Endovascular treatment of visceral artery aneurysms with Cardiatis multilayer flow modulator: preliminary results at six-month follow-up

Abstract

Aim: The aim of this study was to analyze our initial experience with Cardiatis multilayer flow modulator and value its efficacy in the treatment of visceral artery aneurysms (VAA) at one and six months follow up in terms of aneurysms exclusion, patency of collateral vessels (when present) and shrinkage of the lesion.

Methods: Between June 2009 and June 2010, 19 patients (13 men and 6 women, mean age 60 years, range 19-86) with true visceral aneurysms underwent endovascular procedure with Cardiatis multilayer peripheral flow modulator in 12 clinical centers (10 vascular interventional radiology and 2 vascular surgery). The site of aneurysmal lesions was splenic artery in five cases (26.3%), hepatic artery in five cases (26.3%), celiac trunk in three (15.8%), superior mesenteric artery in two cases (10.5%), renal artery in three (15.8%) and gastroduodenal artery in one case (5.3%). The mean size of all the VAAs was 32.75 mm (±21.6). Early results in term of mortality and complications were evaluated. Follow-up consisted of clinical and CT scan examination at 1 and 6 months with particular attention to sac thrombosis, patency of the stent and collateral vessels (when present) and shrinkage/diameter reduction of the lesion.

Results: Technical success was achieved in all patients. The one perioperative death was due to pulmonary embolism at 24 hours yielding a perioperative mortality rate of 5.3% (1/19 patients). We had not major or access related complications. In two cases we had stent occlusion (one at 48 hours and another at two weeks) leading to a stent patency rate at one month of 87.5% (14/16 patients). At the CT scan performed at one month follow-up we achieved sac thrombosis in 14/16 patients (87.5%) with patency of collateral vessels; the mean size of all the visceral artery aneurysms was 31.68 mm (±21.9). At six-month follow-up we still had complete sac thrombosis in 14/16 patients (87.5%) and patency of stent and collateral vessels in all cases. The mean size of all the lesions at this scheduled control was 27.6 mm (±21.1) with shrinkage of the lesions in 12/16 cases (75%) (shrinkage range 2-15 mm, mean 5 mm ±4.7, P=0.0006, P<0.05).

Conclusion: Even if our study has some limitations and longer follow-up is needed, preliminary results showed Cardiatis multilayer flow modulator to be a reliable tool for endovascular aneurysms exclusion of visceral artery aneurysms even in those lesions with collateral vessels arising from the sac or the neck with complete aneurysm thrombosis and shrinkage of the lesion at six-month follow-up. Overcoming limitations of traditional endovascular devices for visceral artery aneurysms exclusion, this new device allows a broaden number of patients, not suitable before for minimally invasive treatment, to undergo exclusion of these lesions with endovascular approach.