Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse

Douglas M Sidle, Pablo Stolovitzky, Randall A Ow, Stacey Silvers, Keith Matheny, Nadim Bikhazi, Manish Wani, W Cooper Scurry, Sam P Most, Douglas M Sidle, Pablo Stolovitzky, Randall A Ow, Stacey Silvers, Keith Matheny, Nadim Bikhazi, Manish Wani, W Cooper Scurry, Sam P Most

Abstract

Objectives: To examine 12-month outcomes for in-office treatment of dynamic nasal valve collapse (NVC) with a bioabsorbable implant.

Study design: Prospective, multicenter, nonrandomized study.

Methods: One hundred sixty-six patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 16 U.S. clinics (November 2016-July 2017). Patients were treated with a bioabsorbable implant (Latera, Spirox Inc., Redwood City, CA) to support the lateral wall, with or without concurrent inferior turbinate reduction (ITR), in an office setting. NOSE scores and Visual Analog Scale (VAS) were measured at baseline and 1, 3, 6, and 12 months postoperatively. The Lateral Wall Insufficiency (LWI) score was determined by independent physicians observing the lateral wall motion video.

Results: One hundred five patients were treated with implant alone, whereas 61 had implant + ITR. Thirty-one patients reported 41 adverse events, all of which resolved with no clinical sequelae. Patients showed significant reduction in NOSE scores throughout 12 months postoperatively (77.4 ± 13.4 baseline vs. 36.2 ± 22.7 at 1 month postoperatively, 33.0 ± 23.4 at 3 months, 32.1 ± 24.6 at 6 months, and 30.3 ± 24.3 at 12 months; P < 0.001). They also showed significant reduction in VAS scores postoperatively (69.7 ± 18.1 baseline vs. 31.3 ± 27.1 at 12 months postoperatively, P < 0.001). These results were similar in patients treated with implant alone and those treated with the implant + ITR. Consistent with patient-reported outcomes, postoperative LWI scores were demonstrably lower (1.42 ± 0.09 and 0.93 ± 0.08 pre- and postoperatively, P < 0.001).

Conclusion: In-office treatment of dynamic NVC with a bioabsorbable implant improves clinical evidence of LWI at 6 months and improves nasal obstructive symptoms in a majority of patients up to 12 months.

Level of evidence: 2b Laryngoscope, 130:1132-1137, 2020.

Keywords: Nasal valve; lateral wall insufficiency; nasal implant; nasal obstruction; valve repair.

© 2019 The Authors. The Laryngoscope published by Wiley Periodicals, Inc. on behalf of The American Laryngological, Rhinological and Otological Society, Inc.

Figures

Figure 1
Figure 1
Changes in NOSE score severity classes at baseline and 12 months after treatment for (A) Latera (Spirox Inc., Redwood City, CA) alone, (B) Latera + ITR, and (C) all patients. ITR = inferior turbinate reduction; NOSE = Nasal Obstruction Symptom Evaluation. [Color figure can be viewed in the online issue, which is available at http://www.laryngoscope.com.]

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