percutaneous mechanical circulatory support

©2015 MFMER | 3474186-1

Percutaneous Mechanical Circulatory Support

Charanjit S. Rihal, MD Professor and Chair, Division of Cardiology, Mayo Clinic

2015 New York Cardiovascular

Symposium

©2015 MFMER | 3474186-2

Relevant Financial Relationship(s)

None

Off Label Usage

Yes

©2015 MFMER | 3474186-3

Learning Objectives

• Know indications for mechanical circulatory support (MCS)

• Understand hemodynamic effects of MCS

• Appreciate benefits, risks, and outcomes of MCS

©2015 MFMER | 3474186-4

History

• CAD s/p multiple PCIs

• Biventricular failure (LVEF 15%,

s/p ICD 2/2015)

• HTN IDDM

• Acute-on-chronic renal

insufficiency

• Congestive hepatopathy with

intermittent encephalopathy

• Fall with subdural bleed

55-Year-Old Female With Decompensated Heart Failure

Meds

• Aspirin 81 mg, Effient 10 mg daily

• Milrinone 0.5 mcg/kg/min

• Bumex 1 mg two times a day

• Metolazone 2.5 mg one time daily

• Carvedilol 25 mg two times a day

• Imdur 30 daily/ hydralazine 25 mg TID

• Novolog 10 units daily, Levemir 10-14 units SC bid

©2015 MFMER | 3474186-5

NT-ProBNP 10260

©2015 MFMER | 3474186-8

Nitroprusside challenge, 4.5 mcg/kg/min

Right Heart Catheterization

©2015 MFMER | 3474186-9

-4,000

-3,000

-2,000

-1,000

0

1,000

2,000Day 1 Day 2 Day 3 Day 4 Day 5 Day 6

Course Severe L RA stenosis

Residual bleeding IC calcifications

Fluid balance

Fluid out

Fluid in

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Creatinine

Day 1 Day 2 Day 3 Day 4 Day 5 Day 6

©2015 MFMER | 3474186-10

Palliative Care

Mechanical Support

Heart Transplant

What To Do?

©2015 MFMER | 3474186-12

TandemHeart Placement

©2015 MFMER | 3474186-13

TandemHeart Placement

©2015 MFMER | 3474186-15

With MCS

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

14th 17th 18th 19th 20th 21st 22nd 23rd 26th 27th

TandemHeart

Creatinine

©2015 MFMER | 3474186-16

VAD implantation 5 days later

• Explantation of TandemHeart

• HeartMate II as destination therapy

• Tricuspid valve repair with a 26-mm CarboMedics ring

• Prolonged hospital stay but rehabilitating well

©2015 MFMER | 3474186-18

LV Assist Devices

TandemHeart

A B C

Impella

IABP

©2015 MFMER | 3474186-22

Fundamental Hemodynamic Principles External Stroke Work (SW)

0

100

200

0 100 200

Mitral valve opens

Aortic valve opens

Aortic valve closes

Mitral valve closes

Pressure-volume (PV) loop

LV

pre

ssu

re (

mm

Hg

)

LV vol (mL)

©2015 MFMER | 3474186-24

Pressure vs Flow Cardiac Power Output (CPO)

Cardiac Power Output (CPO)

= 1 watt = 1 J/sec = 100 cJ/sec

= Cardiac Output (CO) * Mean Arterial Pressure (MAP)

= 5.0 L/min flow * 90 mm Hg pressure = 100 cJ/sec work

Br Heart J 64:121–8, 1990; Eur J Heart Fail 5:443–51, 2003 JACC 44:340–349, 2004

©2015 MFMER | 3474186-25

0

25

50

75

100

125

0 40 80 120

0

10

20

30

40

50

60

70

80

90

100

0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0 2.2

Pressure vs Flow Cardiac Power Output (CPO)

Estim

ate

d in

-hospita

l m

ort

alit

y (

%)

Cardiac power output

Cardiac power 451

Mean arterial pressure x cardiac output =

Pre

ssure

(m

m H

g)

