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IRCCS Ospedale San Raffaele Milano Università Vita-Salute San Raffaele. Pharmacological pre-emptive strategies to reduce peri-operative risk : give me the magic bullet , please. INTERCEPT 2009 S Donato Milanese, Milan, April 17h 2009. Speaker: Landoni G.

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slide1

IRCCS Ospedale San Raffaele Milano

Università Vita-Salute San Raffaele

Pharmacologicalpre-emptivestrategiesto reduce peri-operative risk: give me the magicbullet, please

INTERCEPT 2009

S Donato Milanese, Milan, April 17h 2009

Speaker: Landoni G

magic bullets to reduce mortality in cardiac surgery
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
an overview of meta analysis
AN OVERVIEW OF META-ANALYSIS
  • PEXELIZUMAB
  • LEVOSIMENDAN
  • FENOLDOPAM
  • VOLATILE AGENTS (Intercept 2006)
an overview of meta analysis4
MAGIC BULLET

PEXELIZUMAB

LEVOSIMENDAN

FENOLDOPAM

VOLATILE AGENTS

NNT TO PREVENT ONE DEATH

100

12

19 or 26

84

AN OVERVIEW OF META-ANALYSIS
slide12

Description of the ten studies included in the meta-analysis.

* CABG: coronary artery bypass graft

† CPB: cardiopulmonary bypass

‡ OPCABG: off-pump coronary artery bypass graft

slide13

Number of patients and interventions of included studies.

† CPB: cardiopulmonary bypass

# LCOS: low cardiac output syndrome

slide15

Levosimendan and Mortality in Cardiac Surgery

  • 11/235=4.7% v 26/205=12.7%
  • P=0.007
  • NNT = 12
itacta ongoing rcts topics hospitals patients grants
VOLATILE ANESTHETICS

FENOLDOPAM

DESMOPRESSIN

ESMOLOL

LEVOSIMENDAN

VALVOLE PERCUTANEE

landoni.giovanni@hsr.it

www.itacta.org

4 200 AIFA 2006

34 1.000 MINISTRY 2008

3 200

3 200

10 1.000

3 150

ITACTA ONGOING RCTsTOPICS HOSPITALS PATIENTS GRANTS
slide21

AIM OF THE STUDY

To evaluate the renoprotective action of fenoldopam

in a selected high-risk group of patients

undergoing cardiac surgery

results
RESULTS
  • Post-operative data
slide24

Fenoldopam and Death in Critically ill patients

81/487(17%) versus 109/531 (21%) p=0.01 NNT=26

slide25

Pooled estimates of risk for need for renal replacement therapy

34/526 (6%) versus 59/570 (10%) p=0.007 NNT=26

slide27

Fenoldopam and Death in Cardiovascular Surgery

28/503 (6%) versus 55/503 (11%) p=0.002 NNT=19

slide28

Fenoldopam and renal replacement therapy in cardiovascular surgery

30/528 (6%) versus 71/531 (13%) p<0.001 NNT=13

itacta ongoing rcts topics hospitals patients grants29
VOLATILE ANESTHETICS

FENOLDOPAM

DESMOPRESSIN

ESMOLOL

LEVOSIMENDAN

VALVOLE PERCUTANEE

landoni.giovanni@hsr.it

www.itacta.org

4 200 AIFA 2006

34 1.000 MINISTRY 2008

3 200

3 200

10 1.000

3 150

ITACTA ONGOING RCTsTOPICS HOSPITALS PATIENTS GRANTS
feno hsr

FENO-HSR

FENOLDOPAM E INSUFFICIENZA RENALE

slide31

DESIGN

  • Fenoldopam vs placebo
  • randomized
  • double blind
  • multicenter (32 centers, 1000 patients)
slide32

Which patients?

“R” (RIFLE) after cardiac surgery

Serum creatinine increase by 50%

or

Urinary output <0,5 ml/kg/h for 6 h

Planned ICU stay > 24 hours

slide33

AIM OF THE STUDY

Reduction of the need for renal replacement therapy

From 10% to 5%

meta analysis cardiac anaesthesia
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)
slide46

Evidence!

Mortality

mortality

Evidence!

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
myocardial infarction49

Evidence!

Myocardial infarction
  • 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
slide52

8

P=0.022

6

RISK-ADJUSTED MORTALITY (%)

4

2

0

PART OF THE OPERATION

ALL OF THE OPERATION

ONLY INCISION/ STERNOTOMY

NO USE

DURATION OF USE OF INHALATORY ANESTHETICS DURING SURGERY

slide53

8

P=0.007

P=0.007

6

RISK-ADJUSTED MORTALITY (%)

4

2

0

0% TO <50%

OF CASES

≥50% OF CASES

USE OF INHALATORY ANESTHETICS

cardioprotection anaesthesia volatile anesthetics
Cardioprotection & anaesthesiaVolatile Anesthetics
  • b blockers“recommended”
  • Statins “suggested” in selected pts
  • a2 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”
every 1 000 patients receiving extended release metoprolol
Every 1.000 patients receiving extended release METOPROLOL
  • PREVENTION OF 15 MYOCARDIAL INFARCTON
  • PREVENTION OF 3 CABG
  • PREVENTION OF 7 ATRIAL FIBRILLATION
every 1 000 patients receiving extended release metoprolol60
Every 1.000 patients receiving extended release METOPROLOL
  • EXCESS OF 8 DEATHS
  • EXCESS OF 5 STROKE
  • EXCESS 53 HYPOTENSION
  • EXCESS 42 BRADICARDIA
a meta analysis in noncardiac surgery
A meta-analysis in noncardiac surgery

Evidence?

6219 patients

2842 sevoflurane

609 desflurane

2768 propofol

slide64

Evidence?

A meta-analysis in noncardiac surgery

Total 79

Anesth analg 20

BJA 14

EJA 11

Acta anaesthesiol scand 8

Anaesthesia 5

J Anesth 4

Anesthesiology 3

Minerva anestesiol 2

Altri 13

slide65

Evidence?

A meta-analysis in noncardiac surgery

  • 400 authors
  • 240 reviewers
  • 90 editors

0 deaths

0 myocardial infarctions

take home message
MAGIC BULLET

PEXELIZUMAB

LEVOSIMENDAN

FENOLDOPAM

VOLATILE AGENTS

NNT TO PREVENT ONE DEATH

100

12

19 or 26

84

TAKE HOME MESSAGE
itacta ongoing rcts topics hospitals patients grants68
VOLATILE ANESTHETICS

FENOLDOPAM

DESMOPRESSIN

ESMOLOL

LEVOSIMENDAN

VALVOLE PERCUTANEE

landoni.giovanni@hsr.it

www.itacta.org

4 200 AIFA 2006

34 1.000 MINISTRY 2008

3 200

3 200

10 1.000

3 150

ITACTA ONGOING RCTsTOPICS HOSPITALS PATIENTS GRANTS
gruppi di interesse itacta coordinati da anestesisti under 40
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 (covello.remodaniel@hsr.it)
  • 2. Monitoraggio emodinamico mini-invasivo (giuliamaj@hotmail.com)
  • 3. Statistica in anestesia e terapia intensiva (monaco.fabrizio@hsr.it)
  • 4. Analgesia selettiva in chirurgia toracica (drpiraccini@gmail.com)
slide71
For these and further slides on these topics please feel free to visit the metcardio.org website:http://www.metcardio.org/slides.html