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 PopulationBen Swanson, MPS, CCPStaff PerfusionistAssociate ProfessorUniversity of Kansas HospitalCenter for Advanced Heart Care
2 DisclosureI do not have a financial relationship with Terumo Cardiovascular SystemsThe University of Kanas does not have a financial relationship nor partnership with Terumo Cardiovascular
3 Center for Advanced Heart Care Ranked 39th in U.S. News and World Reports for Heart CareAverage 600 Heart cases per yearStarted blood management program in 2009Clinical affiliate for the University of Nebraska Medical Center’s Clinical Perfusion Education Program.KCK, program was re-established about 10 years ago. Blood management program started in 2009, Min-invasive MVR, Per AVR
4 Position on Blood Management Building an organization for “good success” means creating a culture that will live on through succeeding generationTony Dungy
5 Position on Blood Management This is one part of blood managementWithout 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 pediatricsReduced prime volume for patient with low body weightIntergraded arterial filter allows even lower prime and surface areaTerumo FX15 and FX25
8 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 cm2Blood inlet pressure 1000 mmHg maxHeat-exchanger surface area .14 m2
9 Specifications FX25 Bundle fiber surface area 2.5 m2 Prime 260 mL, Maximum Flow 7.0 L/min.,Integrated 32 micron Arterial FilterSurface Area 600 cm2Blood inlet pressure 1000 mmHg maxHeat-exchanger surface area .2 m2Preferred in DCHA cases
10 Clinical Significance The 2011 level (1A) recommendations from the Society of Thoracic Surgeons (STS)1Reduce prime volume and surface areaIdentify high risk patients / prepare accordinglyPrevious 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 21. 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;91:944-822. 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 CPBStroke, 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 for242 cases requiring CPB with accordance to institutional protocolIsolated CABG, AVR, MVREfficacy in primingGas exchangeOxygen deliveryPatient selection bias for either FX unit.Blood conservationAll blood productsStrait forward CABG, same as STS data collection
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 establishedSamplesJust prior to initiation of CPBtaken approx. 5-8 min post initiation of CPBAfter initial dose of cardioplegiai-stat blood gas POC devicePerfusion parameters had been optimized
31 Discussion The FX series was remarkably efficient in priming Absence of CO2 flushing andDe-airing of an arterial line filterThe effect of the integral arterial filter on ventilation and gas exchange was minimalOptimal PCO2 levels were achieved at sweep ratios between of .8-1Comparable PO2 levels at 100% FIO2.Early issues with FX 25 unitRecommended to prime a 4-5 L/min with all shunts open to easily remove air from the integrated unit
32 DiscussionMarkedly, the FX15 performed optimally above and at the limit of its manufacturer’s recommended flow ratesRendering 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 mostconstraining factor when it came to patient selectionAgeComplexity 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.
34 SummaryDecreased prime volumes increased on pump Hct respectively in FX15 and FX25 unitsHowever, more pronounced in smaller patientsDecrease in blood usage in isolated CABG’s for all 2010 when compared to 2009Marketable decrease in blood usage in isolated valve proceduresAVR intra-op/post-op MVR intra-op/post-opSpecific to time in pump run, more of a trended increase than a certain number
35 Concerns / Future Directions Hard to distinct reduction in prime is the sole reason for reduced blood product usage, without randomized prospective studyHowever, data does suggest that It most likely contributedImprovements in decreased morbidity and mortality are still being investigatedOrdering issuesNot just one type, try not to run out of 25s
36 ConclusionTerumo® 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 areaThus, have the potential to reduce of blood transfusions intra and post operativelyEspecially in patients under 65 kg
37 Special Thanks University of Kansas Perfusion Staff Carrie Kilgore, STS database coordinatorAmSECTThey made it all work
38 Thank YouQuestions?Feel free to contact me anytime