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Associate Professor of Medicine Director, Interventional Cardiology
Co-Director, Hans Hecht Cardiac Catheterization Laboratory University of Chicago Medical Center
Chicago, IL
Sandeep Nathan, MD, MSc, FACC, FSCAI
Extracorporeal Life Support
(ECLS) and Beyond:
New Directions in Percutaneous
Mechanical Circulatory Support
IABP Impella TandemHeart ECMO / ECLS
Impella 2.5 Impella CP Impella 5.0 Impella RP*
Percutaneous mechanical support options
* Investigational device
IABP Impella TandemHeart ECMO / ECLS
Impella 2.5 Impella CP Impella 5.0 Impella RP*
Percutaneous mechanical support options
V-V V-A
V-A-V
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 / ECLS
Central ECMO cannulation Peripheral ECMO cannulation
ECMO cannulation
Marasco SF, et al. Heart, Lung and Circulation 2008;17S:S41–S47.
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 Venous blood is withdrawn through the drainage lumen with ports in both the SVC and IVC.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
• 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
Thoratec Centrimag
Maquet CardioHelp ECLS
CARDIOHELP HLS Module Advanced
Hardware Disposables Applications
CARDIOHELP System
Software
Transitioning to
Therapy
V-V Support/ Assist
V-A Support/ Assist
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
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)
HLS Module Advanced:
Maquet CardioHelp ECLS
Arterial cannulae (15-19 Fr) Venous cannulae (20-24 Fr)
Maquet CardioHelp ECLS
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
Raman et al. Ann Thorac Surg 2010;90:1032-4
• 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
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
Antegrade 6 Fr Arrow sheath
in SFA for limb perfusion
15 Fr arterial cannula
(Medtronic BioMedicus)
21 Fr venous cannula
(Medtronic BioMedicus)
Extracorporeal life support (ECLS) was initiated in the
cardiac cath lab using the Maquet CardioHelp system
and peripherally placed cannulae.
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
• Low cost of disposables
• Rapid cannulation (with ability to perform blind bedside procedures)
• Rate- and rhythm-independent support
• Pulmonary vs. cardiopulmonary support
ECLS in perspective
• 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
PROS CONS
Near horizon for MCS
• Percutaneous
– Reitan Pump
– PHP
• Minimally invasive / Percutaneous
– NuPump
– Symphony
– Circulite
• The RCP is a 10 French collapsible percutaneous cardiovascular support device
• Positioned in the descending part of the thoracic aorta via the femoral artery.
Reitan Pump* – CardioBridge
* 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
Impeller
Coated
Cannula
Cannula
Inlet
Cannula
Outlet
Insertion Sequence
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
Delivered through 12F sheath
Expands to 24F when unsheathed
Thoratec HeartMate PHP (Percutaneous Heart Pump)
HeartMate PHP Impeller Design
• CFD-aided design of PHP impeller blade optimizes hydrodynamic efficiency to allow for reduced pump RPMs
• Shear stress and hemolysis are potentially reduced
Initial design: 4LPM, 24Krpm, 60mmHg generated pressure head
Optimized design: 4.25LPM, 21Krpm, 62mmHg generated pressure head
+40%
HeartMate PHP Case Study (HR PCI)
0
0.5
1
1.5
2
2.5
3
3.5
4
Baseline On support Post-procedure
Cardiac index
0
20
40
60
80
100
120
Baseline On support Post-procedure
MAP
+70%
Time HR SBP DBP MAP CVP PAP PCWP CO CI
Baseline 80 92 54 70 4 21 13 4.42 2.15
On support
125 125 85 101 6 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
Development & Testing
Major upcoming milestones 1. Initiate CE Mark study 2. Initiate US PMA pivotal study 3. Commercial launch OUS
EU Clinical
US Clinical
2015 2016
Abiomed SYMPHONY *
* Investigational technology
1 2
3 4
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
• Bleeding, bleeding, bleeding
• Vascular complications
• Cholesterol / air embolization
• CVA
• Sepsis
• Thrombocytopenia
• Hemolysis
• Groin / line infections
• Peripheral Neuropathy
Complications of mechanical support
• 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
Summary
Thank you!