ace inhibitors and arbs: perioperative management...test: held acei/arbs 24 hours before surgery....
TRANSCRIPT
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ACE Inhibitors and ARBs:Perioperative Management
Matthew Sigakis, MD
Assistant ProfessorDivision of Critical Care
Department of AnesthesiologyUniversity of Michigan
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DisclosuresNone
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Outline• Background / history
• Mechanisms of BP maintenance and RAS antagonists
• Review of most current literature and guidelines• Perioperative ACEI/ARB management• Intraoperative BP goals
• Approaches to treatment
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Hypertension100 million!
Circulation 2018
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Hypertension100 million!
Circulation 2018
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Hypertension
CAD
Stroke
Heart Failure
Diabetes
100 million!
Circulation 2018
Sear JW. Anesth Analg. 2014; Bian B. et al. J Manag Care Pharm. 2010
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Shah SJ, et al. Am J Hypertens. 2017
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FDA Approval Generic
Bian B. et al. J Manag Care Pharm. 2010
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FDA Approval Generic
Bian B. et al. J Manag Care Pharm. 2010
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Kantor ED et al. Trends in Prescription Drug Use Among Adults in the United States From 1999-2012. JAMA. 2015
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ACEI and ARBs - benefits
Hypertension
Sear JW. Anesth Analg. 2014; Bian B. et al. J Manag Care Pharm. 2010
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ACEI and ARBs - benefits
Hypertension↓ ischemic events• MI• Stroke
Sear JW. Anesth Analg. 2014; Bian B. et al. J Manag Care Pharm. 2010
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ACEI and ARBs - benefits
Sear JW. Anesth Analg. 2014; Bian B. et al. J Manag Care Pharm. 2010
Hypertension↓ ischemic events• MI• Stroke
↑ cardiac function and survival
• Post-MI• HFrEF
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ACEI and ARBs - benefits
Hypertension↓ ischemic events• MI• Stroke
↑ cardiac function and survival
• Post-MI• HFrEF
↓ CKD• DM• Non-DM
Sear JW. Anesth Analg. 2014; Bian B. et al. J Manag Care Pharm. 2010
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• Spinal fusion surgery – deliberate hypotension• 12 patients• Captopril given in preop • Observed impact on MAP and blood CN level
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• ↓ MAP with Anesthesia• ↓ SNP required by >50%• Reduced cyanide level
MAP
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Continue vs. hold ACEI
Effects on blood pressure
47 patients on ACEI chronically
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24h 12h
SBP
MAP
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“Exaggerated hypotensive response to induction”
“Temporary withdrawal …attenuated the hypotensive response…”
“…help to provide stable blood pressure.”
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ARBs↓
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ACEI and ARBs: Withhold?
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Blood pressure
maintenance
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RAS antagonists
Blood pressure
maintenance
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RAS antagonists
Recent literature
Current guidelines
TreatmentBlood
pressure maintenance
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Maintenance of blood pressure
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Maintenance of blood pressure
RASRenin-Angiotensin
System
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Maintenance of blood pressure
RASRenin-Angiotensin
System
SNSSympathetic
Nervous System
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Maintenance of blood pressure
RASRenin-Angiotensin
System
VSVasopressinergic
System
SNSSympathetic
Nervous System
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Maintenance of blood pressure
RASRenin-Angiotensin
System
VSVasopressinergic
System
SNSSympathetic
Nervous System
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• Renal hypoperfusion• Hypotension• Volume depletion
• Increased sympathetic activity
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• Renal hypoperfusion• Hypotension• Volume depletion
• Increased sympathetic activity
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• Renal hypoperfusion• Hypotension• Volume depletion
• Increased sympathetic activity
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• Renal hypoperfusion• Hypotension• Volume depletion
• Increased sympathetic activity
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• Renal hypoperfusion• Hypotension• Volume depletion
• Increased sympathetic activity
Angiotensin II – Type 1 receptor
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• Renal hypoperfusion• Hypotension• Volume depletion
• Increased sympathetic activity
Angiotensin II – Type 1 receptor
- Angiotensin II – Type 2 receptoro ↓ Renino NO release
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Maintenance of blood pressure
