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Extracorporeal Life Support

(ECLS) and Beyond:


New Directions in Percutaneous
Mechanical Circulatory Support
Sandeep Nathan, MD, MSc, FACC, FSCAI
Associate Professor of Medicine
Director, Interventional Cardiology
Co-Director, Hans Hecht Cardiac Catheterization Laboratory
University of Chicago Medical Center
Chicago, IL

Percutaneous mechanical
support options
IABP

Impella

Impella 2.5 Impella CP

TandemHeart

Impella 5.0

ECMO / ECLS

Impella RP*
* Investigational device

Percutaneous mechanical
support options
IABP

Impella

TandemHeart

ECMO / ECLS

V-V

V-A
V-A-V

Impella 2.5 Impella CP

Impella 5.0

Impella RP*

ECMO / ECLS
Extracorporeal Membrane Oxygenation

2 primary modes of ECMO:


Veno-venous (V-V) ECMO primarily used for isolated
pulmonary failure
Veno-arterial (V-A) ECMO used for cardiac or
combined cardiopulmonary failure
A dialysis membrane may be added to the circuit for
renal replacement therapy

ECMO cannulation
Central ECMO cannulation

Peripheral ECMO cannulation

Marasco SF, et al. Heart, Lung and Circulation 2008;17S:S41S47.

V-V ECMO
V-V ECMO using
2 sites for
venous
cannulation.
Cannulae are
inserted into
the internal
jugular
vein (extending
into the right
atrium) and the
femoral
vein (extending
into the inferior
vena cava

Single-site
approach to V-V
ECMO cannulation.
A dual-lumen
cannula is inserted
into the IJ vein
(extending
through the RA and
into the IVC).
Venous blood is
withdrawn through
the drainage lumen
with ports in both
the SVC and IVC.
Reinfusion of
oxygenated blood
occurs through the
second lumen with
a port situated in
the RA.
Brodie D, et al. N Engl J Med 2011;365:1905-14.

Indications and contraindications


for V-V ECMO in ARDS

Brodie D, et al. N Engl J Med 2011;365:1905-14.

V-A ECMO

Thoratec Centrimag
Extracorporeal
circulatory support
device approved for
short-term (6 hrs LV
support, 30 hrs as an
RVAD)
Magnetically-levitated
pump impeller
Capable of delivering
high flows up to 9.9
LPM

Maquet CardioHelp ECLS

Maquet CardioHelp ECLS


CARDIOHELP System

Hardware

Disposables

Applications
Software
Transitioning to
Therapy

V-V Support/ Assist


V-A Support/ Assist

CARDIOHELP

HLS Module Advanced

Maquet CardioHelp ECLS

Smallest commercially available, pump and


integrated oxygenator (All in one heart-lung
support system)

Biocompatible surface coatings for optimum


protection

Extracorporeal Mechanical Circulatory Support

Partial or complete cardiac output

Support for CO2 removal and Oxygenation

10 kg (22lbs)
14 x 10 x 17 inches
Optional Sprinter Cart for in hospital mobility

Maquet CardioHelp ECLS


HLS Module Advanced:
Integrated sensors for:
Venous pressure (P-ven)
Internal pressure (P-int)
Arterial pressure (P-art)
Arterial temperature (T-art)
Integrated cell for:

Venous oxygen saturation


Hemoglobin / Hematocrit
Venous temperature (T-ven)

Maquet CardioHelp ECLS


Arterial cannulae (15-19 Fr)

Venous cannulae (20-24 Fr)

General range of flows achievable:


15 Fr arterial
3.5 4 L/min
17 Fr arterial
4 4.5 L/min
19 Fr arterial
Up to 6 L/min

Data for adult ECMO


in cardiac failure

N = 2,088 (total)
Indications: cardiac arrest, cardiogenic shock, shock with mixed
etiologies, post-cardiotomy shock, acute myocarditis, shock after
cardiac transplant
Series range in size from 5-219 patients,
Survival ranges from 0-91%
Allen S, et al. J Intensive Care Med 26(1); 13-26.

