The ADVANCE II Study: A Prospective, Randomized, Multi‐center Study to Assess the Safety and Efficacy of a Bioabsorbable Steroid‐Eluting Sinus Implant

Abstract

Objective: The United Airways Disease hypothesis suggests a link between upper and lower airways in asthmatics. However, there is a need to know more about nose and sinus related quality of life, sinonasal symptoms, and objective nasal air flow in asthmatics compared with healthy individuals.Method: One hundred asthmatics and 96 nonasthmatic controls underwent a prospective controlled survey from June 2009 to December 2010. Symptoms, quality of life, and nasal airflow were assessed on Visual Analogue Scales (VAS, 0-100), Sino-Nasal-Outcome-Test (SNOT-20), and Peak Nasal Inspiratory Flow (PNIF), respectively.Results: Asthmatics (male/female 41/59; mean age, 44.1 years; range, 19-64 years) reported significantly more symptoms of nasal obstruction [mean VAS 38mm (SD 26) vs 9 mm (SD 12), P < .001] than controls (male/female 43/53; mean age, 41 years; range, 20-65 years). PNIF was significantly lower in asthmatics than controls [mean PNIF 85 l/min (SD 24) vs 102 l/min (SD 19), P < .001].Conclusion: This study provides further evidence of the clinical importance of the upper airway in the diagnostic and therapeutic management of asthmatic patients. Rhinology/Allergy

International Consensus Statement on Allergy and Rhinology: Rhinosinusitis

“…Topical corticosteroids can be useful in improving healing but are limited by patient compliance due to the requirement for multiple applications, and effectiveness may be impacted by postoperative edema, discharge, and crusting within the sinus cavity. 1307 In order to improve postoperative healing, a wide variety of techniques have been developed and include the use of packing, stents, and spacers. Nasal packing is principally designed for postoperative hemostasis and in animal models some packing materials demonstrate improved wound healing.…”

“…There was also no significant corticosteroid systemic absorption or ocular toxicity. 1307,1317,1318 A meta-analysis combined the results from the 2 RCTs to demonstrate statistically significant reductions in the need for postoperative intervention, oral corticosteroid usage, polyposis, and adhesions. 1319 An economic evaluation also demonstrated that Propel TM is cost-effective in decreasing postoperative intervention.…”

New innovations in office-based rhinology

“…Multiple studies have demonstrated the feasibility, efficacy, and safety of the steroid-eluting spring implant for intraoperative use in the ethmoid cavity [22][23][24]. With respect to in-office placement, Matheny et al [25 && ] presented a case series of 20 CRS patients who underwent sinus implantation 5-7 days after total ethmoidectomy, allowing postoperative hemostasis to occur prior to its insertion.…”

Medical Management of Frontal Sinusitis

“…This same technology has already been shown to hold significant benefit when used in postoperative ethmoid cavities-reducing adhesions, middle turbinate lateralization, and polypoid change. 29 Studies are currently under way to evaluate the application of this same technology in maintenance of frontal sinus ostial patency after frontal sinusotomy. If successful, this type of localized drug delivery could be a powerful adjuvant in the management of frontal sinusitis.…”