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Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures.
Sidle, Douglas M; Stolovitzky, Pablo; O'Malley, Ellen M; Ow, Randall A; Nachlas, Nathan E; Silvers, Stacey.
Afiliación
  • Sidle DM; Department of Otolaryngology-Head and Neck Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
  • Stolovitzky P; Department of Otolaryngology, Emory University School of Medicine, Atlanta, Georgia.
  • O'Malley EM; ENT Clinical Affairs, Stryker Corp, Plymouth, Minnesota.
  • Ow RA; Sacramento Ear Nose and Throat Medical and Surgical Group, Roseville, California.
  • Nachlas NE; Ear, Nose, Throat, and Allergy Associates of Florida, Boca Raton, Florida.
  • Silvers S; Madison ENT and Facial Plastic Surgery, New York, New York.
Facial Plast Surg ; 37(5): 673-680, 2021 Oct.
Article en En | MEDLINE | ID: mdl-33853139
The aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Obstrucción Nasal / Implantes Absorbibles Tipo de estudio: Clinical_trials / Observational_studies Límite: Humans Idioma: En Revista: Facial Plast Surg Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Obstrucción Nasal / Implantes Absorbibles Tipo de estudio: Clinical_trials / Observational_studies Límite: Humans Idioma: En Revista: Facial Plast Surg Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos