rodney j. schlosser, md - southern states … op... · post op care and topical therapies rodney j....
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Post op care and topical therapies
Rodney J. Schlosser, MD
Professor and Director of Rhinology
Department of Otolaryngology - HNS
Medical University of South Carolina
Charleston, SC
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Post operative care EBRR
Treatment Grade of
EBM
Benefit v
harm
Recommend Protocol
Saline
irrigation
B Benefit For Normal saline
within 24-48h
Debridement B Benefit For Sinus
debridements
post ESS
Systemic
steroid
N/A Equal Option Single 1b
study
Abx B Equal Option Short term
benefit
INCSpray A Benefit For Start post ESS
Off label
topical steroid
D Equal Option Single 3b
study, 1b pend
Drug eluting
spacer/stent
B Equal Option Two level 1b’s
Rudmik L, IFAR 2011
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Middle meatal dressings
Product Material Improvement v no drsg
Propel implant Lactide, glycolide copolymers w MMF
Merocel Polyvinyl alcohol Synechiae
Salman stent Silicone
Gelfilm/foam Gelaton (collagen)
Floseal Gelatin/thrombin Hemostasis/pain
Surgiflo Gelatin (collagen)
Surgicel Oxidized cellulose
Merogel Hyaluronic acid
Sepragel/pack HA/CMC Synechiae, pain, congestion
Sinufoam CMC
MPH Microporous polysacchardie Hemostasis
Chitosan gel Chitosan/dextran Synechiae, hemostasis
Nasopore Polyurethane foam
Quixil Thrombin/fibrinogen
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Postop antibiotics
• Cefuroxime x 2 days: no benefit
• Amox/clav x 2 wks: improved endoscopy
and sx
Rudmik L, IFAR 2011
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Mucociliary clearance
PCD
Rheologic properties
Obstructed os
Acquired dysfunction
Microbial community
Bacteria (Staph)
Fungi
Biofilm
Viruses
Mucosal inflammation
Th2 skewing
IgE/LTs
ASA triad
Superantigen
Remove polyps &
inflammatory
mucin
Topical steroids
CRS & changing role of surgery?
Remove
organisms/biofilm
Topical
antimicrobials
Eliminate ostial
obstruction
Topical MC
stimulants
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Topical therapies
• Delivery to anatomic site (target sinus)
• The proper active agent
• Impact upon lower airway
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Richard Harvey
Bewildering variety?
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Prescription versions
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What we don’t want to become
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Topical drug considerations Macro factors
• Surgical state
• Delivery device & volume
• Patient position
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Impact of surgery
Surgical State Findings
Unoperated No consistent delivery regardless of device
Balloon Sphenoid
Frontal
Maxillary
ESS Delivery increases especially with large
volume
Endoscopic Lothrop or
medial maxillectomy
Possible benefit
• Cadaver (n=5) and human studies (n=3)
• Conclusion: ESS optimal, critical os size 4-5 mm
Thomas III, WT et al, IFAR 2013 (in press)
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Critical os size
Brenner etal, IFAR 2012
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What type of surgery is needed
for postop topical therapies?
Balloon MIST FESS
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Ventilation ≠ access for topical treatments
Prior to successful ESS, topical therapies are ONLY nasal cavity treatments
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Access for topical treatments
Harvey RJ, Schlosser RJ. J OHNS, 2009
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Impact of device
Device Findings
Spray/Drops Little sinus distribution with either
technique. Some delivery to olfactory
cleft/MT that may be position dependent.
