Twelve-month outcomes following temperature-controlled radiofrequency treatment of the septal swell body for nasal airway obstruction.

BACKGROUND: Improved nasal airway obstruction (NAO) symptoms were reported at 3 months following temperature-controlled radiofrequency (TCRF) treatment of the septal swell body (SSB). This report provides results from assessments of the long-term safety and efficacy of TCRF treatment of SSB hypertrophy to treat NAO through 12 months posttreatment. METHODS: This prospective, multicenter, long-term, open-label study was conducted in nine centers within the United States and included patients with severe/extreme NAO attributed to SSB hypertrophy. Outcome measures included assessments of Nasal Obstruction Symptom Evaluation Score (NOSE), Numeric Rating Scale (NRS) ease-of-breathing, patient satisfaction, and adverse events at 6 and 12 months. RESULTS: Of the 70 patients treated, 65 and 62 patients completed the 6- and 12-month follow-up assessments. Compared to baseline, there was a 67.5% decrease in adjusted mean NOSE scores at 6 months (mean change -49.6, 95% confidence interval [CI] -54.8 to -44.4; p < 0.001) and a 65.4% decrease at 12 months (mean change -48.1, 95% CI -53.7 to -42.5); p < 0.001), which is consistent with previously published 3-month results. A 62.0% and 62.5% improvement compared to baseline was observed in the NRS ease-of-breathing score at 6 and 12 months, respectively (p < 0.001). No serious adverse were reported overall and no new device- or procedure-related adverse events were reported in the interval between 3 and 12 months posttreatment. CONCLUSION: TCRF treatment of SSB hypertrophy has a significant and durable effect on improving the symptoms of NAO and health-related quality of life in patients with symptoms of nasal obstruction and congestion through 12 months postprocedure.

Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: Two-year outcomes from a prospective multicenter trial.

BACKGROUND: Minimally invasive temperature-controlled radiofrequency (TCRF) ablation of the posterior nasal nerve (PNN) demonstrated a significant larger treatment effect on the symptom burden of chronic rhinitis patients than a sham control (no energy delivery) at the 3-month primary endpoint of this trial. METHODS: Two-year posttreatment outcomes for patients treated in a prospective, multicenter, patient-blinded randomized controlled trial were determined by combining the index active treatment-arm and index control-arm crossover patients into a single group (after the primary endpoint) to evaluate the treatment effect durability and long-term effects on concomitant chronic rhinitis medication usage. RESULTS: The mean baseline reflective total nasal symptom score (rTNSS) was 8.2 (95% confidence interval [CI], 7.9-8.6; N = 104). At 2 years (N = 79), the mean change in rTNSS was -5.3 (95% CI, -5.8 to -4.8; p < 0.001; 64.6% improvement). The 2-year responder rate (≥30% improvement in rTNSS) was 87.3% (95% CI, 78.0-93.8). All four components of the rTNSS (rhinorrhea, congestion, sneezing, and nasal itching) showed significant improvement over baseline, with rhinorrhea and congestion showing the most improvement. Postnasal drip and cough symptoms were also significantly improved. At 2 years, 81.0% (95% CI, 70.6-89.0) reported a minimal clinically important difference of ≥0.4-point improvement in the mini-rhinoconjunctivitis quality of life questionnaire score. Of 56 patients using chronic rhinitis medications at baseline, 25 of 56 (44.6%) either stopped all medication use (7/56 [12.5%]) or stopped/decreased (18/56 [32.1%]) use of ≥1 medication class at 2 years. No serious adverse events related to the device/procedure were reported over 2 years. To determine the potential effect of patients who left the trial over 2 years on the responder rate, the responder statuses of the 14 patients with follow-up data who were lost to follow-up/withdrew/died were imputed by the last observation carried forward and the responder statuses of all nine patients who had an additional nasal procedure were imputed to nonresponder, resulting in a 2-year responder rate of 79.4% (95% CI, 70.3-86.8). CONCLUSION: TCRF ablation of the PNN is safe and resulted in a significant and sustained reduction in chronic rhinitis symptom burden through 2 years and a substantial reduction in concomitant medication burden.

Temperature-controlled radiofrequency device treatment of septal swell bodies for nasal airway obstruction: An open-label, single arm multicenter study.

