Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study

Michael T Chang, Sunhee Song, Peter H Hwang, Michael T Chang, Sunhee Song, Peter H Hwang

Abstract

Objective: To assess the efficacy and safety of cryoablation of the posterior nasal nerve (PNN) for treatment of chronic rhinitis.

Methods: This was a prospective single-arm trial of 98 adult patients at six U.S. centers with chronic allergic and nonallergic rhinitis. PNN cryoablation was performed in-office under local anesthesia using a handheld device. Patients discontinued use of intranasal ipratropium 3 days prior to treatment and throughout the study period. Reflective Total Nasal Symptom Score (rTNSS) was measured at pretreatment baseline and posttreatment at 1 month, 3 months, 6 months, and 9 months. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was completed at pretreatment and 3 months posttreatment. Adverse effects and postprocedure medication usage were recorded.

Results: Ninety-eight procedures (100%) were successfully completed. rTNSS significantly improved over pretreatment baseline (6.1 ± 1.9) at 1 month (2.9 ± 1.9, P < 0.001), 3 months (3.0 ± 2.3, P < 0.001), 6 months (3.0 ± 2.1, P < 0.001), and 9 months (3.0 ± 2.4, P < 0.001) postprocedure. Nasal congestion and rhinorrhea subscores improved significantly at all time points (P < 0.001). Both allergic and nonallergic rhinitis subcohorts showed improvement (P < 0.001), with a comparable degree of improvement between groups. RQLQ significantly improved over pretreatment baseline (3.0 ± 1.0) at 3 months (1.5 ± 1.0, P < 0.001), and all RQLQ subdomains demonstrated improvement. Of 54 patients using intranasal medication at baseline, 19 (35.2%) were able to discontinue use. Twenty-nine adverse effects were reported, including headache, epistaxis, and sinusitis.

Conclusion: Cryoablation of the PNN for chronic rhinitis is safe and can result in relief of nasal symptoms and improvements in quality of life.

Level of evidence: 4 Laryngoscope, 130: 1877-1884, 2020.

Trial registration: ClinicalTrials.gov NCT03181594.

Keywords: Rhinitis; congestion; cryoablation; cryosurgery; posterior nasal nerve; rhinorrhea.

© 2019 The Authors. The Laryngoscope published by Wiley Periodicals, Inc. on behalf of The American Laryngological, Rhinological and Otological Society, Inc.

Figures

Figure 1
Figure 1
Device (left) and treatment site (right). [Color figure can be viewed in the online issue, which is available at www.laryngoscope.com.]
Figure 2
Figure 2
(A) rTNSS scores following the cryoablation procedure for all subjects (dark line), the nonallergic subcohort (dotted line), and the allergic subcohort (light line). (B) The proportion of subjects with improvements exceeding the rTNSS MCID for all subjects (dark line), the nonallergic subcohort (dotted line), and the allergic subcohort (light line). Error bars represent standard deviation. Statistically significant improvements from baseline (P < 0.001) are identified by: *All subjects; †nonallergic subcohort; ‡allergic subcohort. MCID = minimum clinically important difference; rTNSS = Reflective Total Nasal Symptom Score.
Figure 3
Figure 3
Significant changes in rTNSS subscores were observed following the cryoablation procedure across all subjects. Error bars represent standard deviation. Statistically significant improvements from baseline (P < 0.001) are identified by: *All domains. rTNSS = Reflective Total Nasal Symptom Score.
Figure 4
Figure 4
Significant changes in RQLQ total and domain scores were observed following cryoablation procedure the cryoablation procedure. Markers represent means ± standard deviation. Statistically significant improvements from baseline (P < 0.001) are identified (*). rTNSS = Reflective Total Nasal Symptom Score.