RASRenin-Angiotensin
System
VSVasopressinergic
System
SNSSympathetic
Nervous System
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↑ Catecholamines
↓ Vagal tone
RAS activation:↑ Angiotensin II
Reid IA. Am J Physiol. 1992
SNSSympathetic
Nervous System
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Reid IA. Am J Physiol. 1992
↑ Catecholamines
↓ Vagal tone
RAS activation:↑ Angiotensin II• Sympathetic outflow• Heart rate• Vasoconstriction
SNSSympathetic
Nervous System
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Maintenance of blood pressure
RASRenin-Angiotensin
System
VSVasopressinergic
System
SNSSympathetic
Nervous System
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V3
CNS
ACTH secretion
GluconeogenesisAnti-inflammatory
VSVasopressinergic
System
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V3
CNS
ACTH secretion
GluconeogenesisAnti-inflammatory
VSVasopressinergic
System
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V3
CNS
ACTH secretion
GluconeogenesisAnti-inflammatory
Den Ouden, DT et al. Neth J Med. 2005
VSVasopressinergic
System
Endothelium: vWF, F8
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Den Ouden, DT et al. Neth J Med. 2005
VSVasopressinergic
System
V3
CNS
ACTH secretion
GluconeogenesisAnti-inflammatory
Arginine vasopressin“ADH”
Endothelium: vWF, F8
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Den Ouden, DT et al. Neth J Med. 2005
VSVasopressinergic
System
V3
CNS
ACTH secretion
GluconeogenesisAnti-inflammatory
DesmopressinTerlipressin
Arginine vasopressin“ADH”
Endothelium: vWF, F8
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Maintenance of blood pressure
RASRenin-Angiotensin
System
VSVasopressinergic
System
SNSSympathetic
Nervous System
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General Anesthesia
RASRenin-Angiotensin
System
VSVasopressinergic
System
SNSSympathetic
Nervous System
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General Anesthesia + ACEI/ARB
RASRenin-Angiotensin
System
VSVasopressinergic
System
SNSSympathetic
Nervous System
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RAS antagonists
Blood pressure
maintenance
ACEI
ARB
Directant-Renin
Combo
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Messerli FH et al. J Am Coll Cardiol. 2018Messerli FH et al. J Am Coll Cardiol. 2018
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Messerli FH et al. J Am Coll Cardiol. 2018
• Endothelium-Derived Hyperpolarizing Factor
• Prostacyclin
Messerli FH et al. J Am Coll Cardiol. 2018
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Messerli FH et al. J Am Coll Cardiol. 2018
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Messerli FH et al. J Am Coll Cardiol. 2018
Renin Antagonist
Direct Renin Antagonist
Aliskiren (FDA 2008):TekturnaRasilez
half life: 24 - 40 h
BEWARE!
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Pharmacokinetic Parameters
Setty, S. Anesth Analg. 2018
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Combination Medications
Yancey R. Anesth Prog. 2018
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Recent literature
Current guidelines
Treatment
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ACEI / ARBs
Intraop hypotension
Mortality
Myocardial InfarctionStroke
Renal Failure
What is the evidence?2000-2020
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Evidence
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Evidence
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Evidence
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Evidence• Small• Heterogenous• No comparator
group• Definitions
• When stop• Type of med• Reason stop• Outcomes
measured
Inconsistent
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Definitions Requirement StudySBP < 80 mmHg > 1 minute
Post-inductionVasopressor used
Bertrand M. Anesth Analg. 2001• ARB only• Vascular surgery
SBP < 85 mmHg > 1 minutePost-induction and shortly thereafter
Coriat P. Anesthesiology. 1994• ACEI only• Vascular surgery
SBP < 85 mmHg > 1 minute0-30 and 31-60 min
Comfere T. Anesth. Analg. 2005• Elective surgery
SBP < 90 mmHg That prompted clinical interventionAny durationAt any time
Roshanov P. Anesthesiology 2017• Major NC surgery, including
emergent
MAP < 60 mm Hg Any durationPost-inductionVasopressor used
Schirmer U. Anaesthesist. 2007• ENT/ophthalmology
ACEI/ARB studies: variable definitions of hypotension
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Two themes in literature
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Two themes in literature
Chronic ACEI exposure
Never ACEI exposurevs
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Two themes in literature
Chronic ACEI exposure
Never ACEI exposurevs
Withheldoperative day
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Two themes in literature
Chronic ACEI exposure
Never ACEI exposurevs
Withheldoperative day
• University of Michigan• Cleveland Clinic
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J Cardiothorac Vasc Anesth 2008
Background:• Retrospective, Propensity matched • Non-cardiac surgery• 12,000 pts (chronic ACEI/ARB held vs never ACEI/ARB)
Assessment: • Intraoperative hypotension • Perioperative MI and AKI• ACEI / ARB
