Original Article

American Journal of Rhinology & Allergy

2022, Vol. 36(6) 747–754
Clinical and Quality of Life Outcomes © The Author(s) 2022

Following Temperature-Controlled Article reuse guidelines:

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Radiofrequency Neurolysis of the Posterior DOI: 10.1177/19458924221109987
journals.sagepub.com/home/ajr
Nasal Nerve (RhinAer) for Treatment of
Chronic Rhinitis

Jivianne T. Lee, MD1 , Gregory M. Abbas, MD2,

Daniel D. Charous, MD3, PD Dr. med. Mandy Cuevas4,
Prof. Dr. med. Önder Göktas5, Patricia A. Loftus, MD6,
Nathan E. Nachlas, MD7, Elina M. Toskala, MD, PhD, MBA8,
Jeremy P. Watkins, MD9, and Prof. Dr. med. Detlef Brehmer10,11,12

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.

1
Department of Head and Neck Surgery, UCLA David Geffen School of Medicine, Los Angeles, CA, USA
2
Advanced ENT and Allergy, Louisville, KY, USA
3
Arizona Desert Ear, Nose & Throat Specialists, Goodyear, AZ, USA
4
Department of Otorhinolaryngology, University Clinic Carl Gustav Carus, Technical University of Dresden, Dresden, Germany
5
ENT-Center, HNO-Zentrum am Kudamm, Berlin, Germany
6
Department of Otolaryngology-Head and Neck Surgery, University of California, San Francisco, San Francisco, CA, USA
7
ENT and Allergy Associates of Florida, Boca Raton, FL, USA
8
Department of Otolaryngology – Head & Neck Surgery, Thomas Jefferson University, Philadelphia, PA, USA
9
Fort Worth ENT Group, Fort Worth, TX, USA
10
Faculty of Medicine, University Witten/Herdecke, Witten, Germany
11
Department of Electrical Engineering and Applied Natural Sciences, Westphalian University of Applied Sciences, Gelsenkirchen, Germany
12
Department of Otorhinolaryngology, Private ENT Practice, Göttingen, Germany

Corresponding Author:
Jivianne T. Lee, Department of Head and Neck Surgery, UCLA David Geffen School of Medicine, 1131 Wilshire Boulevard, Suite 302, Santa Monica, CA
90401, USA.
Email: [email protected]
748 American Journal of Rhinology & Allergy 36(6)

