The Anaconda (TM) AAA Stent Graft System: 2-Year Clinical and Technical Results of a Multicentre Clinical Evaluation

ANA 004 Study Grp; S. G. J. Roedel; R. H. Geelkerken; R. J. Prescott; H. J. Florek; P. Kasprzak; J. Brunkwall

doi:10.1016/j.ejvs.2009.08.007

The Anaconda (TM) AAA Stent Graft System: 2-Year Clinical and Technical Results of a Multicentre Clinical Evaluation

ANA 004 Study Grp, S. G. J. Roedel, R. H. Geelkerken, R. J. Prescott, H. J. Florek, P. Kasprzak, J. Brunkwall

Deanery of Clinical Sciences

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

Introduction: This study reports the technical and mid-term clinical results of the second-generation Anaconda (TM) AAA Stent Graft System endovascular device for treatment of abdominal aortic aneurysm (AAA). The design of the Anaconda (TM) AAA Stent Graft System is characterised by a three-piece system consisting of two proximal independent saddle-shaped nitinol self-expandable rings with hooks fixation, zero body support and vacuum-cleaner tube leg design.

Methods: From July 2002 to April 2005, a total of 61 patients with AAA were enrolled in a multi-centre, prospective, non-randomised controlled design study. All patients received a second-generation Anaconda (TM) AAA Stent Graft System. They entered a standard follow-up protocol at discharge for 3, 6, 12 and 24 months. Follow-up data included survival; rupture-free survival; incidence of aneurysm rupture, death from aneurysm rupture, aneurysm-related death; freedom from aneurysm expansion; freedom from Types I and III endoleaks; endograft patency and technical and clinical success rates.

Results: Successful access to the arterial system was achieved in all patients. The primary technical success was 59 out of 61 and the primary assisted technical success was 60 out of 61, All endovascular grafts were patent without significant twists, kinks or obstructions. Migration was not observed in any of the grafts. During the first 30-day period, two serious adverse events (3%), both not related to the procedure, were observed. Nine patients (15%) needed a secondary intervention; two of these interventions were related to stent graft (3%). The mean aneurysm sac diameter decreased significantly from 57 mm pre-operative to 45 mm after 24 months, without aneurysm growth. There was one Type I endoleak at initial implantation, which was corrected using a proximal extension cuff. In total, three Type II endoleaks were still present after 24 months without any signs of aneurysm growth.

Conclusion: The design features of the second-generation Anaconda (TM) AAA Stent Graft System are effective in the treatment of AAAs on mid-term evaluation. (C) 2009 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. \

Original language	English
Pages (from-to)	732-740
Number of pages	9
Journal	European Journal of Vascular and Endovascular Surgery
Volume	38
Issue number	6
DOIs	https://doi.org/10.1016/j.ejvs.2009.08.007
Publication status	Published - Dec 2009

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@article{9914c638fa7349408bf92737f213784e,

title = "The Anaconda (TM) AAA Stent Graft System: 2-Year Clinical and Technical Results of a Multicentre Clinical Evaluation",

abstract = "Introduction: This study reports the technical and mid-term clinical results of the second-generation Anaconda (TM) AAA Stent Graft System endovascular device for treatment of abdominal aortic aneurysm (AAA). The design of the Anaconda (TM) AAA Stent Graft System is characterised by a three-piece system consisting of two proximal independent saddle-shaped nitinol self-expandable rings with hooks fixation, zero body support and vacuum-cleaner tube leg design.Methods: From July 2002 to April 2005, a total of 61 patients with AAA were enrolled in a multi-centre, prospective, non-randomised controlled design study. All patients received a second-generation Anaconda (TM) AAA Stent Graft System. They entered a standard follow-up protocol at discharge for 3, 6, 12 and 24 months. Follow-up data included survival; rupture-free survival; incidence of aneurysm rupture, death from aneurysm rupture, aneurysm-related death; freedom from aneurysm expansion; freedom from Types I and III endoleaks; endograft patency and technical and clinical success rates.Results: Successful access to the arterial system was achieved in all patients. The primary technical success was 59 out of 61 and the primary assisted technical success was 60 out of 61, All endovascular grafts were patent without significant twists, kinks or obstructions. Migration was not observed in any of the grafts. During the first 30-day period, two serious adverse events (3%), both not related to the procedure, were observed. Nine patients (15%) needed a secondary intervention; two of these interventions were related to stent graft (3%). The mean aneurysm sac diameter decreased significantly from 57 mm pre-operative to 45 mm after 24 months, without aneurysm growth. There was one Type I endoleak at initial implantation, which was corrected using a proximal extension cuff. In total, three Type II endoleaks were still present after 24 months without any signs of aneurysm growth.Conclusion: The design features of the second-generation Anaconda (TM) AAA Stent Graft System are effective in the treatment of AAAs on mid-term evaluation. (C) 2009 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. \",

author = "{ANA 004 Study Grp} and Roedel, {S. G. J.} and Geelkerken, {R. H.} and Prescott, {R. J.} and Florek, {H. J.} and P. Kasprzak and J. Brunkwall",

year = "2009",

month = dec,

doi = "10.1016/j.ejvs.2009.08.007",

language = "English",

volume = "38",

pages = "732--740",

journal = "European Journal of Vascular and Endovascular Surgery",

issn = "1078-5884",

publisher = "W.B. Saunders Company",

number = "6",

}

TY - JOUR

T1 - The Anaconda (TM) AAA Stent Graft System: 2-Year Clinical and Technical Results of a Multicentre Clinical Evaluation

AU - ANA 004 Study Grp

AU - Roedel, S. G. J.