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Blood pressure parameters
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Background:• Retrospective, Propensity matched • Non-cardiac surgery• 18,000 (9,000 ACEI users who withheld vs 9,000 non-ACEI)
Test: • Intraoperative hypotension, vasoactive medications, IVF• Perioperative mortality, MI and AKI• ACEI only
Anesth. Analg. 2012
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Anesth. Analg. 2012
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Anesth. Analg. 2012
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Two themes in literature
Chronic ACEI exposure
Never ACEI exposurevs
Withheldoperative day
Chronic ACEI exposure
Withheldoperative day
vs
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Two themes in literature
Chronic ACEI exposure
Never ACEI exposurevs
Withheldoperative day
Chronic ACEI exposure
Withheldoperative day
vsChronic ACEI
exposure
Continuedoperative day
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Two themes in literature
Chronic ACEI exposure
Withheldoperative day
vsChronic ACEI
exposure
Continuedoperative day
• VISION study• South Africa
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Study name: The “VISION” study (Vascular events in noncardiac surgery patients cohort evaluation)
Background:• International, prospective, cohort study• Non-cardiac surgery
Size: Subgroup analysis of 4,802 on ACEI or ARBs
Test: Held ACEI/ARBs 24 hours before surgery
Outcome: 30 day mortality
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• Holding ACEI / ARB 24hrs preop• less intraoperative hypotension
• aRR 0.80 (0.73-0.88), p < 0.001
• “holding is associated with lower risk of death” • composite outcome (mortality, MINS, stroke)• aRR 0.82 (0.70-0.96), p = 0.01
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• Holding ACEI / ARB 24hrs preop• less intraoperative hypotension
• aRR 0.80 (0.73-0.88), p < 0.001
• “holding is associated with lower risk of death” • composite outcome (mortality, MINS, stroke)• aRR 0.82 (0.70-0.96), p = 0.01
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Anesth Analg. 2018.
Background:• 9 studies
• 5 randomized clinical trials• 4 retrospective cohort studies
Size:• 6,000 patients
Test:• Continued vs held ACEI/ARBs 24 hours before surgery
Outcomes: intraop hypotension, major cardiovascular outcomes
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Anesth Analg. 2018.
• Holding ACEI / ARB preoperatively • Less intraop hypotension
• OR 0.63; (0.47-0.85), p = 0.002
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Mortality
MACE
• Holding ACEI / ARB preoperatively • 0.002
• No association with mortality, MACE, stroke or AKI
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No clear association with adverse outcomes
ACEI/ARB Intraoperative hypotension
Intraoperative hypotension ≠ Adverse outcomes?
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Keep MAP > 55 mmHgCumulative BP
A. Postop Renal Injury B. Postop Myocardial Injury
Relationship between Intraoperative Mean Arterial Pressure and Clinical Outcomes after Noncardiac Surgery…
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Keep MAP > 60 mmHgCumulative BP
A. Postop Renal Injury B. Postop Myocardial Injury
Relationship between Intraoperative Mean Arterial Pressure and Clinical Outcomes after Noncardiac Surgery…
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Intraoperative Hypotension (MAP and Duration) and Postoperative Organ Injury: A Meta-analysis
Wesselink EM, Kappen TH, et al. British Journal of Anaesthesia 2018; 121(4):706-721.
Mortality AKI MI Stroke Delirium AllMAP
80 mmHg
60 mmHg
40 mmHg
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Acute Kidney Injury Incidence versus Intraoperative Hypotension Nadirby Preoperative Risk Quartile
Mike Mathis, Robert Freundlich, et al. Anesthesiology, Nov 2019
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“Avoid Hypotension” Individualize BP ManagementAnd Cumulative “damage” so keep track
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“Avoid Hypotension” Individualize BP ManagementAnd Cumulative “damage” so keep track
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Benefits to continuing ACEI/ARB• Improved mortality to perioperative ACEI use in
patients with reduced LV function.
• Reduced post operative hypertension• Patients with poorly controlled preoperative blood
pressure
• Not restarting within 48hours post-operatively associated with increased morbidity/30d mortality
• Lee SM et al. Anesthesiology. 2015• Mudumbai SC et al. J Hosp Med. 2014
• Feringa et al. Semin Cardiothorac Vasc Anesth 2006
• Vasallo MC. J Cardiothorac Vasc Anesth. 2017• Pigott DW. Br J Anaesth. 1999
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Guidelines (Non-cardiac surgery)
• 2014 ACC/AHA guidelines• Continuation is “reasonable” • If withheld, restart as “soon as feasible”
• 2017 Canadian Cardiovascular Society Guidelines• okay to hold 24 hours prior• Restart on post op day 2
• 2014 ESC/ESA Guidelines• Continue in stable patients with LV dysfunction / HF• Otherwise okay to hold 24 hours
• ASA - none• UM – hold 24 hours prior to operative day (but don’t cancel
case because of this….)
