Cryoablation for the treatment of chronic rhinitis: a systematic review

Desai et al. Journal of Otolaryngology - Head & Neck Surgery https://doi.org/10.1186/s40463-023-00645-6 (2023) 52:37 Open Access REVIEW Cryoablation for the treatment of chronic rhinitis: a systematic review Veeral Desai1 , Gianluca Sampieri2, Amirpouyan Namavarian2 and John M. Lee2,3* Abstract Background ClariFix is a novel intranasal cryotherapy device developed for clinic-based cryosurgical ablation of the posterior nasal nerves region. As a relatively new technology, there is a paucity of studies within the literature assessing the efficacy and safety profile of ClariFix for chronic rhinitis. Methods A systematic review was completed in accordance with PRISMA guidelines. Databases searched included: Ovid Medline, Ovid EMBASE, Pubmed, Cochrane and Web of Science. Inclusion criteria consisted of studies investigating the use of ClariFix in chronic rhinitis (i.e., allergic and non-allergic rhinitis) in patients of all ages. Results The initial search identified 1110 studies. Final analysis consisted of 8 articles, evaluating a total of 472 patients. The data showed a significant reduction in scores post-treatment across all studies based on validated outcome measures. In all studies, at all time intervals, there was a significant improvement in outcome scores from baseline. Minor adverse effects included post-procedural pain and discomfort, headache and palate numbness. No major adverse events were identified. Conclusion ClariFix is a novel intranasal cryotherapy device that was introduced in Canada in 2021. This is the first systematic review evaluating its efficacy and safety profile. Across all studies, there was a significant reduction in validated outcome scores at multiple time intervals. Further, the treatment is safe with only minor adverse effects reported by patients. Overall, the consensus from this study highlights an apparent benefit in using this intervention for chronic rhinitis that is refractory to medical management. Keywords Rhinitis, Endoscopic sinus surgery, Chronic disease Introduction Chronic rhinitis is a common disease with an estimated 320 million people affected worldwide [1]. A study that surveyed the Canadian population reported that approximately 15% had chronic or recurrent rhinitis or sinusitis [2]. Pharmacologic interventions such as intranasal *Correspondence: John M. Lee 1 Faculty of Medicine, Queen’s University, Kingston, ON, Canada 2 Department of Otolaryngology – Head and Neck Surgery, University of Toronto, Toronto, ON, Canada 3 Division of Rhinology, Department of Otolaryngology ‑ Head and Neck Surgery, St. Michael’s Hospital, Unity Health Toronto, Toronto, ON, Canada anticholinergics, antihistamines, and decongestants are usually the first line of therapy for rhinitis; however, these first-line therapies fail to control symptoms due to lack of efficacy or intolerance to treatment in 10–22% of patients [3, 4]. For these patients that have rhinitis refractory to medical treatment, surgical interventions may be indicated [3, 4]. Historically, vidian neurectomy and posterior nasal nerve (PNN) sectioning were used to disrupt preganglionic parasympathetic innervation to the nasal mucosa to decrease secretions and symptoms in patients [3, 5]. The risk of serious complications and the need for general anesthesia have limited the broad acceptance of both vidian neurectomy and PNN resection despite their effectiveness [6]. © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Desai et al. Journal of Otolaryngology - Head & Neck Surgery (2023) 52:37 Cryotherapy is a surgical technique that offers the advantage of ablating soft tissue and nerve with predictable depth of penetration, preserving arterial vascular supply to the region and minimizes the risk of necrosis [7]. A novel transnasal cryotherapy device (ClariFix™) has been developed for clinic-based cryosurgical ablation of the PNN region, requiring only local anesthesia. This device was approved for use in the United States in June 2016 and Canada in June 2021 as a less invasive surgical option for rhinitis refractory to medical management [8, 9]. The device is a hand-held, endoscopically placed cryoprobe through which nitrous oxide cryogen is delivered at the tip in a closed system to ablate the nerves [8]. An image of internasal device position is visible in Fig. 1, courtesy of Stryker [8]. A qualitative systematic review in 2018 commented that although cryotherapy appeared safe and efficacious, heterogeneous and low-quality evidence made strong, evidence-based assessments difficult [6]. Since then, a number of prospective studies have been published assessing the efficacy and potential side effects of ClariFix™. These studies have shown significant reductions in nasal symptom scores and quality of life through validated metrics [10, 11]. Additionally, a database analysis published by Singh et al. in 2021, highlighted minor adverse events such as epistaxis and nasal swelling in ClariFix™ use [12]. The aim of this study is to assess the efficacy and adverse outcomes of ClariFix™ use by pooling existing data, thereby increasing the sample size. Methods Search strategy This systematic review was completed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (Fig. 2). The database searches were performed by two reviewers (V.D. / G.S.). Databases searched included: Ovid Medline, Ovid EMBASE, Pubmed, Cochrane and Web of Science. The Fig. 1 Intranasal device position for ClariFix™ application Page 2 of 9 search was completed from database inception (1946) to November 23, 2021. Keywords and Medical subject headings (MeSH) that were searched included: cryoablation, cryosurgery, cryotherapy, cryosurgical ablation, posterior nasal nerve cryoablation, posterior nasal nerve, chronic rhinitis, rhinitis, allergic rhinitis, non-allergic rhinitis, vasomotor rhinitis, rhinorrhea and congestion. Inclusion and exclu (...truncated)