xRead - September 2022

The Laryngoscope © 2021 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.

Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study

Randall A. Ow, MD; Ellen M. O ’ Malley, MS ; Joseph K. Han, MD; Kent K. Lam, MD; David M. Yen, MD

Objectives/Hypothesis: To assess the long-term (12 – 24 months) safety and effectiveness of cryoablation of the posterior nasal nerve as treatment for chronic rhinitis. Study Design: A multicenter, prospective, single-arm clinical study. Methods: The study was conducted from February 2017 to April 2020. Study endpoints included change from baseline in the re fl ective Total Nasal Symptom Score (rTNSS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), physician assessment of improvement using the Clinical Global Impression – Improvement (CGI – I), and the incidence of treatment-related adverse events. Results: Ninety-one participants completed the study through the initial 12-month study period. Sixty-two participants con sented to the long-term follow-up with 57 completing the 24-month follow-up. Signi fi cant improvements in the total rTNSS were re fl ected in a median change from baseline of − 3.0 or − 4.0 at all timepoints ( P < .001). Greater than 80.0% of participants achieved the minimum clinically important difference (MCID) of improvement by ≥ 1 point on the rTNSS at all follow-ups. Total RQLQ scores indicated signi fi cant improvement ( P < .0001) in quality of life. Over 77% of participants achieved the MCID ( ≥ 0.5 points) for the total RQLQ score. According to the CGI – I, ≥ 83.0% experienced improvement at all but the 12-month visit (61.9%). One participant experienced two treatment-related serious adverse events (epistaxis and retained pledget). A total of 29 nonserious treatment-related AEs were reported in 23 participants; most events were transient and resolved with little to no intervention. Conclusions: Cryotherapy signi fi cantly and clinically improves rhinitis symptoms and quality of life with outcomes that are durable through 24 months after treatment. Key Words: Allergic rhinitis, chronic rhinitis, nonallergic rhinitis, cryotherapy, posterior nasal nerve cryoablation. Level of Evidence: 4 Laryngoscope , 131:1952 – 1957, 2021

INTRODUCTION Chronic rhinitis is a common disease with an esti mated 2 billion people affected worldwide, including nearly 87 million in the United States. 1 The cardinal symptoms of rhinitis — rhinorrhea, congestion, itching, and sneezing — have a signi fi cant impact on the quality of life and productivity of people affected. 2 Pharmacologic interventions are usually the fi rst line of therapy; however, these fi rst-line therapies frequently fail to control symptoms due to lack of ef fi cacy or intolerance to treatment. 3 For these patients, surgical interventions may This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distri bution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. From the Sacramento Ear, Nose, and Throat ( R . A . O .), Roseville, CA, U.S.A.; Clinical Affairs, Stryker ENT ( E . M . O .), Plymouth, MN, U.S.A.; Otolaryngology ( J . K . H ., K . K . L .), Eastern Virginia Medical School, Norfolk, VA, U.S.A.; and the Specialty Physician Associates ( D . M . Y .), Bethlehem, PA, U.S.A. Editor ’ s Note: This Manuscript was accepted for publication on January 29, 2021 The study was funded by Arrinex (now part of Stryker ENT). Dr Ow is a consultant for Stryker ENT, Aerin Medical, Optinose, and Smith Nephew. Ms O ’ Malley is an employee of Stryker ENT. Dr Yen is a consul tant for Stryker ENT. Drs Han and Lam have no con fl icts to disclose. The authors have no other funding, fi nancial relationships, or con fl icts of inter est to disclose. Send correspondence to Randall A. Ow, MD, Sacramento Ear, Nose, and Throat Roseville, CA 95661. E-mail: row@sacent.com

be indicated. Surgical options, such as vidian neurectomy and posterior nasal nerve (PNN) sectioning, have been shown to provide symptom relief but typically require gen eral anesthesia in an operating room setting, and serious complications can occur. 3 Cryoablation of the PNN has been known to be an effective treatment since the 1970s, but the devices were not fully optimized for endoscopic use and did not gain wide adoption. 4 In June 2016, the United States Food and Drug Admin istration (FDA) cleared a novel cryotherapy device (Clari fi x, Stryker Corporation, Plymouth, MN) designed speci fi cally to facilitate an of fi ce-based, transnasal approach for cryoablation of the PNN. Hwang et al published a pilot study demonstrating the safety and feasibility of the device. 5 Recently, the 9-month outcomes were reported for a larger cohort. 6 Procedural success was high (100%) in this larger study performed under local anesthesia. Because peripheral neuroregeneration can occur at a rate of 1 to 6 inches per month, 7,8 evaluating results beyond a year is important to determine durability of the treatment. We now report longer-term outcomes (12-month through 24-month) of this larger cohort of rhinitis patients to evaluate the safety and durability of the treatment modality.

MATERIALS AND METHODS Study Design and Population

This prospective, multicenter, interventional, single-arm study was conducted at six US investigational centers from

DOI: 10.1002/lary.29453

Laryngoscope 131: September 2021

Ow et al.: Two-Year Outcomes of Cryoablation for Rhinitis

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