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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International consensus statement on rhinosinusitis

need the implant more or less frequently. 292 Also, both RCTs removed implants at 60 days despite their ability to elute steroids up to 90 days and both RCTs required the treatment and control groups to continue intranasal mometasone once per day. 292,1605–1607 It is unclear how the implant would perform without the additional benefit of intranasal steroid. Clinical experience with this device is still relatively limited and the evidence, though at a high level, is restricted to short-term outcomes. Steroid Eluting Implants for CRSwNP Aggregate Grade of Evidence: A (Level 1: 1 study; level 2: 3 studies; Table X-20). Benefit: Reduction in ethmoid sinus obstruction and polyp grade leading to decreased need for revi sion ESS and reduced nasal obstruction patient scores. Harm: No prior findings of increased risk of ele vated intraocular pressure or cataracts. Cost: Cost of implant and risk of nasal discomfort and/or epistaxis. Benefits-Harm Assessment: Benefit outweighs harm. Value Judgments: Corticosteroid eluting implants have been shown to have beneficial impact on eth moid polyposis and obstruction, and 1 study has shown them to be cost-effective in preventing revi sion ESS. Experience is early and although evi dence is high level, only short-term outcomes are

Atomization/nebulization: Recommendation. Direct injection: No recommendation due to insuf ficient evidence. Intervention: Following sinus surgery, those patients with CRSwNP that have moderate-severe disease or are not controlled with simple INCS should be offered corticosteroid irrigation and/or atomized delivery.

X.D.3 Management of CRSwNP: Steroid-Eluting Implants (Nonsurgical)

Biodegradeable corticosteroid eluting-implants provide targeted sustained release of medication into the sinus cav ity to reduce nasal polyposis (NP) and obstruction. 1605–1608 Currently, the only steroid-eluting implant approved by the US FDA to treat adult patients with NP is the Sin uva implant (Intersect ENT, Palo Alto, CA). The implant contains 1350 μ g of mometasone furoate and is typically inserted in the clinic setting under local anesthesia. It is designed for NP patients who have previously undergone ESS of the ethmoid sinuses. The self-expanding implant softens over time and provides up to 90 days of steroid treat ment. A non-US FDA approved steroid eluting implant designed for placement in an unoperated ethmoid cavity has also been reported. 1609,1610 The Sinuva implant has been investigated in 2 RCTs and a pooled analysis (n = 375), which showed signif icant improvement in endoscopic polyp grade, ethmoid sinus obstruction, and patient-reported symptoms relative to controls at 90 days. 1607,1608,1611 The RCTs utilized bilat eral sham procedures as interpatient controls, with both implant and control groups receiving intranasal steroid sprays. At 90 days, 59% of treated patients vs 31% of con trols were no longer indicated for revision ESS, although this decreased to 31% of treated patients and 11% of controls at 6 months. 1608,1612 In terms of adverse events, there was no significant increase in intra ocular pressure or cataracts but 1 episode of epistaxis was reported in the larger Phase 3 trial. 1606,1607 An economic evaluation estimated cost saving of USD$0.21 per-member per-month or a total of USD$2.56 million per year for a commercial health plan with 1 mil lion members. 292 The evaluation assumed that 50% of eli gible patients would undergo implant placement instead of revision ESS and would require 2 implant placements during a 1 year period. 292 Limitations of the current data include the relatively short term 90 day follow up of the larger Phase 3 study vs the 6 months available for the prior RCT. 1606,1607 It is not known whether some patients may

currently available. Policy Level: Option.

Intervention: Corticosteroid-eluting implants can be considered as an option in a previously operated ethmoid cavity with recurrent nasal polyposis.

X.D.4 Management of CRSwNP: Oral Corticosteroids Since the publication of ICAR-RS-2016, there have been 2 Cochrane Reviews analyzing the data on oral corticos teroid use in the management of CRSwNP. Both reviews were from the same group in the United Kingdom and very thoroughly summarize the existing data. The first review evaluated the data on short courses of oral corticosteroids alone for CRS. 1613 The authors iden tified 7 studies, all of which were randomized controlled trials. Two studies were unblinded while the remaining 5 blinded both the patients and the health care providers to the treatment group. All patients were adults with the