Practical considerations

Indications and contraindications


Mode of ECMO: V-V vs. V-A, vs. V-A-V
Timing & location of initiation
Availability of primary and provisional equipment
Type of system to be used
Vascular access
Timing of anticoagulation
Perfusionist support
Need for renal replacement therapy?
Aftercare, nursing instructions, securing of cannulae,
instructions regarding moving patient
Exit strategy???

Case study 1
67 year old man with ischemic
cardiomyopathy (EF 25%) presents
with progressive dyspnea,
confusion, acute on chronic renal
failure and refractory hypotension.
Recent history of MI/cardiogenic
shock requiring inotropic and
balloon pump support, complicated
by respiratory failure and
ischemia/gangrene to right foot.

Other co-morbidities
Peripheral Arterial
Disease
Chronic Kidney
Disease
Multiple prior MIs
Recent DES implants
Paroxysmal AFib
History of prostate CA
Malnutrition

Hospital Course:
Refractory Cardiogenic Shock

Started on Milrinone for inotropic support


Brief initial improvement, followed by progressive decline (increasing
lactate, decreased systemic perfusion, shock)
Pressors (dopamine, norephinephrine) initiated
Increasing frequency of tachyarrhythmias (atrial fib, NSVT)
Spiraling hemodynamics / progressive hypoperfusion / multi-organ
failure ensued despite extensive support with vasoactive
medications

Key clinical considerations:


Progressive shock state
PAD precluding large-bore arterial access with ongoing R foot
ischemia following prior arterial cannulation
No residual ischemic/viable myocardium
Not a cardiac transplant candidate (for a variety of reasons)

IABP Placement:
Subclavian Approach
Given the extensive co-morbidities and
clear need for additional hemodynamic
support pending a decision on
destination-LVAD therapy, the decision
was made to proceed with a right
subclavian IABP.
This was performed without
complications in the OR using a limited
cut-down and synthetic graft
anastomosed to the RSCA with
fashioning of a hemostatic valve through
which a Maquet 7.5 Fr. IABP was placed
into the descending aorta
Raman et al. Ann Thorac Surg 2010;90:1032-4

Hospital Course Continued:


Following IABP Placement
Continued patient decompensation:
Increasing pressor requirement despite IABP
Worsening tachyarrythmias during which there was
no IABP augmentation
Worsening perfusion (increasing lactate, decreasing
SVO2)
Decision made to initiate percutaneous extracorporeal
life support [V-A ECLS (ECMO)] after extensive
discussion between Interventional Cardiology,
Cardiothoracic Surgery and Heart Failure / Transplant

ECMO Cannula Placement:


Femoral Approach with Antegrade Sheath
Extracorporeal life support (ECLS) was initiated in the
cardiac cath lab using the Maquet CardioHelp system
and peripherally placed cannulae.

21 Fr venous cannula
(Medtronic BioMedicus)
15 Fr arterial cannula
(Medtronic BioMedicus)
Antegrade 6 Fr Arrow sheath
in SFA for limb perfusion

Effect of Counterpulsation with


ECMO & IABP in Combination
IABP Console

Maquet Cardiohelp ECLS Console

Decision was made to leave subclavian IABP in place for coronary


perfusion and LV venting while circulatory / oxygenation support
was provided by ECLS circuit.

IABP on Hold: Complete Loss of


Intrinsic Cardiac Pulsatility
IABP Console

ICU Monitoring Screen

Hospital Course Continued:


Improvement on Combined Therapy
Perfusion parameters begin improving with
combination IABP and ECLS
Decreasing lactate
Improving renal function, urine output
without diuretic support
Vasoactive medications slowly able to be
weaned off
With increasing stability, patient able to receive
permanent LVAD (Thoratec HeartMate II) on
post-ECLS day 3

Case study 2
39 yo female with severe pulmonary
HTN due to unrepaired ASD, s/p
cardiac arrest post-op (ASD repair,
DeVega TV ring) with refractory shock

ECLS initiation
ECLS initiated in cath lab:
15 Fr retrograde arterial cannula
(Medtronic BioMedicus)
23 Fr retrograde venous cannula
(Medtronic BioMedicus)
6 Fr antegrade sheath in SFA for limb
perfusion (Arrow)

