CC BY-NC-ND 4.0 · Facial Plast Surg
DOI: 10.1055/s-0041-1740948
Original Research

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

Nadim Bikhazi
1   Department of ENT, Ogden Clinic, South Ogden, Utah
,
Randall A. Ow
2   Sacramento Ear Nose and Throat Medical and Surgical Group, Roseville, California
,
3   ENT Clinical Affairs, Stryker Corp, Plymouth, Minnesota
,
Nora Perkins
4   Department of ENT, Albany ENT and Allergy Services, Albany, New York
,
Douglas M. Sidle
5   Department of Otolarygology—Head and Neck Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois
,
Pablo Stolovitzky
6   Department of Otolaryngology, Emory University School of Medicine, Atlanta, Georgia
› Author Affiliations

Abstract

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.

Trial Registration

This study is registered on www.clinicaltrials.gov (NCT03400787).




Publication History

Article published online:
29 December 2021

© 2021. 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/)

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