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

Chronic Sinusitis Quality of life drives innovation Sinusitis affects 37 million Americans each year One of the most common health problems in the US Significant impact on people physically, functionally, and emotionally $6 billion in direct healthcare expenditures and a significant loss of workplace productivity 1 National Institute of Allergy and Infectious Diseases

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

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

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

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

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

Anatomy

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

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

Mucociliary Transport

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

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

Patency of ostia/omc

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

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

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

Acute Sinusitis Diagnosis of acute sinusitis History “suggestive” 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

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

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

Treatment options Medical therapy Surgery 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

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

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

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

Image Guidance

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

Traditional Treatment Options Medical 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 1.4M Patients Patient often require multiple courses of medication

Traditional Treatment Options Surgical techniques 330K Patients 1.4M Patients 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 With no desirable treatment, over 600,000 patients are left living with their sinus condition

Balloon Sinuplasty™ Technology Further Evolving Sinus Surgery The Relieva Balloon Sinuplasty™ devices are endoscopic tools and may be used with other medical therapies or FESS techniques

Marry Endoscopic Techniques with New Technologies Advancements 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

Step One Gain initial access and deliver the Relieva™ Sinus Balloon Catheter Images provided by Frederick Kuhn, MD

Step Two - Endoscopic view Place the Relieva™ Sinus Balloon Catheter across the ostium Images provided by Frederick Kuhn, MD

Step Three Deflate and remove the Relieva Balloon Frontal Sinus Dilation Final endoscopic image Frontal sinus Post-procedure CT scan Images provided by Frederick Kuhn, MD

CLinical Evaluation to Confirm SAfety & Efficacy of 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 Screen Right

CLinical Evaluation to Confirm SAfety & Efficacy of 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 Screen Right As reported at the AAO-HNS Annual Meeting 2006

CLinical Evaluation to Confirm SAfety & Efficacy of 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 Screen Right As reported at the AAO-HNS Annual Meeting 2006

CLinical Evaluation to Confirm SAfety & Efficacy of 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

24 WK. FOLLOW-UP COMPLETED 95 patients / 307 sinuses (90%) CLinical Evaluation to Confirm SAfety & Efficacy of 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 1 sinus exited (personal decision) 24 WK. FOLLOW-UP COMPLETED 95 patients / 307 sinuses (90%) As reported at the AAO-HNS Annual Meeting 2006

The CLEAR Study Results Summary Safety Efficacy Patient outcomes 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

CLinical Evaluation to Confirm SAfety & Efficacy of 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

CLinical Evaluation to Confirm SAfety & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) * *p<.0001 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

There were no serious adverse events CLinical Evaluation to Confirm SAfety & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Type of Event Frequency Description Mild nasal bleeding requiring packing or intervention Moderate periorbital swelling or bruising, moderate pain Severe cerebrospinal fluid leak, orbital hematoma, visual loss, loss of sense of smell, nasolacrimal duct injury, orbital entry/injury, severe pain. 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

CLinical Evaluation to Confirm SAfety & Efficacy of 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

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 Screen Right

Postoperative Recovery: FESS with Balloon Sinuplasty™ Devices Catheter-Based Dilation of the Sinus Ostia: Initial Safety & Feasibility Analysis in a Cadaver Model Safety & Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia: A Preliminary Investigation CLinical Evaluation to Confirm SAfety & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Postoperative Recovery: FESS with Balloon Sinuplasty™ Devices Functional Endoscopic Dilatation of the Sinuses: Quality of Life, Pt Satisfaction, Postoperative Pain, and Cost Screen Left Note this screen stays up through the first set of data or until the next bar on this chart is added Note: Screen two

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

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.