Zenith AAA endovascular graft: intermediate-term results of the US multicenter trial.

摘要: Abstract Purpose The intent of this study was to assess the safety and effectiveness Zenith AAA Endovascular Graft compared with conventional aneurysm repair. Material methods conducted in a prospective, multicenter, nonrandomized, concurrent control manner. Physiologically similar patients infrarenal abdominal aortic aneurysms (AAAs) underwent either open surgery or repair Graft. Separate analyses physiologically challenged were performed. Follow-up at hospital discharge 1, 6, 12 months (endovascular group) 1 (open surgical group). Evaluation included computed tomography, radiography, laboratory tests, physical examination. Mortality (AAA-related overall), morbidity, in-hospital recovery, renal function, secondary interventions assessed. Patients endovascular group evaluated for change size, endoleak, graft migration, conversion, rupture, device integrity. Statistical performed Kaplan-Meier method, Blackwelder test, propensity score assessment, two-sample t Yates-corrected Pearson χ 2 Fisher exact test. Results Conventional used 80 patients, 200 Technical success accomplished 98.8% 99.5% group. had fewer significant adverse events within 30 days (80% vs 57%; P = .04). In-hospital recovery procedural measures better all categories ( 5 mm) noted more than two thirds three fourths 24 months. Renal dysfunction rate did not differ between groups. Migration (>5 detected four (2%) through months; none greater 10 mm associated Three conversions months, one because rupture. Secondary procedures common (11% 2.5%; .03). In total, 351 endografts implanted, 6 have barb separations 12-month follow-up. No stent fractures noted. Conclusions is safe effective treatment AAAs. high likelihood decrease size provides evidence that reverses natural history aneurysmal disease. importance long-term follow-up underscored by small but defined incidence separation potential unforeseen failure modes.