A prospective, non-randomized evaluation of a novel low energy radiofrequency treatment for nasal obstruction and snoring.

BACKGROUND: Weak or inward-bent cartilage of the nasal sidewall at the level of the internal nasal valve (INV) can produce narrowness or collapse of the nasal valve. This is a common cause of impaired nasal breathing during daily activities and there is also an established connection between nasal obstruction and snoring. The condition is often difficult to treat, although even a small enlargement of the lumen at the nasal valve can lead to a significant improvement in the ease of nasal breathing. METHODS: The primary objective of this prospective study was to evaluate the safety and efficacy of the Vivaer system for the treatment of narrowed nasal valves and to measure changes in the symptoms of nasal obstruction and snoring. The Vivaer system uses low energy radiofrequency to remodel the nasal sidewall in order to improve airflow. RESULTS: The study involved 31 patients presenting from 1st September 2017 to 1st May 2018 with symptoms of nasal obstruction and snoring. In all patients, an improvement was observed in nasal breathing measured by NOSE score, sleep quality by SOS questionnaire and quality of life as measured by EQ-5D and SNOT-22. CONCLUSION: Vivaer intranasal remodeling can provide a durable and well-tolerated non-invasive treatment for those patients who are suffering congestion due to narrowness or collapse of the INV.

Efficacy and safety of AM-111 in the treatment of acute sensorineural hearing loss: a double-blind, randomized, placebo-controlled phase II study.

OBJECTIVE: To evaluate the efficacy and safety of AM-111, a c-Jun N-terminal Kinase (JNK) ligand, in patients with acute sensorineural hearing loss (ASNHL). STUDY DESIGN: Prospective, double-blind, randomized, placebo-controlled study with follow-up visits on Days 3, 7, 30, and 90. SETTING: Twenty-five European sites (academic tertiary referral centers, private ENT practices). PATIENTS: Approximately 210 patients aged 18 to 61 years presenting within 48 hours after acute acoustic trauma or idiopathic sudden sensorineural hearing loss with mean hearing loss of 30 dB or greater at the 3 most affected contiguous test frequencies. INTERVENTIONS: Single-dose intratympanic injection of AM-111 (0.4 or 2.0 mg/ml) or placebo; optionally, oral prednisolone if hearing improvement was less than 10 dB at Day 7. MAIN OUTCOME MEASURES: Efficacy was assessed by absolute hearing improvement (primary end point, Day 7), percentage hearing improvement, complete hearing recovery, speech discrimination improvement, and complete tinnitus remission. Safety was evaluated by the frequency of clinically relevant hearing deterioration and adverse events. RESULTS: The study failed to demonstrate a treatment benefit for the entire study population because mild-to-moderate ASNHL cases showed unexpectedly strong spontaneous recovery. In severe-to-profound ASNHL patients (threshold ≥60 dB), AM-111 0.4 mg/ml showed statistically significant, clinically relevant, and persistent improvements in hearing and speech discrimination and higher tinnitus remission compared with placebo. The study drug and the intratympanic injections were well tolerated. CONCLUSION: The study established proof of concept for AM-111 in the treatment of severe-to-profound ASNHL. Control for spontaneous hearing recovery is essential for ASNHL studies.

Safety of cold ablation (coblation) in the treatment of tonsillar hypertrophy of the tongue base.

The treatment of diseases of the lingual tonsils is still under debate, and surgical interventions are often associated with significant morbidity and complications. The aim of the present study was to evaluate the safety of lingual tonsillectomy using cold ablation (coblation) as a new treatment of lingual tonsil diseases. In this retrospective, bicentric study, we included all patients between 2005 and 2012 who underwent cold ablation (Coblation(®)) of the lingual tonsils. We assessed the frequency of postoperative complications based on the patients' charts. A total of 108 patients (47 ± 13, 6 years) underwent lingual tonsillectomy using coblation. All patients were operated on under general anesthesia as inpatients. Intraoperative complications did not occur. Three patients (2.8%) needed revision surgery due to postoperative hemorrhage, and in one of those cases, three revisions were necessary. There was no postoperative airway compromise and no need for tracheostomy. There was no hypoglossal nerve paralysis, but in the case needing multiple revisions, a weakness of the hypoglossal nerve persisted. In all the cases, oral intake was possible with adequate analgesia. Coblation of the tongue base is a safe procedure with a relatively low rate of postoperative complications. Postoperative hemorrhage is the most relevant complication that occurred in our series of patients. Future studies are needed to evaluate the efficacy of the procedure in the treatment of obstructive sleep apnea.