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Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse

We report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve...

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Autores principales: Bikhazi, Nadim, Ow, Randall A., O'Malley, Ellen M., Perkins, Nora, Sidle, Douglas M., Stolovitzky, Pablo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Thieme Medical Publishers, Inc. 2021
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9763033/
https://www.ncbi.nlm.nih.gov/pubmed/34965603
http://dx.doi.org/10.1055/s-0041-1740948
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author Bikhazi, Nadim
Ow, Randall A.
O'Malley, Ellen M.
Perkins, Nora
Sidle, Douglas M.
Stolovitzky, Pablo
author_facet Bikhazi, Nadim
Ow, Randall A.
O'Malley, Ellen M.
Perkins, Nora
Sidle, Douglas M.
Stolovitzky, Pablo
author_sort Bikhazi, Nadim
collection PubMed
description We report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant. Visits included collection of the following patient-reported outcome measures: nasal obstructive symptom evaluation (NOSE), nasal obstruction visual analog scale (VAS), and the Epworth Sleepiness Scale (ESS). Adverse events were evaluated at each visit. One-hundred-eleven participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates are greater than 80% at all follow-ups through 24 months. Mean reduction from baseline in NOSE scores is ≥30 points and statistically significant ( p <0.001) at all time points through 24 months. Mean VAS score reduction is ≥29.7 points and statistically significant ( p <0.001) at all time points. The subgroup of participants with baseline ESS values >10 experienced statistically significant ( p <0.001) and clinically meaningful reductions at all postimplant periods, suggesting that the reduction in nasal symptoms may reduce daytime sleepiness for patients who have problems with sleep quality. No serious device-/procedure-related adverse events were reported. Implant migration/retrieval rate was 4.5% (10/222) of total implants or 9% of participants (10/111). The implant is safe and effective for dynamic nasal valve collapse in patients with severe/extreme nasal obstruction and provides durable symptom improvement 24 months after placement.
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spelling pubmed-97630332022-12-20 Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse Bikhazi, Nadim Ow, Randall A. O'Malley, Ellen M. Perkins, Nora Sidle, Douglas M. Stolovitzky, Pablo Facial Plast Surg We report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant. Visits included collection of the following patient-reported outcome measures: nasal obstructive symptom evaluation (NOSE), nasal obstruction visual analog scale (VAS), and the Epworth Sleepiness Scale (ESS). Adverse events were evaluated at each visit. One-hundred-eleven participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates are greater than 80% at all follow-ups through 24 months. Mean reduction from baseline in NOSE scores is ≥30 points and statistically significant ( p <0.001) at all time points through 24 months. Mean VAS score reduction is ≥29.7 points and statistically significant ( p <0.001) at all time points. The subgroup of participants with baseline ESS values >10 experienced statistically significant ( p <0.001) and clinically meaningful reductions at all postimplant periods, suggesting that the reduction in nasal symptoms may reduce daytime sleepiness for patients who have problems with sleep quality. No serious device-/procedure-related adverse events were reported. Implant migration/retrieval rate was 4.5% (10/222) of total implants or 9% of participants (10/111). The implant is safe and effective for dynamic nasal valve collapse in patients with severe/extreme nasal obstruction and provides durable symptom improvement 24 months after placement. Thieme Medical Publishers, Inc. 2021-12-29 /pmc/articles/PMC9763033/ /pubmed/34965603 http://dx.doi.org/10.1055/s-0041-1740948 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.
spellingShingle Bikhazi, Nadim
Ow, Randall A.
O'Malley, Ellen M.
Perkins, Nora
Sidle, Douglas M.
Stolovitzky, Pablo
Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse
title Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse
title_full Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse
title_fullStr Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse
title_full_unstemmed Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse
title_short Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse
title_sort long-term follow-up from the treatment and crossover arms of a randomized controlled trial of an absorbable nasal implant for dynamic nasal valve collapse
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9763033/
https://www.ncbi.nlm.nih.gov/pubmed/34965603
http://dx.doi.org/10.1055/s-0041-1740948
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