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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

Acute

Subacute

Recurrent

Chronic

  • 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

Drainage

Bony

Scaffold

Mucosal

Surface

Bone and tissue structure enable natural sinus clearance

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

Anatomic

Factors

Microbial

Factors

Acute Sinusitis

Allergic

Factors

Immune

Factors

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




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

Sinus Drainage


Coronal ct scans for rhinosinusitis

2 Weeks Later, No Treatment cannot be reversed by medical 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

      resolution

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


Xoran cannot be reversed by medical treatmentMiniCAT 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? cannot be reversed by medical treatment

  • 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 cannot be reversed by medical treatment

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

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


History – Sinus surgery prior to 1985 cannot be reversed by medical treatment

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


Functional cannot be reversed by medical treatmentEndoscopic 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 cannot be reversed by medical treatment


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 Functional Endoscopic Sinus Surgery™ Technology


    Fess balloon catheter cost in or
    FESS & Balloon Catheter Cost in OR Functional Endoscopic Sinus Surgery

    1

    2

    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 Functional Endoscopic Sinus Surgery

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


    Current in office sinus procedures
    Current in Office Sinus Procedures Functional Endoscopic Sinus Surgery

    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 Functional Endoscopic Sinus SurgeryLavage

    • Patient Selection and Tolerance

    Access sinus cavity

    Dilate natural ostium

    Directly irrigate sinus

    Remove system


    Patient selection typical profiles
    Patient Selection – Typical profiles Functional Endoscopic Sinus Surgery

    • 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 Functional Endoscopic Sinus Surgery

    OR

    Office

    • 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


    Sino-nasal Innveration Functional Endoscopic Sinus Surgery

    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)

    Spheno-

    palatine

    Block

    Anterior

    Ethmoid Block


    Operating room vs in office study
    Operating Room vs. In-Office Study Functional Endoscopic Sinus Surgery

    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 Functional Endoscopic Sinus Surgery

    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 Functional Endoscopic Sinus Surgery

    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

    events

    Safety

    91.6% patency @ 1 yr

    2.4% patient

    revision rate

    Efficacy

    Patient

    Satisfaction

    SNOT-20 Score

    -1.30 @ 2 yr (1)

    95.2% symptom

    improvement

    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 Functional Endoscopic Sinus Surgery

    Successful post-sinuplasty

    “big hole surgery”


    Summary
    Summary Functional Endoscopic Sinus 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 Functional Endoscopic Sinus Surgery

    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 Functional Endoscopic Sinus Surgery

    * Avoid sinusitis complications

    * Avoid anesthesia complications

    * PCN allergy & dental issues


    Case 2 fungal sinusitis
    Case 2: Fungal Sinusitis Functional Endoscopic Sinus Surgery

    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 Functional Endoscopic Sinus Surgery

    Kenneth D Faw MD Evergreen Sinus Center


    Case 2 pearls
    Case 2 Pearls Functional Endoscopic Sinus Surgery

    * Calcifications on CT


    Case Functional Endoscopic Sinus Surgery3: Revision L Frontal and R Sphenoid Sinus

    KD, 2/26/09

    KD, 7/27/09


    Case 3 pearls
    Case 3 Pearls Functional Endoscopic Sinus Surgery

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


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