A Clinical Evaluation of Terumo’s Prescriptive Oxygenation™ Series Capiox® FX15 and FX25

Hollow Fiber oxygenators with Integrated Arterial Filter in the Adult Population

Ben Swanson, MPS, CCPStaff PerfusionistAssociate ProfessorUniversity of Kansas HospitalCenter for Advanced Heart Care

Disclosure

• I do not have a financial relationship with Terumo Cardiovascular Systems

• The University of Kanas does not have a financial relationship nor partnership with Terumo Cardiovascular

Center for Advanced Heart Care

• Ranked 39th in U.S. News and World Reports for Heart Care

• Average 600 Heart cases per year• Started blood management program in

2009• Clinical affiliate for the University of

Nebraska Medical Center’s Clinical Perfusion Education Program.

Position on Blood Management

Building an organization for “good success” means creating a culture that will live on through succeeding generation

» Tony Dungy

Position on Blood Management

• This is one part of blood management

• Without all parts of a multidisciplinary program working, reducing prime volume is a mood point

Purpose

• Evaluate device and system– Is it a cost effective alternative?– Should we continue to use it?– Will it work? – What effect if any will it have on blood product

usage?

Prescriptive Oxygenation

• Being able to match oxygenator to patient, similar to pediatrics– Reduced prime volume for patient with low

body weight• Intergraded arterial filter allows even

lower prime and surface area• Terumo FX15 and FX25

Specifications

• FX15 R40 – Bundle fiber surface area 1.5 m2

– Prime 144 mL, Maximum Flow 5.0 L/min.,– Integrated Arterial 32 micron filter,

• Surface Area 360 cm2

– Blood inlet pressure 1000 mmHg max– Heat-exchanger surface area .14 m2

Specifications

• FX25 – Bundle fiber surface area 2.5 m2

– Prime 260 mL, Maximum Flow 7.0 L/min.,– Integrated 32 micron Arterial Filter

• Surface Area 600 cm2

– Blood inlet pressure 1000 mmHg max– Heat-exchanger surface area .2 m2

• Preferred in DCHA cases

Clinical Significance

• The 2011 level (1A) recommendations from the Society of Thoracic Surgeons (STS)1

– Reduce prime volume and surface area– Identify high risk patients / prepare accordingly

• Previous studies have determined that a reduction in surface area–priming volume of the CPB circuit reduces the frequency of low HCT values and subsequently reduces the incidence of allogeneic blood transfusions 2

• 1. Frerraris, et al. 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg 2011;91:944-82

• 2. Shann, et al. Focus on neurologic injury, glycemic control, hemodilution, and the inflammatory An evidence-based review of the practice of cardiopulmonary bypass in adults: J Thorac Cardiovasc Surg 2006;132:283-290

Clinical Significance

• DeFoe and colleagues reported results from a multicenter study of 6980 patients undergoing isolated CABG surgery.

• Patients experiencing a single HCT value of 19% or less during CPB had more than twice the mortality as patients with a nadir HCT value of 25%.

• Furthermore, the lowest HCT value during CPB was significantly associated with increased intraoperative or postoperative placement of an intra-aortic balloon pump and return to CPB after attempted separation.

– DeFoe GR, Ross CS, Olmstead EM, et al. Lowest hematocrit on bypass and adverse outcomes associated with coronary artery bypass grafting. Ann Thorac Surg 2001;71:769 –76.

Clinical Significance

• Habib et al. retrospectively analyzed 5000 patients undergoing cardiac operations with CPB

• Stroke, myocardial infarction, low cardiac output, cardiac arrest, renal failure, prolonged ventilation, pulmonary edema, reoperation caused by bleeding, sepsis, and multi-organ failure were all significantly and systematically increased as the lowest HCT value decreased to less than 22%.– Adverse effects of low hematocrit during cardiopulmonary bypass in the adult: should current

practice be changed? J Thorac Cardiovasc Surg 2003;125:1438 –50.

• Karkouti et al. analyzed 9080 consecutive patients undergoing cardiac operations with CPB and found an independent and nonlinear relationship between the nadir HCT value during CPB and acute renal failure, necessitating dialysis support.

• Nadir hematocrit concentration <21%– The Journal of Thoracic and Cardiovascular Surgery Volume 129, Number 2 391

Study Design and Methods

• This was a clinical, non-randomized retrospective evaluation of the Terumo® Capiox® FX15 and FX25 series oxygenators for – 242 cases requiring CPB with accordance to

institutional protocol– Isolated CABG, AVR, MVR – Efficacy in priming – Gas exchange – Oxygen delivery – Patient selection bias for either FX unit. – Blood conservation

• All blood products

Why not only Red Cells• Reduction in

surface area

• Effect of hemodilution on coagulation

Methods

• Normothermia maintained on bypass• Appropriate perfusion adequacy

parameters were established• Samples

– Just prior to initiation of CPB– taken approx. 5-8 min post initiation of CPB– After initial dose of cardioplegia– i-stat blood gas POC device– Perfusion parameters had been optimized

FX15 Age Female Male FX25 Age Female Male0

20

40

60

80

100

120

140

140.0

64.2

48.0

92.0

122.0

60.3

18.0

104.0

12.3 11.4

FX Series Demographics

Average Std Dev

FX15 FX25 FX25<2.0 P Value0

10

20

30

40

50

60

70

80

64.04 60.38 56.47

11.7011.44

8.54

0.630.63

0.02

Age Specification between FX Series

Average Std Dev P value

BSA m2 Q L/min C.I. L/

min/m²

BSA m2 Q L/min C.I. L/

min/m²FX15 FX25

0

1

2

3

4

5

6

1.92

4.55

2.37 2.27

5.11

2.26

0.21

0.56

0.21 0.26

0.66

0.25

FX Series Bypass Demographics

Average Std Dex

38.5 39 39.5 40 40.5 41 41.50

0.2

0.4

0.6

0.8

1

1.2

Optimal Sweep Settings

PCO2 mmHg

Gas /

Blo

od

flow

R

ati

o

VO

2 O

2/m

in-m

2

DO

2 O

2/m

in-m

2

VO

2 O

2/m

in-m

2

DO

2 O

2/m

in-m

2

FX15 FX25

0

200

400

600

800

109.94

555.42

133.44

667.58

29.5

128.4

33.8

135.0

Oxygen consumption and Delivery

Average Std Dev

O2ER O2ER O2ERFX15 FX25 FX15 Q> 5 L/min

0.00

0.05

0.10

0.15

0.20

0.25

0.20 0.20 0.20

0.04 0.04 0.03

Oxygen Extraction Ratio

Average Std Dev

Pre Hct Post HCt FX15 PostHct RX 25 Percent Chg (Hct)

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

35.4%

26.6%

22.0%

24.0%5.30%

4.26%

4.00%6.00%

Effect of Prime Reduction FX15 all Patients(400ml)

Average Std Dev

Pre Hct Post HCt FX15 Post Hct RX25 % Chg in Hct0%

5%

10%

15%

20%

25%

30%

35%

40%

32.9%

23.5%

17.7%

32.7%

3.3%

3.3%

2.7%

3.5%

Estimated Trend in Prime Reduction FX15 Patients Under 65 kg

(400ml)

Average Std Dev

Pre Hct Post HCt FX15 PostHct RX 25 Percent Chg (Hct)

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%36.6%

28.4%

24.0%

18.7%

5.0%

4.1%

3.7%

3.9%

Effect of Prime Reduction FX25 (300ml)

Series1 Series2

2008 2009 Jan-Jun 2010

2010 2010 2010

KUMed Like STS

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0% 34.5%

19.4%15.4% 14.2%

33.4%36.6%

Intraop Blood Products UsedIsolated CABG only

Perc

en

tag

e o

f P

ati

en

ts

FY 2008 FY 2009 Jan-Jun 2010

FY 2010 FY 2010 FY 2010

KUMed Like STS

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%56.7%

39.1% 37.8%

28.7%

53.2%56.4%

Intaop/Postop Blood Products UsedIsolated CABG

Perc

en

tag

e o

f P

ati

en

ts

FY 2008 FY 2009 Jan-Jun 2010

FY 2010 FY 2010 FY 2010

KUMed Like STS

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

50.0%46.9%

30.3%

25.0%

13.6%

45.5% 47.0%

Intraop Blood Products UsedAVR

Perc

en

tag

e o

f P

ati

en

ts

FY 2008 FY 2009 Jan-Jun 2010

FY 2010 FY 2010 FY 2010

KUMed Like STS

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0% 53.1%

42.4%

31.3%

25.0%

49.4% 47.8%

Postop Blood Products UsedAVR

Perc

en

tag

e o

f P

ati

en

ts

FY 2008 FY 2009 Jan-Jun 2010

FY 2010 FY 2010 FY 2010

KUMed Like STS

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

50.0%

20.0%

80.0%

44.4%

58.0%61.0%

Intraop Blood Products UsedMVR

Perc

en

tag

e o

f P

ati

en

ts

FY 2008 FY 2009 Jan-Jun 2010

FY 2010 FY 2010 FY 2010

KUMed Like STS

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

50.0%

20.0%

80.0%

44.0%

61.0% 58.9%

Postop Blood Products UsedMVR

Perc

en

tag

e o

f P

ati

en

ts

Discussion

• The FX series was remarkably efficient in priming – Absence of CO2 flushing and – De-airing of an arterial line filter

• The effect of the integral arterial filter on ventilation and gas exchange was minimal

• Optimal PCO2 levels were achieved at sweep ratios between of .8-1

• Comparable PO2 levels at 100% FIO2.– Early issues with FX 25 unit

Discussion

• Markedly, the FX15 performed optimally above and at the limit of its manufacturer’s recommended flow rates

• Rendering it the preferred oxygenator of choice even in larger patients that we may have previously used a FX25 when considering the reduction in prime

Discussion

• Selection Bias– Decidedly, body surface area (BSA) was the most – constraining factor when it came to patient selection– Age – Complexity of surgery and sex. – However, in borderline patients, BSA 2.0(±.2) m2, a reverse

relationship between BSA and age was observed, based on metabolic demands, advanced aged patients trended towards the FX15 while the FX25 was preferred for younger patients.

Summary

• Decreased prime volumes increased on pump Hct respectively in FX15 and FX25 units– However, more pronounced in smaller patients

• Decrease in blood usage in isolated CABG’s for all 2010 when compared to 2009

• Marketable decrease in blood usage in isolated valve procedures– AVR intra-op/post-op MVR intra-op/post-op

Concerns / Future Directions

• Hard to distinct reduction in prime is the sole reason for reduced blood product usage, without randomized prospective study– However, data does suggest that It most likely

contributed • Improvements in decreased

morbidity and mortality are still being investigated

• Ordering issues

Conclusion

• Terumo® Capiox® FX15 and FX25 series oxygenators are extremely safe and effective adjuncts to our previous system, and are able to reduce prime volume and surface area

• Thus, have the potential to reduce of blood transfusions intra and post operatively– Especially in patients under 65 kg

Special Thanks

• University of Kansas Perfusion Staff• Carrie Kilgore, STS database

coordinator• AmSECT

Thank You

• Questions?

• bswanson@kumc.edu