Comparison of Bioabsorbable Steroid-Eluting Sinus Stents Versus Nasopore After Endoscopic Sinus Surgery: A Multicenter, Randomized, Controlled, Single-Blinded Clinical Trial

Abstract

Objectives: The aim of this study was to compare the efficacy of bioabsorbable steroid-eluting sinus stents versus absorbable Nasopore packs after endoscopic sinus surgery (ESS) for the treatment of chronic rhinosinusitis (CRS). Methods: One hundred eighty-one patients with CRS who underwent ESS were randomly assigned to receive a steroid-eluting sinus stent in one ethmoid sinus cavity, whereas the contralateral control side received a Nasopore pack. Endoscopic evaluations were performed 14, 30, and 90 days after the ESS. Postoperative intervention, polyp formation, adhesions, and middle turbinate (MT) position were assessed as efficacy outcomes. Results: The stents were successfully deployed in all 181 sinuses. Thirty days after the ESS, the stents significantly reduced the need for surgical intervention compared to the Nasopore ( P < .0001). The percentage of cases with polyp formation was significantly lower on the stent sides compared with the Nasopore sides ( P < .0001) at 14, 30, and 90 days after ESS. The percentage of severe adhesion was significantly lower on the stents sides than on the Nasopore sides at postoperative day 90 ( P = .0003), whereas they were not significantly lower at postoperative days 14 and 30. There were no significant differences between the stent sides and the Nasopore sides regarding the frequency of MT lateralization at all end points. No device-related adverse events occurred. Conclusions: Our study demonstrated significant improvement in the early postoperative outcomes by reducing the need for postoperative surgical intervention and polyp formation using steroid-eluting stents when compared with absorbable Nasopore packs. The steroid-eluting sinus stents and the Nasopore packs were each effective in preserving the ethmoid sinus patency and in preventing MT lateralization. A further prospective cohort study with long-term postoperative outcomes is warranted.

Efficacy of Steroid-Impregnated Spacers After Endoscopic Sinus Surgery in Chronic Rhinosinusitis: A Systematic Review and Meta-Analysis

“…The definitions of terms were taken from a previous study [26]: "mucosal edema" refers to edema in areas where the bony contour is difficult to distinguish, "polypoid change" to outpouching filling the ethmoid cavity, and "polyposis" to polyp formation and growth beyond the middle meatus. The outcomes were compared between the treatment and control groups [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23].…”

“…This can slow recovery, potentially leading to the need for revision surgery [5,6]. To overcome this problem, steroid-impregnated spacers have been devised to reduce local inflammation around the surgical area and prevent stenosis during postoperative recovery [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23]. In this study, we reviewed the steroid-impregnated spacers reported to date and evaluated their effects on treatment outcomes using validated scales.…”

Perspectives in Therapy of Chronic Rhinosinusitis

“…This technique used in type 2 inflammatory CRSwNP significantly reduces the recurrence of NPs postoperatively [ 90 ]. Steroid-eluting sinus implants have been shown in clinical trials to improve postoperative outcomes after ESS [ 91 , 92 , 93 , 94 , 95 , 96 ]. Preoperative administration of OCS improves the perioperative visibility by reducing blood loss and shortens the operation time [ 71 ].…”

Sinonasal Stent Coated with Slow-Release Varnish of Chlorhexidine Has Sustained Protection against Bacterial Biofilm Growth in the Sinonasal Cavity: An In Vitro Study

“…SNS is used for the prevention of lateralization of the middle concha and to liberate steroids preventing the recurrence of nasal polyp [25]. Currently, no commercially available stents can reduce biofilms in the nasal cavity.…”