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Guidelines (Non-cardiac surgery)
• 2014 ACC/AHA guidelines• Continuation is “reasonable” • If withheld, restart as “soon as feasible”
• 2017 Canadian Cardiovascular Society Guidelines• okay to hold 24 hours prior• Restart on post op day 2
• 2014 ESC/ESA Guidelines• Continue in stable patients with LV dysfunction / HF• Otherwise okay to hold 24 hours
• ASA - none• UM – hold 24 hours prior to operative day (but don’t cancel
case because of this….) JUST BE PREPARED TO TREAT BP!
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Conventional Therapy
• Reduce anesthetic agent• Volume expansion• Vasoactive medications
- Phenylephrine- Ephedrine
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Vasopressin
• 0.5-1 unit bolus• Infusions:
- AVP: 0.03 unit/min - Terlipressin: 1-2mcg/kg/h
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Treatment
Conventional Therapy Vasopressin
Methylene Blue
AT2Angiotensin II
Tertiary agents
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Methylene Blue
• Interferes with NO – cGMP pathway, inhibiting the vasorelaxan effect on smooth muscle.
• Bolus dose of 1-2mg/kg over 10 – 20 minutes
• Followed by infusion of 0.25mg/kg/hr for 48-72 hours
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Contraindications to MB• SSRIs• G6PD deficiency
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MB contraindicated w/ SSRIs• Methylene Blue is a potent monoamine oxidase (MAO)
inhibitor.• MB can produce serotonin toxicity in the perioperative period
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MB contraindicated w/ SSRIs• Methylene Blue is a potent monoamine oxidase (MAO)
inhibitor.• MB can produce serotonin toxicity in the perioperative period
• SSRIs• SNRIs• TCAs• Tramadol• Clomipramine• Methamphetamines
https://www.apsf.org/article/methylene-blue-and-the-risk-of-serotonin-toxicity/
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MB contraindicated w/ G6PD deficiency• Methylene Blue needs to be reduced
• NADPH from Pentose Phosphate pathway• Requires G6PD enzyme
• MB Methylene Leucoblue• G6PD deficiency
• MB promotes oxidative stress methemoglobinemia, hemolysis
• The next slide is very busy, please don’t freak out.
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Gly
coly
sis
Pentose Phosphate pathway (hexose monophosphate shunt)
NADH and NADPH-dependent methemoglobin reduction
(reduced) (oxidized)
oxidant
Cytochrome b5 reductase (95-99%)(aka methemoglobin reductase)
Glutathione reductase (<5%)
Methylene leucoblue
5x
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AT2Angiotensin II
• Approved by FDA 12/21/2017
• Indication: increase blood pressure in distributive shock
• Mechanism of action: vasoconstriction and aldosterone release
• Half-life of less than one minute
• High-dose vasopressors: > 0.2 mcg/kg/min NE equivalent or greater
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AT2Angiotensin II
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AT2Angiotensin II
Administration:• Starting dose is 20 NANOgrams/kg/min• Central access “recommended”• Infusion only• Compatible with norepinephrine,
epinephrine, vasopressin, phenylephrine and dopamine
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AT2Angiotensin II
Titration (per FDA): https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209360s000lbl.pdf
• Titrate increments of 5-15 ng/kg/min every 5 minutes
• Max 80ng/kg/min within the first 3 hours• Maintenance dose: 40 ng/kg/min
• as low as 1.25 ng/kg/min may be used
• To allow downtitration of catecholamines
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Adverse events to be aware of:
DVT prophylaxis should be considered
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Hold or not hold?
Which patients?
How long?
High quality RTCs are needed
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• ClinicalTrials.gov, NCT03374449. Registered on 11 December 2017.
• Prospective, RCT• France, > 30 centers• 2,222 patients planned• Estimated completion date: 4/2021
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• Episodes of hypotension defined as MAP < 60• Lowest and duration of hypotension recorded
• Mortality • LOS• Vascular• Renal related
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Conclusion
• Some patients may benefit from continuing ACEI/ARBs (and others will forget to hold)• Preoperative planning
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Conclusion
• Some patients may benefit from continuing ACEI/ARBs (and others will forget to hold)• Preoperative planning
• Don’t cancel the case!• Be prepared to treat• Vasopressin is likely the best choice
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Conclusion
• Some patients may benefit from continuing ACEI/ARBs (and others will forget to hold)• Preoperative planning
• Don’t cancel the case!• Be prepared to treat• Vasopressin is likely the best choice
• At least MAP > 60 cumulative damage!• future decision support for individualized care
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Thank you!