Chronic rhinosinusitis (CRS) is characterized by purulent nasal discharge, usually without fever, that persists for weeks to months. Symptoms of congestion often accompany the nasal discharge. There also may be mild pain and/or a headache. Thickening of mucosa may restrict or close natural openings between sinus cavities and the nasal fossae, although symptoms vary considerably because of the location and shape of these sinus ostia.

Recurrent acute rhinosinusitis (RARS) is defined as 4 or more episodes per year of acute bacterial rhinosinusitis without signs or symptoms of rhinosinusitis between episodes.

Medical Treatment

Most cases of CRS and RARS are treated with medical therapy (e.g., antihistamines, steroids, nasal lavage, and antibiotics).^1,

Functional Endoscopic Sinus Surgery

FESS involves the insertion of an endoscope into the nose for a direct visual examination of the openings into the sinuses. Using the endoscope and a combination of surgical tools (e.g., curettes, forceps, powered micro-debriders, powered shavers, and/or sinus balloon catheters), surgeons enlarge the patient’s sinus openings to clear passageways in order to restore normal sinus ventilation and drainage. The goal of surgery is to improve sinus ventilation and drainage by enlarging the openings of the sinuses, removing any polyps and correcting significant structural problems that may be hindering drainage.

The maxillary sinus creates a unique challenge. The maxillary ostia, located within the ethmoid infundibulum, often cannot be accessed transnasally without excising a portion of the uncinate process. An alternative approach to the maxillary ostia is through the sinus, via the canine fossa. A guidewire can be advanced from within the maxillary sinus to the nasal fossa. The dilating balloon can enlarge the ostia while deflecting the uncinate process.

Approximately 350,000 FESS procedures are done each year in the United States for CRS.

Balloon Ostial Dilation

A newer procedure, balloon ostial dilatation can be used as an alternative or as an adjunct to FESS for those with CRS or RARS. The goal of this technique, when used as an alternative to FESS, is to improve sinus drainage using a less invasive approach. The procedure involves placing a guidewire in the sinus ostium, advancing a balloon over the guidewire, and then stretching the opening by inflating the balloon. The guidewire location is confirmed with fluoroscopy or with direct transillumination of the targeted sinus cavity. General anesthesia may be needed for this procedure to minimize patient movement. According to the manufacturer, the RELIEVA SPINPLUS® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.https://www.jnjmedicaldevices.com/en-US/product/relieva-spinplus-balloon-sinuplasty-system

This evidence review is limited to BOD when used as a stand alone procedure. BOD may also be used in combination with FESS.^2,3, When used as an adjunct to FESS, it is intended to facilitate and/or increase access to the sinuses. BOD may also be used on one sinus and FESS on another sinus in the same patient during the same operation.

Regulatory Status

In 2008, the Relieva™ Sinus Balloon Catheter (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA determined that this device was substantially equivalent to existing devices for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. Subsequent devices developed by Acclarent have also been cleared by FDA through the 510(k) process. They include the Relieva Spin Sinus Dilation System® (cleared in 2011) and the Relieva Seeker Balloon Sinuplasty System® (cleared in 2012).

In 2008, the FinESS™ Sinus Treatment (Entellus Medical, Maple Grove, MN) was cleared for marketing by FDA through the 510(k) process. The indication noted is to access and treat the maxillary ostia/ethmoid infundibulum in adults using a transantral approach (FDA product code: EOB). The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. Two other balloon sinus ostial dilation devices, the ENTrigue® Sinus Dilation System (ENTrigue Surgical, acquired by more recently by Smith & Nephew), and the XprESS™ Multi-Sinus Dilation Tool, also received 510(k) clearance in 2012.

In 2013, a sinus dilation system (Medtronic Xomed, Jacksonville, FL), later named the NuVent™ EM Balloon Sinus Dilation System, was cleared for marketing by FDA through the 510(k) process for use in conjunction with a Medtronic computer-assisted surgery system when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone, or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, or sphenoid sinuses.

Also in 2013, a sinus dilation system (Smith & Nephew), later named the Ventera™ Sinus Dilation System, was cleared for marketing through the 510(k) process to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a transnasal approach. Ventera™ Sinus Dilation System does not require a guide wire or an illumination system as it is intended for use as a tool in combination with endoscopic sinus surgery.^2,

Table 1 summarizes the currently FDA cleared balloon sinus dilation devices.

