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4. Acoustic resonance therapy is safe and effective for the treatment of nasal congestion in rhinitis: A randomized sham‐controlled trial

Author

Luong, Amber U., primary, Yong, Michael, additional, Hwang, Peter H., additional, Lin, Bryant Y., additional, Gopi, Paramesh, additional, Mohan, Vivek, additional, Ma, Yifei, additional, Johnson, Jacob, additional, Yen, David M., additional, DeMera, Richard S., additional, and Bleier, Benjamin S., additional

Published
2023
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5. Two‐Year Outcomes After Pediatric In‐Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System

Author

Waldman, Erik H., primary, Ingram, Amy, additional, Vidrine, D. Macy, additional, Gould, Andrew R., additional, Zeiders, Jacob W., additional, Ow, Randall A., additional, Thompson, Christopher R., additional, Moss, Jonathan R., additional, Mehta, Ritvik, additional, McClay, John E., additional, Brenski, Amy, additional, Gavin, John, additional, Ansley, John, additional, Yen, David M., additional, Chadha, Neil K., additional, Murray, Michael T., additional, Kozak, Frederick K., additional, York, Christopher, additional, Brown, David M., additional, Grunstein, Eli, additional, Sprecher, Robert C., additional, Sherman, Denise A., additional, Schoem, Scott R., additional, Puchalski, Robert, additional, Hills, Susannah, additional, Harfe, Dan, additional, England, Laura J., additional, Syms, Charles A., additional, and Lustig, Lawrence R., additional

Published
2023
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11. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps

Author

Kern, Robert C., Stolovitzky, J. Pablo, Silvers, Stacey L., Singh, Ameet, Lee, Jivianne T., Yen, David M., Iloreta, Alfred M.C., Langford, Francis P.J., Karanfilov, Boris, Matheny, Keith E., Stambaugh, James W., and Gawlicka, Anna K.

Subjects
Adult, Drug Implants, Male, mometasone furoate implant, chronic rhinosinusitis, polyposis, Original Articles, Middle Aged, Placebos, Nasal Mucosa, Nasal Polyps, Double-Blind Method, Recurrence, Chronic Disease, Paranasal Sinuses, otorhinolaryngologic diseases, corticosteroid use, sinus surgery, ESS, Humans, Original Article, Female, Sinusitis, Mometasone Furoate
Abstract

Background Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid‐eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days. Methods A randomized, sham‐controlled, double‐blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in‐office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co‐primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review. Results Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant‐related serious adverse event (epistaxis). Conclusion Significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.

Published
2018

14. In Response to Letter to the Editor Regarding In ‐ Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery

Author

Lustig, Lawrence R., primary, Grunstein, Eli, additional, Hills, Susannah, additional, Ingram, Amy, additional, Gould, Andrew R., additional, Vidrine, D. Macy, additional, Puchalski, Robert, additional, Zeiders, Jacob W., additional, Ow, Randall A., additional, Thompson, Christopher R., additional, Moss, Jonathan R., additional, Mehta, Ritvik, additional, Calzada, Audrey, additional, McClay, John E., additional, Brenski, Amy, additional, Gavin, John, additional, Waldman, Erik H., additional, Ansley, John, additional, Yen, David M., additional, Brown, David M., additional, Chadha, Neil K., additional, Kozak, Frederick K., additional, Murray, Michael T., additional, York, Christopher, additional, Sprecher, Robert C., additional, Sherman, Denise A., additional, Schoem, Scott R., additional, Harfe, Dan, additional, England, Laura J., additional, and Syms, Charles A., additional

Published
2020
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15. In‐Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery

Author

Lustig, Lawrence R., primary, Ingram, Amy, additional, Vidrine, D. Macy, additional, Gould, Andrew R., additional, Zeiders, Jacob W., additional, Ow, Randall A., additional, Thompson, Christopher R., additional, Moss, Jonathan R., additional, Mehta, Ritvik, additional, McClay, John E., additional, Brenski, Amy, additional, Gavin, John, additional, Waldman, Erik H., additional, Ansley, John, additional, Yen, David M., additional, Chadha, Neil K., additional, Murray, Michael T., additional, Kozak, Frederick K., additional, York, Christopher, additional, Brown, David M., additional, Grunstein, Eli, additional, Sprecher, Robert C., additional, Sherman, Denise A., additional, Schoem, Scott R., additional, Puchalski, Robert, additional, Hills, Susannah, additional, Calzada, Audrey, additional, Harfe, Dan, additional, England, Laura J., additional, and Syms, Charles A., additional

Published
2020
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20. Clinical Outcomes After Innovative Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis

Author

Davis, Greg E., Ow, Randall A., Yen, David M., O’Malley, Ellen M., and Del Signore, Anthony G.

