Abstract

ObjectiveAortic arch aneurysms and thoracoabdominal aortic arch aneurysms are technically challenging to manage by established surgical and endovascular methods. The Streamliner Multilayer Flow Modulator device (Cardiatis, Isnes, Brussels, Belgium) offers an unorthodox option for these high-risk cases. The Streamliner device for aortic arch repair (STAR) study investigated complex aneurysm cases managed by the Streamliner Multilayer Flow Modulator device and offers an analytic solution for a clinical dilemma. MethodsSix cases were included, with a 1-year follow-up, comprising 4 pure arch aneurysms and 2 thoracoabdominal aortic arch aneurysms Crawford type I, from a multicenter database hosted by the Streamliner Multilayer Flow Modulator Global Registry. A total of 50% of cases were performed under instructions for use. All were American Society of Anesthesiology IV and originated from zone 0. All cases were computationally analyzed, which consisted of (1) simulating the treatment on the basis of the postoperative data, (2) repositioning the stents for the failed technical cases, and (3) assessing the effects of overlapping devices on branch patency. ResultsCorrect device placement induced aneurysm flow streamlining, which reduced the dynamic pressure by 23% to 66%, whereas incorrect placements promoted Failure Mode I with 58% and 16% dynamic pressure increases and aneurysm volume expansion up to 23%. Overlapped devices improved distal perfusion by increasing arch branch outflows from 5% to 24%. The Streamliner Multilayer Flow Modulator device does not benefit a sac volume greater than 400 cm3. ConclusionsThe Streamliner Multilayer Flow Modulator device is a new technology that can manage complex aortic arch aneurysms and thoracoabdominal aortic arch aneurysms with favorable clinical outcomes if it is performed under instructions for use. Careful procedure planning and perioperative virtual stent placement will avoid foreshortening, prevent inadequate stent overlap lengths, and provide insight into the sufficient numbers of required implanted devices.

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