New Treatments for Sinus Disease

San Francisco Otolaryngology Medical GroupDavid Schindler, Brian Schindler, Jacob Johnson, Andrea Yeung, Theresa Kim

Definition – Rhinosinusitis

Mucopurulent drainage (anterior or posterior) Nasal obstruction (congestion) Facial pain-pressure fullness Decreased sense of smell

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Reported Factors - Major

A group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses

• Nasal Endoscopy– Purulence– Edema, erythema– Polyps

• CT imaging

• Allergy and immune testing

Additional Examination

“Clinical practice guideline: Adult sinusitis”Rosenfeld et al., Otolaryngology–Head and Neck Surgery (2007) 137, S1-S31

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• Up to 4 weeks in duration

• Purulent nasal discharge and/orNasal obstructionFacial pain-pressure-

fullness

• 4-12 Weeks in duration

• Symptoms as in acute disease

• 4+ episodes/yr, 10+ days in duration or worsening symptoms within 10 days of onset

• Symptoms as in acute disease

• 12+ weeks in duration

• 2+ symptoms

Mucopurulent drainage

Nasal ObstructionFacial Pain-pressure-

fullnessDecreased sense of

smell

• Pathology evident on endoscopic or CT examination

Acute Subacute Recurrent Chronic

Increasing symptom duration & frequency

Rhinosinusitis Disease Progression

“Clinical practice guideline: Adult sinusitis”Rosenfeld et al., Otolaryngology–Head and Neck Surgery (2007) 137, S1-S31

Rhinosinusitis Disease ModelBone and tissue structure enable natural sinus clearance

AnatomicFactors

Chronic Sinusitis/ Recurrent Acute Sinusitis

ImmuneFactors

MicrobialFactors

Acute Sinusitis

MucosalSurface

Natural MucociliaryTransport and

Drainage

AllergicFactors

BonyScaffold

Multiple factors can impair mucociliary clearance, hindering or stopping normal drainage of the sinuses

Acute sinusitis can progress to a recurrent or chronic disease state

Although medical management is adequate for ~80-90%1 of patients; recalcitrant disease may require surgical treatment

1. Data on file

Anatomy of the Sinuses

Sino-nasal Filter

Sinus Drainage

• Sinusitis is a medical disease until ostial restriction cannot be reversed by medical treatment

• Surgical Intervention in Disease Progression

– Anatomy- Filtering system– Allergy/ Inflammation– Immune

Diagnosis Targeted historyPhysical examinationAnterior rhinoscopyTransilluminationNasal endoscopyCulture of the NC, MMAntral puncture

Imaging proceduresBlood testsAllergy evaluation and testingImmune function testingGastroesophageal refluxPulmonary function testsMucocilliary dysfunction tests

Treatment ObservationSystemic antibioticsTopical antibioticsOral/topical steroidsSystemic/topical decongestantsAntihistaminesMucolytics

Leukotriene modifiersNasal saline irrigations/lavageAnalgesicsComplementary/alternative medPostural drainage/heatAntral puncture and lavageSinus surgery

Prevention Topical steroidsImmunotherapyNasal lavageSmoking cessationHygeine

EducationPneumococcal vaccinationInfluenza vaccinationEnvironmental controls

Coronal CT Scans for Rhinosinusitis• Indicated for:

– questions of diagnosis &/or therapy– strong history & not responding to therapy– extrasinus spread of infection– in chronic RS, after 4 weeks or more of appropriate therapy– prior to sinus surgery

• Timing of CT scan– Note in acute viral URIs that 87% of sinus CTs are positive, & 21% remain so 2 weeks after clinical

resolution

Source: Gwaltney J, et al. N Engl J Med 1994;330:25–30.

Acute Viral URI 2 Weeks Later, No Treatment

10-40 secondsOnline access for outside providersIndependent review from outside radiology0.04-0.17 msv of radiation vs 2msv in traditional CT sinus

XORAN MINICAT CT SCANNER

What are the goals of Sinus Surgery?

