Endovascular repair of peripheral and visceral aneurysms with the Cardiatis multilayer flow modulator: one-year results from the Italian Multicenter Registry.

PURPOSE To assess the efficacy of the Cardiatis multilayer flow modulator (CMFM), a bare cobalt alloy self-expanding stent, in the treatment of peripheral and visceral artery aneurysms. METHODS In this multicenter (n=22), prospective, voluntary registry, 54 patients (47 men; mean age 68 years, range 19-87) who underwent CMFM deployment for peripheral (n=35) or visceral aneurysms (n=19) in a variety of target arteries were enrolled between June 2009 and June 2010. Among the 54 lesions, 44 had a total of 53 side branches. The main effectiveness endpoint was stent and side branch patency with no aneurysm rupture or reperfusion at 1, 6, and 12 months after stent implantation. Outcome measures were complete aneurysm thrombosis and sac shrinkage. The safety endpoint was freedom of complications (death, aneurysm rupture, endoleak, need for reintervention, stent foreshortening, stent occlusion, and access-site sequelae). Aneurysms were categorized as saccular (type I) or fusiform (type II) without a side branch or with branch(es) in the sac (subtype A), neck (subtype X), or both (subtype AX). Kaplan-Meier estimates were calculated for primary and secondary endpoints. Sac shrinkage was correlated to aneurysm morphology subtypes and presence/absence of mural thrombus. RESULTS Technical success was achieved in all patients. Mortality at 1 year was 5.5% (n=3), including 1 perioperative death. Six patients were lost to follow-up. There was no aneurysm rupture. Six (11.1%) stents occluded over the 1-year period; 3 asymptomatic patients were not treated, 2 symptomatic patients had successful stent dilation to restore patency, and 1 symptomatic patient required bypass (the only side branch lost). Cumulative primary and secondary patency estimates were 86.9% and 90.7% at 1 year. The cumulative side branch patency was 96.1% and the freedom from all complications was 83.0% at 1 year. Complete aneurysm thrombosis was recorded in 42 (93.3%) of 45 patients at 1 year. Percent diameter reduction was 15.5%, 3.8%, and 11.0% at 1, 6, and 12 months (p<0.05), respectively. Presence of mural thrombus did not influence the time course of shrinkage (p>0.05), while complex lesion anatomy (presence of side branches) delayed shrinkage (p<0.05). CONCLUSION Results at 1 year show that CMFM can be safely used in the treatment of PAA and VAA, with good results in terms of freedom from rupture, patency of the stents and side branches, complete aneurysm thrombosis, shrinkage, and acceptable freedom from morbidity and mortality.