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

CURRENT CURRENT CONCEPTS IN THE CONCEPTS IN THE MANAGEMENT OF MANAGEMENT OF

CHRONIC CHRONIC SINUSITISSINUSITIS

Kevin D. Meakin, DO, Kevin D. Meakin, DO, FAOCOFAOCO

Lakeview Medical CenterLakeview Medical Center

ENT & AllergyENT & Allergy

Chronic Sinusitis

Economic Burden(2005 Inflation Adjusted)

$293M spent on Rx cold meds$7.8B direct and indirect costs

PrevalenceAfflicts 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 SinusitisQuality of life drives innovation

Anatomy Anatomy

8 sinuses8 sinuses 4 right and 4 left4 right and 4 left Maxillary, ethmoid, frontal, Maxillary, ethmoid, frontal,

sphenoidsphenoid Lined with a mucous membraneLined with a mucous membrane Communicate with the nasal cavityCommunicate with the nasal cavity

AnatomyAnatomy

Maxillary sinusesMaxillary sinuses 2 cells, right and left2 cells, right and left 15ml volume per side15ml volume per side Pneumatized at birthPneumatized at birth Fully developed by age 20Fully developed by age 20

AnatomyAnatomy Frontal sinusesFrontal sinuses

2 cells, right and left2 cells, right and left Pneumatize in middle childhoodPneumatize in middle childhood 7ml total volume per side7ml total volume per side

AnatomyAnatomy

Sphenoid sinusesSphenoid sinuses 2 cells, right and left2 cells, right and left Pneumatize in middle childhoodPneumatize in middle childhood Developed by 12-15 years of ageDeveloped by 12-15 years of age 7ml total volume7ml total volume

AnatomyAnatomy

Ethmoid sinusesEthmoid sinuses 3 or 4 cell at birth3 or 4 cell at birth The most dev sinus at birthThe most dev sinus at birth Adult size by age 12Adult size by age 12 10-15 cells per side in adult10-15 cells per side in adult 14-15 ml total volume14-15 ml total volume

AnatomyAnatomy

Physiology of the Nose and Physiology of the Nose and SinusesSinuses

Function of the sinus cavitiesFunction of the sinus cavities Humidify and warm inspired airHumidify and warm inspired air Assist in regulating intranasal pressureAssist in regulating intranasal pressure Increase the surface area of olfactory Increase the surface area of olfactory

membranesmembranes Lighten the skullLighten the skull Voice resonanceVoice resonance Shock absorber for the headShock absorber for the head Contribute to facial growthContribute to facial growth Evolutionary remains of useless spacesEvolutionary remains of useless spaces

Physiology of the Nose and Physiology of the Nose and SinusesSinuses

EpitheliumEpithelium Traps bacteriaTraps bacteria 50-200 cilia per cell, beat 10-20X/s50-200 cilia per cell, beat 10-20X/s Cells:Cells:

ciliated columnarciliated columnar non-ciliated microvillinon-ciliated microvilli goblet cellsgoblet cells basal cellsbasal cells submucosal glands - symp/parasym controlsubmucosal glands - symp/parasym control

Mucociliary Transport

Pathophysiology of Pathophysiology of SinusitisSinusitis

Related to 3 thingsRelated to 3 things Patency of ostiaPatency of ostia Function of ciliaFunction of cilia Quality of mucousQuality of mucous


Patency of ostiaPatency of ostia Acute and chronic inflammation Acute and chronic inflammation Allergic rhinitisAllergic rhinitis Nasal polypsNasal polyps Anatomic obstructionAnatomic obstruction

Function of the ciliaFunction of the cilia Quality of the mucousQuality of the mucous

Patency of ostia/omcPatency of ostia/omc


Patency of OstiaPatency of Ostia Function of cilia

Bacterial invasionBacterial invasion Quality of mucous layerQuality of mucous layer Ig deficiencyIg deficiency Squamous metaplasia-chronic infection, Squamous metaplasia-chronic infection,

surgerysurgery Low temperatureLow temperature Mucosal surfaces in contactMucosal surfaces in contact Primary ciliary defectsPrimary ciliary defects

