Fockens P et al. (2004) Endoscopic augmentation of the lower esophageal sphincter for the treatment of gastroesophageal reflux disease: multicenter study of the Gatekeeper Reflux Repair System. Endoscopy 36: 682–689

Fockens et al. have recently presented the first international, multicenter clinical trial results for the Gatekeeper Reflux Repair System (Medtronic Europe, Tolochenaz, Switzerland) for the treatment of gastroesophageal reflux disease (GERD). This new, antireflux technique is based on the endoscopic placement of expandable, biocompatible prostheses at the gastroesophageal junction, to mimic its normal function.

Sixty seven patients with typical GERD symptoms were treated with the device. The primary endpoints were improvement in the GERD Heartburn-Related Quality of Life (GERD-HRQL) score and overall complication rate. Secondary endpoints included measurements of esophageal pH and sphincter pressure. Follow-up was at one, 3 and 6 months after the procedure.

A total of 77 procedures were carried out, during which 270 prostheses (93.1%) were successfully placed. Success rates were 93.1% for the device and 98.7% for the procedure. There was a statistically significant improvement in GERD-HRQL scores, from 24.0 at baseline to 5.0 at 6 months (P < 0.01). The incidence of serious adverse events was 3.0% at 30 days. Abnormal esophageal acid exposure decreased from 9.1% at baseline to 6.1% at 6 months (P < 0.05), while median LES pressure increased from 8.8 mmHg to 13.8 mmHg (P < 0.01) in the same period. Although data on medication use was not collected systematically, a post-study review indicated reduced usage.

The authors conclude that the Gatekeeper system is relatively safe and effective for the treatment of GERD symptoms. They await results of a randomized, sham-controlled study and long-term efficacy data.