Success and complications associated with placement of fully covered removable self-expandable metal stents for benign esophageal diseases

Background: Fully covered esophageal self-expandable metal stems (FCSEMSs) are thought to induce less mucosal hyperplasia and are potentially removable. They may constitute an attractive alternative for the treatment of benign esophageal diseases. Objective: To evaluate the efficacy and safety of FCSEMSs in the treatment: of benign esophageal diseases. Design: Patients referred for management of benign esophageal disease underwent placement of an FCSEMS and were entered into a prospective database and analyzed retrospectively for clinical response, efficacy, and morbidity. Setting: Two tertiary care centers with long-standing experience in the management of benign esophageal strictures. Patients: Between January 2006 and September 2007, 35 patients (mean age 61 years, range 20-85 years) underwent FCSEMS placement for benign esophageal diseases at 2 tertiary academic medical centers. There were 19 patients with benign esophageal strictures and 16 patients with leaks/perforations. Intervention: Temporary placement of FCSEMS until stricture resolution. Main Outcome Measurements: Clinical response, efficacy, and morbidity. Results: Indications for stent placement were esophageal leak/fistulae (n = 12), refractory benign strictures (n = 10), anastomotic strictures (n = 7), perforations (n = 4), and radiation-induced strictures (n = 2). Immediate complications were chest pain (2 patients), stent migration (2 patients), dysphagia (1 patient), respiratory compromise (1 patient), and arrhythmia (1 patient). Long-term complications included recurrent dysphagia (6 patients.), aspiration pneumonia (2 patients), globus sensation (2 patients), abdominal pain (2 patients), and fever (1 patient). Stent migration Was observed in 12 patients (34%). After placement, dysphagia scores at 1 month improved significantly from 3.1 +/- 1.0 to 1.2 +/- 1.3 (P < .0001). A total of 11 of 35 patients (31%) were treated successfully. Specifically, 21% of patients with refractory strictures and 44% of patients with leaks/fistulae had successful long-term outcomes without any need for reinterventions. All stems were retrieved successfully, except for 1 stent, which fractured and was retrieved in 2 pieces without any complications. Conclusion: Use of FCSEMSs for benign esophageal conditions was associated with frequent stent migration and long-term improvement in only one third of patients. Further investigation is required before recommending FCSEMS placement to treat benign diseases of the esophagus and to further characterize the subgroup that might benefit from these interventions. (Gastrointest Endosc 2011;73:673-81.)