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PULSION Medical Systems AG

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

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  1. PULSION Medical Systems AG PiCCO2 vs. Edwards EV1000

  2. 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!

  3. EV 1000 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 NitinolGuidewire “Fancy” guidewire dispensor Suture Kit Scalpel 5F20cm 4F16cm 3pin PA 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 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

  14. “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

  15. 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

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

  17. 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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