pharmacological pre-emptive strategies to reduce peri-operative risk: give me the magic bullet,...
TRANSCRIPT
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Pharmacological pre-emptive Pharmacological pre-emptive strategies to reduce peri-strategies to reduce peri-operative risk: operative risk: give me the magic bullet, pleasegive me the magic bullet, please
Speaker:Speaker: Landoni GLandoni G INTERCEPT 2009INTERCEPT 2009
S Donato Milanese, Milan, April 17h 2009S Donato Milanese, Milan, April 17h 2009
IRCCS Ospedale San Raffaele MilanoIRCCS Ospedale San Raffaele MilanoUniversità Vita-Salute San RaffaeleUniversità Vita-Salute San Raffaele
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MAGIC BULLETS TO REDUCE MORTALITY IN CARDIAC SURGERY
THERE ARE NO GUIDELINES
THERE IS NO CONSENSUS CONFERENCE
THERE IS NO LARGE RANDOMIZED CONTROLLED STUDY ADEQUATELY POWERED TO SUGGEST A REDUCTION IN MORTALITY
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AN OVERVIEW OF META-ANALYSIS
PEXELIZUMAB
LEVOSIMENDAN
FENOLDOPAM
VOLATILE AGENTS (Intercept 2006)
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AN OVERVIEW OF META-ANALYSIS
MAGIC BULLET
PEXELIZUMABLEVOSIMENDANFENOLDOPAMVOLATILE AGENTS
NNT TO PREVENT ONE DEATH
1001219 or 2684
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LEVOSIMENDAN 1
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LEVOSIMENDAN 2
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Description of the ten studies included in the meta-analysis.
First author
Journal Year Cardiac surgery procedures Control
Al-Shawaf J Cardiothorac Vasc Anesth 2006 Elective CABG* Milrinone
Alvarez 2005 Rev Esp Anestesiol Reanim 2005 Cardiac surgery with CPB† Dobutamine
Alvarez 2006 Rev Esp Cardiol 2006 Cardiac surgery with CPB† Dobutamine
Barisin J Cardiovasc Pharmacol 2004 OPCABG‡ Placebo
De Hert 2007 Anesth Analg 2007 Elective cardiac surgery with CPB† Milrinone
De Hert 2008 J Cardiothorac Vasc Anesth 2008 Cardiac surgery with CPB† Milrinone
Husedzinovic Croat Med J 2005 OPCABG‡ Placebo
Jarvela J Cardiothorac Vasc Anesth 2008 Aortic valve surgery Placebo
Levin Rev Esp Cardiol 2008 CABG* with CPB† Dobutamine
Tritapepe Br J Anaesth 2006 CABG* with CPB† Placebo
* CABG: coronary artery bypass graft† CPB: cardiopulmonary bypass‡ OPCABG: off-pump coronary artery bypass graft
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Number of patients and interventions of included studies.
