Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse

We report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant. Visits included collection of the following patient-reported outcome measures: nasal obstructive symptom evaluation (NOSE), nasal obstruction visual analog scale (VAS), and the Epworth Sleepiness Scale (ESS). Adverse events were evaluated at each visit. One-hundred-eleven participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates are greater than 80% at all follow-ups through 24 months. Mean reduction from baseline in NOSE scores is ≥30 points and statistically significant (p <0.001) at all time points through 24 months. Mean VAS score reduction is ≥29.7 points and statistically significant (p <0.001) at all time points. The subgroup of participants with baseline ESS values >10 experienced statistically significant (p <0.001) and clinically meaningful reductions at all postimplant periods, suggesting that the reduction in nasal symptoms may reduce daytime sleepiness for patients who have problems with sleep quality. No serious device-/procedure-related adverse events were reported. Implant migration/retrieval rate was 4.5% (10/222) of total implants or 9% of participants (10/111). The implant is safe and effective for dynamic nasal valve collapse in patients with severe/extreme nasal obstruction and provides durable symptom improvement 24 months after placement.

Addressing the Nasal Valves: The Endonasal Approach

The external and internal nasal valves are directly implicated in nasal valve collapse. A variety of endonasal techniques have been developed to address nasal dysfunction while maintaining or improving aesthetic appearance. This review discusses the biomechanics, surgical approach, indications, and evidence of functional and aesthetic results for each maneuver. While the endonasal approach is safe and effective, a thorough understanding of the advantages and limitations is fundamental to selecting the most appropriate surgery for the individual patient.

Nasal decongestants in the treatment of nasal obstruction

Nasal congestion is one of the most common symptoms of common colds and rhinitis, due to an inflammatory reaction, vasodilation, increased nasal blood flow and vascular permeability. Nasal obstruction is often a multifactorial problem, in addition to infectious causes, it can be caused by a combination of anatomical aberrations, swelling of the nasal mucosa and enlargement of the turbinates. Anatomical and structural problems, such as nasal septum deviation and nasal valve collapse, are usually treated surgically. Drug therapy of nasal obstruction is aimed at reducing edema and inflammation of the nasal mucosa. Pharmacotherapy of nasal obstruction is aimed at reducing inflammation and/or swelling of the mucous membrane. Decongestants are widely prescribed to relieve symptoms. The drugs used have different mechanisms of action and include systemic and topical drugs. This article discusses decongestants as a treatment for nasal obstruction. When applied topically, the drugs of this group act directly on the α2 and α1-adrenergic receptors of the nasal cavity, causing vasoconstriction, a decrease in the volume of the nasal conch, an increase in nasal patency, and relieving the symptoms of obstruction. The existing risk of developing side effects, both systemic and local, is reduced with atopic exposure and proper dosing of the drug used. Preferably, the use of drugs with low bioavailability. The suppression of the ciliated epithelium can be caused not only by the pathological process, but also by the composition of drugs. The value is given to the acidity of the buffer system. The optimal pH value of intranasal agents is about 6 (neutral range). The combination with anticholinesterase substances reduces the production of pathological discharge. The use of multi-component medicines allows you to restore nasal breathing and suppress excessive nasal secretion. One of the effective and safe drugs of topical action is Xylometazoline, as a monocomponent agent or in combination with ipratropium bromide.

Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

The aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

Functional and aesthetic outcomes of spreader graft and auto-spreader flap after nasal hump removal

Background Following the reduction of the nasal hump to a desired level, spreader grafts are usually positioned to prevent the complication of nasal valve collapse. Auto-spreader flap is a new technique that gained more popularity recently and can be used as an alternative to spreader graft. This RCCT compared between both techniques aesthetically and functionally as well as the operative time. Results Forty patients, 17 males (42.5%) and 23 females (57.5%), were included. The mean duration of operation in auto-spreader flap was 11.8 ± 3.4 min, while it was 19.2 ± 3.2 min in spreader graft. The difference between the two procedures was statistically significant (P < 0.05). Functional assessment of nasal obstruction was done for all patients in both groups preoperative that was (75.6 ± 19.9) which showed marked improvement when re-evaluated 3 moths postoperatively (18.9 ± 14.7), and after 6 months NOSE scale was (29.1 ± 20.2). The overall aesthetic satisfaction was 62.5% (25 of 40) irrespective of the surgery done. Sixteen out of 20 patients in spreader group and 9 out of 20 in auto-spreader flap group. Conclusion Auto-spreader flap and spreader graft are very effective surgical procedure for treatment of nasal obstruction due to internal nasal valve dysfunction, but the auto-spreader flap had shorter operative time. However, spreader graft has a superior aesthetic outcome.