Quality of MucousQuality of Mucous


Patency of the ostiaPatency of the ostia Function of the ciliaFunction of the cilia Quality of mucousQuality of mucous

PollutentsPollutents AllergensAllergens Low oxygen tension- Blocked sinus ostiumLow oxygen tension- Blocked sinus ostium Irritants- too much mucousIrritants- too much mucous Cold environmentCold environment Loss of the normal mucosal lining-scar, Loss of the normal mucosal lining-scar,

stripping, chronic dz, high air flowstripping, chronic dz, high air flow DehydrationDehydration Low humidityLow humidity

Sinusitis OverviewSinusitis Overview

Acute sinusitisAcute sinusitis Symptoms < 4 weeksSymptoms < 4 weeks

Chronic sinusitisChronic sinusitis Symptoms > 3 months Symptoms > 3 months Chronic sinusitis is a Chronic sinusitis is a

disease in which the disease in which the mucosal damage is no mucosal damage is no longer reversible longer reversible without surgery despite without surgery despite appropriate medical appropriate medical therapytherapy

Acute SinusitisAcute Sinusitis Diagnosis of acute sinusitisDiagnosis of acute sinusitis

2 major criteria2 major criteria 1 major, 2 minor criteria1 major, 2 minor criteria

History “suggestive”History “suggestive” 1 major criterion1 major criterion 2 minor criterion2 minor criterion

Symptoms longer than 10 days or Symptoms longer than 10 days or worsening after 5-7 daysworsening after 5-7 days

Acute SinusitisAcute Sinusitis

Major criteriaMajor criteria Facial pain/pressureFacial pain/pressure Facial congestion/fullnessFacial congestion/fullness Nasal obstruction/blockageNasal obstruction/blockage Nasal discharge/postnasal drainageNasal discharge/postnasal drainage Hyposmia/anosmiaHyposmia/anosmia Observed nasal purulence on examObserved nasal purulence on exam

Mechanism of Chronic Mechanism of Chronic SinusitisSinusitis

Anatomic FactorsAnatomic Factors

Chronic SinusitisChronic Sinusitis

Immune FactorsImmune Factors

Microbial FactorsMicrobial Factors

Acute SinusitisAcute Sinusitis

Mucosal SurfaceMucosal Surface

MucociliaryTransport and

Drainage

MucociliaryTransport and

Drainage

Allergic FactorsAllergic Factors

Ostial patencyOstial patency

Treatment optionsTreatment options Medical therapyMedical therapy

AntibioticsAntibiotics MucolyticsMucolytics Decongestants- Oral, topical (3 days only)Decongestants- Oral, topical (3 days only) Nasal saline irrigationNasal saline irrigation Address allergic componentAddress allergic component

Steroids- nasal/oralSteroids- nasal/oral Antihistamines only if allergic symptomsAntihistamines only if allergic symptoms Allergy testing and/or immunotherapy Allergy testing and/or immunotherapy

SurgerySurgery FESSFESS SinuplastySinuplasty

Medical TherapyMedical 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/SMXTMP/SMX Respiratory quinolones: Levaquin, Tequin, Respiratory quinolones: Levaquin, Tequin,

AveloxAvelox

History of sinus surgeryHistory of sinus surgery

Initially done with a headlight through the Initially done with a headlight through the nosenose

or externallyor externally Endoscopic using blunt Endoscopic using blunt

instruments/curettesinstruments/curettes Endoscopic using thru-cut and powered Endoscopic using thru-cut and powered

instrumentsinstruments Minimal surgeryMinimal surgery Mucosal preservationMucosal preservation

Image guidance added accuracy and safetyImage guidance added accuracy and safety SinuplastySinuplasty

FESSFESS

Functional Endoscopic Sinus Surgery

Restoration of normal aeroation and mucociliary clearance

Image GuidanceImage Guidance

Ethmoid Cells

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

Traditional Treatment Traditional Treatment OptionsOptions

Medical therapies – the Medical therapies – the usual 1st line of treatmentusual 1st line of treatment Medications have Medications have advancedadvanced Basic remediesBasic remedies

