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TRANSCRIPT
Slide 1
CHOOSE WISELYPharmacokinetics of Intracameral Antibiotics for Endophthalmitis
ProphylaxisLee Schelonka, MD, PhD
Kaiser Permanente, Denver, CO, USA
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Slide 2
Disclosure
I have no financial conflicts of interest.
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Slide 3 Off-Label Use
• No drug has been approved by the FDA for prevention of endophthalmitis after cataract surgery
• THEREFORE,
• Every use of antibiotics for prevention of endophthalmitis is off-label:• Topical
• Subconjunctival
• Intracameral
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Slide 4 Postcataract Endophthalmitis
• Uncommon• Rate: less than 1/10,000 up to 3.6% of cataract cases
• Severe: • Months of disability
• Less than half of patients return to 20/40 acuity
• 30% suffer severe, longterm visual loss, less than 20/200 acuity
• Preventable
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Slide 5 Risk factors for postcataract endophthalmitis
• Leaky incisions• If aqueous gets out, bacteria can get in
• Posterior capsule tear/vitreous loss• Even 5 bacteria in the vitreous can cause endophthalmitis
• Using Silicone IOL’s• Bacteria adhere to silicone
• Failure to use Povidone/Iodine on the surface of the eye
• Failure to use intracameral antibiotics
• Cao H. PLoS One 2013, 8(8)e71731
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Slide 6
The Kaiser Permanente Colorado Endophthalmitis Story
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Slide 7 1998-2001: increase in postcataract
endophthalmitis
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• 1998-2001: Increased postcataract endophthalmitis
• 13 cases/8382 cataracts, rate =1.55/1000
• Similar to U.S. Medicare increase
• Prophylaxis was Betadine skin prep and postop antibiotics
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Slide 8
What to do (in 2001)?
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Slide 9 Mark Speaker, MD
• Povidone-iodine versus silver protein irrigation of ocular surface, added to skin prep
• Povidone-iodine: 2/3384 cases of postcataract endophthalmitis
• Silver protein: 8/3289 cases
• 4-fold reduction
• P=0.05
• Ophthalmology 1991;98:1769-75
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Slide 10 Why put antibiotics into the eye?
•PHARMACOKINETICS!• Much higher drug concentration in the eye,
• Example: Moxifloxacin• Drops: 2 ug/mL
• Subconj injection: 4 ug/mL
• Intracameral: 500 ug/mL
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Slide 11 Local intervention to reduce endophthalmitis (2001)
• Reviewed aseptic technique with OR staff
• Reviewed importance of meticulous wound closure with surgeons
• Switched to acrylic IOL’s
• Monitored surgeon’s cataract complications• Mentored surgeons with high complication surgeons
with high-volume, low-complication surgeons
• Moved Multiply-comorbid cases to high-volume surgeons
• Added povidoine/iodine irrigation of the ocular surface to the usual prep and drape
• Added vancomycin 20 mg/mL to the Balanced Salt Solution irrigation
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Slide 12 Results! HOWEVER…
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Slide 13 What to do in 2006?
• Switch to bolus injection of intracameral cefuroxime? Vancomycin?
• Our surgeons were reluctant to inject a bolus of intracameral antibiotics at the end of surgery• Concentration errors• Contamination• Toxic Anterior Segment Syndrome
• Chang D, JCRS 2007;33:1801
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Slide 14 So what did we do at Kaiser Permanente Colorado in 2006?
