A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant

Pablo Stolovitzky; Douglas M. Sidle; Randall A. Ow; Nathan E. Nachlas; Sam P. Most

doi:10.1002/lary.27242

A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant

Pablo Stolovitzky, Douglas M. Sidle, Randall A. Ow, Nathan E. Nachlas, Sam P. Most^*

^*Corresponding author for this work

Otolaryngology

Research output: Contribution to journal › Article › peer-review

32 Scopus citations

Abstract

Objective: To examine 6-month outcomes for treatment of lateral nasal wall insufficiency with a bioabsorbable implant. Study Design: Prospective, multicenter, nonrandomized, single-blinded study. Methods: One hundred and one patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 14 U.S. clinics (September 2016–March 2017). Patients were treated with a bioabsorbable implant designed to support lateral wall, with or without concurrent septoplasty and/or turbinate reduction procedure(s). NOSE scores and visual analog scale (VAS) were measured at baseline and month 1, 3, and 6 postoperatively. The Lateral Wall Insufficiency (LWI) score was determined by independent physicians observing the lateral wall motion video. Results: Forty-three patients were treated with implant alone, whereas 58 had adjunctive procedures. Seventeen patients reported 19 adverse events, all of which resolved with no clinical sequelae. Patients showed significant reduction in NOSE scores at 1, 3, and 6 months postoperatively (79.5 ± 13.5 preoperatively, 34.6 ± 25.0 at 1 month, 32.0 ± 28.4 at 3 months, and 30.6 ± 25.8 at 6 months postoperatively; P < 0.01 for all). They also showed significant reduction in VAS scores postoperatively (71.9 ± 18.8 preoperatively, 32.7 ± 27.1 at 1 month, 30.1 ± 28.3 at 3 months, and 30.7 ± 29.6 at 6 months postoperatively; P < 0.01 for all). These results were similar in patients treated with the implant alone compared to those treated with the implant and adjunctive procedures. Consistent with patient-reported outcomes, postoperative LWI scores were demonstrably lower (1.83 ± 0.10 and 1.30 ± 0.11 pre- and postoperatively; P < 0.01). Conclusion: Stabilization of the lateral nasal wall with a bioabsorbable implant improves patients' nasal obstructive symptoms over 6 months. Level of Evidence: 2b. Laryngoscope, 2483–2489, 2018.

Original language	English (US)
Pages (from-to)	2483-2489
Number of pages	7
Journal	Laryngoscope
Volume	128
Issue number	11
DOIs	https://doi.org/10.1002/lary.27242
State	Published - Nov 2018

Funding

This study was funded by Entellus, Inc. Pablo Stolovitzky, MD; Douglas M. Sidle, MD; Randall A. Ow, MD; Nathan E. Nachlas, MD; and Sam P. Most, MD, were paid consultants of Entellus, Inc. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

Keywords

Nasal valve
lateral wall insufficiency
nasal implant
nasal obstruction
valve repair

ASJC Scopus subject areas

Otorhinolaryngology

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10.1002/lary.27242

Cite this

@article{f79af1b9aabe484cadc761de814fcadd,

title = "A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant",

abstract = "Objective: To examine 6-month outcomes for treatment of lateral nasal wall insufficiency with a bioabsorbable implant. Study Design: Prospective, multicenter, nonrandomized, single-blinded study. Methods: One hundred and one patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 14 U.S. clinics (September 2016–March 2017). Patients were treated with a bioabsorbable implant designed to support lateral wall, with or without concurrent septoplasty and/or turbinate reduction procedure(s). NOSE scores and visual analog scale (VAS) were measured at baseline and month 1, 3, and 6 postoperatively. The Lateral Wall Insufficiency (LWI) score was determined by independent physicians observing the lateral wall motion video. Results: Forty-three patients were treated with implant alone, whereas 58 had adjunctive procedures. Seventeen patients reported 19 adverse events, all of which resolved with no clinical sequelae. Patients showed significant reduction in NOSE scores at 1, 3, and 6 months postoperatively (79.5 ± 13.5 preoperatively, 34.6 ± 25.0 at 1 month, 32.0 ± 28.4 at 3 months, and 30.6 ± 25.8 at 6 months postoperatively; P < 0.01 for all). They also showed significant reduction in VAS scores postoperatively (71.9 ± 18.8 preoperatively, 32.7 ± 27.1 at 1 month, 30.1 ± 28.3 at 3 months, and 30.7 ± 29.6 at 6 months postoperatively; P < 0.01 for all). These results were similar in patients treated with the implant alone compared to those treated with the implant and adjunctive procedures. Consistent with patient-reported outcomes, postoperative LWI scores were demonstrably lower (1.83 ± 0.10 and 1.30 ± 0.11 pre- and postoperatively; P < 0.01). Conclusion: Stabilization of the lateral nasal wall with a bioabsorbable implant improves patients' nasal obstructive symptoms over 6 months. Level of Evidence: 2b. Laryngoscope, 2483–2489, 2018.",

keywords = "Nasal valve, lateral wall insufficiency, nasal implant, nasal obstruction, valve repair",

author = "Pablo Stolovitzky and Sidle, {Douglas M.} and Ow, {Randall A.} and Nachlas, {Nathan E.} and Most, {Sam P.}",

