This consecutive case series provides clinical evidence of the safety, effectiveness, and clinical utility of a bioabsorbable steroid-eluting implant for use in CRS patients. The implant was associated with favorable rates of sinus patency. At 1 month, minimal degrees of inflammation and adhesions were observed, suggesting a positive clinical impact of local steroid delivery without evidence of ocular risk.
The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP after ESS. These longer-term 6-month study results demonstrate that the steroid-eluting implant represents a durable, safe, and effective treatment strategy for this patient population.
The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.
Background A mometasone furoate (MF) sinus implant (1350 mcg) was evaluated in 2 randomized controlled trials (RCTs) in 400 adults with nasal polyps (NP) who were candidates for revision endoscopic sinus surgery (RESS). We conducted a pooled analysis to evaluate the efficacy of MF implant in specific subgroups of NP patients. Methods Pooled data from 2 RCTs for 375 patients were analyzed across prespecified subjective and objective end points through day 90. Results At day 90, patients receiving implants and MF nasal spray (MFNS) experienced significant improvements in nasal obstruction/congestion (NO/C) score ( P = .0095), bilateral polyp grade (BPG, P = .0008), and ethmoid sinus obstruction ( P < .0001) compared to control using MFNS alone. Fewer treatment than control patients remained candidates for RESS (41.0% vs 69.3%, P < .0001). All subgroups experienced significant treatment effects, except NO/C in smokers ( P = .0509) and patients without altered smell ( P = .1873). Subgroups without asthma and with only 1 prior ESS experienced largest treatment effect on NO/C, and those with recent surgery <24 months and BPG >5 showed largest effect on endoscopic end points and RESS. Control patients with ESS <24 months were at 7 times highest risk for RESS ( P < .0001). One (0.4%) patient experienced implant-related serious adverse event (epistaxis). Conclusion On pooled analysis, MF implants with MFNS showed more favorable results than MFNS alone across several subjective and objective end points at day 90 and may play an important role in management of NP patients, especially those who have allergic rhinitis, expanded polyposis, altered smell, or had most recent ESS < 24 months.
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