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PULSION Medical Systems SE

PULSION Medical Systems SE. 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 SE

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  1. PULSION Medical Systems SE PiCCO2 vs. Edwards EV1000

  2. Edwards EV1000 – Setup VolumeView sensor VolumeView femoral arterial catheter VolumeView thermistor manifold CVC standard TruWave pressure transducer EV1000 clinical platform Patient Monitor AP CVP Additional transducer for injection detection is neccessary! EV1000 basic setting is more complex than a PiCCO basic setting!

  3. EV1000 Hardware

  4. PiCCO2 vs. EV1000 - Hardware monitor

  5. Edwards EV1000 – Disposables (VolumeView set)

  6. Edwards EV1000 – Disposables (VolumeView Set) Instructions for use VolumeView Catheter Set VolumeView Transducer Set CVP Transducer + Injectate Sensor

  7. Edwards VolumeView – Catheter Set Nitinol Guidewire Guidewire dispensor Suture Kit Scalpel VolumeView Catheter5F20cm, 4F16cm3pin TD Connector

  8. PiCCO2 vs. EV1000 - PiCCO kit vs. VolumeView Combo kit *tested with PiCCO2, Philips Intellivue, Dräger Smartpod

  9. PiCCO2 vs. EV1000 - Software GUI / visualisation

  10. PiCCO2 vs. EV1000 - Software GUI / visualisation

  11. PiCCO2 vs. EV1000 - Software GUI / visualisation

  12. PiCCO2 vs. EV1000 – Parameters / algorithms

  13. PiCCO2 vs. EV1000 - Algorithm differences, additional features GEDVsmart, EVLWsmart The EV1000 algorithm does not use transit time analysis but upslope und downslope of the thermodilution curve to calculate GEDV and EVLW. This approach should enhance accuracy in case of a L-R shunt. No data published yet. 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

  14. PiCCO2 vs. EV1000 - Algorithm differences, additional features Right-to-left heart shunt detection Based on the alternation in the shape of the TD curve (“camel curve”). This is also possible with the PiCCO. In PiCCOplus V7.1 the shunt quantification and correction of CO was available (based on a scientific letter letter by F. Michard) but was not validated.Skipped in PiCCO2 because of not proven clinical relevance and accuracy. ELWIsmart, compensation after lobectomy Clinical studies are necessary to prove validity and accuracy. The few studies on this topic are showing no significant EVLW differences before and after lobectomy. A correction might introduce more errors than improve accuracy.

  15. Integration and interfacing Philips Draeger GE Mindray Spacelabs Nihon Kohden Module available (soon) Parameter connection available

  16. 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 • EV1000 is not even a ME2 device, it offers less than the is the original PiCCO • PiCCO is already widely spread, also as modules for monitors • In the Edwards validation study PiCCO is used as gold standard • Edwards promoters can not anymore argue against PiCCO • Risk for the PiCCO installed base? • - Edwards will avoid liability problems (violation of medical device directives) • - promotion of VolumeView sets at the PiCCO sockets is unlikely, no compatibility • Risk of price war? • - EV1000 is a major investment for Edwards and ROI needs to be achieved

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