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

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Presentation on theme: "CURRENT CONCEPTS IN THE MANAGEMENT OF CHRONIC SINUSITIS Kevin D. Meakin, DO, FAOCO Lakeview Medical Center ENT & Allergy."— Presentation transcript:

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

2 Chronic Sinusitis Economic Burden (2005 Inflation Adjusted) $293M spent on Rx cold meds $7.8B direct and indirect costs Prevalence Afflicts estimated 37MM U.S. 1 More common arthritis or hypertension Quality of Life > impact than diabetes or CHF 1 National Institute of Allergy and Infectious Diseases Chronic Sinusitis Quality of life drives innovation

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

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

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

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

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

8 Anatomy

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

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

11 Mucociliary Transport

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

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

14 Patency of ostia/omc

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

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

17 Sinusitis Overview Acute sinusitis Acute sinusitis Symptoms < 4 weeks Symptoms < 4 weeks Chronic sinusitis Chronic sinusitis Symptoms > 3 months Symptoms > 3 months Chronic sinusitis is a disease in which the mucosal damage is no longer reversible without surgery despite appropriate medical therapy 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 Diagnosis of acute sinusitis 2 major criteria 2 major criteria 1 major, 2 minor criteria 1 major, 2 minor criteria History suggestive History suggestive 1 major criterion 1 major criterion 2 minor criterion 2 minor criterion Symptoms longer than 10 days or worsening after 5-7 days Symptoms longer than 10 days or worsening after 5-7 days

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

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

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

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

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

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

25

26 Image Guidance

27 Ethmoid Cells Supraorbital, Frontal Bulla, Concha Bullosa, Hallers, Onodi Cells

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

29 Traditional Treatment Options Surgical 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 330K Patients 1.4M Patients

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 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

32

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 A multi-center, non-randomized, prospective evaluation of 115 patients/358 sinuses treated with balloon dilation Study objectives Study objectives Confirm safety in a larger patient cohort Confirm safety in a larger patient cohort Evaluate efficacy of balloon catheter dilation in achieving and maintaining sinus ostia patency Evaluate efficacy of balloon catheter dilation in achieving and maintaining sinus ostia patency Gain insight into balloon catheter technology to relieve patients symptoms Gain insight into balloon catheter technology to relieve patients symptoms

37 CLinical Evaluation to Confirm SAfety & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Site selection Site selection 9 sites - US and Australia 9 sites - US and Australia Independent IRB-approvals Independent IRB-approvals Study design Study design Safety Safety Assessed by the rate of adverse events Assessed by the rate of adverse events Efficacy Efficacy Ability to cannulate and dilate ostia Ability to cannulate and dilate ostia Endoscopic patency examination: 1, 12, 24 weeks Endoscopic patency examination: 1, 12, 24 weeks QOL / Patient outcomes QOL / Patient outcomes SNOT-20: Baseline, 1, 12, 24 weeks SNOT-20: Baseline, 1, 12, 24 weeks Standardized patient questionnaire: 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 & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Methods Methods A prospective, multi-center, non-randomized evaluation was conducted in patients with chronic sinusitis 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 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 Balloon instrumentation used for maxillary, frontal, sphenoid sinuses at discretion of the investigator Ethmoid treated with current endoscopic forceps and microdebrider concurrently if indicated 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 & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Inclusion Criteria Inclusion Criteria 18 years of age or older 18 years of age or older Diagnosed with chronic sinusitis that is not responsive to medical management. Diagnosed with chronic sinusitis that is not responsive to medical management. Planned endoscopic sinus surgery (recommended by physician and consented to by patient) Planned endoscopic sinus surgery (recommended by physician and consented to by patient) Exclusion Criteria Exclusion Criteria Extensive sinonasal polyps Extensive sinonasal polyps Previous extensive sinonasal surgery Previous extensive sinonasal surgery Extensive sinonasal osteoneogenesis Extensive sinonasal osteoneogenesis Diagnosed with Sampters Triad- Asthma, Polyps, ASA Diagnosed with Sampters Triad- Asthma, Polyps, ASA Sinonasal tumors or other obstructive lesions Sinonasal tumors or other obstructive lesions History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium Ciliary dysfunction Ciliary dysfunction Cystic fibrosis Cystic fibrosis The patient is pregnant The patient is pregnant As reported at the AAO-HNS Annual Meeting 2006

40 CLinical Evaluation to Confirm SAfety & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Patient Demographics & Flow Patient Demographics & Flow Age : Average = 47.8 years (range of 21-76) Age : Average = 47.8 years (range of 21-76) Gender : 41 male, 74 female Gender : 41 male, 74 female Patients with a history of prior FESS : 21 patients (18.3%) Patients with a history of prior FESS : 21 patients (18.3%) 1 sinus exited (personal decision) ENTERED STUDY 115 patients / 358 sinuses SUCCESSFULLY TREATED 109 patients / 342 sinuses 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 Results Summary Safety Safety No serious adverse events occurred during study No serious adverse events occurred during study Efficacy Efficacy Overall patency at 24-weeks - 81% Overall patency at 24-weeks - 81% Observed patency at 24-weeks - 98% Observed patency at 24-weeks - 98% Patient outcomes Patient outcomes SNOT-20 scores demonstrated clinically and statistically significant difference from baseline at all time points 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 & 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) Clinically 1 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. * * * *p<.0001 As reported at the AAO-HNS Annual Meeting 2006

44 CLinical Evaluation to Confirm SAfety & Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Type of Event FrequencyDescription Mild0 nasal bleeding requiring packing or intervention Moderate0 periorbital swelling or bruising, moderate pain Severe0 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 Additional study data Median radiation Median radiation Average 3.1 sinuses per patient Average 3.1 sinuses per patient Fluoro time per sinus: 0.81 minutes Fluoro time per sinus: 0.81 minutes Mean dose per patient: 730 mrem Mean dose per patient: 730 mrem Head CT scan (200 mrem) Head CT scan (200 mrem) Annual natural background radiation in the US (300 mrem) Annual natural background radiation in the US (300 mrem) Chest CT (800 mrem) Chest CT (800 mrem) Coronary angiogram ( mrem) Coronary angiogram ( mrem) Angioplasty (750-5,700 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 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 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 One-year follow-up on CLEAR patients is ongoing Clinical assessment ongoing through surgeon initiated trials Clinical assessment ongoing through surgeon initiated trials Surgeon training and patient care continues to expand Surgeon training and patient care continues to expand

47 Note: Screen two 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

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

49 Final thoughts…. Balloon Sinuplasty technology offers a novel, endoscopic catheter based approach Balloon Sinuplasty technology offers a novel, endoscopic catheter based approach Minimally invasive Minimally invasive Safe and effective Safe and effective Reduced bleeding Reduced bleeding Improved recovery time Improved recovery time Does not limit treatment options Does not limit treatment options Clinically established 1,2 Clinically established 1,2 Now, there is new hope in relief for your chronic sinusitis patients 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 The CLinical Evaluation to Confirm SAfety and Efficacy of Sinuplasty in the PaRanasal Sinuses (CLEAR) Study.


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