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Multicenter Study
. 2022 Nov;36(6):747-754.
doi: 10.1177/19458924221109987. Epub 2022 Jul 11.

Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis

Jivianne T Lee  1 , Gregory M Abbas  2 , Daniel D Charous  3 , Pd Dr Med Mandy Cuevas  4 , Prof Dr Med Önder Göktas  5 , Patricia A Loftus  6 , Nathan E Nachlas  7 , Elina M Toskala  8 , Jeremy P Watkins  9 , Prof Dr Med Detlef Brehmer  10   11   12
Affiliations
Multicenter Study

Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis

Jivianne T Lee et al. Am J Rhinol Allergy. 2022 Nov.

Abstract

Background: Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN; RhinAer) is a minimally invasive treatment option for patients with chronic rhinitis.

Objective: To determine clinical outcomes and quality of life (QoL) following TCRF neurolysis of the PNN.

Methods: A prospective single-arm study of 129 patients with chronic rhinitis at 16 medical centers in the United States and Germany.

Results: The mean 24-h reflective total nasal symptom score (rTNSS) improved from 7.8 (95% CI, 7.5-8.1) at baseline to 3.6 (95% CI, 3.2-4.0) at 3 months and continued to improve to 2.9 (95% CI, 2.5-3.3) at 6 months (p < .001 comparing follow-up to baseline and p = .002 comparing 3 and 6 months). This represents 53.8% improvement over baseline at 3 months and 62.8% improvement at 6 months. Rhinorrhea, congestion, sneezing, and itching subscores and postnasal drip and cough scores were all significantly improved over baseline at both timepoints. At 3 months, 76.2% (95% CI, 68.1%-82.8%) of patients achieved a minimal clinically important difference of ≥30% improvement in rTNSS over baseline and the percentage was higher at 6 months (83.5% [95% CI, 75.8%-89.0%]). At 3 months, 80.3% (95% CI, 72.6%-86.3%) reported a minimal clinically important difference of ≥0.4-point improvement in the mini rhinoconjunctivitis quality of life questionnaire score, and the percentage was higher at 6 months; 87.7% (95% CI, 80.7%-92.4%). There were no serious adverse events with a relationship to the device/procedure reported through 6 months.

Conclusion: In this large, multicenter study, TCRF neurolysis of the PNN was safe and resulted in a significant reduction in rhinitis symptom burden at 3 months that was sustained/improved through 6 months. The majority of patients reported a clinically relevant improvement in QoL at 3 and 6 months postprocedure.

Keywords: MiniRQLQ; chronic rhinitis; neurolysis; posterior nasal nerve; quality of life; rTNSS; radiofrequency; temperature-controlled.

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Conflict of interest statement

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Detlef Brehmer has received research funding from Aerin Medical. Jivianne Lee and Daniel Charous are consultants to Aerin Medical. The other authors have no other funding, financial relationships, or conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Adjusted mean rTNSS at baseline and follow-up. Bars indicate the 95% confidence interval, p < .001 comparing each follow-up timepoint to baseline and p = .002 comparing 3 and 6 months. rTNSS = 24-h reflective total nasal symptom score.
Figure 2.
Figure 2.
Adjusted mean rTNSS subscores at baseline and follow-up. Bars indicate the 95% confidence interval, p < .001 comparing each follow-up timepoint to the baseline for each subscore. Comparing 3 and 6 months, congestion (p = .005) and itching (p = .019) were significantly further improved at 6 months, sneezing (p = .066) and rhinorrhea (p = .261) were not significantly different. rTNSS = 24-h reflective total nasal symptom score.
Figure 3.
Figure 3.
The percentage of patients reporting each rTNSS subscore at baseline and follow-up. p < .001 comparing each follow-up timepoint to baseline. Comparing 3 and 6 months, congestion (p = .002), itching (p = .002), and sneezing (p = .021) were significantly further improved at 6 months, and rhinorrhea (p = .084) was not significantly different. n = 127 at baseline, n = 128 at 3 months, and n = 123 at 6 months. rTNSS = 24-h reflective total nasal symptom score.
Figure 4.
Figure 4.
Adjusted mean postnasal drip and cough scores at baseline and follow-up. Bars indicate the 95% confidence interval, p < .001 comparing each follow-up timepoint to the baseline for each score. Comparing 3 and 6 months, both postnasal drip (p = .002) and cough (p = .019) were significantly further improved at 6 months.
Figure 5.
Figure 5.
The percentage of patients reporting each postnasal drip and cough score at baseline and follow-up, p < .001 comparing each follow-up timepoint to baseline for each score. Comparing 3 and 6 months, both postnasal drip (p < .001) and cough (p = .011) were significantly further improved at 6 months. n = 127 at baseline, n = 128 at 3 months, and n = 123 at 6 months.
Figure 6.
Figure 6.
Adjusted mean mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ) score at baseline and follow-up. Bars indicate the 95% confidence interval, p < .001 comparing each follow-up timepoint to baseline and p = .022 comparing 3 and 6 months.
Figure 7.
Figure 7.
Adjusted mean mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ) domain scores at baseline and follow-up. Bars indicate the 95% confidence interval, p < .001 comparing each follow-up timepoint to the baseline for each domain score. Comparing 3 and 6 months, nose and eye symptoms were improved at 6 months (p < .05); activity and practical limitations and other symptoms were not significantly different (p > .05).
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