WALLSTENT® esophageal prosthesis: Post-market surveillance study

Palliation of esophageal carcinoma has included esophageal prosthesis insertion. Recently, a self-expanding, silicone-covered, WALLSTENT has been introduced. The purpose of this nation-wide, post-market surveillance study was to evaluate the safety, efficacy and morbidity associated with this new stent. METHODS: Survey forms were sent to 56 gastroenterologists who had placed WALLSTENTS. The completed forms were tabulated by MedProbe™, Inc. Demographic data, symptomatology and treatments preand post stent placement as well as morbidity and mortality at 0, 30, and 60 days were analyzed. Dysphagia scores were: 0 - no dysphagia; 1 - solids; 2 - semi-solids; 3 - liquids and 4 -unable to swallow. RESULTS: 101 (27%) forms were returned; the patients' mean age at diagnosis was 68.5 years and male:female ratio was 3.6/1.00. The average time after diagnosis to stent placement was 220 days ± 408 SD; average time of follow-up after diagnosis was 280 days ± 404 SD. Average length of stricture was 5.9 ± 3.6 cm with the majority of the strictures (89%) located at/or distal to the mid-esophagus. 31/101 patients (31%) were alive at 60 days post stent placement. The mean pre-stent dysphagia score was 3, 1.5 at 48 h. and 1.2 at 30 days post-stent. There was a significant improvement (p<0.01) at 48 h. and 30 days after stent placement. The complication rate at the time of stent placement was 12%; 24/100 (24%) at 48 h. and 32/95 (34%) after 48 h. Immediate complications included: failure to deploy - 3; difficulty removing the stent catheter system - 3; perforation - 2; aspiration - 1; inadequate placement -1; and unspecified - 2. Complications at 48 h, included moderate/severe pain 15 (15%); aspiration 3 (3%), nausea & vomiting 3 (3%); GI bleed 2 (2%) and stent migration 2 (2%). Complications beyond the 48-hour period were: moderate/severe pain 14 (14%); GI bleed 9 (9%); tumor overgrowths (5%); aspiration 2 (2%) and stent migration 1 (1%). CONCLUSION: 1) Self-expanding, silicone-covered WALLSTENT results in significant improvement in dysphagia; 2) immediate placement complications occur in 12% of patients; 3) pain is the most frequent complication (15%) at 48 h. and beyond; 4) stent migration occurs in 3% of patients and tumor overgrowth occurs in 5%. SUMMARY: WALLSTENTS offer excellent palliation of dysphagia with acceptable morbidity and mortality rate.