Array of specialized drugsArray of specialized drugs Sophisticated delivery Sophisticated delivery

methodsmethods EffectiveEffective

Reducing mucosal swellingReducing mucosal swelling Relieving sinus obstructionsRelieving sinus obstructions Promoting drainagePromoting drainage

Inherent limitationsInherent limitations 20-25% patients may not 20-25% patients may not

respond or relapse after 1-2 respond or relapse after 1-2 intensive cycles intensive cycles

ExpensiveExpensive Patient compliancePatient compliance Potential for side effectsPotential for side effects

1.4M Patients

Traditional Treatment Traditional Treatment OptionsOptions

Surgical techniquesSurgical techniques Evolution of sinus surgeryEvolution of sinus surgery

From open to less invasive surgery From open to less invasive surgery (FESS)(FESS)

Introduction of endoscopic toolsIntroduction of endoscopic tools Discovery that blocked sinus ostia may Discovery that blocked sinus ostia may

be the primary culprit of this disease be the primary culprit of this disease processprocess

Goals of FESSGoals of FESS Clear blocked sinusesClear blocked sinuses Restore normal sinus drainage and Restore normal sinus drainage and

functionfunction Preserve normal anatomy and mucosal Preserve normal anatomy and mucosal

tissuetissue Inherent limitationsInherent limitations

Removal of bone and tissue may lead to Removal of bone and tissue may lead to post-op pain, scarring, and bleedingpost-op pain, scarring, and bleeding

Nasal packing may be used to control Nasal packing may be used to control bleedingbleeding

Delay in return to work or lifestyleDelay in return to work or lifestyle

330K Patients

1.4M Patients

Balloon SinuplastyBalloon Sinuplasty™™ TechnologyTechnology

Further Evolving Sinus Further Evolving Sinus SurgerySurgery The The Relieva Relieva

Balloon Balloon SinuplastySinuplasty™™ devices are devices are endoscopic tools endoscopic tools and may be used and may be used with other with other medical medical therapies or therapies or FESS techniquesFESS techniques

Marry Endoscopic Techniques Marry Endoscopic Techniques with New Technologieswith New Technologies

Advancements In Surgical Advancements In Surgical Devices ContinuesDevices Continues

Relieva Balloon Relieva Balloon SinuplastySinuplasty™™ devices devices

Designed for customized accessDesigned for customized access Sinus GuidewireSinus Guidewire Sinus Guide Catheter Sinus Guide Catheter

Engineered for sinus dilationEngineered for sinus dilation Sinus Balloon CatheterSinus Balloon Catheter

Developed for controlled Developed for controlled inflationinflation

Sinus Balloon Inflation DeviceSinus Balloon Inflation Device

Step OneStep OneGain initial access and deliver Gain initial access and deliver

the Relieva™ Sinus Balloon the Relieva™ Sinus Balloon CatheterCatheter

Images provided by Frederick Kuhn, MD

Step Two - Step Two - Endoscopic viewEndoscopic viewPlace the Relieva™ Sinus Place the Relieva™ Sinus

Balloon Catheter across the Balloon Catheter across the ostiumostium

Images provided by Frederick Kuhn, MD

Step ThreeStep ThreeDeflate and remove the Relieva Deflate and remove the Relieva

Balloon Balloon

Frontal Sinus DilationFinal endoscopic image

Frontal sinusPost-procedure CT scanImages provided by Frederick Kuhn, MD

CLinical Evaluation to CLinical Evaluation to Confirm SAfety & EfficacyConfirm SAfety & Efficacy

of Sinuplasty in the of Sinuplasty in the PaRanasal Sinuses (CLEAR)PaRanasal Sinuses (CLEAR)

A multi-center, non-randomized, prospective A multi-center, non-randomized, prospective evaluation of 115 patients/358 sinuses treated evaluation of 115 patients/358 sinuses treated with balloon dilationwith balloon dilation

