{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T18:02:44Z","timestamp":1793383364484,"version":"4.5.0"},"reference-count":28,"publisher":"Georg Thieme Verlag KG","issue":"05","license":[{"start":{"date-parts":[[2021,12,29]],"date-time":"2021-12-29T00:00:00Z","timestamp":1640736000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Facial Plast Surg"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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 \u226530 points and statistically significant (p &lt;0.001) at all time points through 24 months. Mean VAS score reduction is \u226529.7 points and statistically significant (p &lt;0.001) at all time points. The subgroup of participants with baseline ESS values &gt;10 experienced statistically significant (p &lt;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.<\/jats:p>","DOI":"10.1055\/s-0041-1740948","type":"journal-article","created":{"date-parts":[[2021,12,29]],"date-time":"2021-12-29T23:38:46Z","timestamp":1640821126000},"page":"495-503","source":"Crossref","is-referenced-by-count":11,"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"],"prefix":"10.1055","volume":"38","author":[{"given":"Nadim","family":"Bikhazi","sequence":"additional","affiliation":[{"name":"Department of ENT, Ogden Clinic, South Ogden, Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Randall A.","family":"Ow","sequence":"additional","affiliation":[{"name":"Sacramento Ear Nose and Throat Medical and Surgical Group, Roseville, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3751-764X","authenticated-orcid":false,"given":"Ellen M.","family":"O'Malley","sequence":"additional","affiliation":[{"name":"ENT Clinical Affairs, Stryker Corp, Plymouth, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nora","family":"Perkins","sequence":"additional","affiliation":[{"name":"Department of ENT, Albany ENT and Allergy Services, Albany, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas M.","family":"Sidle","sequence":"additional","affiliation":[{"name":"Department of Otolarygology\u2014Head and Neck Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo","family":"Stolovitzky","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology, Emory University School of Medicine, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2021,12,29]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"37","DOI":"10.2147\/IJGM.S8077","article-title":"Epidemiology and burden of nasal congestion","volume":"3","author":"M Stewart","year":"2010","journal-title":"Int J Gen Med"},{"issue":"03","key":"ref2","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1097\/01.mlg.0000157831.46250.ad","article-title":"Nasal valve surgery improves disease-specific quality of life","volume":"115","author":"J S Rhee","year":"2005","journal-title":"Laryngoscope"},{"issue":"01","key":"ref3","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1055\/s-0035-1570323","article-title":"The nasal airway: a critical review","volume":"32","author":"C C Wever","year":"2016","journal-title":"Facial Plast 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Islam","year":"2008","journal-title":"Laryngoscope"},{"issue":"11","key":"ref16","doi-asserted-by":"crossref","first-page":"1313","DOI":"10.1001\/archotol.130.11.1313","article-title":"The effect on snoring of structural nasal valve dilatation with a butterfly graft","volume":"130","author":"T Akcam","year":"2004","journal-title":"Arch Otolaryngol Head Neck Surg"},{"issue":"08","key":"ref17","doi-asserted-by":"crossref","first-page":"850","DOI":"10.1002\/alr.22362","article-title":"Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial","volume":"9","author":"P Stolovitzky","year":"2019","journal-title":"Int Forum Allergy Rhinol"},{"issue":"02","key":"ref18","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1016\/j.otohns.2003.09.016","article-title":"Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale","volume":"130","author":"M G 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