Cryotherapy for treatment of chronic rhinitis: 3-month outcomes of a randomized, sham-controlled trial.

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.

Balloon dilation of the Eustachian tube with a seeker-based device: A registry of 169 patients.

OBJECTIVE: To collect real-world data on the safety and effectiveness of balloon dilation of the Eustachian tube using a seeker-based device in patients with persistent/chronic symptoms of Eustachian tube dysfunction. METHODS: A multicenter, prospective, single-arm registry was conducted from June 2018 through August 2020 at 10 US centers, including tertiary care and private practices. Primary endpoints included mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) and the serious related adverse event rate. Secondary endpoints include changes in middle ear assessments, surgical intervention rate, and changes in Sino-Nasal Outcome Test and Work and Activity Impairment (WPAI) questionnaires. RESULTS: A total of 169 participants were treated with balloon dilation of the Eustachian tube, with 166 and 154 participants completing the 6-week and 6-month follow-ups, respectively. Repeated measures analysis of the change in ETDQ-7 scores indicated statistically significant improvement (-2.1; 95% CI -2.40, -1.84; P < .0001) at 6-month follow-up. The minimum clinically important difference of improvement was achieved by 85% of participants at 6 months. Four nonserious adverse events were reported. Middle ear functional assessments were improved in the majority of participants with abnormal baseline findings. There were no statistically significant differences in the change from baseline ETDQ-7 scores between participants who had concurrent procedures and those who did not. WPAI scores demonstrated significant improvement. CONCLUSION: Real-world evidence supports the clinical studies demonstrating that balloon dilation of the Eustachian tube with a seeker-based device is a safe and effective procedure to treat ETD symptoms. LEVEL OF EVIDENCE: 3.

A Meta-Analysis of Complication Rates Among Different SMAS Facelift Techniques.

BACKGROUND: Sub-superficial musculo-aponeurotic system (SMAS) rhytidectomy techniques are considered to have a higher complication profile, especially for facial nerve injury, compared with less invasive SMAS techniques. This results in surgeons avoiding sub-SMAS dissection. OBJECTIVES: The authors sought to aggregate and summarize data on complications among different SMAS facelift techniques. METHODS: A broad systematic search was performed. All included studies: (1) described a SMAS facelifting technique categorized as SMAS plication, SMASectomy/imbrication, SMAS flap, high lateral SMAS flap, deep plane, and composite; and (2) reported the number of postoperative complications in participants. Meta-analysis was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: A total 183 studies were included. High lateral SMAS (1.85%) and composite rhytidectomy (1.52%) had the highest rates of temporary nerve injury and were the only techniques to show a statistically significant difference compared with SMAS plication (odds ratio [OR] = 2.71 and 2.22, respectively, P < 0.05). Risk of permanent injury did not differ among techniques. An increase in major hematoma was found for the deep plane (1.22%, OR = 1.67, P < 0.05) and SMAS imbrication (1.92%, OR = 2.65, P < 0.01). Skin necrosis was higher with the SMAS flap (1.57%, OR = 2.29, P < 0.01). CONCLUSIONS: There are statistically significant differences in complication rates between SMAS facelifting techniques for temporary facial nerve injury, hematoma, seroma, necrosis, and infection. Technique should be selected based on quality of results and not the complication profile.

Toxicity implications for early life stage Japanese medaka (Oryzias latipes) exposed to oxyfluorfen.

We investigated the potential toxic effects of Oxyfluorfen (OXY), an herbicide used in agriculture, on the embryo-larval development of Japanese medaka fish (Oryzias latipes). Embryos (1-day postfertilization) and larvae (2-day posthatch) were exposed to OXY (0.5-8 mg/L) for 96 h and evaluated for mortality and hatching on embryos, and the mortality and growth on larvae during depuration. It was observed that the embryo-mortality was inconsistently altered by OXY; only the 2 mg/L group showed significant reduction on embryo survivability. However, larval-mortality was concentration-dependent and OXY exposure induced scoliosis-like phenotypic features in the surviving larvae; the calculated LC50 was 5.238 mg/L. Our data further indicated that larval skeleton, both axial and appendicular, was the potential target site of OXY. Skeletal growth in larvae exposed to 2 mg/L was inhibited significantly until 1 week of depuration with regard to the linear lengths of neurocranium, Meckel's cartilage, caudal vertebrae (first 10) in the axial skeletons, and pectoral fin and urostyle in the appendicular skeletons. Moreover, the total protein content remained unaltered by OXY after 96 h exposure; while the RNA concentration was reduced significantly in larvae exposed to 2 mg/L. Expression analysis of several genes by quantitative real-time RT-PCR (RT-qPCR) showed significant upregulation of zic5, a zinc-finger type transcription regulator, at the transcription level. This study indicated that the scoliosis induced by OXY in Japanese medaka larvae was the result of stunted skeletal growth, probably because of deregulation of zinc-finger type transcription regulators, at the genomic level.

