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

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.

Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty

“…Overall, this systematic review demonstrates that the conclusions of included studies were not based on the evidence within the papers, which had methodological weaknesses. Our results are consistent with existing evidence that surgical innovations have been poorly reported [ 72 ]. Future work is needed to change how devices are used and evaluated after approvals, to allow transparent incremental evidence to be created to inform clinical practice and decision-making.…”

“…In the USA, invasive devices are now subject to a pivotal clinical study as part of the FDA’s premarket approval pathway. The UK Medicines and Healthcare products Regulatory Agency (MHRA) does not specify the type of study required to achieve device approval, but the majority do not include a control group [ 72 ]. Pressure for reform is mounting.…”

Identification of outcomes to inform the development of a core outcome set for surgical innovation: a targeted review of case studies of novel surgical devices

“…Recent systematic reviews have demonstrated that outcome reporting in studies of innovative surgical procedures and devices focuses on short-term, clinical and technical outcomes 21 22. These outcomes are critical to assess in any early-phase study and are required for US FDA and the UK Medicines and Healthcare products Regulatory Agency approval 23 24.…”

AngelChik Device Removal and Revisional Fundoplication

“…A recent systematic review by Kirkham et al 30 evaluating the evidence of the device shows a concerning lack of unbiased evidence in the literature with no longterm safety demonstrated. Only one RCT has been carried out and this compared the surgery to medical management rather than fundoplication.…”