ECLS initiation

Maquet CardioHelp ECLS

ECLS in perspective
PROS
Low cost of disposables
Rapid cannulation (with
ability to perform blind
bedside procedures)
Rate- and rhythmindependent support
Pulmonary vs.
cardiopulmonary support

CONS
No direct LV unloading
ideally need LV venting
Possible cerebral / visceral
hypoxemia with peripheral
cannulation
Modest support with 15 Fr
arterial cannula
Difficulty with securing of
currently available
cannulae
Large-bore vascular access

Near horizon for MCS


Percutaneous
Reitan Pump
PHP

Minimally invasive / Percutaneous


NuPump
Symphony
Circulite

Reitan Pump* CardioBridge


The RCP is a 10 French
collapsible percutaneous
cardiovascular support device
Positioned in the descending
part of the thoracic aorta via
the femoral artery.

* Investigational technology

The Reitan Catheter Pump System

CardioBridge Mechanism of action

Acute on Chronic Study

Hemodynamics

Hemodynamics

Renal Function

Renal Function

Renal Function

Conclusions

Principles of Support

Percutaneous insertion (10 F)


High pumping capacity
Afterload reduction
Increased peripheral perfusion
No crossing of aortic valve
No ECG synchronisation
Quick and easy setup

Device properties

Propeller diameter 15 mm
Diameter closed 10F (3.3 mm)
Pump Speed up to 13,000 rpm
Application time: approx. 7
days
Minimal anticoagulation
technology

Potential Areas of Application

Heart failure
High-risk PCI (need upper extremity access)
Cardio-renal syndrome
Pre-renal acute kidney injury (AKI)
Pre- and post-open-heart surgery

Thoratec HeartMate PHP*


(Percutaneous Heart Pump)

* Investigational technology

Thoratec HeartMate PHP


(Percutaneous Heart Pump)
Low-profile, rapid-insertion, catheter-based
percutaneous heart pump
Designed to provide high forward flow to
unload the LV and perfuse end organs
Designed to deliver 4-5 lpm average
flow at 21k RPM

Collapsible elastomeric impeller and nitinol


cannula

Coated
Cannula

Cannula
Outlet
Impeller

Delivered through 12F sheath


Expands to 24F when unsheathed

Insertion Sequence

Cannula
Inlet

HeartMate PHP Impeller Design

Initial design:
4LPM, 24Krpm,
60mmHg generated
pressure head

Optimized design:
4.25LPM, 21Krpm,
62mmHg generated
pressure head

CFD-aided design of PHP impeller blade optimizes hydrodynamic


efficiency to allow for reduced pump RPMs
Shear stress and hemolysis are potentially reduced

HeartMate PHP Case Study (HR PCI)

Cardiac index

MAP

4
3.5

120

+70%

+40%

100

3
2.5

80

60

1.5

40

1
20

0.5

0
Baseline

On support

Baseline

Post-procedure

On support

Post-procedure

Time

HR

SBP

DBP

MAP

CVP

PAP

PCWP

CO

CI

Baseline

80

92

54

70

21

13

4.42

2.15

On
support

125

125

85

101

31

20

7.39

3.64

Post
support

130

88

43

72

14

60

40

3.74

1.82

HeartMate PHP Development Timeline

2011

2012

2013

2014

2015

US Clinical
Development & Testing

EU Clinical

Major upcoming milestones


1. Initiate CE Mark study
2. Initiate US PMA pivotal study
3. Commercial launch OUS

2016

Abiomed SYMPHONY *

* Investigational technology

Abiomed SYMPHONY

Abiomed SYMPHONY
Device output 3.0
L/min at 100 bpm
Synchronized LV
unloading
GOALS of THERAPY:
Increased coronary
perfuion
Increased cardiac
output
Reduced myocardial
O2 consumption

Complications of mechanical support

Bleeding, bleeding, bleeding


Vascular complications
Cholesterol / air embolization
CVA
Sepsis
Thrombocytopenia
Hemolysis
Groin / line infections
Peripheral Neuropathy

Summary
Graded approach to device choice / strategy
should be based on:
Extent of support required
Duration of support anticipated
Consideration use of hemodynamic support early
in the treatment course and plan accordingly
Cost considerations, anatomic/technical issues
and cardio vs. cardiopulmonary failure issues
factor in to decision

Thank you!

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