FDA product code: LRC.

Table 1. Balloon Ostial Dilation Devices Cleared by the US Food and Drug Administration

Device	Manufacturer	510(k) No.	Date Cleared	Indication
MESIRE - Balloon Sinus Dilatation System	Meril Life Sciences	K172737	12/12/2017	Sinus Ostia Dilation
Relieva UltirraNav Sinus Balloon Catheter	Acclarent Inc.	K161698	10/24/2016	Sinus Ostia Dilation
Vent-Os Sinus Dilation Family	Sinusys Corp.	K160770	6/29/2016	Sinus Ostia Dilation
Relieva Scout Multi-Sinus Dilation System	Acclarent Inc.	K153341	2/12/2016	Sinus Ostia Dilation
XprESS Multi-Sinus Dilation System	Entellus Medical Inc.	K152434	11/20/2015	Sinus Ostia Dilation
DSS Sinusplasty Balloon Catheter	Intuit Medical Products LLC	K143738	8/27/2015	Sinus Ostia Dilation
Relieva SpinPlus Balloon Sinuplasty System	Acclarent Inc.	K143541	4/22/2015	Sinus Ostia Dilation
XprESS Multi-Sinus Dilation Tool	Entellus Medical Inc.	K142252	10/17/2014	Sinus Ostia Dilation
Relieva Scout Multi-Sinus Dilation System	Acclarent Inc.	K140160	2/20/2014	Sinus Ostia Dilation

Related Policies

• Steroid-Eluting Sinus Stents (Policy #133 in the Surgery Section)

1. The member has 2 or more of the following signs and symptoms of chronic rhinosinusitis which are present for at least 12 continuous weeks:
a. Mucopurulent nasal drainage;
b. Nasal congestion;
c. Facial pain-pressure-fullness;
d. Anosmia or hyposmia.

AND

2. Appropriate medical therapy has been attempted, including all of the following:
a. Topical nasal steroids for at least 4 consecutive weeks;
b. Nasal lavage for at least 8 consecutive weeks;
c. Consideration for allergic and/or immune evaluation if the member has symptoms consistent with allergic rhinitis and/or immunodeficiency.
AND

3. There is objective evidence of mucosal inflammation as demonstrated by one of the following:
a. Sinus computed tomography or magnetic resonance imaging showing significant mucosal thickening or opacification of the paranasal sinuses; OR
b. Nasal endoscopy with purulent mucus or edema in the middle meatus.
AND

4. A stand-alone balloon ostial dilation procedure was not performed in the sinus to be treated within the past 6 months.

AND

5. There are no serious urgent complications of acute sinusitis that would suggest orbital cellulitis or abscess, intracranial extension of infection, or other complication that would require urgent or emergent surgery such that "appropriate medical therapy" for 8 weeks would not be appropriate.

(NOTE: Horizon BCBSNJ has a reimbursement policy that denies balloon ostial dilation (balloon sinuplasty) as incidental when performed in conjunction with functional endoscopic sinus surgery (FESS) on the same sinus.

1. Nasal polyposis (Grade 2 or greater)
2. Samter's triad (aspirin sensitivity)
3. Severe sinusitis secondary to autoimmune or connective tissue disorders
4. Severe sinusitis secondary to ciliary dysfunction, including but not limited to, cystic fibrosis
5. Contraindications to, or inability to tolerate local and/or topical anesthetic
6. History of failed balloon ostial procedure in the sinus to be treated
7. Sinusitis with extensive fungal disease
8. Isolated ethmoid sinus disease
9. Significant neo-osteogenesis

________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Balloon Ostial Dilation as an Alternative to Endoscopic Sinus Surgery for Treatment of Chronic Rhinosinusitis
Balloon Sinuplasty as an Alternative to Endoscopic Sinus Surgery for Treatment of Chronic Sinusitis
Entellus Medical RS Series System
Functional Endoscopic Dilation of the Sinuses (FEDS)
FEDS (Functional Endoscopic Dilation of the Sinuses)
Relieva Balloon Sinuplasty System
Relieva Spin Sinus Dilation System
Relieva Seeker Balloon Sinuplasty System
Sinuplasty, Balloon
FinESS Sinus Treatment
ENTrigue Sinus Dilation System
XprESS Multi-Sinus Dilation Tool

References:
1. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. Apr 2015;152(2 Suppl):S1-S39. PMID 25832968

