Endoscopic implantation of enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial.
OBJECTIVE
This study aimed to assess the efficacy and safety of endoscopically implanting a nonresorbable biocompatible polymer (Enteryx) in the distal esophagus and proximal gastric cardia for the treatment of gastroesophageal reflux disease (GERD).


METHODS
In a prospective, multicenter, international trial, 85 well-controlled GERD patients who were receiving chronic proton pump inhibitor (PPI) therapy underwent Enteryx implantation under fluoroscopic visualization, without general anesthesia. After the procedure, patients were discharged within approximately 2-4 h. Patients were judged to be treatment responders if after implantation they reduced PPI dosage by >/=50%. Follow-up evaluations were conducted at 1, 3, 6, and 12 months and included medication usage, symptoms, quality of life, endoscopy, pH monitoring, manometry, and documentation of adverse events.


RESULTS
At 12 months, 80.3% (95% CI = 69.9%-88.3%) of 81 evaluable patients were treatment responders. Of the responders, 87.7% completely discontinued PPIs, and 12.3% reduced PPI dosage by >/=50%. Treatment response was more likely in patients with residual implant volume of >/=5 mL (p = 0.027). Other patient and treatment variables were not predictive. Both GERD heartburn and regurgitation symptom scores significantly improved at 12 months compared with baseline (p < 0.001). There were significant reductions in median supine, upright, and total percent time of esophageal exposure to pH <4. Endoscopically assessed esophagitis grades were unchanged. No serious adverse events were encountered. Transient retrosternal chest pain was experienced by 91.8% of patients. This pain was seldom severe and was typically successfully managed with prescription pain medication.


CONCLUSIONS
Enteryx implantation allows most patients to discontinue PPI therapy, improves their symptoms, and reduces esophageal acid exposure. The effects of implantation are long-lasting, and morbidity is transient and minimal. The procedure requires basic endoscopic skills and seems to provide a useful option in the effective clinical management of GERD.
D000328:Adult; D016001:Confidence Intervals; D004945:Esophagoscopy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007391:International Cooperation; D008297:Male; D008365:Manometry; D008875:Middle Aged; D015999:Multivariate Analysis; D017060:Patient Satisfaction; D011145:Polyvinyls / Q000627:therapeutic use*; D011446:Prospective Studies; D012044:Regression Analysis; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
D011145:Polyvinyls; C020320:ethylene-vinyl alcohol copolymer