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

Introduction not be discontinued prior to the procedure; and prior proce-

dure/surgery for chronic rhinitis.
Chronic rhinitis is a widespread disease with a significant
effect on the quality of life (QoL) and work productivity.1,2
If pharmacological therapy does not offer adequate relief, Study Procedure
patients may consider surgical interventions such as Vidian
neurectomy3 or posterior nasal nerve (PNN) neurectomy.4,5 Patients were treated with the RhinAer Stylus (Aerin
A minimally invasive temperature-controlled radiofrequency Medical), a single-use, disposable device. The target tissue
(TCRF) device designed to treat chronic rhinitis via PNN was the posterior middle meatus and superior portion of the
neurolysis exhibited superiority over a sham procedure at 3 posterior inferior turbinate, in the region of the PNN. The
months postprocedure in a randomized controlled trial protocol dictated treatment at 1-5 nonoverlapping regions
(RCT).6 The treatment also showed a sustained effect on each side, where the number of treatment areas was
through 12 months postprocedure in a separate, single-arm based on target anatomy size. Patients were treated in-office
study.7 Interest in minimally invasive options (cryoablation and received topical anesthesia followed by lidocaine (with
and laser ablation) with potential for in-office application or without epinephrine) administered by submucosal infiltra-
has increased in recent years.8–12 Here, we report the safety tion in the treatment area. Treatment settings were: tempera-
and efficacy results of a large, pragmatic, single-arm study ture, 60 °C; power, 4 W; treatment time, 12 s. No repeat
of TCRF neurolysis of the PNN for the treatment of (touch-up) procedures were allowed during follow-up.
chronic rhinitis. In addition to the standard reflective total
nasal symptom score (rTNSS),13 this study included use of Primary and Secondary Endpoints
the mini rhinoconjunctivitis quality of life questionnaire
(MiniRQLQ),14 which is the first time this QoL instrument The primary endpoint was the mean change in 24-h rTNSS
has been used to report outcomes of the technology. from baseline to 3 months. Secondary efficacy endpoints
were responder rate (defined as the minimal clinically impor-
tant difference [MCID] of ≥30% improvement [decrease] in
Methods rTNSS15) and the mean change in the MiniRQLQ14 score
from baseline to 3 months. The validated MiniRQLQ instru-
Study and Eligibility Criteria ment consists of 14 questions across 5 domains: activity lim-
This prospective single-arm study enrolled patients across 16 itations, practical problems, nose symptoms, eye symptoms,
centers in the United States (13) and Germany (3). The study and other symptoms, based on a 1-week recall. The safety
was approved by WCG Institutional Review Board for all endpoint was the frequency of device-related and
centers in the United States (20202473), the Ethics procedure-related serious adverse events over 3 months.
Committee of Witten/Herdecke University (219/2020), and These data were also collected through 6 months.
the Ethics Committee of the Technical University Dresden
(BO-EK-463102020) for the centers in Germany. Patients
gave written informed consent prior to the initiation of Additional Outcome Measures
study procedures. The study was registered at clinicaltrials.- Responder rate based on the MCID of ≥1 point improvement
gov; NCT04614324. in rTNSS from baseline was also determined.13 Postnasal
A complete list of eligibility criteria is available in drip and cough symptoms were recorded on a 4-point scale
Supplemental information. Key inclusion criteria were 18 (0-3) at baseline and all follow-up timepoints. MiniRQLQ
to 85 years of age, chronic rhinitis symptoms (≥6 months), domain scores were also determined at baseline and all
total 24-h rTNSS ≥6, moderate to severe rhinorrhea follow-up timepoints. The MCID for MiniRQLQ score is a
(rTNSS rhinorrhea subscore 2-3), and mild to severe nasal 0.4-point improvement from baseline.16 The proportion of
congestion (rTNSS congestion subscore 1-3). The main patients achieving the MiniRQLQ MCID was determined
exclusion criteria were anatomic obstructions limiting at 3 and 6 months. Nasal pain was recorded on a 100-point
access to the posterior nasal passage; altered anatomy of visual analog scale immediately after the procedure and at
the posterior nose via prior sinus or nasal surgery/injury; 3 months; with 0 being no pain and 100 indicating the
active nasal/sinus infection; history of significant dry eye, worst pain imaginable.17 Medication use was not dictated
chronic epistaxis, nose bleeds, rhinitis medicamentosa, by the protocol, however, medication classes (antihistamines,
head/neck irradiation; seasonal allergic rhinitis; a predisposi- decongestants, oral leukotriene inhibitors, intranasal steroid
tion to excessive bleeding; anticoagulation therapy that could sprays, and intranasal anticholinergic sprays) were recorded
Lee et al. 749