• Comfortable with experience of vancomycin irrigation• 12,400 cataracts: every patient got vanco irrigation
• 5 endophthalmitis cases in 4 years
• Rate 0.4/1000 (about equal to ESCRS Cefuroxime rate)
• Much lower than U.S. Medicare rate
• No Toxic Anterior Segment Syndrome
• No allergic reactions
• Reluctant to inject intracameral antibiotics directly• Risk of harm from TASS, contamination, mixing errors
• Reviewed the PHARMACOKINETICS of intravitreal injections
• Slightly modified intravitreal technique: “mini-intracameral”
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Slide 15 Pharmacokinetics overview
• Antibiotic sensitivity and resistance• Minimum Inhibitory Concentration for 90% of common endophthalmitis
bacterial strains (MIC90)
• Killing kinetics: depends on bugs and drugs• Hours to kill 99% (2 Log units) of bacteria
• Drug concentration in the anterior chamber at the end of surgery: depends on surgical technique• Inject 0.1 to 0.2 mL into anterior chamber (and bag) at the end of surgery
• Flush 3 to 5 mL into anterior chamber (and bag) at the end of surgery
• Irrigate during surgery
• Drug washout and elimination• Half-life
• Straight line Log plots
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Slide 16 Simple approach
• NO EQUATIONS
• Pattern recognition
• 3 drugs
• 2 bugs
• Straight lines
• Simple concept:• Enough drug in the eye
• For a long enough time
• To kill the most common bugs
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Slide 17 PHARMACOKINETICS plot example
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Slide 18 Log concentration plot: straight line
Decay slope known from half-life measurements
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Slide 19 The FLOOR: MIC90
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Slide 20 KNOWN KILL TIME
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Slide 21 Pattern recognition
• IF THE CONCENTRATION LINE STAYS ABOVE THE MIC90 “FLOOR” FOR LONGER THAN THE KILL TIME:
•EFFECTIVE PROPHYLAXIS
• IF THE CONCENTRATION LINE DIPS BELOW THE MIC90 “FLOOR” BEFORE THE KILL TIME:
•POTENTIAL PROPHYLAXIS FAILURES
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Slide 22 Bugs
• Bacterial contamination of aqueous is common after cataract surgery• Low bacterial load: 20-60 Colony Forming Units (CFU)1
• Killing 99% (2 Log units) of bacteria is sufficient for effective prophylaxis
• Endophthalmitis species are identical to patient’s ocular flora2
• Staphylococcus species are most common2
1. Soto AM. Am J Ophthalmol 2001;131:293-300
2. Han DP. Am J Ophthalmol 1996;122:1
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Slide 23 3 drugs
• Cefuroxime
• Moxifloxacin
• Vancomycin
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Slide 24 Cefuroxime
• ESCRS randomized trial: 5-fold reduction of endophthalmitis rate1
• Inject 1 mg/0.1mL into the anterior chamber at the end of surgery• Concentration: 2745 ug/mL2
• Half-life: 0.5 hours2
• Gram-positive and gram-negative coverage• However, MIC90 for MRSA and MRSE is 256 ug/mL3,4
• In Europe (but not U.S.) commercial intracameral cefuroxime for injection is available• Avoids compounding
1. ESCRS Study Group. JCRS 2007;33:978
2. Montan P. JCRS 2002;28:982
3. Woods GL. AAC 1987;31:1332
4. Mateos-Mora M. AAC 1988;32:170
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Slide 25 Resistant bugs: MRSE, MRSA and cefuroxime
• Multicenter study: eye cultures of 399 cataract surgery patients in the U.S.
• Most common: Staphylococcus epidermidis “coagulase negative” • Of these, about half were
methicillin-resistant (MRSE)1
• Fewer Staph aureus • Of these, 29.5% were
methicillin-resistant (MRSA)
• MRSE and MRSA species are highly resistant to cefuroxime MIC90: 256 ug/mL2,3
1. Olson R. Clin Ophth 2010;4:1505
2. Woods GL. AAC 1987;31:1332
3. Mateos-Mora M. AAC 1988;32:170
MSSE
MRSE
MSSA
MRSA
Other Gram pos
Gram neg
Eye cultures in 399 cataract patients
MSSE MRSE MSSA MRSA Other Gram pos Gram neg
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Slide 26 Cefuroxime kill kinetics versus sensitiveStaphylococcus epidermidis
