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.

Combining Aesthetic Septorhinoplasty With Bioabsorbable Implants for Nasal Valve Insufficiency

This case report demonstrates the usage of a bioabsorbable nasal implant (BNI) in conjunction with an aesthetic septorhinoplasty. The authors uniquely chose to use this allograft due to inadequate autologous tissue secondary to previously performed temporomandibular joint arthroplasties. In addition to evaluating our case of a 22-year-old woman who received a BNI with an aesthetic septorhinoplasty, the authors performed a comprehensive literature review on the topic. Spanning 3 databases (Scopus, PubMed, and Cochrane), this review revealed 4 primary studies, totaling 349 patients. Each utilized nasal obstruction symptom evaluation (NOSE) scores to subjectively measure symptomatic improvement. We chose to use the NOSE questionnaire on our patient both preoperatively and postoperatively, in order to help demonstrate subjective improvement. The patient’s functional and aesthetic concerns were addressed in the operating room at Parkland Memorial Hospital under general anesthesia. Notably, the patient had previously had conchal cartilage harvested bilaterally, had insufficient septal cartilage for adequate grafting, and did not desire to undergo costal cartilage harvest. Therefore, all parties agreed to use a BNI to complete the functional component of the patient’s septorhinoplasty. This day-surgery first focused on the aesthetic septorhinoplasty followed by the placement of the BNI bilaterally. Following an uneventful postoperative course, our patient endorsed not only an aesthetic improvement but also an 88% functional improvement based on her NOSE score within 4 months of surgery. The authors were able to successfully integrate functional as well as aesthetic septorhinoplasty techniques under the constraints of having both limited autologous tissue and limited accepted options from the patient. For the patient and provider team, this newer allograft was confirmed to be effective and efficient. With the correct patient selection, this is an excellent adjunct procedure that can be quickly and safely performed either in conjunction with surgical rhinoplasty or as a standalone procedure by facial surgeons.

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).