2018 Section 5 - Rhinology and Allergic Disorders

Lavigne et al.

FIGURE 4. Mean bilateral polyp grade at baseline before implant and through 6 months following placement. Error bars are 95% confidence in- tervals. All changes from baseline are statistically significant.

due to recurrent rhinorrhea and asthma symptoms despite widely patent sinuses. In both patients, the SNOT-22 scores and bilateral polyp grades actually increased (worsened) slightly after these steroids were commenced. In order to analyze the sensitivity of the study conclusions to these 2 interventions, efficacy outcomes were analyzed both with and without inclusion of these patients’ post-steroid data points. All changes from baseline in bilateral polyp grades, percentage of ethmoid sinus obstruction, and SNOT-22 scores remained statistically significant using both analy- sis methods. In the results presented below, efficacy data at time points after steroid prescription were excluded for these 2 patients. Efficacy Mean bilateral polyp grade at baseline was 4.50 ± 1.65 (Fig. 4). Within the first week, the mean bilateral polyp grade had been reduced to 2.80, representing a change from baseline of − 1.70 ( p = 0.0039). At days 30, 60, 90, and 6 months the mean bilateral polyp grades were 2.30, 2.10, 2.00, and 2.33, representing changes from baseline in mean bilateral polyp grade of − 2.20, − 2.40, − 2.50, and − 2.10 at these time points, respectively. All changes from base- line were statistically significant ( p 0.0078). The mean percentage of ethmoid sinus obstruction at baseline was 66.37% ± 29.41% and was reduced to 27.84% ± 32.81% at 6 months ( p < 0.0007; Fig. 5). The average SNOT-22 score changed from 2.19 ± 1.03 at baseline to 1.48 ± 0.67 by day 7 (Fig. 6), represent- ing a reduction of − 0.71 ( p = 0.0273). At days 30, 60, 90, and month 6 the average score was 0.90, 0.83, 0.74, and 1.03, respectively, representing changes from baseline of − 1.28, − 1.23, − 1.32, and − 0.99 at these time points. All changes from baseline were statistically ( p 0.0117) and clinically significant. 10 The nasal blockage score was significantly ( p 0.0076) reduced from 3.45 at baseline to 1.82, 1.64, 1.20, 1.00, and 1.89, representing changes

FIGURE 3. Disposition of study patients.

then described the sensation of pain/pressure after the im- plant placement procedure as none or minimal. Ten of 11 patients (90.9%) were either satisfied or very satisfied with the convenience of the office implant procedure in compar- ison to having another sinus surgery, and 10 of 11 patients (90.9%) described the recovery process as satisfactory or very satisfactory. Ten of 11 patients (90.9%) were satisfied or very satisfied with their overall experience with the pro- cedure. When asked how the procedure compares to other in-office medical procedures (eg, dental), 6 of 11 patients (54.5%) said it was about the same. Nine of 11 patients (81.8%) said they would have the procedure again and 8 of 11 (72.7%) said they would recommend it to a family member or friend. Safety No serious adverse events were reported during the study. Two device-related adverse events (nasal irritation on 1 side and ocular irritation with dryness and tearing on 1 side) were reported by the patient in whom the implants had been placed incorrectly. Both events resolved without sequelae after in-office removal of the implants. The protocol required that all patients continue the use of their topical steroid spray during the follow-up period through at least the day 90 time point. Two patients were prescribed additional higher-dose forms of steroids during the study follow-up period. The patient that had received the study implant on only 1 side had persistent polyposis and mucosal edema on the untreated side at day 21 and re- ceived a course of oral prednisone for 1 week. Another pa- tient received the study implants bilaterally and responded well to the treatment. The patient was prescribed budes- onide irrigations twice daily at approximately 4 months

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

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