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Cryoablation, Radiofrequency Ablation and Laser Ablation for Treatment of Chronic Rhinitis | |
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Description: |
Ablation therapy is proposed as an alternative to medical management for patients with chronic rhinitis symptoms. Ablation therapy includes cryoablation (also known as cryosurgical ablation, cryosurgery, or cryotherapy), radiofrequency ablation, and laser ablation. Ablation therapy is thought to correct the imbalance of autonomic input to the nasal mucosa thereby reducing nasal antigen responses and vascular hyperreactivity.
Medical management is the standard of care for chronic rhinitis. Surgical options such as vidian nerve resection have been investigated for patients with chronic rhinitis symptoms refractory to multiple medical therapies, and cryoablation is proposed as a less invasive alternative. Vidian neurectomy has not been widely adopted however, due to the need for general anesthesia, risk of serious adverse events (e.g., dry eyes in up to 25% of patients), and uncertainty about the procedure's long-term benefits (Lieberman, 2021). Ablation therapy includes cryoablation (also known as cryosurgical ablation, cryosurgery, or cryotherapy), radiofrequency ablation, and laser ablation. Ablation therapy is thought to correct the imbalance of autonomic input to the nasal mucosa, thereby reducing nasal antigen responses and vascular hyperreactivity.
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.
Six months of follow-up is considered necessary to demonstrate efficacy. Adverse events can 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: Not established; 30% change from baseline has been proposed.
Timing: At least 6 months or longer.
The Chronic Sinusitis Survey (CSS): Measure of symptoms and medication usage over an 8-week recall period. Includes 3 questions regarding symptoms and 3 regarding medication usage, yielding a total score, symptom subscore, and medication subscore. Ranges from 0 to 100 in which a low CSS score represents greater symptoms and/or medication usage.
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): Measures the functional (physical, emotional, and social) problems associated with rhinitis.
Minimal Clinically Important Difference: Not established.
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 ClarifixTM 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.
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.
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 Investigational 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.
For members with contracts without primary coverage criteria, cryoablation for chronic rhinitis (allergic or nonallergic) is considered investigational. 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.
For members with contracts without primary coverage criteria, radiofrequency ablation for chronic rhinitis (allergic or nonallergic) is considered investigational. 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.
For members with contracts without primary coverage criteria, laser ablation for chronic rhinitis (allergic and non allergic) is considered investigational. 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).
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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 |
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