from baseline through 6 months. Patients were asked about linear mixed effect model to test for an overall change over
their satisfaction with the treatment and whether they were time; adjusted (least squares) means are presented, with
likely to recommend the treatment to a friend suffering Tukey–Kramer comparisons between baseline and follow-up
from chronic rhinitis at 3 and 6 months postprocedure. visits and between follow-up visits. Generalized estimating
Responses were provided on a 5-point scale (0-4, with 4 equations were used to assess repeated binomial outcome
being “very satisfied” for satisfaction or “yes, absolutely” measures and repeated multinomial ordered categorical dis-
for a recommendation). Patients will contribute data over 3 tributions. Responses to the questions on satisfaction and
years and the results presented in this report represent the likelihood to recommend are presented as median (interquar-
data available at the time of submission for publication. tile range [IQR]). SAS/STAT version 15.2 (SAS Institute)
was used for analyses.
The analysis population includes all patients treated,
Statistical Analysis including 5 patients who were determined to be ineligible
Continuous data are presented as mean and 95% confidence due to an inadequate rTNSS at screening.
intervals (CI), and categorical data as numbers and percent-
ages of the total, unless stated otherwise. Primary and sec-
ondary endpoints were defined by the protocol at 3 months
Results
postprocedure; unadjusted means are presented and a t-test A total of 129 patients were treated with TCRF neurolysis of
was used to compare follow-up to baseline. Missing data the PNN between October 2020 and March 2021. Patient dis-
were not imputed (including some baseline data); population position is shown in Supplemental information. A total of
sizes are reported with the result and in Supplemental 128 patients reached 3 months (1 lost to follow-up) and
information. All other outcomes were assessed using a 123 patients reached 6 months (2 lost to follow-up, 3 with-
drew). Baseline demographics and characteristics of the
129 patients treated with the TCRF device are shown in
Table 1. The majority of patients had been suffering from rhi-
Table 1. Baseline Demographics and Characteristics of Patients nitis for >1 year (n = 124, 96.1%).
Treated with the TCRF Device.* In the 126 patients with an rTNSS at baseline and 3
Characteristic N = 129 months, the mean change in rTNSS at 3 months (primary
endpoint) was −4.2 (95% CI, −4.6 to −3.7; p < .001), a
Female sex 69 (53.5) 53.8% improvement from baseline. At 6 months (n = 121),
Age, years 57.9 ±13.4 the adjusted mean change in rTNSS was −4.9 (95% CI,
BMI, kg/m2 27.2 ±5.7 −5.5 to −4.3), a 62.8% improvement from baseline, p <
Race
.001 comparing 3 and 6 months to baseline and p = .002 com-
Asian 4 (3.1)
paring 3 and 6 months (Figure 1).
Black or African American 5 (3.9)
White 117 (90.7) At 3 months, 76.2% (95% CI, 68.1%-82.8%) of patients
Other 3 (2.3) were responders (secondary endpoint); they had achieved
Nasal exam (1 or both sides) an MCID of ≥30% improvement in rTNSS over baseline.
Turbinate enlargement 30 (23.3)
Nasal polyps 3 (2.3)
Prior nasal surgery 44 (34.1)
Rhinitis typea
Allergic 10 (7.8)
Nonallergic 93 (72.1)
Mixed allergic and nonallergic 1 (0.8)
Not known 25 (19.4)
Medication useb
Antihistamines 64 (50.0)
Decongestants 32 (25.0)
Oral leukotriene inhibitors 14 (10.9)
Intranasal steroid sprays 82 (64.1)
Intranasal anticholinergic sprays 33 (25.8)
Abbreviations: TCRF, temperature-controlled radiofrequency neurolysis;
BMI, body mass index; rTNSS, 24-h reflective total nasal symptom score.
Notes. *Continuous variables are presented as mean ± standard deviation. Figure 1. Adjusted mean rTNSS at baseline and follow-up. Bars
Categorical variables are presented as number (% of total). indicate the 95% confidence interval, p < .001 comparing each
a
Based on prior knowledge (patient report or physician assessment). follow-up timepoint to baseline and p = .002 comparing 3 and 6
b
n = 128. months. rTNSS = 24-h reflective total nasal symptom score.
750 American Journal of Rhinology & Allergy 36(6)

Figure 2. Adjusted mean rTNSS subscores at baseline and Figure 4. Adjusted mean postnasal drip and cough scores at
follow-up. Bars indicate the 95% confidence interval, p < .001 baseline and follow-up. Bars indicate the 95% confidence interval,
comparing each follow-up timepoint to the baseline for each p < .001 comparing each follow-up timepoint to the baseline for
subscore. Comparing 3 and 6 months, congestion (p = .005) and each score. Comparing 3 and 6 months, both postnasal drip
itching (p = .019) were significantly further improved at 6 months, (p = .002) and cough (p = .019) were significantly further improved
sneezing (p = .066) and rhinorrhea (p = .261) were not significantly at 6 months.
different. rTNSS = 24-h reflective total nasal symptom score.

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.

The responder rate was significantly higher at 6 months

(83.5% [95% CI, 75.8%-89.0%]; p = .039).
Mean rTNSS subscores (rhinorrhea, nasal congestion,
itching, and sneezing) were significantly improved from base-
line at both timepoints, p < .001 comparing each follow-up
timepoint to baseline for each subscore (Figure 2).
Comparing 3 and 6 months, congestion and itching were sig-
nificantly further improved at 6 months (p < .05); rhinor-
rhea and sneezing were not significantly different (p > .05).
The distributions of the rTNSS subscores further illus-
Figure 3. The percentage of patients reporting each rTNSS
trate the significant decrease in symptom burden postproce-
subscore at baseline and follow-up. p < .001 comparing each
dure, p < .001 comparing each follow-up timepoint to
follow-up timepoint to baseline. Comparing 3 and 6 months,
congestion (p = .002), itching (p = .002), and sneezing (p = .021) baseline for each subscore (Figure 3; tabulated data in
were significantly further improved at 6 months, and rhinorrhea Supplemental information). Comparing 3 and 6 months, con-
(p = .084) was not significantly different. n = 127 at baseline, gestion, itching, and sneezing were significantly further
n = 128 at 3 months, and n = 123 at 6 months. rTNSS = 24-h improved at 6 months (p < .05), but rhinorrhea was not signif-
reflective total nasal symptom score. icantly different (p > .05).
Lee et al. 751