Volume (mL)

CPO = SW x HR

JACC 44:340–349, 2004

SW

©2015 MFMER | 3474186-26

0

25

50

75

100

125

150

0 50 100 150 200

• Contractility

• BP

• SV

• Baroreflex

• HR

• Preload

• Afterload

Intervent Cardiol Clin 2 (2013) 407– 416

Cardiogenic Shock P

ressu

re (

mm

Hg

)

Volume (mL)

CGS

Ea

Acute CGS PV loop

©2015 MFMER | 3474186-27

IABP

• Universally available

• Limited support

• Pressure waveform

• Not flow based 60

80

100

120

140

mm

Hg

A B

60

80

100

120

140

mm

Hg

60

80

100

120

140

mm

Hg

C D

60

80

100

120

140

mm

Hg

E

60

80

100

120

140

mm

Hg

Diastolic augmentation

Unassisted systole

Assisted systole

Balloon inflation

Unassisted aortic EDP

Assisted aortic EDP

Assisted aortic EDP

Assisted systole


Unassisted systole

Assisted aortic EDP


Assisted systole

Unassisted systole

Dicrotic notch

Assisted aortic EDP

Assisted systole

Unassisted aortic EDP


Assisted aortic EDP

Unassisted systole


Prolonged rate of rise of assisted

systole

Widened appearance

©2015 MFMER | 3474186-29

Available Evidence on IABP

Study Randomized IABP Control

Primary or

clinical

outcome

IABP vs

control P

NRMI-21

No 7,268 15,912 In-hospital

mortality

67 vs 49

47 vs 45 N/A

GUSTO-I2

No/Post-hoc 62 248

All-cause

mortality

at 30 days

47 vs 60

(60 vs 67)

0.06

(0.04)

CRISP-AMI3

Yes 161 176

All-cause

death at

6 mo

1.9 vs 5.2% 0.12

BCIS-I4

Yes 151 150 MACCE

at 28 days 15.2 vs 16% 0.85

IABP-SHOCK II5

Yes 301 299

All-cause

death at

30 days

39.3 vs

41.7% 0.69

1) Am Heart J 141:933-939,2001; 2) JACC 30:708-715, 1997; 3) JAMA 306:1329-1337, 2011; 4) JAMA 304:867-874, 2010; 5) NEJM 367(14):1287, 2012

©2015 MFMER | 3474186-40

0

25

50

75

100

Hemodynamic Effects of LA→AO

Parameter Change

CO

PCWP ↓

SBP

DBP

MAP

CPO

PVA →/↓

60

70

80

90

100

110

AoP

(m

m H

g)

Pre

ssure

(m

m H

g)

Volume (mL) 140 160 180

0.5 sec

B

A

©2015 MFMER | 3474186-46

Catheterization and Cardiovascular Interventions 2012

©2015 MFMER | 3474186-50

Right Heart Pressures

0

10

20

30

40

50

T1 T2 T3

mm Hg

16.5

24.7

44.6

10.7

17.5

36.3

9.7

18.7

37.8

P<0.001

P=0.02

P=0.04

RAP PAWP PASP

©2015 MFMER | 3474186-51

Cardiac Output

0

1

2

3

4

5

6

7

T1 T2 T3

CO

4.7

5.8

P=0.03

L/min

5.7

23%

©2015 MFMER | 3474186-53

Survival TandemHeart Assisted PCI

0

20

40

60

80

100

In-hospital 30-day 180-day

%

87.2 87.2 80.6

©2015 MFMER | 3474186-54

Complications

Variable (%) Mean

Major vascular complication* 13

Stroke 1

Worsening renal function 2

Thrombocytopenia 10

*Includes elective repair

©2015 MFMER | 3474186-58

Kar et al: JACC 57:688-96, 2011

(TandemHeart PVAD, N = 117)

