Balloon Sinuplasty for Chronic Sinusitis: The Latest Recommendations

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1 Balloon Sinuplasty for Chronic Sinusitis: The Latest Recommendations Shannon Hunter, MD Board-Certified Otolaryngologist

2 Thank you for joining us today We are recording this webinar and will be sending a link as well as an in-depth white paper we have developed specifically for this topic. Everyone who is attending this webinar will receive a certificate of completion. Feel free to ask questions at any time by typing them into your GoToWebinar tool bar in the Questions box. We will be answering all questions at the end of the presentation.

3 Overview Treatment options for chronic sinusitis, including functional endoscopic sinus surgery (FESS) and balloon sinuplasty Clinical i l findings in patients t with chronic or recurrent symptoms Diagnostic criteria for chronic sinusitis Indications and contraindications for surgical treatment Evolution of balloon sinuplasty Overview of health plan coverage for surgical treatment of chronic sinusitis The American Academy of Otolaryngology Head and Neck Surgery (AAOHNS) and the American Rhinologic Society (ARS) position statements on balloon sinuplasty The role of external independent medical review for determining medical necessity for balloon sinuplasty

4 Chronic Sinusitis: An Introduction Centers for Disease Control and Prevention (CDC) estimates Chronic sinusitis affects about 30 million adults Each year, there are more than 12 million ambulatory care visits for chronic sinusitis Chronic sinusitis may be: Noninfectious Related to allergy, cystic fibrosis, i gastroesophageal reflux, or exposure to environmental pollutants Known risk factors Allergic rhinitis, nonallergic rhinitis, anatomic obstructions in the ostiomeatal complex, and immunological disorders CDC. Ambulatory Medical Care Utilization Estimates for Data From the National Health Care Surveys. April DHHS Publication No. (PHS) CDC. Summary Health Statistics for U.S. Adults: National Health Interview Survey, Data From the National Health Interview Survey. January DHHS Publication No. (PHS)

5 Treatment Options for Chronic Sinusitis Medical treatment often involves a combination of: Topical or oral glucocorticoids Antibiotics Nasal irrigation Surgery is usually reserved for patients who have not responded to medical therapy Most commonly performed surgeries FESS Balloon sinuplasty (balloon sinus dilation)

6 Goals of Surgery for Chronic Sinusitis Re-establish sinus ventilation Correct mucosal opposition in order to restore: The mucociliary clearance system The functional integrity of the inflamed mucosal lining

7 FESS: The Current Gold Standard for Inflammatory Sinus Disorders A fiber-optic nasal endoscope is used to visualize the sinus passages (the ostia) Any abnormal and obstructive tissues are removed with the use of micro-instruments Resection of periosteal bone and tissue is often required

8 Balloon Sinuplasty: A Less Invasive Alternative to FESS Endoscopic, catheter-based system introduced in 2005 as a less invasive alternative to FESS for patients who have failed medical management The procedures involves: Placing a guide-wire in the sinus ostium under the direction of endoscopy and fluoroscopy Advancing a balloon dilation catheter over the guide-wire Inflating the balloon to widen the sinus walls Eliminates need for sinus tissue removal and bone resection Recent increase in use, but remains controversial and has not yet gained widespread acceptance

9 Chronic Sinusitis: Symptom Overview Purulent nasal discharge, usually without fever, that persists for weeks to months Symptoms of congestion often accompany the nasal discharge Mild pain and/or headache h Thickening of mucosa may restrict or close natural openings between the sinus cavities and the nasal fossae The location and shape of these sinus ostia vary considerably Some cases may require surgical drainage with FESS and/or balloon sinuplasty

10 A Closer Look at Patient History Symptoms may be subtle, making the diagnosis easy to miss unless an appropriate history is taken Symptoms commonly associated with chronic sinusitis: Nasal stuffiness Nasal discharge Postnasal drip Facial fullness, discomfort, and headache Chronic, unproductive cough Hyposmia (decreased sense of smell) Sore throat t Fetid breath Malaise Easy fatigability Anorexia Exacerbation of asthma Dental pain Visual disturbances Sneezing Stuffy ears Unpleasant taste Fever of unknown origin

