Is a steroid-releasing implant placed in the frontal sinus opening (FSO) following endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS) safe and effective?
Placement of steroid-releasing sinus implants in the FSO significantly reduces the need for postoperative interventions in patients with CRS who are undergoing frontal sinus surgery and optimizes wound healing by reducing the potential for inflammation and scarring.
Background: CRS is characterized by chronic inflammation of the mucosal lining of the nasal cavity and paranasal sinuses. Endoscopic sinus surgery (ESS) is largely successful in treating CRS. However, frontal sinusotomy has been shown to have a lower success rate depending on the preoperative conditions, extent of frontal sinusotomy, and postoperative medical management of the frontal recess. A steroid-releasing implant (PROPEL Mini Sinus Implants, Intersect ENT, Menlo Park, Calif.) currently approved by the U.S. FDA has been shown to significantly reduce the need for postoperative interventions in the ethmoid sinuses through physical scaffolding of the middle turbinate and localized, controlled delivery of corticosteroid (370 μg of mometasone furoate).
Study design: Prospective, multicenter, randomized, blinded trial using an intrapatient control design.
Method: The study included 80 (≥18 years) patients with CRS who underwent successful bilateral frontal sinusotomy were randomized to receive a steroid-releasing implant in one FSO, whereas the contralateral control side received no implant. All patients received standard postoperative care. Endoscopic evaluations recorded at 30-days after undergoing endoscopic sinus surgery (ESS) were graded real time by clinical investigators and by an independent, blinded sinus surgeon to assess the need for postoperative interventions in the FSO.
Synopsis: Implants were successfully placed in all 80 frontal sinuses, resulting in 100% implant delivery success. At 30-days post-ESS, steroid-releasing implants provided a statistically significant (P=0.0070) reduction in the need for postoperative interventions compared to surgery alone by an independent reviewer, representing 38% relative reduction. Clinical investigators reported statistically significant reduction in this measure at 30 days (P<0.0001) and 90 days (P=0.0129). Clinical investigators also reported a 55.6% reduction in the need for oral steroid interventions (P = 0.0015), 75% reduction in the need for surgical interventions (P=0.0225), 16.7% reduction in inflammation score, 54.3% reduction in restenosis rate (P=0.0002), and 32.2% greater diameter of FSO (P<0.0001) on treated sides compared to control at 30 days. No implant-related adverse events were reported.
Intersect ENT (Menlo Park, Calif.) provided funding for the investigation, as well as administrative and logistical support in coordinating the study across the study sites. Authors JKH, TLS, and RAO were were consultants for Intersect ENT during the conduction of this study, and authors JS and AR are employees of Intersect ENT.
Citation: Smith TL, Singh A, Luong A, et al. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016;126:2659–2664.