Abstract

Objective:Chronic rhinitis substantially impacts a person’s quality of life. We evaluated a novel, multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Methods:This was a prospective, multicenter, single-arm clinical study of posterior nasal nerve ablation in adults with chronic rhinitis. The primary efficacy endpoint was the change in reflective Total Nasal Symptom Score (rTNSS) at 6-month follow-up. Additional assessments included the Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction Symptom Evaluation (NOSE), and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ). The primary safety endpoint was the incidence of related serious adverse events. Results:Seventy-nine of 80 enrolled participants completed 6-month follow-up. Statistically significant improvements were observed for mean change in rTNSS (−4.2), ETDQ-7 (−1.2), NOSE (−33.5), and mini-RQLQ (−1.8; P< .0001 for all). Allergic and nonallergic rhinitis subgroups demonstrated significant improvement in all assessments (P< .0001) with no significant differences between subgroups. Higher baseline rTNSS was associated with greater improvements at follow-up. One serious adverse event of epistaxis was reported. Conclusions:The results of this study demonstrate the efficacy and safety of a multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Significant improvements were observed in rTNSS, ETDQ-7, NOSE, and mini-RQLQ assessments.Study registration:www.clinicaltrials.gov. Unique identifier NCT05591989.

Published
2024
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21. Incorporating Microdebrider Use in a Community-Based Thyroidectomy Practice

Author

Conti, Keith R., Ohlstein, Jason F., Brown, David M., Bedrosian, Jeffrey C., and Yen, David M.

Abstract

Objectives:Substernal goiters often require surgery, yet their location presents challenges. Most can be removed via transcervical approach, but extent and relationship to mediastinal structures can merit consideration of sternotomy and assistance of colleagues. Despite widespread use in sinus surgery and previous literature reports, microdebrider use to facilitate transcervical removal of substernal goiters has not been broadly adopted. Our objective was to report our experience with use of the soft tissue shaver to facilitate substernal goiter deliver through a cervical incision in a community-based thyroidectomy practice. Methods:We reviewed thyroidectomy cases performed by a general otolaryngologist (D.M.Y.) in a community setting from January 2017 through December 2019. Four patients required microdebrider use for intracapsular debulking of substernal goiter to allow for transcervical removal. We discuss pre- and perioperative considerations, present computed tomography (CT) and operative images, review surgical technique, and report estimated blood loss (EBL), surgical time (T), complications, and length of stay. Results:Average EBL was 237.5 ml (range 100-500 ml). Average T was 137 minutes (range 121-170 minutes). No patients required sternotomy. One patient developed postoperative hematoma requiring evacuation and cautery of a bleeding site. No other complications were encountered, all patients were discharged after overnight observation. Conclusions:The microdebrider can be safely utilized by general otolaryngologists to facilitate transcervical removal of substernal goiters. Adoption of this familiar tool for a different surgical application can reduce the need for sternotomy, assistance of colleagues, or referral to a tertiary care center, with associated decrease in risk, morbidity, surgical time, length of stay, and cost, and improved patient convenience and satisfaction.

