Durability of aortouniiliac endografting with femorofemoral crossover: 4-year experience in the Evt/Guidant trials.

OBJECTIVES We evaluated mid-term results of the multicenter EVT/Guidant aortouniiliac endograft (AI) trial and ascertained the durability of this endovascular technique in patients unable to undergo standard bifurcated endografting. METHODS From November 1996 to December 1998, 121 patients were enrolled to receive the AI device on the basis of complex iliac artery anatomy contraindicating bifurcated endografting. Clinical data were centrally collected, and radiographic data were evaluated by core facility. RESULTS AI placement was technically successful in 113 of 121 patients. At operation, patients who underwent AI had significantly more arrhythmias, congestive heart failure, and peripheral occlusive disease (P <.05) compared with patients who underwent open aneurysmorrhaphy in the EVT/Guidant trials, indicating comorbid features in this anatomic cohort. Distal AI attachment was performed to the external iliac artery in 40 (36%) patients. Median follow-up was 38 months. In the AI group, overall aneurysm diameter decreased over the duration of study from 54.4 +/- 9.6 mm to 44.4 +/- 16.4 mm (P =.004). At 24 and 36 months after repair, reduction in aneurysm size was associated with absence of endoleak (P =.003 and P =.008, respectively). Aneurysms shrunk or remained stable in 109 (96.5%) patients. Endoleak was identified in 52.3% of patients at discharge, and at follow-up in 30.9% at 1 year, 34.8% at 2 years, 28.6% at 3 years, and 30.4% at 4 years. Type II endoleak predominated. Leak from failure to completely occlude contralateral iliac flow accounted for 8 of 58 endoleaks (13.8%) at discharge. Sixteen patients (14.2%) underwent postoperative endoleak treatment; in one of these patients open conversion was necessary at 20 months. Post-procedure thigh or buttock claudication developed in 16 patients (14.2%). Thirteen patients (81.3%) had either distal attachment in the external iliac artery or contralateral type IIA occlusion. Fifteen patients (13.3%) required intervention because of reduced limb flow; one of these patients underwent open conversion at 27 months, and another underwent axillofemoral grafting at 28 months. Device migration was confirmed in 2 (1.8%) patients, without current clinical sequelae. Whereas no femorofemoral graft thromboses occurred, graft infection developed in 3 patients (2.6%). During follow-up, aneurysm in 2 patients ruptured. Late death occurred in 41 patients (36.3%). Twenty-four patients (58.5%) died of cardiopulmonary disease; one death was endograft-related after aneurysm rupture; and one death was related to femorofemoral bypass infection. Actuarial survival was 78.4% (95% confidence interval [CI], 71%-86%) at 2 years and 63.4% (95% CI, 54%-73%) at 4 years. CONCLUSIONS In patients with significant comorbid conditions and complex iliac anatomy unfavorable for bifurcated endografting, AI with femorofemoral bypass grafting is safe and effective. In most patients this endovascular option provides satisfactory mid-term results.