AU - Geelkerken, R. H.

AU - Prescott, R. J.

AU - Florek, H. J.

AU - Kasprzak, P.

AU - Brunkwall, J.

PY - 2009/12

Y1 - 2009/12

N2 - Introduction: This study reports the technical and mid-term clinical results of the second-generation Anaconda (TM) AAA Stent Graft System endovascular device for treatment of abdominal aortic aneurysm (AAA). The design of the Anaconda (TM) AAA Stent Graft System is characterised by a three-piece system consisting of two proximal independent saddle-shaped nitinol self-expandable rings with hooks fixation, zero body support and vacuum-cleaner tube leg design.Methods: From July 2002 to April 2005, a total of 61 patients with AAA were enrolled in a multi-centre, prospective, non-randomised controlled design study. All patients received a second-generation Anaconda (TM) AAA Stent Graft System. They entered a standard follow-up protocol at discharge for 3, 6, 12 and 24 months. Follow-up data included survival; rupture-free survival; incidence of aneurysm rupture, death from aneurysm rupture, aneurysm-related death; freedom from aneurysm expansion; freedom from Types I and III endoleaks; endograft patency and technical and clinical success rates.Results: Successful access to the arterial system was achieved in all patients. The primary technical success was 59 out of 61 and the primary assisted technical success was 60 out of 61, All endovascular grafts were patent without significant twists, kinks or obstructions. Migration was not observed in any of the grafts. During the first 30-day period, two serious adverse events (3%), both not related to the procedure, were observed. Nine patients (15%) needed a secondary intervention; two of these interventions were related to stent graft (3%). The mean aneurysm sac diameter decreased significantly from 57 mm pre-operative to 45 mm after 24 months, without aneurysm growth. There was one Type I endoleak at initial implantation, which was corrected using a proximal extension cuff. In total, three Type II endoleaks were still present after 24 months without any signs of aneurysm growth.Conclusion: The design features of the second-generation Anaconda (TM) AAA Stent Graft System are effective in the treatment of AAAs on mid-term evaluation. (C) 2009 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. \

AB - Introduction: This study reports the technical and mid-term clinical results of the second-generation Anaconda (TM) AAA Stent Graft System endovascular device for treatment of abdominal aortic aneurysm (AAA). The design of the Anaconda (TM) AAA Stent Graft System is characterised by a three-piece system consisting of two proximal independent saddle-shaped nitinol self-expandable rings with hooks fixation, zero body support and vacuum-cleaner tube leg design.Methods: From July 2002 to April 2005, a total of 61 patients with AAA were enrolled in a multi-centre, prospective, non-randomised controlled design study. All patients received a second-generation Anaconda (TM) AAA Stent Graft System. They entered a standard follow-up protocol at discharge for 3, 6, 12 and 24 months. Follow-up data included survival; rupture-free survival; incidence of aneurysm rupture, death from aneurysm rupture, aneurysm-related death; freedom from aneurysm expansion; freedom from Types I and III endoleaks; endograft patency and technical and clinical success rates.Results: Successful access to the arterial system was achieved in all patients. The primary technical success was 59 out of 61 and the primary assisted technical success was 60 out of 61, All endovascular grafts were patent without significant twists, kinks or obstructions. Migration was not observed in any of the grafts. During the first 30-day period, two serious adverse events (3%), both not related to the procedure, were observed. Nine patients (15%) needed a secondary intervention; two of these interventions were related to stent graft (3%). The mean aneurysm sac diameter decreased significantly from 57 mm pre-operative to 45 mm after 24 months, without aneurysm growth. There was one Type I endoleak at initial implantation, which was corrected using a proximal extension cuff. In total, three Type II endoleaks were still present after 24 months without any signs of aneurysm growth.Conclusion: The design features of the second-generation Anaconda (TM) AAA Stent Graft System are effective in the treatment of AAAs on mid-term evaluation. (C) 2009 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved. \

U2 - 10.1016/j.ejvs.2009.08.007

DO - 10.1016/j.ejvs.2009.08.007

M3 - Article

SN - 1078-5884

VL - 38

SP - 732

EP - 740

JO - European Journal of Vascular and Endovascular Surgery

JF - European Journal of Vascular and Endovascular Surgery

IS - 6

ER -

The Anaconda (TM) AAA Stent Graft System: 2-Year Clinical and Technical Results of a Multicentre Clinical Evaluation

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