• 3 h for 1-log kill of sensitive staph species,1 probably 6 h for 2-log kill
• Concentration remains above MIC90 (1ug/mL) for 6 hours
• Effective prophylaxis
1. O’Brien T. JCRS 2007;33:1790.
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Log cefuroxime concentration vs time
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Slide 27 Cefuroxime kill kinetics versus resistant Staphylococcus epidermidis
• Over 3 h for 1-log kill of sensitive staph species,1 probably over 6 h for 2-log kill
• Slower for resistant species: MRSA and MRSE
• Concentration drops below MIC90 (256ug/mL) in less than 2 hours
• Prophylaxis failures are possible for MRSA and MRSE
1. O’Brien T. JCRS 2007;33:1790.
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Log cefuroxime concentration vs time
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Slide 28 Moxifloxacin
• Non-randomized trial showed a 3-fold reduction in the endophthalmitis rate1
• Inject 0.2 mL of a 3:1 dilution of unpreserved moxifloxacin 0.5% drops into the anterior chamber, OR
• Flush 3-5 mL of 10:1 dilution of unpreserved moxifloxacin 0.5% into the capsular bag and anterior chamber1
• Concentration is 500 ug/mL
• Half-life is 1 hour3
• MIC90 for staphylococcus epidermidis endophthalmitis isolates is 32 ug/mL2
1. Matsuura K. JCRS 2013;39:1702
2. Harper T. Ophthalmology 2007;114:871
3. Matsuura K. Graefes Arch Clin Exp Ophthalmol 2013;251(8):1955
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Slide 29 Resistant bugs: moxifloxacin
• Bascom Palmer study of 59 coagulase-negative endophthalmitis isolates in the U.S.1
• 52% of isolates were resistant to moxifloxacin
• MIC90 was 32ug/mL
1. Harper T. Ophthalmology 2007;114:871
Moxifloxacin resistance of 59 coagulase-negative endophthalmitis isolates
Sensitive Resistant
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Slide 30 Moxifloxacin kill kinetics versus fluoroquinolone-
sensitive Staphylococcus epidermidis
• Less than 2 hours for 1000-fold kill of fluoroquinolone-sensitivestaphylococcus isolates1
• Concentration stays above MIC90 (1 ug/mL) over 8 hours
• Effective prophylaxis
1. Stroman DW. Surv Ophthalmol 2005;50:S16
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Log moxifloxacin concentration vs time
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Slide 31 Moxifloxacin kill kinetics versus RESISTANTStaphylococcus epidermidis
• Over 2.5 hours for 10-fold kill of fluoroquinolone-resistant staph epidermidis,1 probably 5 hours for 2-log kill
• Concentration drops below MIC90 (32 ug/mL) in 4 hours
• Prophylaxis failures are possible for fluoroquinolone-resistant staphylococcus epidermidis
1. Stroman DW. Surv Ophthalmol 2005;50:S16
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Log moxifloxacin concentration vs time
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Slide 32 Vancomycin
• Non-randomized trials show very low endophthalmitis rates1,2,3
• Inject 1 mg/0.1 mL into anterior chamber as the last step of surgery, • Concentration is 5458 ug/mL after surgery4
OR
• Irrigate 10mg/500 mL balanced salt solution (20 ug/mL) during surgery
• Half-life is 1.9 hours for the first 2 hours, then 3.2 hours for the next 20 hours4
• MIC90 for staphylococcus endophthalmitis isolates is 3 ug/mL5
1. Gills J. JCRS 2004;30:1616
2. Gimbel HV. CRS Today 2005;73
3. Arshinoff SA. JCRS 2011;37:2105
4. Murphy CC. Br J Ophthalmol 2007;91:1350
5. Harper T. Ophthalmology 2007;114:871
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Slide 33 Resistant bugs: vancomycin
• Vancomycin has little to no activity against gram-negative bacteria
• Isolated cases of vancomycin-resistant enterococcus endophthalmitis• In Japan, 20% of endophthalmitis isolates are enterococci,1 versus 2%
in the United States2
• In large U.S. series of gram-positive endophthalmitis cultures, 99-100% of isolates were sensitive to vancomycin2,3,4
1. Matsuura K. JCRS 2013;39:1702
2. Han DP. Am J Ophthalmol 1996;122:1
3. Recchia FM. Arch Ophthalmol 2005;123:341
4. Harper T. Ophthalmology 2007;114:871
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Slide 34 Vancomycin kill kinetics versus Staphylococcus epidermidis: injection
• 4.6 hours to kill 99% of Staphylococcus epidermidis1
• Vancomycin dislodges resistant, slime-forming bacteria from silicone IOL’s in 1 hour2
• Concentration remains well above MIC90 of 3 ug/mL throughout the kill time
• Effective prophylaxis
1. Lowdin E. Antimicrob Agents Chemother 1998;42:2741
2. Kodjikian L. JCRS 2005;31:1050
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Log Vancomycin concentration vs time(injection)
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Slide 35
Hang on. We’re almost there!
