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. This was a prospective, multicenter, single-arm clinical study of posterior nasal nerve ablation in adults with chronic rhinitis.
View Article and Find Full Text PDFHeterotopic triplet pregnancy, cesarean scar ectopic pregnancy, and pregnancy following uterine ablation are all rare events that confer significant morbidity including spontaneous abortion, intrauterine fetal demise, preterm labor, abnormal placentation, and uterine rupture. A woman in her 30s, G6P4014, with a history of uterine ablation presented with delayed menses and vaginal spotting with imaging showing two intrauterine pregnancies (one with cardiac activity) and one live pregnancy at the cesarean scar. The patient was extensively counseled on risk to her and to the pregnancies; treatment options were discussed including expectant management and termination of pregnancy.
View Article and Find Full Text PDFBackground: Minimally invasive temperature-controlled radiofrequency (TCRF) ablation of the posterior nasal nerve (PNN) demonstrated a significant larger treatment effect on the symptom burden of chronic rhinitis patients than a sham control (no energy delivery) at the 3-month primary endpoint of this trial.
Methods: Two-year posttreatment outcomes for patients treated in a prospective, multicenter, patient-blinded randomized controlled trial were determined by combining the index active treatment-arm and index control-arm crossover patients into a single group (after the primary endpoint) to evaluate the treatment effect durability and long-term effects on concomitant chronic rhinitis medication usage.
Results: The mean baseline reflective total nasal symptom score (rTNSS) was 8.
Background: Chronic rhinosinusitis (CRS) is a prevalent inflammatory disease. No medications are Food and Drug Administration-approved for the most common form, CRS without nasal polyps (also called "chronic sinusitis"). Novel biomechanics of the exhalation delivery system deliver fluticasone (EDS-FLU; XHANCE) to sinonasal areas above the inferior turbinate, especially sinus drainage pathways not reached by standard-delivery nasal sprays.
View Article and Find Full Text PDFA 58 year old male with a history of prostate adenocarcinoma presented with diplopia, severe headaches, and eye pain, consistent with sinusitis. Imaging was concerning for invasive fungal sinusitis (IFS) and an urgent ENT consultation was requested. Endoscopic sinus surgery was performed revealing metastatic prostate adenocarcinoma to the sinuses and anterior cranial fossa.
View Article and Find Full Text PDFObjective: Commonly used endoscopic grading scales, such as the nasal polyp scale, inadequately describe the degree of polyposis found postoperatively in the paranasal sinus cavities. The purpose of this study was to create a novel grading system that more accurately characterizes polyp recurrence in postoperative sinus cavities, the Postoperative Polyp Scale (POPS).
Methods: A modified Delphi method was utilized to establish the POPS using consensus opinion among 13 general otolaryngologists, rhinologists, and allergists.
Background: Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis was previously reported as superior to a sham-control procedure at 3 months postprocedure in a randomized controlled trial (RCT). The primary endpoint was a responder rate of ≥30% improvement (decrease) for 24-hour reflective total nasal symptom score (rTNSS) compared with baseline. Herein, 12-month outcomes after active treatment are reported.
View Article and Find Full Text PDFBackground: The efficacy of topical corticosteroids is limited in chronic rhinosinusitis (CRS) due to rapid clearance from the nasal cavity and insufficient drug delivery to inflamed sinonasal passages. LYR-210 is an implantable corticosteroid matrix designed to provide up to 24 weeks of treatment to patients with CRS by locally delivering mometasone furoate (MF) to the sinonasal mucosa. In a randomized, controlled, dose-ranging LANTERN study, LYR-210 (7500 µg) achieved clinically relevant improvement in CRS cardinal symptom composite scores, the 22-item Sinonasal Outcome Test (SNOT-22), ethmoid opacification, and the need for rescue treatment at 24 weeks.