Study objectivesStudy objectives Confirm safety in a larger patient cohortConfirm safety in a larger patient cohort Evaluate efficacy of balloon catheter dilation Evaluate efficacy of balloon catheter dilation

in achieving and maintaining sinus ostia in achieving and maintaining sinus ostia patencypatency

Gain insight into balloon catheter technology Gain insight into balloon catheter technology to relieve patient’s symptoms to relieve patient’s symptoms

CLinical Evaluation to Confirm SAfety & CLinical Evaluation to Confirm SAfety & EfficacyEfficacy

of Sinuplasty in the PaRanasal Sinuses of Sinuplasty in the PaRanasal Sinuses (CLEAR)(CLEAR)

Site selectionSite selection 9 sites - US and Australia9 sites - US and Australia Independent IRB-approvalsIndependent IRB-approvals

Study designStudy design Safety Safety

Assessed by the rate of adverse eventsAssessed by the rate of adverse events EfficacyEfficacy

Ability to cannulate and dilate ostia Ability to cannulate and dilate ostia Endoscopic patency examination: 1, 12, 24 weeksEndoscopic patency examination: 1, 12, 24 weeks

QOL / Patient outcomes QOL / Patient outcomes SNOT-20: Baseline, 1, 12, 24 weeksSNOT-20: Baseline, 1, 12, 24 weeks Standardized patient questionnaire: 1, 12, 24 weeksStandardized patient questionnaire: 1, 12, 24 weeks

As reported at the AAO-HNS Annual Meeting 2006



MethodsMethods A prospective, multi-center, non-randomized A prospective, multi-center, non-randomized

evaluation was conducted in patients with chronic evaluation was conducted in patients with chronic sinusitis sinusitis

Patients for whom endoscopic sinus surgery was Patients for whom endoscopic sinus surgery was recommended were offered treatment with the recommended were offered treatment with the balloon catheter devicesballoon catheter devices

Balloon instrumentation used for maxillary, frontal, Balloon instrumentation used for maxillary, frontal, sphenoid sinuses at discretion of the investigatorsphenoid sinuses at discretion of the investigator

Ethmoid treated with current endoscopic forceps Ethmoid treated with current endoscopic forceps and microdebrider concurrently if indicatedand microdebrider concurrently if indicated




Inclusion CriteriaInclusion Criteria 18 years of age or older18 years of age or older Diagnosed with chronic sinusitis that is not responsive to Diagnosed with chronic sinusitis that is not responsive to

medical management.medical management. Planned endoscopic sinus surgery (recommended by Planned endoscopic sinus surgery (recommended by

physician and consented to by patient)physician and consented to by patient) Exclusion CriteriaExclusion Criteria

Extensive sinonasal polypsExtensive sinonasal polyps Previous extensive sinonasal surgeryPrevious extensive sinonasal surgery Extensive sinonasal osteoneogenesisExtensive sinonasal osteoneogenesis Diagnosed with Sampter’s Triad- Asthma, Polyps, ASADiagnosed with Sampter’s Triad- Asthma, Polyps, ASA Sinonasal tumors or other obstructive lesionsSinonasal tumors or other obstructive lesions History of facial trauma that distorts sinus anatomy and History of facial trauma that distorts sinus anatomy and

precludes access to the sinus ostiumprecludes access to the sinus ostium Ciliary dysfunctionCiliary dysfunction Cystic fibrosisCystic fibrosis The patient is pregnantThe patient is pregnantAs reported at the AAO-HNS Annual Meeting 2006



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

The CLEAR StudyThe CLEAR Study

Results Summary Results Summary SafetySafety

No serious adverse events occurred during No serious adverse events occurred during studystudy

EfficacyEfficacy 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 outcomesPatient outcomes SNOT-20 scores demonstrated clinically and SNOT-20 scores demonstrated clinically and

statistically significant difference from baseline statistically significant difference from baseline at all time pointsat all time points


0% 20% 40% 60% 80% 100%

24 weeks

12 weeks

1 week

Observed Ostial Patentcy Rate Out to 24 weeks

Non-patent 3% 3% 2%

Patent 97% 97% 98%

24 weeks 12 weeks 1 week

N = 341

N = 269

N = 307



Observed patency: Patency rate of the ostia technically able to be visualized endoscopically




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.

