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.

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.

Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis.

Background: Temperature-controlled radiofrequency neurolysis of the posterior nasal nerve has been shown to reduce the symptom burden of patients with chronic rhinitis. Objectives: To evaluate the long-term safety and effectiveness of temperature-controlled radiofrequency neurolysis of the posterior nasal nerve for the treatment of chronic rhinitis. Methods: A prospective extension of a 12-month single-arm study, where reflective total nasal symptom score (rTNSS) and the responses to a study-specific quality of life questionnaire and patient satisfaction survey were collected at 24 months. Results: Forty-seven patients completed initial 12-month follow-up after treatment with the study device, of which 34 patients were reconsented and completed 24-month follow-up. The mean rTNSS of the long-term follow-up patients improved from 8.4 (95% confidence interval (CI), 7.7 to 9.0) at baseline to 2.9 (95% CI, 2.1 to 3.6), P < .001 at 24 months, a 65.5% improvement. On a 6-point scale (0-5), postnasal drip improved from a mean of 4.1 (95% CI, 3.6 to 4.6) to 2.1 (95% CI, 1.7 to 2.5) and chronic cough improved from 3.2 (95% CI, 2.7 to 3.6) to 0.9 (95% CI, 0.5 to 1.3) from baseline through 24 months; P < .001 for both measures. The proportion of patients achieving a minimal clinically important difference of 30% improvement from baseline at 24 months was 88.2% (95% CI, 73.4%-95.3%). At 24 months, 24% of patients were taking overall fewer and 15% taking overall more rhinitis medication classes than at baseline. Patients reported a higher quality of life in terms of sleep, well-being, and lower oral medication/nasal spray use at 24 months. There were no serious adverse events considered related to the procedure in the 12-24-month period. Conclusion: Temperature-controlled radiofrequency neurolysis results in a significant and durable reduction in the symptom burden of chronic rhinitis and patients reported improved quality of life through 24 months postprocedure.

Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Rhinitis.

BACKGROUND: Chronic rhinitis is a prevalent condition with a significant impact on quality of life. Posterior nasal nerve and vidian neurectomy are surgical options for treating the symptoms of chronic rhinitis but are invasive procedures. OBJECTIVE: To determine the outcomes of patients diagnosed with refractory chronic rhinitis and treated with temperature-controlled radiofrequency neurolysis of the posterior nasal nerve area in a minimally invasive procedure. METHODS: A prospective, single-arm multicenter study with follow-up through 52 weeks. Eligible adult patients had chronic rhinitis symptoms of at least 6 months duration with inadequate response to at least 4 weeks usage of intranasal steroids and an overall 12-h reflective total nasal symptom score (rTNSS) ≥ 6 with subscores 2 to 3 for rhinorrhea, 1 to 3 for nasal congestion, and 0 to 3 for each of nasal itching and sneezing. Temperature-controlled radiofrequency energy was delivered to the nasal cavity mucosa overlying the posterior nasal nerve region with a novel single-use, disposable, handheld device. RESULTS: A total of 50 patients were treated (42.0% male; mean age 57.9 ± 11.9 years), and 47 completed the study through 52 weeks. Mean rTNSS significantly improved from 8.5 (95% CI 8.0, 9.0) at baseline to 3.6 (95% CI 3.0, 4.3) at 52 weeks (P < .001), a 57.6% improvement. Similar trends in improvement were noted for rTNSS subscores (rhinorrhea, nasal congestion, itching, sneezing), postnasal drip scores, and chronic cough scores. Subgroup analysis demonstrated the treatment was effective regardless of rhinitis classification (allergic or nonallergic). No serious adverse events with a relationship to the device/procedure occurred. CONCLUSIONS: Temperature-controlled radiofrequency neurolysis of the posterior nasal nerve area for the treatment of chronic rhinitis is safe and resulted in a durable improvement in the symptoms of chronic rhinitis through a 52-week follow-up. Data suggest that this novel device could be considered a minimally invasive option in the otolaryngologist's armamentarium for the treatment 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.

In-office balloon sinus dilation versus medical therapy for recurrent acute rhinosinusitis: a randomized, placebo-controlled study.

BACKGROUND: A limited number of studies have demonstrated symptomatic improvement for recurrent acute rhinosinusitis (RARS) patients after endoscopic sinus surgery. In this randomized, controlled study we evaluated 24-week outcomes for balloon sinus dilation (BSD) performed in-office (IO) with medical management (MM) as compared with MM only for RARS patients. METHODS: Adults diagnosed with RARS were randomized to groups with BSD plus MM (n = 29) or MM alone (n = 30). Patients who received MM alone also received a sham BSD-IO procedure to blind them to group assignment. Patients were followed to 48 weeks posttreatment. The primary outcome was the difference between arms in change in Chronic Sinusitis Survey (CSS) score from baseline to 24 weeks. Secondary endpoints included comparisons of Rhinosinusitis Disability Index (RSDI) score, medication usage, medical care visits, and sinus infections. RESULTS: Change in patient-reported quality of life (QOL), as measured by the CSS total score from baseline to 24 weeks, was significantly greater in the BSD plus MM group compared with the MM-only group (37.3 ± 24.4 [n = 26] vs 21.8 ± 29.0 [n = 27]; p = 0.0424). CONCLUSION: BSD plus MM proved superior to MM alone in enhancing QOL for RARS patients. BSD plus MM should be considered as a viable treatment option for properly diagnosed RARS patients.

