Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis (2024)

Abstract

Background

Temperature-controlled radiofrequency (TCRF) neurolysis of the posteriornasal nerve (PNN; RhinAer) is a minimally invasive treatment option forpatients with chronic rhinitis.

Objective

To determine clinical outcomes and quality of life (QoL) following TCRFneurolysis of the PNN.

Methods

A prospective single-arm study of 129 patients with chronic rhinitis at 16medical 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 andcontinued to improve to 2.9 (95% CI, 2.5-3.3) at 6 months(p < .001 comparing follow-up to baseline andp = .002 comparing 3 and 6 months). This represents53.8% improvement over baseline at 3 months and 62.8% improvement at 6months. Rhinorrhea, congestion, sneezing, and itching subscores andpostnasal drip and cough scores were all significantly improved overbaseline at both timepoints. At 3 months, 76.2% (95% CI, 68.1%-82.8%) ofpatients 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 improvementin the mini rhinoconjunctivitis quality of life questionnaire score, and thepercentage was higher at 6 months; 87.7% (95% CI, 80.7%-92.4%). There wereno serious adverse events with a relationship to the device/procedurereported through 6 months.

Conclusion

In this large, multicenter study, TCRF neurolysis of the PNN was safe andresulted in a significant reduction in rhinitis symptom burden at 3 monthsthat was sustained/improved through 6 months. The majority of patientsreported a clinically relevant improvement in QoL at 3 and 6 monthspostprocedure.

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

Introduction

Chronic rhinitis is a widespread disease with a significant effect on the quality oflife (QoL) and work productivity.^1,2 If pharmacological therapy doesnot offer adequate relief, patients may consider surgical interventions such asVidian neurectomy³ or posterior nasal nerve (PNN) neurectomy.^4,5 A minimally invasivetemperature-controlled radiofrequency (TCRF) device designed to treat chronicrhinitis via PNN neurolysis exhibited superiority over a sham procedure at 3 monthspostprocedure in a randomized controlled trial (RCT).⁶ The treatment also showed asustained effect through 12 months postprocedure in a separate, single-armstudy.⁷ Interest in minimally invasive options (cryoablation and laserablation) with potential for in-office application has increased in recentyears.^8–12 Here, we report the safetyand efficacy results of a large, pragmatic, single-arm study of TCRF neurolysis ofthe PNN for the treatment of chronic rhinitis. In addition to the standardreflective total nasal symptom score (rTNSS),¹³ this study included use ofthe mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ),¹⁴ which is thefirst time this QoL instrument has been used to report outcomes of thetechnology.

Methods

Study and Eligibility Criteria

This prospective single-arm study enrolled patients across 16 centers in theUnited States (13) and Germany (3). The study was approved by WCG InstitutionalReview Board for all centers in the United States (20202473), the EthicsCommittee of Witten/Herdecke University (219/2020), and the Ethics Committee ofthe Technical University Dresden (BO-EK-463102020) for the centers in Germany.Patients gave written informed consent prior to the initiation of studyprocedures. The study was registered at clinicaltrials.gov; NCT04614324.

A complete list of eligibility criteria is available in Supplemental information. Key inclusion criteria were 18 to 85years of age, chronic rhinitis symptoms (≥6 months), total 24-h rTNSS ≥6,moderate to severe rhinorrhea (rTNSS rhinorrhea subscore 2-3), and mild tosevere nasal congestion (rTNSS congestion subscore 1-3). The main exclusioncriteria were anatomic obstructions limiting access to the posterior nasalpassage; altered anatomy of the posterior nose via prior sinus or nasalsurgery/injury; active nasal/sinus infection; history of significant dry eye,chronic epistaxis, nose bleeds, rhinitis medicamentosa, head/neck irradiation;seasonal allergic rhinitis; a predisposition to excessive bleeding;anticoagulation therapy that could not be discontinued prior to the procedure;and prior procedure/surgery for chronic rhinitis.

