sinusitis and the primary care practice - dcomcme.lmunet.edu online module.pdf · sinusitis affects...
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Sinusitis and the Primary Care Practice
Leonard W. Brown, MDJan Zieren, DO, MPH, FACOFPdist
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Dr. Leonard Brown - Disclosure
I have a financial relationship with or interest in a commercial interest connected with this presentation.
Speaker and Training site for IOBS Acclarent /J&J
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Dr. Jan Zieren - Disclosure
Dr. Zieren has no financial relationships to disclose.
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Learning Objectives
Be able to diagnose sinusitis and allergies Recognize the incidence and economic impact of sinus and allergy Discover current recommended treatment Recognize the need for long term therapy Recognize SAHP disease classifications Discover current surgical technique Understand usage of tools such as the SNOT-22
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Disease Burden of Sinusitis - U.S. Data
Estimated 37 million cases of sinusitis each year 26.7 million hospital outpatient, physician office and emergency department encounters
attributed to sinusitis* (1996) Over 15 million office visits per year result in primary diagnosis of sinusitis* (1996)
Approximately 20 million cases of acute bacterial sinusitis (ABS) in the U.S. annually
Sinusitis is the fifth most common diagnosis for which antibiotics are prescribed
The economic impact of work loss in the United States for sinus and allergy disease is greater than back and heart conditions combined.
National Institute of Allergy and Infectious Diseases. Sinusitis fact sheet. 2002. http://www.niaid.nih.gov/factsheets/sinusitis.htm. Accessed Dec 2003; Ray NF, et al. J Allergy ClinImmunol. 1999;103:408-414; SAHP. Otolaryngol Head Neck Surg. 2004;130:1-45.
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MUCOUS PRODUCTION HEATING COOLING FILTERING LACTOFERRIN LYSOZYMES
NITRIC OXIDE IMPROVED VENTILATION IMPROVED PULMONARY
FUNCTIONS IMMUNOGLOBULINS GLYCOPROTEINS
Nasal/Sinus Organ
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Secretions stay fluid; contain antibodies and IgA
Mucous composition is
normal
Mucous secretion is
normal
Ostium is Open
Soluble pollutants are absorbed in
the mucosa
Particulate matter and bacteria are
removed by mucociliary clearance
Mucociliary flow prevents local mucosal
damage Host defenses resist infection
Adapted from Kennedy DW, et al. Ann Otol Rhinol Laryngol Suppl. 1995;167:22-30.Fagnan LJ. Am Fam Phys. 1998;58:1795-1802.
Ostiomeatalcomplex
Frontalsinuses
Maxillarysinuses
Ethmoidsinuses
Normal Sinus Health Cycle
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Ostium is Closed
Mucosal congestion (often due to viral
rhinitis) or anatomic obstruction blocks air
flow and drainage
Secretions stagnate
Secretions thicken, pH changes
Mucosal gas metabolism changes
Cilia and epithelium are damaged
Change in host milieu creates culture
medium for bacterial growth in closed
cavity
Retained secretions cause tissue inflammation
Bacterial infection develops in the sinus
cavity
Mucosal thickening creates further
blockage
Adapted from Kennedy DW, et al. Ann Otol Rhinol Laryngol Suppl. 1995;167:22-30. Sinus and Allergy Health Partnership (SAHP). Otolaryngol Head Neck Surg. 2004;130:1-45. Fagnan LJ. Am Fam Phys. 1998;58:1795-1802.
Ostiomeatal complex
Frontalsinuses
Maxillarysinuses
Ethmoidsinuses
Sinus Cycle Leading to Sinusitis
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RhinosinusitisEpidemiology and Impact
31 million cases annually 25 million office visits for acute bacterial sinusitis from 1993-1994 Most often preceded by viral upper respiratory tract infection
Adapted from Spector et al. www.jcaai.org/Param/Sinusitis. Accessed July 22.
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DIAGNOSIS AND TREATMENT OF RHINOSINUSITIS
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Types of Sinusitis
Acute Less than 4 weeks
Recurrent Acute 4 or more episodes of acute sinusitis per year
Potential Balloon Sinuplasty candidate
Chronic More than 12 weeks
Potential Balloon Sinus Dilation candidate
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Facts About Sinusitis
Sinusitis affects 37 million Americans each year, making it one of the most common health problems in the U.S.
