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.

© 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).

Figures

Figure 1

Zones of lateral wall insufficiency and implant placement. (A) Nasal valve collapse due to dynamic inward collapse of the nasal wall occurs in distinct zones.2 Zone 1 is more superior and roughly correlates to inward collapse at the level of the internal nasal valve. Zone 2 is more caudad and roughly corresponds to classically described external valve collapse. (B) Implant position in the nose.

Figure 2

Modified Cottle manuever. This is performed by performed by gently supporting the lateral wall cartilage on each side of the nose while the patient is asked to inspire in a normal fashion.

Figure 3

Percent of patients with clinically significant response to treatment. Patients were grouped as responders as noted in Methods. Shown are percent of patients who met criteria for clinical response at 1, 3, and 6 months posttreatment. Error bars indicate 95th percentile confidence intervals.

Figure 4

Changes in disease severity with varied treatments. Patients were grouped into disease severity classes at baseline and 6 months postoperatively, as noted in Methods. Shown severity classes pre‐ and postoperatively for (A) patients treated with implant alone, (B) patients treated with the implant and an adjunctive procedure (as described in Methods), or (C) all patients taken together.