1. Open blocked ostia to restore ventilation and to restore normal sinus function• Allows drainage and reversal of mucosal disease

2. Preserve as much normal anatomy and mucosa as possible• Promotes faster healing• Reduces the inflammatory response• Improves surgical outcomes

Sinus surgery has continued to evolve over time

1893 - 1985

90 years 20 years

Caldwell-Luc Antrostomy

Functional Endoscopic Sinus Surgery (FESS)

FESS w/ balloon catheters

1985 - 2005 2005 - Present

1. The advent of FESS in 1985 allowed for sinus surgery without traumatic trans-antral penetration or inferior antrostomies1

2. Recent advances in instrumentation enable ENT surgeons to perform FESS without traumatic bone resection or mucosal stripping Drainage via natural ostia can be restored in a minimally-invasive manner2

1 2

1. DW Kennedy, “Functional Endoscopic Sinus Surgery”Arch Otolaryngol. 1985;111(10):643-649.2. Weiss et. Al, “Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients”Otolaryngology-Head and Neck Surgery (2007) 137, 10-20

Caldwell-Luc Antrostomy

Intranasal Ethmoidectomy

History – Sinus surgery prior to 1985

Inferior Antrostomy

Prior to the advent of FESS, sinus surgery was highly disruptive to natural structures in the face and nasal cavity

3. Image-guided navigation

2. More precise instrumentation

1. Trans-nasal approach

Functional Endoscopic Sinus Surgery

1. Nasal approach reduces structural trauma2. Microdebriders enable a more targeted dissection/resection process3. Image guidance reduces uncertainty during approach to treatment site

FESS significantly reduced the invasiveness of sinus surgery, and it continues to evolve today

Functional Endoscopic Sinus Surgery

The paradox between the goals and the application of Functional Endoscopic Sinus Surgery

– First goal, to open blocked sinuses, is usually achieved at the expense of

– The second goal, the preservation of normal anatomy and mucosa.

• The flexible instruments of the balloon technology platform provide tools designed to navigate the complex paranasal anatomy and to achieve ostial dilation with minimal intervention .

• Preserving the filtering function of the nose.

Balloon Sinuplasty™ Technology

Friedman M, et al., Functional Endoscopic Dilatation of the Sinuses: Safety, Feasibility, Patient Satisfaction and CostAm J Rhinol 2008; 22:204–9.

FESS with balloon FESS without balloonp-value

N Cost N Cost

All cases 35 $12,656.57 35 $14,471.14 p=0.013

Revision cases 13 $10,346.15 12 $16,190.00 p<0.0001

Average Hospital ChargesBalloon catheter devices (with balloon): $1,500

Microdebrider and blades (without balloon): $500C-arm fluoroscopy (with balloon): $750Image-guidance (without balloon): $500

OR time: $600 per 15 minPACU time: $300 per 15 min

FESS & Balloon Catheter Cost in OR

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2

Balloon Catheter Cost in OR vs. in Office

IO Costsn=35

OR Costs n=33

Mean Median Mean Median

Materials and Supplies* $2,299 305.0 $2,190 $4,799 4,679 $2,291

Facility Costs^Procedure Room

PACU

$201.0 57.23$201.0 57.2

NA

$190.4$190.4

NA

$7,065 4,420 $5,815 3,648 $1,250 1,185

$5,744 5,196

775.5

Anesthesia Anesthesia Service

$42.65 61.3NA

$15.4NA

$1,171 851.5 $910.0 653.0

$714.1 551.9

Other** $439.8 2,227 -- -- --

Total $2,983 2,219 $2,500 $13,035 7,120 $12,719

**Other includes the cost related to OR treatment for cross-over patients.

Current in Office Sinus Procedures

Office procedures to understand/ influence anatomy:• Endoscopy• CT sinus• Proetz sinus displacement• Maxillary sinus tap• Office Sinuplasty/ sinus lavage• Inferior Turbinate reduction• Nasal Polypectomy

Office Sinuplasty/ Sinus Lavage

• Patient Selection and Tolerance

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Access sinus cavity Dilate natural ostium Directly irrigate sinus Remove system

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Patient Selection – Typical profiles

