CURRENT CONCEPTS IN THE MANAGEMENT OF CHRONIC SINUSITIS

1. CURRENT CONCEPTS IN THE MANAGEMENT OF CHRONIC SINUSITIS Kevin D. Meakin, DO, FAOCO Lakeview Medical Center ENT & Allergy

2. Chronic SinusitisQuality of life drives innovation 1 National Institute of Allergy and Infectious Diseases

3. Anatomy • 8 sinuses • 4 right and 4 left • Maxillary, ethmoid, frontal, sphenoid • Lined with a mucous membrane • Communicate with the nasal cavity

4. Anatomy • Maxillary sinuses • 2 cells, right and left • 15ml volume per side • Pneumatized at birth • Fully developed by age 20

5. Anatomy • Frontal sinuses • 2 cells, right and left • Pneumatize in middle childhood • 7ml total volume per side

6. Anatomy • Sphenoid sinuses • 2 cells, right and left • Pneumatize in middle childhood • Developed by 12-15 years of age • 7ml total volume

7. Anatomy • Ethmoid sinuses • 3 or 4 cell at birth • The most dev sinus at birth • Adult size by age 12 • 10-15 cells per side in adult • 14-15 ml total volume

8. Anatomy

9. Physiology of the Nose and Sinuses • Function of the sinus cavities • Humidify and warm inspired air • Assist in regulating intranasal pressure • Increase the surface area of olfactory membranes • Lighten the skull • Voice resonance • Shock absorber for the head • Contribute to facial growth • Evolutionary remains of useless spaces

10. Physiology of the Nose and Sinuses • Epithelium • Traps bacteria • 50-200 cilia per cell, beat 10-20X/s • Cells: • ciliated columnar • non-ciliated microvilli • goblet cells • basal cells • submucosal glands - symp/parasym control

11. Mucociliary Transport

12. Pathophysiology of Sinusitis • Related to 3 things • Patency of ostia • Function of cilia • Quality of mucous

13. Pathophysiology of Sinusitis • Patency of ostia • Acute and chronic inflammation • Allergic rhinitis • Nasal polyps • Anatomic obstruction • Function of the cilia • Quality of the mucous

14. Patency of ostia/omc

15. Pathophysiology of Sinusitis • Patency of Ostia • Function of cilia • Bacterial invasion • Quality of mucous layer • Ig deficiency • Squamous metaplasia-chronic infection, surgery • Low temperature • Mucosal surfaces in contact • Primary ciliary defects • Quality of Mucous

16. Pathophysiology of Sinusitis • Patency of the ostia • Function of the cilia • Quality of mucous • Pollutents • Allergens • Low oxygen tension- Blocked sinus ostium • Irritants- too much mucous • Cold environment • Loss of the normal mucosal lining-scar, stripping, chronic dz, high air flow • Dehydration • Low humidity

17. Sinusitis Overview • Acute sinusitis • Symptoms < 4 weeks • Chronic sinusitis • Symptoms > 3 months • Chronic sinusitis is a disease in which the mucosal damage is no longer reversible without surgery despite appropriate medical therapy

18. Acute Sinusitis • Diagnosis of acute sinusitis • 2 major criteria • 1 major, 2 minor criteria • History “suggestive” • 1 major criterion • 2 minor criterion • Symptoms longer than 10 days or worsening after 5-7 days

19. Acute Sinusitis • Major criteria • Facial pain/pressure • Facial congestion/fullness • Nasal obstruction/blockage • Nasal discharge/postnasal drainage • Hyposmia/anosmia • Observed nasal purulence on exam

20. Mechanism of Chronic Sinusitis Mucociliary Transport and Drainage Ostial patency Mucosal Surface Anatomic Factors Microbial Factors Acute Sinusitis Allergic Factors Immune Factors Chronic Sinusitis

21. Treatment options • Medical therapy • Antibiotics • Mucolytics • Decongestants- Oral, topical (3 days only) • Nasal saline irrigation • Address allergic component • Steroids- nasal/oral • Antihistamines only if allergic symptoms • Allergy testing and/or immunotherapy • Surgery • FESS • Sinuplasty