Study Procedure

Patients were treated with the RhinAer Stylus (Aerin Medical), a single-use,disposable device. The target tissue was the posterior middle meatus andsuperior portion of the posterior inferior turbinate, in the region of the PNN.The protocol dictated treatment at 1-5 nonoverlapping regions on each side,where the number of treatment areas was based on target anatomy size. Patientswere treated in-office and received topical anesthesia followed by lidocaine(with or without epinephrine) administered by submucosal infiltration in thetreatment area. Treatment settings were: temperature, 60 °C; power, 4 W;treatment time, 12 s. No repeat (touch-up) procedures were allowed duringfollow-up.

Primary and Secondary Endpoints

The primary endpoint was the mean change in 24-h rTNSS from baseline to 3 months.Secondary efficacy endpoints were responder rate (defined as the minimalclinically important difference [MCID] of ≥30% improvement [decrease] inrTNSS¹⁵) and the mean change in the MiniRQLQ¹⁴ scorefrom baseline to 3 months. The validated MiniRQLQ instrument consists of 14questions across 5 domains: activity limitations, practical problems, nosesymptoms, eye symptoms, and other symptoms, based on a 1-week recall. The safetyendpoint was the frequency of device-related and procedure-related seriousadverse events over 3 months. These data were also collected through 6months.

Additional Outcome Measures

Responder rate based on the MCID of ≥1 point improvement in rTNSS from baselinewas also determined.¹³ Postnasal drip and cough symptoms were recorded on a4-point scale (0-3) at baseline and all follow-up timepoints. MiniRQLQ domainscores were also determined at baseline and all follow-up timepoints. The MCIDfor MiniRQLQ score is a 0.4-point improvement from baseline.¹⁶ Theproportion of patients achieving the MiniRQLQ MCID was determined at 3 and 6months. Nasal pain was recorded on a 100-point visual analog scale immediatelyafter the procedure and at 3 months; with 0 being no pain and 100 indicating theworst pain imaginable.¹⁷ Medication use was not dictated by the protocol,however, medication classes (antihistamines, decongestants, oral leukotrieneinhibitors, intranasal steroid sprays, and intranasal anticholinergic sprays)were recorded from baseline through 6 months. Patients were asked about theirsatisfaction with the treatment and whether they were likely to recommend thetreatment to a friend suffering from chronic rhinitis at 3 and 6 monthspostprocedure. Responses were provided on a 5-point scale (0-4, with 4 being“very satisfied” for satisfaction or “yes, absolutely” for a recommendation).Patients will contribute data over 3 years and the results presented in thisreport represent the data available at the time of submission forpublication.

Statistical Analysis

Continuous data are presented as mean and 95% confidence intervals (CI), andcategorical data as numbers and percentages of the total, unless statedotherwise. Primary and secondary endpoints were defined by the protocol at 3months postprocedure; unadjusted means are presented and at-test was used to compare follow-up to baseline. Missing datawere not imputed (including some baseline data); population sizes are reportedwith the result and in Supplemental information. All other outcomes were assessed usinga linear mixed effect model to test for an overall change over time; adjusted(least squares) means are presented, with Tukey–Kramer comparisons betweenbaseline and follow-up visits and between follow-up visits. Generalizedestimating equations were used to assess repeated binomial outcome measures andrepeated multinomial ordered categorical distributions. Responses to thequestions on satisfaction and likelihood to recommend are presented as median(interquartile range [IQR]). SAS/STAT version 15.2 (SAS Institute) was used foranalyses.

The analysis population includes all patients treated, including 5 patients whowere determined to be ineligible due to an inadequate rTNSS at screening.

Results

A total of 129 patients were treated with TCRF neurolysis of the PNN between October2020 and March 2021. Patient disposition is shown in Supplemental information. A total of 128 patients reached 3 months(1 lost to follow-up) and 123 patients reached 6 months (2 lost to follow-up, 3withdrew). Baseline demographics and characteristics of the 129 patients treatedwith the TCRF device are shown in Table1. The majority of patients had beensuffering from rhinitis for >1 year (n = 124, 96.1%).

