Augmentation of the lower esophageal sphincter with a magnetic ring placed during a minimally invasive procedure was more effective than increasing proton pump inhibitor therapy for treating regurgitation in patients with GERD, according to research published in Gastrointestinal Endoscopy.
Reginald C.W. Bell, MD, FACS, of the Institute of Esophageal and Reflux Surgery, and colleagues wrote that because PPIs do not address the functionality of the lower esophageal sphincter, patients with GERD can still experience persistent regurgitation.
“Perhaps because of perceived lack of alternative treatments, it remains common practice to treat complaints of persistent regurgitation with increasing doses of PPIs, even when patients are refractory to once-daily PPIs,” they wrote. “Treating GERD surgically corrects the sphincter defects and significantly reduces the number of reflux events, rather than merely reducing the acidity of the refluxate.”
Bell and colleagues conducted a randomized controlled trial to compare magnetic sphincter augmentation (MSA) with increased doses of PPI. They randomly assigned 152 patients with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy into two groups. One group received treatment with twice-daily PPIs (n = 102), and the second group underwent laparoscopic MSA (LINX Reflux Management System, Torax Medical).
Investigators performed foregut symptom questionnaires and ambulatory esophageal reflux monitoring at baseline and at 6 months. They tested for relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs and adverse events.
Of the 47 patients treated with MSA and who completed the 6 months of follow up, 42 achieved resolution of their moderate-to-severe regurgitation compared with 10 of 101 patients in the PPI group who completed follow-up (89% vs. 10%, P < .001).
Patients in the MSA group also experienced better improvements in Gastroesophageal Reflux Disease Health Related Quality of Life scores, Reflux Disease Questionnaire regurgitation scores and in satisfaction with current condition.
Investigators also found that 91% of patients in the MSA arm discontinued PPI use at 6 months and no significant safety issues were observed.
Bell and colleagues wrote that their findings show that MSA provides significantly better control of moderate-to-severe regurgitation.
“GERD patients whose regurgitation is inadequately controlled after initial dosing of acid-suppressive medication should be considered for minimally invasive surgical treatment with the MSA rather than treated with increased dosing of medication,” they wrote. – by Alex Young
Disclosures: The study was sponsored by Torax Medical.