LA SYSTEMIC TOXICITY(LAST) AND INTRAVENOUS LIPID EMULSION (ILE) (IN COLLABORATION WITH MALAYSIAN SIGRA)
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2 LA SYSTEMIC TOXICITY(LAST) AND INTRAVENOUS LIPID EMULSION (ILE) (IN COLLABORATION WITH MALAYSIAN SIGRA) DR LING KWONG UNG, ANAESTHETIST, RAMSAY-SIME DARBY MEDICAL CENTRE, ARA DAMANSARA, MALAYSIA.
3 RAMSAY-SIME DARBY MEDICAL CENTRE ARA DAMANSARA, SELANGOR, MALAYSIA
4 MAYRA CABRERA 30yr/ OT nurse Delivered at 8:14am, 11 May 2004 in Britain 9am, felt dizzy, before fitted and suffered a cardiac arrest Resuscitated but unsuccessful, pronounced death at 10:47am Epidural catheter was wrongly connected to her iv line Died of Bupivacaine toxicity
5 INCIDENCE OF LAST Since the use of Cocaine in the late 19 th century 1928, American Medical Association reported 40 deaths d/t LAST, majority cocaine & procaine Before 1981 epidural use for labor analgesia had reported LAST in 100 per 10,000 cases Mulroy MF ( Reg Anesth Pain Med 2002), reported from , rate of LAST for epidural anaesthesia of per 10,000 anaesthetics reported LAST for PNB was : 7.5 per 10,000 in 1997 (Auroy Y,Anesthesiology 2002) 2.5 per 10,000 in 2004 (Auroy Y,Anesthesiology 2002) 9.8 per 10,000 in 2009 ( Barrington Mj, Rej Anesth Pain Med 2009) 8.7 per 10,000 in 2013 when using US (Barrington Mj, Reg Anesth Pain Med 2013)
6 MECHANISM OF LA TOXICITY The actual mechanism remains elusive Systemic absorption ( delayed onset) Accidental iv inj (rapid onset) BRAIN - LA affect the balance between inhibitory & excitatory pathway
7 MECHANISM OF LA TOXICITY HEART Conduction block - Na+, K+ & Ca++ dysrhytmia & reduced contractility Disrupt intracellular signals originating at metabotropic receptors cyclic adenosine monophosphate reduce contractility
8 RISK FACTORS FOR LAST 1)LA - Type - Dose 2) The block site - single vs continuous - conduct of block 3)The patient
9 RISK FACTORS FOR LAST 1) Type of LA Mazoit J ( Anesth 1993)- more L-Bupivacaine than bupivacaine was required to induce cardiac arrest in rabbit hearts Huang Y (Anesth Analg 1998)- L-bupivacaine caused fewer convulsions and arrhythmias than bupivacaine L-bupivacaine & ropivacaine have intrinsic vasoconstriction properties that may prolong duration of action and slow systemic absorption this may be safer than bupivacaine but the clinical significant of this difference remains unclear
10 RISK FACTORS FOR LAST 1) Type of LA Ropivacaine may cause less motor block, but whether it is clinically significantly less toxic is unknown LA with lower CC/CNS ratio can progress from CNS to CVS collapse faster ; bupivacaine(2.0) vs lidocaine (7.1) Indeed, it is not clear that any one agent is less toxic than another to a degree that is clinically relevant
11 RISK FACTORS FOR LAST 1) Dose of LA The recommended maximum weight-based dose is not based on solid evidence, is just a rough guide for clinical use -? Vary significantly between countries -? Patient factors?pregnant?obese -? Site of injection -? Actual or ideal body weight -? Co-morbidities of the patient Use the lowest effective dose
12 RISK FACTORS FOR LAST 2) Block related a) Site of block higher risk of direct iv inj: -interscalene - stellate ganglion block higher risk of rapid absorption - scalp -bronchial mucosa - pleura Absorption of LA Intercostal Caudal Epidural Brachial plexus Subcutaneous
13 RISK FACTORS FOR LAST 3) Block related b) single vs continuous infusion continuous infusion LA accumulation over time delayed LAST continuous monitoring throughout the period of infusion
14 RISK FACTORS FOR LAST 2) Block related c) Conduct of the block to reduce the risk of LAST - frequent aspiration - incremental injection - test dose -tracer, eg. Epinephrine ( controversial) - US guided needle placement
15 RISK FACTORS FOR LAST 3) Patient related factors a) Renal impairment - a hyperdynamic circulation systemic absorption - a reduced clearance of LAs - an α₁ - acid glycoprotein (AAG) free LA conc. => overall toxicity risk recommended to dose by 10-20% according to the degree of renal impairment
16 RISK FACTORS FOR LAST 3) Patient related factors b) Liver disease - LA clearance - single dose unaffected - but doses for repeated boluses & continuous infusion should be reduced
