Terumo FX05 evaluation in clincal setting, with regard to air handling

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. Skånes 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 Krokström
• Thomas Hansson
• And all the staff at our unit.