Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group

a randomized control trial

Pablo Stolovitzky*, Brent Senior, Randall A. Ow, Neelesh Mehendale, Nadim Bikhazi, Douglas Mathew Sidle

*Corresponding author for this work

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)850-856
Number of pages7
JournalInternational Forum of Allergy and Rhinology
Volume9
Issue number8
DOIs
StatePublished - Jan 1 2019

Fingerprint

Absorbable Implants
Nose
Nasal Obstruction
Symptom Assessment
Therapeutics
Randomized Controlled Trials
Safety
Visual Analog Scale
Demography
Outcome Assessment (Health Care)

Keywords

  • disease severity
  • evidence-based medicine
  • nasal airway obstruction in-office procedures
  • quality of life
  • sham-control

ASJC Scopus subject areas

  • Immunology and Allergy
  • Otorhinolaryngology

Cite this

Stolovitzky, Pablo ; Senior, Brent ; Ow, Randall A. ; Mehendale, Neelesh ; Bikhazi, Nadim ; Sidle, Douglas Mathew. / Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group : a randomized control trial. In: International Forum of Allergy and Rhinology. 2019 ; Vol. 9, No. 8. pp. 850-856.
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title = "Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial",
abstract = "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.",
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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 Mathew.

In: International Forum of Allergy and Rhinology, Vol. 9, No. 8, 01.01.2019, p. 850-856.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group

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AU - Stolovitzky, Pablo

AU - Senior, Brent

AU - Ow, Randall A.

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AU - Sidle, Douglas Mathew

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