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| Cryoablation, Radiofrequency Ablation and Laser Ablation for Treatment of Chronic Rhinitis | |
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| Description: |
Chronic rhinitis is a common medical condition that encompasses allergic rhinitis, nonallergic rhinitis, and mixed rhinitis and can severely impact quality of life (Settipane, 2007). The initial treatment for chronic rhinitis often involves medical management with pharmacotherapy that may include steroids, anticholinergics, nasal decongestants, and antihistamines. Although medications are the mainstay treatment option, approximately 10% to 22% of the patients with chronic rhinitis still have persistent symptoms despite medical therapy and may require further interventions (Lieberman, 2005). For individuals who do not attain improvement in chronic rhinitis symptoms after receiving adequate medical therapy (referred to as refractory chronic rhinitis), invasive surgical options to block posterior nasal nerve may be considered. Historically, vidian neurectomy which targets the vidian nerve was offered for refractory rhinitis (Halderman, 2015; Marshak, 2016). Although vidian neurectomy was shown to be effective in reducing symptoms like rhinorrhea, it is associated with side effects of cheek and palate numbness and dry eyes (in nearly 50% of cases, ranging between 35% to 72%) (Halderman, 2015). In an effort to improve on complications of vidian neurectomy such as xerophthalmia, interventions that specifically target the posterior nasal nerve branches of the vidian nerve have been developed. It is thought that such interventions would help to reduce the morbidity associated with vidian neurectomy (Senanayake, 2022). These interventions range from surgical ablation of the post-ganglionic posterior nasal nerve to minimally invasive options of cryotherapy, radiofrequency, or laser ablation of the nerve. These minimally invasive procedures can be performed under endoscopy. The efficacy of ablation of posterior nasal nerve is thought to result from the interruption of efferent parasympathetic stimulation of the nasal mucosa, which leads to reduction in submucosal gland secretions and blood flow (Zubair, 2024).
To quantify the severity of chronic rhinitis and to assess treatment response, various outcome measures can be used, including radiologic scores, endoscopic grading, and patient-reported quality of life measures. The primary outcome measures relevant for the treatment of chronic rhinitis are patient-reported symptoms and quality of life. Examiner evaluation of the nasal and sinus appearance and polyp size may provide some information about treatment outcomes, but these evaluations are limited by the lack of universally accepted standards.
Frequently used outcome measures for treatments of chronic rhinitis in adults are listed below. A consensus on the minimally clinically important difference (MCID) for some of these outcomes has not been established. The U.S. Food and Drug Administration (FDA) guidance on drugs for rhinitis recommends patient-reported total nasal symptom scores as the primary measure of efficacy. The FDA guidance on drugs for rhinitis does not specify a MCID for patient-reported symptom measures but notes that a MCID should be prespecified in studies and the rationale explained. Adverse events must be assessed immediately (perioperative complications and postoperative pain) or over the longer term.
Outcome Measures for Chronic Rhinitis Interventions:
Outcome - Symptoms
reflective Total Nasal Symptom Score (rTNSS): Sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0 = none, 1 = mild, 2 = moderate, or 3 = severe. Maximum 12 points.
Minimal Clinically Important Difference: Change in score of 1 point; greater than or equal to 30% change from baseline has been proposed.
Timing: At least 6 months or longer.
Nasal obstruction symptom evaluation (NOSE):
A 5-item patient-reported scale assessing how much of a problem congestion, blockage, trouble breathing, trouble sleeping, and exertional airflow were over the last month. Each item is scored 0 to 4 and the 5 items are summed and then multiplied by 5 to yield a score ranging from 0 to 100. Higher scores indicate worse nasal obstruction symptoms.
Minimal Clinically Important Difference: Not established.
Timing: At least 6 months or longer.
Visual Analog Scale (VAS): Patient-reported.
Minimal Clinically Important Difference: Not established.
Timing: At least 6 months or longer.
