Ethmoidal drug-eluting stent therapy is not superior to nasal corticosteroid spray in the prevention of endoscopic sinus surgery: Results from a randomised, clinical trial.

OBJECTIVES: To evaluate whether an ethmoidal drug-eluting stent (DES) (the Relieva Stratus™ MicroFlow Spacer) could better prevent endoscopic sinus surgery (ESS) than standard non-invasive therapy using corticosteroid nasal spray in patients suffering from chronic rhinosinusitis (CRS). DESIGN: Prospective, randomised clinical trial. SETTING: Tertiary referral centre. PARTICIPANTS: Sixty-three adult patients with ethmoidal involvement in cone beam computerised tomography (CBCT) whose first-line medical treatment with topical corticosteroids had failed and who were candidates for ESS were randomised either to a DES group, which received triamcinolone acetonide stents (n = 34), or to a topical intranasal corticosteroid group (n = 29) that used optimally dosed triamcinolone acetonide nasal spray. OUTCOME MEASURES: Patients were followed up prospectively for 6 months and at 36 months. Freedom from ESS was the primary endpoint. Further, we identified those factors predicting ESS. RESULTS: At 6 months, ESS could be prevented in almost half of the patients in both groups (DES 13/28, 46.4%, nasal spray 14/29, 48.3%). At 36 months, 20/28 (71.4%) patients in the DES group and 18/29 (62.1%) in the nasal spray group had been operated. The differences were not statistically significant at either timepoint. Patients who smoked (14/19, 73.7% vs 16/38, 42.1%) were more likely to be operated at 6 months. CONCLUSION: Endoscopic sinus surgery can be prevented using both therapies in the medium term in almost half of cases with neither therapy being statistically superior. This effect was somewhat diminished in the long term with a trend towards more patients being operated in the DES group. Considering the additional costs, the need for general anaesthesia and the potential side effects associated with DES, its potential clinical role appears to be limited. Smoking was significantly associated with ESS.

A Modified Single-Stage Endoscopic Repair for Bilateral Choanal Atresia.

The work illustrates a step-by-step surgical approach to demonstrate technical feasibility of a single-stage endoscopic repair for bilateral choanal atresia with adjuvant bioabsorbable steroid-eluting stent placement to safely mitigate unique perioperative challenges in the pediatric population. Laryngoscope, 2024.

Safety and Feasibility of Steroid-Eluting Stent as a Bolster in Endoscopic Anterior Skull Base Reconstruction.

BACKGROUND: With a rising incidence of cerebrospinal fluid (CSF) leaks, endoscopic endonasal CSF leak repair is increasingly performed. Current approaches utilize a variety of materials including free mucosal grafts and vascularized flaps, but post-op leaks continue to be reported. Steroid-eluting bioabsorbable stents (SES) are used during functional endoscopic sinus surgery for chronic rhinosinusitis to reduce inflammation and scarring while maintaining patency of sinus ostia. OBJECTIVE: The aim of this study is to assess the feasibility of SES as a graft/flap bolster for endoscopic endonasal CSF leak repair. METHODS: This is a retrospective review of patients undergoing endoscopic endonasal CSF leak repair with SES placed as part of the bolster technique at a tertiary care center between January 2019 and May 2022. Age, sex, BMI, comorbid idiopathic intracranial hypertension, pathology, location of CSF leak, intraoperative CSF leak flow, reconstruction type, and presence of post-op CSF leak were recorded. RESULTS: Twelve patients (mean age 52, median BMI 30.9, 58% female) had SES placement as part of the bolster technique. The most common pathology was meningoencephalocele (75%). Reconstruction was performed with either a free mucosal graft (6), or a flap (6). No post-op CSF leaks occurred at a reconstruction site with a stent, and no known complications were reported. All sinusotomies were patent at the last follow-up visit. CONCLUSIONS: SES placement as an adjunct to graft and/or flap bolster appears to be safe and feasible during anterior skull base reconstruction and CSF leak repair providing longer term structural support and preserving sinus drainage patency.

Outcomes of Frontal Sinus Stenting With Steroid Impregnated Microsponge Versus Steroid-Eluting Implant.