22. Medical Therapy • Microbiology: Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella (formerly Branhamella) catarrhalis • Amoxicillin 875mg PO BID X 10 days. • Augmentin 875mg PO BID X 10 days. • PCN allergic: • TMP/SMX • Respiratory quinolones: Levaquin, Tequin, Avelox

23. History of sinus surgery • Initially done with a headlight through the nose or externally • Endoscopic using blunt instruments/curettes • Endoscopic using thru-cut and powered instruments • Minimal surgery • Mucosal preservation • Image guidance added accuracy and safety • Sinuplasty

24. FESS • Functional • Endoscopic • Sinus • Surgery • Restoration of normal aeroation and mucociliary clearance

26. Image Guidance

27. Ethmoid Cells Supraorbital, Frontal Bulla, Concha Bullosa, Haller’s, Onodi Cells

28. 1.4M Patients Traditional Treatment OptionsMedical therapies – the usual 1st line of treatment • Medications have advanced • Basic remedies • Array of specialized drugs • Sophisticated delivery methods • Effective • Reducing mucosal swelling • Relieving sinus obstructions • Promoting drainage • Inherent limitations • 20-25% patients may not respond or relapse after 1-2 intensive cycles • Expensive • Patient compliance • Potential for side effects

29. 330K Patients 1.4M Patients Traditional Treatment OptionsSurgical techniques • Evolution of sinus surgery • From open to less invasive surgery (FESS) • Introduction of endoscopic tools • Discovery that blocked sinus ostia may be the primary culprit of this disease process • Goals of FESS • Clear blocked sinuses • Restore normal sinus drainage and function • Preserve normal anatomy and mucosal tissue • Inherent limitations • Removal of bone and tissue may lead to post-op pain, scarring, and bleeding • Nasal packing may be used to control bleeding • Delay in return to work or lifestyle

30. Balloon Sinuplasty™ TechnologyFurther Evolving Sinus Surgery • The Relieva Balloon Sinuplasty™ devices are endoscopic tools and may be used with other medical therapies or FESS techniques

31. Marry Endoscopic Techniques with New TechnologiesAdvancements In Surgical Devices Continues • Relieva Balloon Sinuplasty™ devices • Designed for customized access • Sinus Guidewire • Sinus Guide Catheter • Engineered for sinus dilation • Sinus Balloon Catheter • Developed for controlled inflation • Sinus Balloon Inflation Device

33. Step OneGain initial access and deliver the Relieva™ Sinus Balloon Catheter Images provided by Frederick Kuhn, MD

34. Step Two - Endoscopic viewPlace the Relieva™ Sinus Balloon Catheter across the ostium Images provided by Frederick Kuhn, MD

35. Frontal Sinus DilationFinal endoscopic image Frontal sinusPost-procedure CT scan Step ThreeDeflate and remove the Relieva Balloon Images provided by Frederick Kuhn, MD

36. CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) • A multi-center, non-randomized, prospective evaluation of 115 patients/358 sinuses treated with balloon dilation • Study objectives • Confirm safety in a larger patient cohort • Evaluate efficacy of balloon catheter dilation in achieving and maintaining sinus ostia patency • Gain insight into balloon catheter technology to relieve patient’s symptoms

37. CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) • Site selection • 9 sites - US and Australia • Independent IRB-approvals • Study design • Safety • Assessed by the rate of adverse events • Efficacy • Ability to cannulate and dilate ostia • Endoscopic patency examination: 1, 12, 24 weeks • QOL / Patient outcomes • SNOT-20: Baseline, 1, 12, 24 weeks • Standardized patient questionnaire: 1, 12, 24 weeks As reported at the AAO-HNS Annual Meeting 2006

38. CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) • Methods • A prospective, multi-center, non-randomized evaluation was conducted in patients with chronic sinusitis • Patients for whom endoscopic sinus surgery was recommended were offered treatment with the balloon catheter devices • Balloon instrumentation used for maxillary, frontal, sphenoid sinuses at discretion of the investigator • Ethmoid treated with current endoscopic forceps and microdebrider concurrently if indicated As reported at the AAO-HNS Annual Meeting 2006

39. CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) • Inclusion Criteria • 18 years of age or older • Diagnosed with chronic sinusitis that is not responsive to medical management. • Planned endoscopic sinus surgery (recommended by physician and consented to by patient) • Exclusion Criteria • Extensive sinonasal polyps • Previous extensive sinonasal surgery • Extensive sinonasal osteoneogenesis • Diagnosed with Sampter’s Triad- Asthma, Polyps, ASA • Sinonasal tumors or other obstructive lesions • History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium • Ciliary dysfunction • Cystic fibrosis • The patient is pregnant As reported at the AAO-HNS Annual Meeting 2006

40. 1 sinus exited (personal decision) CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) • Patient Demographics & Flow • Age : Average = 47.8 years (range of 21-76) • Gender : 41 male, 74 female • Patients with a history of prior FESS : 21 patients (18.3%) ENTERED STUDY 115 patients / 358 sinuses SUCCESSFULLY TREATED 109 patients / 342 sinuses 24 WK. FOLLOW-UP COMPLETED95 patients / 307 sinuses (90%) As reported at the AAO-HNS Annual Meeting 2006

41. The CLEAR Study • Results Summary • Safety • No serious adverse events occurred during study • Efficacy • Overall patency at 24-weeks - 81% • Observed patency at 24-weeks - 98% • Patient outcomes • SNOT-20 scores demonstrated clinically and statistically significant difference from baseline at all time points As reported at the AAO-HNS Annual Meeting 2006

42. N = 341 N = 269 N = 307 CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) Observed patency: Patency rate of the ostia technically able to be visualized endoscopically As reported at the AAO-HNS Annual Meeting 2006

43. * * * *p<.0001 CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) Clinically1 and statistically significant difference demonstrated at all time points. 1 Piccirillo, JF, et al. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolarynhol Head Neck Surg 2002;126:41-7. As reported at the AAO-HNS Annual Meeting 2006

44. CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) • There were no serious adverse events • 9 events of bacterial sinusitis post dilation : resolved with antibiotic treatment As reported at the AAO-HNS Annual Meeting 2006

45. CLinical Evaluation to Confirm SAfety & Efficacyof Sinuplasty in the PaRanasal Sinuses (CLEAR) • Additional study data • Median radiation • Average 3.1 sinuses per patient • Fluoro time per sinus: 0.81 minutes • Mean dose per patient: 730 mrem • Head CT scan (200 mrem) • Annual natural background radiation in the US (300 mrem) • Chest CT (800 mrem) • Coronary angiogram (460-1580 mrem) • Angioplasty (750-5,700 mrem) As reported at the AAO-HNS Annual Meeting 2006

46. Clinical Program Summary • The Balloon Sinuplasty™ technology has undergone vigorous development and clinical validation • The technology is shown to be safe, effective and a viable alternative for widening selected ostia currently targeted for classic FESS instrumentation • One-year follow-up on CLEAR patients is ongoing • Clinical assessment ongoing through surgeon initiated trials • Surgeon training and patient care continues to expand

47. Functional Endoscopic Dilatation of the Sinuses: Quality of Life, Pt Satisfaction, Postoperative Pain, and Cost Postoperative Recovery: FESS with Balloon Sinuplasty™ Devices CLinical Evaluation to Confirm SAfety & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Safety & Feasibility of Balloon Catheter Dilatationof Paranasal Sinus Ostia: A Preliminary Investigation Catheter-Based Dilation of the Sinus Ostia: Initial Safety & Feasibility Analysis in a Cadaver Model Note: Screen two

48. Final thoughts…. • Chronic sinusitis is highly prevalent among our patients • Medical therapies & FESS may be effective in some patients • 600,000 people are left living with their sinus condition

49. Final thoughts…. • Balloon Sinuplasty™ technology offers a novel, endoscopic catheter based approach • Minimally invasive • Safe and effective • Reduced bleeding • Improved recovery time • Does not limit treatment options • Clinically established1,2 • Now, there is new hope in relief for your chronic sinusitis patients 1 Safety & Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia: A Preliminary Investigation. Presented at American Rhinologic Society Annual Meeting. Nov. 2004. 2 The CLinical Evaluation to Confirm SAfety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Study.