Objective:Compare Eustachian tube balloon dilation versus continued medical therapy (control) for treating persistent Eustachian tube dysfunction (ETD).Study Design:Prospective, multicenter, randomized controlled trial.Setting:Tertiary care academic center and private practice.Patients:Diagnosed with medically refractory persistent ETD.Interventions:1:1 Randomization to balloon dilation or control. After 6 weeks, control participants had the option to undergo balloon dilation if symptoms persisted.Main Outcome Measures:Primary efficacy endpoint was the comparison between treatment arms in the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Primary safety endpoint was complication rate.Results:Sixty participants were randomized (31 balloon dilation, 29 control). Mean (SD) change in overall ETDQ-7 score at 6 weeks was −2.9 (1.4) for balloon dilation compared with −0.6 (1.0) for control: balloon dilation was superior to control (p < 0.0001). No complications were reported in either study arm. Among participants with abnormal baseline assessments, improvements in tympanogram type (p < 0.006) and tympanic membrane position (p < 0.001) were significantly better for balloon dilation than control. Technical success was 100% (91 successful dilations/91 attempts) and most procedures (72%) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation.Conclusions:Balloon dilation is a safe and effective treatment for persistent ETD. Based on improved ETDQ-7 scores, balloon dilation is superior to continued medical management for persistent ETD. Symptom improvement is durable through a minimum of 12 months. Procedures are well tolerated in the office setting under local anesthesia.

Background The purpose of this study was to test whether cryotherapy is superior to a sham procedure for reducing symptoms of chronic rhinitis. Methods This study was a prospective, multicenter, 1:1 randomized, sham‐controlled, patient‐blinded trial. The predetermined sample size was 61 participants per arm. Adults with moderate/severe symptoms of chronic rhinitis who were candidates for cryotherapy under local anesthesia were enrolled. Participants were required to have minimum reflective Total Nasal Symptom Scores (rTNSSs) of 4 for total, 2 for rhinorrhea, and 1 for nasal congestion. Follow‐up visits occurred at 30 and 90 days postprocedure. Patient‐reported outcome measures included the rTNSS, standardized Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)], and Nasal Obstruction Symptom Evaluation (NOSE) questionnaires. Adverse events were also recorded. The primary endpoint was the comparison between the treatment and sham arms for the percentage of responders at 90 days. Responders were defined as participants with a 30% or greater reduction in rTNSS relative to baseline. Results Twelve US investigational centers enrolled 133 participants. The primary endpoint analysis included 127 participants (64 active, 63 sham) with 90‐day results. The treatment arm was superior at the 90‐day follow‐up with 73.4% (47 of 64) responders compared with 36.5% (23 of 63) in the sham arm (p < 0.001). There were greater improvements in the rTNSS, RQLQ(S), and NOSE scores for the active arm over the sham arm at the 90‐day follow‐up (p < 0.001). One serious procedure‐related adverse event of anxiety/panic attack was reported. Conclusion Cryotherapy is superior to a sham procedure for improving chronic rhinitis symptoms and patient quality of life.

The Wallgraft Endoprosthesis for the treatment of traumatic arterial injuries offers a promising alternative to conventional operative repair with comparable patency and less major morbidity and mortality.

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 reflective 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 consented to the long‐term follow‐up with 57 completing the 24‐month follow‐up. Significant improvements in the total rTNSS were reflected 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 significant 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 significantly and clinically improves rhinitis symptoms and quality of life with outcomes that are durable through 24 months after treatment. Level of Evidence 4 Laryngoscope, 131:1952–1957, 2021

Background Cryoablation of the posterior nasal nerve at the middle meatus has been shown to successfully treat nasal obstruction and symptoms of chronic rhinitis. Cryoablation of both the middle and inferior meatus has not yet been studied. Objectives To evaluate the safety and feasibility of cryoablation of the posterior nasal nerve at both the middle and inferior meatus locations to treat chronic rhinitis. Methods Participants underwent bilateral cryoablation of the posterior nasal nerve at both the middle meatus and inferior meatus and were assessed through 3 months post treatment. The primary endpoint is the change from baseline to 3-month follow-up in the reflective Total Nasal Symptom Score (rTNSS). Other assessments include additional patient-reported outcomes, physician assessment, and independent review and scoring of imaging. Results Thirty participants were enrolled at 3 US centers. There was a significant improvement from baseline in the median rTNSS (–4.0, P < .001) at 3 months. Statistically significant improvements from baseline ( P < .001) were also observed with the Nasal Obstruction Symptom Score (NOSE), nasal symptom visual analog scale (VAS), Sino-Nasal Outcomes Score (SNOT-22), and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ). Clinical Global Impression – Improvement (CGI-I) indicated that 89.7% (26/29) of participants experienced improvement at 3 months. No serious adverse events were reported. Conclusion Cryoablation at both the middle meatus and inferior meatus appears to be a safe and feasible option for treatment of chronic rhinitis. In this feasibility study, there is significant improvement in symptoms post treatment. Adverse events are minor and transient.