Table1.

Baseline Demographics and Characteristics of Patients Treated with the TCRFDevice.*

Characteristic	N = 129
Female sex	69	(53.5)
Age, years	57.9	±13.4
BMI, kg/m²	27.2	±5.7
Race
Asian	4	(3.1)
Black or African American	5	(3.9)
White	117	(90.7)
Other	3	(2.3)
Nasal exam (1 or both sides)
Turbinate enlargement	30	(23.3)
Nasal polyps	3	(2.3)
Prior nasal surgery	44	(34.1)
Rhinitis type^a
Allergic	10	(7.8)
Nonallergic	93	(72.1)
Mixed allergic and nonallergic	1	(0.8)
Not known	25	(19.4)
Medication use^b
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)

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Abbreviations: TCRF, temperature-controlled radiofrequency neurolysis;BMI, body mass index; rTNSS, 24-h reflective total nasal symptomscore.

Notes. *Continuous variables are presented asmean ± standard deviation. Categorical variables are presented as number(% of total).

^{^a}

Based on prior knowledge (patient report or physician assessment).

^{^b}

n = 128.

In the 126 patients with an rTNSS at baseline and 3 months, the mean change in rTNSSat 3 months (primary endpoint) was −4.2 (95% CI, −4.6 to −3.7;p < .001), a 53.8% improvement from baseline. At 6 months(n = 121), the adjusted mean change in rTNSS was −4.9 (95% CI,−5.5 to −4.3), a 62.8% improvement from baseline, p < .001comparing 3 and 6 months to baseline and p = .002 comparing 3 and 6months (Figure1).

Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis (1)

At 3 months, 76.2% (95% CI, 68.1%-82.8%) of patients were responders (secondaryendpoint); they had achieved an MCID of ≥30% improvement in rTNSS over baseline. Theresponder 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) weresignificantly improved from baseline at both timepoints,p < .001 comparing each follow-up timepoint to baseline for eachsubscore (Figure2).Comparing 3 and 6 months, congestion and itching were significantly further improvedat 6 months (p < .05); rhinorrhea and sneezing were notsignificantly different (p > .05).

Figure2.

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The distributions of the rTNSS subscores further illustrate the significant decreasein symptom burden postprocedure, p < .001 comparing eachfollow-up timepoint to baseline for each subscore (Figure3; tabulated data in Supplemental information). Comparing 3 and 6 months, congestion,itching, and sneezing were significantly further improved at 6 months(p < .05), but rhinorrhea was not significantly different(p > .05).

Figure3.

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Mean postnasal drip and cough scores were significantly improved at both timepoints,p < .001 comparing each follow-up timepoint to baseline foreach score, and both further improved between 3 and 6 months(p < .05) (Figure4).

Figure4.

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The distributions of the postnasal drip and cough scores also illustrate asignificant decrease in symptom burden postprocedure, p < .001comparing each follow-up timepoint to baseline for each score, and both furtherimproved between 3 and 6 months (p < .05) (Figure5, tabulated data in Supplemental information).

Figure5.

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Patient reports of periprocedural pain, assessed immediately after completion of theprocedure, as well as nasal pain at 3 months, were low on the 100-point scale. Themean periprocedural pain score was 19.0 (95% CI, 14.7-23.2;n = 129) and at 3 months, the mean pain score was significantlylower at 4.4 ([95% CI, 2.1-6.7]; p < .001 by Wilcoxon signedranks test). There were no serious adverse events related to the studydevice/procedure through 6 months. A total of 10 adverse events with at least apossible relationship to the study device or procedure were reported in 8 patientswith all but 1 reported as mild to moderate in severity (tabulated data in Supplemental information). Single occurrences of vasovagal reaction,dry eye, nasal mucosa changes, ear discomfort, eye pressure, and two events each ofsinusitis and nasal soreness were reported during the 6-month follow-up period. Onepatient developed a late severe nasal adhesion at 96 days postprocedure.

