xRead - Nasal Obstruction (September 2024) Full Articles

20426984, 2021, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/alr.22741 by Stanford University, Wiley Online Library on [01/07/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

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(Chitogel R ) showed a significant improvement in ostial size when compared to Chitogel R and to no packing. 2189 In a retrospective cohort study, Xu et al. showed that Merogel R soaked in triamcinolone had no significant dif ference in adhesion formation than Merocel R in a finger cot. 2163 In an “off-label” use, non-biodegradable spacers such as the Relieva Stratus Microflow Spacer™ (Acclarent, Irvine, CA) have been used as a drug eluting stent by filling the spacer with triamcinolone. 2238,2239 However, these can be difficult to remove with a case report of retained spac ers leading to inflammation and infection 7 months after initial insertion. 2240,2241 There has also been a case report of orbital violation leading to pain and a permanently dilated pupil. 2242 One downside to the”off-label” addition of drug to materials is the unpredictable and unknown local release dynamics of the drug as well as the potential for systemic absorbtion. Biodegradable drug eluting stents offer the benefit of having both a mechanical spacer combined with precise sustained release of medication into the sinus cavity over a known period of time. 2243 Unlike non-biodegradable stents, they may not require potentially painful postop erative removal. Currently, the only drug eluting postop erative stent approved by the US FDA is the Propel™ corticosteroid-releasing implant (Intersect ENT, Palo Alto California, USA). It consists of a self-expanding, bioab sorbable, drug eluting stent with the active ingredient of 370 μ g mometasone furoate embedded in a polymer matrix composed of polylactide-co-glycolide that degrades over 30 days. Once inserted, its spring-like action helps maintain the patency of the middle meatus allowing continued sinus irrigation. In animal studies, this stent showed minimal mucosal inflammatory reaction. 2244 The Propel™ stent has been investigated in 1 cohort study and 2 RCTs, which have demonstrated its efficacy and safety. All 3 studies found similar outcomes with improvements in symptom scores and endoscopic findings (decreased polyposis and adhesions) as well need for post operative intervention when compared to the stent with out corticosteroids. There was also no significant corticos teroid systemic absorption or ocular toxicity. 1612,2237,2245 A meta-analysis combined the results from the 2 RCTs to demonstrate statistically significant reductions in the need for postoperative intervention, oral corticosteroid usage, polyposis and adhesions. 1611 An economic evaluation also demonstrated that Propel™ is cost-effective via a decrease in the need for postoperative interventions. 281 Other drug eluting stents have been developed but as yet remain unap proved by the US FDA. Adriaensen et al. looked at the safety and efficacy of a bioabsorbable fluticasone eluting stent (Sinuband FP, BioInspire Technologies, Palo Alto, California) and showed it to be safe with some improve

ment in post-operative edema and wound healing when compared to Merocel. Concerns raised regarding the data to date have included the lack of a non-stented arm in these studies, which might show that the stenting material without the corticos teroid is pro-inflammatory. Previous work in biomaterials in the sinuses has shown the potential for some materials to induce inflammation. 2246,2247 The lack of a non-stented arm was identified in a recent Cochrane review of steroid eluting sinus stents 2248 in which the authors stated that no conclusion was possible on whether steroid-eluting stents had any potential advantages and disadvantages because the 2 RCTs and the meta-analysis based on these 2 studies used within patient comparisons. A recent RCT by Rawl et al. compared Merocel in a finger cot to Propel and found that the Merocel in the finger cot had less adhesions and a better SNOT 22 on day 20. The QoL differences disappeared after that time point. Corticosteroid eluting materials appear to have promise in the postoperative period. 2249 Additional indications and devices are on the horizon. 1605 Drug Eluting Stents in Sinus Surgery Aggregate Grade of Evidence: A (Level 1: 3 studies; level 2: 6 studies; level 3: 1 study; level 4: 4 studies; Table XII-24). Benefit: Reduction in polyposis and adhesions for mation, which translates to a reduction in postop erative interventions. Harm: Potential for misplacement and local reac tion. Cost: Variable depending on stents and medica tion. The Propel™ system is estimated at USD$700 per implant. Benefits-Harm Assessment: Preponderance of benefit over harm. Value Judgments: Corticosteroid-eluting stents have been demonstrated to have beneficial impact on postoperative healing although 1 study showed that Merocel in a finger cot had superior healing with less middle meatal adhesions. One study has shown steroid eluting stents to be cost-effective in preventing additional postoperative interventions. Specific usage should be at the clinician’s discre tion taking into consideration various important patient-specific factors. Policy Level: While the authors recognize the high cost of these implants, given the level of evi dence, absorbable steroid-eluting implants are rec ommended in carefully selected patients that are