2018 Section 5 - Rhinology and Allergic Disorders

RESOLVE 6-month outcomes

endoscopy or imaging, and outcomes of medical manage- ment. All patients in the study were required to have had prior sinus surgery followed by continued medical therapy, history of repeat courses of systemic steroid therapy, with 1 of those courses being within 6 months, continued use of topical intranasal steroid spray, and presentation with bilateral polyposis and hallmark CRS symptoms. Patients were required to use topical steroid sprays dur- ing the screening phase leading up to the baseline proce- dure. At the baseline procedure, which occurred in the office setting, patients were masked to treatment assign- ment by being both blindfolded and “earmuffed,” using eye masks and noise-cancelling audio headphones, respec- tively. All patients were then anesthetized locally using a standardized protocol consisting of spraying the nasal cav- ity with 4% lidocaine (or equivalent) and oxymetazoline nasal decongestant, followed by middle meatal placement of cottonoids or pledgets soaked in 4% lidocaine and de- congestant solution. Local injection into the sinus tissue and nasal septum was permitted per physician discretion. Patients were randomized in 1:1 ratio to either the treat- ment or control group. The treatment group had the study implants inserted and deployed bilaterally in the ethmoid sinuses using the supplied delivery system. Patients in the control group underwent a sham procedure, which con- sisted of insertion of the implants into the ethmoid sinus and then removal without deployment. After the procedure and throughout the study follow- up period, all patients were required to take mometasone furoate nasal spray (Nasonex R ; 100 µ g/nostril once daily) and were encouraged to use saline sprays or irrigations, as needed. The use of Nasonex was required to ensure that the control patients continued to receive an FDA-approved topical steroid therapy for their sinonasal polyposis and the treatment patients remained blinded to treatment as- signment (patients could not guess their treatment assign- ment based upon use and taste of the nasal steroid spray). Topical steroid irrigations were not allowed for the first 90 days, but patients were permitted to continue stable reg- imens of orally-inhaled steroids and sinus-related medical therapy such as immunotherapy or leukotriene antagonists throughout the 90-day follow-up interval. Use of antibiotics was allowed at any time if sinus infection was suspected. Follow-up visits to 6 months involved endoscopic ex- amination and grading, monitoring for adverse events and patient-scoring of nasal obstruction/congestion, the hall- mark symptom of sinonasal polyposis. To maintain patient blinding throughout all study visits, the symptom question- naires were administered by a member of the research staff who was unaware of the patient’s treatment assignment, and patients were again blindfolded and earmuffed during the endoscopic examinations. A panel of 3 sinus surgeons was established to grade the baseline and 3-month video-endoscopies in order to in- dependently corroborate the findings reported by clinical investigators. The panel was kept blinded to origin of the videos, all clinical information, and treatment assignment.

FIGURE 2. Endoscopic images of ethmoid sinus from 2 study patients from the treatment group (left) and control group (right) before and through 6 months after placement of a steroid-eluting implant or sham procedure, respectively.

In order to ensure that panel members were blinded to treatment assignment, clinical investigators were required to remove the implants at day 60. The video-endoscopies obtained at baseline and day 90 were edited to remove pa- tient identifying information. The files for each patient were presented in chronological order (ie, baseline followed by day 90), but patients were randomly ordered and provided to the panel for grading. The panel graded polyposis and percent ethmoid sinus obstruction using standardized case report forms, and the same scales as those used by clinical investigators. Because there were 3 panel members, average scores were computed for each patient and time point. Endoscopic assessments Objective outcomes were determined by endoscopic exam- ination. The evaluations were instantaneous on the day of each study visit, meaning study investigators were not permitted to review grading from prior visits, and all endo- scopic examinations were recorded (Fig. 2). Prior to partic- ipation, study investigators attended a training session on

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