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.

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.

Contemporary management of nasal polyps.

Nasal polyposis is a multifactorial disease process resulting in a common pathologic structure. Better understanding of the pathophysiology has resulted in improved protocols for treatment. Different causes of polyposis are discussed with attention to both medical and surgical therapy. Recent advances in aspirin desensitization are detailed.

Incidence of complications for subtotal ionized field ablation of the tonsils.

OBJECTIVE: Ionized field ablation, or coblation-assisted subtotal tonsillectomy, has been described as a new alternative technique for the management of tonsillar disease. This study was designed to review the incidence of complications in patients undergoing this procedure. STUDY DESIGN: A 10-surgeon retrospective chart review of the intraoperative and postoperative complications of patients undergoing ionized field ablation subtotal removal of tonsils was performed. Postoperative pain, dietary restrictions, and activity level were not reviewed. RESULTS: Of the 528 patients who underwent ionized field ablation of their tonsils, the incidence of intraoperative and postoperative complications compared favorably with those reported in retrospective studies in the literature for traditional subcapsular tonsillectomy. Significant postoperative bleeding occurred in less than 1%, and only 1 patient required surgical control of bleeding in the operating room. No patients required transfusions of any blood products. CONCLUSIONS: Ionized field ablation subtotal tonsillectomy may offer an alternative to traditional subcapsular tonsillar surgery with a decreased incidence of postoperative complications. Further study is necessary to establish the complication rate of this technique.