11 Key Factors in the Patient History: Consideration of Major and Minor Diagnostic Criteria Consideration of major and minor diagnostic criteria Major symptoms: purulent anterior nasal drainage, purulent discolored posterior nasal drainage, nasal obstruction or blockage, facial congestion or fullness, facial pain or pressure, and hyposmia or anosmia (the inability to detect odors) Minor symptoms: headache, ear pain or fullness, halitosis, dental pain, cough, fever, or fatigue Duration of symptoms Exacerbating and relieving factors History of previous nasal or paranasal sinus surgery Current medications Previous treatments and their duration Other confounding health problems Asthma, allergy, and immunocompromising disorders Active or passive tobacco smoke

12 Physical Examination: Various Components and Potential Findings Complete head and neck examination (lymphadenopathy) Confirm the diagnosis Rule out more serious disorders Sinus palpation Evaluate for tenderness or swelling Pain or tenderness on palpation of the frontal or maxillary sinuses may be noted Transillumination of the maxillary or frontal sinuses may be useful Lacks sensitivity, but may have value in experienced hands

13 Physical Examination: Various Components and Potential Findings (cont d) Oral cavity and oropharynx examination Evaluate the integrity of the palate and the condition of dentition Look for evidence of postnasal drip Oropharyngeal erythema and purulent secretions may be noted Dental caries may be present Anterior rhinoscopy with the use of a nasal speculum Evaluate the condition of the nasal mucosa Look for purulent drainage or evidence of polyps or other nasal masses

14 Physical Examination: Various Components and Potential Findings (cont d) Nasal endoscopy (if available) findings may include: Nasal mucosal erythema and edema Purulent secretions Nasal obstruction due to deviated nasal septum or hypertrophied turbinates Nasal polyps Nasal examination should be carried out both before and after the use of a topical decongestant

15 Physical Examination: Various Components and Potential Findings (cont d) Ear examination Indicated for presence of middle ear fluid, which may be the sign of a mass in the nasopharynx Ocular examination Determine spread of disease to the orbit and evaluate the function of the ocular musculature Laryngeal examination Look for other confounding upper airway pathology including laryngeal-pharyngeal reflux (LPR) Lung examination Determine whether coexisting lower airway disease is present Cranial nerve examination Look for an underlying sinus malignancy or an underlying neurological disorder

16 The AAOHNS: Diagnostic Criteria for Chronic Sinusitis The presence of two or more of the following signs or symptoms that persist for more than 12 weeks is highly sensitive for diagnosing chronic sinusitis: Anterior or posterior mucopurulent drainage Nasal obstruction Facial pain, pressure, or fullness Decreased sense of smell Inflammation must also be documented by demonstrating one of the following: Purulent mucus or edema in the middle meatus or ethmoid regions Polyps in the nasal cavity or middle meatus Imaging that shows inflammation of the paranasal sinuses Rosenfeld. Otolaryngol Head Neck Surg. 2007;137:

17 Balloon Sinuplasty vs. FESS Balloon sinuplasty Originally envisioned as a less invasive alternative to FESS Remains controversial as a stand-alone procedure Some practitioners feel that the procedures does not address underlying issues of sinusitis Currently, no randomized studies have compared balloon sinuplasty with FSS A recent Cochrane review found one unpublished small study, which did not find evidence of using balloon sinuplasty over FESS Ahmed et al. Cochrane Database Syst Rev Jul 6;7:CD

18 Existing Data for Balloon Sinuplasty: A Safe and Effective Option for Sinus Surgery Balloon sinuplasty, either alone or in combination with conventional surgical treatment, is a viable option for sinus surgery in patients with chronic sinusitis that has been unresponsive to medical management Retrospective chart reviews Small, prospective uncontrolled studies Short-term studies Studies have demonstrated the procedure s safety and efficacy, along with improved quality of life for patients Bolger et al. Otolaryngol Head Neck Surg. 2007;137: Brown et al. Ann Otol Rhinol Laryngol. 2006;115: Levine et al. Postgrad Med. 2011;

19 Balloon Sinuplasty Indications Indications are identical to those for FESS, which include chronic sinusitis that is refractory to medical treatment Endoscopic surgery is typically reserved for patients: With documented rhinosinusitis, based on a thorough history and a complete physical examination, including CT scans if appropriate In whom appropriate medical treatment has failed Balloon sinuplasty is used solely for dilation of obstructed ostia, with its use limited to the frontal, sphenoid, and maxillary (extranasal) sinuses

20 Balloon Sinuplasty Contraindications Balloon sinuplasty alone should not be considered for patients with: Pansinus polyposis Extensive fungal disease Advanced connective tissue disease Suspected neoplasms Balloon sinuplasty is not appropriate for use in patients: Who require revision surgery With severe disease in which h bony thickening i or dehiscence of the orbital wall or skull base bone has occurred

