2018 Section 5 - Rhinology and Allergic Disorders

Lavigne et al.

CRSwNP who have failed to respond to medical therapy, recurrence rates for patients with significant polyposis are higher than the general ESS population. Wynn and Har-El 3 reported that 70 of 118 (60%) patients who underwent ESS for significant polyposis developed recurrent polypo- sis, and 55 (47%) were indicated for another revision ESS. Only 32 (58%) of those indicated for revision ESS elected to undergo the procedure again, illustrating the conundrum facing patients with CRSwNP, and reinforcing the need for development of additional therapeutic options for this population. The safety and efficacy of localized, controlled steroid de- livery to the sinus mucosa from a bioabsorbable sinus im- plant have been demonstrated in the perioperative setting in 3 clinical studies and a meta-analysis. 4–7 The present study evaluated the technical feasibility of in-office insertion of a steroid-eluting sinus implant and its initial safety and effi- cacy. The sinus implant used in this study was designed to dilate sinuses reobstructed by polyps and provide localized, controlled steroid delivery for 3 months to reestablish si- nus patency. The study was conducted in CRSwNP patients who were candidates for revision surgery due to recurrent sinus polyposis and symptomatology that were refractory to medical therapy. A steroid-eluting sinus implant was supplied by Intersect ENT (Menlo Park, CA) for investigational use, and at the time of this manuscript was not for sale in the United States nor approved by the U.S. Food and Drug Administration (FDA). The implant has a self-expanding, non-obstructive design (Fig. 1) composed of a biodegradable polymer that allows it to adjust to fit in a previously-operated sinus cav- ity. This product is similar in concept to the previously studied mometasone furoate–eluting implant (PROPEL R steroid-eluting sinus implant; Intersect ENT), with some unique differences to allow for treatment of polyp patients. In order to dilate an obstructed sinus cavity, the implant has greater radial strength owing to its arched design. The arched design also aids in retention by maintaining strength and apposition in the cavity as polypoid tissue recedes. The rounded tip of the implant facilitates in-office insertion and placement in a polyp-filled cavity. The polymer matrix con- tains 1350 μ g of mometasone furoate and provides for gradual release of the drug over 3 months. The combina- tion of these attributes allows the implant to create and maintain an opening in the sinus both mechanically and medically. Study design A prospective, multicenter, nonrandomized study was con- ducted at 4 private otolaryngology clinics in the United States between November 2011 and May 2012. The study protocol and informed consent form were reviewed and Patients and methods Device description

IRB-approved for all study centers. All study patients pro- vided written informed consent prior to study entry. Table 1 provides the schedule of assessments. Adult patients were included if they were at least 18 years old, had been diagnosed with chronic sinusitis and had undergone prior bilateral ethmoidectomy more than 90 days earlier. Patients had endoscopically confirmed re- current ethmoid sinus obstruction due to polyposis or sig- nificant mucosal edema that was refractory to medical ther- apy. Polyposis was graded on a scale of 0 to 4. Patients were required to have at least grade 2 polyps on 1 side. Patients were required to be candidates for revision sinus surgery, defined as having a symptom burden consisting of 2 or more of the prominent symptoms of chronic sinusitis despite ongoing treatment with intranasal steroids, having received oral steroids within 6 months prior to enrollment, and having a known history of repeated oral steroid use for recurrent sinusitis. Patients were excluded if they had known history of in- tolerance to corticosteroids, an oral-steroid dependent con- dition (eg, chronic obstructive pulmonary disease [COPD]), history of immune deficiency, insulin dependent diabetes, clinical evidence of either acute bacterial sinusitis or in- vasive fungal sinusitis, or had previously undergone ESS and experienced a cerebrospinal fluid (CSF) leak or ocular complication in a prior ESS procedure. Leading up to the implant placement procedure, patients were required to have been continually using a topical steroid spray and were required to continue that regimen during the study follow-up period. Prior to enrollment, there was a 2-week restriction on the use of oral steroids or topical steroid irrigations. After implant placement, no oral steroids were allowed during the first 30 days unless med- ically necessary. Topical steroid irrigations were restricted for the first 90 days. Patients were permitted to continue stable regimens of orally-inhaled steroids and sinus-related medications (eg, Singulair [montelukast], leukotriene in- hibitors [eg, Zileuton], immunotherapy, etc.) throughout the 90-day follow-up interval. Use of antibiotics was al- lowed at any time if sinus infection was suspected. The study implants were placed in the office setting us- ing topical/local anesthesia consisting of spraying the nasal cavity with 4% lidocaine (or equivalent) and oxymetazo- line nasal decongestant, followed by middle meatal place- ment of cottonoids or pledgets soaked in 4% lidocaine and decongestant solution. Local injection of the sinus tissue and nasal septum was permitted as necessary to ensure pa- tient comfort. After the procedure, patients were encour- aged to use saline sprays or irrigations as needed during follow-up. Follow-up visits involved endoscopic examination and grading, monitoring for adverse events, and completion of the 22-item Sino-Nasal Outcomes Test (SNOT-22; see Table 1). During the follow-up period, the implants were left in place to gradually soften and reabsorb, and could be removed at the discretion of the physician. Implant rem- nants remaining by day 60 were removed.

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

233