Evaluation of a steroid releasing sinus implant for the treatment of patients undergoing frontal sinus surgery for chronic rhinosinusitis

ABSTRACT

Introduction: Management of the frontal sinus places great demands on the otolaryngologist. Given that the fronto-ethmoidal region is susceptible to recurrent inflammation, scarring, and stenosis, maintaining long-term patency of the frontal sinus is a difficult challenge. Oral and topical anti-inflammatory therapy, post-operative stenting, and ‘home-brew’ drug elution have been used for the treatment of the frontal sinus with mixed success. Recently an implant has been approved for post-operative placement into the frontal recess. This implant provides reliable and consistent steroid drug elution to address inflammation of the frontal recess secondary to chronic sinusitis.

Areas covered: This review discusses the development and application of steroid eluting implants in the postoperative care of patients with chronic frontal sinusitis. All randomized controlled trials evaluating steroid eluting implants are discussed. Relevant supporting material discussing background, economics, safety are included.

Expert commentary: Steroid eluting implants fulfill a unique niche in the treatment following frontal sinus surgery. They are shown to decrease the need for post-operative interventions and improve outcomes in patients with chronic sinusitis. There is significant potential for growth in the use of steroid eluting implants.

KEYWORDS:

• Chronic frontal sinusitis
• frontal recess
• steroid-eluting implant
• steroid stent
• mometasone furoate

Information Resources

The four clinical trials (PILOT, ADVANCE, ADVANCE II, PROGRESS) provide the strongest evidence for use of steroid eluting implants following sinus surgery, with the PROGRESS study exclusively addressing the frontal sinus. Economic studies are noted in annotated bibliography below. Currently there is one manufactur er who has FDA approval for steroid eluting implants of the frontal sinus (Intersect ENT), and their website (www.intersectent.com) has material demonstrating use and mechanics of the device. Coding information may be found at an industry sponsored site (www.propelopens.com).

Declaration of interest

A. Singh is a consultant for and has received research funding from Intersect ENT. A. Singh has also participated in clinical studies for Intersect ENT. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Notes

1. This paragraph utilizes several economic terms. Third party payer is when a third party, such as an insurance company, pays healthcare provider for services rendered. Willingness to pay is a term from economics used in cost benefit analysis for expected health outcomes. In this study, the context of terms refers to how much an insurance company is willing to spend in an insured population.

Additional information

Funding

This paper was not funded.