BACKGROUND: Nasal airway obstruction (NAO) is a highly prevalent disorder. Septal swell body (SSB) hypertrophy is an often overlooked contributor to NAO. SSB treatment may relieve symptoms of NAO. The objective of this study was to assess the clinical use of a temperature-controlled radiofrequency (TCRF) device to treat SSBs to improve symptoms in adults with NAO. METHODS: In this prospective, multicenter, open-label, single arm study, patients with severe or extreme NAO related to SSB hypertrophy received bilateral TCRF treatment in the SSB area. The primary endpoint was improvement in Nasal Obstruction Symptom Evaluation (NOSE) Scale scores from baseline to 3 months postprocedure. A subset of study patients underwent computed tomography (CT) imaging to evaluate posttreatment changes in SSB size. RESULTS: Mean NOSE Scale scores significantly improved from 73.5 (SD 14.2) at baseline to 27.9 (SD 17.2) at 3 months postprocedure, a reduction of -45.3 (SD 21.4, 95% confidence interval [CI]: -50.4 to -40.1; p < 0.0001); the responder rate was 95.7% (95% CI: 0.88 to 0.99; p < 0.0001). CT evaluation at 3 months showed statistically significant reductions in the SSB with the greatest reduction in the middle thickness (mean change -3.4 [SD 1.8] mL, 95% CI: -4.0 to -2.8; p < 0.0001). Minimal adverse events with any relationship to the device or procedure were reported; none were serious in nature and no septal perforations occurred. CONCLUSIONS: This study demonstrates that TCRF treatment of SSB hypertrophy is well tolerated and effective at reducing both SSB size and symptoms of NAO at 3 months posttreatment.

Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial.

BACKGROUND: Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis was previously reported as superior to a sham-control procedure at 3 months postprocedure in a randomized controlled trial (RCT). The primary endpoint was a responder rate of ≥30% improvement (decrease) for 24-hour reflective total nasal symptom score (rTNSS) compared with baseline. Herein, 12-month outcomes after active treatment are reported. METHODS: In this prospective, multicenter, patient-blinded RCT, patients in the index active treatment arm were unblinded at 3 months and followed through 12 months. At 3 months, eligible patients from the sham-control arm of the study were invited to crossover to active treatment. Eligibility criteria included rTNSS ≥6, with moderate-severe rhinorrhea and mild-severe congestion. The TCRF stylus was applied bilaterally to nonoverlapping areas in the region of the PNN. RESULTS: Patients in the index active treatment arm (n = 77) had a mean baseline rTNSS of 8.3 (95% confidence interval [CI], 7.9-8.7). At 12 months, the responder rate was 80.6% (n = 67) (95% CI, 69.1%-89.2%). At 12 months, the mean change in rTNSS was -4.8 (95% CI, -5.5 to -4.1; p < 0.001), a 57.8% improvement. The available initial rTNSS-based outcomes in the crossover active treatment arm (n = 27) were following the same course as the index treatment arm. No serious adverse events and 8 adverse events related to the device/procedure were reported in the trial to date. CONCLUSION: TCRF neurolysis of the PNN area is safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months.

Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction.

Importance: Nasal valve collapse is a primary cause of nasal airway obstruction (NAO). Patients with NAO and nasal valve collapse experience a variety of symptoms that lower their quality of life, such as nasal congestion, headache, sleep disturbance, daytime sleepiness, and snoring. Objective: To determine if active treatment of the nasal valve with a temperature-controlled radiofrequency (TCRF) device, previously demonstrated superior to a sham procedure at 3 months, was safe and associated with sustained improvements in symptoms of NAO through 12 months. Design, Setting, and Participants: In a prospective, multicenter, single-blinded, randomized clinical trial, patients in 16 centers in the US with index procedures between August and December 2020 were assigned to TCRF device treatment of the nasal valve or a sham control procedure (no RF energy). Patients had a baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score of 55 or greater with nasal valve collapse as the primary or substantial contributor to NAO. After primary end point evaluation at 3 months, eligible patients in the sham control arm crossed over to active treatment. Data analysis was performed between April and May 2022. Interventions: Patients were treated bilaterally with the TCRF device at 4 or fewer nonoverlapping areas on the nasal mucosa at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Main Outcomes and Measures: The primary end point measure was responder rate, defined as 20% or greater reduction in NOSE Scale score or 1 or greater reduction in NOSE Scale clinical severity category. Results: A total of 108 patients received active treatment (77 as index active treatment, 31 after crossover). The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) were women. The combined group of patients receiving active treatment had a mean baseline NOSE Scale score of 76.3 (95% CI, 73.6-79.1). At 12 months (n = 88), the responder rate was 89.8% (95% CI, 81.7%-94.5%). The NOSE Scale score improved from baseline (mean change, -44.9 [95% CI, -52.1 to -37.7]). No device/procedure-related serious adverse events were reported. Conclusions and Relevance: In this follow-up of a cohort from a randomized clinical trial, the minimally invasive TCRF device, previously demonstrated to be superior to a sham procedure, was safe and associated with improvement in symptoms of NAO through 12 months postprocedure. Trial Registration: ClinicalTrials.gov Identifier: NCT04549545.

Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial.

OBJECTIVE: To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis. STUDY DESIGN: A multicenter, prospective, single-blinded, randomized controlled trial, in which the control arm underwent a sham procedure. SETTING: Sixteen otolaryngology centers. METHODS: Patients with 24-hour reflective Total Nasal Symptom Score (rTNSS) ≥6, including moderate to severe rhinorrhea and mild to severe congestion, were randomized 2:1 to active treatment of the posterior nasal nerve area with a temperature-controlled RF device or a sham procedure, with no RF energy delivery. The stylus was applied bilaterally to nonoverlapping areas of the posterior middle meatus and posterior inferior turbinate in each nostril in the region of the PNN. The primary endpoint was responder rate at 3 months, where a response was defined as ≥30% improvement (decrease) in rTNSS from baseline. RESULTS: Patients had a mean baseline rTNSS of 8.3 (95% CI, 7.9-8.7) and 8.2 (95% CI, 7.6-8.8) (P = .797) in the active treatment (n = 77) and sham control (n = 39) arms, respectively. At 3 months, responder rate was significantly higher in the active treatment arm: 67.5% (95% CI, 55.9%-77.8%) vs 41.0% (95% CI, 25.6%-57.9%) (P = .009). The active treatment arm had a significantly greater decrease in rTNSS (mean, -3.6 [95% CI, -4.2 to -3.0] vs -2.2 [95% CI, -3.2 to -1.3]) (P = .013). Three adverse events related to the device/procedure were reported, and all resolved. CONCLUSION: This randomized controlled trial showed temperature-controlled neurolysis of the PNN area is free from significant adverse events and superior to a sham procedure in decreasing the symptom burden of chronic rhinitis.

Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial.

BACKGROUND: Nasal valve collapse is one of several causes of nasal obstruction. The safety and efficacy of a temperature-controlled radiofrequency (RF) device for the treatment of the nasal valve for nasal airway obstruction (NAO) has been established in single-arm studies. The objective of this trial was to compare active device treatment against a sham procedure (control). METHODS: In a prospective, multicenter, single-blinded, randomized controlled trial (RCT), patients were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area. The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall. The primary endpoint was responder rate at 3 months, defined as a ≥20% reduction in Nasal Obstruction Symptom Evaluation (NOSE)-scale score or ≥1 reduction in clinical severity category. RESULTS: At baseline, patients had a mean NOSE-scale score of 76.7 (95% confidence interval [CI], 73.8 to 79.5) and 78.8 (95% CI, 74.2 to 83.3) (p = 0.424) in the active treatment and sham-control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3% [95% CI, 79.2%-93.7%] vs 42.5% [95% CI, 28.5%-57.8%]; p < 0.001). The active treatment arm had a significantly greater decrease in NOSE-scale score (mean, -42.3 [95% CI, -47.6 to -37.1] vs -16.8 [95% CI, -26.3 to -7.2]; p < 0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved. CONCLUSION: This RCT shows temperature-controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short-term follow-up.

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.

A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps.

BACKGROUND: Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid-eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 µg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days. METHODS: A randomized, sham-controlled, double-blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in-office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 µg once daily. Co-primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review. RESULTS: Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant-related serious adverse event (epistaxis). CONCLUSION: Significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.

Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study.

