LINX eliminated daily dependence on acid-reflux medications in 79% of GERD patients
The LINX Reflux Management System provides effective long-term control of gastroesophageal reflux disease (GERD) and eliminates the need for daily reflux medications in 79% of patients according to the study, ‘Six to 12-year outcomes of magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease’, published in the journal Nature Scientific Reports.
The LINX Reflux Management System is a flexible ring of small magnets placed around the lower part of the oesophagus, the body’s natural barrier to reflux, during a minimally invasive procedure. The magnetic ring expands when a person ingests food and then contracts to prevent stomach contents, including gastric acid, from backing up into the oesophagus and causing GERD. The system is indicated for those patients diagnosed with GERD as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy.
In the single-centre (IRCCS Policlinico San Donato, Italy) retrospective study of 335 patients who had an MSA procedure with LINX between 2007 and 2020, 124 patients who had been implanted for at least six years and up to 12 years (median 9 years) were followed.
“Our new study corroborates the findings of previous studies but over a longer period of time, which is important for an implanted device,” said study co-author, Dr Luigi Bonavina, Professor of Surgery at University of Milan School of Medicine and Chief of the Department of Surgery at IRCCS Policlinico San Donato. “The efficacy of the LINX System remained strong and the risk of complications did not increase many years after implantation. Based on these results and the high levels of patient satisfaction, MSA may represent a true paradigm shift that has the potential to fill the current therapy gap in GERD.”
At the latest follow-up, 92 of 124 patients (74.2%) did not report any oesophageal symptoms (grade 0–1 for heartburn, regurgitation, dysphagia, and chest pain). The mean total GERD-HRQL score decreased from 19.9 at baseline to 4.01 at the latest follow-up (p < 0.001); 89% of patients met the criteria of favourable long-term outcome and clinically significant improvement in GERD-HRQL is also reflected by the reported patient satisfaction, which was achieved in 92.7% of patients. The prevalence of grade 2–4 regurgitation significantly decreased from 59.6% at baseline to 9.6% postoperatively (p<0.01), complete or at least 50% reduction in the average daily dose of PPI was achieved by 79% and 89.5% of patients, respectively.
A majority of patients (86.3%) underwent upper gastrointestinal endoscopy after six years of follow-up. Hiatus hernia was found in seven patients (6.5%), grade A esophagitis in five patients (4.7%) and incomplete intestinal metaplasia in three (2.8%). Four additional patients, who had been treated with radiofrequency ablation for short-segment Barrett’s oesophagus without dysplasia before the MSA procedure, were followed endoscopically for up to eight years without recurrence of intestinal metaplasia. The Hill grade was measured in 45 patients before and after surgery. At the latest endoscopic follow-up, 41 patients (91%) retained their preoperative Hill grade I or improved, 3 (7%) remained stable and in 1 (2%) patient the Hill grade worsened (p<0.01).
Esophageal pH testing off PPI therapy showed that the mean percentage of time that pH was < 4 decreased from 9.7% at baseline to 4.2% at latest follow-up (p<0.001). All the other pH monitoring variables were significantly reduced at 6–12 years compared with baseline. Eighty-nine percent of patients who completed oesophageal pH monitoring at 6- to 12 years follow-up achieved either normal oesophageal acid exposure or had at least a 50% reduction compared to baseline. Overall patient satisfaction, based on the question “would you undergo the operation again or recommend it to a friend?”, was 93.8%. There were no device erosions or migrations and only three instances (2.4%) of device removal due to either continued reflux symptoms, dysphagia or the need for an MRI in this long-term group.
“When offered as a first-line surgical option, MSA allows durable control of symptoms and oesophageal acid exposure, and improves patient quality of life up to 12 years of follow-up without significant safety issues,” the authors concluded. “A preoperative GERD-HRQL total score>15 and age below 40 years are independent predictive factors of favourable outcome…MSA may represent a true paradigm shift that has the potential to fill the current therapy gap in GERD. A randomised clinical trial comparing MSA and either total or partial fundoplication could provide more robust and definitive conclusions.”
“Despite extensive clinical evidence, including this long-term study, and support from leading societies and academic centres, treatment with the LINX System remains out of reach for many patients due to inconsistent insurance coverage throughout the US,” said Tom O’Brien, Worldwide Endomechanical President, Ethicon. “We are committed to providing the clinical and economic evidence that insurance carriers demand so patients with severe GERD can finally have access to the long-term relief they need and the potential for an improved quality of life wherever they happen to live.”
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