The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial.

摘要: The aim of the study was to review results abdominal aortic aneurysm (AAA) repair with Powerlink Bifurcated endovascular graft, when compared open AAA repair. A prospective, controlled, multicenter trial System for (EVAR) conducted at 15 sites as part a pivotal FDA trial. Between July 2000 and March 2003, 258 patients were enrolled (192 test 66 control patients). Stent grafts oversized by 10-20% relative computed tomography (CT)-based diameter measurements. All repairs performed in operating room through one surgically exposed femoral artery contralateral 9 French sheath percutaneously placed. Results assessed using contrast-enhanced CT plain X-rays 1, 6, 12 months annually postoperatively. Mean follow-up 36 available. Technical success achieved 97.9% patients, 4 failed insertions: 3 early conversions deployment issues access failure. There significant difference 30-day mortality between (1%) (6.1%) only 1 death procedure-related (P=0.0389). Blood loss (341 mL vs 583 mL, P<0.0001), operative time (136 min 222 min, Intensive Care Unit (ICU) stay (0.78 days 4.1 days, P<0.0001) hospital length (3.3 9.5 significantly less cohort controls. Secondary procedures have been on 16 post-implant 48 follow-up. At first month scan, endoleaks noted 25 yielding endoleak rate 22.3%. Type II predominated there no type III or IV endoleaks. 4-year endoleak-free survival 73%. No I, reported post-implant. ruptures, graft fabric defects wire fractures. Sac regression 83% patients. Significant reduction mean volume over every interval. In comparison 1-month 2 had an increase 5 mm months. system appears be safe, effectively protects from rupture period. stent materials are still free failure fatigue. Contralateral limb (9 Fr) facilitates placement disadvantaged routes. EVAR produces adverse events than Continued longer term is necessary assure durability these results.