2. Hathorn IF, Pace-Asciak P, Habib AR, et al. Randomized controlled trial: hybrid technique using balloon dilation of the frontal sinus drainage pathway. Int Forum Allergy Rhinol. Feb 2015;5(2):167-173. PMID 25360863

3. Plaza G, Eisenberg G, Montojo J, et al. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. Aug 2011;120(8):511-518. PMID 21922974

4. Bizaki AJ, Taulu R, Numminen J, et al. Quality of life after endoscopic sinus surgery or balloon sinuplasty: a randomized clinical study. Rhinology. Dec 2014;52(4):300-305. PMID 25479206

5. Hopkins C, Browne JP, Slack R, et al. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. Oct 2007;137(4):555-561. PMID 17903570

6. Greguric T, Trkulja V, Baudoin T, et al. Association between computed tomography findings and clinical symptoms in chronic rhinosinusitis with and without nasal polyps. Eur Arch Otorhinolaryngol. May 2017; 274(5): 2165-2173. PMID 28154930

7. Levy JM, Marino MJ, McCoul ED. Paranasal sinus balloon catheter dilation for treatment of chronic rhinosinusitis: a systematic review and meta-analysis. Otolaryngol Head Neck Surg. Jan 2016;154(1):33-40. PMID 26519456

8. Chandra RK, Kern RC, Cutler JL, et al. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. Jan 2016;126(1):44-50. PMID 26228589

9. Minni A, Dragonetti A, Sciuto A et al. Use of balloon catheter dilation vs. traditional endoscopic sinus surgery in management of light and severe chronic rhinosinusitis of the frontal sinus: a multicenter prospective randomized study. Eur Rev Med Pharmacol Sci. 2018 Jan;22(2). PMID 29424885

10. Cutler J, Bikhazi N, Light J, et al. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. Sep-Oct 2013;27(5):416-422. PMID 23920419

11. Bikhazi N, Light J, Truitt T, et al. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. Jul 2014;28(4):323-329. PMID 24823902

12. Achar P, Duvvi S, Kumar BN. Endoscopic dilatation sinus surgery (FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of chronic rhinosinusitis: a pilot study. Acta Otorhinolaryngol Ital. Oct 2012;32(5):314-319. PMID 23326011

13. Chaaban MR, Rana N, Baillargeon J et al. Outcomes and Complications of Balloon and Conventional Functional Endoscopic Sinus Surgery. Am J Rhinol Allergy. 2018 Sep;32(5). PMID 29947260

14. Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope. 2015 Oct;125(10). PMID 26390386

15. Bizaki AJ, Numminen J, Taulu R, et al. A controlled, randomized clinical study on the impact of treatment on antral mucociliary clearance: uncinectomy versus balloon sinuplasty. Ann Otol Rhinol Laryngol. May 2016;125(5):408-414. PMID 26611244

16. Sikand A, Ehmer DR, Stolovitzky JP et al. In-office balloon sinus dilation versus medical therapy for recurrent acute rhinosinusitis: a randomized, placebo-controlled study. Int Forum Allergy Rhinol. 2019 Feb;9(2). PMID 30452127

17. Piccirillo JF, Payne SC, Rosenfeld RM et al. Clinical Consensus Statement: Balloon Dilation of the Sinuses. Otolaryngol Head Neck Surg. 2018 Feb;158(2). PMID 29389303

18. American Academy of Otolaryngology - Head and Neck Surgery. Position Statement: Dilation of sinuses, any method (e.g., balloon, etc.). 2017; http://www.entnet.org/content/position-statement-dilation-sinuses-any-method- eg-balloon-etc. Accessed January 21, 2020.

19. National Institute of Health and Care Excellence (NICE). Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis [IPG273]. 2008; http://www.nice.org.uk/guidance/IPG273/chapter/1-Guidance. Accessed January 21, 2020.

20. National Institute of Health and Care Excellence (NICE). XprESS multi sinus dilation system for treating chronic sinusitis [MTG30]. 2016; https://www.nice.org.uk/guidance/mtg30. Accessed January 21, 2020.

21. American Rhinologic Society (ARS). Ostial Balloon Dilation Position Statement. 2017; https://www.american-rhinologic.org/index.php?option=com_content&view=article&id=33:ostial-balloon-dilation-position-statement&catid=26:position-statements&Itemid=197. Accessed January 21, 2020.

31295
31296
31297
31298