©2015 MFMER | 3474186-60

Stratified Survival Analysis

JACC 57(6):688-96, 2011

0.0

0.2

0.4

0.6

0.8

1.0

0 200 400 600 800 1,000 1,200 1,400

Days

Cu

mu

lative

su

rviv

al

Bridge to transplant

Bridge to recovery

Bridge to LVAD

©2015 MFMER | 3474186-62

Flow rate up to 2.5 L/min

Impella Platform

9 Fr Catheter diameter

2.5 L

12 Fr pump motor Blood inlet area

Outlet area

Received FDA 510(k) clearance June 2008

©2015 MFMER | 3474186-66

0

25

50

75

100

Hemodynamic Effects of Impella

Parameter Change

CO /

PCWP ↓/↓↓

SBP →

DBP /

MAP /

CPO /

PVA ↓/

60

70

80

90

100

110

AoP

(m

m H

g)

Pre

ssure

(m

m H

g)

Volume (mL) 140 160 180

0.5 sec

B

A

©2015 MFMER | 3474186-67

O’Neill WW et al: Circulation 126:1717, 2012

PROTECT II Trial

• Multicenter RCT for high-risk PCI patients

• Complex 3VD, UPLM, EF <35%

• Stopped early for futility; no difference in primary endpoint (MACE) at discharge or 30 days

Randomized Intent-to-treat

(N=448)

IABP (N=223) 30-day, N=222

90-day follow-up, N=219

Impella 2.5 (N=225) 30-day, N=225

90-day follow-up, N=224

©2015 MFMER | 3474186-68

20

25

30

35

40

45

50

0 10 20 30 40 50 60 70 80 90

PROTECT-II Trial

20

25

30

35

40

45

50

0 10 20 30 40 50 60 70 80 90

Time post index procedure

(days)

Time post index procedure

(days)

Ma

jor

ad

ve

rse

eve

nts

ra

te (

%)

IABP

Impella 2.5

P=0.147

IABP

Impella 2.5

P=0.048

©2015 MFMER | 3474186-70

0

25

50

75

100

ECMO

60

70

80

90

100

110

AoP

(m

m H

g)

Pre

ssure

(m

m H

g)

Volume (mL) 140 160 180

0.5 sec

B

A

Parameter Change

CO →

PCWP /

SBP /

DBP /

MAP /

CPO /

PVA /

©2015 MFMER | 3474186-73

Crit Care Med. 2010 Sep;38(9):1810-7.

ECMO in STEMI

Conclusion: Early extracorporeal membrane

oxygenator-assisted primary percutaneous coronary

intervention improved 30-day outcomes in patients

with ST-segment elevation myocardial infarction with

complicated with profound cardiac shock.

(Crit Care Med 2010; 38:1810-1817)

©2015 MFMER | 3474186-76

Indications for Percutaneous MCS (2015 Multi society Consensus Statement)

• Complications of AMI

• Severe HF in the setting of nonischemic CMP

• Acute cardiac allograft failure

• Post-transplant RV failure

• Patients slow to wean from CPB post-heart surgery

• Refractory arrhythmia

• High-risk coronary and structural cases

• High-risk VT ablation

©2015 MFMER | 3474186-77

High Syntax Score

Noncomplex PCI

Complex PCI

Normal/ mildly reduced LVEF (>35%)

None IABP/Impella as back up

Severe LV dysfunction (LVEF<35%) or recent

decompensated heart failure

IABP/Impella as back up

Impella or TandemHeart

Suggested Schema for Support Device in High-Risk PCI

©2015 MFMER | 3474186-79

MCS Device Selection Considerations

• Pressure vs Flow

• Devices can be complementary

• Hemodynamics and oxygenation

• RV function

• Experience of the operator, cath lab staff and the institution

©2015 MFMER | 3474186-81

http://media.corporate-ir.net/media_files/irol/95/95989/2010AR/index.html

On the Horizon

Thoratec HeartMate PHP 2012 Thoratec HeartMate PHP, x-ray from first human experience

March 2013

Penn State PHP prototype

circa 2008

percutaneous mechanical circulatory support

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