Efficacy and safety of a new fully covered self-expandable non-foreshortening metal esophageal stent

• Published in: Gastrointestinal endoscopy 2014-10, Vol.80 (4), p.577-585
• Main Authors: Dua, Kulwinder S., MD, FASGE, FACP, FRCP, Latif, Sahibzada U., MD, Yang, Juliana F., MD, Fang, Tom C., MD, Khan, Abdul, MD, Oh, Young, MD
• Format: Article
• Language: English
• Subjects: Aged; Cohort Studies; Deglutition Disorders - etiology; Deglutition Disorders - therapy; Esophageal Stenosis - complications; Esophageal Stenosis - pathology; Esophageal Stenosis - therapy; Esophagoscopy - methods; Female; Follow-Up Studies; Gastroenterology and Hepatology; Humans; Male; Metals; Middle Aged; Patient Safety; Prosthesis Design - methods; Quality of Life; Retrospective Studies; Severity of Illness Index; Statistics, Nonparametric; Stents; Tertiary Care Centers; Treatment Outcome
• ISSN: 0016-5107; 1097-6779
• DOI: 10.1016/j.gie.2014.02.005

Background Fully covered esophageal self-expandable metal stents (SEMSs) are potentially removable but can be associated with high migration rates. For precise positioning, non-foreshortening SEMSs are preferred. Recently, a new fully covered non-foreshortening SEMS with anti-migration features was introduced. Objective To evaluate the efficacy and safety of this new esophageal SEMS. Design Retrospective study. Setting Single, tertiary-care center. Patients Consecutive patients with malignant and benign strictures with dysphagia grade of ≥3 and patients with fistulas/leaks were studied. Interventions Stent placement and removal. Main Outcome Measurements Technical success in stent deployment/removal, efficacy in relieving dysphagia and sealing fistulas/leaks, and adverse events. Results Forty-three stents were placed in 35 patients (mean [± standard deviation] age 65 ± 11 years; 31 male), 24 for malignant and 11 for benign (5 strictures, 6 leaks) indications. Technical success in precise SEMS placement was 100%. The after-stent dysphagia grade improved significantly (at 1 week: 1.5 ± 0.7; at 4 weeks: 1.2 ± 0.4; baseline: 3.8 ± 0.4; P  < .0001). Twenty stents were removed for clinical indications, with technical success of 100%. All leaks sealed after SEMS placement and did not recur after stent removal. All benign strictures recurred after stent removal. Adverse events included migration (14%), chest pain (11%), and dysphagia from tissue hyperplasia (6%). There was no stent-related mortality. Limitations Nonrandomized, single-center study. Conclusion The new esophageal SEMS was effective in relieving malignant dysphagia, allowed for precise placement, and was easily removable. It was effective in treating benign esophageal fistulas and leaks. Stent-related adverse events were acceptable.