Mean postnasal drip and cough scores were significantly from baseline, p < .001 comparing 3 and 6 months to baseline
improved at both timepoints, p < .001 comparing each and p = .022 comparing 3 and 6 months (Figure 6).
follow-up timepoint to baseline for each score, and both At 3 months, 80.3% (95% CI, 72.6%-86.3%) of patients
further improved between 3 and 6 months (p < .05) (Figure 4). had achieved an MCID of ≥0.4-point improvement in
The distributions of the postnasal drip and cough scores MiniRQLQ score over baseline. The percentage at 6
also illustrate a significant decrease in symptom burden post- months had significantly increased to 87.7% (95% CI,
procedure, p < .001 comparing each follow-up timepoint to 80.7%-92.4%; p = .022).
baseline for each score, and both further improved between Mean MiniRQLQ domain scores (activity limitations,
3 and 6 months (p < .05) (Figure 5, tabulated data in practical problems, nose symptoms, eye symptoms, and
Supplemental information). other symptoms) were all significantly improved from base-
Patient reports of periprocedural pain, assessed immedi- line, p < .001 comparing each follow-up timepoint to baseline
ately after completion of the procedure, as well as nasal for each domain score (Figure 7). Comparing 3 and 6 months,
pain at 3 months, were low on the 100-point scale. The nose and eye symptoms were further improved at 6 months
mean periprocedural pain score was 19.0 (95% CI, (p < .05); activity and practical limitations and other symp-
14.7-23.2; n = 129) and at 3 months, the mean pain score toms were not significantly different (p > .05).
was significantly lower at 4.4 ([95% CI, 2.1-6.7]; p < .001 Medication use was not dictated by the protocol. To
by Wilcoxon signed ranks test). There were no serious ensure medication use was not substantially affecting the
adverse events related to the study device/procedure treatment effect size, the changes in rTNSS and
through 6 months. A total of 10 adverse events with at rTNSS-based responder rate were determined after imputing
least a possible relationship to the study device or procedure the data of any patients with an increase in at least 1 medica-
were reported in 8 patients with all but 1 reported as mild to tion class (antihistamines, decongestants, oral leukotriene
moderate in severity (tabulated data in Supplemental inhibitors, intranasal steroid sprays, and intranasal anticholin-
information). Single occurrences of vasovagal reaction, dry ergic sprays) from the timepoint of increase onwards; the
eye, nasal mucosa changes, ear discomfort, eye pressure, change in rTNSS was imputed as zero and a responder was
and two events each of sinusitis and nasal soreness were imputed as a nonresponder if not already a nonresponder.
reported during the 6-month follow-up period. One patient Baseline medication use is shown in Table 1. Seven patients
developed a late severe nasal adhesion at 96 days had an increase in at least 1 medication class from baseline at
postprocedure. some point in the study and the results of the data imputation
Patient QoL was significantly improved at 3 months post- for these patients are shown in Table 2, illustrating the
procedure. In the 127 patients with MiniRQLQ scores at minimal change in result. The same imputation methods
baseline and 3 months, the mean change in MiniRQLQ were applied to evaluate the change in MiniRQLQ score
score at 3 months (secondary endpoint) was −1.6 (95% CI, and the percentage of patients achieving the MiniRQLQ
−1.8 to −1.4; p < .001), a 53.3% improvement from baseline. ≥0.4-point improvement MCID. Table 3 shows the results
At 6 months, the adjusted mean change in MiniRQLQ score of these analyses, again illustrating the minimal difference
was −1.8 (95% CI, −2.1 to −1.5), a 60.0% improvement in the results obtained after data imputation.

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
Figure 6. Adjusted mean mini rhinoconjunctivitis quality of life comparing each follow-up timepoint to the baseline for each
questionnaire (MiniRQLQ) score at baseline and follow-up. Bars domain score. Comparing 3 and 6 months, nose and eye symptoms
indicate the 95% confidence interval, p < .001 comparing each were improved at 6 months (p < .05); activity and practical
follow-up timepoint to baseline and p = .022 comparing 3 and 6 limitations and other symptoms were not significantly different (p >
months. .05).
752 American Journal of Rhinology & Allergy 36(6)

Table 2. Adjusted Mean Change in rTNSS and Percentage of Patients Achieving an rTNSS MCID (Responder Rate): (i) With no Data
Imputation and (ii) With Data Imputation for Increased Medication Use.