Sinusitis affects approximately 14% of the adult U.S. population
Sinusitis affects 17% of women and 10% of men each year
Chronic sinusitis (not including acute sinusitis) results annually in an estimated 7 million physician office visits
Direct healthcare expenditures due to sinusitis costs are well over $8 billion each year
Total restricted activity days due to sinusitis are over 58 million per year
At least 20% of chronic sinusitis patients are not successfully treated with medical therapy
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Sinusitis Care Continuum
MedicationNasal Steroids
AntibioticsDecongestantsOral Steroids
Mucus-thinning Drugs
FESS
Functional Endoscopic
Sinus Surgery
Balloon Sinus Dilation
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Diagnosis is made when two or more major factors are present, or
one major and two minor factors are present and there is purulence
on examination.
2004 SAHP Sinusitis GuidelinesDefinition & Diagnosis
MAJOR Nasal congestion/fullness Nasal obstruction/ blockage Nasal purulence/drainage Facial pressure/pain Hyposmia/anosmia Fever
MINOR Cough Ear pressure/fullness Fatigue Halitosis Headache Maxillary dental pain
Sinus and Allergy Health Partnership. Otolaryngology-Head and Neck Surgery. 2000;123:S1-S38.
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DiagnosisNasal Endoscopy
Normal Anatomy Patent Ostia Culture must come from
the ostia or the sinus
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SNOT-22
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Computerized Tomography
Plain Sinus X-rays are no longer recommended CT of the Sinus is superior CT is required before surgical intervention Volumetric CT for GPS location MACRA GUIDELINES
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Etiology of Sinusitis
Viral Allergic Bacterial Pollutant Anatomic Mass/Tumors Foreign Bodies GERD Tobacco
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Medical Treatment of Sinusitis
Antibiotic Therapy Nasal Lavage Oxymetazoline 3/5 Nasal Steroids Culture of Osteomeatal Complex Mucolytics/ Guaifenesin 1200mg bid
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Medication Options
Healthcare professionals often find it difficult to treat chronic sinusitis sufferers with medication.
At least 20% of chronic sinusitis patients are not successfully treated with medical therapy. If multiple uses of antibiotics, medications or other sinusitis treatments have failed to relieve your symptoms, your ENT doctor may recommend sinus surgery.
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WHAT IS THE GOAL?
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Restore Normal Flow
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Beaver Dam Scenario
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Etiology Directed Therapy
Normal sinuses drain over a liter a day. If there is chronic obstruction or sinusitis then you have established the BEAVER DAM SCENARIO. In order to alleviate the problem you must not only BLOW UP THE DAM, but you must also REMOVE THE BEAVERS
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Local Surveillance Data U.S., 2001-2002 Penicillin-Nonsusceptible S. pneumoniae TENNESSEE
44%130/297
35%104/297
Penicillin intermediate (MIC = 0.12-1.0 µg/mL)
Penicillin resistant (MIC 2.0 µg/mL)
U.S. Surveillance Data - All Ages 2001-2002. Surveillance Data Inc., Plymouth
Meeting, PA, Focus Technologies, Herndon, VA.
24%4,470/18,511
20%3,773/18,511
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What are the Beavers?
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BacterialCULTURE O-M COMPLEX
Photo courtesy J. Hadley, MD.
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Pollutants
Tobacco smoke Toxic fumes Perfumes Poor ventilation Smog Ozone
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Anatomic
Septal deviation Turbinate hypertrophy Concha bullosa Septal perforation Choanal atresia
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Foreign Bodies
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Foreign Body
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Masses/Tumors
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Antral Mucocele
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Smoking
You need to develop a smokers cessation program and offer it to all of your smoking patients in a non-confrontational manner. Include in your program support, follow-up and rewards.
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Blow Up the Dam, Relocate the Beavers
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GUIDELINE RECOMMENDATIONS FOR ANTIMICROBAL THERAPY IN ABS
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Goals of Antimicrobial Therapy for ABS*
Eradication of bacterial pathogen from site of infection Return sinuses back to health Decrease duration of symptoms Prevent severe complications Decrease likelihood of chronic disease
SAHP. Otolaryngol Head Neck Surg. 2004;130:1-45.
