One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial
| Autor: | Robert Rhee, Gustavo Oderich, Sukgu Han, Chandler Long, Patrick Muck, Erin Moore, Jon Matsumura, Alex Powell, Patrick Geraghty, Jason Lee, Georges Al-Khoury, W. Charles Sternbergh, William Clouse, Charles Acher, Christopher Smolock, Douglas Hood, Mark Androes, Bjoern Suckow, Jonathan Eliason, Amit Patel, Michael Shih, Mark Mewissen, Alan Lumsden, Christopher DeMaioribus, Michael Freeman, Jessica Titus, Martyn Knowles, William McMillan, Pegge Halandras, Michael Lepore, Brian G. Peterson, Michael Douglas, Maciej Dryjski |
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| Rok vydání: | 2022 |
| Předmět: |
Aged
80 and over Time Factors Endoleak Endovascular Procedures Middle Aged Prosthesis Design United States Blood Vessel Prosthesis Blood Vessel Prosthesis Implantation Postoperative Complications Treatment Outcome Humans Stents Surgery Prospective Studies Cardiology and Cardiovascular Medicine Aged Aortic Aneurysm Abdominal |
| Zdroj: | Journal of Vascular Surgery. 76:951-959.e2 |
| ISSN: | 0741-5214 |
| Popis: | To report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial.The study is a prospective, multicenter, investigational device exemption clinical trial at 31 US sites with core laboratory assessment of imaging and independent event adjudication. The primary safety (incidence of major adverse events at 30 days) and effectiveness end points (successful aneurysm treatment at 1 year) were assessed in a cohort of patients with abdominal aortic aneurysms (AAAs).We enrolled 80 patients between December 19, 2017, and February, 27, 2019. The mean maximum aortic diameter was 57.7 ± 7.95 mm (range, 42.5-82.7 mm) with an average patient age of 73.5 ± 8.14 years (range, 56-96 years). Overall technical success was 100% (80/80). The mean hospital length stay was 1.2 ± 0.6 days (range, 1-4 days). No primary safety end point events were observed, including no death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, procedural blood loss of more than 1000 mL, or thromboembolic events including limb occlusion or distal emboli. There were no type I or III endoleaks detected on the 1-, 6-, or 12-month follow-up computed tomography scans. There were no stent fractures, device migrations (≥10 mm), AAA ruptures, or conversions to open surgical repair observed. Two patients had AAA sac growth of more than 5 mm at 1 year owing to type II endoleaks. There were no aneurysm-related deaths within the 12-month follow-up, and freedom from aneurysm-related mortality was 100% through 1 year.The safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis system has been demonstrated with 98.5% freedom from primary effectiveness end point events at 1 year and 100% freedom from primary safety end point events assessed through 30 days. |
| Databáze: | OpenAIRE |
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