Transcript PiCCO 2 vs. EV1000 - PULSION Medical Systems SE

PULSION Medical Systems AG
PiCCO2 vs. Edwards EV1000
Edwards EV1000 – Setup
VolumeView sensor
VolumeView femoral arterial catheter
VolumeView thermistor manifold
CVC standard
TruWave pressure transducer
AP
CVP
Patient
Monitor
EV1000 clinical platform
Additional transducer 2for injection
detection is neccessary!
EV1000 basic setting is
more complex than a
PiCCO basic setting!
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EV 1000 Hardware
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PiCCO2 vs. EV1000 - Hardware monitor
PULSION
PiCCO2
PULSION
PulsioFlex
Edwards
EV1000
ICU
OR
OR, ICU
Monitor, modules
Monitor, modules
Screen, bedbox,
modules
PiCCO
CeVOX
LiMON
(ProAQT)
(PiCCO)
CeVOX
LiMON
ProAQT
(CiMON)
etc.
PiCCO
PreSep, PediaSat
Appr. 15k EUR
Appr. 8k EUR
Appr. 15k EUR
Battery
Yes
No
No
Screen
13“
8” (800x480)
10“ (800x600)
Yes
Multitouch
Target market segment
Design
Technologies available
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End-customer price
Touch screen
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FloTrac
Yes
Edwards EV1000 – Disposables (VolumeView set)
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Edwards EV1000 – Disposables (VolumeView Set)
Instructions for use
VolumeView
Catheter Set
VolumeView
Transducer Set
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CVP Transducer + Injectate Sensor
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Edwards VolumeView – Catheter Set
Nitinol
Guidewire
“Fancy”
guidewire
dispensor
Suture Kit
Scalpel
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5F20cm
4F16cm
3pin PA
Connector
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PiCCO2 vs. EV1000 - PiCCO kit vs. VolumeView Combo kit
PULSION PiCCO kit
Edwards
VolumeView
Combo kit
Pressure sensor
Standard DPT
Double sensor
Injectate sensor
Thermistor plus
switch
Standard PAC
injectate sensor
CVP necessary
5F20 femoral
4F22 brachial cubital
4F16 brachial prox
4F8 axillary
3F7 children femoral
4F50 radial
Catheters available (preliminary
status)
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End-customer price
Additional accessories
Compatibility to competitor‘s platform
5F20 femoral
4F16 brachial
160-220 EUR
Not yet
communicated
Needle, dilator
Nitinol giude wire
Scalpel, suture kit,
Steel guide wire ?
No
No*
*tested with PiCCO2, Philips Intellivue, Dräger Smartpod
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PiCCO2 vs. EV1000 - Software GUI / visualisation
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PiCCO2 vs. EV1000 - Software GUI / visualisation
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PiCCO2 vs. EV1000 - Software GUI / visualisation
PULSION
PiCCO2
Pulsion
PulsioFlex
Edwards EV1000
Use via touch screen
Yes
Yes
(Gestures
control)
Yes
Target ranges adjustable
Yes
Yes
Yes
SpiderVision
Profile bars
Trends
Physiology tree
(SpiderVision)
(Profile bars)
Trends
?
?
Cockpit
Trends
Physiology tree
Physiology animation
Context driven
Context driven
Menu driven
No
No, planned
Yes
No, planned
Network
printing
HL7planned
Yes
Visualisation modes
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Software architecture
Event Management
LAN connection to hospital network
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PiCCO2 vs. EV1000 – Parameters / algorithms
PULSION
PiCCO2
PULSION
PulsioFlex
Edwards EV1000
Yes
Yes
No
Continuous CO
PCCO
PCCO
PCCO / Vigileo mix
Preload volume
GEDV
(GEDV)
GEDVsmart (changed
algorithm?)
EVLW
(EVLW)
EVLWsmart (changed
algorithm?)
Yes (patent
appl.)
Yes
No
SVV/PPV
standard
standard
SVVextra
R-L shunt detection
Based on manual double hump detection in TD curve
Continuous AP with curve
Lung water
Indexing with PBW
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(not yet stable)
Consideration of lung resection
No
No
(Yes)
Volume site adaptation
Yes
Yes
No?
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PiCCO2 vs. EV1000 - Algorithm differences, additional features
ELWIsmart compensation after lobectomy
Clinical studies necessary to prove
validity and accuracy, until today three
studies on this topic showing no
significant EVLW differences before and
after lobectomy
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SVVextra
Already in the PiCCO algorithm since
PiCCOclassic V4.1 (from 2000); means,
the Edwards SVV algorithm was and is
still erroneous
Compensation of
arrhythmias in AP
Curve
1 Detection
2. Rejection
3. Interpolation
4. “Correct” calculation
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“Lung Resection Compensation Feature”
Argumentation tips:
• Lung tissue is mainly removed if it is damaged, mostly by trauma, inflammation or tumors.
• Local lung perfusion is therefore already reduced even before resection.
• Where there are local lung perfusion disturbances, ELWI is measured as a false low before resection,
because only the perfused parts of the lung are integrated into the ELWI measurement.
• So ELWI may be the same before and after resection, especially where there is reduced local perfusion.
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• If a compensation factor for different segments of the lung are used in the EV1000,
ELWI can be changed to any level. There is no literature to support this factor.
• It is more objective to measure ELWI before and after lung removal, to get accurate
information about real changes in PiCCO ELWI
• Even if ELWI is altered , the trend and dynamics of the PICCO ELWI is are correct!
•Remember only the PiCCO ELWI is indexed to predicted body weight ensuring its increased accuracy
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PiCCO2 vs. EV1000 - Algorithm differences, additional features
GEDVsmart, EVLWsmart
EV1000 EVLW validation was done by
using PiCCO as gold standard with
excellent agreement, means no significant
improvement in the new algorithm.
GEDVsmart should enhance accuracy in
case of a L-R shunt. No data published
regarding this.
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Right-to-left heart shunt detection
also possible with the TD curve in the
PiCCO, until today only one publication
(letter by Michard), no quantification of
shunt volume or cardiac output, which was
already included in PiCCOplus V7.1 but
skipped in PiCCO2 because of not proven
clinical relevance and accuracy
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Integration and interfacing
Philips
Draeger
GE
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Mindray
Spacelabs
Nihon Kohden
Module available (soon)
Parameter connection available
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EV1000 market entry – Challenges and advantages
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Edwards confirms the PULSION philosophy of heamodynamic monitoring and
promotes volumetric monitoring, lung water and calibrated pulse contour CO
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Edwards has a ME2 device, PiCCO is the original
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PiCCO is already widely spread, also as modules for monitors
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In the validation study PiCCO is used as gold standard
•
Edwards promoters can not anymore argue against PiCCO
•
17 installed base?
Risk for the PiCCO
- as US company Edwards will avoid liability problems
- direct promotion of VolumeView sets to be used with PiCCO is unlikely
•
Risk of price war?
- Edwards is focusing on high margins and need them to achieve ROI
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