Translumenal applications of a novel EUS-guided lumen apposition stent

Introduction: Tubular stents designed for ductal drainage have been used for endoscopic translumenal drainage of the gallbladder, pseudocysts, and extraintestinal fluid collections. Limitations are the potential for leakage, migration, and trauma to the surrounding tissue. Purpose: To evaluate a novel lumen apposition stent (LAS) for the following translumenal applications: 1) gallbladder drainage; 2) gastro-enteric bypass; 3) creation of a NOTES port. Methods: LAS devices were implanted in acute and survival animals (swine) under general anesthesia. The LAS is made of braided nitinol wire and fully coated to prevent tissue ingrowth, leakage, and enable removability. Dual-flanged anchors provide lumen-to-lumen apposition. Fully expanded, the flange & body diameters measure 20mm and 10mm, respectively. The LAS is constrained onto a 10.5Fr delivery catheter and deployed with a proprietary handle that luer-locks onto the inlet port of a 3.7mm channel echoendoscope. A standardized 4-step technique was used: 1) Lumen access with 19G needle; 2) Tract dilation with 4mm balloon; 3) LAS deployment across the tract; 4) LAS lumen dilation with a 10mm balloon. Translumenal endoscopy using an ultraslim 5.9mm gastroscope was performed across the deployed LAS. Survival animals underwent endoscopy at weekly intervals. Results: Devices were successfully deployed under EUS-guidance from the stomach lumen into each of the following target lumens: 1) gallbladder; 2) colon; 3) peritoneum. After dilation, the gastroscope could be easily advanced through the LAS into the target lumen. The LAS stabilized the endoscope for translumenal interventions. Gallbladder: mucosa inspected, cystic duct identified. Bowel: mucosa inspected, advancement into afferent and efferent limbs, retroflexion view of LAS possible. NOTES port: biopsies obtained from organ surfaces, small bowel grasped with forceps and pulled into the stomach through the LAS. Follow-up for 5 weeks: the LAS remained stable, patent, and the covering intact without tissue ingrowth or overgrowth. One device was removed with a snare at 4 weeks. Gross necropsy showed the devices were well-tolerated by the surrounding tissue. Conclusion: 1. EUS-guided deployment of the LAS is feasible and safe. 2. The LAS enables a robust, reliable, and removable lumen approximating conduit for translumenal endoscopic procedures.