Atomizer/
Nebulizer
Pulsating aerosols/nebs with some limited
distribution to sinuses
Squeeze bottle/
Neti Pot
Larger volumes have best distribution
• Cadaver (n=5) and human studies (n=15)
• Recommend for: Large volume devices post ESS
• Recommend against: Low volume devices do not
consistently reach sinuses
Thomas III, WT et al, IFAR 2013 (in press)
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Sprays
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Combined effects of surgery & volume
Harvey RJ et al, OHNS 2009
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Impact of position
• Cadaver (n=3) & human (n=7) studies
• Recommend for: HDF with high volume devices
• Recommend for: LHB or LHL with drops and sprays
Position Findings
Head upright Inferior meatus with gtt
LHB (Mygind)
Middle meatus
LHL (Ragan) Middle meatus
HDF (Mecca) Increased superior distribution
(Olfactory, limited
ethmoid/max)
Thomas III, WT et al, IFAR 2013 (in press)
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Drops and LHB Position
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Now that we can reach the
sinuses, which active agent ?
• Mechanical
– Saline
– Baby Shampoo
• Pharmaceutical
– Steroids
– Antibiotic
• Mupirocin
• Gentamycin / Tobramycin
• Ampho B
– Novel agents
• Honey
• Surfactants
• Dornase Alpha
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Mechanical Effects
MCC
Mucus rheology
Surfactants
Removal of Ag
Drug Delivery
Absorption
Distribution
What’s the goal?
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Summary of active agents
Agent Grade of
evidence
Benefit
vs Harm
Recommendation
Level
Protocol
Saline B Benefit Recommend Use saline
as adjunct
to other
topical
therapies
Standard
INCS
A Benefit Strong
recommendation
Use in
CRSsNP
and
CRSwNP
Off label
steroid
C Equal Option Irrigation
vs drop
Rudmik L, et al, IFAR 2012
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Topical steroids
• Meta-analyses demonstrate benefit in both
CRSwNP and CRSsNP with greatest benefit
with direct sinus delivery
• Safety with steroid irrigations
Snidvongs K, etal Cochrane 2011
Rudmik L, etal Laryngoscope 2012
Welch K, etal, AJRA 2010
Steinke JW, etal JACI 2009
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Surgery improves
topical steroid delivery
Fokkens W etal EPOS 2012
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Steroid irrigations
• N=111 post ESS pts (56% CRSwNP)
• BUD or BET (1mg qd) via squeeze bottle
• 1 year f/u improved SNOT22, endoscopy
• Most improvement in those
with high eosinophilia
• UNC DBPCT no benefit
– needs further study
Snidvongs K, et al, IFAR 2012
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Safety and drug absorption?
• What % of total irrigation solution
remains?
• What is safe dose?
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How much solution remains in the sinuses?
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How much solution remains in the sinuses?
2.51.5%
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Benefit to patient
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Safety of budesonide irrigations
• Respules (0.5mg/2ml) BID = 1 mg/day
• 3% retained volume = 30 mcg drug
• Rhinocort: 32 mcg/spray=128 mcg/day
• Current irrigations are about ¼ dose of
topical spray!
• Probably doesn’t apply to drops which have
higher retention
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Other methods for getting steroid
to the sinus cavity
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Mometasone bioresorbable stent
• Meta-analysis, 2
DBRCTs, 143 pts
• Endoscopy,
adhesions, oral
steroid need
improved
• Cost/duration of
effect?
Han JK, et al, IFAR 2012
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Summary of active agents
Agent Grade of
evidence
Benefit
vs Harm
Recommend
ation Level
Protocol
Antibiotic B Equal Option vs
recommend
against
Variable, high
volumes
appear to be
better
Antifungal A- Harm Recommend
against
Alternative
agents
C N/A N/A Surfactants,
honey, xylitol
Rudmik L, etal, IFAR 2012
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The future of topical therapeutics
• Great potential to improve “micro” factors
– Newer active agents with fewer side effects
– Modulation of wound healing
– Better carriers to optimize dosing and
concentration protocols
• Better understanding of “macro” factors, such
as role of surgery, delivery device, target sinus
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CRS treatments
• Approach based upon pathophysiology & evidence
• Topical therapies likely to make a major impact
• Evidence supports large volume delivery of saline
and steroids in post operative patients
• Other agents and delivery devices have limited
evidence to support their use
• May improve lower airway disease