3 months 6 months

Change in rTNSSa
No imputationb −4.2 (−4.7 to −3.7) −4.9 (−5.5 to −4.3)
Medication increase imputationc −4.1 (−4.7 to −3.6) −4.6 (−5.3 to −4.0)
Responder rated
No imputationb 76.2% (68.1% to 82.8%) 83.5% (75.8% to 89.0%)
Medication increase imputationc 74.6% (66.4% to 81.4%) 78.5% (70.4% to 84.9%)
Abbreviations: MCID, minimal clinically important difference; rTNSS, 24-h reflective total nasal symptom score.
Notes. rTNSS presented as mean (95% confidence intervals). MCIDs presented as percentages (95% confidence intervals).
a
Change in rTNSS from baseline.
b
n = 126 at 3 months and n = 121 at 6 months.
c
Imputing data from the 7 patients with an increase in at least 1 class of medication class (antihistamines, decongestants, oral leukotriene inhibitors, intranasal
steroid sprays, intranasal anticholinergic sprays) from the timepoint of increase onwards to a change in rTNSS of zero or to nonresponder status (not achieving
MCID) if not already a nonresponder. Three data points were imputed at 3 months, and 7 data points were imputed at 6 months.
d
Percentage of patients that achieved a decrease in rTNSS of ≥30% from baseline (responder rate).

Table 3. Adjusted Mean Change in MiniRQLQ Score and Percentage of Patients Achieving the MiniRQLQ MCID, (i) With no Data
Imputation and (ii) With Data Imputation for Increased Medication Use.

3 months 6 months
a
Change in MiniRQLQ score
No imputationb −1.6 (−1.9 to −1.3) −1.8 (−2.1 to −1.5)
Medication increase imputationc −1.6 (−1.9 to −1.3) −1.7 (−2.0 to −1.4)
Achieved MiniRQLQ MCIDd
No imputationb 80.3% (72.6%-86.3%) 87.7% (80.7%-92.4%)
Medication increase imputationc 78.7% (70.8%-85.0%) 82.8% (75.1%-88.5%)
Abbreviations: MCID: minimal clinically important difference; MiniRQLQ: mini rhinoconjunctivitis quality of life questionnaire.
Notes. MiniRQLQ score presented as mean (95% confidence intervals). MCIDs presented as percentages (95% confidence intervals).
a
Change in MiniRQLQ score from baseline.
b
n = 127 at 3 months and n = 122 at 6 months.
c
Imputing data from the 7 patients with an increase in at least 1 class of medication class (antihistamines, decongestants, oral leukotriene inhibitors, intranasal
steroid sprays, and intranasal anticholinergic sprays) from the timepoint of increase onwards to a change in MiniRQLQ score of zero or to below the MCID if
not already below the MCID. Three data points were imputed at 3 months, and 7 data points were imputed at 6 months.
d
Percentage of patients that achieved a decrease in MiniRQLQ score of ≥0.4 points from baseline.

In response to a question on satisfaction with the treat- improvement,13 which has previously been used to evaluate
ment, the median score was 3 (IQR, 2-4) at both 3 and 6 the TCRF device7 and other technologies targeting the
months. In response to a question on whether patients were PNN area (cryoablation).18,19 The responder rate based on
likely to recommend the treatment to a friend who suffered ≥1 point improvement in this study was >90% at both time-
from chronic rhinitis, the median score was 4 (IQR, 2-4) at points (96.0% [95% CI, 91.1%-98.3%] at 3 months and
3 months and 4 (IQR, 3-4) at 6 months. 95.0% [95% CI, 89.6%-97.7%] at 6 months). The 3-month
results of this single-arm study are on par with the results
of an RCT, in which active TCRF device treatment was dem-
Discussion onstrated to be superior to a sham procedure at 3 months.6
The results of this study contribute to the increasing amount The results of the postnasal drip and cough assessments
of data demonstrating a significant and clinically important are interesting as these symptoms are not assessed by the
reduction in symptom burden from minimally invasive widely used rTNSS instrument but are commonly associated
TCRF neurolysis of the PNN.7 A high percentage of patients with chronic rhinitis; both showed significant improvement
achieved the MCID of ≥30% improvement in rTNSS over at 3 and 6 months.
baseline (76.2% and 83.5% at 3 and 6 months, respectively). This large study also showed an improvement in QoL as
This MCID is a more stringent test than ≥1-point early as 3 months postprocedure, reported using a validated
Lee et al. 753

