For the vast majority of people who have gastroesophageal reflux disease, proton pump inhibitors offer minimal to no relief from persistent regurgitation.
According to a recent study, an antireflux procedure using a magnetic implant is a promising approach to control regurgitation. The prospective randomized controlled trial found that laparoscopic magnetic sphincter augmentation relieves regurgitation and reduces the need for PPIs in patients with GERD significantly more than simply increasing PPI dosing, which is often the standard response to severe regurgitation (Gastrointest Endosc 2018 Jul 18. [Epub ahead of print]).
“Providers frequently, almost reflexively, increase PPI dosing without considering the primary symptom or other options,” said Reginald Bell, MD, the study’s first author and the founder of the Institute of Esophageal and Reflux Surgery in Denver. “We believed that magnetic sphincter augmentation—which effectively controls reflux with minimal risk and minimal side effects—would provide a very attractive, and far more effective, alternative to increased PPI dosing.”
In the trial, called CALIBER, researchers randomly assigned 152 patients with ongoing moderate to severe regurgitation symptoms while on once-daily PPIs to receive either twice-daily omeprazole 20 mg or undergo laparoscopic magnetic sphincter augmentation. The procedure involves implanting a magnetic device—the LINX Reflux Management System (Ethicon)—around the esophagus to enhance lower esophageal sphincter pressure and reflux control. Of the 148 patients who ultimately remained in the study, 47 had laparoscopic magnetic sphincter augmentation and 101 received a double dose of the PPI.
Dr. Bell and his colleagues found that almost 90% of patients who underwent the surgical intervention reported mild to no regurgitation at six months and remained off PPI therapy whereas only 10% of patients who doubled up on their PPI dose obtained relief (P<0.001). Scores on the GERD–Health-Related Quality of Life Questionnaire—which assesses the degree of heartburn, dysphagia and bloating—decreased fourfold in the surgical group but remained steady in the PPI group between baseline and the six-month mark. Similarly, scores on the Reflux Disease Questionnaire—which evaluates heartburn, regurgitation and dyspepsia—improved significantly in the surgical group at six months but not in the PPI group. As for safety, no device required explantation and side effects were minimal—just over 25% of patients experienced transient dysphagia and two reported continued dysphagia at six months.
“The CALIBER study demonstrated that the symptom of regurgitation responds beautifully to magnetic sphincter augmentation, regardless of response to PPIs, and far better than increased dosing of PPIs,” Dr. Bell said.
The results are in line with previous analyses of the effectiveness of laparoscopic magnetic sphincter augmentation to control regurgitation and reduce PPI use in patients with GERD (Clin Gastroenterol Hepatol 2016;14[5]:671-677; Ann Surg 2018 Apr 24. [Epub ahead of print]). The current analysis takes the research a step further by comparing the two interventions in a randomized controlled fashion and not limiting the study population to patients who responded to PPI therapy.
Dr. Bell’s team concluded that this minimally invasive treatment should be considered for patients with GERD whose regurgitation symptoms remain inadequately controlled with PPIs.
“This is an excellent randomized study comparing an antireflux procedure versus standard treatment with PPI for patients with moderate to severe regurgitation,” said Ninh T. Nguyen, MD, the chair of the Department of Surgery at the University of California, Irvine, who was not involved in the current analysis. “PPI alone doesn’t control regurgitation, and the current study objectively shows that relief from regurgitation is significantly better with the magnet than medication alone.”
Dr. Nguyen said he would be interested in a randomized controlled trial comparing PPI use with magnetic sphincter augmentation and with Nissen fundoplication, the traditional antireflux treatment.
“Magnetic sphincter augmentation is a promising antireflux operation that could replace the current standard procedure,” Dr. Nguyen said. “A randomized controlled trial comparing both antireflux procedures to PPI over time could further clarify the best treatment options for patients.”
Dr. Bell noted that as GERD phenotypes begin to be understood, recognizing GERD is not one disease entity, the treatment should be tailored to patients. “We need to start thinking about the conditions for which a LINX may be the best option versus Nissen or other modalities.”
Dr. Bell and the trial authors received grant support from Torax Medical. Dr. Nguyen reported no relationships with any antireflux device.
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