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Slide 36 Howard Gimbel, MD
• “The actual concentration (of intracameral vancomycin) is much lower, because the drug is diluted by BSS added to repressurize the eye after the injection.”
• CRS Today, Feb 2005, 73-75
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Slide 37 Vancomycin kill kinetics versus Staphylococcus epidermidis: Irrigation, with BSS hydration and
pressurization
• Initial concentration 20 ug/mL
• Repressurizing eyes and hydrating incisions with plain BSS washes some vancomycin out of the eye• Our experiments: 2-fold or more
dilution
• Concentration drops below MIC90 (3 ug/mL) in less than the 4.6 h killing time
• Potential prophylaxis failures (as we experienced)
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Log Vancomycin concentration vs time (Irrigation, with BSS pressurization)
20 ug/mL irrigation
20 ug/mL irrigation, with BSShydration
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Slide 38 James Gills, MD
• Repressurize the eye using the “anterior chamber mixture,” (not plain balanced salt solution)• Antibiotics, steroids, NSAID’s
• JCRS 2004;30:1616-7
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Slide 39 Vancomycin kill kinetics versus Staphylococcus epidermidis: Irrigation, pressurization and
hydration with vancomycin solution
• Initial concentration: 20 ug/mL
• Remains 20 ug/mL when the eye is repressurized with the irrigating solution
• Concentration remains above the MIC90 (3 ug/mL) for longer than the killing time
• Effective prophylaxis3
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Log Vancomycin concentration vs time Irrigation, with vanco pressurization
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Slide 40 2006-2015 KP Colorado endophthalmitis intervention
• Intervention: Irrigate, repressurize eyes, and hydrate incisions with vancomycin 20 ug/mL1
• 17 surgeons, 6 venues, 10 years
• Outcome: Reduced endophthalmitis to one case after 52,603 cataracts1
• Versus 2002-2005: Relative Risk: 21.2, p < 0.0001
• Yes, mere mortals can attain endophthalmitis rates equal to Dr. Gills’ rate!
• Schelonka LP. Clin Ophth 2015;9:1337
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Slide 41 RESULTS!
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Slide 42 We chose wisely!
• But why did it work?
