In this section we have selected scientific papers which we have found to be of interest or that are acknowledged as important. The selection is intended as a resource for those wishing to read academic evidence supporting the treatment of Gastro Oesophageal Reflux Disease. Where possible, the links are to the full article but for copyright reasons, if this is not possible, they are links to abstracts.
We will be adding more scientific papers with comments from our expert reflux surgeons. The first two papers below are such papers.
We will add more papers as well as recommendations from professional associations and societies. We welcome any further suggestions from interested readers.
Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.) (Gastrointest Endosc 2018;-:1-9.)
Magnetic sphincter augmentation in patients with large hiatal hernias demonstrates improved outcomes with respect to postoperative PPI requirement and mean GERDHRQL scores. The incidence of symptom resolution or improvement and dysphagia requiring intervention are similar to patients with smaller or no hiatal hernia. Shortterm outcomes of MSA are encouraging in patients with gastroesophageal reflux disease and large hiatal hernias.
A magnetic implant for the treatment of gastroesophageal reflux disease (GERD) was Food and Drug Administration– approved in 2012 and has been extensively evaluated. The device is a ring of magnets that are placed around the gastroesophageal junction, augmenting the native lower esophageal sphincter and preventing reflux yet preserving lower esophageal sphincter physiologic function and allowing belching and vomiting. Magnetic force is advantageous, being permanent and precise, and forces between magnets decrease with esophageal displacement. Multiple patient cohorts have been studied using the magnetic device, and trials establish consistent, long-term improvement in pH data, GERD symptom scores, and proton-pump inhibitor use. A 5-year Food and Drug Administration trial demonstrated that most patients achieved normal pH scores, 85% stopped proton-pump inhibitors, and GERD health-related quality of life symptom scores improved from 27 to 4 at 5 years. Seven studies have compared magnetic augmentation with laparoscopic Nissen fundoplication and demonstrated that the magnetic device achieved comparable efficacy with regard to protonpump inhibitor cessation, GERD symptom score improvement, and heartburn and regurgitation scores. However, to date there have been no randomized, controlled trials comparing the 2 techniques, and the study cohorts are not necessarily comparable regarding hiatal hernia size, severity of reflux, body mass index scores, or esophagitis scores. Dysphagia incidence was similar in both groups. Reoperation rates and safety profiles were also comparable, but the magnetic device demonstrated significant beneficial differences in allowing belching and vomiting. The magnetic device is safe, with the main adverse event being dysphagia with an approximate 3%– 5% chronic incidence. Device removals in clinical trials have been between 0% and 7% and were uneventful. There have been no erosions, perforations, or infections in FDA clinical trials; erosions have rarely been noted in practice. Magnetic augmentation of the lower esophageal sphincter is a safe and effective operation for GERD, and should be considered a surgical option for those seeking a fundicsparing operation, particularly those with parameters consistent with study cohorts. Additional randomized, controlled trials are underway
During a 4-year period in more than 3000 patients, no unanticipated MSAD complications have emerged, and there is no data to suggest a trend of increased events over time. The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GERD. MSAD is considered safe for the widespread treatment of GERD.
One Hundred Consecutive Patients Treated with Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease: 6 Years of Clinical Experience from a Single Center. Journal American College of Surgeons. Bonavina et al. 2013
A randomized controlled trial of laparoscopic nissen fundoplication versus proton pump inhibitors for treatment of patients with chronic gastroesophageal reflux disease: One-year follow-up. Surgical Innovations. Anvari et al. 2006