Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Rhinitis

Abstract

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.

Keywords: allergic; congestion; neurectomy; neurolysis; posterior nasal nerve; rTNSS; radiofrequency ablation; rhinitis; rhinorrhea; temperature-controlled.

Figure 1.

(A) Aerin Console, which delivers low doses of temperature-controlled RF energy. (B) The tip of the RhinAer Stylus, a single-use disposable handheld device that delivers bipolar RF energy to tissue. (C) The RhinAer Stylus is placed at the target tissue, the nasal cavity mucosa overlying the PNN region (the posterior middle meatus and posterior inferior turbinate). The stylus delivers bipolar RF energy maintained at ∼60°C.

Figure 2.

Patient disposition: 94% of patients completed a 52-week follow-up.

Figure 3.

Mean reflective total nasal symptom score (rTNSS) at baseline and follow-up. Bars represent 95% confidence intervals. All values were statistically significantly improved throughout follow-up (P < .001 at all time points based on a linear mixed-effect model).

Figure 4.

Mean reflective total nasal symptom score (rTNSS) subscores at baseline and follow-up. Bars represent 95% confidence intervals. All values were statistically significantly improved from baseline throughout follow-up (P < .001 at all time points based on a linear mixed-effect model).

Figure 5.

Mean postnasal drip and chronic cough scores at baseline and follow-up. Bars represent 95% confidence intervals. All values were statistically significantly improved from baseline throughout follow-up (P < .001 at all time points based on a linear mixed-effect model).

Figure 6.

(A) The proportion of patients who rarely or never used oral rhinitis medications, nasal sprays, or nasal breathing strips increased relative to baseline at each of the posttreatment follow-ups. (B) Concomitant medication tracking through the study indicated that more patients decreased their usage of antihistamines/decongestants, decongestant nasal sprays, and steroid nasal sprays during the study than increased use.