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Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial
BACKGROUND: Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in‐office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This stud...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771676/ https://www.ncbi.nlm.nih.gov/pubmed/31226238 http://dx.doi.org/10.1002/alr.22362 |
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author | Stolovitzky, Pablo Senior, Brent Ow, Randall A. Mehendale, Neelesh Bikhazi, Nadim Sidle, Douglas M. |
author_facet | Stolovitzky, Pablo Senior, Brent Ow, Randall A. Mehendale, Neelesh Bikhazi, Nadim Sidle, Douglas M. |
author_sort | Stolovitzky, Pablo |
collection | PubMed |
description | BACKGROUND: Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in‐office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control. METHODS: In this prospective, multicenter, single‐blinded RCT, 137 patients from 10 clinics were randomized into 2 arms: treatment arm (70 patients) and sham control arm (67 patients). Outcome measures were followed through 3 months after the procedure. The primary endpoint was the responder rate (percentage of patients with reduction in clinical severity by ≥1 category or ≥20% reduction in Nasal Obstruction Symptom Evaluation [NOSE] score). RESULTS: Before the procedure, there were no statistically significant differences in patient demographics and nasal obstruction symptom measures between the 2 arms. Three months after the procedure, responder rate was significantly higher for the treatment arm compared to the control (82.5% vs 54.7%, p = 0.001). Patients in the treatment arm also had a significantly greater decrease in NOSE score (–42.4 ± 23.4 vs –22.7 ± 27.9, p < 0.0001) and significantly lower visual analogue scale (VAS) scores (–39.0 ± 29.7 vs –13.3 ± 30.0, p < 0.0001) than the sham control arm. Seventeen patients reported 19 procedure/implant‐related adverse events, all of which resolved with no clinical sequelae. CONCLUSION: Our study shows the safety and effectiveness of the bioabsorbable implant in reducing patients’ nasal obstruction symptoms. |
format | Online Article Text |
id | pubmed-6771676 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-67716762019-10-07 Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial Stolovitzky, Pablo Senior, Brent Ow, Randall A. Mehendale, Neelesh Bikhazi, Nadim Sidle, Douglas M. Int Forum Allergy Rhinol Original Articles BACKGROUND: Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in‐office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control. METHODS: In this prospective, multicenter, single‐blinded RCT, 137 patients from 10 clinics were randomized into 2 arms: treatment arm (70 patients) and sham control arm (67 patients). Outcome measures were followed through 3 months after the procedure. The primary endpoint was the responder rate (percentage of patients with reduction in clinical severity by ≥1 category or ≥20% reduction in Nasal Obstruction Symptom Evaluation [NOSE] score). RESULTS: Before the procedure, there were no statistically significant differences in patient demographics and nasal obstruction symptom measures between the 2 arms. Three months after the procedure, responder rate was significantly higher for the treatment arm compared to the control (82.5% vs 54.7%, p = 0.001). Patients in the treatment arm also had a significantly greater decrease in NOSE score (–42.4 ± 23.4 vs –22.7 ± 27.9, p < 0.0001) and significantly lower visual analogue scale (VAS) scores (–39.0 ± 29.7 vs –13.3 ± 30.0, p < 0.0001) than the sham control arm. Seventeen patients reported 19 procedure/implant‐related adverse events, all of which resolved with no clinical sequelae. CONCLUSION: Our study shows the safety and effectiveness of the bioabsorbable implant in reducing patients’ nasal obstruction symptoms. John Wiley and Sons Inc. 2019-06-21 2019-08 /pmc/articles/PMC6771676/ /pubmed/31226238 http://dx.doi.org/10.1002/alr.22362 Text en © 2019 The Authors International Forum of Allergy & Rhinology published by Wiley Periodicals, Inc. on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Stolovitzky, Pablo Senior, Brent Ow, Randall A. Mehendale, Neelesh Bikhazi, Nadim Sidle, Douglas M. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial |
title | Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial |
title_full | Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial |
title_fullStr | Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial |
title_full_unstemmed | Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial |
title_short | Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial |
title_sort | assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771676/ https://www.ncbi.nlm.nih.gov/pubmed/31226238 http://dx.doi.org/10.1002/alr.22362 |
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