2018 Section 5 - Rhinology and Allergic Disorders

Steroid-eluting implant for recurrent NP

TABLE 2. Baseline demographics and clinical characteristics*

the number of patients requiring some high-dose form of steroid therapy during the follow-up period.

Age, years, mean (minimum, maximum)

42.2 (21, 61)

Data analysis All data were entered into a validated database. Descriptive statistics and graphical summaries were used to summarize the data. For categorical variables, counts, percentages, and exact 95% confidence intervals using Clopper-Pearson’s method were calculated. For continuous variables, means, standard deviations (SDs), and 95% confidence intervals for the mean assuming a normal distribution were calcu- lated. The Wilcoxon signed-rank p values for changes from baseline are presented, unless otherwise specified. Values of p < 0.05 were considered statistically significant. Results All 12 patients were enrolled at 4 investigational centers in November 2011. The mean age was 42.2 years and 58% of patients were male (Table 2). All patients complained of nasal obstruction. Other most commonly reported symp- toms were postnasal drainage, anosmia, hyposmia, discol- ored nasal drainage, and facial pain/pressure. The average time since the most recent sinus surgery was 13.9 months and 7 patients had undergone more than 1 prior surgery. Endoscopic examinations revealed sinus obstruction due to polyps, lateralized middle turbinate, adhesions/synechiae, and combinations thereof. As a result of these various forms of obstruction, the mean ± SD percentage of ethmoid si- nus obstruction was 69.4% ± 28.6%. All 12 patients were judged to have met the criteria for revision sinus surgery. Placement and performance The sinus implant was successfully placed at the target lo- cation in 21 of 24 sinuses (87.5%). One patient had uni- lateral implant placement because the contralateral sinus could not be implanted due to septal deviation and signif- icant mucosal edema that precluded insertion. In another patient, the implants were placed incorrectly, anterior to the middle turbinates rather than in the ethmoid sinuses. They were removed at 14 and 21 days, respectively, due to nasal discomfort. For these reasons, this patient was followed through the final 6-month time point and was in- cluded in the safety analyses, but was excluded from the efficacy analyses. Thus there were 11 patients (21 sinuses) evaluable for efficacy outcomes, and all patients completed follow-up through 6 months (Fig. 3). Clinicians provided a visual estimate by endoscopy of the percentage of implant remaining at each time point, which is a reflection of both bioabsorption and removal of the implant. The mean percentage remaining at days 30, 45, and 60 was 95.5%, 90.0%, and 53.8%, respectively. One implant was expelled uneventfully during irrigation just before the day 45 visit, 4 implants were removed by the clinician at day 45, 3 implants were expelled unevent- fully between the day 45 and day 60 visits, and 1 implant

Males, n (%)

7 (58)

Medical history, n (%)

Aspirin intolerance/allergy

2 (17)

Asthma

7 (58)

Samter’s triad

2 (17)

Most common symptoms, n (%) Nasal obstruction/congestion

12 (100)

Postnasal drainage

10 (83)

Anosmia

9 (75)

Hyposmia

8 (67)

Discolored nasal drainage

7 (58)

Facial pain/pressure

5 (42)

Endoscopic characteristics, n (%) a Middle turbinate lateralized

4 (17)

Adhesions/scarring None

16 (67)

Grade 1 or 2

4 (17)

Grade 3 or 4

4 (17)

Polyposis

Grade 0

1 (4)

Grade 1

5 (21)

Grade 2

12 (50)

Grade 3

4 (17)

Grade 4

2 (8)

Ethmoid sinus obstruction,%, mean (SD)

69.4 (28.6)

Prior ESS Months since last ESS, mean (minimum, maximum)

13.9 (3,38)

Number of prior ESSs, n (%) 1

5 (42)

2

3 (25)

3

3 (25)

> 4

1 (8)

* n = 12. a Presented on a by-sinus count. ESS = functional endoscopic sinus surgery; SD = standard deviation. was removed at approximately 10 weeks. Twelve of the 23 implants were removed at day 60, per the study protocol. The majority of patients (8/11; 72.7%) described the sen- sation of pain/pressure during the implant placement pro- cedure as mild or moderate. Nine of 11 patients (81.8%)

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