Impella Ins & Outs

CarVasz November 21 201410:45 – 12:15

Nicolas M. Van Mieghem, MD, PhD, FESCClinical Director of Interventional Cardiology

Thoraxcenter, Erasmus MCRotterdam

Background

IABP is widely used for LV support in high-risk PCI &

cardiogenic shock

The increase in cardiac output by IABP is limited

Measurable effects on clinical outcome is scarce

What we need…

Assist Device should be safe

User-friendly

Effective LV support

Measurable (clinical) benefit

LV Support in EP?

Ventricular Tachycardia & EP-Ablation

High Risk for Hemodynamic Instability

Complex congenital heart disease (Fontan, …)

Poor LV function

Ischemic

Non-ischemic

LV support to overcome BP drop while inducing & ablating VT

IMPELLA

Impella CP

5 Strut Inlet Cage14 Fr Cannula

• 4.66mm

Optimized Impeller

Up to 4L/min – continuous flow

Impella Principle

PROTECT II Trial Design

IMPELLA 2.5 +

PCI

IABP +

PCI

Primary Endpoint = 30-day Composite MAE* rate

1:1

R

8

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

CPO= Cardiac Power Output = Cardiac Output x Mean Arterial Pressure x 0.0022 (Fincke R, Hochman J et al JACC 2004; 44:340-348)

Hemodynamic Support EffectivenessImpella 2.5 vs. IABP

9

Cardiac Power Output

Maximal Decrease in CPO on device Support from Baseline

IABP Impella

N=138 N=141

- 4.2 ± 24

- 14.2 ± 27

p=0.001

CPO data available only for 279 patients (N=138 IABP and N=141 Impella)

Learning curve - Impella 2.5 vs. IABP

10

N=82N=82 N=63N=63 N=68N=65

IABP

IMPELLA

Per Protocol Population 90day Outcome (N=423)

Impella 2.5 and CP

Impella 2.5 Impella CP

Mean Flow Rate (L/min)

2.3 - 2.5> 1 L/min additional

Flow

Catheter Size 9 Fr 9 Fr

Pump Size 12 Fr 14 Fr

Insertion MethodPercutaneous

via 13 Fr or 14 FrIntroducer Sheath

Percutaneous via 14 Fr Introducer

Sheath

Guidewire0.018” Silicone

Wire0.018” PTFE Wire

Placement Measurement

Fluid-filled Pressure Lumen

Fluid-filled Pressure Lumen

Cannula Geometry

Curved, Pigtail Curved, Pigtail

RPM 51,000 46,000

VT Ablation with Impella or not

Miller et al. JACC 2011;58:1363-71

Impella in VT Ablation

Impella in VT Ablation

Heart Pumps and Hemolysis?

15

• Heart Pumps apply “shear” forces to

red blood cells that if strong enough

can damage cell structure

• Shear forces result from differences

in blood velocity (i.e. force) from

one side of RBC to the other

• Shear forces in a heart pump are

strongest in regions of high blood

velocity differences and small flow

channels

Shear Force

Hgb

Hgb

Hgb

Hgb

Cannula Wall / Fixed Structure

Speed low due to dragging along the wall

Speed high away from wall

Shear forces “pull apart” or distort cell membrane and can cause rupture

Hemolysis with Impella and Other Heart Pumps in Bench Testing?

16

1CentriMag/Industry standard data – Levitronix Website2FDA Comparative Bench Test Data for Impella 2.5 510(k) Clearance

1 1 12 2

Thoratec PHP

• Low-profile

• Designed to provide high forward flow at low RPMs to unload the LV and perfuse end organs

– Designed to deliver 4-5 lpm average flow

• Collapsible elastomeric impeller within expandable nitinol cannula

• 13F insertion profile

• Expands to 24F when unsheathed

Impeller

Coated

CannulaCannula

Inlet

Cannula

Outlet

Insertion Sequence

HeartMate PHP

HeartMate PHP

Pivotal CE Mark study kick-off Q3 2014

Up to 50 patients undergoing high-risk PCI at up to 10

sites in Europe and South America

Primary performance endpoint: Freedom from

hemodynamic compromise during PCI

Primary safety endpoint: Composite of major adverse

events.

Thoratec PHP

PulseCath iVAC 2L

PulseCath Principle

17F catheter across

aortic valve is connected

to an extracorporeal

membrane pump

Pulsecath actively

aspirates blood from the

left ventricle in systole

and ejects this blood into

the ascending aorta

during diastole

Pump is compatible with

standard IABP console as

a driver

PULSECATH iVAC 2L

Hemodynamics Pulsecath

100

40

100

40

Counterpulsation

Diastolic Pressure increases

MAP increases

C.O. increases*

0,00,51,01,52,02,53,03,54,0

C.O.

C.Output

PULSECATH iVAC 2L

LV Support & Access Strategy

Large caliber system (17F)

Pulsatile LV Support

Genuine IABP console

Compared to IABP: C.O. X3

LV Support ≠ replacement

Safety & efficacy Study ongoing in Rotterdam

PULSECATH iVAC 2L

In Conclusion

LV support is valuable in particular clinical settings

Powerful devices are entering the clinical field

LV support may also serve complex EP procedures