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PULSION Medical Systems AG. PiCCO 2 vs. Edwards EV1000. Edwards EV1000 – Setup. VolumeView sensor VolumeView femoral arterial catheter VolumeView thermistor manifold CVC standard TruWave pressure transducer EV1000 clinical platform. Patient Monitor. AP. CVP.

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pulsion medical systems ag

PULSION Medical Systems AG

PiCCO2 vs. Edwards EV1000

slide2

Edwards EV1000 – Setup

VolumeViewsensor

VolumeViewfemoralarterialcatheter

VolumeViewthermistormanifold

CVC standard

TruWavepressuretransducer

EV1000 clinicalplatform

Patient Monitor

AP

CVP

Additional transducer for injection detection is neccessary!

EV1000 basic setting is more complex than a PiCCO basic setting!

slide6

Edwards EV1000 – Disposables (VolumeView Set)

Instructions for use

VolumeView Catheter Set

VolumeView Transducer Set

CVP Transducer + Injectate Sensor

slide7

Edwards VolumeView – Catheter Set

NitinolGuidewire

“Fancy” guidewire dispensor

Suture Kit

Scalpel

5F20cm 4F16cm

3pin PA

Connector

slide8

PiCCO2 vs. EV1000 - PiCCO kit vs. VolumeView Combo kit

*tested with PiCCO2, Philips Intellivue, Dräger Smartpod

slide13

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

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

slide14

“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.
  • 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
slide15

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.

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

integration and interfacing

Integration and interfacing

Philips

Draeger

GE

Mindray

Spacelabs

Nihon Kohden

Module available (soon)

Parameter connection available

slide17

EV1000 market entry – Challenges and advantages

  • Edwards confirms the PULSION philosophy of heamodynamic monitoring and promotes volumetric monitoring, lung water and calibrated pulse contour CO
  • Edwards has a ME2 device, PiCCO is the original
  • PiCCO is already widely spread, also as modules for monitors
  • In the validation study PiCCO is used as gold standard
  • Edwards promoters can not anymore argue against PiCCO
  • Risk for the PiCCO installed base?
    • - 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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