Assist Devices in STEMI- Intra-aortic Balloon Pumpstatic.livemedia.gr/kebe/documents/al2354_us63... · 2014. 6. 4. · Assist Devices in STEMI-Intra-aortic Balloon Pump Ioannis Iakovou,

KEBE 2014, Θεσσαλονίκη 30 Mαίου

Assist Devices in STEMI-

Intra-aortic Balloon Pump

Ioannis Iakovou, MD, PhD

Onassis Cardiac Surgery Center

Athens, Greece


Cardiogenic shock

• 5-10% of pts after a heart attack

• 60000-70000 pts in Europe/year

• In the last years the mortality rate was reduced mainly by early

reopening of the infarct-related artery

• Still extremely high, approx. 50% @ 30 days


PREDICTION OF CARDIOGENIC SHOCK IN THE

CARDIAC CATHETERISATION LABORATORY

Poor coronary reperfusion (TIMI Grade <3)

Left main coronary occlusion

Left ventricular ejection fraction <25%

Age >75 years

All with 2 of the 4 risk factors died.

Garcia-Alverez A et al. Am j Cardiol 2009; 103:1073-77


OUTLOOK FOR SURVIVORS OF CARDIOGENIC

SHOCK

• GUSTO: 88% of those discharged from hospital are alive at one year

• SHOCK: 3 and 6 year survival 79% and 62%

• Around 50% of patients remain free from heart failure symptoms.


The Damaging Effects of High Dose Inotropes

Elevated stroke work and wall tension.

Increased myocardial oxygen consumption.

Depletion of energy reserves.

Endocardial necrosis & impaired diastolic function.

Overall negative effect on myocardial recovery.


CPS/ECMO

• Percutaneous heart lung-machine

• Centrifugal pump

• Hemodynamic support>4.5l/min

• Can increase preload and afterload

• No randomized control trials or

large cohorts.


Routine vs prophylactic use of CPS

for high-risk PCI

Teirstein et al JACC 1993


IABP history

History:

• 1962 Animal studies

Moulopoulos et al, Am Heart J 1962;63:669-675

• 1968 clinical description in shock

Kantrowitz et al, JAMA 1968;203:135-140

• 1973 Hemodynamic effects in shock, Mortality unchanged

Scheidt et al, NEJM 1973;288:979-984

• > 40 years > 1 Million patients treated, low complication rate,

Benchmark registry

Ferguson et al, JACC 2001;38:1456-1462


IABP - why use it?

Increase coronary perfusion pressure

Increase myocardial oxygen supply without increasing demand

Decrease afterload

But increase in cardiac output is only 0.5-0.8 L/min


• Cardiogenic shock

• Refractory angina despite maximal medical management

• Cardiac failure after a cardiac surgical procedure

• Perioperative treatment of complications due to myocardial

infarction

• Failed PCI

• Mitral regurgitation

• As a bridge to cardiac transplantation

Indications for IABP


• Severe aortic insufficiency

• Aortic aneurysm

• Aortic dissection

• Limb ischemia

• Thromboembolism

Contraindications to IABP


• Limb ischemia

• Thrombosis

• Emboli

• Bleeding and insertion site

• Groin hematomas

• Aortic perforation and/or dissection

• Renal failure and bowel ischemia

• Neurologic complications including paraplegia

• Heparin induced thrombocytopenia

• Infection

Complications


PAMI-II trial

Stone et al JACC 1997

a prophylactic IABP strategy after primary PTCA in hemodynamically stable high risk patients

with AMI does not decrease the rates of infarct-related artery reocclusion or reinfarction (p=NS for

both), promote myocardial recovery or improve overall clinical outcome

High risk patients were randomized to 36 to 48 h of IABP (n = 211) or traditional care (n = 226)


BCIS-1 Trial


BCIS-1 Trial



CRISP-AMI340 pts with ST elevation MI within 6 hours of the onset of pain

Patel et al JAMA 2011

Among patients with acute anterior STEMI without shock, IABC plus primary PCI

compared with PCI alone did not result in reduced infarct size.



7 RCT, 1000 patients No difference in Death, LVEF


IABP prior to PCI vs. IABP after PCI


Rapid Reperfusion. Would you go the

same speed on these two Cases?


