Use of a balloon-expandable sheath for transfemoral complex endovascular aortic repair

Authors' Note: On April 30, 2019, Terumo Medical Corporation issued a voluntary product recall for and discontinued manufacturing of the SoloPath Balloon Expandable Sheath System, the device used for the procedures outlined in this article. Data collection, data analysis, and manuscript submission occurred prior to notice of this recall. The authors of this article were unaware of adverse events associated with this device and the 15 procedures reviewed for this series were free of events related to the reason for this device recall. Management of iliac artery disease remains a challenging problem in the setting of complex endovascular aortic procedures. In spite of the nonavailability of the device outlined in this article, the authors feel that the value of innovative solutions to this clinical problem (including the use of a balloon expandable sheath) merits public review of this technique and its results. Vascular access complications contribute to the morbidity of fenestrated endovascular aneurysm repair (FEVAR). As the ability to perform these procedures progresses, new techniques emerge to overcome difficult peripheral vascular anatomy and to minimize these complications. We describe our use of a balloon-expandable sheath to accommodate the multiple accesses needed for bridging stent placement during FEVAR in patients with highly calcified, tortuous, or small-diameter access vessels. We used this sheath for successful completion of FEVAR in 15 patients with challenging iliofemoral disease. There was one iliofemoral complication and no limb loss. Given the significant source of morbidity that vascular access complications contribute to endovascular procedures, we believe that a balloon-expandable sheath is a useful adjunct in FEVAR with complex iliac anatomy.