CURRENT CONCEPTS IN THE MANAGEMENT OF CHRONIC SINUSITIS Kevin D. Meakin, DO, FAOCO Lakeview Medical...
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Transcript of 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
Pathophysiology of Pathophysiology of SinusitisSinusitis
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
Pathophysiology of Pathophysiology of SinusitisSinusitis
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
Pathophysiology of Pathophysiology of SinusitisSinusitis
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
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)
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
As reported at the AAO-HNS Annual Meeting 2006
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)
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
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)
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
As reported at the AAO-HNS Annual Meeting 2006
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
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)
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 & CLinical Evaluation to Confirm SAfety & EfficacyEfficacy
of Sinuplasty in the PaRanasal Sinuses of Sinuplasty in the PaRanasal Sinuses (CLEAR)(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.
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
As reported at the AAO-HNS Annual Meeting 2006
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)
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
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) 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)
As reported at the AAO-HNS Annual Meeting 2006
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.