Premium
Effect of steroid‐releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta‐analysis
Author(s) -
Han Joseph K.,
Marple Bradley F.,
Smith Timothy L.,
Murr Andrew H.,
Lanier Brent J.,
Stambaugh James W.,
Mugglin Andrew S.
Publication year - 2012
Publication title -
international forum of allergy and rhinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.503
H-Index - 46
eISSN - 2042-6984
pISSN - 2042-6976
DOI - 10.1002/alr.21044
Subject(s) - medicine , randomized controlled trial , surgery , sinus (botany) , clinical endpoint , meta analysis , implant , functional endoscopic sinus surgery , prospective cohort study , sinusitis , botany , biology , genus
Background: Endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS) can be compromised by postoperative inflammation, polyposis, and adhesions, often requiring subsequent interventions. A bioabsorbable, steroid‐releasing sinus implant has been studied in 2 prospective, randomized clinical trials for its ability to preserve sinus patency and reduce medical and surgical interventions after ESS in patients with CRS. The objective of this study was to perform a meta‐analysis of the efficacy results from the 2 trials. Methods: The 2 prospective, randomized, double‐blinded, multicenter trials enrolled a total of 143 patients utilizing an intrapatient control design. Postoperative day 30 videos were obtained for each patient, randomly ordered, and presented to an independent panel of 3 otolaryngologists for grading of efficacy endpoints. The need for postoperative interventions, formation of polyposis, and adhesions were assessed. Results from the 2 studies were then pooled. Results: Implants were successfully placed in all 286 ethmoid sinuses. According to the grading done by the panel, drug‐releasing implants reduced postoperative interventions by 35% ( p = 0.0008), lysis of adhesions by 51% ( p = 0.0016), and oral steroid need by 40% ( p = 0.0023), compared to controls. The relative reduction in frank polyposis was 46% ( p < 0.0001). Conclusion: Early postoperative healing is a predictor of longer‐term success after sinus surgery. Evaluation of postoperative outcomes by a blinded independent panel demonstrates that steroid‐releasing implants that provide a sustained release of corticosteroid improve surgical outcomes by reducing frank polyp formation, sinus adhesions, and middle turbinate lateralization. Steroid‐releasing implants reduce the need for surgical intervention, and the need for oral steroid treatment. © 2012 ARS‐AAOA, LLC.