New treatments for sinus disease
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New Treatments for Sinus Disease. San Francisco Otolaryngology Medical Group David Schindler, Brian Schindler, Jacob Johnson, Andrea Yeung, Theresa Kim. Definition – Rhinosinusitis . A group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses.

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New treatments for sinus disease

New Treatments for Sinus Disease

San Francisco Otolaryngology Medical Group

David Schindler, Brian Schindler, Jacob Johnson, Andrea Yeung, Theresa Kim

Definition rhinosinusitis

Definition – Rhinosinusitis

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

Reported Factors - Major

  • Mucopurulent drainage (anterior or posterior)

  • Nasal obstruction (congestion)

  • Facial pain-pressure fullness

  • Decreased sense of smell

Additional Examination

  • Nasal Endoscopy

  • Purulence

  • Edema, erythema

  • Polyps

  • CT imaging

  • Allergy and immune testing

“Clinical practice guideline: Adult sinusitis”

Rosenfeld et al., Otolaryngology–Head and Neck Surgery (2007) 137, S1-S31

Rhinosinusitis disease progression

Rhinosinusitis Disease Progression

Increasing symptom duration & frequency





  • Up to 4 weeks in duration

    • Purulent nasal discharge and/or

      • Nasal obstruction

      • Facial 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 Obstruction

    • Facial Pain-pressure-fullness

    • Decreased sense of smell

    • Pathology evident on endoscopic or CT examination

“Clinical practice guideline: Adult sinusitis”

Rosenfeld et al., Otolaryngology–Head and Neck Surgery (2007) 137, S1-S31

Rhinosinusitis disease model

Rhinosinusitis Disease Model

Natural Mucociliary

Transport and






Bone and tissue structure enable natural sinus clearance

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





Acute Sinusitis





Chronic Sinusitis/

Recurrent Acute Sinusitis

Acute sinusitis can progress to a recurrent or chronic disease state

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

1. Data on file

Anatomy of the sinuses

Anatomy of the Sinuses

Sino nasal filter

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


Sinus Drainage

Coronal ct scans for rhinosinusitis

2 Weeks Later, No Treatment

Acute Viral URI

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


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

New treatments for sinus disease

XoranMiniCAT CT Scanner

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

What are the goals of sinus surgery

What are the goals of Sinus Surgery?

  • Open blocked ostia to restore ventilation and to restore normal sinus function

    • Allows drainage and reversal of mucosal disease

  • 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

Sinus surgery has continued to evolve over time

90 years

20 years

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

  • 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

1893 - 1985

1985 - 2005

2005 - Present

Caldwell-Luc Antrostomy

Functional Endoscopic Sinus Surgery (FESS)

FESS w/ balloon catheters



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

New treatments for sinus disease

History – Sinus surgery prior to 1985

Caldwell-Luc Antrostomy

Intranasal Ethmoidectomy

Inferior Antrostomy

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

New treatments for sinus disease

Functional Endoscopic Sinus Surgery

1. Trans-nasal approach

2. More precise instrumentation

3. Image-guided navigation

  • Nasal approach reduces structural trauma

  • Microdebriders enable a more targeted dissection/resection process

  • 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

Functional Endoscopic Sinus Surgery

New treatments for sinus disease

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

    Balloon Sinuplasty™ Technology

    Fess balloon catheter cost in or

    FESS & Balloon Catheter Cost in OR



    Average Hospital Charges

    Balloon catheter devices (with balloon): $1,500

    Microdebrider and blades (without balloon): $500

    C-arm fluoroscopy (with balloon): $750

    Image-guidance (without balloon): $500

    OR time: $600 per 15 min

    PACU time: $300 per 15 min

    Friedman M, et al., Functional Endoscopic Dilatation of the Sinuses: Safety, Feasibility, Patient Satisfaction and Cost

    Am J Rhinol 2008; 22:204–9.

    Balloon catheter cost in or vs in office

    Balloon Catheter Cost in OR vs. in Office

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

    Current in office sinus procedures

    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 l avage

    Office Sinuplasty/ Sinus Lavage

    • Patient Selection and Tolerance

    Access sinus cavity

    Dilate natural ostium

    Directly irrigate sinus

    Remove system

    Patient selection typical profiles

    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 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, Cough

    New treatments for sinus disease

    Sino-nasal Innveration

    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)





    Ethmoid Block

    Operating room vs in office study

    Operating Room vs. In-Office Study

    Tolerability Rating

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

    Highly tolerable

    Not tolerated

    Operating room vs in office study1

    Operating Room vs. In-Office Study

    Pain Rating

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

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

    Intense Pain

    No Pain

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

    6 months

    1 year

    40 weeks

    2 years

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

    CLEAR Study

    PatiENT Registry

    No serious adverse events

    No serious adverse



    91.6% patency @ 1 yr

    2.4% patient

    revision rate




    SNOT-20 Score

    -1.30 @ 2 yr (1)

    95.2% symptom


    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

    The Old and the New – Paradigm shift

    Successful post-sinuplasty

    “big hole surgery”



    • 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

    Case 1: Acute Dental Rhinosinusitis

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

    Immune: Anaerobic infection (PCN allergy)

    Allergy: Pollen

    Structure: Dental implant

    Plan: L maxillary sinuplasty, Clindamycin and removal of implant

    Case 1 pearls

    Case 1 Pearls

    * Avoid sinusitis complications

    * Avoid anesthesia complications

    * PCN allergy & dental issues

    Case 2 fungal sinusitis

    Case 2: Fungal Sinusitis

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

    Kenneth D Faw MD Everen Sinus Center

    Mycetoma endoscopic case 2

    Mycetoma Endoscopic Case 2

    Kenneth D Faw MD Evergreen Sinus Center

    Case 2 pearls

    Case 2 Pearls

    * Calcifications on CT

    New treatments for sinus disease

    Case 3: Revision L Frontal and R Sphenoid Sinus

    KD, 2/26/09

    KD, 7/27/09

    Case 3 pearls

    Case 3 Pearls

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

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