Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease

Abstract

The magnetic sphincter augmentation (MSA) device has been proven safe and effective in controlling typical reflux symptoms and esophageal acid exposure for up to 6-year follow-up. Longer term outcomes have not been reported yet. A prospectively maintained database was reviewed to assess long-term safety and efficacy of the laparoscopic MSA procedure at a single referral center. Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), use of proton-pump inhibitors (PPI), and esophageal acid exposure were compared to baseline. Favorable outcomes were defined as ≥ 50% improvement of GERD-HRQL total score and PPI discontinuation. Between March 2007 and March 2020, 335 patients met the study inclusion criteria, and 124 of them were followed from 6 to 12 years after surgery (median 9 years, IQR 2). Mean total GERD-HRQL score significantly improved from 19.9 to 4.01 (p < 0.001), and PPI were discontinued by 79% of patients. The mean total percent time with pH < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving pH normalization. Independent predictors of a favorable outcome were age at intervention < 40 years (OR 4.17) and GERD-HRQL score > 15 (OR 4.09). We confirm long-term safety and efficacy of MSA in terms of symptom improvement, decreased drug dependency, and reduced esophageal acid exposure. The global burden of gastroesophageal reflux disease (GERD) is enormous, with a pooled prevalence of 13.3% in community-based studies 1. Symptoms and complications of GERD persist in up to 40% of patients treated with proton-pump inhibitors (PPI) 2,3 , and fundoplication is largely underused because of the steep learning curve and reported variability in outcomes 4. The aim of fundoplication is to restore lower esophageal sphincter (LES) function by remodeling the esophagogastric junction 5. Both total (Nissen) and partial (Toupet) fundoplication procedures require mobilization of the gastric fundus to be wrapped around the distal esophagus 6. To further enhance the antireflux barrier, a crural diaphragmatic repair is routinely added 7. Currently, the fact that fundoplication is offered to less than 1% of the GERD population may have an impact on the progression of symptoms and the development of Barrett's esophagus 8. The magnetic sphincter augmentation (MSA) procedure (Linx Reflux Management System, Ethicon, Johnson & Johnson, Shoreview, Mn, USA) was developed as a less disruptive and more standardized and reproducible laparoscopic surgical option for the treatment of GERD. The MSA device is composed by a variable number of interlinked titanium beads with a magnetic core inside. This ring-like system produces a magnetic force that augments the LES. The first feasibility trial and a large prospective nonrandomized study were published in 2008 9 and 2013 10 , respectively. The MSA procedure has been granted approval for clinical use by the Food and Drug Administration in 2012. Previous reports from our group have shown feasibility, safety, and efficacy of the MSA procedure...

Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation

“…In 2020, Bonavina, in Ferrari et al . 14 published on their single institution experience with MSA in 335 patients, beginning in 2007. This publication embodies the learnings over 12 years of implanting MSA.…”

Alternative operative Verfahren zur Behandlung der gastroösophagealen Refluxerkrankung

“…Die MSA führt sowohl zu einer signifikanten Verlängerung des gesamten als auch des intraabdominellen unteren Ösophagussphinkters sowie zu einer signifikanten Erhöhung des IRP (integrated relaxation pressure) [18]. Rezent veröffentlichte Langzeitergebnisse (mediane Nachbeobachtungszeit 9 Jahre) haben die Kurzzeitergebnisse bestätigt: signifikante Lebensqualitätsverbesserung (GERD-HRQL19,9 auf 4,1; p = 0,001), PPI-Freiheit bei 79 % der Patienten und Normalisierung der Säureexposition im distalen Ösophagus (pH < 4 von 9,6 auf 4,1 %; p < 0,001) bei 89 % der Patienten nach MSA [19]. Im randomisierten Vergleich mit optimierter PPI-Einnahme zeigt sich ein statistisch signifikanter Vorteil für die MSA bez.…”

Reference high‐resolution manometry values after magnetic sphincter augmentation

“…Magnetic sphincter augmentation (MSA) is a novel laparoscopic procedure designed to augment the barrier function of the lower esophageal sphincter (LES). It has been shown that MSA can reduce GERD symptoms and improve patients' quality of life up to 12 years of follow‐up 3 …”