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

Background
Magnetic sphincter augmentation (MSA) is reported to be an innovative alternative to antireflux surgery for patients with gastro-oesophageal reflux disease. Although increasingly used in clinical practice, little is known about how it has been evaluated. This study aimed to systematically summarise and appraise the reporting of MSA and its introduction into clinical practice, in the context of guidelines (such as IDEAL) for evaluating innovative surgical procedures and devices.

Methods
Systematic searches identified 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 (5 cohort, 3 case-control, 26 case-series, 5 case-reports). Twenty-one followed FDA eligibility criteria for MSA insertion. Twenty-six documented ethical approval was obtained. Two reported participating surgeons received training in MSA; 18 provided information about how MSA insertion was performed, although techniques varied between studies. Follow-up ranged from four weeks to five years; in fourteen, it was less than one-year.

Conclusion
Most studies on MSA were case-reports and series, without an incremental increase in the quality of evidence about MSA. Information about patient selection, governance, expertise, techniques, and outcomes was either lacking or varied between studies, making comparisons difficult. Currently, MSA is being used in clinical practice despite a lack of robust evidence about its effectiveness.