Management of Acute Shock and Right Ventricular Failure

Nader Moazami, MD

Department of Thoracic and Cardiovascular Surgery and Biomedical Engineering, Cleveland Clinic

Disclosures

• NONE

CARDIOGENIC SHOCKScope of the Problem

Diverse etiology− 7-10% Acute MI− Cardiac Arrest− Post-cardiotomy 0.2-0.5%− Decompensated CHF− Acute fulminant myocarditis− Acute Cardiac Allograft Rejection

CARDIOGENIC SHOCKDefinition

• Arterial hypotension (systolic arterial blood pressure below 90 mmHg or mean arterial blood pressure below 70

mmHg for 30 minutes or longer with or without therapy); • PCWP >18 mmHg (in patients with a pulmonary artery

catheter) or an acute decrease of the left ventricular ejection fraction below 40%

• Need for a continuous infusion of inotropic drugs

• IABP

C. Torgerson, et al Crit Care. 2009; 13(5): R157

N pts yr AMI (%)

% shock on all AMI

% shock at admission on all shock

Mortality pts in shock (%)

NRMI-2 426,233 94-97

STEMI 52NSTEMI 48

8.14.9

28 74 %

BLITZ-1 1,959 Ott 01

STEMI 65NSTEMI 35

6 29 70

GISSI-1 11,806 84-85

STEMI 90NSTEMI 10

8.5 28 70

ISIS-3 41,299 89-91

STEMI 77NSTEMI 23

7.0 - -

GUSTO-1 41,021 90-93

STEMI 7.2 11 56

GUSTO-2b 12,084 94-95

STEMI 34NSTEMI 66

4.22.5

00

6373

GUSTO-3 15,059 95-97

STEMI 5.4 10.1 62

GRACE 8,951 99-01

STEMI 66NSTEMI 34

6.7 26 59

6.2

Incidence and mortality cardiogenic shock with AMI

N pts yr AMI (%)

% shock on all AMI

% shock at admission on all shock

Mortality pts in shock (%)

NRMI-2 426,233 94-97

STEMI 52NSTEMI 48

8.14.9

28 74 %

BLITZ-1 1,959 Ott 01

STEMI 65NSTEMI 35

6 29 70

GISSI-1 11,806 84-85

STEMI 90NSTEMI 10

8.5 28 70

ISIS-3 41,299 89-91

STEMI 77NSTEMI 23

7.0 - -

GUSTO-1 41,021 90-93

STEMI 7.2 11 56

GUSTO-2b 12,084 94-95

STEMI 34NSTEMI 66

4.22.5

00

6373

GUSTO-3 15,059 95-97

STEMI 5.4 10.1 62

GRACE 8,951 99-01

STEMI 66NSTEMI 34

6.7 26 59

6.2

Incidence and mortality cardiogenic shock with AMI

A. Babaev, et al. JAMA 2005;294:448-454

Trends in Management and Outcomes of Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

A. Babaev, et al. JAMA 2005;294:448-454

Trends in Management and Outcomes of Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

SHOCK II Trial

Limitations of Conventional Therapy

• IABP decreases LV workload and increase C.O. by 10-15%

• Need for high dose inotropic support increases myocardial oxygen demand

• Mortality for cardiogenic shock remains >50%

Could more powerful mechanical support

improve outcomes?

Emerging Role of Early Mechanical Circulatory

Support−Hemodynamic stabilization−Normalization of end organ

perfusion−Potential for Cardiac recovery and

weaning−Time for evaluation of other

options• Transplant• Long-term Mechanical Therapy

(Destination Therapy)

Early intervention increases

the probability of survival:

Timing is Critical

In Acute Settings, Cardiac Function is RECOVERABLE

LV “Recovery” Goals

• To decompress the ventricle(s).• Wean toxic levels of inotropes.• Allow ATP stores to return.• Allow cytokines to be metabolized.• Preserve end organ function.

Impella study – Flameng et al 2000

Massive Myocardial damage Up to 5-times Reduction in infarct size over base line

without offloading

Infarct

with offloading

Infarct

LAD occlusion model

Potential reduction in infarct size

Increasing Use of ECMO

Paden ML et al ELSO Registry.ASAIO J. 2013 May-Jun;59(3):202-10.

Why ECMO?

