Abstract
Objective
The objective of this study is to assess the safety and efficacy of managing chronic ethmoid sinusitis with an implantable drug-eluting spacer filled with triamcinolone acetate.
Methods
13 patients with chronic ethmoid sinusitis had drug-eluting spacers inserted on 22 sides under fluoroscopic guidance. The spacers were filled with triamcinolone acetate and their position was checked fluoroscopically. The spacers remained in place for 2–4 weeks. The measured post-treatment outcomes were SNOT-20 and Lund-MacKay CT scores. Serum triamcinolone levels were measured and complications were monitored.
Results
All patients demonstrated a reduction in post-treatment LMK score; the average ethmoid sinus score decreased from 3.9 to 1.6 (59% reduction) (p<0.001). Average SNOT-20 scores changed from 1.91 to 1.12, a clinical and statistically significant reduction from baseline (p<0.001). Drug plasma testing did not demonstrate presence of drug in all samples tested; however, drug was detected in a majority, suggesting drug elution. One patient experienced epistaxis 1 week after surgery at the retention suture site. There were no orbital or intracranial injuries.
Conclusions
This study introduces a catheter-based, self-retaining temporary drug-eluting spacer as an alternative to ethmoidectomy for chronic ethmoid sinusitis treatment. The spacer has a perforated balloon membrane, specifically designed to allow the slow local delivery of a low corticosteroid dose over an extended time period. The spacers were delivered safely and there was significant resolution of ethmoid sinus disease without surgically removing the sinuses.
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