ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants.

OBJECTIVES/HYPOTHESIS: Disease recurrence and adverse wound healing in the form of inflammation, polyposis, adhesions, and middle turbinate lateralization may induce suboptimal outcomes following sinus surgery. The study objective was to assess the safety and effectiveness of a bioabsorbable, steroid-eluting implant used following functional endoscopic sinus surgery in patients with chronic rhinosinusitis (CRS).

STUDY

DESIGN

Prospective, multicenter, single-cohort trial enrolling 50 patients.

METHODS

The study allowed bilateral or unilateral steroid-eluting implant placement. Oral and topical steroids were withheld for 60 days postoperatively. Endoscopic follow-up was performed to 60 days. Patient-reported outcomes (Sino-Nasal Outcome Test-22 Questionnaire, Rhinosinusitis Disability Index) were collected to 6 months. Efficacy was assessed by grading inflammation, polyp formation, adhesions, and middle turbinate position. Safety assessment included ocular exams at baseline and 30 days.

RESULTS

Implants were successfully placed in all 90 sinuses. Mean inflammation scores were minimal at all time points. At 1 month, the prevalence of polypoid edema was 10.0%, significant adhesions 1.1%, and middle turbinate lateralization 4.4%. Changes from baseline in patient-reported outcomes were statistically significant (P < .0001). No clinically significant changes from baseline in intraocular pressure occurred.

CONCLUSIONS

This consecutive case series provides clinical evidence of the safety, effectiveness, and clinical utility of a bioabsorbable steroid-eluting implant for use in CRS patients. The implant was associated with favorable rates of sinus patency. At 1 month, minimal degrees of inflammation and adhesions were observed, suggesting a positive clinical impact of local steroid delivery without evidence of ocular risk.