• Advantages− Rapid insertion (Fem

artery, Fem Vein)− Ease of insertion− Low cost− Low maintenance

• Disadvantages− Loads the failing LV− Immobility− Truly short term

rescue device

Impella 2.5 Technology

Clinical Adoption in USFDA Clearance in

June’08 1000+ patients treated

300+ US Centers

2 Trials OpenUSpella Registry

18

19

Impella® 5.0 Miniaturized Blood Pump Technology• 21 Fr micro-axial pump (requires

22-24 Fr Sheath)

High-Flow Circulatory Support• Delivers up to 5 L/min blood flow

support

Directly Unloads Left Ventricle• Actively unloads up to 5 L/min

from LV

Peripheral Placement• Single peripheral insertion point• Femoral Artery Cut-down/ Axillary

artery approach

HCS-P110-062609

USpella AMI Population20

Baseline Characteristics

Mean ± SD or % Mean ± SD or %

ShockNo Shock

p-value

64 ± 16

92 %

69% (31%)

31 ± 14

50 %

91 %

65% / 23% / 12%

14%

2.2 ± .4

Age (yrs)

Gender (Male in %)

STEMI (NSTEMI)

LVEF (%)

Unprotected LM or LPC

Multivessel Disease

Revasc (PCI/CABG/None)

Impella placement Pre-PCI

Pump Flow (L/min)

74 ± 10

72 %

3% (97%)

33 ± 15

50 %

75 %

100% / 0 / 0

95%

2.2 ± .3

0.003

0.04

<0.001

0.6

0.9

0.2

0.002

0.001

0.9

Cardiac Index

Car

dia

c In

dex

(l/m

in/m

2)

Wedge Pressure

0

1.6

1.8

2.0

2.2

2.4

2.6

OnImpella

PC

WP

(mm

Hg

)

0

20

24

28

22

26

30

PreImpella*

1.9±0.5

SVR

SV

R(x

100

0 d

ynes

/sec

x c

m-5)

0

1.2

1.4

1.6

1.8

2.0

1.0

1.8±0.7

Impella Improves Hemodynamicsin AMI Shock

OnImpella

PreImpella*

OnImpella

PreImpella*

2.5±0.6

28±8

20±10

p=0.02

p=0.001p=0.01

Mean Arterial Pressure

62±19

87±16p=0.003

*Pre-Impella measurements were recorded with optimal medical management measures (inotropes + IABP)

1.3±0.5M

AP

(mm

Hg

)

0

50

60

70

80

90

OnImpella

PreImpella*

100

Survival to DischargeBy Indication

0%

25%

50%

75%

100%

AMI withNo Shock

AMI withShock

(n=36)

89%

(n=26)

58%

USpella 22

• Removes oxygenated blood from the LA via a transeptal cannula

• Returns blood to the femoral artery

• Continuous flow, centrifugal pump 4-5 LPM

TandemHeart®

PTVA

TandemHeart®

PTVA Transseptal Cannulation

TandemHeart®

PTVA Transseptal Cannulation

Highlights of Texas Heart Institute Experience

Refractory Cardiogenic Shock Pre TandemHeart

Post TandemHeart

P value

CI (lpm) 0.7 +/- 0.5 2.79 +/- 0.97 <0.0001

SVO2 (%) 39 +/- 10 66 +/- 8 <0.0001

PCWP (mmHg)

29 +/- 9 14 +/- 5 <0.0001

SBP (mmHg) 79 +/- 20 101 +/- 13 <0.0001

Lactic acid (mg/dl)

64 +/- 54 27 +/- 30 <0.03

Creatinine (mg/dl)

2.3 +/- 1.3 1.5 +/- 0.7 <0.02

Heartmate PHP

Cardiac Catheter Pump •Low-profile percutaneous device delivered through 13F sheath

•Expands to 24F across aortic valve

•Designed to deliver over 4 lpm for up to 10 days

Cardiac Catheter Pump •Low-profile percutaneous device delivered through 13F sheath

•Expands to 24F across aortic valve

•Designed to deliver over 4 lpm for up to 10 days

Target Applications

• Acute MI

• Cardiogenic Shock

• High-risk PCI

• Acutely decompensated heart failure

Treatment of RV Failure• Pulmonary vasodilators (inhaled nitric oxide or

prostacyclin)• Inotropic drugs (milrinone, epinephrine)• Avoidance of Hypoxia and Hypercarbia• Adequate drainage of the pleural spaces• Maintain MAP>70 mmHg, CVP,15 mmHg

• RVAD Temporary (short- to mid-term )

Current Short-Term RVAD Devices

New Devices for Temporary RVAD support

New Devices for Temporary RVAD support

Old Concepts New Designs• Impella RP• IDE Study ongoing

for RV failure − Within 48 hours post

LVAD

− Within 48 hours post surgery or post MI.

IMPELLA RP

Conclusion

• Increasing Use of Mechanical Pumps for LV and RV support

• Majority will be percutaneously placed• In addition to hemodynamic support

ambulation will be possible• The biggest driver for use will be cost • Value-based medicine will mandate

stricter selective use in patients