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Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval
Brian E Louie1, C Daniel Smith2, Christopher C Smith3
1Division of Thoracic Surgery, Swedish Medical Center, Seattle, WA.
Annals of Surgery
|April 27, 2018
Summary
Magnetic sphincter augmentation (MSA) effectively treats gastroesophageal reflux disease (GERD), significantly reducing acid exposure and improving quality of life. One-year results show high patient success rates with minimal adverse events, confirming MSA
Area of Science:
- Gastroenterology and Surgical Innovation
- Medical Device Technology
- Acid Reflux Management
Background:
- The LINX Reflux Management System (magnetic sphincter augmentation - MSA) was approved by the FDA in 2012 for surgical GERD treatment.
- A mandated Post Approval Study monitors the ongoing safety and effectiveness of MSA.
- Gastroesophageal reflux disease (GERD) affects a significant population requiring effective long-term management.
Purpose of the Study:
- To present 1-year outcomes from a mandated 5-year study evaluating magnetic sphincter augmentation (MSA).
- To assess the safety and effectiveness of MSA in a real-world clinical setting.
- To confirm MSA as a viable treatment option for patients with GERD.
Main Methods:
- A prospective, multicenter study involving 200 patients undergoing MSA for confirmed pathologic acid reflux.
- Clinical outcomes were evaluated annually, including validated GERD-specific questionnaires, endoscopy, and esophageal pH monitoring.
- Proton pump inhibitor (PPI) usage was also tracked as a measure of treatment success.
Main Results:
- One-year follow-up demonstrated a significant decrease in mean esophageal acid exposure (10.0% to 3.6%), with 74.4% achieving normal acid levels.
- GERD Health-Related Quality of Life scores improved dramatically (median 26.0 to 4.0), with 84% meeting success criteria (≥50% score reduction).
- The device removal rate was low (2.5%), with one reported erosion and no serious adverse events.
Conclusions:
- One-year data confirm the safety and effectiveness of magnetic sphincter augmentation (MSA) for GERD treatment.
- MSA demonstrates significant objective and subjective improvements in patients with GERD outside of investigational settings.
- The study supports MSA as a validated therapeutic option for managing gastroesophageal reflux disease.
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