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Antibiotic Therapy
Initial first line therapy No response to therapy within 4-6 weeks Amoxicillin/Clavulinic Acid 4000mg/day Levofloxin Moxifloxacin HCL Clindamycin No response – refer for possible procedure
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PREVALENCE AND SOCIOECONOMIC IMPACT OF ALLERGIC RHINITIS
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PathophysiologyAllergy
Blue Mucosa Cobblestoning Clear Drainage Food Environmental
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Prevalence of Allergic Rhinitis Affects 20–40 million Americans
10% – 30% of adults Up to 40% of children affected
Remains constant in young adults but gradually declines in later years
More common in young boys than girls but little gender difference after adolescence
No impact of race or socioeconomic status
Dykewicz MS, et al. Ann Allergy Asthma Immunol. 1998;81(5, pt 2):478-518.
Fireman P. Allergic rhinitis. In: Atlas of Allergies. Philadelphia, Pa: JB Lippincott Co; 1991:9.2-9.18.
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Prick Testing Allergen Tray
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RAST
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Intradermal Testing
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BALLOON SINUS DILATION TECHNOLOGY
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What is Balloon Sinus Dilation?
Balloon Sinuplasty is an innovative procedure used by ENT doctors to treat patients with recurrent acute or chronic sinusitis. Balloon Sinuplasty relieves the pain and pressure associated with sinusitis.
Balloon Sinuplasty uses a soft, flexible guidewire to access the inflamed sinuses. A small balloon catheter is advanced over the flexible guidewire, gradually inflated to restructure the previously blocked nasal passage, and then removed.
Balloon Sinuplasty preserves the normal anatomy of the sinuses and mucosal tissue, and unlike traditional sinus surgery, Balloon Sinuplasty requires no cutting and no removal of bone and tissue.
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Benefits of Balloon Sinus Dilation In-Office
Local AnesthesiaBalloon Sinuplasty In-Office is an option for patients who decline or are ineligible for general anesthesia.
Fast RecoveryWhile recovery time varies with each patient, patients who have Balloon Sinuplasty In-Office procedure may return to work and normal activities as soon as 24 hours.10
Comfortable SurroundingsExperience the procedure in the comfort of your physician’s office rather than a hospital operating room.
High Patient SatisfactionThe majority of patients who had Balloon Sinuplasty In-Office would recommend the procedure to family and friends.10
Potential for Significant Cost SavingsSome eligible patients may have lower out-of-pocket costs if the procedure is performed in a lower cost of care setting, such as a physician’s office.
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Instrumentation is the Key
Flexible Instrumentation Excellent for when the surgical goal is to restore sinus drainage and function with maximum bone
and tissue preservation
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In-Office Procedure No fasting period Local anesthesia Wear own clothes Potential out of pocket savings Patient return to normal activity in as soon as 24
hours
Hospital Surgery Designed for customized access Fasting prior to surgery General anesthesia Hospital gown Intubation and IV May be conducted in conjunction with other
procedures requiring general anesthesia
Balloon Sinus Dilation In-Office Patient Experience
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Pre-endoscopic Surgery Assessment
• Assess the patient’s condition
• Determine the appropriate care pathway
Frontal sinus
Pre-procedure CT scan
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Step OneGain initial access and deliver the Balloon Sinus Dilation Catheter
Sinus Guide CatheterAccess under endoscopic guidance
Sinus Guide Catheter
Sinus Balloon Catheter
Sinus Guidewire
Images provided by Frederick Kuhn, MD
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Step Two - Endoscopic viewPlace the Balloon Sinus Dilation Catheter across the ostium
Sinus Balloon CatheterPlaced under endoscopic guidance
Inflated to gently remodel the ostium
Images provided by Frederick Kuhn, MD
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Step Two – Fluoroscopic viewRelieva™ Sinus Balloon Catheter inflated to gently remodel the
ostium
Sinus Guide Catheter
Sinus Balloon Catheter
Sinus Guidewire
(inflated)
Images provided by Frederick Kuhn, MD
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Step ThreeDeflate and remove the Relieva Balloon Sinuplasty™ devices
Frontal Sinus Dilation
Final endoscopic image
Frontal sinus
Post-procedure CT scan
Images provided by Frederick Kuhn, MD
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Sinus Guide
Catheter
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Sinus
Guidewire
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Sinus Balloon
Catheter(prior to inflation)
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Sinus Balloon
Catheter(during inflation)
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Catheter-based Dilation of the Sinus OstiaInitial Safety and Feasibility Analysis in a Cadaver Model
Endoscopic examples Dilated ostia carefully examined for unwanted catheter-induced trauma
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Safety and Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia
Study objective Assess safety and feasibility of dilation of sinus ostia and recesses in patients with rhinosinusitis
Primary end points Procedural success
Ability to access targeted sinus and complete balloon dilation
Procedural safety
Absence of significant adverse events
Brown CL, Bolger, WE. Safety & Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia: A
Preliminary Investigation. Annals of Otology, Rhinology and Laryngology. 2006; 115(4):293 – 299.