Published
2024
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22. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study

Author

Forwith, Keith D., primary, Han, Joseph K., additional, Stolovitzky, J. Pablo, additional, Yen, David M., additional, Chandra, Rakesh K., additional, Karanfilov, Boris, additional, Matheny, Keith E., additional, Stambaugh, James W., additional, and Gawlicka, Anna K., additional

Published
2016
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23. Extensive Intracranial Xanthoma Associated with Type II Hyperlipidemia

Author

Bonhomme, Gabrielle R., Loevner, Laurie A., Yen, David M., Deems, Daniel A., Bigelow, Douglas C., and Mirza, Natasha

Subjects
Adult, Male, Brain Diseases, Metabolic, Inborn, musculoskeletal system, Diagnosis, Differential, Hyperlipoproteinemia Type II, Postoperative Complications, Parietal Lobe, Xanthomatosis, Humans, Occipital Lobe, Tomography, X-Ray Computed, Craniotomy, Head and Neck
Abstract

Summary: Xanthomas are associated with a spectrum of medical conditions, most commonly disorders of lipid storage and lipid metabolism. They occur primarily in the subcutaneous tissues, especially along the Achilles tendon and the extensor tendons of the hands. Intracranial xanthomas are extremely rare. We present a case of an extensive xanthoma of the temporal bone in a patient with hyperlipidemia.

Published
2000

25. In Response to Letter to the Editor Regarding In‐Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery.

Author

Lustig, Lawrence R., Grunstein, Eli, Hills, Susannah, Ingram, Amy, Gould, Andrew R., Vidrine, D. Macy, Puchalski, Robert, Zeiders, Jacob W., Ow, Randall A., Thompson, Christopher R., Moss, Jonathan R., Mehta, Ritvik, Calzada, Audrey, McClay, John E., Brenski, Amy, Gavin, John, Waldman, Erik H., Ansley, John, Yen, David M., and Brown, David M.

Abstract

In Response to Letter to the Editor Regarding In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery Thank you for your comments regarding our article "In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery."1 We appreciate the opportunity to provide additional information and clarification in response to your Letter to the Editor. Verbal and physical responses to the anesthesia assessment were evaluated to determine anesthesia effectiveness. [Extracted from the article]

Published
2021
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30. Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction.

Author

Han JK, Silvers SL, Rosenthal JN, McDuffie CM, and Yen DM

Subjects
Female, Humans, Male, Middle Aged, Prospective Studies, Quality of Life, Temperature, Treatment Outcome, Nasal Obstruction complications, Nasal Obstruction surgery
Abstract

Importance: Nasal valve collapse is a primary cause of nasal airway obstruction (NAO). Patients with NAO and nasal valve collapse experience a variety of symptoms that lower their quality of life, such as nasal congestion, headache, sleep disturbance, daytime sleepiness, and snoring., Objective: To determine if active treatment of the nasal valve with a temperature-controlled radiofrequency (TCRF) device, previously demonstrated superior to a sham procedure at 3 months, was safe and associated with sustained improvements in symptoms of NAO through 12 months., Design, Setting, and Participants: In a prospective, multicenter, single-blinded, randomized clinical trial, patients in 16 centers in the US with index procedures between August and December 2020 were assigned to TCRF device treatment of the nasal valve or a sham control procedure (no RF energy). Patients had a baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score of 55 or greater with nasal valve collapse as the primary or substantial contributor to NAO. After primary end point evaluation at 3 months, eligible patients in the sham control arm crossed over to active treatment. Data analysis was performed between April and May 2022., Interventions: Patients were treated bilaterally with the TCRF device at 4 or fewer nonoverlapping areas on the nasal mucosa at the junction of the upper and lower lateral cartilage on the lateral nasal wall., Main Outcomes and Measures: The primary end point measure was responder rate, defined as 20% or greater reduction in NOSE Scale score or 1 or greater reduction in NOSE Scale clinical severity category., Results: A total of 108 patients received active treatment (77 as index active treatment, 31 after crossover). The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) were women. The combined group of patients receiving active treatment had a mean baseline NOSE Scale score of 76.3 (95% CI, 73.6-79.1). At 12 months (n = 88), the responder rate was 89.8% (95% CI, 81.7%-94.5%). The NOSE Scale score improved from baseline (mean change, -44.9 [95% CI, -52.1 to -37.7]). No device/procedure-related serious adverse events were reported., Conclusions and Relevance: In this follow-up of a cohort from a randomized clinical trial, the minimally invasive TCRF device, previously demonstrated to be superior to a sham procedure, was safe and associated with improvement in symptoms of NAO through 12 months postprocedure., Trial Registration: ClinicalTrials.gov Identifier: NCT04549545.

Published
2022
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