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Percutaneous Ventricular Assist Devices:

High Risk PCI and Shock

Michael J. Lim, MD, FACC, FSCAI

Jack Ford Shelby Endowed Professor

Co-Director, Center for Comprehensive Cardiovascular Care

Saint Louis University

Disclosures

Relevant Financial Relationships over the past 12 months:

Research Support Astellas

Consultant Acist Medical

Speaker St. Jude Medical, Abiomed

Case Scenerio

• 69 yr old man with DM, HTN, and smoker presents complaining of dyspnea on exertion, orthopnea, PND, and chest pressure. Chest pressure episodes lasting up to 20 minutes.

• ROS + for claudication symptoms

• Workup – EF 20%. Troponin peak at 1.0

Summary

• 3 Vessel CAD

• Terrible LV function

• Diabetic CABG

SYNTAX Score: 43.5 Surgeon’s view: STS • Mortality 4.7% • Morbidity or Mortality 41.6%

NO

Percutaneous Ventricular Support

CO

MAP

PCWP

Hemodynamic Effects

• Trans-septal cannula into left atrium

• 15–17 F arterial cannula

• Nonpulsatile pump (~4 L/min)

TandemHeart Impella • 13 F arterial cannula

• Non-pulsatile

• 2.5 and CP catheters for purcutaneous use

IMPELLA 2.5 + PCI

IABP + PCI

Primary Endpoint = 30-day Composite MAE* rate

1:1 R

Patients Requiring Prophylactic Hemodynamic Support During Non-Emergent High Risk PCI on

Unprotected LM/Last Patent Conduit and LVEF≤35% OR 3 Vessel Disease and LVEF≤30%

Follow-up of the Composite MAE* rate at 90 days *Major Adverse Events (MAE) : Death, MI (>3xULN CK-MB or Troponin) , Stroke/TIA, Repeat Revasc, Cardiac or Vascular Operation or Vasc. Operation for limb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failure

PROTECT II - Design

Circulation 2012; 126:1717-27

Patient Characteristics IABP (N=211)

Impella (N=216)

p-value

Age 67±11 68±11 0.583

Gender-Male 82.0% 80.6% 0.704

History of CHF 82.9% 91.2% 0.011

Current NYHA (Class III / IV) 54.9% 58.5% 0.485

Diabetes Mellitus 49.3% 53.2% 0.414

Renal insufficiency 30% 22.7% 0.086

Peripheral Vascular Disease 27.0% 25.4% 0.697

Implantable Cardiac Defib. 31% 35.6% 0.304

Prior CABG 28.9% 39.4% 0.023

LVEF 24.0±6.3 23.3±6.3 0.258

STS Mortality score 6±7 6±6 0.562

Not Surgical Candidate 64.5% 63.4% 0.825

SYNTAX score 29.5±13.7 30.3±13.2 0.595

Circulation 2012; 126:1717-27

Procedural

Characteristics IABP (N=211)

Impella (N=216)

p-

value

Use of Heparin 82.4% 93.5% <0.001

IIb/IIIa Inhibitors 26.5% 13.4% <0.001

Total Contrast Media (cc) 241±115 267±141 0.035

Rotational Atherectomy (RA) 9.0% 14.2% 0.083

Median # of RA Passes/lesion (IQ

range) 1 (1-2) 3 (2-5) 0.001

Median # of RA passes/pt (IQ range) 2.0 (2.0-4.0) 5.0 (3.5-8.5) 0.003

Median RA time/lesion (IQ range sec) 40 (20-47) 60 (40-97) 0.004

RA of Left Main Artery 3.1% 8.0% 0.024

Total Support Time (hours) 8.23±21.0 1.86±2.7 <0.001

Discharge from Cath Lab on device 37.7% 5.6% <0.001

Circulation 2012; 126:1717-27

PROTECT II MAE Outcome

IABP

IMPELLA

MAE= Major Adverse Event Rate

Intent to Treat (N=448)

p=0.294

N=225

p=0.066

N=224

p=0.092

N=216

↓ 22% MAE

p=0.023

N=215

Per Protocol (N=427)

Per Protocol= Patients that met all incl./ excl. criteria.