21 Balloon Sinuplasty: A Continually Evolving Technology Recently, there has been an increase in the use of balloon dilation devices as an adjunct to conventional FESS Some physicians believe that inflammation of the bone contributes to the disease and that simply pushing the bone aside with a balloon may lead to continued problems In complex cases, many physicians use the balloon to initially open the sinuses and then use more traditional surgical tools to remove disease bone and tissue The effects of removing the bone fragments in conjunction with balloon sinuplasty have not been studied to date Fink. ENT Today. Nov Stewart et al. Curr Allergy Asthma Rep May;10(3):

22 Health Plan Coverage Many health plans consider the stand-alone use of balloon sinuplasty to be experimental/investigational and do not provide coverage for the procedure Balloon sinuplasty is sometimes covered as an adjunct to FESS Some plans state: When performed on the same sinus in conjunction with another surgical procedure, such as functional endoscopic sinus surgery, balloon sinuplasty is considered inclusive/incidental to the surgical procedure and is not eligible for separate reimbursement by the company.

23 Position Statement on Balloon Sinuplasty: The AAOHNS The AAOHNS issued their first position statement on balloon sinuplasty in 2007, declaring that: The evidence regarding the safety of sinus balloon catheterization has been supportive Balloon catheterization is a promising technique for the treatment of selected cases of rhinosinusitis Includes those patients without polyposis involving the frontal, sphenoid, or maxillary sinuses, either in conjunction with or in place of conventional instruments AAO-HNS Issues Position Statement on Balloon Sinuplasty [press release]. March 19, 2007.

24 Position Statement on Balloon Sinuplasty: The ARS The ARS endorses the AAOHNS position statement on balloon sinuplasty, and its own statement declares the following: Based on currently available scientific medical evidence, endoscopic balloon dilation technology is acceptable and safe for use in the management of sinus disease Endoscopic c balloon dilation technology ogy is a tool, not a procedure, e, available a ab to the operating surgeon at his/her discretion for the surgical management of sinus disease Patients who are treated with this technology may require concurrent conventional endoscopic sinus surgery especially in the ethmoid sinuses much like any surgical instrument that may be used in some parts of the sinus and not others or in combination with other technologies In a group of selected patients, the use of balloon catheter dilation technology alone may eliminate i the need for other surgical techniques Endoscopic balloon catheter dilation as a tool for dilating the opening of the maxillary, sphenoid, and frontal sinuses is not investigational or experimental and should not be viewed as such ARS. Balloon Sinuplasty. Available at:

25 The AAOHNS: A Recent Public Letter In a recent public letter, the AAOHNS stated that: Using the balloon as a tool in a standard approach to sinus ostial dilation along with other indicated endoscopic surgery is acceptable It disagrees with policies designating stand-alone sinus ostial dilations as investigational/not medically necessary AAOHNS. [Public letter]. Available at: t t /P ti / /l d l it / tfil id

26 The Role of External Independent Review in Determining Medical Necessity for Balloon Sinuplasty An independent medical review looks at whether or not a specific therapy or procedure is medically necessary Effective care for patients with chronic sinusitis who have failed medical management requires an in-depth understanding of the continually evolving technologies for sinus surgery Independent review organizations (IROs) provide ready access to specialists, which healthcare plans may lack internally Allows for unbiased and timely determinations of whether the requested treatment falls under the medical necessity guidelines Board-certified physician specialists who work with IROs keep up-to-date with the latest medical research literature and the latest standard of care, staying on top of continually evolving technical advances as they are studied more extensively and potentially accepted into the clinical guidelines

27 Conclusions There is limited peer-reviewed literature that has evaluated the outcomes of patients undergoing balloon sinuplasty FESS is the gold standard for surgical treatment of inflammatory sinus disorders, but there are currently no randomized studies comparing balloon sinuplasty with FESS Existing data show that balloon sinuplasty by itself or as an adjunct to FESS is safe and effective for the treatment of chronic sinusitis that is unresponsive to medical management Balloon sinuplasty may gain more widespread acceptance and eventually become accepted as a standard of care as more randomized studies are conducted and longer-term data become available

28 Questions and Answers Please use the questions box within the GoToWebinar tool bar, located on the right side of your screen towards the bottom of the gray bar.

29 Thank You AllMed Healthcare Management, Inc. (800)

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