• Chronic maxillary, frontal, sphenoid sinusitis• Revision cases with scarring. Incomplete outflow tract

obstruction• Chronic sinusitis with need for lavage • Avoid:

– Cases with extremely complex anatomy, complete scar occlusion, etc

– Cases requiring significant ancillary procedures (e.g. turbinectomy, septoplasty)

– Patients with anxiety, claustrophobia, low pain threshold

Patient Selection

• Patient Motivation– Cash pay patients– Primary vs. Revision Cases– Anesthesia concerns

• Patient Tolerance– Dental procedure tolerance

• Patient Anatomy– Deviated Nasal Septum (3 mm)– Inferior Turbinate– Uncinate Process– Ethmoid Bulla– Nasal Polyps– Middle Turbinate: Scar bands,

Lateralized Middle Turbinate, Concha Bullosa

– Image guidance

• Patient General Health– Monitoring, Bleeding, Cardio-

pulmonary status, Cough24

OR Office

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Anterior Ethmoid Block

Spheno-palatine Block

Nerve Block for Local Anesthesia

Anesthesia Options

• Oral (valium, optional)

•Sprays (pontocaine, ephedrine 1%, afrin)

• Injection (lidocaine with epinephrine 7mg/kg)

• Nerve block (ethmoid, sphenopalatine)

Sino-nasal Innveration

Operating Room vs. In-Office Study

31.8%

50.0%

13.6%

4.5%0.0% 0.0%

5 4 3 2 1 0

Highly tolerable

Not tolerated

Tolerability Rating

95% of respondents rated in-office procedure as tolerable or better

Operating Room vs. In-Office Study

No Pain Intense Pain

• 70% reported pain as Low Intensity (0-2) during balloon inflation

• No correlation between type of local anesthetic used and pain level

Pain Rating

Multicenter registry confirms findings of CLEAR 24 week, 1 and 2 year studies

PatientSatisfaction

Safety

Efficacy

CLEAR Study

SNOT-20 Score-1.30 @ 2 yr (1)

No serious adverse events

91.6% patency @ 1 yr

2 years6 months 1 year 40 weeks

No serious adverse events

2.4% patientrevision rate

95.2% symptom improvement

PatiENT Registry

Levine, HL, et al, “Multicenter Registry of Balloon Catheter Sinusotomy Outcomes for 1,036 Patients.” Annals of Otology, Rhinology & Laryngology. April 2008; Vol. 117(4): 263-270.

The Old and the New – Paradigm shift

“big hole surgery”

Successful post-sinuplasty

Summary• In a small percentage of patients, rhinosinusitis becomes a recurrent or chronic disease which

is refractory to medical management.

• There has been an evolution of sinus procedures to improve sinus drainage in medically refractory rhinosinusitis.

• Functional Endoscopic Sinus Surgery (FESS) has advanced the management of chronic rhinosinusitis.

• Current research is exploring the limitations of traditional rigid instrumentation in FESS.

• FESS with balloon catheters offers a minimally-invasive way to achieve classic sinus surgery goals.

• Balloon catheters and other office based procedures are now available to improve medically refractory rhinosinusitis.

Case 1: Acute Dental Rhinosinusitis

Immune: Anaerobic infection (PCN allergy)Allergy: PollenStructure: Dental implantPlan: L maxillary sinuplasty, Clindamycin and removal of implant

81 yo female with L acute face pain and yellow dc after dental procedure

Case 1 Pearls

* Avoid sinusitis complications* Avoid anesthesia complications* PCN allergy & dental issues

Case 2: Fungal Sinusitis

Kenneth D Faw MD Everen Sinus Center

83 yo female with Crohn’s disease and on Coumadin for coronary issues

Mycetoma Endoscopic Case 2

Kenneth D Faw MD Evergreen Sinus Center

Case 2 Pearls

* Calcifications on CT

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KD, 2/26/09

Case 3: Revision L Frontal and R Sphenoid Sinus KD, 7/27/09

Case 3 Pearls

* Post op care and need for revisions -avoid surgery complications and take backs