MA: Drug Eluting Sinus Stents

Policy

1. The use of drug-eluting sinus stents for postoperative treatment following endoscopic sinus surgery and for treatment of recurrent sinonasal polyposis is considered investigational.
2. The use of drug-eluting sinus stents is considered investigational in all other conditions.

Guidelines

Sinus stents are defined as implantable devices specifically designed to improve patency and/or deliver local medication. These devices are inserted under endoscopic guidance and are distinguished from sinus packing and variations on packing devices routinely employed after sinus surgery.

Foam dressings, such as Sinu-Foam^TM, are used as nasal packs for a variety of conditions, including nosebleeds, and have also been used after endoscopic sinus surgery. They are considered different types of nasal packing.

Middle meatal spacers are related but separate devices intended to maintain sinus patency post-endoscopic sinus surgery. They are splint-like devices inserted directly rather than under endoscopic guidance, and do not have the capability of delivering local medication.

Description

Steroid-eluting sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS) or for treatment of recurrent sinonasal polyposis following ESS. These devices maintain patency of the sinus openings in the postoperative period, and/or serve as a local drug delivery vehicle. Reducing postoperative inflammation and maintaining patency of the sinuses may be important in achieving optimal sinus drainage and may impact recovery from surgery and/or reduce the need for additional surgery.

For individuals who have chronic rhinosinusitis who have undergone ESS who receive implantable steroid-eluting sinus stents, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and treatment-related morbidity. The most direct evidence relating to use of steroid-eluting nasal stents as an adjunct to ESS comes from 4 RCTs comparing steroid-eluting stents with either a non-steroid-eluting stent or medical management. The need for post-operative intervention at 30 days was reduced by 14% to 24%, translating to a number needed to treat of 4.7 or more. Three trials used blinded assessors to evaluate post-implantation sinus changes, an important strength, but the trials had potentials for bias. To most accurately evaluate the benefit from PROPEL devices it is important to ensure that the comparison group is not undertreated (ie, receives some form of packing, intranasal steroids, and irrigation). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have recurrent sinonasal polyposis who have undergone endoscopic sinus surgery who receive implantable steroid-eluting sinus stents, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and treatment-related morbidity. Two RCTs were identified evaluating the use of steroid-eluting nasal stents for recurrent or persistent nasal polyposis after ESS, which demonstrated improvements in polyp grade and ethmoid obstruction. Strengths of these trials included use of a sham control and adequate power for its primary outcome. However, the trials had a high risk of bias due to unblinded outcome assessment. Although avoidance of repeat ESS and oral steroids may be relevant outcomes for this indication, it would be more important if decisions about repeat ESS or other treatments were standardized and, in the trial setting, if decisions were prespecified or made by a clinician blinded to treatment group. Sinus stents may prove to have a role in nasal polyposis; however, further follow-up is needed to evaluate the durability of the results. The evidence is insufficient to determine the effects of the technology on health outcomes.

Codes