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.

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).

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

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.

Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.

BACKGROUND: Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in-office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control. METHODS: In this prospective, multicenter, single-blinded RCT, 137 patients from 10 clinics were randomized into 2 arms: treatment arm (70 patients) and sham control arm (67 patients). Outcome measures were followed through 3 months after the procedure. The primary endpoint was the responder rate (percentage of patients with reduction in clinical severity by ≥1 category or ≥20% reduction in Nasal Obstruction Symptom Evaluation [NOSE] score). RESULTS: Before the procedure, there were no statistically significant differences in patient demographics and nasal obstruction symptom measures between the 2 arms. Three months after the procedure, responder rate was significantly higher for the treatment arm compared to the control (82.5% vs 54.7%, p = 0.001). Patients in the treatment arm also had a significantly greater decrease in NOSE score (-42.4 ± 23.4 vs -22.7 ± 27.9, p < 0.0001) and significantly lower visual analogue scale (VAS) scores (-39.0 ± 29.7 vs -13.3 ± 30.0, p < 0.0001) than the sham control arm. Seventeen patients reported 19 procedure/implant-related adverse events, all of which resolved with no clinical sequelae. CONCLUSION: Our study shows the safety and effectiveness of the bioabsorbable implant in reducing patients' nasal obstruction symptoms.

Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group.

OBJECTIVE: Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks. STUDY DESIGN: Prospective cohort follow-up study from the treatment group in a previously reported multicenter randomized controlled trial. SETTING: Twenty-one investigational sites across the United States. SUBJECTS AND METHODS: Here we report on secondary and exploratory endpoints for patients with OETD who previously failed MM and were randomized to the BDET + MM cohort. Analyses of tympanogram outcomes are reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time. RESULTS: Among subjects randomized to BDET + MM, the overall number with normalized tympanograms and ETDQ-7 scores (Eustachian Tube Dysfunction Questionnaire-7) remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0%) versus 71 of 128 (55.5%); ETDQ-7, 79 of 142 (55.6%) versus 71 of 124 (57.3%). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57%) versus 119 of 187 (63.6%). CONCLUSIONS: The present study suggests that the beneficial effects of BDET + MM on tympanogram normalization and symptoms of subjects with refractory OETD demonstrate significant durability that is clinically relevant through 52 weeks.

A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant.

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.

Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study.

BACKGROUND: Although previous studies of sinus surgery that used balloon catheter dilation technology for the paranasal sinuses (balloon sinus dilation [BSD]) demonstrated safety and efficacy, data that compare BSD with continued medical management (MM) are lacking. OBJECTIVE: To evaluate the outcomes of sinus surgery when using BSD instruments versus MM for patients with chronic rhinosinusitis for whom MM failed. METHODS: Adult patients with chronic rhinosinusitis for whom a minimum of 3 weeks of oral antibiotics, 4 weeks of daily saline solution therapy, and 4 weeks of daily nasal corticosteroids failed were included. Qualifying participants were allowed to self-select sinus surgery with BSD (either an office or operating room setting) or continued MM. The primary end point was the comparison of change in the Chronic Sinusitis Survey score from baseline to 24 weeks. Secondary end points included comparisons of change for the Rhinosinusitis Disability Index (RSDI) and the Sino-Nasal Outcome Test (SNOT-20). RESULTS: A total of 198 patients were enrolled (146 surgery and 52 MM). Of the patients who chose BSD, 72% (105/146) had their procedures completed in an office setting. Overall, BSD instruments were successful in dilating 97.6% of targeted sinuses (561/575). Patients who chose BSD showed a significantly greater improvement in the Chronic Sinusitis Survey score versus MM (42.0 versus 27.0, p < 0.001). Results from the RSDI and SNOT-20 surveys showed similar improvements for surgery versus MM (RSDI, 36.0 versus 18.1, p < 0.001; SNOT-20, 1.7 versus 1.0, p < 0.002). CONCLUSION: Patients who selected sinus surgery in which BSD instruments were used on the peripheral sinuses demonstrated significantly greater improvements in quality of life compared with those who elected ongoing MM. These results were achieved through office-based procedures with the patient under local anesthesia in the majority of patients.