Fully covered removable nitinol self-expandable metal stents (SEMS) in malignant strictures of the esophagus: a multicenter analysis.

Background: Fully covered esophageal self-expandable metallic stents (SEMS) often are used for palliation of malignant dysphagia. However, experience and data on these stents are still limited. The purpose of this multicenter study was to evaluate the efficacy and safety of fully covered nitinol SEMS in patients with malignant dysphagia.

Methods: 37 patients underwent placement of a SEMS during a 3 year period. Five patients underwent SEMS placement as a bridge to surgery: one for tracheoesophageal fistula in the setting of squamous cell carcinoma of the esophagus, one for perforation in setting of esophageal adenocarcinoma, 27 for unresectable esophageal cancer (16 adenocarcinoma, 11 squamous cell carcinoma), two for lung cancer, and one for breast-cancer-related esophageal strictures.

Results: SEMS placement was successful in all 37 patients. Immediate complications after stent deployment included chest pain (n = 6), severe heartburn (n = 1), and upper gastrointestinal bleeding requiring SEMS revision (n = 1). Dysphagia scores improved significantly from 3.2 ± 0.4 before stent placement to 1.4 ± 1.0 at 1 month (P < 0.0001), 1.1 ± 1.2 (P < 0.0001) at 3 months, and 1.3 ± 1.4 (P = 0.0018) at 6 months. The stent was removed in 11 patients (30%) for the following indications: resolution of stricture (n = 3), stent malfunction (n = 5), and stent migration (n = 3). After stent removal, three patients were restented, three underwent dilation, and two underwent PEG placement. Mean survival for the 37 patients after stent placement was 146.3 ± 143.6 (range, 13-680) days.

Conclusions: Our study suggests that fully covered SEMS placement improve dysphagia scores in patients with malignant strictures, particularly in the unresectable population. Further technical improvements in design to minimize long-term malfunction and migration are required.