occlusion
KW - Blood Vessel Prosthesis Implantation/adverse effects
KW - Prospective Studies
KW - Endoleak/epidemiology
KW - Endovascular Procedures/adverse effects
KW - Humans
KW - Male
KW - Treatment Outcome
KW - Aortic Aneurysm, Abdominal/mortality
KW - Survival Analysis
KW - Female
KW - Registries
KW - Aged
KW - Blood Vessel Prosthesis/adverse effects
KW - France
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UR - http://www.scopus.com/inward/citedby.url?scp=85082430724&partnerID=8YFLogxK
U2 - 10.1016/j.ejvs.2020.02.005
DO - 10.1016/j.ejvs.2020.02.005
M3 - Article
C2 - 32184061
AN - SCOPUS:85082430724
SN - 1078-5884
VL - 60
SP - 16
EP - 25
JO - European Journal of Vascular and Endovascular Surgery
JF - European Journal of Vascular and Endovascular Surgery
IS - 1
ER -