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6-weeks Post-op
Safety and Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia
Right Maxillary Sinus - Patient A
Note: Uncinate process taken down
9-months Post-op
Brown CL, Bolger, WE. Safety & Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia: A
Preliminary Investigation. Annals of Otology, Rhinology and Laryngology. 2006; 115(4):293 – 299.
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Safety and Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia
Right Sphenoid Sinus - Patient B
2-weeks Post-op 6-weeks Post-op
Brown CL, Bolger, WE. Safety & Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia: A
Preliminary Investigation. Annals of Otology, Rhinology and Laryngology. 2006; 115(4):293 – 299.
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Clinical Evaluation to Confirm Safety & Efficacyof Balloon Sinus Dilation in the Paranasal Sinuses
(CLEAR)
Type of Event
Frequency Description
Mild 0nasal bleeding requiring packing or intervention
Moderate 0periorbital swelling or bruising, moderate pain
Severe 0
cerebrospinal fluid leak, orbital hematoma, visual loss, loss of sense of smell, nasolacrimal duct injury, orbital entry/injury, severe pain.
There were no serious adverse events 9 events of bacterial sinusitis post dilation : resolved with antibiotic treatment
As reported at the AAO-HNS Annual Meeting 2006
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Clinical Evaluation to Confirm Safety & Efficacyof Balloon Sinus Dilation in the Paranasal Sinuses (CLEAR)
Case Study - Frontal SinusitisBaseline 24-weeks Post-op
Images provided by Frederick Kuhn, MD
As reported at the AAO-HNS Annual Meeting 2006
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Clinical Evaluation to Confirm Safety & Efficacyof Balloon Sinus Dilation in the Paranasal Sinuses (CLEAR)
Case Study - Right Maxillary Sinusitis
Baseline 24-weeks Post-op
Images provided by Frederick Kuhn, MD
As reported at the AAO-HNS Annual Meeting 2006
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Clinical Evaluation to Confirm Safety & Efficacyof Balloon Sinus Dilation in the Paranasal Sinuses (CLEAR)
Sinus Balloon Catheter devices demonstrate a remarkable safety profile
Observed patency of 98% at 24 weeks was achieved, indicating an efficacious and durable result
Via a validated patient outcomes measure, patients show significant symptom improvement at all time points
As reported at the AAO-HNS Annual Meeting 2006
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Case Study: Chronic sinusitis unresolved following maximum medical therapy
23 yo female, unilateral left sided AFS, operated on in 1998, no current Rx
Right sided chronic ethmoid, frontal, maxillary, and sphenoid sinusitis, diagnosed March 2005
Maximal medical Rx Clindamycin, 150 mg tid x 6 weeks
Sinuses do not completely clear
Patient still symptomatic
As reported at the AAO-HNS Annual Meeting 2005
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Case Study: Right frontal sinus
Sinus Balloon Catheter– During inflation
As reported at the AAO-HNS Annual Meeting 2005
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Steroid Eluting Implants
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Steroid-Releasing Implants
standard mini
mometasone furoate implants
First localized, controlled drug delivery technology for chronic sinusitis patients
Targeted, sustained delivery of 370 ug of Mometasone Furoate for 30 days
Spring-like implant provides middle turbinate support
Implant bioreabsorbs after 4-6 weeks
Maintains surgical result by preventing inflammation & scarring
Only sinus surgery product with Level 1-A clinical evidence
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Control
(Polyp recurrence)
Significant improvement observed in post-op outcomes
Da
y 0
Da
y 3
0
Marple BF, Smith TL, Han JK et al. Otolaryngol Head Neck Surg. 2012; 146(6) 1004–1011.
Steroid Releasing
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77
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78
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63-year-old male w/ hx of multiple ESS Recurrent unilateral, left-sided frontal pressure and headache
refractory to medical therapy. Stenosed frontal recess with complete opacification of the left
frontal sinus Multiple surgical procedures unsuccessful; Declined Draf 3
Endoscopic frontal sinus ostial balloon dilation in the clinic Steroid eluting sinus stent was placed in the frontal sinus at
the end of the procedure.
