2018 Section 5 - Rhinology and Allergic Disorders

Steroid-eluting implant for recurrent NP

Current treatment options for CRSwNP include topical steroid sprays, off-label use of topical steroid irrigations or drops, steroid injection into polyps, systemic steroids, and ESS to remove polyps and diseased mucosa. Regard- less of the treatment, polyps have a strong tendency to re- occur, and therefore repeated courses of these medications and repeat ESS is often needed. Each of these treatment options and their repeated use present various concerns for patients and their managing otolaryngologists. Topi- cal steroid sprays lack systemic side effects, but they do not sufficiently reach the middle meatus from which polyps originate 11 and they have not been rigorously studied in postsurgical patients with recurrent polyposis. Use of top- ical steroid drops for 12 weeks in surgical candidates has been shown to reduce the need for sinus surgery compared to placebo, but more than one-half of treated patients still required surgery, and application of the steroid drops re- quired awkward head-hanging positions to be performed daily by patients. 12 Short courses of systemic steroid treat- ment have resulted in subjective and objective improve- ments with reduction in polyposis, but the effect is short- lived and recurrence is seen within 1 to 5 months. 13,14 Oral corticosteroids, especially with repeated use, pose sys- temic risks including aseptic necrosis of the femoral head, calcium demineralization, osteoporosis, posterior cataract formation, mood changes, and increases in blood glucose levels. 15,16 Vaidyanathan et al. 17 studied oral steroids for 2 weeks followed by steroid drops for 2 months and then topical sprays for 4 months, as compared to placebo fol- lowed by steroid drops and then topical sprays. Although overall improvements were observed in the treatment group in both subjective and objective measures, the results were not statistically significantly different between groups after the first 10 weeks. Poor patient compliance can also com- promise the effectiveness of any of these steroid regimens. This study was designed to evaluate the technical fea- sibility, safety, and efficacy of office-based insertion of a drug-eluting sinus implant in this patient population. It confirmed the tolerance of the implants in the sinus cav- ity, because they were not felt by patients once implanted. The implants are designed to provide long-term local steroidal therapy deep within the middle meatal/ethmoid sinus anatomy. We hypothesized that the design of the im- plant would physically dilate sinuses obstructed by polyps and mucosal edema, allowing for aeration and drainage, and would then maintain a physical opening in the sinus both medically and mechanically. The mechanical dilative pressure exerted by the implant compresses polyps, often breaking the membranous surface stroma, which may allow penetration of the steroid. The selection and engineering of the bioabsorbable polymers used to fabricate the implant provide a radial, dilating force that compresses polypoid tissue and medializes the middle turbinate, which are func- tions that allow the implant to be retained in the sinus anatomy to serve as a drug delivery platform. The long- term controlled delivery of the corticosteroid is intended to reduce polyposis and help to restore the sinus cavity to

FIGURE 5. Mean percent ethmoid sinus obstruction at baseline before im- plant and through 6 months after placement. Error bars are 95% confidence intervals. All changes from baseline are statistically significant.

FIGURE 6. Mean total SNOT-22 scores at baseline before implant and through 6 months after placement. Error bars are 95% confidence intervals. All changes from baseline are statistically significant. SNOT-22 = 22-item Sino-Nasal Outcomes Test.

from baseline of − 1.64, − 1.82, − 2.10, − 2.30, and − 1.33 at days 7, 30, 60, 90, and month 6, respectively. At month 6, bilateral polyp burden was reduced in 10 of the 11 (90.9%) evaluable patients, and 7 of the 11 patients (63.6%) were no longer considered to be candidates for revision sinus surgery based on the surgeon’s endoscopic evaluation and symptomatic improvement. One patient elected to have revision sinus surgery during the 6-month follow-up. Discussion The results of the study demonstrated procedural technical success, patient tolerability, and initial significant clinical outcomes, suggesting that the drug-eluting sinus implant may provide an in-office treatment option for CRSwNP patients indicated for repeat surgery.

International Forum of Allergy & Rhinology, Vol. 4, No. 4, May 2014

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