First author Time of administrationSetting
Bolus dose Continuous infusion dose Length of infusion
Al-Shawaf LCOS# 12 g/kg 0.1-0.2g/kg/min 24 hours
Alvarez 2005 LCOS# 12g/kg 0.2g/kg/min 24 hours
Alvarez 2006 LCOS# 12g/kg 0.2g/kg/min 24 hours
Barisin Before surgery 12/24g/kg
no no
De Hert 2007 After CPB† No bolus 0.1g/kg/min 19+4 hours
De Hert 2008 First group : after induction of anesthesiaSecond group : after CPB†
No bolus 0.1g/kg/min 22+4 hours in the first group, 23+3 hours in the second one
Husedzinovic Before surgery 12g/kg no no
Jarvela After induction No bolus 0.2g/kg/min 24 hours
Levin LCOS# 10g/kg 0.1g/kg/min 24 hours
Tritapepe Before CPB† 24g/kg no no
† CPB: cardiopulmonary bypass# LCOS: low cardiac output syndrome
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Levosimendan and Mortality in Cardiac Surgery
Review: LEVOSIMENDAN CCH (12/1/2009)Comparison: 01 perioperative levosimendan Outcome: 02 Mortality
Study Levosimendan Control Peto OR Peto ORor sub-category n/N n/N 95% CI 95% CI
Al-Shawaf 1/14 1/16 1.15 [0.07, 19.41] Alvarez 2005 1/15 0/15 7.39 [0.15, 372.38] Alvarez 2006 1/25 1/25 1.00 [0.06, 16.45] Barisin 0/21 0/10 Not estimable De Hert 2007 0/15 3/15 0.12 [0.01, 1.22] De Hert 2008 1/40 4/20 0.11 [0.02, 0.72] Husedzinovic 0/12 0/12 Not estimable Jarvela 1/12 0/12 7.39 [0.15, 372.38] Levin 6/69 17/68 0.31 [0.13, 0.77] Tritapepe 0/12 0/12 Not estimable
Total (95% CI) 235 205 0.35 [0.18, 0.71]Total events: 11 (Levosimendan), 26 (Control)Test for heterogeneity: Chi² = 8.27, df = 6 (P = 0.22), I² = 27.4%Test for overall effect: Z = 2.95 (P = 0.003)
0.001 0.01 0.1 1 10 100 1000
Favours levosimendan Favours control
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11/235=4.7% v 26/205=12.7% P=0.007 NNT = 12
Levosimendan and Mortality in Cardiac Surgery
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Levosimendan and Myocardial Infarction
Review: LEVOSIMENDAN CCH (12/1/2009)Comparison: 01 perioperative levosimendan Outcome: 04 Myocardial infarction
Study Levosimendan Control OR (fixed) OR (fixed)or sub-category n/N n/N 95% CI 95% CI
Al-Shawaf 1/14 0/16 3.67 [0.14, 97.49] Barisin 0/21 1/10 0.15 [0.01, 3.96] De Hert 2007 0/15 0/15 Not estimable De Hert 2008 0/40 0/20 Not estimable Husedzinovic 0/12 0/12 Not estimable Levin 1/69 8/68 0.11 [0.01, 0.91] Tritapepe 0/12 0/12 Not estimable
Total (95% CI) 183 153 0.26 [0.07, 0.97]Total events: 2 (Levosimendan), 9 (Control)Test for heterogeneity: Chi² = 3.25, df = 2 (P = 0.20), I² = 38.5%Test for overall effect: Z = 2.01 (P = 0.04)
0.001 0.01 0.1 1 10 100 1000
Favours levosimendan Favours control
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LEVOSIMENDAN VS CONTROLMyocardial Infarction in cardiac surgery
2/183=1.1% v 9/153=5.9% P=0.04
Evidence!
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Levosimendan and Acute Renal FailureNNT = 6
Review: LEVOSIMENDAN CCH (12/1/2009)Comparison: 01 perioperative levosimendan Outcome: 05 Acute renal failure
Study Levosimendan Control OR (fixed) OR (fixed)or sub-category n/N n/N 95% CI 95% CI
Al-Shawaf 2/14 5/16 0.37 [0.06, 2.29] Alvarez 2005 1/15 0/15 3.21 [0.12, 85.20] Barisin 0/21 0/10 Not estimable Levin 5/69 21/68 0.17 [0.06, 0.50]
Total (95% CI) 119 109 0.26 [0.12, 0.60]Total events: 8 (Levosimendan), 26 (Control)Test for heterogeneity: Chi² = 2.95, df = 2 (P = 0.23), I² = 32.1%Test for overall effect: Z = 3.16 (P = 0.002)
0.001 0.01 0.1 1 10 100 1000
Favours levosimendan Favours control
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LEVOSIMENDAN 2
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ITACTA ONGOING RCTsTOPICS HOSPITALS PATIENTS GRANTS
VOLATILE ANESTHETICS
FENOLDOPAM
DESMOPRESSIN
ESMOLOL LEVOSIMENDAN VALVOLE PERCUTANEE
4 200 AIFA 2006
34 1.000 MINISTRY 2008
3 200
3 200 10 1.000 3 150
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AIM OF THE STUDY