Pre-Op CT
Allergy Rhinol. 2015; 6(1): e68-e75.
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Allergy Rhinol. 2015; 6(1): e68-e75.
Frontal Obstruction Steroid eluting device placement after in-office balloon dilation
3 weeks post-implant 11 months post-implant
Frontal ostial patency maintained at 11 months follow-up
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PURULENT DISCHARGE FROM OSTIA
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SPHENOID OSTIA PRE DILATION
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SPHENOID DILATION
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POLYP
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SPHENOID BALLOON DILATION
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SPHENOID POST DILATION
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STEROID ELUTING IMPLANT
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ENCEPHALOCELE
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FRONTAL SINUS BALLOON
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POLYP EXTRUDING FROM FRONTAL SINUS AFTER DILATION
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PYOMUCOCELE IN MAXILLARY ANTRUM
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Summary
Sinusitis is diagnosed with the use of nasal endoscopy, SNOT-22, and CT scans. The economic impact of work loss in the United States for sinus and allergy
disease is greater than back and heart conditions combined. Current recommended treatment for sinusitis includes antibiotic therapy,
nasal lavage, nasal steroid, and sinus surgery or balloon sinus dilation. Long term therapy for allergies or other underlying conditions is needed in
order to prevent recurrent episodes. Sinusitis may be classified as acute, recurrent acute, or chronic. Current surgical techniques include traditional endoscopic sinus surgery or
balloon sinus dilation
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• Agnieszka Janisiewicz, MD, and Jivianne T. Lee, MD. In-office use of a steroid-eluting implant for maintenance of frontal ostial patency after revision sinus surgery. Allergy Rhinol. 2015; 6(1): e68-e75.• Alexander Project. 2000. AXR0206. GlaxoSmithKline.• American Academy of Allergy, Asthma, and Clinical Immunology. Fast facts: allergies. • Available at: http://www.aaaai.org/public/fastfacts/allergies.htm. Accessed November 6, 2001• Brown CL, Bolger, WE. Safety & Feasibility of Balloon Catheter Dilatation of Paranasal Sinus Ostia: A
Preliminary Investigation. Annals of Otology, Rhinology and Laryngology. 2006; 115(4):293 – 299. • Doern GV, et al. Antimicrob Agents Chemother. 2001;45:1721-1729. • Dykewicz MS, et al. Ann Allergy Asthma Immunol. 1998;81(5, pt 2):478-518.• Fagnan LJ. Am Fam Phys. 1998;58:1795-1802.• Fireman P. Allergic rhinitis. In: Atlas of Allergies. Philadelphia, Pa: JB Lippincott Co; 1991:9.2-9.18. • Gilbert DN, et al. Sanford Guide. 2003.• Jacobs MR, et al. N Engl J Med. 1978;299:735-740. • Kennedy DW, et al. Ann Otol Rhinol Laryngol Suppl. 1995;167:22-30.• Marple BF, Smith TL, Han JK et al. Otolaryngol Head Neck Surg. 2012; 146(6) 1004–1011• National Institute of Allergy and Infectious Diseases. Sinusitis fact sheet. 2002. http://www.niaid.nih.gov/factsheets/sinusitis.htm. Accessed Dec 2003; Ray NF, et al. J Allergy Clin Immunol. 1999;103:408-
414; SAHP. Otolaryngol Head Neck Surg. 2004;130:1-45.• SAHP. Otolaryngol Head Neck Surg. 2004;130:1-45.• Sinus and Allergy Health Partnership. Otolaryngology-Head and Neck Surgery. 2000;123:S1-S38.• Spector et al. www.jcaai.org/Param/Sinusitis. Accessed July 22• Timothy L Smith, MD, MPH; Ameet Singh, MD; Amber Luong, MD, PhD; Randall A. Ow, MD; Steven D. Shotts, MD; Nathan B. Sautter, MD; Joseph K. Han, MD; James Stambaugh, BS; Aarthi Raman, PhD.
Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016; ePub on July 1, 2016.• U.S. Surveillance Data - All Ages 2001-2002. Surveillance Data Inc., Plymouth Meeting, PA, Focus Technologies, Herndon, VA.
References
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