OBJECTIVE: Balloon sinus dilation (BSD) instruments afford the opportunity for office-based sinus procedures in properly selected patients with chronic rhinosinusitis (CRS). This study evaluated patient-reported outcomes 1 year after office-based BSD. METHODS: Adult patients with medically refractory CRS were prospectively enrolled into a multicenter, single-arm study and treated with office-based BSD under local anesthesia. Follow-up on 203 patients was conducted at 2, 8, and 24 weeks postsurgery using validated outcome measures for quality of life (SNOT-20) and computed tomography imaging (Lund-Mackay score). After 24 weeks, patients were re-enrolled for 1-year follow-up to evaluate changes in SNOT-20 scores and revisions. RESULTS: All patients who re-enrolled (n = 122) completed the study, with an average follow-up of 1.4 years. Neither preoperative SNOT-20 nor Lund-Mackay CT scores were predictive of re-enrollment and return for follow-up. Compared to baseline, improvements in SNOT-20 scores remained statistically significant (P < .001) and clinically meaningful (mean decrease ≥ 0.8). In patients followed to 1.4 years, 9 of 122 (7.4%) had revision surgery. CONCLUSION: Following office-based BSD, significant improvements in quality of life observed at 24 weeks were maintained 1 year postsurgery. These extended results provide further evidence of office-based BSD as an effective, minimally invasive procedure for appropriately selected patients with CRS.

Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients.

BACKGROUND: Balloon sinus dilation (BSD) is an increasingly used tool in endoscopic sinus surgery (ESS). The tissue-sparing nature of the instrumentation allows for properly selected patients to undergo office-based procedures under local anesthesia. METHODS: This was an Institutional Review Board (IRB)-approved, prospective, 14-center trial. Patients (n = 203) requiring ESS for medically refractory chronic sinusitis underwent transnasal BSD treatment in an office setting under local anesthesia. Safety, tolerability, technical success, clinical efficacy (20-item Sino-Nasal Outcome Test [SNOT-20]), and radiographic outcome (Lund-Mackay [LMK] score) of ESS with BSD in the office setting were assessed. Subjects were followed at 2, 8, and 24 weeks. RESULTS: A total of 552 sinuses were dilated in 203 patients: 47.6% maxillaries, 45.5% frontals, and 6.9% sphenoids. Seventy-seven patients were revisions of prior ESS. The mean number of sinuses dilated per subject was 2.7. Technical dilation success was 93.3%, 90.5%, and 93.7% for maxillary, sphenoid, and frontal sinuses, respectively. SNOT-20 and LMK computed tomography (CT) scoring showed statistically significant improvement at 24 weeks (p < 0.0001) and clinically significant improvement in quality of life. The procedure was reported as tolerable or highly tolerable by 82.3% of patients. There were 0.15 postoperative debridements per patient and the majority returned to normal activity within 48 hours. One (0.5%) procedure-related adverse event related to periorbital swelling was reported, which spontaneously resolved shortly after the procedure without further sequelae. CONCLUSION: Performance of ESS with BSD in the office under local anesthesia is feasible, well-tolerated, safe, and effective. Twenty-four week follow-up demonstrates clinical and statistical improvement in patient quality of life and radiographic outcomes.

Prospective, open-label, 18-month trial of calcium hydroxylapatite (Radiesse) for facial soft-tissue augmentation in patients with human immunodeficiency virus-associated lipoatrophy: one-year durability.

BACKGROUND: The objective was to evaluate the safety and effectiveness of soft-tissue augmentation of calcium hydroxylapatite (Radiesse) in patients with facial lipoatrophy secondary to human immunodeficiency virus disease. METHODS: This 18-month, prospective, open-label, multicenter clinical trial of calcium hydroxylapatite for soft-tissue augmentation of patients with facial lipoatrophy enrolled 100 subjects (94 men and six women). RESULTS: Correction of facial lipoatrophy was evaluated by comparing changes from baseline using the Global Aesthetic Improvement Scale, with confirmation using standardized photography. All 100 patients were determined to be improved or better at 3 months. Secondary effectiveness endpoints-improvement at 6 months on the scale and skin thickness measurements at 3 and 6 months-were also met. Twelve-month data and 18-month scale scores were also available. One hundred percent of assessable patients were rated as improved or better on the scale at every time point through 12 months; 91 percent were improved or better at 18 months. "Yes" responses to all patient satisfaction questions ranged from 97 percent to 100 percent at every evaluation through 12 months. In addition, skin thickness measurements at 12 months remained statistically better than those at baseline. Eighteen-month patient satisfaction and skin thickness measurements were not available at the time of submission. Adverse events reported through 12 months were generally mild (ecchymosis, edema, erythema, pain, and pruritus), not unexpected, and generally short in duration. Eighteen-month safety data were not available at the time of submission. CONCLUSIONS: Radiesse is an appropriate and well-tolerated treatment for patients with facial lipoatrophy. It demonstrates an excellent safety profile, causes immediate augmentation of the soft tissues, and appears to provide relatively long-lasting improvement in appearance, with very high patient satisfaction.