New Treatments for Sinus Disease San Francisco Otolaryngology Medical Group David 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 2 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

3 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 AcuteSubacuteRecurrentChronic 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 Model Bone and tissue structure enable natural sinus clearance Anatomic Factors Chronic Sinusitis/ Recurrent Acute Sinusitis Immune Factors Microbial Factors Acute Sinusitis Mucosal Surface Natural Mucociliary Transport and Drainage Allergic Factors Bony Scaffold 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

DiagnosisTargeted history Physical examination Anterior rhinoscopy Transillumination Nasal endoscopy Culture of the NC, MM Antral puncture Imaging procedures Blood tests Allergy evaluation and testing Immune function testing Gastroesophageal reflux Pulmonary function tests Mucocilliary dysfunction tests TreatmentObservation Systemic antibiotics Topical antibiotics Oral/topical steroids Systemic/topical decongestants Antihistamines Mucolytics Leukotriene modifiers Nasal saline irrigations/lavage Analgesics Complementary/alternative med Postural drainage/heat Antral puncture and lavage Sinus surgery PreventionTopical steroids Immunotherapy Nasal lavage Smoking cessation Hygeine Education Pneumococcal vaccination Influenza vaccination Environmental 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 seconds Online access for outside providers Independent review from outside radiology 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 years20 years Caldwell-Luc Antrostomy Functional Endoscopic Sinus Surgery (FESS) FESS w/ balloon catheters Present 1.The advent of FESS in 1985 allowed for sinus surgery without traumatic trans- antral penetration or inferior antrostomies 1 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 manner DW Kennedy, “Functional Endoscopic Sinus Surgery” Arch Otolaryngol. 1985;111(10): 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 trauma 2.Microdebriders enable a more targeted dissection/resection process 3.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 Cost Am J Rhinol 2008; 22:204–9. FESS with balloonFESS without balloon p-value NCostN All cases35$12, $14,471.14p=0.013 Revision cases 13$10, $16,190.00p< 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 FESS & Balloon Catheter Cost in OR 1 2

Balloon Catheter Cost in OR vs. in Office IO Costs n=35 OR Costs n=33 MeanMedianMeanMedian Materials and Supplies* $2,299  $2,190 $4,799  4,679 $2,291 Facility Costs^ Procedure Room PACU $201.0  $201.0  57.2 NA $190.4 NA $7,065  4,420 $5,815  3,648 $1,250  1,185 $5,744 5, Anesthesia Anesthesia Service $42.65  61.3 NA $15.4 NA $1,171  $910.0  $ Other** $439.8  2, 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 22 Access sinus cavityDilate natural ostium Directly irrigate sinusRemove system

23 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, Cough 24 OROffice

25 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 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 Patient Satisfaction Safety Efficacy CLEAR Study SNOT-20 Score 2 yr (1) No serious adverse events 91.6% 1 yr 2 years 6 months1 year40 weeks No serious adverse events 2.4% patient revision 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):

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: Pollen Structure: Dental implant Plan: 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

36 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