Clinical trial finds LINX procedure most effective treatment for GERD

By Lindsay Hughes
lahughes@health.southalabama.edu

USA Health participated in a Caliber clinical trial to determine the effectiveness of the LINX Reflux Management System for the treatment of gastroesophageal reflux disease (GERD). Results of the study were recently published in Gastrointestinal Endoscopy, the peer-reviewed journal of the American Society for Gastrointestinal Endoscopy.

GERD, commonly referred to as acid reflux or heartburn, is a disease that is caused by a weak lower esophageal sphincter. This weak muscle allows stomach acid and bile to flow back into the esophagus, often damaging the lining of the esophagus and causing symptoms like heartburn or chest pain.

Dr. William Richards, professor and chair of surgery at the University of South Alabama College of Medicine and director of the USA Surgical Weight Loss Center, performs the LINX procedure at USA Health and was one of the authors of the study.

According to Dr. Richards, proton pump inhibitors (PPIs) like Prilosec and Nexium provide temporary relief for GERD symptoms, but they do not treat the underlying cause – a weak lower esophageal sphincter. "Once you've been on these medications for one or two years, the medication is no longer effective," he said. "That's where I come in as a surgeon."

LINX is the only device approved by the Food and Drug Administration for the treatment of GERD and has proven to eliminate dependence on medication and improve quality of life. The device consists of a small, flexible band of magnets that is surgically placed around the esophagus just above the stomach to help prevent reflux.

The multi-centered randomized, controlled trial followed 152 patients who were at least 21 years old and had moderate to severe regurgitation despite eight weeks of once-daily PPI therapy. USA Health was one of 21 sites throughout the United States that participated in the study.

After six months, 89 percent of patients who received the LINX implant reported relief of regurgitation compared with 10 percent of patients who were treated with twice-daily omeprazole. Furthermore, 81 percent of patients treated with LINX reported satisfaction with their current condition versus 2 percent of patients treated with twice-daily omeprazole.

Dr. Richards said candidates for the LINX system are patients who have symptoms of reflux, heartburn and regurgitation despite traditional medical therapy. Patients undergo a comprehensive evaluation that may include X-rays, endoscopy, and outpatient esophageal function testing.

"A skilled gastroenterologist should thoroughly examine what's going on and see if the LINX is right for you," he said.

Read the full results of the Caliber clinical trial published in Gastrointestinal Endoscopy.

Dr. Richards recently visited FOX 10 to discuss the procedure.