17 RISK FACTORS FOR LAST 3) Patient related factors c) Severe heart failure - susceptible to LA induced myocardial depression & arrhythmia - lower liver and renal perfusion slows the metabolism & elimination of LA recommended to reduce initial & maintenance doses of LA
18 RISK FACTORS FOR LAST 3) Patient related factors d) Elderly patients - blood flow and organ function,lowers clearance - multiple co-morbidities altering LA pharmacokinetics & pharmacodynamics - nerves appear more sensitive to LA block d/t reduction in axonal function, altered nerve morphology & reduced surrounding fatty tissue recommended to reduce the LA doses
19 RISK FACTORS FOR LAST 3) Patient related factors e) Pediatrics patients - they have reduced α₁ - acid glycoprotein (AAG) - elimination t½ of LAs - this the risk of accumulation with continuous infusion
20 RISK FACTORS FOR LAST 3) Patient related factors f) Pregnant patients - lower AAG levels - accelerated perfusion of sites of injection increase absorption of LAs
21 SIGN & SYMPTOM OF LAST Excitatory state Perioral tingling Tinnitus Slurred speech Light headedness Tremor Confusion/ agitation convulsion Depressive phase Coma Respiratory depression
22 SIGN & SYMPTOM OF LAST Hypertension Tachycardia Initial phase Intermediate phase Myocardial depression Hypotension Terminal phase Peripheral vasodilatation Severe hypotension Arrhythmia- sinus bradycardia, conduction block, VT, VF & asystole
23 ILE IN LAST! -BRIEF HISTORY
24 1998, Weinberg G First report of successful use of ILE in LAST in a rats model
25 FIRST SUCCESSFUL CASE OF ILE IN LAST IN HUMAN 2006, Rosenblatt et al 58/man, shoulder surgery Developed cardiac arrest 30 sec after NSG interscalene block with mixture of bupivacaine & mepivacaine Failed to respond to ACLS 20min later 100ml of 20% intralipid was given Achieved normal v/s within second No neurologic sequelae
26 THE FIRST SUCCESSFUL CASE OF ILE IN TREATING NON-LA DRUG TOXICITY 2008, Sirianni et al An adolescent suffered cardiac arrest d/t massive overdose of buprobion and lamotrigine Not responding to ACLS 90 min later, a bolus of ILE was given Recovered normal v/s within 1 min No major neurologic deficit
27 ILE IN NON-LA LIPOPHILIC DRUG A) Tricyclic antidepressant -dosulepin -imipramine -amitriptyline B) Other antidepressant/antipsychotic -lamotrigine -olanzapine -hydroxyzine -venlafaxine -haloperidol -sertraline -bupropion -quetiapine C) Organophosphate poisoning D) Antiarrhythmic -verapamil -atenolol -flecainide E) Β blockers -propranolol -nevibolol F) Ca++ channel blocker -diltiazem -amlodipine G) Glophosate herbicite H) Anthelmintic -moxidectin I) Multi drug overdose
28 WHAT IS LIPID EMULSION?
29 LIPID EMULSION A fat emulsion,approved in 1962 in Europe Used as a component of TPN 1 st brand name being Intralipid It is an emulsion of - soy bean oil - egg phospholipids - glycerin Available in 10%, 20% & 30% concentration
30 20%INTRALIPID 20% soy bean oil, predominantly unsaturated long chain fatty acid (FA) 1.2% egg yolk phospholipids 2.25% glycerin Water Sodium hydroxide to adjust the ph to 8.0 Major component of FA: - linoleic acid 44-62% - oleic acid 19-30% - palmitic acid 7-14% - linolenic acid 4-11% - stearic acid %
31 MECHANISM OF ACTION OF ILE IN LAST 1) Lipid sink theory - acts as a sink to capture the lipophilic LAs - the ILE binds the offending toxin to pull drug from the target tissue, thereby reversing the toxicity
32 MECHANISM OF ACTION OF ILE IN LAST 2) Metabolic effect - increase FA uptake by mitochondria -augment the mitochondria FA metabolism ( lipids comprise the heart s preferred energy substrate under normal aerobic conditions)
33 MECHANISM OF ACTION OF ILE IN LAST 3) Through competition/ membrane effect - may directly inhibit LAs binding to cardiac Na+ channels
34 MECHANISM OF ACTION OF ILE IN LAST 4) Cytoprotective effect - by activation of Akt ( proteinkinase B), an enzyme important in cell survival & proliferation
35 MECHANISM OF ACTION OF ILE IN LAST 5) Direct inotrope - by increasing intracellular Ca²+ concentration
36 MECHANISM OF ACTION OF ILE IN LAST 6) Pharmacokinetic effects - accelerated shunting to sequestering organs
37 WHICH LIPID EMULSION (LE)? 10%? 20%? 30%? Long chain FA (LCFA)? Medium chain FA ( MCFA)? Intralipid? Medialipide? Liposyn III? Lipofundin?