Outcome - Disease-Specific Quality of Life
Sino-Nasal Outcome Test-20 (SNOT-20): Patients complete 20 symptom questions on a categorical scale (0 [no bother] to 5 [worst symptoms can be]). Average rankings can be reported over all 20 symptoms, as well as by 4 subclassified symptom domains. The possible range of SNOT-20 scores is 0 to 5, with a higher score indicating a greater rhinosinusitis-related health burden. SNOT-22, a variation of the SNOT-20, includes 2 additional questions (on “nasal obstruction” and “loss of smell and taste”).
Minimal Clinically Important Difference: SNOT-20: change in score of 0.8 or greater and SNOT-22: change in score of 8.9 points.
Timing: At least 6 months or longer.
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ): The RQLQ has 28 questions spanning 7 domains (activities, sleep, non-nasal/ocular symptoms, practical problems, nasal symptoms, eye symptoms, and emotions). Each question uses a 7-point scale from 0 (no impairment) to 6 (maximal impairment). The overall score is the average of all 28 items; higher scores indicate worse quality of life. The mini-RQLQ includes 14 items across 5 domains (activities, practical problems, nose symptoms, eye symptoms, and other symptoms).
Minimal Clinically Important Difference: RQLQ: change in score of 0.5 and miniRQLQ: change in score of 0.4
Timing: At least 6 months or longer.
VAS: Patient-reported.
Minimal Clinically Important Difference: Not established.
Timing: At least 6 months or longer.
Outcome - Adverse Events
Measures: Various; patient- and clinician reported. Potential procedure- and device-related adverse events include postoperative pain, epistaxis, and dry eyes.
Minimal Clinically Important Difference: Not applicable.
Timing: Immediately post procedure to 6 months or longer.
Regulatory Status
In February 2019, the Clarifix device (Stryker) was cleared for use in adults with chronic rhinitis through the 510(k) process (K190356) (FDA, 2019). Clearance was based on substantial equivalence to the predicate device, ClariFix (K162608). The only modification to the subject device was an update to the indications for use to include adults with chronic rhinitis. As per the FDA 510K summary, the ClariFix device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
In December 2019, the RhinAer stylus (Aerin Medical) was cleared by the FDA through the 510(k) process as a tool to treat chronic rhinitis (K192471) (FDA, 2022). Clearance was based on equivalence in design and intended use of a predicate device, the InSeca ARC Stylus (K162810). The RhinAer stylus includes modification of the InSeca ARC stylus shaft components and flexibility. As per the FDA 510K summary, the RhinAer is indicated for use in otorhinolaryngology surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.
In October 2021, the Neuromark System (Neurent Medical) was cleared by the FDA through the 510(k) process as a tool to treat chronic rhinitis (K212666) (FDA, 2021). Clearance was based on equivalence in design and intended use of a predicate device, the RhinAer stylus (K192471). Neuromark is indicated for use in otorhinolaryngology surgery for creation of radiofrequency lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.
There are currently no laser ablation devices with FDA clearance for treatment of chronic rhinitis.
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Policy/ Coverage: |
Effective May 2022
Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria
Cryoablation for chronic rhinitis (allergic or nonallergic) does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without Primary Coverage Criteria, cryoablation for chronic rhinitis (allergic or nonallergic)
is considered Not Medically Necessary or is investigational and is not covered. Not Medically Necessary or investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation for chronic rhinitis (allergic or nonallergic) does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without Primary Coverage Criteria, radiofrequency ablation for chronic rhinitis (allergic or nonallergic)
is considered Not Medically Necessary or is investigational and is not covered. Not Medically Necessary or investigational services are specific contract exclusions in most member benefit certificates of coverage.
