Standalone Balloon Sinus Dilation for Treating Chronic Rhinosinusitis in Adults
July 20, 2016 | Emerging Technology Reports
Proprietary names: Acclarent Relieva FLEX® Sinus Guide Catheter, Acclarent® Balloon Inflation Device, Entellus FinESS™ Endoscope, Entellus FinESS Sinus Treatment Kit, Entellus XprESS ™ Pro Multi-Sinus Dilation System, Lenio®flex System for Sinus Ostia Dilation, Medtronic NuVent™ EM Balloon Sinus Dilation System, Medtronic Fusion® ENT Navigation System, Relieva Luma Sentry™ Sinus Illumination System and Accessories, Relieva SCOUT™ Sinus Dilation System, Relieva Seeker® Balloon Sinuplasty System, Relieva SIDEKICK™ Low Profile Handles, Relieva SIDEKICK Sinus Guide Catheter Handles, Relieva Solo Pro™ Sinus Balloon Catheter, Sinus Balloon Catheter, Relieva Solo™ Sinus Balloon Catheter, Relieva Ultirra™ Sinus Balloon Catheter, Relieva VIGOR® Sinus Guidewire, Relieva VORTEX® 2 Sinus Irrigation Catheter, Relieva® Spin Balloon Sinuplasty System, SinuSys AerOs™ Sinus Dilation System, SinuSys Vent-Os™ Sinus Dilation System, VENTERA® Sinus Dilation System, XprESS™ LoProfile Multi-Sinus Dilation System, XprESS Ultra Multi-Sinus Dilation System
Generic names: balloon dilation sinuplasty, balloon sinuplasty, endoscopic balloon sinus ostial dilation, functional endoscopic balloon dilation, functional endoscopic dilatation sinus surgery
Chronic rhinosinusitis (CRS) is a syndrome defined by inflammation of the nasal passages and paranasal sinuses that persists for 12 weeks or longer.1 Patients with CRS often report nasal congestion/obstruction, nasal drainage, facial pain or pressure, a reduced sense of smell, and headache.1-3 Clinical signs include mucosal erythema, purulent nasal secretions, and nasal polyps.1 Inflammation of the nasal passages and paranasal sinuses can be exacerbated by viral, bacterial, or fungal pathogens.1,2 Frequently, a viral upper respiratory infection precedes subsequent bacterial colonization of the sinuses. Allergic rhinitis can predispose patients to increased swelling of the sinus mucosa and exacerbate CRS.1,2 Some clinicians consider recurrent acute rhinosinusitis (RARS), defined as four or more episodes of acute bacterial rhinosinusitis in a year without signs or symptoms between episodes,4 to be a type of CRS.5
Initial treatment of CRS typically focuses on providing symptomatic relief with oral decongestants, saline lavage, mucolytics, expectorants, and allergy management.3 Physicians may also prescribe oral antibiotics, topical nasal steroid spray, systemic steroids, and topical antibiotics.1,2 Specialists may perform nasal endoscopy to culture the sinuses for appropriate antibiotic selection and to assess anatomic abnormalities that may predispose the patient to recurrent sinus infections.1 Also, a computed tomography (CT) scan can depict the sinus anatomy and show the extent of disease and degree of nasal-passage obstruction.1,2 Despite optimal medical therapy, an estimated 30% to 50% of patients with CRS fail to obtain sufficient symptom improvement.6-8 If individualized medical management fails and CT scanning or endoscopic examination detects an obstruction, physicians may recommend sinus surgery to relieve blocked sinuses, restore normal mucus flow, and optimize topical delivery of medications.1 The U.S. National Survey of Ambulatory Surgery reported performance of 257,000 sinus procedures in 2006, the most recent year for which data are available.9
The most widely used surgical approach to treat patients with CRS is functional endoscopic sinus surgery (FESS), a transnasal technique that involves dissection of the involved sinuses to permit sinus drainage.3 Otolaryngologists perform FESS in an operating room or ambulatory care center with the patient under general anesthesia. During FESS, surgeons dissect and remove tissue and bone using standard surgical cutting tools (e.g., microdebriders, forceps, curettes). Most otolaryngologists perform postoperative debridement procedures after FESS, which "are uncomfortable, require return trips to the office, and add to the overall cost of sinus surgery."10-12 Potential complications of FESS include bleeding from the nose, orbital injury, and cerebrospinal fluid leaks due to skull-base penetration.3 The overall major complication rate for FESS is approximately 1%, with a minor complication rate of approximately 5% to 6%.13,14 Interest in less invasive techniques that do not require cutting or removal of bone and tissue has grown since the introduction of balloon sinus dilation (BSD) technology in 2005. Commercially available sinus balloons "can displace bone and tissue within the sinus transition space and/or ostia."15 Some otolaryngologists perform BSD as a standalone procedure or in conjunction with FESS (i.e., hybrid FESS) in an operating room or ambulatory surgery setting using general anesthesia16 or as a standalone procedure in an office setting using local anesthesia.17,18 However, specific indications for standalone BSD are not well-defined. Manufacturers of BSD devices and some otolaryngologists recommend the standalone procedure for patients with CRS as an alternative to FESS, but some clinicians feel that balloon technology has very limited use for treating patients with CRS due to the inflammatory nature of the disease.19
A population study conducted in 2000 reported an overall age- and sex-adjusted CRS prevalence of 1,955 per 100,000 people (1.96%).20 The incidence of CRS is increasing annually.3 In 2009, CRS was the primary diagnosis for 11.7 million patients who visited ambulatory care facilities (e.g., physician offices, hospital outpatient departments, emergency departments).21
One study of U.S. medical claims data from a large payer database estimated the prevalence of RARS at 1 in 3,000 adults (0.03%).22
CRS is a common disease worldwide.23 A multicenter prevalence study of CRS reported an overall prevalence of 10.9% (range 6.9 to 27.1) in Europe.24
Standalone BSD is a minimally invasive transnasal procedure that involves displacing tissue and dilating natural drainage pathways as a sole means of treating frontal, maxillary, or sphenoid sinus outflow obstruction.25 Basic equipment needed to perform this procedure includes a nasal endoscope, a balloon dilation device, and an inflation device.18 A confirmation tool (e.g., guidewire, light fiber) is optional. To accomplish the standalone BSD procedure in a physician's office setting, an otolaryngologist performs the following steps:18
Postprocedure, physicians may send patients home on over-the-counter analgesics for pain management and antibiotics.17 Patients who undergo this procedure typically return to normal activity within 24 hours.17
The intended benefits of a standalone BSD procedure compared with traditional FESS include the following:10,17,26,27
Also, otolaryngologists may offer standalone BSD to patients who refuse surgery or those who are not surgical candidates due to comorbidities.
Potential disadvantages of standalone...