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Clinical Trial
. 2024 Oct;38(10):6060-6069.
doi: 10.1007/s00464-024-11114-0. Epub 2024 Aug 13.

Treating acid reflux without compressing the food passageway: 4-year safety and clinical outcomes with the RefluxStop device in a prospective multicenter study

László Harsányi  1 , Zsolt Kincses  2 , Joerg Zehetner  3 , Áron Altorjay  4
Affiliations
Clinical Trial

Treating acid reflux without compressing the food passageway: 4-year safety and clinical outcomes with the RefluxStop device in a prospective multicenter study

László Harsányi et al. Surg Endosc. 2024 Oct.

Abstract

Introduction: RefluxStop is an implantable device for laparoscopic surgical treatment of gastroesophageal reflux disease (GERD) to restore and maintain lower esophageal sphincter and angle of His anatomy without encircling and putting pressure on the food passageway, thereby avoiding side effects such as dysphagia and bloating seen with traditional fundoplication. This study reports the clinical outcomes with RefluxStop at 4 years following implantation of the device.

Methods: A prospective, single arm, multicenter clinical investigation analyzing safety and effectiveness of the RefluxStop device in 50 patients with chronic GERD.

Results: Available data are presented for 44 patients at 4 years with the addition of three patients at 3 years carried forward. At 4 years, median GERD-HRQL score was 90% reduced compared to baseline. Two patients (2/44) used regular daily proton pump inhibitors (PPIs) despite subsequent 24-h pH monitoring off PPI therapy yielding normal results. There were no device-related adverse events (AEs), esophageal dilations, migrations, or explants during the entire study period. AEs reported between 1 and 4 years were as follows: one subject with heartburn and a pathologic pH result with device positioned too low at surgery; one subject with dysphagia, thus, 46/47 patients reported no dysphagia-related AEs between years 1 and 4. Two patients (2/47) were dissatisfied with treatment despite normal 24-h pH monitoring, of whom one had manometry-verified dysmotility at 6 months, indicating dissatisfaction for reasons other than acid reflux.

Conclusion: These results confirm the excellent and already published 1-year results as stable in the long-term, supporting the safety and effectiveness of the RefluxStop device in treating GERD for over 4 years. GERD-HRQL score, pH testing, and PPI usage indicate treatment success without dysphagia or gas-bloating and only minimal incidence of other AEs. This favorably low rate of AEs is likely attributable to RefluxStop's dynamic physiologic interaction and non-encircling nature.

Keywords: Dysphagia; Gas-bloating; Gastroesophageal reflux disease (GERD); RefluxStop; Surgery; pH monitoring.

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Conflict of interest statement

Authors László Harsányi, Zsolt Kincses and Áron Altorjay declare that they have no competing interests. Joerg Zehetner has received honoraria from Implantica and Johnson & Johnson and grants/contracts from Implantica and Johnson & Johnson, not in relation to the present manuscript.

Figures

Fig. 1
Fig. 1
Endoscopic view of RefluxStop placed in a fundic pouch (from the outside)
Fig. 2
Fig. 2
Regurgitation over time with individual subject changes up to 4 years after the RefluxStop procedure. Three additional patients reported regurgitation ‘none’ at 3 years, together 45/47 had none or minimal regurgitation
Fig. 3
Fig. 3
The device correctly positioned above the lower esophageal sphincter
See this image and copyright information in PMC

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