Laser ablation for chronic rhinitis (allergic and non allergic) does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes
For members with contracts without Primary Coverage Criteria, laser ablation for chronic rhinitis (allergic and non allergic)
is considered Not Medically Necessary or is investigational and is not covered. Not Medically Necessary or investigational services are specific contract exclusions in most member benefit certificates of coverage
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| Rationale: |
This evidence review was created in September 2019 with a search of the PubMed database. The most recent literature update was performed through December 30, 2021.
Cryoablation
Kompelli et al conducted a systematic review of cryoablation for chronic rhinitis, identifying 15 nonrandomized studies enrolling a total of 1266 patients (Kompelli, 2018). Across all of the studies, 63% to 95.7% of patients noted improvement in overall symptoms, and no serious adverse events were reported. The authors concluded that although the procedure appeared to be safe and efficacious, methodological weaknesses and heterogeneity limited the strength of conclusions that could be drawn from this body of evidence. In addition to their uncontrolled design, most studies were outdated, published between 1977 and 1997. Only 1 study, reported by Hwang et al used an FDA-cleared device and a validated outcome measure (Hwang, 2017).
One RCT conducted by Del Signore et al, compared cryoablation using the Clarifix system with a sham procedure in 133 adults (age 21 years or older) with chronic rhinitis (Del Signore, 2021). Outcomes assessed included the reflective Total Nasal Symptom Score (rTNSS) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score. Duration of follow-up was 3 months. Individuals randomized to active cryoablation were more likely than those in the sham group to respond to treatment (73.4% vs. 36.5%, p<.001), based on a rTNSS reduction of >30%. Active cryoablation was also associated with greater reductions in RQLQ score from baseline at 3-month follow-up (-1.5, 95% confidence interval [CI], -1.8 to -1.2) versus sham cryoablation (-0.8, 95% CI, -1.1 to -0.5; p<.001). This study is limited by the short duration of follow-up.
Three recent single arm, nonrandomized studies including 149 patients, reported in 4 publications, have evaluated cryoablation for patients with chronic rhinitis. The largest study (N = 98) was reported by Chang et al, with 2-year follow-up data on a subset of patients (n = 62) reported by Ow et al (Chang, 2020; Ow, 2021). Scores on the rTNSS improved significantly over baseline at 1 month, 3 months, 6 months, and 9 months, and improvements were sustained for up to 2 years among those patients who enrolled in the follow-up study. Smaller single-arm studies reported by Hwang et al and Gerka Stuyt et al also reported improvements in symptoms from baseline (Hwang, 2017; Gerka Stuyt, 2021). Chang et al reported 2 serious procedure-related adverse events: severe epistaxis occurring on posttreatment day 19 due to a pledget inadvertently left in the nasal cavity from the day of treatment, and 1 case of mild epistaxis occurring on posttreatment day 36 which resolved with in-office cautery. Of 72 patients completing a telephone questionnaire about procedure-related discomfort, 56 (77.8%) experienced some degree of pain or discomfort. Seventeen patents reported severe headache, 5 reported severe nasal pain, and 2 reported severe sinus pain (Chang, 2020). No serious adverse events were reported in the other studies.
A major limitation was their uncontrolled, open-label design. Additionally, loss to follow-up was high and MCID were not pre-specified for important outcome measures. Randomized controlled trials are needed to confirm improvements in symptom scores observed in nonrandomized studies.