0.00 0.50 1.00 1.50 2.00

24 weeks

12 weeks

1 week

Baseline

SNOT-20Quality of Life

SNOT-20 (Mean) 1.09 1.07 1.39 2.25

24 weeks 12 weeks 1 week Baseline

**

*

*p<.0001




Type of Type of EventEvent

FrequencFrequencyy

DescriptionDescription

MildMild 00 nasal bleeding requiring packing nasal bleeding requiring packing or interventionor intervention

ModerateModerate 00 periorbital swelling or bruising, periorbital swelling or bruising, moderate painmoderate pain

SevereSevere 00

cerebrospinal fluid leak, orbital cerebrospinal fluid leak, orbital hematoma, visual loss, loss of hematoma, visual loss, loss of sense of smell, nasolacrimal duct sense of smell, nasolacrimal duct injury, orbital entry/injury, injury, orbital entry/injury, severe pain. severe pain.

There were no serious adverse events There were no serious adverse events 9 events of bacterial sinusitis post dilation : 9 events of bacterial sinusitis post dilation :

resolved with antibiotic treatmentresolved with antibiotic treatmentAs reported at the AAO-HNS Annual Meeting 2006


of Sinuplasty in the PaRanasal Sinuses of Sinuplasty in the PaRanasal Sinuses (CLEAR)(CLEAR) Additional study dataAdditional study data

Median radiation Median radiation Average 3.1 sinuses per patientAverage 3.1 sinuses per patient Fluoro time per sinus: 0.81 minutesFluoro time per sinus: 0.81 minutes Mean dose per patient: 730 mremMean dose per patient: 730 mrem

Head CT scan (200 mrem)Head CT scan (200 mrem) Annual natural background radiation in the US Annual natural background radiation in the US

(300 mrem)(300 mrem) Chest CT (800 mrem) Chest CT (800 mrem) Coronary angiogram (460-1580 mrem) Coronary angiogram (460-1580 mrem) Angioplasty (750-5,700 mrem) Angioplasty (750-5,700 mrem)


Clinical Program Clinical Program SummarySummary

The The Balloon SinuplastyBalloon Sinuplasty™ technology has ™ technology has undergone vigorous development and clinical undergone vigorous development and clinical validationvalidation

The technology is shown to be safe, effective and The technology is shown to be safe, effective and a viable alternative for widening selected ostia a viable alternative for widening selected ostia currently targeted for classic FESS currently targeted for classic FESS instrumentationinstrumentation One-year follow-up on CLEAR patients is ongoingOne-year follow-up on CLEAR patients is ongoing

Clinical assessment ongoing through surgeon Clinical assessment ongoing through surgeon initiated trialsinitiated trials

Surgeon training and patient care continues to Surgeon training and patient care continues to expandexpand

Note: Screen two

Catheter-Based Dilation of the Sinus Ostia: Initial Safety & Feasibility Analysis in a Cadaver Model

Safety & Feasibility of Balloon Catheter Dilatationof 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

Final thoughts….Final thoughts….

Chronic sinusitis is highly prevalent Chronic sinusitis is highly prevalent among our patientsamong our patients

Medical therapies & FESS may be Medical therapies & FESS may be effective in some patientseffective in some patients 600,000 people are left living with their 600,000 people are left living with their

sinus condition sinus condition

Final thoughts….Final thoughts…. Balloon SinuplastyBalloon Sinuplasty™™ technology offers a technology offers a

novel, endoscopic catheter based novel, endoscopic catheter based approachapproach Minimally invasiveMinimally invasive Safe and effectiveSafe and effective Reduced bleedingReduced bleeding Improved recovery timeImproved recovery time Does not limit treatment optionsDoes not limit treatment options Clinically establishedClinically established1,21,2

Now, there is new hope in relief for your Now, there is new hope in relief for your chronic sinusitis patients 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.

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

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