Electrical stimulation of post-irradiated head and neck squamous cell carcinoma to improve xerostomia.

OBJECTIVE: We observed a significant improvement in the complaints of dysphagia in patients with head and neck cancer who had received noninvasive neuromuscular electrical stimulation (E-stim) of their pharyngeal muscles. We wanted to determine if the improvement in dysphagia was a result of decreased complaints of xerostomia and increased saliva production, since one of our first patients being treated with E-stim noticed a significant improvement in xerostomia. STUDY DESIGN: Prospective trial to determine the effects of E-stim by evaluating saliva production and dysphagia questionnaires instituted by our speech pathologists on head and neck cancer patients that had received radiotherapy (XRT) and were to undergo E-stim for dysphagia. METHODS: Prior to the initiation of E-stim and one to two months after E-stim, saliva samples were collected and patients were asked to answer a Dysphagia and Xerostomia Index Questionnaire. All patients received E-stim two to four months after completing XRT. Patients received three E-stim treatments per week for a total of one to two months. Four electrodes were placed along anterior neck over pharyngeal muscles. E-stim was initiated using four to 30mA at 80-100 pulse-widths. RESULTS: Five patients that received either postoperative radiation therapy or concomitant chemoradiotherapy had been treated with E-stim. All five patients noticed a significant improvement in dysphagia. Five out of five patients noticed a definite increase in saliva production with symptoms of decreased intake of water with meals, sleeping longer hours at night, and increased moistness of lips. CONCLUSION: E-stim therapy appears to be an effective and approved treatment for dysphagia. Our study shows that it may also be beneficial for xerostomia in the post-irradiated head and neck cancer patients. SIGNIFICANCE: To determine if E-stim will benefit the previously irradiated patient with dysphagia and xerostomia.

Predictive factors for posterior triangle metastasis in HNSCC.

OBJECTIVE: Surgical modifications sparing uninvolved structures such as the spinal accessory nerve have been implemented since the advent of the radical neck dissection in 1906. The increased morbidity to the spinal accessory nerve involved with the dissection of level V lymph nodes has led to much controversy. In this study, we examine the incidence of nodal metastasis to all nodal levels involved with upper aerodigestive squamous cell carcinoma and attempt to determine when level V dissection is indicated. STUDY DESIGN: Retrospective chart review. METHODS: A study of all radical and modified radical neck dissections was performed at Louisiana State University - Shreveport Health Sciences Center and Overton Brooks Veterans Administration Hospital between 1996 and 2003 for upper aerodigestive squamous cell carcinoma. Univariate and multivariate analyses were performed to determine which neck and patient factors were significantly associated with level V metastasis. RESULTS: Seventy-nine patients with a total of 94 neck dissections were analyzed. The prevalence of level V metastasis was 7.4% of the total neck dissections. Multivariate analysis found that positive lymph nodes involving levels II, III, and IV was the only independent significant factor for level V metastasis (P = .0003). CONCLUSION: Our study is in concordance with other studies in the literature, revealing a low prevalence of level V metastasis in upper aerodigestive squamous cell carcinoma. Unlike other studies, we have found if levels II, III, and IV lymph nodes are found to be positive, dissection of level V is warranted.

Tracheostomy in preterm infants: current trends.

OBJECTIVE: To study the indications for and outcomes of tracheostomy in a population of preterm infants. DESIGN: Retrospective analysis of case records. SETTING: Two university-affiliated tertiary care children's hospitals. Patients We identified premature infants who required tracheostomies from January 1, 1997, through January 31, 2001. Information on weight, gestational age, comorbid conditions, indication for tracheostomy, and outcomes was collected. Infants were divided by birth weight into group 1 (<1000 g; n = 19 [very low birth weight]) and group 2 (> or =1000 g; n = 14). Comorbid conditions were scored and a total score was calculated for each patient. RESULTS: Group 1 had a higher incidence of patent ductus arteriosus, bronchopulmonary dysplasia, intraventricular hemorrhage, and retinopathy of prematurity. The incidence of congenital or genetic defects was equal in groups 1 and 2 (11 infants [58%] and 8 infants [57%], respectively). Group 1 had a higher average number of failed extubations (5.17 vs 3.18) and a higher oxygen requirement (48.7% vs 30.3%) compared with group 2. Weight at tracheostomy was essentially equal in groups 1 and 2 (3.6 vs 3.7 kg). Subglottic stenosis and laryngotracheomalacia were equally common findings in groups 1 and 2. The average comorbidity score for group 1 was higher than that for group 2 (6.7 vs 2.8). The most common indication for tracheostomy was ventilatory dependence (n = 24 [73%]), compared with airway obstruction (n = 6 [18%]) and pulmonary toilet (n = 3 [9%]). Overall, 6 patients (18%) had a complication related to the tracheostomy. CONCLUSIONS: Severity of pulmonary disease was the most significant factor associated with the need for tracheostomy in preterm infants. A tracheostomy can safely be performed in these infants with minimal morbidity.