Authors' objectives: Gastroesophageal reflux (GERD) is one of the most common health problems, affecting approximately 10-20% of the population in high-income countries. Although the majority of patients respond to proton pump inhibitor (PPI) therapy, approximately 42% of GERD patients are dissatisfied with PPI treatment and are potential candidates for surgical therapy options. This systematic review aimed to analyse whether laparoscopically implantable medical devices for the lower oesophageal sphincter are more effective and equally safe than currently used standard treatments (PPI medication and laparoscopic fundoplicatio) for the treatment of GERD patients. The focus was on the following three devices: Magnetic sphincter augmentation (MSA) with a magnetic ring implant (LINX® Reflux Management System from Ethicon, Johnson & Johnson/Torax Medical), a non-active implant made of medical silicone (RefluxStopTM [RS] from Implantica Trading AG) and electrostimulation therapy (EST) (EndoStim® from EndoStim® Inc.).

Authors' results and conclusions: In total, seven studies (in nine publications) met the predefined inclusion criteria for the analysis of the three products. No comparative evidence was found for two of the three medical devices, RS and EST. MSA seems to improve health-related quality of life (HRQoL), heartburn symptoms as well as regurgitation symptoms over time, but only an improvement compared to PPI medication was found. To date, no randomised trial has been published directly comparing the MSA, RS implant or EST with the gold standard LF. Furthermore, there are limited long-term safety data, e.g. on the occurrence of device-related erosions, and no differences in the safety profile of the three medical devices compared to surgical comparators could be identified.

Authors' recommendations: Due to the very low quality of the currently available evidence and the lack of studies with relevant comparators, the inclusion of the three laparoscopic approaches in the Austrian hospital service catalogue is currently not recommended. Higher quality evidence and longer follow-up times (>2-3 years) will be required in the future to clarify the currently uncertain evidence situation and to complement the current findings on the safety profile.

Project Status: Completed

URL for project: https://aihta.at/page/bewertung-medizinischer-einzelleistungen-mel-berichte/en

Year Published: 2022

URL for published report: https://eprints.aihta.at/1394/1/DSD_134.pdf

URL for additional information: https://eprints.aihta.at/1394

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Austria

Organisation Name: Austrian Institute for Health Technology Assessment

Contact Address: Garnisongasse 7/20, A-1090 Vienna, Austria

Contact Name: office@aihta.at

Contact Email: office@aihta.at