Enhanced Delivery System for Direct Visualization of Esophageal Stent Implantation

Abstract

Background: Visualization methods used in stent implantation procedures are often dictated by the delivery method. Direct visualization during the stent implant procedure is possible via side-saddle flexible endoscopy; however, the distal end of the stent is not visible using this method. To enhance direct visualization, an esophageal stent delivery system has been introduced that allows visualization of the entire stent deployment from the distal end to the proximal end. The objective of this study is to describe early observations using this direct visualization deployment system. Methods: The novel device is a covered self-expanding metal stent (SEMS) with a dedicated delivery system. The delivery catheter fits over the endoscope and features a window at the proximal end of the stent. These features allow direct visualization and positioning at both the distal and proximal stent ends. Sixteen stent implants were performed with 14 placements in the esophagus and 2 in the gastric cardia. Results: The stent delivery system allowed direct visualization of the distal and proximal stent ends in all patients. In one patient, the proximal esophageal lumen could not be visualized through the window in the catheter because of friability and consequently bleeding from the tumor. Deployment was executed without complication in 11 cases with good catheter insertion, ease of deployment, stent expansion and ease of catheter removal. In 5 cases, stent placement was also possible, however, tight fibrotic strictures delayed full stent deployment (2 cases) or made repositioning (2 cases) and retraction of the delivery device (1 case) more difficult. Conclusion: The delivery device allows visualization of the distal end of the stent during deployment without the use of fluoroscopy unlike other stent delivery systems. Our initial experience in 16 patients suggests that further modifications to the device, including an increase in flexibility and a tapered tip, would make it suitable to pass more readily through tight strictures. This device is especially useful in stent placements at the GE junction and for real-time visual verification of fistula coverage. Further assessment of the delivery system is needed, however, to provide definitive conclusions.