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ORIGINAL ARTICLES  NEW RESULTS IN THE ENDOVASCULAR MANAGEMENT OF ABDOMINAL AORTIC ANEURYSMS 

The Journal of Cardiovascular Surgery 2010 August;51(4):481-91

Copyright © 2010 EDIZIONI MINERVA MEDICA

lingua: Inglese

Rationale and design of the Endurant Stent Graft Na-tural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled

Böckler D., Fitridge R., Wolf Y., Hayes P., Silveira P. G., Numan F., Riambau V. , for the Engage Investigators

1 University of Heidelberg, Heidelberg, Germany; 2 Queen Elizabeth Hospital, Adelaide, Australia; 3 Sourasky Medical Center, Tel-Aviv, Israel; 4 Addenbrookes Hospital, Cambridge, Great Britain; 5 CORIS – UFSC, Florianopolis, Brazil; 6 Memorial Hospital, Istanbul, Turkey; 7 Hospital Clínico de Barcelona, Barcelona, Spain


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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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