N=223 N=229 N=211 N=210

Circulation 2012; 126:1717-27

PROTECT II MAE Timing Per Protocol Population, N=427

Log rank test, p=0.048

IABP

IMPELLA

Composite Major Adverse Event (MAE)

LVEF Improvement Post PCI

p<0.001

Baseline 90 days

LVEF (%) N=303 patients with LVEF measurements available at baseline and 90 days

22%

NYHA Improvement Post PCI p<0.001

Baseline 90 days

NYHA Class Distribution

N=223 patients with NYHA measurements available at baseline and 90 days

Class I

Class II

Class III

Class IV 58% reduction

in Class III,IV

Case Scenerio #2

• 73 yr old man s/p CABG in 1996 and subsequent DES to his LCX in 2005 presents complaining of significant chest discomfort worsening over the last 6 months

• Over the past 2 weeks, he gets it at rest and it wakes him from sleep

Case Scenerio #2

• Angina relieved – walks all around the hospital all night. Discharged home…

• Decides that he only needs to take his aspirin, and not his second anti-platelet agent. 1 week after stents placed, presents to local ER with severe substernal chest pain. BP drops into the 80’s. Started vasopressors. 1 episode of Vtach requiring cardioversion. Emergent transfer

Hemodynamics

Initial Pressure – On Levophed

Hemodynamics

LV Pressure – 80/25

Insertion of Impella CP

Final Aortic Pressure – Levophed OFF

Cardiogenic Shock: In-Hospital Mortality

0

10

20

30

40

50

60

70

80

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

Total <75 y ≥ 75 y

Babaev et al, JAMA 2005; 294:448

60.3

47.9

IABP Shock II Trial Design

OMM n=301 IABP n=299

Primary Efficacy Endpoint = 30-day all-cause mortality rate

1:1

R

Patients Presenting with AMI complicated by cardiogenic shock are randomized to IABP or to Optimal Medical Management. Mechanical

complications or resuscitation >30 min were excluded. All patients were to be revascularized by PCI or CABG

Safety measures include major bleeding, peripheral ischemic complications, sepsis, and stroke

Lancet 2013; 382:1638-45

No Difference in Outcomes

Lancet 2013; 382:1638-45

USPella Registry

• Retrospective observational multicenter study documenting use of hemodynamic support in patients with acute myocardial infarction / cardiogenic shock undergoing percutaneous revascularization

• 119 patients with Impella 2.5 at 32 centers in US and Canada

J Intervent Cardiol 2014; 27:1-11

Presentation Characteristics at Admission

All

(N=119)

STEMI

(N=86)

NSTEMI

(N=33) p-value

Transferred from outlying hospital 53% (112) 48% (79) 64% (33) 0.133

Preadmission Cardiogenic shock 59% (111) 69% (80) 32% (31) 0.0005

Preadmission Cardiac Arrest 20% (100) 27% (73) 0% (27) 0.002

Transfer Admission on IABP 15% (111) 20% (81) 3% (30) 0.037

Door to Impella time for patients

admitted with CS (Median, min.) 227 185 1283 <0.0001

Patient Characteristics Prior to Impella Support Initiation

54%

17%

0%

20%

40%

60%

80%

53%

58%

77%

46%

84%

Improvement of Hemodynamic and Metabolic Parameters with Impella

Cardiac Index

Car

dia

c In

dex

(l

/min

/m2)

Wedge Pressure

0

1.6

1.8

2.0

2.2

2.4

2.6

On Impella

PC

WP

(m

mH

g)

0

20

24

28

22

26

30

Pre Impella*

1.9±0.7

pH

pH

Level

0

7.1

7.2

7.3

7.4

7.5

7.0

7.2±0.2

On Impella

Pre Impella

On Impella

Pre Impella

2.8±0.7

32±12

20±11

p=0.0001

P<0.0001 p<0.0001

Mean Arterial Pressure

61±18

94±23 p<0.0001

7.4±0.1

MA

P

(mm

Hg

)

0

50

60

70

80

90

On Impella

Pre Impella*

100

Outcome: Survival to Discharge Post PCI

Pre-PCI

64.6%

Post-PCI

39.4%

Timing of Support Initiation

Impella Support Initiation

Survival to Discharge For ALL Patients

p=0.007

N=48 N=71

Post-PCI

60.0%

Pre-PCI

37.7%

Impella Support Initiation

STEMI

N=25 N=61

Post-PCI

69.6%

Pre-PCI

50.0%

Impella Support Initiation

NSTEMI

N=23 N=10

Summary

• Percutaneous ventricular support possible through a single arterial access

• High-Risk PCI

• Allows more-complete revascularization

• Translates into improved long-term outcomes

• Cardiogenic Shock

• No benefit for balloon pump therapy

• No prospective randomized trials

• Observational data supporting use