To evaluate the renoprotective action of fenoldopam
in a selected high-risk group of patients
undergoing cardiac surgery
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RESULTSVariables Fenoldopa
mN=40
DopamineN=40
p
ARF(25%Creatinine increase), n(%)
17(42.5%)
16(40.0%)
0.9
ARF(50% Creatinine increase), n(%)
10(25%) 10(25%) 0.8
Renal Replacement Therapy.,n(%)
4(10%) 4(10%) 0.9
Exitus,n(%) 4(10%) 3(7.5%) 0.5
Transfusion,n(%) 21(56.8) 18(51.4) 0.8
Post-operative inotropes,n(%)
27(67.5) 26(65.0) 0.9
Post-operative hemolysis,n(%)
6(15) 1(2.5) 0.054
Mechanical ventilation hours
20.5(11.5-77) 21(10.5-96) 0.7
ICU stay,days 3(1-6) 3(1-8.5) 0.9
Hospital stay,days 13(7-19) 10.5(6-20.5) 0.8
Post-operative data
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Am J Kidney Dis. 2007;4956-68. IF 4.4
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Fenoldopam and Death in Critically ill patients
81/487(17%) versus 109/531 (21%) p=0.01 NNT=26
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Pooled estimates of risk for need for renal replacement therapy
34/526 (6%) versus 59/570 (10%) p=0.007 NNT=26
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Fenoldopam and Death in Cardiovascular Surgery
28/503 (6%) versus 55/503 (11%) p=0.002 NNT=19
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Fenoldopam and renal replacement therapy in cardiovascular surgery
30/528 (6%) versus 71/531 (13%) p<0.001 NNT=13
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ITACTA ONGOING RCTsTOPICS HOSPITALS PATIENTS GRANTS
VOLATILE ANESTHETICS
FENOLDOPAM
DESMOPRESSIN
ESMOLOL LEVOSIMENDAN VALVOLE PERCUTANEE
4 200 AIFA 2006
34 1.000 MINISTRY 2008
3 200
3 200 10 1.000 3 150
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FENO-HSR
FENOLDOPAM E INSUFFICIENZA RENALE
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• Fenoldopam vs placebo
• randomized
• double blind
• multicenter (32 centers, 1000 patients)
DESIGN
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“R” (RIFLE) after cardiac surgeryWhich patients?
Serum creatinine increase by 50%
or
Urinary output <0,5 ml/kg/h for 6 h Planned ICU stay > 24 hours
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AIM OF THE STUDY
Reduction of the need for renal replacement therapy
From 10% to 5%
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DESFLURANEDESFLURANEversusversus
PROPOFOLPROPOFOL((fentanyl-based cardiac anesthesia)fentanyl-based cardiac anesthesia)
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RCT(382 PATIENTS)
OFF-PUMP CABG(112 PATIENTS)
ON-PUMP CABG(150 PATIENTS)
MITRAL SURGERY(120 PATIENTS)
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PeakTROPONIN I
ng/ml
OFF-PUMP CABG
1.2 (0.9-1.9) versus
2.7 (2.1-4.0)
*P<0.001
ON-PUMP CABG
2.5 (1.1-5.3)versus
5.5 (2.3-9.5)
*P<0.001
MITRAL SURGERY
11.0 (7.5-17.4)versus
11.5 (6.9-18.8)
P=0.7
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Troponin I after OFF-PUMP CABG
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Troponin I after CABG (CPB)
volatile anaesthetics
total intravenous anaesthesia
p=0,7
p<0,001
p=0,03
0
1
2
3
4
5
6
7
8
9
10
preop 0 4 18time, hour
cTn
I,
ng/m
l
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Troponin I after MITRAL SURGERY
total intravenous anaesthesia
volatile anaesthetics
p=0,4
p=0,7
p=0,8
p=0,9
0
2
4
6
8
10
12
14
16
18
preop ICU arrival 4 hours day I day I I
time, hour
cTnI,
ng/m
l
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Volatile AnestheticsVolatile Anesthetics
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META-ANALYSIS(cardiac anaesthesia)
22 randomized studies (15 CPB-CABG; 6 OP-CABG; 1 mitral valve surgery)
1922 patients (904 TIVA and 1018 DES or SEVO)
16 studies administered volatile anesthetics throughout all the procedure (6 studies for 5-30 minutes)
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MortalityEvidence!
