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Clinical evaluation of Fx 05 with regard to GME handling Marx Runge Peadiatric Perfusion Division Lund, Sweden

Gme milano 2014,1

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1. Clinical evaluation of Fx 05 with regard to GME handling Marx Runge Peadiatric Perfusion Division Lund, Sweden 2. Disclosure Terumo Europe has arranged my travel here and covered the expenses. The GAMPT BCC 200 which we have used in this evaluation was made available to us by Terumo Europe 3. Sknes University hospital, Lund 4. Children's hospital, cardiac One of two centers in the country, with a population of about 10 million All cardiac surgery patients up to 18 years 271 cardiac procedures in 2013, 218 on pump Full VAD program ECMO, Berlin heart, Heartware Heart transplantation 5. Background Depend on how you classify, up to 50% of pediatric cardiac patients suffer some sort of neurological deficit after surgery, (Chen J et all 2009) There are many contributing factors Gaseous micro emboli are considered to have a major impact on patient outcome (Barak M et all 2005) 6. From out of the blue? Perfusionist interventions (Ruth L et all 1999) Low level reservoir operation (Nielsen PF et all 2008) Anesthesia Venous line air Temperature gradients (Geissler HJ et all 1997) Suction and venting Equipment design (LaPietra et al, 2000) 7. Muth C M, New England Journal of Medicine,2000 - 8. Bubbles are trouble Mechanical damage of Endothelial fluid leakage Complement activation-C3 and C5 rise, histamine release Inflammatory response End organ ischemia Reperfusion injury Cognitive impairment 9. Methods 20 Patients < 8 kg First time, elective cardiac surgery Gampt BCC 200 messurement points before and after the oxygenator Purgeline open at all times Sampleline returns to venous reservoir Perfusion/anesthesia and surgery were performed according to local protocol 10. Set up 11. Demographic data 12. Screenshot after a AVSD 13. Screenshot after a AVSD 14. Results GME Number Median Range % Mean ( SD) Number V 282799,5 (16416-849595) Number A 23171 (817-145040) Reduction 87,29 ( 6,9) 15. GME No 0 100000 200000 300000 400000 500000 600000 700000 800000 900000 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 % Reduction Mean 87,3 SD 6,9 16. Results GME Volumen Median Range % Mean ( SD) Volumen V 659,6 (4,9-3080) Volumen A 0,23 (0,013-3,8) Reduction 99,8 ( 0,1) 17. GME Vol 0 500 1000 1500 2000 2500 3000 3500 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 % Reduction Mean 99,8 SD 0,1 18. In sumary Bobbles are trouble, but how many ? When some is bad the goal must be to eliminate as much as possible This is a common road, for perfusion, surgeon and anesthesia Future research should aim at identifying the threshold for what that is tolerated 19. In summary The Fx 05 eliminate almost all air Others have showed have samme(Lin J,et all) The GAMPHT BCC200 is a useful tool for research and product evaluation 20. Sustainability 21. Thanks to my colleagues Ann katrin Krokstrm Thomas Hansson And all the staff at our unit.