Health Technology Assessment (HTA) Feasibility Study: The XprESS Device for the Treatment of Patients With Eustachian Tube Dysfunction

OBJECTIVES: The XprESS device is a minimally invasive technique for Eustachian tube dysfunction (ETD), relieving symptoms like hearing difficulties and plugged ears. It improves tube function, increasing middle ear ventilation and drainage, making it a valuable tool for ETD management. The project aims to examine the existing evidence in the literature to establish a subsequent multidimensional assessment of the patient treated with XprESS.

METHODS: Based on the multiple indications of the XprESS device, three literature reviews were developed. The first search strategy targeted the treatment of frontal and sphenoid sinuses in chronic rhinosinusitis (CRS) patients 12 years and older; the second one focused on the treatment of maxillary sinuses in CRS patients 2 years and older; the third one targeted the treatment of ETD patients 18 years and up. The search was conducted on Pubmed and Scopus databases, with no search filter.

RESULTS: The first and second search strategies included in the review a total of 6 and 5 studies, respectively. The result analysis showed that the XprESS device is effective for up to 24 months, controlling symptoms, reducing hospitalization time, and improving quality of life. The safety evaluation confirms the XprESS device's safety and its comparable risk profile to current surgical techniques. The third search strategy included a total of 17 articles after screenings, from which a promising long-term improvement in the investigated outcomes arises.

CONCLUSIONS: Current evidence from the first two research strategies, albeit limited, shows promising results for the device. However, additional studies are needed to confirm its long-term efficacy for CRS treatment. For the third research strategy, sufficient evidence is available to support the use of the device. However, the study methods for this condition are still under discussion, and further long-term studies are needed to more completely and uniformly assess the effectiveness of the device.