What`s New in VADs 2014: Small, Smaller and in Pairs?

What’s New in VADs 2014:
Small, Smaller and in Pairs?
Scott C. Silvestry MD
Associate Professor/Surgical Director
Cardiac Transplantation and Mechanical Circulatory Support
Program
Disclosures
Thoratec: Research funding ( material) and scientific advisor.
Heartware: Scientific advisor.
Off label uses will be discussed.
MOST devices presented are in development
pre-clinical trial use or clinical trials except
where noted.
Q66. My current preference for post‐
cardiotomy pump failure is:
a.
b.
c.
d.
e.
Inotropes‐ there is no maximum dose
Inotropes plus IABP
VAD‐ direct central cannulation as necessary
ECMO central or peripheral
Percutaneous VADs such as Impella
VAD EVOLUTION
AXIAL FLOW VADS
Micromed
HeartAssist
Berlin Heart
Incor ®
Jarvik Heart®
2000
Thoratec
HeartMate II®
• Smallest size full
support pump
•Snap-in
connectors
•Intraventricular
•Excellent durability
•Manual control
• Above diaphragm
implant
•Straight cable exit
•Hydrodynamic
bearing
• Flow probe
5
•Magnetically
suspended rotor
•Post-auricular
cable
•Only DT device
approved in US
CENTRIFUGAL (RADIAL) FLOW
VADS
6
Ventracor Ventrassist
Terumo DuraheartTM
HeartWare HVAD®
• Hydrodynamic
suspension
• Magnetically levitated
impeller
• Magnetically driven
• Magnetically driven
•Passive magnetic and
hydrodynamic
suspension
• 1,800-3,000 RPM
• 1,400-1,800 RPM
•2,300-3,200 RPM
• Not FDA Approved
• Not FDA Approved
•FDA Approved: BTT
Centrifugal versus Axial
• Centrifugal (“radial’) pump has impeller outflow directed
perpendicular from axis of rotation
• Axial pump has impeller outflow directed parallel to axis of rotation
centerline
centerline
Centrifugal
Axial
HQ for HVAD and HMII
HVAD
Impeller OD = 34.5 mm
Outflow graft = 10 mm
1,800 rpm ↔ 4,000 rpm
HMII
Impeller OD = 12.2 mm
Outflow Graft = 14 mm
6,000 rpm ↔ 15,000 rpm
Centrifugal pumps typically
have flatter HQ curves with
resulting:
Larger flow /pulsatility levels
than axial flow pumps
Slide 8
Chest roentgenogram of patient 6 after implantation of 2 HeartWare HVAD ventricular assist
devices for biventricular support.
Krabatsch T et al. Circulation 2011;124:S179-S186
Copyright © American Heart Association, Inc. All rights reserved.
Patient 9 after implantation of 2 HeartWare HVAD ventricular assist devices for biventricular
support before discharge home.
Krabatsch T et al. Circulation 2011;124:S179-S186
Copyright © American Heart Association, Inc. All rights reserved.
VADS Are Getting Smaller
Mini-VAD Technologies
– Alternative Technology using different
paradigms of assisting cardiac
function/unloading
• Direct Flow
– Impella/Archimedes screw
– Emphasis on flow as opposed to pulsatility (IABP)
• Partial Flow VADS
– Miniaturization of pump technology-Micro-continuous flow
VADs
• Pulsatile “Assistance”
– Chronic pulsatile unloading for long term recovery
13
13
PV Loop Changes vs. Treatment
Inotropic Drugs
IABP
Reduces aortic
pressure “afterload”
ESPVR shifts
up
Stroke volume
increases
Increases
pressure,
stroke
volume, work
ECMO/CPS
No change in work
VAD/Impella
Reduces
ventricular
volume
(indirectly)
Increases peak
pressure
(afterload)
Increases work
Reduces
ventricular
volume
Reduces
peak
pressure
Reduces
work
Impella 5.0/LD-Femoral/Axillary/Aortic
Approaches
Baseline
Pressure
“Unloaded”
Volume
s
14
14
Before Impella LD
After Impella LD
15
16
IMPELLA® 5.0 and LD
ECMO LOADS
UNLOAD¹
Figure 1. Successive chest X-rays after extracorporeal membrane oxygenation. One day before implantation of the transfemoral Impella LP 2.5, severe global pulmonary
congestion
can be seen (a). Two days after implantation of the micro-axial flow pump (white arrow), pulmonary edema is clearing and enlargement of the left ventricle is markedly reduced (b).
“… in trying to get LV recovery ECMO is not really an
unloading strategy. It is rather, a loading strategy…”²
1. Jouan et al Jour of Hrt Lung Transplant June 2009
2. Rastan et al – Jour. of Thor. and Card Surgery, Feb
2010
Mini-VADs
Low-profile percutaneous device
Collapsible elastomeric impeller and nitinol
cannula;
expands to full size once in position
Designed to deliver over 4L per minute of flow
under
normal physiologic conditions
Percutaneous Heart Pump
HEARTWARE, HVAD and the HEARTWARE logo are registered trademarks of HeartWare.