Patient QoL was significantly improved at 3 months postprocedure. In the 127 patientswith MiniRQLQ scores at baseline and 3 months, the mean change in MiniRQLQ score at3 months (secondary endpoint) was −1.6 (95% CI, −1.8 to −1.4;p < .001), a 53.3% improvement from baseline. At 6 months, theadjusted mean change in MiniRQLQ score was −1.8 (95% CI, −2.1 to −1.5), a 60.0%improvement from baseline, p < .001 comparing 3 and 6 months tobaseline and p = .022 comparing 3 and 6 months (Figure6).

At 3 months, 80.3% (95% CI, 72.6%-86.3%) of patients had achieved an MCID of≥0.4-point improvement in MiniRQLQ score over baseline. The percentage at 6 monthshad significantly increased to 87.7% (95% CI, 80.7%-92.4%;p = .022).

Mean MiniRQLQ domain scores (activity limitations, practical problems, nose symptoms,eye symptoms, and other symptoms) were all significantly improved from baseline,p < .001 comparing each follow-up timepoint to baseline foreach domain score (Figure7). Comparing 3 and 6 months, nose and eye symptoms were furtherimproved at 6 months (p < .05); activity and practicallimitations and other symptoms were not significantly different(p > .05).

Figure7.

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Medication use was not dictated by the protocol. To ensure medication use was notsubstantially affecting the treatment effect size, the changes in rTNSS andrTNSS-based responder rate were determined after imputing the data of any patientswith an increase in at least 1 medication class (antihistamines, decongestants, oralleukotriene inhibitors, intranasal steroid sprays, and intranasal anticholinergicsprays) from the timepoint of increase onwards; the change in rTNSS was imputed aszero and a responder was imputed as a nonresponder if not already a nonresponder.Baseline medication use is shown in Table1. Seven patients had an increase inat least 1 medication class from baseline at some point in the study and the resultsof the data imputation for these patients are shown in Table2, illustrating the minimal changein result. The same imputation methods were applied to evaluate the change inMiniRQLQ score and the percentage of patients achieving the MiniRQLQ ≥0.4-pointimprovement MCID. Table3 shows the results of these analyses, again illustrating theminimal difference in the results obtained after data imputation.

Table2.

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

	3 months		6 months
Change in rTNSS^a
No imputation^b	−4.2	(−4.7 to −3.7)	−4.9	(−5.5 to −4.3)
Medication increase imputation^c	−4.1	(−4.7 to −3.6)	−4.6	(−5.3 to −4.0)
Responder rate^d
No imputation^b	76.2%	(68.1% to 82.8%)	83.5%	(75.8% to 89.0%)
Medication increase imputation^c	74.6%	(66.4% to 81.4%)	78.5%	(70.4% to 84.9%)

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Table3.

Adjusted Mean Change in MiniRQLQ Score and Percentage of Patients Achievingthe MiniRQLQ MCID, (i) With no Data Imputation and (ii) With Data Imputationfor Increased Medication Use.

	3 months		6 months
Change in MiniRQLQ score^a
No imputation^b	−1.6	(−1.9 to −1.3)	−1.8	(−2.1 to −1.5)
Medication increase imputation^c	−1.6	(−1.9 to −1.3)	−1.7	(−2.0 to −1.4)
Achieved MiniRQLQ MCID^d
No imputation^b	80.3%	(72.6%-86.3%)	87.7%	(80.7%-92.4%)
Medication increase imputation^c	78.7%	(70.8%-85.0%)	82.8%	(75.1%-88.5%)

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Abbreviations: MCID: minimal clinically important difference; MiniRQLQ:mini rhinoconjunctivitis quality of life questionnaire.

