Evaluation of In-Office Cryoablation of Posterior Nasal Nerves for the Treatment of Rhinitis

Abstract

Background Chronic rhinitis is a common condition generally treated with medical therapies. However, 10–22% of patients are refractory to medical therapies. A cryotherapy handheld device targeting the postganglionic nerve fibers of the posterior nasal nerve (PNN) now serves as an additional option for therapy. This study evaluates the efficacy of the cryosurgical ablation device of the PNN in the clinic setting. Methods This was a prospective single-arm trial of 24 adult patients at seven locations within a large health maintenance organization. Patients with chronic rhinitis that failed medical therapy were offered an in-office cryoablation of PNN. Patients completed the Total Nasal Symptom Score (TNSS) questionnaire consisting of 5 items reported based on the previous 12 hours and 2 weeks at the following time points: pre-treatment, 30 days, 90 days and 1 year post-treatment. Results Following cryoablation of the PNN, the TNSS 12-hour symptom score improved from 6.92 (±2.9) to 3.17 (±2.4, P < 0.001) at 30 days, 2.92 (±1.4, P < 0.001) at 90 days and 3.08 (±2.6, P < 0.001) at 1 year post treatment. Similar results were noted for the 2 weeks scores improving from 7.75 (±3.1) to 3.79 (±2.1, P < 0.001) at 30 days, 3.88 (±1.9, P < 0.001) at 90 days and 3.76 (±2.1, P < 0.001) at 1 year post-treatment. 64.7% of respondents stated the procedure decreased or eliminated nasal sprays. Conclusions Our independent evaluation of cryoablation of the PNN shows improvement in nasal symptoms over a 1 year period and is consistent with other published data.

Cryotherapy for treatment of chronic rhinitis: 3‐month outcomes of a randomized, sham‐controlled trial

“…The results of this study validate the use of cryoablation of the posterior nasal nerve as an effective treatment for chronic rhinitis. In comparison with previous studies on cryoablation of the posterior nasal nerve, our baseline rTNSS score of 8.1 was higher than those previously described by Hwang et al 14 (6.2), Chang et al 15 (6.1), and Yen et al 16 (7.0), and similar to that described by Gerka Stuyt et al 18 (7.8). Despite our participants having more severe baseline symptom scores, our 90‐day active treatment change (−3.7) was similar to changes in those other studies (−3.5, −3.1, −4.0, and −3.9, respectively).…”

“… 7 More recently, selective cryoablation of the posterior nasal nerve has shown promise in nonrandomized studies for reducing rhinorrhea and nasal congestion in patients with allergic and nonallergic rhinitis, but the lack of a control arm has limited interpretation of the data from these trials. 14 , 15 , 16 , 17 , 18 The present study was designed to address this limitation by including a randomized, sham‐controlled arm.…”

“…The posterior nasal nerve was later identified as a better target for surgical intervention to focally disrupt only nasal parasympathetic innervation, as it is distal to the parasympathetic fibers for lacrimal innervation 7 . More recently, selective cryoablation of the posterior nasal nerve has shown promise in nonrandomized studies for reducing rhinorrhea and nasal congestion in patients with allergic and nonallergic rhinitis, but the lack of a control arm has limited interpretation of the data from these trials 14–18 . The present study was designed to address this limitation by including a randomized, sham‐controlled arm.…”

“…In 2016, the US Food and Drug Administration cleared the (ClariFix) cryotherapy device (Stryker ENT, Plymouth, MN) 13 for the destruction of unwanted tissue, including in adults with chronic rhinitis. Several nonrandomized clinical studies of this device have demonstrated clinical improvement in rhinitis symptoms after treatment 14 , 15 , 16 , 17 , 18 ; however, those studies were not randomized, and the patient‐reported outcomes used to evaluate efficacy were subject to recall bias. This study was undertaken to provide high‐level evidence from a patient‐blinded, randomized, controlled trial to test whether cryotherapy is superior to a sham procedure for reducing symptoms of chronic rhinitis.…”

International consensus statement on allergy and rhinology: Allergic rhinitis – 2023

“…in 1983. Studies utilizing cryoablation, including a randomized, sham‐controlled trial, have shown improvement in symptoms and QOL 275,2404–2409 . Though no study specifically evaluated an AR‐specific cohort, many performed subgroup analysis (which showed similar improvement) or controlled for the presence of AR (which showed that AR did not modify outcomes).…”