Rakesh K. Chandra, MD, is a consultant for Johnson & Johnson, Medtronic, and Olympus. Henry D. Jampel, MD, is a shareholder of Allergan Corporation, and a consultant for Transcend, Endo-optics, Ivantis, and Intersect ENT. Paul T. Yun, MD, is a consultant for Intersect ENT. The sponsor (Intersect ENT, Palo Alto, CA) provided funding for the investigation, as well as administrative and logistical support in coordinating the study across the study centers. The authors have no other funding, financial relationships, or conflicts of interest to disclose.
Article first published online: 21 OCT 2011
Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.
Volume 121, Issue 11, pages 2473–2480, November 2011
How to Cite
Forwith, K. D., Chandra, R. K., Yun, P. T., Miller, S. K. and Jampel, H. D. (2011), ADVANCE: A multisite trial of bioabsorbable steroid-eluting sinus implants. The Laryngoscope, 121: 2473–2480. doi: 10.1002/lary.22228
Editor's Note: This Manuscript was accepted for publication May 16, 2011.
- Issue published online: 21 OCT 2011
- Article first published online: 21 OCT 2011
- functional endoscopic sinus surgery;
- sinus implant;
- Level of Evidence: 2b.
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).
Prospective, multicenter, single-cohort trial enrolling 50 patients.
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.
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.
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. Laryngoscope, 121:2473-2480, 2011