Notes. MiniRQLQ score presented as mean (95% confidenceintervals). MCIDs presented as percentages (95% confidenceintervals).

^{^a}

Change in MiniRQLQ score from baseline.

^{^b}

n = 127 at 3 months and n = 122 at 6months.

^{^c}

Imputing data from the 7 patients with an increase in at least 1 class ofmedication class (antihistamines, decongestants, oral leukotrieneinhibitors, intranasal steroid sprays, and intranasal anticholinergicsprays) from the timepoint of increase onwards to a change in MiniRQLQscore of zero or to below the MCID if not already below the MCID. Threedata points were imputed at 3 months, and 7 data points were imputed at6 months.

^{^d}

Percentage of patients that achieved a decrease in MiniRQLQ score of ≥0.4points from baseline.

In response to a question on satisfaction with the treatment, the median score was 3(IQR, 2-4) at both 3 and 6 months. In response to a question on whether patientswere likely to recommend the treatment to a friend who suffered from chronicrhinitis, the median score was 4 (IQR, 2-4) at 3 months and 4 (IQR, 3-4) at 6months.

Discussion

The results of this study contribute to the increasing amount of data demonstrating asignificant and clinically important reduction in symptom burden from minimallyinvasive TCRF neurolysis of the PNN.⁷ A high percentage of patientsachieved the MCID of ≥30% improvement in rTNSS over baseline (76.2% and 83.5% at 3and 6 months, respectively). This MCID is a more stringent test than ≥1-pointimprovement,¹³ which has previously been used to evaluate the TCRFdevice⁷ and other technologies targeting the PNN area(cryoablation).^18,19 The responder rate based on ≥1 point improvement in this studywas >90% at both timepoints (96.0% [95% CI, 91.1%-98.3%] at 3 months and 95.0%[95% CI, 89.6%-97.7%] at 6 months). The 3-month results of this single-arm study areon par with the results of an RCT, in which active TCRF device treatment wasdemonstrated to be superior to a sham procedure at 3 months.⁶

The results of the postnasal drip and cough assessments are interesting as thesesymptoms are not assessed by the widely used rTNSS instrument but are commonlyassociated with chronic rhinitis; both showed significant improvement at 3 and 6months.

This large study also showed an improvement in QoL as early as 3 monthspostprocedure, reported using a validated instrument, and the effect was maintainedthrough 6 months. The MiniRQLQ was selected for this study based on ease of use,with 14 questions in 5 domains. Again, a large percentage of patients achieved theMCID of ≥0.4-point improvement at 3 and 6 months. This MCID has been used in reportson other technologies targeting the PNN area for the treatment of chronicrhinitis.^18,19 There does not appear to be any domain of the MiniRQLQ that wasdominating the overall outcome, as all domains showed significant improvement ateach follow-up timepoint.

The safety profile of the device/procedure was excellent during this study and nosafety concerns arose. The in-office procedure utilizes a combination of topicalanesthesia followed by submucosal infiltration with lidocaine (with or withoutepinephrine) at the treatment sites. Patients reported minimal periprocedural pain,which may be a consequence of the controlled temperature feature of the device. Theadvantage of TCRF over radiofrequency (RF), in general, is that a therapeutictreatment temperature of ∼60°C is maintained as the stylus delivers bipolar RFenergy to tissue and monitors tissue temperature, and automatically adjusts the RFcurrent. The controlled temperature allows neurolysis to occur but limits the damageto overlying mucosa and adjacent tissues. Importantly, no headaches or othersignificant pain-related adverse events were reported. In comparison with othertechnologies targeting the PNN area for the treatment of chronic rhinitis, headache,and postprocedural pain at the treatment site are among the most commonly reportedpain-related symptoms after cryoablation of the PNN.^9,11,20 A report on diode laserablation included patients treated under sedation in the operating room (21 of 31)and in the office (10 of 31), where the postprocedural pain score was 1.8 out of 10for patients treated in the office.¹²