80 57 45

600

55

302

398

0

100

200

300

400

500

600

700

SHOCK TRIUMPH SMASH PRAGUE -

7

TACTICS IABP-

SHOCK I

IABP-

SHOCK II

N P

atients

Patient Inclusion in Cardiogenic Shock-Studies

Sto

pp

ed

du

e to

mis

sin

g e

ffe

ct

Sto

pp

ed

slo

w r

ecru

itm

en

t

Sto

pp

ed

Slo

w r

ecru

itm

en

t

Un

de

rpo

we

red

Su

rro

ga

te e

nd

po

int



IABP-shock II study600 pts randomized to conventional optimal Rx vs. IABP

Theile et al ESC 2012


30 Day Mortality: Good to be YOUNG


12 mo data…good if <50 yo!


Antman et al. Circulation. 2004;110:82-292

O’Gara et al. Circulation. 2013;127:e362-e425

Van de Werf et al. Eur Heart J. 2008;29:2909-2945

Steg et al. Eur Heart J. 2012;33:2569-2619

Guidelines

IABP in STEMI complicated by cardiogenic shock


LVAD THEORETICAL ADVANTAGES

Superior LV pressure and volume unloading with enhanced

remodeling capability

Decreased wall tension with improved endocardial blood

flow

Beating, non-working heart has low metabolic requirement

Presumed enhanced ability for cellular repair and survival

New Devices and Strategies to Manage CGS


Tandem Heart pLVAD

Left atrial-to-femoral arterial LVAD

Low speed centrifugal continuous

flow pump

21F venous transseptal cannula

17F arterial cannula

Maximum flow 4L/minute


Tandem Heart Outcome Data

42%

47%45%

36%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Thiele (n=41) Burkhoff (n=33)

30

day m

ort

ali

ty (

%)

Tandem Heart

IABP

Improved haemodynamic parameters

Increase in bleeding, limb ischaemia, and sepsis

Thiele EHJ 2005;26:1276. Burkhoff AHJ 2006;152:e1

p=NS


Impella

Axial flow pump

Much simpler to use

Increases cardiac output & unloads LV

LP 2.5

12 F percutaneous approach; Maximum 2.5 L flow

LP 5.0

21 F surgical cutdown; Maximum 5L flow

Pressure Lumen

Motor

Blood outlet

Blood Inlet


Impella outcome data

1 RCT of Impella 2.5 in AMI Cardiogenic Shock

ISAR-SHOCK

26 patient RCT Impella vs IABP

Cardiac Index, MAP (by 10mmHg) vs IABP

Complications ≤ IABP

Overall 30-day mortality was 46% in both groups

JACC 2008;52:1584-8


Thiele et al. Burkhoff et al. Seyfarth et al.

LVAD TandemHeart TandemHeart Impella LP2.5

Control IABP IABP IABP

N of patients 41 33 26

Setting Single-center Multi-center Two-center

Inclusion period 2000-2003 2002-2004 2004-2007

Randomization Yes Yes Yes

PLVAD vs. IABP for treatment of cardiogenic

shock: a meta-analysis of controlled trials

Cheng et al. Eur Heart J 2009;30:2102-2108


-2 -1 1 20

0.55 (0.23 ; 0.87)

0.16 (-0.14 ; 0.46)

0.36 (-0.16 ; 0.88)

0.35 (0.09 ; 0.61)Pooled

2.30.6 1.80.4

LVAD

meansd

IABP

meansd

2.20.6 2.10.2

2.20.6 1.80.7

Favors IABP Favors LVAD

P(heterogeneity) = 0.22

I2 = 34.0%

Cardiac IndexMean Difference

Burkhoff et al.

Seyfarth et al.

Thiele et al.

Cardiac index

Percutaneous LVAD patients had higher CI


Mean Arterial Pressure

Percutaneous LVAD patients had higher MAP

-50 -25 0 25 50

5.5 (-2.9 ; 13.9)

18.6 (9.4 ; 27.9)

16.0 (0.5 ; 31.5)

12.8 (3.6 ; 22.0)Pooled

7610 7016

LVAD

meansd

IABP

meansd

9116 7212

8718 7122

Favors IABP Favors LVAD


I2 = 55.9%

Mean Arterial PressureMean Difference

Burkhoff et al.

