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Open surgery (with ligation, aneurysmectomy, and venous or synthetic grafting) has historically been considered the treatment of choice for peripheral and visceral artery aneurysms. More recently, endovascular therapies have evolved to provide successful treatment of aneurysms, reducing the morbidity and mortality associated with open surgery. Today, a plethora of different devices is available for endovascular procedures.1-5
One of the major drawbacks of endovascular treatment is that side branches are generally occluded when using stent-grafts or coils. Also, covered stents need large introducers and have limited flexibility, making them frequently unsuitable for complex anatomies. Trying to overcome these limitations, a novel endovascular device was recently developed. The Cardiatis Multilayer Stent (CMS) is a bare self-expanding device constructed in multiple interconnecting layers of metallic cobalt wire. Due to its peculiar 3-dimensional geometry, the CMS has been reported to slow and laminate blood flow inside an aneurysm, thus theoretically minimizing the chances of aneurysm rupture. By reducing turbulence inside the sac, a CMS encourages the formation of an organized thrombus within the aneurysm. Similarly, the stent is designed to maintain laminar flow directed toward the collateral branches, which should theoretically remain patent after stent placement.6,7 Having a unique design and an uncovered structure, the CMS has been reported to adapt easily to the diameter, morphology, dimension, and course of the target artery. Also, the CMS is provided with a low profile, highly flexible delivery system that seems to allow simpler intravascular deployment in comparison with commercially available stent-grafts. These features should theoretically make CMS an ideal therapeutic device, especially for complex aneurysms with multiple collateral branches or in cases with difficult anatomies not suitable for treatment with traditional stent-grafts. However, this device has been only recently introduced to clinical practice, and evidence of its efficacy is based on case series with limited follow-up. Also, no data regarding superiority or non-inferiority of the CMS compared to other commercial devices are available.
The largest series of CMS use in the periphery was recently reported by Ruffino et al.4 They used the device in 54 patients with peripheral and visceral artery aneurysms located in 12 different districts throughout the body. They reported complete aneurysm thrombosis in 93.3% of 45 patients at 1-year follow-up. Stent occlusion was seen...