AXIOS stents: not a solution to every problem – or the problems will keep surfacing

Comment on: Failure of release of the Hot AXIOS distal flange: "handle springing" as a rescue technique Endoscopy eFirst DOI: 10.1055/a-2800-4292 10.1055/a-2800-4292 On the eve of the 16th International Symposium on Endoscopic Ultrasonography (EUS) in San Francisco in 2008, a working group of 20 international experts convened to chart a roadmap for interventional EUS, a discipline then in its infancy [ 1 ]. Among the group’s key recommendations was the development of dedicated devices to facilitate EUS-guided drainage of pancreatic fluid collections (PFCs). In response, Xlumena Inc. developed the cautery-enhanced AXIOS lumen-apposing metal stent (LAMS) and delivery system [ 2 ]. Following Xlumena’s acquisition by Boston Scientific Corporation in 2015, the clinical footprint of the AXIOS stent expanded beyond PFC drainage to include gallbladder drainage for symptomatic acute cholecystitis. Subsequently, and largely off-label, the stent has been adopted for an increasingly broad range of complex interventions, including palliation of malignant distal biliary obstruction, creation of a gastroenterostomy in gastric outlet obstruction, and EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) in patients with Roux-en-Y gastric bypass [ 3 ]. As with many transformative medical devices, this expansion has been accompanied by a series of “red flag” signals, each prompting incremental clinical or technical adaptations. The first such signal was reported by our group in 2016, during a randomized trial comparing the AXIOS with double-pigtail plastic stents for PFC drainage [ 4 ]. Prolonged LAMS indwelling, beyond 3–4 weeks, was associated with bleeding due to mechanical friction against adjacent vasculature, which led to recommendations for early LAMS removal or exchange to plastic stents. Subsequent challenges emerged with biliary applications, where stent dysfunction prompted the adjunctive placement of double-pigtail plastic stents to optimize axis orientation [ 5 ]. Perforation has also been reported when the stent is deployed in nondilated bile ducts (