The data imputation methods used in this study to evaluate the potential that anincrease in medication use confounds the treatment effect delivered by the devicewere similar to that used in the RCT evaluating the technology.⁶ Medications arewidely used to manage the symptoms of chronic rhinitis and it was thereforeconsidered pragmatic not to dictate medication use in the protocol, thereby enablingthe results to more closely reflect real-world outcomes. Considering that changes inrTNSS responder rate, MiniRQLQ score, and the number of patients achieving theMiniRQLQ MCID were minimally affected when imputing the data of patients with anincrease in medication use, supports the hypothesis that the treatment effect isprimarily from the device.

Patient satisfaction with the procedure was high and the majority of patients werelikely to recommend the procedure to a friend suffering from chronic rhinitis, basedon responses to questions at both 3 and 6 months.

The limitations of this study were the lack of a control arm and the limitedfollow-up to date. The effect sizes of the primary and secondary efficacy endpointswere large; although unlikely, it is possible that placebo effects may havecontributed to the overall observed effect. Medication use was not limited by theprotocol, but the study was pragmatically designed to collect real-world outcomes.While the current study shows the efficacy of this technology, future research isneeded to determine cost–benefit analysis.

Conclusion

In this large, pragmatic study in the United States and Europe, TCRF neurolysis ofthe PNN resulted in a significant improvement in both chronic rhinitis symptomburden and disease-specific QoL at 3 and 6 months postprocedure. Patients reported asignificant reduction in rhinorrhea, nasal congestion, itching, and sneezing, inaddition to a significant reduction in postnasal drip and cough symptoms. No seriousadverse events with a relationship to the device/procedure were reported through 6months. Continued follow-up will confirm that treatment effects are consistent withpreviously published long-term evidence.

Supplemental Material

sj-docx-1-ajr-10.1177_19458924221109987 - Supplemental material forClinical and Quality of Life Outcomes Following Temperature-ControlledRadiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) forTreatment of Chronic Rhinitis

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Supplemental material, sj-docx-1-ajr-10.1177_19458924221109987 for Clinical andQuality of Life Outcomes Following Temperature-Controlled RadiofrequencyNeurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of ChronicRhinitis by Jivianne T. Lee, Gregory M. Abbas, Daniel D. Charous, PD Dr. med.Mandy Cuevas, Prof. Dr. med. Önder Göktas, Patricia A. Loftus, Nathan E.Nachlas, Elina M. Toskala, Jeremy P. Watkins and Prof. Dr. med. Detlef Brehmerin American Journal of Rhinology & Allergy

Acknowledgments

The authors thank enrolling site principal investigators: Tim. A. Fife, MD; John T.Lanza, MD; Scott A. Powell, MD; Jordan Pritikin, MD; Neelesh H. Mehendale, MD; JohnH. Willis, MD; and Henry P. Barham, MD. The authors also thank Jeff Doerzbacher, MS,for statistical analysis and Julie Perkins, PhD, for assistance with manuscriptwriting, both independent consultants to Aerin Medical.

Footnotes

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

Funding: The authors disclosed receipt of the following financial support for theresearch, authorship, and/or publication of this article: The study wassponsored by Aerin Medical.

ORCID iD: Jivianne T. Lee https://orcid.org/0000-0002-0711-855X

Supplemental material: Supplemental material for this article is available online.

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Associated Data

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Supplementary Materials

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Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis (2024)

Abstract

Background

Objective

Methods

Results

Conclusion

Introduction

Methods

Study and Eligibility Criteria

Study Procedure

Primary and Secondary Endpoints

Additional Outcome Measures

Statistical Analysis

Results

Table1.

Figure1.

Figure2.

Figure3.

Figure4.

Figure5.

Figure6.

Figure7.

Table2.

Table3.

Discussion

Conclusion

Supplemental Material

Acknowledgments

Footnotes

References

Associated Data

Supplementary Materials