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

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 AE 13.4 baseline vs. 36.2 AE 22.7 at 1 month postoperatively, 33.0 AE 23.4 at 3 months, 32.1 AE 24.6 at 6 months, and 30.3 AE 24.3 at 12 months; P < 0.001). They also showed significant reduction in VAS scores postoperatively (69.7 AE 18.1 baseline vs. 31.3 AE 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 AE 0.09 and 0.93 AE 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.

Effectiveness of using a bioabsorbable implant (Latera) to treat nasal valve collapse in patients with nasal obstruction: systemic review and meta‐analysis

“…If the patient is less symptomatic with inspiration during the maneuver, it is assumed that the nasal valve has been widened from the dynamic nasal valve collapse. Among 5 enrolled studies, 4 studies used the modified Cottle maneuver for seeking patients with nasal airway obstruction due to dynamic nasal valve collapse 4‐7 …”

“…An important advantage of this minimally invasive technique is that although the procedure can be performed in the operating room with septoplasty and/or turbinate surgery, it can also be done as a stand‐alone procedure or in conjunction with turbinate redirection 5,7,21 . If this minimally invasive technique could reinforce the lateral wall over an extensive period of time, and it is also easy to conduct and associated with a low incidence of complications, it is likely to become a staple procedure for addressing nasal obstruction.…”

“…In addition, studies were excluded from analysis if outcomes of interest were not clearly reported with quantifiable data or it was not possible to extract and calculate outcomes from published results. As a result, 5 articles were included in the meta‐analysis 3‐7 . Figure 1 summarizes the search strategy used to identify the studies selected for the meta‐analysis.…”

Nasal Airflow Changes With Bioabsorbable Implant, Butterfly, and Spreader Grafts

“…Future work using CFD with patients following BNI insertion could further clarify the impact that BNI has on both objective measures (e.g., heat flux and nasal airflow resistance) as well as PROMs. 27,28 As previously demonstrated, the butterfly graft has more consistent reduction in nasal airway resistance than the spreader graft, and it is more effective in achieving equivalent airflow allocation between the right and left nasal airways. 5 This study confirms our prior findings, and demonstrates statistically significant improvement in nasal airway resistance following butterfly graft placement (Fig.…”

Treating Symptomatic Midvault Soft Tissue Collapse in Revision Rhinoplasty with a Nasal Wall Implant

“…Studies have described a novel technique to treat nasal valve collapse (NVC) with an absorbable Latera implant; however, they have not investigated its use in multiple revision functional rhinoplasty patients. 8 – 11 We describe a case series of patients with a history of multiple nasal procedures who underwent revision functional rhinoplasty with application of the Latera implant to improve NAO symptoms from soft tissue midvault collapse, an area not being treated by standard nasal obstruction techniques.…”