For individuals with chronic rhinitis who receive cryoablation, the evidence includes nonrandomized studies and a systematic review of nonrandomized trials. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Three single-arm, open-label studies enrolling a total of 149 patients reported improvements from baseline in patient-reported symptom scores up to 1 year. Sustained improvement for up to 2 years was observed in 1 study, however only 62 of 98 patients enrolled in the longer-term follow-up phase. In the largest study, there were 2 serious procedure-related adverse events (2%), and 77.8% of patients who responded to a post-procedure questionnaire reported some degree of pain or discomfort. Study limitations, including lack of a control group and high loss to follow-up, preclude drawing conclusions from this body of evidence. Randomized controlled trials are needed to confirm improvements reported in nonrandomized studies. A systematic review of 15 nonrandomized studies reported improvements with cryoablation; however, only 1 study used an approved device and validated outcome measuring, limiting conclusions from this systematic review. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Radiofrequency Ablation for Chronic Rhinitis
Stolovitsky et al conducted an RCT comparing radiofrequency ablation using the RhinAer device with sham treatment (Stolovitsky, 2021). The trial enrolled 117 adults (age 18 to 85 years; mean age 57 years) with chronic rhinitis. Use of medication to treat chronic rhinitis was allowed in both groups. Based on an intention to treat analysis that accounted for all randomized participants, after 3-months follow-up the proportion of participants with a
≥30% improvement in rTNSS score was higher in the active radiofrequency ablation group (66.7%, 95% CI 55.1% to 76.9%) than in the sham group (41.0%, 95% CI 25.6% to 57.9%; p=.01). A similar number of participants in the active (9.1% [7/77] and sham groups (12.8% [5/39] increased their medication use during the study. Limitations of the study include the short duration of follow-up. Follow-up is ongoing, and publication of longer-term results is planned.
Ehmer et al reported the results of a 1-year nonrandomized study of radiofrequency ablation for treatment of chronic rhinitis (Ehmer, 2021). The study found radiofrequency ablation associated with reductions from baseline (indicating improvement of symptoms) in rTNSS score at 12 and 52 weeks. The proportion of responders to treatment, based on an improvement of
≥30% in rTNSS score, was greater than 80% at all timepoints. This study is limited by the nonrandomized, open-label design and lack of control group.
Laser Ablation for Chronic Rhinitis
Krespi et al conducted a nonrandomized study evaluating laser ablation for treatment of chronic rhinitis (Krespi, 2020). The study enrolled 32 adults treated with an endoscopic diode laser in an outpatient setting. Duration of follow-up was 3 months. Mean rTNSS was reduced from 6.0 (standard deviation [SD] 0.7) at baseline to 2.3 (SD 0.4) at 3-month follow-up. Adverse events were not reported. The study had multiple limitations, including the small sample size, uncontrolled design, and duration of follow-up less than 6 months. Randomized studies comparing laser ablation with medical management and with longer follow-up are needed to determine efficacy and safety.
Practice Guidelines and Position Statements
No clinical practice guidelines on cryoablation, radiofrequency ablation, or laser ablation for chronic rhinitis were identified through clinical consultation or literature searches conducted through January 5, 2022.
American Academy of Allergy, Asthma, and Immunology
A 2020 practice parameter update on rhinitis from the American Academy of Allergy, Asthma, and Immunology did not address ablation techniques, including cryoablation, radiofrequency ablation, or laser ablation (Dykewicz, 2020).
Ongoing and Unpublished Clinical Trials:
Ongoing
Unpublished
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Takashima et al reported 12-month follow-up for patients (n=77) initially randomized to the active intervention group (Takashima, 2022). Treatment response and mean change from baseline remained stable through 12 months in the active intervention group, while concomitant medication use increased. The study is ongoing, with planned 3-year follow-up.
The effectiveness of radiofrequency ablation with the RhinAer device has been assessed in 2 industry-sponsored, nonrandomized, uncontrolled, open-label studies (Lee, 2022; Ehmer, 2022). Both studies included patients with chronic rhinitis. Lee et al enrolled 129 patients and reported outcomes of radiofrequency ablation up to 6 months (Lee, 2022). Ehmer et al enrolled 50 patients, 47 of whom had 1-year follow-up; 2-year results were subsequently reported in an extension study of 34 patients (Ehmer, 2022; Ehmer, 2022). Both studies found symptom response rates and the proportion of responders durable at time points ranging from 3 months to 2 years. Lee et al reported quality of life outcomes using the miniRQLQ, a validated measure with an established MCID of 0.4 points. At 3 and 6 months post-treatment, the mean change in miniRQLQ scores from baseline was -1.6 and -1.8, respectively, indicating clinically important improvement in symptom-related quality of life. These studies are limited by nonrandomized, open-label designs and lack of control groups.
