1. CURRENT CONCEPTS IN THE MANAGEMENT OF CHRONIC SINUSITIS
Kevin D. Meakin, DO, FAOCO
Lakeview Medical Center
ENT & Allergy
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2. 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

3. 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

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 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
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 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

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 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

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. 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

29. 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

30. 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

31. 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

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

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

35. 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

36. 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
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37. 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
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As reported at the AAO-HNS Annual Meeting 2006

38. 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
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As reported at the AAO-HNS Annual Meeting 2006

39. 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

40. 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

41. 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

42. 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

43. 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

44. 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

45. 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 ( 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
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47. 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
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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
2 The CLinical Evaluation to Confirm SAfety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Study.