Original Title: Efectividad y seguridad del implante nasal absorbible para el tratamiento de la obstrucción nasal debida al colapso de la válvula nasal

Authors' objectives: The main objective of this report is to evaluate the efficacy and safety of the absorbable nasal implant LATERA® for the treatment of nasal obstruction caused by NVC in comparison with the standard treatment, septoplasty.

Authors' results and conclusions: Conclusions The available scientific evidence on the efficacy and safety of the LATERA® bioabsorbable nasal implant compared to conventional surgery for the treatment of nasal obstruction due to nasal valve collapse is still limited and primarily consists of single-arm prospective studies, retrospective studies, and case series with low-quality evidence. Only one simple randomized controlled trial (RCT) has been identified. Regarding the efficacy of the procedure, the available results are positive. All studies reported reductions in NOSE and VAS scores compared to baseline values, as well as a positive patient response on the NOSE scale. In terms of safety, although initial data are promising and show low rates of adverse events, the results are variable, and some inconsistencies highlight the need for additional data on potential long-term adverse effects. No economic evaluations have been found regarding the use of the LATERA® bioabsorbable nasal implant. Cost-effectiveness studies would be necessary to better understand the potential economic impact of the technology in our setting. Despite the limitations of the identified studies, the LATERA® absorbable implant could represent a less invasive alternative to conventional surgery and other invasive surgical treatments. However, new prospective studies are needed, with larger sample sizes, longer follow-up, comparative designs with other therapeutic options, and independent of industry funding.

Authors' methods: A systematic review (SR) of the scientific literature was conducted across various databases (Medline, Embase, Cochrane Library, clinical trial registries, and grey literature from health technology assessment agency websites) using a research question based on the PICO framework. The review included randomized controlled trials (RCTs), observational studies, systematic reviews with and without meta-analysis, economic and cost-effectiveness studies, health technology assessment reports, and clinical practice guidelines. Additionally, retrospective studies and secondary event database analyses were considered for the safety assessment, as well as narrative reviews for the description of the technology of interest and the analysis of organizational, legal, and ethical considerations. Studies that were duplicates or outdated, as well as narrative reviews, editorials, conference abstracts and communications, letters to the editor, and opinion articles, were excluded from the report. The study selection process, critical risk of bias assessment, and data extraction were carried out independently by two reviewers. Specifically, the AMSTAR 2 tool was used to assess the quality of included systematic reviews, the Cochrane RoB-II tool for randomized controlled trials, and the MINORS tool for single-arm prospective and retrospective studies. The outcome measures selected to evaluate the effectiveness of this review were, regarding efficacy/Effectiveness, the assessment of nasal obstruction symptoms (NOSE score), NOSE response rate, visual analogue scale (VAS) scores, and mean procedure time (in minutes) and, in relation to safety, the adverse events associated with the use of the technology. Other outcomes were also considered, such as quality of life, patient satisfaction, procedure success, and implementation aspects of the technology, including procedure costs, organizational, ethical, and legal impact.

Project Status: Completed

Year Published: 2025

URL for published report: https://hdl.handle.net/20.500.12105/26981

URL for additional information: https://redets.sanidad.gob.es/productos/buscarProductos.do?metodo=detalle&id=1341

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Esther E. García Carpintero

Contact Email: eegarcia@isciii.es

Copyright: Agencia de Evaluacion de Tecnologias Sanitarias