38 WHICH LIPID EMULSION (LE)? Intralipid 20% was used in majority of the studies published on lipid rescue in LAST From a physio-chemical perspective, LE with LCFA seen to have an advantage, but laboratory study showed mixed result
39 WHICH LIPID EMULSION (LE)? 2009, Mazoit et al Compared Intralipid (LCFA) & Medialipide (LCFA/MCFA) in their binding capacity for racemic bupivacaine, L-bupivacaine & ropivacaine Intralipid was 2.5X more efficacious But it is unclear in actual clinical efficacy Also found that low ph reduced lipid binding of LAs
40 WHICH LIPID EMULSION (LE)? 2012, Ruan et al Reported that an LCT/MCT (50:50) mixture extracted bupivacaine, ropivacaine & mepivacaine better than LCT emulsion
41 WHICH LIPID EMULSION (LE)? 2011, Li et al Reported that LCT and LCT/MCT mixture were equally effective in initial reversal of severe Bupivacaine overdose, but subsequently LCT group has better survival
42 WHICH LIPID EMULSION (LE)?
43 WHICH LIPID EMULSION (LE)? Optimizing the lipid emulsion will still require further comparison of different formulation
44 SAFETY OF ILE IN TREATING LAST
45 POSSIBLE COMPLICATION / ADVERSE EFFECT OF LIPID INFUSION Total Hb & methb are falsely elevated - interference with spectrophotometric assessment Significant interference in: - albumin - Mg++ assay - amylase lipase - phosphate - creatinine - total protein - ALT - CK - bilirubin t½ hypertriglyceridemia is about 15 min, the effect should completely dissipated after a few hour
46 POSSIBLE COMPLICATION / ADVERSE EFFECT OF LIPID INFUSION No interference in: - Na++ - K+ - Cl - Ca++ - Bicarbonate - Urea - troponin assays
47 POSSIBLE COMPLICATION / ADVERSE EFFECT OF LIPID INFUSION Microbial contamination, proinflammatory effects, hepatosplenomegaly are unlikely in the treatment of LAST No serious clinical complication have been reported following the use of ILE in LAST
48 IS THERE A SAFE UPPER LIMIT OF LIPID DOSING?
49 IS THERE A SAFE UPPER LIMIT OF LIPID DOSING? Lethal dose in 50% of test animal (LD50) of Intralipid for bolus administration in rats at 48 hour to be 67.7± 10.7ml/kg Excellent safety profile as recommended max dose of ILE in LAST is 10-12ml/kg However the correct conversion of allometric scaling of this dose to a human is unknown Furthermore the LD50 per se cannot be readily converted to a maximal safe or lowest toxic dose??? Dosing limit for ILE
50 DOES IT WORK WELL FOR ALL LAs?
51 DOES IT WORK WELL FOR ALL LAs? Widely accepted for bupivacaine toxicity Also successful treatment in: - mepivacaine - ropivacaine - lidocaine - prilocaine - levo-bupivacaine
52 ILE IN BUPIVACAINE LAST
53 ILE IN NON BUPIVACAINE RELATED LAST Aveline et al ; patient was taking carbamazepine, may caused drug interaction with LA as it bind to voltage-gated sodium channels also. And also lidocaine has low lipid solubility