BACKGROUND: Mometasone-eluting poly-L-lactide-coglycolide (MPLG) is available commercially for frontal sinus ostium (FSO) stenting. An alternative chitosan polymer-based drug delivery microsponge is also available at a lower cost per unit. OBJECTIVE: To compare the outcomes of MPLG stents versus triamcinolone-impregnated chitosan polymer (TICP) microsponge in frontal sinus surgery. METHODS: Patients who underwent endoscopic sinus surgery from December 2018 to February 2022 were reviewed to identify those with the intraoperative placement of TICP microsponge or MPLG stent in the FSO. FSO patency was evaluated by endoscopy at follow-up. Twenty-two-item sinonasal outcome test (SNOT-22) was also recorded, and complications were noted. RESULTS: A total of 68 subjects and 96 FSOs were treated. TICP was first used in August 2021 and MPLG in December 2018. MPLG placement in a Draf 3 cavity was excluded since TICP had not been used during Draf 3 procedure. Both cohorts (TICP 20 subjects, 35 FSOs; MPLG 26 subjects, 39 FSOs) had similar clinical characteristics. At a mean total follow-up of 249.2 days for TICP and 490.4 days for MPLG, FSO patency was 82.9% and 87.1%, respectively (P = .265). At an equivalent follow-up of 130.6 days in TICP and 154.0 days in MPLG, patency was 94.3% and 89.7%, respectively (P = .475). Both groups showed significant reductions in SNOT-22 (P < .001). MPLG demonstrated crusting within the FSO at 1 month (none in TICP). CONCLUSION: FSO patency for both stents was similar, although TICP had significantly lower costs per unit. Additional comparative trials may be helpful for guiding clinicians on the appropriate clinical situations for the use of these devices.

Non-invasive Fungal Sinusitis as a Complication of a Steroid-Eluting Stent Following Endoscopic Sinus Surgery: A Case Report.

OBJECTIVE: Steroid eluting stents have proven to be a highly useful adjunctive therapy for chronic rhinosinusitis (CRS) and play an important role in the treatment of many inflammatory diseases of the sinuses. Few reports of adverse events were reported in clinical trials and are described in the literature. However, we describe the first known case of an immunocompetent patient developing non-invasive fungal tissue infection as a sequelae of stent-related tissue necrosis requiring surgical debridement. METHODS: A 69-year-old immunocompetent male with CRS had Propel™ stents placed in the bilateral frontal sinus outflow tracts during revision endoscopic sinus surgery. He presented 2 weeks post-operatively with severe facial pain without vision changes, fevers, mental status changes, or evidence of cranial neuropathies. On rigid nasal endoscopy, necrotic tissue and gross fungal elements were visualized in the left frontal sinus outflow tract at the area of previous steroid stent position. RESULTS: The patient was taken for urgent endoscopic sinus surgery and debridement given significant symptoms and concern for invasive fungal infection. A revision left maxillectomy, ethmoidectomy, and draf 2b frontal sinus drillout were performed, with healthy bleeding tissue encountered beneath necrotic tissue. Pathology revealed tissue necrosis, exudative lumenal debris, and extensive fungal elements with no evidence of tissue invasion, and cultures yielded growth of aspergillus niger. The patient's symptoms improved significantly on post-operative day 1, he had normal post-operative changes at 2 weeks following debridement, and had no recurrence of fungal infection with complete healing at 4 months. CONCLUSION: While likely rare, steroid-eluting stents may pose a risk of saprophytic tissue infection as a result of tissue necrosis and local immunosuppression. Caution should be taken in using these devices in immunocompromised patients.

Efficacy of steroid-eluting stents in management of chronic rhinosinusitis after endoscopic sinus surgery: updated meta-analysis.

BACKGROUND: Recently, there has been mounting evidence suggesting the efficacy of steroid-eluting stents (SES) for management of chronic rhinosinusitis after endoscopic sinus surgery (ESS). This meta-analysis serves to evaluate the efficacy of SES in improving postoperative outcomes after ESS. METHODS: A systematic literature search was performed of PubMed for articles published between 1985 and 2018. The outcome variables were reported at, on average, 30 days postintervention. RESULTS: Seven of the 76 published studies, all of which were industry-sponsored, were included for a collective cohort of 444 SES and 444 control sinuses. In patients who received SES vs controls, collective odds ratios (ORs) for postoperative need for intervention, surgery, and oral steroid were 0.45 (95% confidence interval [CI], 0.33-0.62; p < 0.001), 0.30 (95% CI, 0.18-0.52; p < 0.001), and 0.58 (95% CI, 0.40-0.84; p = 0.004), respectively. In addition, collective ORs for frontal sinus ostia (FSO) patency, moderate-to-severe adhesion/scarring, and increase in polyp score were 2.53 (95% CI, 1.61-3.97; p < 0.001), 0.28 (95% CI, 0.13-0.59; p < 0.001), and 0.42 (95% CI, 0.25-0.74; p = 0.002), respectively. Collective mean differences for FSO/ethmoid inflammation and FSO diameter were -10.86 mm (p < 0.001) and +1.34 mm (p < 0.001), respectively. CONCLUSION: Aggregate evidence suggests that SES can improve ESS outcomes by reducing rates of postoperative intervention and recurrent polyposis and inflammation, while promoting FSO patency. All included and analyzed studies were industry-sponsored and ruling-out publication bias was not possible. Future independent and nonsponsored studies to further evaluate SES's long-term efficacy are warranted.