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A Clinical Evaluation of Terumo’s Prescriptive Oxygenation™ Series Capiox® FX15 and FX25 Hollow Fiber oxygenators with Integrated Arterial Filter in the.

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Presentation on theme: "A Clinical Evaluation of Terumo’s Prescriptive Oxygenation™ Series Capiox® FX15 and FX25 Hollow Fiber oxygenators with Integrated Arterial Filter in the."— Presentation transcript:

1 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, CCP Staff Perfusionist Associate Professor University of Kansas Hospital Center for Advanced Heart Care

2 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

3 Center for Advanced Heart Care Ranked 39 th 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.

4 Position on Blood Management Building an organization for “good success” means creating a culture that will live on through succeeding generation »Tony Dungy

5 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

6 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?

7 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

8 Specifications FX15 R40 –Bundle fiber surface area 1.5 m 2 –Prime 144 mL, Maximum Flow 5.0 L/min., –Integrated Arterial 32 micron filter, Surface Area 360 cm 2 –Blood inlet pressure 1000 mmHg max –Heat-exchanger surface area.14 m 2

9 Specifications FX25 –Bundle fiber surface area 2.5 m 2 –Prime 260 mL, Maximum Flow 7.0 L/min., –Integrated 32 micron Arterial Filter Surface Area 600 cm 2 –Blood inlet pressure 1000 mmHg max –Heat-exchanger surface area.2 m 2 Preferred in DCHA cases

10 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 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg 2011;91: 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:

11 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.

12 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

13 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

14 Why not only Red Cells Reduction in surface area Effect of hemodilution on coagulation

15 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

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31 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

32 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

33 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) m 2, 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.

34 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

35 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

36 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

37 Special Thanks University of Kansas Perfusion Staff Carrie Kilgore, STS database coordinator AmSECT

38 Thank You Questions?


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