•PHARMACOKKINETICS
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Slide 43
When the capsule breaks
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Slide 44 Pharmacokinetics change with broken capsules
• The vitreous is contaminated
• As few as 5 bacteria in the vitreous can cause endophthalmitis
• Antibiotics are distributed into a larger volume (5 mL vitreous)
• Injected or flushed moxifloxacin 500 ug/mL does not reach MIC90 of 32 ug/mL in the vitreous1
• Switching to irrigation may be helpful1
• Cefuroxime may not reach the MIC90 of 256 ug/mL
• Vancomycin injection widely exceeds the MIC90 of 3 ug/mL
• Vancomycin irrigation gives 20 ug/mL in the vitreous, exceeding the MIC90
1. Matsuura K. Clin Ophthalmol 2013;7:1397
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Slide 45 Summary of Pharmacokinetics
• Cefuroxime• Effective prophylaxis for methicillin-sensitive staphylococci
• Potential prophylaxis failures for methicillin-resistant staphylococci; intact and torn lens capsules
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Slide 46 Summary of Pharmacokinetics
• Moxifloxacin• Effective prophylaxis for fluouroquinolone-sensitive staphylococci
• Potential prophylaxis failures for fluoroquinolone-resistant staphylococci; intact and torn lens capsules
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Slide 47 Summary of Pharmacokinetics
• Vancomycin• Effective prophylaxis for essentially all staphylococci, intact and torn lens
capsules
• Incision hydration and eye pressurization with plain BSS may cause prophylaxis failures with vancomycin irrigation
• Surgeons who irrigate with vancomycin should strongly consider pressurizing eyes and hydrating incisions with the vancomycin irrigating solution
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Slide 48 Safety of intracameral antibiotics
• Cefuroxime, moxifloxacin, and vancomycin have been used safely in hundreds of thousands of cataract operations
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Slide 49 Safety of intracameral antibiotics - cefuroxime
• Mixing/concentration errors with cefuroxime have caused Toxic Anterior Segment Syndrome (TASS), macular edema and corneal edema
• Using cefuroxime axetil (versus cefuroxime) has also caused TASS
• Anaphylaxis has been reported with intracameral cefuroxime in penicillin allergic patients
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Slide 50 Safety - moxifloxacin
• No compounding required
• Injecting extended-release moxifloxacin 0.5% drops, with sorbitol and tyloxapol, has been associated with severe Toxic Anterior Segment Syndrome
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Slide 51 Safety of intracameral antibiotics - vancomycin
• Vancomycin irrigation • Compounded vancomycin 10 mg/1 mL, diluted 500:1 in balanced salt solution
• Dilutes and buffers contaminants, toxins, mixing, osmolarity, and pH errors
• TASS is unlikely
• Postoperative cystoid macular edema with vancomycin irrigation was noted in a teaching hospital (extended case times)1
• No CME in recent series2
• Recent reports have associated devastating postoperative Hemorrhagic Occlusive Retinal Vasculitis with intracameral vancomycin3
• We have not experienced a case after 14 years and 65,003 cataract operations with vancomycin irrigation
1. Axer-Siegel R. Ophthalmology 1999;106:1660
2. Ball JL. JCRS 2006;32:789
3. Witkin AJ. Ophthalmology 2015;122:1438
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Slide 52 Summary: CHOOSE WISELY in 2016
• Endophthalmitis is preventable
• Strict asepsis
• Monitor and mentor surgeons with high complication rates
• Use acrylic lenses
• Irrigate the eye with povidone-iodine before surgery
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Slide 53 Summary: CHOOSE WISELY in 2016
• Choose intracameral antibiotics• “Know your bugs to pick your drugs”
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Slide 54 Summary: CHOOSE WISELY in 2016
• Europe: cefuroxime • Commercially available single-dose injection
• Lower rate of MRSA and MRSE than U.S.
• Watch for beta-lactam allergies
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Slide 55 Summary: CHOOSE WISELY in 2016
• Japan: Moxifloxacin may be best • Available in preservative-free eye drops
• High rate of Enterococcalendophthalmitis, vancomycin resistance
• Do not use extended release formulation (TASS)
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Slide 56 Summary: CHOOSE WISELY in 2016
• United States: all work well, vancomycin may protect best• Injection: effective
• Surgeons who irrigate with vancomycin should pressurize eyes and hydrate incisions with the vancomycin mixture
• Watch for postop retinal vasculitis• Exceedingly rare: less than 1/65,000 in our
series
• Devastating
• Consider other agents for sequential bilateral surgery
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Slide 57
Thank You!
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