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Background

Patients with intractable GERD that have undergone laparoscopic sleeve gastrectomy (LSG) have limited treatment options. Fundoplication is difficult post-LSG. Roux-en-Y gastric bypass may be used as a conversion procedure but is more invasive with potential for serious complications. Magnetic sphincter augmentation (LINX) is a less invasive, currently ACS-recommended GERD treatment alternative with fewer reported complications. The objective of this study is to confirm safety and efficacy of LINX after LSG.

Methods

The primary outcome of this observational, multicenter, single-arm prospective study was the rate of serious device and/or procedure-related adverse events (AEs). Patients were evaluated by endoscopy to assess the mucosa, and x-rays to verify device location 12 months post-implant. Efficacy was measured comparing baseline to 12-month post-implant assessing 3 criteria: normalization of total distal acid exposure, at least a 50% reduction in total GERD-HRQL scores, lowered average daily PPI usage.

Results

30 who patients had LINX implantation were followed 12-months post-implant. No unanticipated adverse device effects were observed. Fifteen patients reported 21 device and/or procedure-related AEs. Of those, two were deemed serious (dysphagia, pain, 6.7%) and resolved without sequelae. Two subjects underwent explant without complication. GERD-HRQL scores showed improvement (80.8%, P<0.001), and reduction in daily PPI usage was seen (95.8%, P<0.001). Forty-four percent of subjects demonstrated normalization or >= 50% reduction of total distal acid exposure time compared to baseline (baseline 16.2%, 12-months 11%; P=0.038).

Conclusions

LINX safety was confirmed post-LSG with an overall improvement of GERD symptoms and reduction in PPI use with explants within anticipated range.