Sinonasal Carcinoma: Racial and Ethnic Disparities in Survival--A Review of 4714 Patients.

OBJECTIVE: To determine whether or not patient race and ethnicity affect sinonasal cancer survival. STUDY DESIGN: Retrospective database analysis. SETTING: National Cancer Institute's Surveillance, Epidemiology, and End Results Database, 1988-2010. SUBJECTS AND METHODS: Sinonasal carcinoma cases were extracted according to site codes and histology recode-broad groupings. The cohort was used to calculate disease-specific survival in regard to race and ethnicity. Extracted data were further analyzed through direct comparisons and multivariable Cox regression models controlling for patient, tumor, and treatment characteristics. RESULTS: Unadjusted survival curves for all sinonasal carcinomas showed poorer disease-specific survival for black versus white patients (P = .02), which was eliminated after controlling for tumor characteristics (hazard ratio: 1.02, P = .86). Specifically for sinonasal squamous cell carcinoma, significantly poorer disease-specific survival was found for both black (P = .01) and Hispanic (P = .01) patients as compared with white patients. Similarly, when controlling for tumor characteristics, the disease-specific survival disparity was eliminated for black (hazard ratio: 0.93, P = .59) and Hispanic patients (hazard ratio: 1.01, P = .94). CONCLUSION: Black race is a risk factor for poorer disease-specific survival when all sinonasal histologic subtypes are examined together. Specifically for sinonasal squamous cell carcinoma, both black race and Hispanic ethnicity are risk factors for poorer disease-specific survival. When tumor characteristics are controlled for in this cohort, the survival disparity is eliminated, demonstrating that the disparity can be accounted for exclusively by more advanced disease at presentation, opposed to the more complex effect seen in other subsites of the head and neck.

Racial and Ethnic Disparities in Salivary Gland Cancer Survival.

IMPORTANCE: Several recent US studies have documented racial disparities in head and neck cancer outcomes, but few have investigated racial and ethnic differences in salivary gland cancer (SGCA) survival. OBJECTIVE: To determine whether patient race or ethnicity affects SGCA survival. DESIGN, SETTING, AND PARTICIPANTS: Retrospective survival analysis of all patients with SGCA from 1988 through 2010 in the Surveillance, Epidemiology, and End Results database. MAIN OUTCOMES AND MEASURES: Disease-specific survival according to race and ethnicity. End points assessed included age at diagnosis, sex, tumor grade, tumor size at diagnosis, extension at diagnosis, lymph node involvement at diagnosis, and treatment. Results were further analyzed by histologic subtype of SGCA. RESULTS: Of 11,007 patients with SGCA, 1073 (9.7%) were black, and 1068 (9.7%), Hispanic. Whites' mean age at diagnosis was 63 years vs 53 and 52 years for blacks and Hispanics, respectively (P < .001). Twenty-year disease-specific survival rates for all SGCA histologic subtypes combined for whites, blacks, and Hispanics were 78%, 79%, and 81%, respectively. Unadjusted survival curves showed no significant difference between blacks and whites and an apparent advantage for Hispanics. However, multivariable Cox regression models controlling for patient, tumor, and treatment characteristics showed poorer disease-specific survival vs whites for blacks (hazard ratio [HR], 1.22 [95% CI, 1.03-1.46]; P = .03) but not for Hispanics (HR, 0.97 [0.79-1.19]; P = .77). The overall disease-specific survival disparity was due to poorer disease-specific survival for blacks vs whites with mucoepidermoid (P = .03) and squamous cell carcinomas (P = .05). Less surgical treatment for blacks than whites (57.26% vs 76.94%; P < .001) was a source of the survival disparity for squamous cell but not mucoepidermoid SGCA. CONCLUSIONS AND RELEVANCE: Black race is a risk factor for poorer disease-specific survival for patients with mucoepidermoid or squamous cell carcinoma, whereas Hispanic ethnicity has no effect. Differing treatment between black and white patients affects survival in squamous cell but not mucoepidermoid SGCA. Differences in chemotherapy treatment, comorbidities, socioeconomic status, tumor genetic factors, and environmental exposures are potential but unproven additional sources of the racial survival disparities for mucoepidermoid and squamous cell SGCA.

Pediatric cochlear implantation: expanding applications and outcomes.

Cochlear implantation is a revolutionary yet time-sensitive treatment for deaf children that must be performed within a critical window of time, in early life, for a congenitally deafened child to receive maximum benefit. Potential candidates should therefore be referred for evaluation early. Primary reasons for delay of cochlear implantation include slow referrals for care, parental delays, and payer delays. It is vital that all newborn children undergo hearing screening to identify deaf children at birth, and for parents, health care providers, and health care payers to be educated about the indications, important benefits, and reasonable risks of cochlear implantation for deaf children.