Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study

Abstract

Objective: To assess the efficacy and safety of cryoablation of the posterior nasal nerve (PNN) for treatment of chronic rhinitis.

Methods: This was a prospective single-arm trial of 98 adult patients at six U.S. centers with chronic allergic and nonallergic rhinitis. PNN cryoablation was performed in-office under local anesthesia using a handheld device. Patients discontinued use of intranasal ipratropium 3 days prior to treatment and throughout the study period. Reflective Total Nasal Symptom Score (rTNSS) was measured at pretreatment baseline and posttreatment at 1 month, 3 months, 6 months, and 9 months. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was completed at pretreatment and 3 months posttreatment. Adverse effects and postprocedure medication usage were recorded.

Results: Ninety-eight procedures (100%) were successfully completed. rTNSS significantly improved over pretreatment baseline (6.1 ± 1.9) at 1 month (2.9 ± 1.9, P < 0.001), 3 months (3.0 ± 2.3, P < 0.001), 6 months (3.0 ± 2.1, P < 0.001), and 9 months (3.0 ± 2.4, P < 0.001) postprocedure. Nasal congestion and rhinorrhea subscores improved significantly at all time points (P < 0.001). Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups. RQLQ significantly improved over pretreatment baseline (3.0 ± 1.0) at 3 months (1.5 ± 1.0, P < 0.001), and all RQLQ subdomains demonstrated improvement. Of 54 patients using intranasal medication at baseline, 19 (35.2%) were able to discontinue use. Twenty-nine adverse effects were reported, including headache, epistaxis, and sinusitis.

Conclusion: Cryoablation of the PNN for chronic rhinitis is safe and can result in relief of nasal symptoms and improvements in quality of life.

Level of evidence: 4 Laryngoscope, 130: 1877-1884, 2020.

Trial registration: ClinicalTrials.gov NCT03181594.

Keywords: Rhinitis; congestion; cryoablation; cryosurgery; posterior nasal nerve; rhinorrhea.

Figure 1

Device (left) and treatment site (right). [Color figure can be viewed in the online issue, which is available at www.laryngoscope.com.]

Figure 2

(A) rTNSS scores following the cryoablation procedure for all subjects (dark line), the nonallergic subcohort (dotted line), and the allergic subcohort (light line). (B) The proportion of subjects with improvements exceeding the rTNSS MCID for all subjects (dark line), the nonallergic subcohort (dotted line), and the allergic subcohort (light line). Error bars represent standard deviation. Statistically significant improvements from baseline (P < 0.001) are identified by: *All subjects; ^†nonallergic subcohort; ^‡allergic subcohort. MCID = minimum clinically important difference; rTNSS = Reflective Total Nasal Symptom Score.

Figure 3

Significant changes in rTNSS subscores were observed following the cryoablation procedure across all subjects. Error bars represent standard deviation. Statistically significant improvements from baseline (P < 0.001) are identified by: *All domains. rTNSS = Reflective Total Nasal Symptom Score.

Figure 4

Significant changes in RQLQ total and domain scores were observed following cryoablation procedure the cryoablation procedure. Markers represent means ± standard deviation. Statistically significant improvements from baseline (P < 0.001) are identified (*). rTNSS = Reflective Total Nasal Symptom Score.