WHAT’S NEW- RIGHT SIDE SUPPORT
Impella RP
•
The Impella RP is a 3D catheterbased system, implanted via the
femoral vein
•
Used as a temporary circulatory
support device for treatment of RV
failure (per IDE support can be
provided up to 14 days)
•
Size 22 Fr pump on a 11 Fr catheter
•
Flows > 4 L/min
•
The device inlet resides in the inferior
vena cava (IVC)
•
The device outlet resides in the
pulmonary artery (PA)
outflow
inflow
TandemHeart Support
Naidu S. Circulation 2011;123:533-543
Copyright © American Heart Association, Inc. All rights reserved.
Characteristics of Ideal VAD
Definite
Open
• Easy to implant- standard
operation, MIS
• Durable use
• Hardy Peripherals
• Power source
• Anticoagulation not
mandatory
• Modular replacement
• Full vs partial support
• Pulsatile vs continuous
mode
• Wi-Fi- Telemetry- remoteInterrogation &
Manipulation
• Ambient/ TET Power
source
HeartMate III
Ultra-compact, fully magnetically-levitated LVAD.
Full magnetic levitation
Ability to induce pulsatility
Optimized for efficient, low-power operation
Full support LVAD (10L / min)
“Simple intrathoracic placement”
Modular driveline and next-generation controller
Potential for reduced anti-coagulation, pump thrombosis, and bleeding
Heartmate III*: Full Mag-Lev Technology
Fluid Dynamics
•
The HeartMate III rotor and volute have
been designed to minimize shear and
avoid stasis over the entire range of
operation (2 to 10 L/min)
•
The relatively large secondary flow paths
facilitate smooth flow transitions,
generous washing, and low shear
•
Low hemolysis has been demonstrated
in both in vitro and in vivo (plasma-free
hemoglobin always <10 mg/dL) studies
*In development. Not approved for clinical use.
Smaller Devices, Targeted Flow, Less
Invasive Implant
MVAD
SYNERGY
Transapical
CAUTION – Investigational Device. Limited by United States law to investigational use.
Exclusively for Clinical Investigations.
CAUTION – Investigational Device. Limited by United States law to investigational use.
Exclusively for Clinical Investigations.
MVAD® Pump Platform
MVAD® Pump is a next-generation
platform designed to enable:
• Support for a wider range of
patients
• Left and right ventricular support
(LVAD, RVAD)
• Partial and full flow (turn-down
capability)
• Less invasive implant technique
(e.g. thoracotomy)
CAUTION – Investigational Device. Limited by United States law to investigational use.
Exclusively for Clinical Investigations.
®
MVAD
Pump Animation
CAUTION – Investigational Device. Limited by United States law to investigational use.
Exclusively for Clinical Investigations.
Transapical Cardiac Assist
• Design based on MVAD Pump platform
• Transapical placement, pump cannula
sits across aortic valve
• Axial design, continuous flow
• In vitro studies demonstrate no
intraventricular or aortic valve thrombus
• Aortic valve seals around cannula with
minimal to no regurgitation
CAUTION – Investigational Device. Limited by United States law to investigational use.
Exclusively for Clinical Investigations.
Synergy Micro-Pump
Technology
•
Smallest implantable blood pump
•
Miniature size allows superficial
pacer-like “pocket” placement
•
Provides partial support: up to
3L/minute of blood flow
•
Designed for long-term support
29
CircuLite Technology
Outflow Graft
Inflow
Cannula
Motor
Washout area
Impeller
Percutaneous
Lead
Percutaneous
Lead
30
Chronic extra-aortic balloon counterpulsation:
First-in-human pilot study in end-stage heart failure
Hayward et al: The Journal of Heart and Lung Transplantation,
Vol 29, No 12, December 2010
C-Pulse- Sunshine Heart
Endovascular meets Implantable VAD
Accurate Flow
92 gm Pump
Remote Monitoring
Pericardial Placement
RPM 7,000-12,000
www.Micro
HEARTMATE FULLY IMPLANTED
SYSTEM*
Mobile
Tethered
Flexible Lifestyle: Eliminates the driveline and “around the clock” worn equipment.
35
*In development. Not approved for clinical use.
Free
High-efficiency,
user-friendly
wireless energy
transfer across
a distance
Custom battery
technology tailored
for implantable
LVAD application
Summary
• Next generation ventricular assist devices target the
complications of current devices and target improved
device durability and enhanced biocompatibility
• Novel methods of cardiac support achieve unloading and
yield insight into future directions in the treatment of HF.
• Closed chest support devices continue to evolve and
their experience advances acute and chronic cardiac
support
Q67. The currently available percutaneous VADs maximally provide approximately:
a.
b.
c.
d.
2.5 L/minute flow
3 L/minute flow
4 L/minute flow
5 L/minute flow
Q68. The primary advantage of Percutaneous VAD support of ECMO includes:
a.
b.
c.
d.
Direct LV unloading
Improved Perfusion
Easier assess
Decreased cost