Use of the EvolutionTM Fully Covered Self-Expandable Metal Stent for the Endoscopic Therapy of Esophageal Leaks

Abstract

Purpose: Fully covered self-expandable metal stents (FCSEMS) have been utilized increasingly in the endoscopic therapy of benign esophageal conditions, thereby obviating the need for surgery. We present our experience with the use of the Cook Medical EvolutionTM FCSEMS for esophageal leaks, highlighting its efficacy and safety. Methods: We undertook a retrospective case review of patients with esophageal leaks in whom the EvolutionTM FCSEMS was utilized, analyzing for technical success with stent placement and removal, stent migration, treatment success and complications. Results: Twenty-one FCSEMS were placed in 8 patients from April 2011 to March 2012. Causes for esophageal leaks include 6 post-surgical leaks, 1 traumatic injury, and 1 tracheoesophageal fistula in a patient who received radiation for NSCLC. Surgery included esophageal adenocarcinoma (n=3, two of whom received neo-adjuvant chemo-radiotherapy), esophageal diverticulum (n=1), achalasia (n=1), and hiatal hernia repair (n=1). Six (75%) were male with the median age 62 (range 47-70) years. The median time from surgery to stent placement was 43 days (range 1-169). Median size of defect as assessed endoscopically was 23 mm (range 5-70 mm). Immediate closure of the leak was achieved in 9/21 (43%) endoscopies, confirmed by radiologic studies. However, of the 12/21 (57%) unsuccessful closures, 6 occurred in 1 patient who had a 70 mm defect. Median time from stent deployment to re-positioning or removal was 20 days (range 3-47). We report a 100% successful uncomplicated removal rate. 9/21 (43%) stents migrated, causing a clinically significant leak requiring re-positioning or repeat stenting. Eventual closure of esophageal leak was reported in 3/8 (38%) patients, after 9, 28 and 87 days of stenting, with initial 5 mm, 10 mm, and 60 mm defects respectively. A total of 10 endoscopies and 7 FCSEMs were required to achieve this result. Of the patients with persistent leak, 1 patient with a 10 mm defect had considerable reduction in the amount of leak post FCSEMS removal at day 203 of follow up. Three patients with 10 mm, 20 mm, and 70 mm defects are still undergoing continued endoscopic management with esophageal stents in situ, at day 149, 197, and 121 of follow up respectively. The patient with a 5 mm defect from TE fistula currently has a stent in place with plans for removal in 20 days. Conclusion: The EvolutionTM fully covered esophageal stent has moderate clinical efficacy in the treatment of esophageal leaks. Though it may obviate further surgery, multiple endoscopies and numerous stents may be needed for a successful long-term outcome. This is due in part to stent migration and the size of the initial defect. They are however, reliable to deploy and safely removable with ease.