References

    1. Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol 2007;19:23–34.
    1. Lieberman P, Kaliner MA, Wheeler WJ. Open‐label evaluation of azelastine nasal spray in patients with seasonal allergic rhinitis and nonallergic vasomotor rhinitis. Curr Med Res Opin 2005;21:611–618.
    1. Golding‐Wood PH. Observations on petrosal and vidian neurectomy in chronic vasomotor rhinitis. J Laryngol Otol 1961;75:232–247.
    1. Kanaya T, Kikawada T. Endoscopic posterior nasal neurectomy: an alternative to Vidian neurectomy. Clin Exp Allergy Rev 2009;9:24–27.
    1. Hwang PH, Lin B, Weiss R, Atkins J, Johnson J. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol 2017;7:952–956.
    1. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) . Allergic rhinitis: developing drug products for treatment. Guidance for industry 2018. Available at: . Accessed August 26, 2019.
    1. US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) . Nonallergic rhinitis: developing drug products for treatment. Guidance for industry 2018. Available at: . Accessed August 26, 2019.
    1. Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol 1999;104:364–369.
    1. Meltzer EO, Wallace D, Dykewicz M, Shneyer L. Minimal clinically important difference (MCID) in allergic rhinitis: agency for healthcare research and quality or anchor‐based thresholds? J Allergy Clin Immunol Pract 2016;4:682–688.e6.
    1. Bernstein JA. Nonallergic rhinitis: therapeutic options. Curr Opin Allergy Clin Immunol 2013;13:410–416.
    1. Baraniuk JN, Silver PB, Kaliner MA, Barnes PJ. Perennial rhinitis subjects have altered vascular, glandular, and neural responses to bradykinin nasal provocation. Int Arch Allergy Immunol 1994;103:202–208.
    1. Kompelli AR, Janz TA, Rowan NR, Nguyen SA, Soler ZM. Cryotherapy for the treatment of chronic rhinitis: a qualitative systematic review. Am J Rhinol Allergy 2018;32:491–501.
    1. Kim KS, Kim SS, Yoon JH, Han JW. The effect of botulinum toxin type A injection for intrinsic rhinitis. J Laryngol Otol 1998;112:248–251.
    1. Braun T, Gurkov R, Kramer MF, Krause E. Septal injection of botulinum neurotoxin A for idiopathic rhinitis: a pilot study. Am J Otolaryngol 2012;33:64–67.
    1. Ozenberger JM. Cryosurgery for the treatment of chronic rhinitis. Laryngoscope 1973;83:508–516.
    1. Terao A, Meshitsuka K, Suzaki H, Fukuda S. Cryosurgery on postganglionic fibers (posterior nasal branches) of the pterygopalatine ganglion for vasomotor rhinitis. Acta Otolaryngol 1983;96:139–148.
    1. Girdhar‐Gopal H, Okurowski L, Strome M. An assessment of postganglionic cryoneurolysis for managing vasomotor rhinitis. Am J Rhinol Allergy 1994;8:157–164.
    1. Robinson SR, Wormald PJ. Endoscopic vidian neurectomy. Am J Rhinol 2006;20:197–202.
    1. Kikawada T. Endoscopic posterior nasal neurectomy: An alternative to vidian neurectomy. Oper Tech Otolayngol Head Neck Surg 2007;18:297–301.
    1. Halderman A, Sindwani R. Surgical management of vasomotor rhinitis: a systematic review. Am J Rhinol Allergy 2015;29:128–134.
    1. Ikeda K, Yokoi H, Saito T, Kawano K, Yao T, Furukawa M. Effect of resection of the posterior nasal nerve on functional and morphological changes in the inferior turbinate mucosa. Acta Otolaryngol 2008;128:1337–1341.
    1. Yan CH, Hwang PH. Surgical management of nonallergic rhinitis. Otolaryngol Clin North Am 2018;51:945–955.
    1. Tan G, Ma Y, Li H, Li W, Wang J. Long‐term results of bilateral endoscopic vidian neurectomy in the management of moderate to severe persistent allergic rhinitis. Arch Otolaryngol Head Neck Surg 2012;138:492–497.
    1. Ratner P, Van Bavel J, Mohar D, et al. Efficacy of daily intranasal fluticasone propionate on ocular symptoms associated with seasonal allergic rhinitis. Ann Allergy Asthma Immunol 2015;114:141–147.
    1. Ogawa T, Takeno S, Ishino T, Hirakawa K. Submucous turbinectomy combined with posterior nasal neurectomy in the management of severe allergic rhinitis: Clinical outcomes and local cytokine changes. Auris Nasus Larynx 2007;34:319–326.
    1. Kobayashi T, Hyodo M, Nakamura K, Komobuchi H, Honda N. Resection of peripheral branches of the posterior nasal nerve compared to conventional posterior neurectomy in severe allergic rhinitis. Auris Nasus Larynx 2012;39:593–596.
    1. Marshak T, Yun WK, Hazout C, Sacks R, Harvey RJ. A systematic review of the evidence base for vidian neurectomy in managing rhinitis. J Laryngol Otol 2016;130(suppl 4):S7–S28.

Source: PubMed

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