View Article and Find Full Text PDFBackground: Sinus surgery removes inflamed tissue, restores airflow, and improves delivery of medication into surgically opened spaces. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE ) uses a novel delivery system to create closed-palate, positive-pressure, bidirectional mechanics that significantly alter the deposition of the topically acting anti-inflammatory medication. We ask whether EDS-FLU efficacy differs for patients with recurrent symptoms after sinus surgery versus patients without surgery.
View Article and Find Full Text PDFBackground: Exhalation delivery system with fluticasone (EDS-FLU) delivers medication high and deep in the nasal passages and has been shown to reduce nasal polyp (NP) grade, an objective measure of efficacy, and to yield clinically meaningful improvements on subjective measures of symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Objectives: To better characterize EDS-FLU treatment, we analyzed responder rates for four outcome measures used in the EDS-FLU pivotal trials, in the overall study population as well as in subgroups of patients with or without prior sinus surgery or prior use of a standard intranasal corticosteroid spray (INS).
Methods: Data were pooled from two randomized, 24-week (16-week, double-blind + 8-week, open-label), placebo-controlled studies (NAVIGATE I and II).
We report the long-term safety and efficacy outcomes of the treatment and crossover arms of a randomized controlled trial evaluating an absorbable nasal implant to address dynamic nasal valve collapse. Participants were adults with severe/extreme nasal airway obstruction primarily due to nasal valve insufficiency who had implant placement. Follow-up visits were at 3, 6, 12, 18, and 24 months post implant.
View Article and Find Full Text PDFBackground: Chronic rhinosinusitis with nasal polyps (CRSwNP) frequently remains uncontrolled despite maximal medical therapy and sinonasal surgery, presenting several unmet needs and challenges. Omalizumab previously demonstrated efficacy in CRSwNP in duplicate phase 3, randomized, placebo-controlled trials (POLYP 1, POLYP 2).
Objective: This open-label extension evaluated the continued efficacy, safety, and durability of response of omalizumab in adults with CRSwNP who completed POLYP 1 or 2.
Objective: To determine the safety and efficacy of temperature-controlled radiofrequency (RF) neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis.
Study Design: A multicenter, prospective, single-blinded, randomized controlled trial, in which the control arm underwent a sham procedure.
Setting: Sixteen otolaryngology centers.
The aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty.
View Article and Find Full Text PDFObjectives/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.
Many studies show that carers of people with mental illness experience a negative impact on their wellbeing. Given the growing number of people relocating to Australia every year, there are limited studies examining the experience of carers of people with mental illness from culturally and linguistically diverse communities in Australia. Using cultural safety as a conceptual framework, this exploratory study recruited 14 carers of Chinese and Vietnamese heritage who were attending culturally and linguistically oriented support groups in Sydney, Australia.
View Article and Find Full Text PDFObjectives: The current analysis queries rhinologists' attitudes about the use of telemedicine, including the degree to which it has impacted practice patterns during the COVID-19 pandemic. Our objective was to survey rhinologists and understand the extent to which telemedicine serves as a rejoinder to in-person consultation: appreciation of relevant factors may be important in planning for present and future considerations.
Methods: A 14-question anonymous survey sent out to the American Rhinologic Society (ARS) membership in April 2020.
Health Soc Care Community
January 2021
Despite the importance of carers supporting the lives of people with mental illness, there are limited studies investigating the well-being and needs of Malay carers in multicultural Singapore. The Malays consist of 13.4% of Singapore's population.
View Article and Find Full Text PDFObjectives/hypothesis: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting.
Study Design: Prospective individual cohort study.
Methods: This prospective multicenter study evaluated in-office tube placement in children ages 6 months through 12 years of age.
Objectives: (1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices.
Study Design: Prospective, multicenter, single arm.
Setting: Patients were recruited in 8 community-based practices in the United States between June and September 2017.
Objectives: To examine 12-month outcomes for in-office treatment of dynamic nasal valve collapse (NVC) with a bioabsorbable implant.
Study Design: Prospective, multicenter, nonrandomized study.
Methods: One hundred sixty-six patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 16 U.