Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis

Int Forum Allergy Rhinol. Jul-Aug 2012;2(4):271-9. doi: 10.1002/alr.21044. Epub 2012 May 1.

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.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage*
  • Chronic Disease
  • Drug Implants / therapeutic use*
  • Endoscopy
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Nasal Polyps / drug therapy
  • Nasal Polyps / prevention & control
  • Nasal Surgical Procedures
  • Paranasal Sinuses / drug effects
  • Paranasal Sinuses / surgery*
  • Postoperative Complications / prevention & control*
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Rhinitis / drug therapy*
  • Rhinitis / surgery*
  • Sinusitis / drug therapy
  • Sinusitis / surgery*
  • Treatment Outcome

Substances

  • Adrenal Cortex Hormones
  • Drug Implants