54 DOES ILE CONFER BENEFIT IN THE PAEDIATRIC & ELDERLY POPULATION SUFFERING LAST
55 ILE IN PAEDIATRIC & ELDERLY PATIENT Octogenerian Infant Octogenerian 6 yr Octogenerian
56 OPTIMAL DOSE OF ILE IN LAST?
57 OPTIMAL DOSE OF ILE IN LAST - The optimal dose is unknown!
58 DOSES OF ILE Recommended dose of 20% Intralipid in LAST: 1.5ml/kg bolus over 1 min ( 100ml in 70 kg) followed by infusion of 0.25ml/kg/min,by ideal body weight, ( 1000ml/hr in 70kg) if no respond, repeat the bolus dose up to a total of 3 boluses, 3-5 min apart, followed by increasing the infusion to 0.5ml/kg/min continue the infusion for roughly 10 min following the recovery of the V/S max dose is 10-12ml/kg, given over 30 min ( 800ml in 70 kg)
59 HOW DO WE INTERGRATE ILE INTO STANDARD ACLS RESUSCITATION? - 9 CASE REPORTS OF LAST WITH CVS TOXICITY ILE administered late ( min of ACLS) ILE administered early (2-3 min of ACLS) 4 cases Given a few doses of epinephrine and vasopressin Responded within minutes of ILE All patients survive 2 cases given ILE only, no vasopressors 3 cases single dose of epinephrine before the ILE, no further vasopressors needed All patients survived
60 SHOULD LIPID BE USED ALONE OR IN COMBINATION WITH EPINEPHRINE AND OTHER COMPONENT OF STANDARD RESUSCITATION COCKTAILS? Epinephrine > 10μg /kg in conjunction with ILE - lesser rates of recovery of spontaneous circulation (ROSC) - deteriorating metabolic parameters ( hyperlactatemia) - cardiac arrhythmogenesis
61 EPINEPHRINE AS CO-TREATMENT WITH ILE IN LAST LI & colleague ( BR J Anaesth 2012) superior outcome with epinephrine + LE compound when compared with lipid alone Mauch & colleagues (Paediac Anaesth 2012) - reported greatest survival (86%) with a combination of lipid and epinephrine compared with just 29% with lipid only Mayr & colleagues ( Anesth Analg 2008) - epinephrine/vasopressin combination was superior in achieving ROSC when compared with ILE alone
62 EPINEPHRINE AS CO-TREATMENT WITH ILE IN LAST Weinberg G (2008 Anesthesiology) & Di Gregorio G ( Crit Care Med 2009) - ILE result in superior haemodynamic & metabolic recovery compared with epinephrine either alone or in combination with vasopressin Hiller D, Gregorio G ( Anesthesiology 2009) - identical rate of ROSC when ILE was co administered with or without low-dose epinephrine, albeit, epinephrine was associated with more rapid circulation return
63 EPINEPHRINE AS CO-TREATMENT WITH ILE IN LAST Liu & colleagus ( Anesth Analg 2012) - time to heart beat recovery was significantly shorter in both the lipid and lipid + epinephrine group compared to control and epinephrine alone - cardiac tissue bupivacaine concentration was noted to be significantly higher in the control and epinephrine treated group
64 EPINEPHRINE AS CO-TREATMENT WITH ILE IN LAST Carreiro S & colleagues ( J Med Toxcol 2013) - interaction between ILE and epinephrine in animals models - ILE pretreatment was shown to delayed the peak effect on MAP and prolong its duration without altering the peak increase in either MAP or HR respond in rats administered iv epinephrine at 15μg/kg - some interaction between ILE and additional lipophilic resuscitation drugs likewise may occur potentially limiting their intended utility
65 EPINEPHRINE AS CO-TREATMENT WITH ILE IN LAST Conclusion from pre clinical data, ILE used alone: - may confer equivalent resuscitation outcome - lesser arrhythmogenesis - improved post- arrest metabolic parameters However this will still need more greater power studies
66 LIMITATION IN ANIMALS STUDY Variation in animal models used - rat - rabbit - dog - pig ( allergic to LE) Different resuscitation regimes Small sample sizes
67 ONGOING RESEARCH The optimal dose is unknown Use of epinephrine in cardiac arrest, in the present of ILE, is beneficial or not Whether ILE is associated with long term sequelae ILE may be used for other intoxication treatment although the evidence is small ILE may have a role in ischemic-reperfusion injury
68 CURRENT RECOMMENDATION & PRACTICAL CONSIDERATION Guidelines for the use of ILE in LAST are available through: - ASRA - AAGBI ( Asso. Of Anaesthetists of Great Britain and Ireland) - AHA Early ACLS/ BLS including adrenaline with immediate ILE injection in LAST - airway, O₂,circulation - seizure suppression (benzodiazepine/ STP/ propofol) -early ILE - treat arrhythmias, conduction block, hypotension & bradycardia as in ACLS» avoid LIDOCAINE as an anti-arrhythmic
69 CURRENT RECOMMENDATION & PRACTICAL CONSIDERATION In toxic cardiomyopathy, raising PVR with potent vasopressors can impair CO & impede resuscitation - therefor, vasopressin is not considered useful & epinephrine should be used in small doses ( < 10μg/kg) These guidelines will likely subject to frequent modification based on the new finding
70 CONCLUSION LAST is rare, but may be fatal LAST is unpredictable, but many are preventable The key is to recognize it early and institute appropriate management immediately Early ILE therapy has significant advanced management of this emergency
71 THANK YOU! (In collaboration with Malaysian SIGRA) - lingkupisces@yahoo.com
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