instrument, and the effect was maintained through 6 months. have contributed to the overall observed effect. Medication
The MiniRQLQ was selected for this study based on ease of use was not limited by the protocol, but the study was prag-
use, with 14 questions in 5 domains. Again, a large percentage matically designed to collect real-world outcomes. While the
of patients achieved the MCID of ≥0.4-point improvement at current study shows the efficacy of this technology, future
3 and 6 months. This MCID has been used in reports on other research is needed to determine cost–benefit analysis.
technologies targeting the PNN area for the treatment of
chronic rhinitis.18,19 There does not appear to be any domain
of the MiniRQLQ that was dominating the overall outcome, Conclusion
as all domains showed significant improvement at each In this large, pragmatic study in the United States and
follow-up timepoint. Europe, TCRF neurolysis of the PNN resulted in a significant
The safety profile of the device/procedure was excellent improvement in both chronic rhinitis symptom burden and
during this study and no safety concerns arose. The in-office disease-specific QoL at 3 and 6 months postprocedure.
procedure utilizes a combination of topical anesthesia fol- Patients reported a significant reduction in rhinorrhea, nasal
lowed by submucosal infiltration with lidocaine (with or congestion, itching, and sneezing, in addition to a significant
without epinephrine) at the treatment sites. Patients reported reduction in postnasal drip and cough symptoms. No serious
minimal periprocedural pain, which may be a consequence of adverse events with a relationship to the device/procedure
the controlled temperature feature of the device. The advan- were reported through 6 months. Continued follow-up will
tage of TCRF over radiofrequency (RF), in general, is that a confirm that treatment effects are consistent with previously
therapeutic treatment temperature of ∼60°C is maintained as published long-term evidence.
the stylus delivers bipolar RF energy to tissue and monitors
tissue temperature, and automatically adjusts the RF Acknowledgments
current. The controlled temperature allows neurolysis to
occur but limits the damage to overlying mucosa and adja- The authors thank enrolling site principal investigators:
cent tissues. Importantly, no headaches or other significant Tim. A. Fife, MD; John T. Lanza, MD; Scott A. Powell, MD;
pain-related adverse events were reported. In comparison Jordan Pritikin, MD; Neelesh H. Mehendale, MD; John H. Willis,
with other technologies targeting the PNN area for the treat- MD; and Henry P. Barham, MD. The authors also thank Jeff
ment of chronic rhinitis, headache, and postprocedural pain at Doerzbacher, MS, for statistical analysis and Julie Perkins, PhD,
the treatment site are among the most commonly reported for assistance with manuscript writing, both independent consul-
pain-related symptoms after cryoablation of the PNN.9,11,20 tants to Aerin Medical.
A report on diode laser ablation included patients treated
under sedation in the operating room (21 of 31) and in the Declaration of Conflicting Interests
office (10 of 31), where the postprocedural pain score was The authors declared the following potential conflicts of interest
1.8 out of 10 for patients treated in the office.12 with respect to the research, authorship, and/or publication of this
The data imputation methods used in this study to evalu- article: Detlef Brehmer has received research funding from Aerin
ate the potential that an increase in medication use confounds Medical. Jivianne Lee and Daniel Charous are consultants to
the treatment effect delivered by the device were similar to Aerin Medical. The other authors have no other funding, financial
that used in the RCT evaluating the technology.6 relationships, or conflicts of interest to disclose.
Medications are widely used to manage the symptoms of
chronic rhinitis and it was therefore considered pragmatic
Funding
not to dictate medication use in the protocol, thereby
enabling the results to more closely reflect real-world out- The authors disclosed receipt of the following financial support for
comes. Considering that changes in rTNSS responder rate, the research, authorship, and/or publication of this article: The study
MiniRQLQ score, and the number of patients achieving was sponsored by Aerin Medical.
the MiniRQLQ MCID were minimally affected when imput-
ing the data of patients with an increase in medication use, ORCID iD
supports the hypothesis that the treatment effect is primarily Jivianne T. Lee https://orcid.org/0000-0002-0711-855X
from the device.
Patient satisfaction with the procedure was high and the
Supplemental material
majority of patients were likely to recommend the procedure
to a friend suffering from chronic rhinitis, based on responses Supplemental material for this article is available online.
to questions at both 3 and 6 months.
The limitations of this study were the lack of a control arm References
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