Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease

• Published in: British journal of surgery Vol. 107; no. 1; pp. 44 - 55
• Main Authors: Kirkham, E N, Main, B G, Jones, K J B, Blazeby, J M, Blencowe, N S
• Format: Journal Article
• Language: English
• Published: Chichester, UK Oxford University Press 01-01-2020; John Wiley & Sons, Ltd
• Subjects: Clinical outcomes; Device Removal; Epidemiologic Methods; Esophageal Sphincter, Lower - surgery; Gastroesophageal reflux; Gastroesophageal Reflux - therapy; Gastrointestinal surgery; Humans; Magnetic Field Therapy - adverse effects; Magnetic Field Therapy - instrumentation; Magnets; Patient Reported Outcome Measures; Systematic Review; Systematic Reviews; Upper GI
• ISSN: 0007-1323; 1365-2168
• DOI: 10.1002/bjs.11391

Abstract
Background
Magnetic sphincter augmentation (MSA) is reported to be an innovative alternative to antireflux surgery for patients with gastro-oesophageal reflux disease. Although used in practice, little is known about how it has been evaluated. This study aimed to systematically summarize and appraise the reporting of MSA and its introduction into clinical practice, in the context of guidelines (such as IDEAL) for evaluating innovative surgical devices.
Methods
Systematic searches were used to identify all published studies reporting MSA insertion. Data collected included patient selection, governance arrangements, surgeon expertise, technique description and outcome reporting.
Results
Searches identified 587 abstracts; 39 full-text papers were included (1 RCT 5 cohort, 3 case–control, 25 case series, 5 case reports). Twenty-one followed US Food and Drug Administration eligibility criteria for MSA insertion. Twenty-six documented that ethical approval was obtained. Two reported that participating surgeons received training in MSA; 18 provided information about how MSA insertion was performed, although techniques varied between studies. Follow-up ranged from 4 weeks to 5 years; in 14 studies, it was less than 1 year.
Conclusion
Most studies on MSA lacked information about patient selection, governance, expertise, techniques and outcomes, or varied between studies. Currently, MSA is being used despite a lack of robust evidence for its effectiveness.
Graphical Abstract
This systematic review summarizes published evidence for a novel procedure, magnetic sphincter augmentation of the oesophagus, a treatment for gastro-oesophageal reflux. It found limited governance arrangements, a lack of long-term follow-up and varied methods of device insertion. There is a need for improvement in the rigour with which innovative surgical procedures are evaluated. Ideally, this would comprise high-quality RCTs and long-term registries, to allow safe adoption of the device into clinical practice.
Graphical Abstract
Innovation in need for IDEAL investigation