Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis.

Objective: Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis. Methods: A prospective, single-arm, multicenter study was performed on adults with chronic rhinitis who underwent radiofrequency ablation to the posterior nasal nerves. Primary endpoints were device-related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months. Total nasal symptom score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated. Results: Thirty-six participants were enrolled and completed follow-up at 1 and 3 months. Mean VAS NSS scores for rhinorrhea and nasal congestion demonstrated significant improvement at 3 months (both p < .0001). The mean percent changes from baseline in VAS rhinorrhea and nasal congestion were 53% and 55%, respectively. Total scores and all individual rTNSS items significantly improved (all p < .001) over the measured interval. Percent responder rate (≥30% reduction from baseline in total rTNSS) at 3 months was 78%. The total mean mini RQLQ scores, as well as all subdomains, improved significantly (all p < .0001). At 3 months, 89% of participants reported a minimal clinically important difference of ≥0.4 point improvement in the mini RQLQ score. No SAEs occurred during the study. Conclusions: The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3 months post-procedure. Trial Registration: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. Level of Evidence: 4.

Balloon Catheter Dilation of the Frontal Sinus Ostium.

The decision to operate on the frontal sinus is based on persistent symptoms that have been refractory to appropriate medical therapy with associated radiographic evidence of disease by computed tomography. There is currently no evidence to support operating on radiographically negative frontal sinuses, regardless of the availability of technology or site of service options. There are many surgical procedures as well as a variety of different technologies available for the treatment of symptomatic, medically refractory frontal sinus disease. Balloon catheter dilation can be performed safely in an office setting with outcomes comparable to those in traditional operating room settings.

In-office balloon catheter dilation: analysis of 628 patients from an administrative claims database.

OBJECTIVES/HYPOTHESIS: Balloon catheter dilation (BCD) of the paranasal sinuses is increasingly described as a standalone procedure in the office for minimally invasive treatment of patients with chronic rhinosinusitis (CRS). This study evaluates CRS-related healthcare utilization before and after in-office treatment as performed by otolaryngologists within the United States in an all-comer population. STUDY DESIGN: Retrospective claims database analysis. METHODS: The MarketScan database was queried for patients undergoing BCD (Current Procedural Terminology [CPT] 31295-31297) for CRS (International Classification of Diseases Ninth Edition [ICD-9] 473.x) since 2011 in the office (place of service: 11). Exclusion criteria included < 1 year preoperative enrollment, < 6 months postoperative history, and concurrent (± 30 days) endoscopic sinus surgery (CPT 31254-31288). A cohort of 628 patients was identified. Analyses included preoperative comorbidities and CRS-related healthcare use. RESULTS: Preoperative comorbidities included asthma (29.0%), polyps (11.5%), and aspirin sensitivity (9.9%). An average of 3.0 sinuses (95% confidence interval: 2.91-3.17) were dilated at index. Maxillary, frontal, and sphenoid dilations were performed in 88.9%, 74.5%, and 33.8% of cases, respectively. There were two orbital complications and seven cases of hemorrhage potentially associated with the procedure, but no postoperative cerebrospinal fluid leaks. No blood transfusion, lateral canthotomy, or canthoplasty were reported. CRS-related postoperative healthcare use declined rapidly from the immediate preoperative state. Twenty-one patients underwent revisions, with one patient undergoing two surgeries for a total of 22 reoperations (3.5%). CONCLUSIONS: In-office BCD is associated with low risks of complications and revisions. Whereas not significant for patients with polyps, decreases in healthcare utilization pre- to postsurgery were significant for patients without polyps.