The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial.
The aim of the study was to review the results of abdominal aortic aneurysm (AAA) repair with the Powerlink Bifurcated endovascular graft, when compared with open AAA repair. A prospective, controlled, multicenter trial of the Powerlink System for endovascular abdominal repair (EVAR) was conducted at 15 sites as part of a pivotal FDA trial. Between July 2000 and March 2003, 258 patients were enrolled (192 test and 66 control patients). Stent grafts were oversized by 10-20% relative to computed tomography (CT)-based diameter measurements. All repairs were performed in the operating room through one surgically exposed femoral artery and a contralateral 9 French sheath percutaneously placed. Results were assessed using contrast-enhanced CT and plain abdominal X-rays at 1, 6, and 12 months and annually postoperatively. Mean follow-up of 36 months was available. Technical success was achieved in 97.9% of patients, with 4 failed insertions: 3 early conversions for deployment issues and one access failure. There was a significant difference in 30-day mortality between Powerlink (1%) and control (6.1%) patients and only 1 death was procedure-related (P=0.0389). Blood loss (341 mL vs 1 583 mL, P<0.0001), operative time (136 min vs 222 min, P<0.0001), Intensive Care Unit (ICU) stay (0.78 days vs 4.1 days, P<0.0001) and hospital length of stay (3.3 days vs 9.5 days, P<0.0001) were significantly less in the Powerlink cohort compared with controls. Secondary procedures have been performed on 16 patients post-implant to 48 months follow-up. At the time of the first month CT scan, endoleaks were noted in 25 patients, yielding a 30-day endoleak rate of 22.3%. Type II endoleaks predominated and there were no type III or IV endoleaks. The 4-year endoleak-free survival rate was 73%. No Type I, III or IV endoleaks were reported at 48 months post-implant. There have been no ruptures, graft fabric defects or wire fractures. Sac regression was noted in 83% of patients. Significant reduction in mean AAA diameter and volume was noted over every follow-up interval. In comparison to the 1-month post-implant CT scan, 2 patients had an increase in AAA diameter 5 mm at 48 months. The Powerlink system appears to be safe, and effectively protects patients from AAA rupture over the follow-up period. The graft and stent materials are still free from failure and fatigue. Contralateral limb access (9 Fr) facilitates graft placement in patients with disadvantaged access routes. EVAR performed with the Powerlink produces significantly less early adverse events than open AAA repair. Continued follow-up over the longer term is necessary to assure the durability of these results.
Carpenter
J P
JP
University of Pennsylvania, Philadelphia, PA 19104, USA. jeffrey.carpenter@uphs.upenn.edu
D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000601:surgery*; D001019:Aortic Rupture / Q000209:etiology / Q000517:prevention & control; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004869:Equipment Safety / Q000295:instrumentation; D005500:Follow-Up Studies; D006801:Humans; D007902:Length of Stay; D011474:Prosthesis Design / Q000295:instrumentation; D015607:Stents; D016019:Survival Analysis; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014481:United States