Document Detail

Durability of abdominal aortic endograft with the Talent Unidoc stent graft in common practice: Core lab reanalysis from the TAURIS multicenter study.
MedLine Citation:
PMID:  19341881     Owner:  NLM     Status:  MEDLINE    
BACKGROUND/OBJECTIVE: Durability is the main concern of aortic endografting, but it is not clear to what extent trial results are applicable to "real world" patients. The purpose of this study was to assess the durability of a single model of aortic endograft in an unselected population with core lab analysis of morphological changes.
METHODS: Computed tomography (CT) images of patients treated with Talent Unidoc (Medtronic, Santa Rosa, Calif) endografts from 2002 to 2006 in nine European centers with more than 1 year follow-up were centrally reviewed using a dedicated software with multiplanar and volume reconstructions. Images were checked for aneurysm growth >/=5 mm, neck enlargement >3 mm, graft migration >/=10 mm, endoleak, structural integrity. Morphological changes were defined clinically relevant when associated with reintervention or aneurysm-related death.
RESULTS: A total of 349 patients (mean age 73.8 years, 90% males) were available for analysis; 1187 CT examinations were reviewed. Median abdominal aortic aneurysm (AAA) diameter was 56 mm (interquartile range [IQR] 49-62), neck length 20 mm (IQR 16-30), and neck diameter 25 mm (IQR 23-26). Mean follow-up was 25 months (range 12-60 months). During the study period, 10 late deaths (1 aneurysm-related, 0.3%) with a survival rate of 89.2% at 48 months and 33 reinterventions including 8 conversions (2.2%), 2 AAA ruptures (0.6%) and 1 (0.3%) loss of graft integrity were recorded. Cumulative reintervention rate was 6%, 8%, 13%, and 16% at 1, 2, 3, and 4 years, respectively. According to core lab analysis, 22 AAA grew, 169 were unchanged, and 158 shrunk, with a growing AAA rate of 3.1% patients/year. Five growths required reintervention, one for rupture. Forty-seven (6.5% patients/year) neck enlargements, three clinically relevant, 17 migrations (2.4% patients/year), five clinically relevant, and 70 endoleaks (9.7 % patients/year), 11 clinically relevant, were detected.
CONCLUSION: Data from this real world experience monitored with a centralized imaging review show that endovascular repair of abdominal aortic aneurysm with the latest generation of a single model of endograft is associated with low graft thrombosis and graft fatigue, and low late aneurysm rupture and related death risks. Neck enlargement although common after EVAR, is almost always without clinical consequences but a longer follow-up and prospective clinical studies are advisable to confirm the present results.
Piergiorgio Cao; Paola De Rango; Gianbattista Parlani; Fabio Verzini;
Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  Journal of vascular surgery     Volume:  49     ISSN:  1097-6809     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-04-03     Completed Date:  2009-04-20     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  859-65     Citation Subset:  IM    
Unit of Vascular and Endovascular Surgery, University of Perugia, Italy.
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MeSH Terms
Aortic Aneurysm, Abdominal / complications,  mortality,  radiography,  surgery*
Aortic Rupture / etiology,  prevention & control
Aortography / methods
Blood Vessel Prosthesis*
Blood Vessel Prosthesis Implantation / adverse effects,  instrumentation*,  mortality
Equipment Failure Analysis
Italy / epidemiology
Prosthesis Design
Prosthesis Failure
Radiographic Image Interpretation, Computer-Assisted
Retrospective Studies
Risk Assessment
Thrombosis / etiology,  prevention & control
Time Factors
Tomography, X-Ray Computed
Treatment Outcome
Gustavo Iacono / ; Giuseppe Panuccio / ; Lydia Romano / ; Luciano Carbonari / ; Andrea Angelini / ; Ospedale di Ancona / ; Luciano Pedrini / ; Luigi Sensi / ; Ospedale Maggiore / ; Stefano Bonardelli / ; Marco Gardani / ; Edoardo Cervi / ; Francesco Spigonardo / ; Cristian Manetta / ; Carlo Pratesi / ; Giovanni Pratesi / ; Roberto Pacchioni / ; Maurizio Tedoli / ; Alessandra Nora / ; Pierfranco Salcuni / ; Alessandro De Troia / ; Giuseppe Bianchi / ; Rocco Giudice / ; Carlo Setacci / ; Francesco Setacci / ; Roberto Adovasio / ; Laura Ukovich /

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