Seyfarth et al.

Thiele et al.


-20 -10 0 10 20

-5.6 (-9.2 ; -2.1)

-8.4 (-11.0 ; -5.8)

-1.0 (-5.2 ; 3.2)

-5.3 (-9.4 ; -1.2)

Burkhoff et al.

Seyfarth et al.

Pooled

Thiele et al. 165 227

LVAD

meansd

IABP

meansd

164 253

195 206

Favors LVAD Favors IABP


I2 = 76.6%

Pulmonary Wedge PressureMean Difference

Pulmonary Capillary Wedge Pressure

Percutaneous LVAD patients had lower PCWP


30-day mortality

Percutaneous LVAD patients had similar mortality

0.1 1 10

0.95 (0.48 ; 1.90)

1.33 (0.57 ; 3.10)

1.00 (0.44 ; 2.29)

1.06 (0.68 ; 1.66)Pooled

Favors LVAD Favors IABP

30-day mortalityRelative Risk

9/21 9/20

LVADn/N

IABPn/N

9/19 5/14

6/13 6/13

24/53 20/47


I2 = 0%

Burkhoff et al.

Seyfarth et al.

Thiele et al.


LVAD or IABP?Complications

Cheng et al. Eur Heart J 2009;30:2102-2108

LVAD

n/NIABP

n/N

Limb ischemia

Relative RiskP (heterogeneity)=0.38

R2=0%

Thiele et al

Burkhoff et al

Seyfarth et al

Pooled

0.0001 0.01 1 100 10000IABP betterLVAD better

14.32 (0.87 – 235.4)

1.47 (0.31 – 6.95)

3.00 (0.13 – 67.51)

2.59 (0.75 – 8.97)

7/21 0/20

4/19 2/14

1/13 0/13

12/53 2/47

LVAD

n/NIABP

n/N

Bleeding


R2=0%

Thiele et al

Burkhoff et al

Pooled

0.01 0.1 1 10 100IABP bstterLVAD better

2.26 (1.30 – 3.94)

2.95 (0.74 – 11.80)

2.35 (1.40 – 3.93)

19/21 8/20

8/19 2/14

27/40 10/34

LVAD

n/NIABP

n/N

Fever or sepsis


R2=62.1%

Thiele et al

Burkhoff et al

Pooled

0.01 0.1 1 10 100IABP betterLVAD better

1.62 (1.00 – 2.63)

0.59 (0.19 – 1.80)

1.11 (0.43 – 2.90)

17/21 10/20

4/19 5/14

21/40 15/34


LVAD or IABP?

Bleeding

Invasiveness

+ -

Implantation procedure

LVAD

Hemodynamic support

Better LV-unloading

Costs


Potential treatment algorithm for patients with CS complicating

AMI (asterisks denote supported by randomized controlled

trials).

Thiele H et al. Eur Heart J 2010;31:1828-1835


Recommendations on how to

approach shock

• If a pt has a SBP of 75-80 mm Hg the aim is to increase BP over the

next couple of days while keeping them out of shock; use IABP

• Do not use IABP in all high risk pts; but consider in the following

situations:

• Severe HF

• Bridge to surgery

• Impeding CS

• Mild CS


Conclusions

• For more severe cases of CS (SBP approx 40,50,60, 70 mmHg) or pts

requiring high doses of inotropes or vasopressors we (may) have the

option of percutaneous LVAD (Tandemheart or Impella) which provide

superior hemodynamic support compared to IABP

• Until now, we cannot recommend to replace IABP by percutaneous

LVAD as first-choice approach in the mechanical management of

cardiogenic shock

• Routine use of IABP in AMI is not evidence based

• Studies with pre-PCI deployment of IABP are needed


Thank You!

Email: [email protected]

Documents

Assist Devices in STEMI- Intra-aortic Balloon Pumpstatic.livemedia.gr/kebe/documents/al2354_us63... · 2014. 6. 4. · Assist Devices in STEMI-Intra-aortic Balloon Pump Ioannis Iakovou,