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
| Autor: | Böckler D, Fitridge R, Wolf Y, Hayes P, Pg, Silveira, Numan F, Riambau V, Engage, Investigators |
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| Rok vydání: | 2010 |
| Předmět: |
Male
Reoperation Time Factors Kaplan-Meier Estimate Prosthesis Design Aortography Risk Assessment Blood Vessel Prosthesis Implantation Risk Factors Product Surveillance Postmarketing Humans Prospective Studies Registries Israel Aged Aged 80 and over Endovascular Procedures Australia Blood Vessel Prosthesis Europe Treatment Outcome Elective Surgical Procedures Research Design Female Stents Tomography X-Ray Computed Brazil Aortic Aneurysm Abdominal |
| Zdroj: | Europe PubMed Central |
| ISSN: | 0021-9509 |
| Popis: | 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.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.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.The interim results through 30 days of the first 180 patients enrolled are promising. Longer-term follow-up for more patients will be reported. |
| Databáze: | OpenAIRE |
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