A position statement issued by the American Rhinologic Society stated that posterior nasal nerve ablation, including cryoablation and radiofrequency ablation, should be considered as an effective option in treating chronic rhinitis and improving patient quality of life (ARS, 2022). Specific guidance on usage of these techniques was not issued.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The 2023 International Consensus Statement on Allergy and Rhinology stated the following for cryotherapy/radiofrequency ablation of posterior nasal nerve (Wise, 2023).
2025 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2025. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Takashima et al reported 24-month follow-up for patients initially randomized to the active intervention group (Takashima, 2024). Two-year posttreatment outcomes for patients treated in a prospective, multicenter, patient-blinded randomized controlled trial were determined by combining the index active treatment-arm and index control-arm crossover patients into a single group (after the primary endpoint) to evaluate the treatment effect durability and long-term effects on concomitant chronic rhinitis medication usage. The mean baseline reflective total nasal symptom score (rTNSS) was 8.2 (95% confidence interval [CI], 7.9- 8.6; N = 104). At 2 years (N = 79), the mean change in rTNSS was -5.3 (95% CI, -5.8 to -4.8; p < 0.001; 64.6% improvement). The 2- year responder rate (30% or more improvement in rTNSS) was 87.3% (95% CI, 78.0-93.8). All four components of the rTNSS (rhinorrhea, congestion, sneezing, and nasal itching) showed significant improvement over baseline, with rhinorrhea and congestion showing the most improvement. Postnasal drip and cough symptoms were also significantly improved. At 2 years, 81.0% (95% CI, 70.6-89.0) reported a minimal clinically important difference of greater than or equal to 0.4 point improvement in the mini-rhinoconjunctivitis quality of life questionnaire score. Of 56 patients using chronic rhinitis medications at baseline, 25 of 56 (44.6%) either stopped all medication use (7/56 [12.5%]) or stopped/decreased (18/56 [32.1%]) use of 1 or more medication class at 2 years. No serious adverse events related to the device/procedure were reported over 2 years. To determine the potential effect of patients who left the trial over 2 years on the responder rate, the responder statuses of the 14 patients with follow-up data who were lost to follow-up/withdrew/died were imputed by the last observation carried forward and the responder statuses of all nine patients who had an additional nasal procedure were imputed to nonresponder, resulting in a 2-year responder rate of 79.4% (95% CI, 70.3-86.8). TCRF ablation of the PNN is safe and resulted in a significant and sustained reduction in chronic rhinitis symptom burden through 2 years and a substantial reduction in concomitant medication burden. The study is ongoing, with planned 3-year follow-up.
2026 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2026. No new literature was identified that would prompt a change in the coverage statement.
Additional 2026 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2026. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Choi et al conducted a systematic review and meta-analysis of ClariFix posterior nasal nerve cryoablation for chronic rhinitis (7 studies; N=495) (Choi, 2024). Pooled responder rates for greater than or equal to 30% reduction in total TNSS were 69.1% at 1 month (95% CI, 0.55 to 0.81; I2=89%) and 73.7% at 3 months (95% CI, 0.66 to 0.80; I2=0%; p=.54 between time points). Mean TNSS improvement from baseline was 3.26 at 1 month (95% CI, 2.86 to 3.66; I2=59%), 3.51 at 3 months (95% CI, 3.30 to 3.71; I2=17.4%), 3.54 at 6 months (95% CI, 2.76 to 4.32; I2=83.7%), and 3.77 at 12 months (95% CI, 2.92 to 4.61; I2=85.6%), all exceeding the TNSS MCID of 1. RQLQ scores also improved (Mean difference [MD], 1.30 at 1 month [95% CI, 1.08 to 1.52; I2=0%] and 1.52 at 3 months [95% CI, 1.30 to 1.73; I2=0%]). Minor events included nasal dryness 4.67% (95% CI, 0.89 to 21.06; I2=85.9%), epistaxis 2.80% (1.34 to 5.76; I2=0%), ocular symptoms 1.40% (0.38 to 4.96; I2=0%), palatal numbness 2.67% (0.37 to 16.96; I2=83%), postoperative pain 21.22% (8.96 to 42.45; I2=89.4%) and headache 10.28% (3.98 to 24.05; I2=88.8%). The authors reported heterogeneity in outcome measures and insufficient baseline data on included patients as key study limitations.