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Mortality
4/977=0.4% v 14/872=1.6% NNT=84 RRR=(1,6-0,4)/1,6=75% OR: 0.31(0.12-0.80) P=0.02
Evidence!
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Myocardial infarctionEvidence!
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24/979=2.4% v 45/874=5.1% NNT=37 RRR: (5.1-2.4)/5.1 = 53% OR: 0.51(0.32-0.84) p=0.008
Myocardial infarctionEvidence!
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DURATION OF USE OF INHALATORY ANESTHETICS
DURING SURGERY
RIS
K-A
DJU
STED
MO
RTA
LIT
Y (
%) 8
6
4
2
0
NO USEALL OF THE OPERATION
ONLY INCISION/
STERNOTOMY
PART OF THE
OPERATION
P=0.022
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RIS
K-A
DJU
STED
MO
RTA
LIT
Y (
%)
P=0.007
8
6
4
2
0
USE OF INHALATORY ANESTHETICS
0% TO <50%
OF CASES
≥50% OF CASES
P=0.007
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NON-CARDIAC SURGERY
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Cardioprotection & anaesthesia
Volatile AnestheticsVolatile Anesthetics
blockers “recommended”
Statins “suggested” in selected pts
2 agonists “may be considered” in selected pts
Ca++ antagonists “may be considered” in selected pts
Insulin “reasonable” in hyperglycaemic pts
Volatile Anesthetics “can be beneficial”
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Every 1.000 patients receiving extended release METOPROLOL
PREVENTION OF 15 MYOCARDIAL INFARCTON PREVENTION OF 3 CABG PREVENTION OF 7 ATRIAL FIBRILLATION
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Every 1.000 patients receiving extended release METOPROLOL
EXCESS OF 8 DEATHS EXCESS OF 5 STROKE EXCESS 53 HYPOTENSION EXCESS 42 BRADICARDIA
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A meta-analysis in noncardiac surgery
6219 patients
2842 sevoflurane609 desflurane
2768 propofol
Evidence?
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Total 79
Anesth analg 20
BJA 14
EJA 11
Acta anaesthesiol scand 8
Anaesthesia 5
J Anesth 4
Anesthesiology3
Minerva anestesiol 2
Altri 13
Anesth analg
BJA
EJA
Acta anestesiol scand
Anaesthesia
J anesth
Anesthesiology
Minerva anestesiol
Altri
A meta-analysis in noncardiac surgery
Evidence?
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400 authors 240 reviewers 90 editors
0 deaths
0 myocardial infarctions
A meta-analysis in noncardiac surgery
Evidence?
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TAKE HOME MESSAGE
MAGIC BULLET
PEXELIZUMABLEVOSIMENDANFENOLDOPAMVOLATILE AGENTS
NNT TO PREVENT ONE DEATH
1001219 or 2684
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“PERCHE’ NON SIAM POPOLOPERCHE’ SIAM DIVISI”
MAMELI
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ITACTA ONGOING RCTsTOPICS HOSPITALS PATIENTS GRANTS
VOLATILE ANESTHETICS
FENOLDOPAM
DESMOPRESSIN
ESMOLOL LEVOSIMENDAN VALVOLE PERCUTANEE
4 200 AIFA 2006
34 1.000 MINISTRY 2008
3 200
3 200 10 1.000 3 150
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GRUPPI DI INTERESSE ITACTA(COORDINATI DA ANESTESISTI UNDER 40)
Gruppi esistenti ad oggi 27-3-2009 (per piu’ informazioni www.itacta.org), aperti ad iscrizioni
1. Sostituzioni valvolari percutanee ([email protected])
2. Monitoraggio emodinamico mini-invasivo ([email protected])
3. Statistica in anestesia e terapia intensiva ([email protected])
4. Analgesia selettiva in chirurgia toracica (
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For these and further slides on these topics please feel free to visit the
metcardio.org website:
http://www.metcardio.org/slides.html