Rationale and design of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled.
J Cardiovasc Surg (Torino)
; 51(4): 481-91, 2010 Aug.
Article
em En
| MEDLINE
| ID: mdl-20671632
ABSTRACT
AIM:
The Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) is a long-term 1200-patient multicenter prospective study initiated to augment the knowledge base (poolable and comparable) about endovascular aortic repair (EVAR) in a real-world population implanted with a single latest-generation stent graft system (Endurant). With enrollment ongoing at 80 high-volume sites, the registry has limited inclusion/exclusion criteria or procedural specification. Technical and clinical data will be reported through 5 years.METHODS:
An interim analysis was performed on investigator-reported data for the first 180 patients enrolled. These patients were asymptomatic elderly males (92.1%) with considerable comorbidities. For 47.3% of the patients, the American Society of Anesthesiologists risk class was either III or IV. The Endurant stent graft was successfully deployed in 99.4% of patients for elective treatment of abdominal aortic aneurysm.RESULTS:
Through 30 days, the rate of all-cause mortality was 1.7% (N=3), with all 3 deaths classified as procedure-related but not device-related. The rate of secondary endovascular procedures was 1.1%, and the rate of conversion to open repair was 0.6%. At postprocedure and at 30-day follow-up, there were no type I or type III endoleaks and no instances of stent graft kinking, thrombosis, or occlusion. ENGAGE represents the largest real-world registry for any single EVAR stent graft.CONCLUSION:
The interim results through 30 days of the first 180 patients enrolled are promising. Longer-term follow-up for more patients will be reported.
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Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
/
Projetos de Pesquisa
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Prótese Vascular
/
Stents
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Sistema de Registros
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Aneurisma da Aorta Abdominal
/
Implante de Prótese Vascular
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Procedimentos Endovasculares
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
País como assunto:
America do sul
/
Asia
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Brasil
/
Europa
/
Oceania
Idioma:
En
Ano de publicação:
2010
Tipo de documento:
Article