Kim et al conducted a systematic review and meta-analysis of posterior nasal nerve RFA for chronic rhinitis, including 5 studies (N=406) through June 2023 (Kim, 2024).18, At 12 months, the pooled responder rate (greater than or equal to 30% TNSS reduction) was 79.9% (95% CI, 0.75 to 0.84; I2=44.7%). Mean TNSS improvements from baseline were a mean difference (MD) of 4.14 at 3 months (95% CI, 3.55 to 4.73; I2=67.3%), a MD of 4.81 at 6 months (95% CI, 4.41 to 5.22; I2=27.5%), and a MD of 4.87 at 12 months (95% CI, 4.40 to 5.35; I2=0%). The magnitude of TNSS score reduction exceeded the MCID of 1 at all evaluated timepoints, and the authors found no significant difference in the magnitude of pooled TNSS scores observed through 12 months of follow-up. Similarly, quality of life on the RQLQ also improved in excess of the MCID of.5 at 3 months (MD, 1.62; 95% CI, 1.37 to 1.86; I2=0%) and 6 months (MD, 1.80; 95% CI, 1.50 to 2.11). No severe adverse events were reported in the included studies. The authors noted several limitations, including a small evidence base, including only 1 RCT, heterogeneous outcome assessments, and a lack of medication control, and called for larger, independent trials.
Takashima et al conducted an RCT comparing radiofrequency ablation using the NEUROMARK device with sham treatment (Takashima, 2026). The trial enrolled 132 adults with chronic rhinitis at 16 U.S. sites and randomized participants 2:1 to active treatment (n=88) or sham control (n=44). Participants were required to have at least 6 months of chronic rhinitis symptoms, a baseline reflective Total Nasal Symptom Score (rTNSS) of at least 5, moderate-to-severe rhinorrhea, and mild-to-severe nasal congestion. Use of nasal anticholinergic sprays was discontinued before enrollment and through the 90-day follow-up, and participants were instructed not to change baseline concomitant rhinitis medications before 90 days unless required to treat an adverse event. At 90 days, the proportion of participants with at least 30% improvement in rTNSS from baseline was higher in the active treatment group than in the sham group (73.3% vs 35.0%; p<.001). Mean change in total rTNSS also favored active treatment (-4.0 vs -1.2; p<.0001), and improvements in congestion, rhinorrhea, itching, and sneezing were all significantly greater in the active treatment group. Secondary outcomes, including postnasal drip, cough, NOSE score, mini-RQLQ, and PHQ-9, also improved significantly more with active treatment than with sham. One serious adverse event, epistaxis requiring hospitalization for observation, occurred in the active treatment group and resolved without additional intervention. Nine non-serious, possibly related adverse events were reported overall and resolved within 30 days. Although the trial demonstrated statistically significant improvements across symptom and quality-of-life measures, it is unclear whether the study population reflects the intended use population of individuals refractory to medical management, which limits interpretation of the findings for that population. Follow-up of the randomized comparison was limited to 90 days.
