Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions

An efficacy meta-analysis

Joseph K. Han, Bradley F. Marple, Timothy Smith, Andrew H. Murr, Brent J. Lanier, James W. Stambaugh, Andrew S. Mugglin

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)271-279
Number of pages9
JournalInternational Forum of Allergy and Rhinology
Volume2
Issue number4
DOIs
StatePublished - Jul 2012

Fingerprint

Meta-Analysis
Steroids
Drug Implants
Ethmoid Sinus
Turbinates
Polyps
Multicenter Studies
Adrenal Cortex Hormones
Randomized Controlled Trials
Inflammation
Therapeutics

Keywords

  • Adhesions
  • Bioabsorbable
  • Corticosteroid
  • Endoscopic sinus surgery
  • Implant
  • Inflammation
  • Intervention
  • Nasal polyps
  • Oral steroids
  • Polyposis
  • Steroid-releasing

ASJC Scopus subject areas

  • Immunology and Allergy
  • Otorhinolaryngology

Cite this

Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions : An efficacy meta-analysis. / Han, Joseph K.; Marple, Bradley F.; Smith, Timothy; Murr, Andrew H.; Lanier, Brent J.; Stambaugh, James W.; Mugglin, Andrew S.

In: International Forum of Allergy and Rhinology, Vol. 2, No. 4, 07.2012, p. 271-279.

Research output: Contribution to journalArticle

Han, Joseph K. ; Marple, Bradley F. ; Smith, Timothy ; Murr, Andrew H. ; Lanier, Brent J. ; Stambaugh, James W. ; Mugglin, Andrew S. / Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions : An efficacy meta-analysis. In: International Forum of Allergy and Rhinology. 2012 ; Vol. 2, No. 4. pp. 271-279.
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abstract = "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. {\circledC} 2012 ARS-AAOA, LLC.",
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