note = "Funding Information: This study was funded by Entellus, Inc. Pablo Stolovitzky, MD; Douglas M. Sidle, MD; Randall A. Ow, MD; Nathan E. Nachlas, MD; and Sam P. Most, MD, were paid consultants of Entellus, Inc. The authors have no other funding, financial relationships, or conflicts of interest to disclose. Publisher Copyright: {\textcopyright} 2018 The Authors The Laryngoscope published by Wiley Periodicals, Inc. on behalf of American Laryngological, Rhinological and Otological Society Inc, “The Triological Society” and American Laryngological Association (ALA)",

year = "2018",

month = nov,

doi = "10.1002/lary.27242",

language = "English (US)",

volume = "128",

pages = "2483--2489",

journal = "Laryngoscope",

issn = "0023-852X",

publisher = "Wiley-Blackwell",

number = "11",

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TY - JOUR

T1 - A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency

T2 - Outcomes using a bioabsorbable implant

AU - Stolovitzky, Pablo

AU - Sidle, Douglas M.

AU - Ow, Randall A.

AU - Nachlas, Nathan E.

AU - Most, Sam P.

N1 - Funding Information: This study was funded by Entellus, Inc. Pablo Stolovitzky, MD; Douglas M. Sidle, MD; Randall A. Ow, MD; Nathan E. Nachlas, MD; and Sam P. Most, MD, were paid consultants of Entellus, Inc. The authors have no other funding, financial relationships, or conflicts of interest to disclose. Publisher Copyright: © 2018 The Authors The Laryngoscope published by Wiley Periodicals, Inc. on behalf of American Laryngological, Rhinological and Otological Society Inc, “The Triological Society” and American Laryngological Association (ALA)

PY - 2018/11

Y1 - 2018/11

N2 - Objective: To examine 6-month outcomes for treatment of lateral nasal wall insufficiency with a bioabsorbable implant. Study Design: Prospective, multicenter, nonrandomized, single-blinded study. Methods: One hundred and one patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 14 U.S. clinics (September 2016–March 2017). Patients were treated with a bioabsorbable implant designed to support lateral wall, with or without concurrent septoplasty and/or turbinate reduction procedure(s). NOSE scores and visual analog scale (VAS) were measured at baseline and month 1, 3, and 6 postoperatively. The Lateral Wall Insufficiency (LWI) score was determined by independent physicians observing the lateral wall motion video. Results: Forty-three patients were treated with implant alone, whereas 58 had adjunctive procedures. Seventeen patients reported 19 adverse events, all of which resolved with no clinical sequelae. Patients showed significant reduction in NOSE scores at 1, 3, and 6 months postoperatively (79.5 ± 13.5 preoperatively, 34.6 ± 25.0 at 1 month, 32.0 ± 28.4 at 3 months, and 30.6 ± 25.8 at 6 months postoperatively; P < 0.01 for all). They also showed significant reduction in VAS scores postoperatively (71.9 ± 18.8 preoperatively, 32.7 ± 27.1 at 1 month, 30.1 ± 28.3 at 3 months, and 30.7 ± 29.6 at 6 months postoperatively; P < 0.01 for all). These results were similar in patients treated with the implant alone compared to those treated with the implant and adjunctive procedures. Consistent with patient-reported outcomes, postoperative LWI scores were demonstrably lower (1.83 ± 0.10 and 1.30 ± 0.11 pre- and postoperatively; P < 0.01). Conclusion: Stabilization of the lateral nasal wall with a bioabsorbable implant improves patients' nasal obstructive symptoms over 6 months. Level of Evidence: 2b. Laryngoscope, 2483–2489, 2018.

AB - Objective: To examine 6-month outcomes for treatment of lateral nasal wall insufficiency with a bioabsorbable implant. Study Design: Prospective, multicenter, nonrandomized, single-blinded study. Methods: One hundred and one patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 14 U.S. clinics (September 2016–March 2017). Patients were treated with a bioabsorbable implant designed to support lateral wall, with or without concurrent septoplasty and/or turbinate reduction procedure(s). NOSE scores and visual analog scale (VAS) were measured at baseline and month 1, 3, and 6 postoperatively. The Lateral Wall Insufficiency (LWI) score was determined by independent physicians observing the lateral wall motion video. Results: Forty-three patients were treated with implant alone, whereas 58 had adjunctive procedures. Seventeen patients reported 19 adverse events, all of which resolved with no clinical sequelae. Patients showed significant reduction in NOSE scores at 1, 3, and 6 months postoperatively (79.5 ± 13.5 preoperatively, 34.6 ± 25.0 at 1 month, 32.0 ± 28.4 at 3 months, and 30.6 ± 25.8 at 6 months postoperatively; P < 0.01 for all). They also showed significant reduction in VAS scores postoperatively (71.9 ± 18.8 preoperatively, 32.7 ± 27.1 at 1 month, 30.1 ± 28.3 at 3 months, and 30.7 ± 29.6 at 6 months postoperatively; P < 0.01 for all). These results were similar in patients treated with the implant alone compared to those treated with the implant and adjunctive procedures. Consistent with patient-reported outcomes, postoperative LWI scores were demonstrably lower (1.83 ± 0.10 and 1.30 ± 0.11 pre- and postoperatively; P < 0.01). Conclusion: Stabilization of the lateral nasal wall with a bioabsorbable implant improves patients' nasal obstructive symptoms over 6 months. Level of Evidence: 2b. Laryngoscope, 2483–2489, 2018.

KW - Nasal valve

KW - lateral wall insufficiency

KW - nasal implant

KW - nasal obstruction

KW - valve repair

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A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant

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