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https://hdl.handle.net/2440/63784
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DC Field | Value | Language |
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dc.contributor.author | Bockler, D. | - |
dc.contributor.author | Fitridge, R. | - |
dc.contributor.author | Wolf, Y. | - |
dc.contributor.author | Hayes, P. | - |
dc.contributor.author | Silveira, P. | - |
dc.contributor.author | Numan, F. | - |
dc.contributor.author | Riambau, V. | - |
dc.date.issued | 2010 | - |
dc.identifier.citation | The Journal of Cardiovascular Surgery: a journal on cardiac, vascular and thoracic surgery, 2010; 51(4):481-491 | - |
dc.identifier.issn | 0021-9509 | - |
dc.identifier.issn | 1827-191X | - |
dc.identifier.uri | http://hdl.handle.net/2440/63784 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | D. Böckler, R. Fitridge, Y. Wolf, P. Hayes, P. G. Silveira, F. Numan, V. Riambau | - |
dc.description.uri | http://www.ncbi.nlm.nih.gov/pubmed/20671632 | - |
dc.language.iso | en | - |
dc.publisher | Edizioni Minerva Medica | - |
dc.rights | Copyright status unknown | - |
dc.subject | ENGAGE Investigators | - |
dc.subject | Humans | - |
dc.subject | Aortic Aneurysm, Abdominal | - |
dc.subject | Tomography, X-Ray Computed | - |
dc.subject | Aortography | - |
dc.subject | Treatment Outcome | - |
dc.subject | Blood Vessel Prosthesis Implantation | - |
dc.subject | Reoperation | - |
dc.subject | Registries | - |
dc.subject | Risk Assessment | - |
dc.subject | Risk Factors | - |
dc.subject | Prospective Studies | - |
dc.subject | Prosthesis Design | - |
dc.subject | Product Surveillance, Postmarketing | - |
dc.subject | Blood Vessel Prosthesis | - |
dc.subject | Stents | - |
dc.subject | Research Design | - |
dc.subject | Time Factors | - |
dc.subject | Aged | - |
dc.subject | Aged, 80 and over | - |
dc.subject | Brazil | - |
dc.subject | Israel | - |
dc.subject | Australia | - |
dc.subject | Europe | - |
dc.subject | Female | - |
dc.subject | Male | - |
dc.subject | Kaplan-Meier Estimate | - |
dc.subject | Endovascular Procedures | - |
dc.subject | Elective Surgical Procedures | - |
dc.title | 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 | - |
dc.type | Journal article | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Fitridge, R. [0000-0001-6258-5997] | - |
Appears in Collections: | Aurora harvest Surgery publications |
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