In September 2023, the UK National Institute for Health and Care Excellence (NICE) issued Interventional Procedures Guidance (IPG771) on cryotherapy of the posterior nasal nerve for chronic rhinitis (NICE, 2023). NICE concluded that cryotherapy should be used only in a research setting. Stating that, "The evidence for cryotherapy for chronic rhinitis is limited and includes people with different types of rhinitis. The evidence does not raise any major safety concerns, but the procedure can have complications. The short-term evidence is promising, but it is still uncertain how well the procedure works, particularly which group of patients will benefit most from the procedure and how long the effect of the treatment will last."
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| References: |
Del Signore AG, Greene JB, Russell JL, et al.(2022) Cryotherapy for treatment of chronic rhinitis: 3-month outcomes of a randomized, sham-controlled trial. Int Forum Allergy Rhinol. Jan 2022; 12(1): 51-61. PMID 34355872
Ehmer D, McDuffie CM, Scurry WC, et al.(2022) Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Rhinitis. Am J Rhinol Allergy. Jan 2022; 36(1): 149-156. PMID 34382444 Food & Drug Administration (FDA).(2022) RhinAer (RHIN1 Stylus) 510(k) Premarket Notification. 2019 (K192471). Accessed January 3, 2022. Krespi YP, Wilson KA, Kizhner V.(2020) Laser ablation of posterior nasal nerves for rhinitis. Am J Otolaryngol. May 2020; 41(3): 102396. PMID 31948695 Stolovitzky JP, Ow RA, Silvers SL, et al.(2021) Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial. OTO Open. Jul-Sep 2021; 5(3): 2473974X211041124. PMID 34527852 American Rhinologic Society (ARS).(2022) Posterior Nasal Nerve Ablation ARS Position Statement. January 2022. Accessed December 7, 2022. Chang MT, Song S, Hwang PH.(2020) Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. Aug 2020; 130(8): 1877-1884. PMID 31566744 Dykewicz MS, Wallace DV, Amrol DJ, et al.(2020) Rhinitis 2020: A practice parameter update. J Allergy Clin Immunol. Oct 2020; 146(4): 721-767. PMID 32707227 Ehmer D, McDuffie CM, McIntyre JB, et al.(2022) Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis. Allergy Rhinol (Providence). 2022; 13: 21526575221096045. PMID 35663498 Food & Drug Administration (FDA).(2019) Clarifix 510(k) Premarket Notification. 2019 (K190356) https://fda.report/PMN/K190356/19/K190356.pdf. Accessed August 16, 2021. Gerka Stuyt JA, Luk L, Keschner D, et al.(2021) Evaluation of In-Office Cryoablation of Posterior Nasal Nerves for the Treatment of Rhinitis. Allergy Rhinol (Providence). Jan-Dec 2021; 12: 2152656720988565. PMID 33598336 Hwang PH, Lin B, Weiss R, et al.(2017) Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. Oct 2017; 7(10): 952-956. PMID 28799727 Kompelli AR, Janz TA, Rowan NR, et al.(2018) Cryotherapy for the Treatment of Chronic Rhinitis: A Qualitative Systematic Review. Am J Rhinol Allergy. Nov 2018; 32(6): 491-501. PMID 30229670 Lee JT, Abbas GM, Charous DD, et al.(2022) Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis. Am J Rhinol Allergy. Nov 2022; 36(6): 747-754. PMID 35818709 Lieberman P.L..(2021) Chronic nonallergic rhinitis. In: UpToDate, Corren J (Ed), UpToDate, Waltham, MA. https://www.uptodate.com/contents/chronic-nonallergic-rhinitis. Accessed August 17, 2021. Ow RA, O'Malley EM, Han JK, et al.(2021) Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study. Laryngoscope. Sep 2021; 131(9): 1952-1957. PMID 33616224 Takashima M, Stolovitzky JP, Ow RA, et al.(2022) Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. Jun 17 2022. PMID 35714267 Wise SK, Damask C, Roland LT, et al.(2023) International consensus statement on allergy and rhinology: Allergic rhinitis - 2023. Int Forum Allergy Rhinol. Apr 2023; 13(4): 293-859. PMID 36878860 |
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| Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants. | |
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