2018 Section 5 - Rhinology and Allergic Disorders

Lavigne et al.

a normal phenotype over a clinically meaningful period of time, hence alleviating symptoms. The safety profile of the in-office sinus implant placement appears to be favorable, especially when considering the al- ternatives for this patient population. Only 2 device-related adverse events occurred and both were related to subopti- mal placement of the implants. Minor adjustments to the treatment strategy, such as techniques for gauging the space available in the sinus, may eliminate the few placement dif- ficulties encountered. Based on our experience, we expect that most patients will tolerate placement of the implants with use of topical anesthetic spray and placement of pled- gets soaked in anesthetic, making the in-office procedure accessible to all otolaryngologists. Overall, the study pa- tients tolerated the procedure well, were not able to feel the implants in the sinuses after placement, and the majority were very satisfied with their symptom improvements. The majority of patients said they would recommend this to a family member or friend. The implant placement success rate was 87.5% and sup- ported high technical feasibility. Short-term results at day 7 appear to support that there was an immediate onset of action, which was sustained though 6 months. The statisti- cally significant reductions in both objective (bilateral polyp grade, percentage of ethmoid sinus obstruction) and subjec- tive outcome measures were observed at this first follow-up visit. Further improvements were observed at day 30 and the results were sustained through 6 months. Two patients were prescribed additional forms of steroid therapy during the follow-up period. Such medical interventions have the potential to confound interpretation of the study results. To address this concern, we analyzed efficacy outcomes both with and without inclusion of the data points after steroid prescription in these patients, and the results and conclusions remained the same. Future studies should em- ploy similar analysis methodologies to assess the sensitivity of conclusions to these types of interventions. Given that all patients enrolled in the study were con- sidered to be surgical revision candidates, the study re- sults are quite promising. Nearly 64% of patients were no longer considered to be surgical candidates by the end of the study, and only 1 patient underwent revision sinus surgery within the 6-month follow-up period. This rate compares favorably to revision rates for ESS reported in the litera- ture, which range from 9% to 13% within 9 months to 1 year. 18–20 The 6-month follow-up period is reasonable, given the low-risk, minimally invasive treatment approach. A recent multicenter, longitudinal cohort study concluded that improvements in quality of life (QOL) after ESS do not appear to change between 6 and 20 months, indicating that 6 months is an appropriate follow-up timeframe for clinical study designs incorporating QOL outcomes after ESS. 21 Our study used the SNOT-22 measure, which is a val- idated, disease-specific QOL instrument, and an accepted polyp grading scheme. 8 The observed reductions from base- line (2.19) in mean normalized SNOT-22 score between 1 and 6 months ranged from − 0.99 to − 1.32, surpassing

the threshold of − 0.8, which is accepted to be large and clinically meaningful. 10 The reductions from baseline in bilateral polyp grade between 1 and 6 months were also clinically significant and ranged from − 2.1 to − 2.5. These improvements appear to compare favorably to other treat- ment modalities, both medical and surgical, reported in the literature. Mometasone furoate nasal spray (Nasonex) is currently the only topical steroid spray approved by the FDA for treatment of nasal polyposis. Primary effi- cacy outcome measures in 2 randomized placebo controlled trials were reported at 1 month: change from baseline in bilateral polyp grade in both studies was − 0.96 with twice-daily dosing, and change from baseline in nasal con- gestion/obstruction was approximately − 0.6. 22,23 Hissaria et al. 14 reported on a randomized, double-blind, controlled trial in polyp patients comparing 2 weeks of oral pred- nisolone (50 mg 4 times daily) to placebo. Significant reduc- tions in polyp grade and patient-reported outcomes were observed at 2 weeks. No further follow-up was described and the authors commented that the efficacy of systemic steroids for this indication is variable, ranging from 1 to 6 months. Additionally, the SNOT-22 results were comparable with disease and symptom reductions reported in the surgical lit- erature. Browne et al. 24 reported on a national audit con- ducted in 2256 patients in the United Kingdom that was performed to compare outcomes of all surgical units and surgeons performing ESS to relieve symptoms associated with CRS and nasal polyposis. The mean total preoperative normalized SNOT-22 score was 1.91. At 3 and 12 month follow-up, reductions of − 1.16 and − 0.65 were observed, respectively. Kuhn et al. 25 assessed symptoms in 115 pa- tients using the SNOT instrument before and after tradi- tional ESS with concurrent balloon sinuplasty in patients with CRS. For the 84 patients with a complete dataset, the mean total preoperative SNOT score was 2.3 and the mean change from baseline in total score at 24 weeks was − 1.171. The main limitations of our study design were the small sample size, lack of randomization, and lack of a concur- rent control group. Therefore the potential contribution of placebo effect cannot be ruled out. Randomized, con- trolled, blinded clinical studies can address these limitations and provide further clinical evidence of the safety and effi- cacy of the in-office sinus implant strategy for patients with CRSwNP. Conclusion The study results suggest that in-office placement of steroid- eluting sinus implants in patients with CRSwNP has the ability to improve objective and subjective outcome mea- sures, which translated into elimination of the need for surgical revision in 64% of patients in a 6-month period. Although further studies are needed, the results suggest this therapy may provide a clinically effective and safe

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