Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: Two-year outcomes from a prospective multicenter trial.

Background: 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.

Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse.

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.

Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial.

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.

Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures.

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.

Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse.

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.

Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial.

Background: Dynamic nasal valve collapse (NVC) is a common factor contributing to nasal obstruction; however, it is often underdiagnosed and untreated. An in-office, minimally invasive procedure addressing dynamic NVC uses a bioabsorbable implant (Latera) to support the lateral nasal wall. This study aimed to evaluate the safety and effectiveness of the treatment in a randomized controlled trial (RCT) with sham control.

In-office Placement of Mometasone Furoate Sinus Implants for Recurrent Nasal Polyps: A Pooled Analysis.

Background: A mometasone furoate (MF) sinus implant (1350 mcg) was evaluated in 2 randomized controlled trials (RCTs) in 400 adults with nasal polyps (NP) who were candidates for revision endoscopic sinus surgery (RESS). We conducted a pooled analysis to evaluate the efficacy of MF implant in specific subgroups of NP patients.

Methods: Pooled data from 2 RCTs for 375 patients were analyzed across prespecified subjective and objective end points through day 90.

Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group.

Objective: Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks.

In-office balloon sinus dilation versus medical therapy for recurrent acute rhinosinusitis: a randomized, placebo-controlled study.

Background: A limited number of studies have demonstrated symptomatic improvement for recurrent acute rhinosinusitis (RARS) patients after endoscopic sinus surgery. In this randomized, controlled study we evaluated 24-week outcomes for balloon sinus dilation (BSD) performed in-office (IO) with medical management (MM) as compared with MM only for RARS patients.

Methods: Adults diagnosed with RARS were randomized to groups with BSD plus MM (n = 29) or MM alone (n = 30).

Bioabsorbable steroid-releasing implants in the frontal sinus ostia: a pooled analysis.

Background: Bioabsorbable steroid-releasing implants (mometasone furoate, 370 μg) are effective for improving postsurgical outcomes in the frontal sinus ostia (FSO). In this study we evaluated the effect of these implants on frontal outcomes in various patient subgroups with chronic rhinosinusitis (CRS) using pooled data from 2 randomized, controlled trials (RCTs).

Methods: A total of 160 subjects were enrolled in 2 RCTs.

Medical Therapy Versus Balloon Sinus Dilation in Adults With Chronic Rhinosinusitis (MERLOT): 12-Month Follow-up.

Background Chronic rhinosinusitis (CRS) is a devastating disease affecting nearly 30 million people in the United States. An interim analysis of data from the present study suggested that, in patients who had previously failed medical therapy, balloon sinus dilation (BSD) plus medical management (MM) provides a significant improvement in the quality of life (QOL) at 24 weeks postprocedure compared to MM alone. Objective The primary objective of this final analysis was to evaluate the durability of treatment effects through the 52-week follow-up.

A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant.

Objective: To examine 6-month outcomes for treatment of lateral nasal wall insufficiency with a bioabsorbable implant.

Study Design: Prospective, multicenter, nonrandomized, single-blinded study.

Methods: One hundred and one patients with severe-to-extreme class of Nasal Obstruction Symptom Evaluation (NOSE) scores were enrolled at 14 U.

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

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.

Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial.

Importance: Suboptimal outcomes of endoscopic sinus surgery (ESS) are often associated with restenosis and inflammation of frontal sinus ostia. Steroid-releasing sinus implants have been shown to maintain sinus patency by minimizing inflammation and scar tissue formation. An hourglass-shaped, bioabsorbable, steroid-releasing implant was developed to provide mechanical support and optimize drug delivery to paranasal sinus ostia.

Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study.

Background: Although previous studies of sinus surgery that used balloon catheter dilation technology for the paranasal sinuses (balloon sinus dilation [BSD]) demonstrated safety and efficacy, data that compare BSD with continued medical management (MM) are lacking.

Objective: To evaluate the outcomes of sinus surgery when using BSD instruments versus MM for patients with chronic rhinosinusitis for whom MM failed.

Methods: Adult patients with chronic rhinosinusitis for whom a minimum of 3 weeks of oral antibiotics, 4 weeks of daily saline solution therapy, and 4 weeks of daily nasal corticosteroids failed were included.

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.

Background: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer-term outcomes.