OBJECTIVES:
We evaluated whether the presence of aortic neck anatomy that falls outside of the instructions for use (IFU) predicts increased aneurysm related complications following EVAR.
METHODS:
Between 1/05 and 12/06, 199 patients underwent EVAR with Zenith endografts. Sixty patients (30%) had anatomic aortic necks in preoperative imaging that violated IFU (<15mm in length, >60 degrees angulation). Inverted conical neck shape alone or ruptured AAA were not included as IFU violations. All patients were followed with serial CTA/MRA with 3D reconstruction for evidence of graft migration, endoleak, or sac enlargement.
RESULTS:
Primary technical success was achieved in 100% of the patients. There were no perioperative deaths, ruptures, or open conversions. Three patients (1 with a hostile neck) were lost to follow-up. Mean follow-up was 15.9 + 10.4 months. There were no initial or delayed type I or type III endoleaks in either group. There were no graft migrations in either group detected on CT or MR angiograms. The complication rate, secondary interventions, and aneurysm enlargement were 4.5%, 3.4%, and 1.7% for patients who fell outside the IFU compared with 6.0%, 5.1%, and 2.2% for those within the IFU (p= NS.). The development of type II endoleaks was higher in patients that met IFU specifications (3.4% vs. 16.9%, p< 0.02).
CONCLUSIONS:
Midterm results of outcomes after Zenith endograft placement show that patients with unfavorable neck anatomy can be treated safely and effectively. Rates of complications, graft migration, secondary interventions, or sac enlargement equal those in patients with more favorable aortic neck anatomy. However, longer follow-up is needed to confirm sustained benefit in this high anatomic risk group of patients.