3530 ANTI-REFLUX SELF-EXPANDING METAL ESOPHAGEAL STENT: CLINICAL EVALUATION IN PATIENTS.

Abstract

Introduction: SMES are used for palliation of malignant dysphagia. However, when deployed across the gastroesophageal (GE) junction, they can predispose to GE reflux and related complications. In a previous study on dogs, we showed that the Z-25-18, AR-SMES (Wilson-Cook, NC) was effective in preventing GE reflux. Aim: The aim of this study was to evaluate the clinical efficacy of the AR-SMES in patients with malignant dysphagia. Methods: 11 patients (age 68±12SD) referred for palliation of malignant dysphagia (adenoca 9, sq.ca 1, adeno & sq.ca 1) with involvement of the GEJ were prospectively studied. Two of these patients presented with reflux symptoms after having a different SMES (Ultraflex 1, Wallstent 1) placed across the GEJ. The AR-SMES was placed across the GEJ in all patients using standard techniques. All patients underwent a barium study after stent placement. Pre and post-stent dysphagia score (0- 4), Karnofsky Performance Status (KFS, 8 pts) and symptoms of heartburn and regurgitation (visual analog scale 0-10, 10 severe; 8 pts) were recorded. Patients were followed up at regular intervals. Results: Post stent barium study showed free ante grade flow of barium in all patients. This correlated with significant improvement in dysphagia score (Table). Reflux provocation by head tilting to -30o (done in 7 pts) showed no reflux of barium. Although the anti-reflux valve can invert at high-pressure gradients, the mean daytime heartburn and regurgitation scores were 0.3±0.3 and 0.7±0.4 respectively (Table) and no patient complained of nocturnal symptoms. Median follow up was 8 weeks (range 1 day to 37 weeks). Conclusions: AR-SMES is effective is relieving dysphagia and, as previously shown in animal studies, when deployed across the GEJ, AR-SMES is also effective in preventing GE reflux in humans.