optimizing blood management - terumo cardiovascular systems

A Multi-Strategy Approach to Controlling Inflammatory Response

Optimizing Blood Management TM

Terumo Introduces the Optimizing Blood Management Relationship Browser. For the full interactive experience, visit

www.terumo-cvs.com/optimizingbloodmanagement

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… To a Multi-Strategy Approach for Cardiopulmonary Bypass

For decades, surgeons, anesthesiologists and perfusionists have studied the causes and effects of inflammatory response in attempts to minimize the negative consequences of cardiopulmonary bypass (CPB).

In doing so, they have identified four important blood management strategies to control inflammatory response: • Control hemodilution• Control the blood/foreign surface interface 6 ,7, 8 • Control microemboli 9

• Reduce activated leukocytes

Each of these strategies can be addressed, at least partly, through the conduct of CPB, where the incremental adoption of new technologies and techniques can help reduce the incidence of inflammatory response.

Beyond the Economics of Transfusion…

According to Timothy Hannon, M.D., President and Founder of the blood management consulting firm, Strategic Healthcare Group: “In 2008, everyone was talking about [blood management]. In 2009, everyone wants to do it.1

Indeed, as the cost of donor blood has risen in recent years and supplies have dwindled, interest in reducing blood transfusions has increased substantially. Hospital administrators have been scrutinizing their use of blood products and encouraging clinicians to adopt blood management programs. As an economic issue, blood management has attracted attention outside the clinical community; the topic has been reported on in such far-reaching non-clinical publications as the Wall Street Journal. 2

While much of the renewed attention to blood management may be driven by economic concerns, clinicians have long recognized the clinical benefits associated with minimizing the use of donor blood. Transfusions have been linked to a number of negative outcomes, including the single biggest cause of morbidity and mortality after cardiac surgery – inflammatory response. 3,4,5

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About the Optimizing Blood ManagementTM Relationship Browser

For clinicians interested in reducing blood transfusions, the Optimizing Blood Management Relationship Browser is an interactive exploration of the causes and effects of inflammatory response in cardiac surgery – and how some perfusionists are using Terumo technologies to control it.

It explores relationships between:

Where Product, Protocol and Information Intersect

Terumo has long been an advocate for combining perfusion technology with techniques to achieve optimal clinical results. This is particularly true in a multi-strategy approach to controlling inflammatory response. The perfusion community has at its disposal a myriad of protocols – from retrograde autologous priming to sequestering cardiotomy suction blood and more – that are considered best practice and can be employed in any of these blood management strategies.

Relationships between objects are defined by arrows.

StrategiesBlood management strategies to control inflammatory response that are within the perfusionist’s control

Outcomes Clinical or financial outcomes that are addressed by controlling inflammatory response

Studies Peer reviewed studies in which the authors discuss products or protocols as part of their blood management strategies.Note: The studies’ conclusions about a product represent the authors’ findings and are not necessarily performance claims about the product. Refer to the instructions for use for the intended use of this product.

is addressed by

is referenced by

is associated with

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Features Features of perfusion products that studies have shown to be effective in addressing blood management strategies

Products Products manufactured or distributed by Terumo Cardiovascular Systems that have those features (see Features)

For the full interactive experience, visit www.terumo-cvs.com/optimizingbloodmanagement

Control Hemodilution

Of these four strategies to limit inflammatory response, controlling hemodilution has been attracting the most attention.

In one of the most significant recent publications on the subject, Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery,10 authors for the Society of Thoracic Surgeons (STS) Workforce on Evidence-Based Surgery write, “A great deal is known with regard to blood transfusion risks yet little is known of its benefits.”

The authors cite a number of clinical risks associated with blood transfusion, the most common of which are febrile nonhemolytic transfusion reactions, bacterial infection, leukocyte-related target organ injury, and transfusion-related acute lung injury.

Their evidence-based review of all published literature – that were available at the time of writing – results in a set of guidelines and recommendations that address blood conservation strategies, many of which can be addressed by the perfusionist during the conduct of cardiopulmonary bypass.

Booke, M, et al. Anesth

Analg, 1997.

El-Essawi, A, et al. 2009.

Decrease Hospital

Costs

Decrease blood

transfusions

Gunaydin, S, et al.

Perfusion, 2009.

Gomez, D, et al.

Perfusion, 2009.

Murphy, G, et al.

Circulation, 2007.

Djaiani, G, et al.

Circulation, 2007.

Shulman. et al. JECT,

2000.

Leal-Noval, S, et al.

Chest, 2001.

Ranucci, M, et al. Annals of Thoracic

Surgery, 2008.

Kulat, B, et al. JECT,

2009.

Kutschka, I, et al.

Perfusion, 2009.

Preston T, et al. JECT,

2009.

Ging AL, et al.

Perfusion, 2008.

Control Hemodilution

Reduce ICU/Hosp

LOS

CAPIOX® FX and RX Oxygenators

Terumo® Advanced Perfusion System 1

ROCSafe™ Hybrid Perfusion System with Terumo® Advanced Perfusion System 1

Fresenius C.A.T.S Continuous Auto

Transfusion System

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Terumo Products with Features that

Address Controlling Hemodilution

is addressed by is referenced by is associated withStrategies Features Studies Outcomes

Control Foreign Surface

In a landmark study conducted more than 25 years ago, John Kirklin blamed the heart-lung machine for causing inflammatory response, authoring one of the first studies to associate the blood’s contact with a foreign surface with inflammatory response.11 Other clinicians have since substantiated the association; none have disproven it.

In the decades that followed, clinicians and industry have worked to reduce the inflammatory consequences created by the interface between the blood and foreign surfaces, including air, tubing, membranes, and filter media.

They now consider several techniques that minimize the interface as best practice for CPB, including the careful administration of negative pressure when using vacuum-assisted venous drainage and reducing excessive use of cardiotomy suction.

El-Essawi, A, et al. 2009.

Decrease blood

transfusions

Gunaydin, S, et al.

Perfusion, 2009.

Gomez, D, et al.

Perfusion, 2009.


Surgery, 2009.

Shann, K, etal. J ThoracCardiovascSurg, 2006.

Kulat, B, et al. JECT,

2009.

Ging AL, et al.

Perfusion, 2008.

Control ForeignSurface (CircuitMiniturization)

Reduce Afib

Reduce ICU/Hosp

LOS

CAPIOX® FX Oxygenator with integrated

arterial filter

Terumo® Advanced Perfusion System 1

CAPIOX® RX Oxygenator

ROCSafe™ Hybrid Perfusion System with Terumo® Advanced Perfusion System 1

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Terumo Products with Features that Address

Controlling Foreign Surface


Whether comprised of gas, fat, or other particulate matter, microemboli in the blood can lodge in the capillary beds, contributing to inflammatory response in two ways. The emboli acts as a foreign surface to activate neutrophils, complements, and cytokines in the vascular tissue. In addition, the embolus can strip cells from the endothelial lining, creating leaks and edema in the interstitial space. The ensuing irritation of the endothelial lining initiates an inflammatory response that can ultimately result in an occluded vessel and subsequent organ damage.

Cardiac teams can employ a combination of techniques to reduce microemboli during CPB, including: taking precautions during placement and suturing of venous cannulae12; taking precautions while drawing samples or injecting drugs or other fluids into the circuit9; and isolating cardiotomy suction blood13.

Control Microemboli

6

CAPIOX® FX Oxygenator with integrated

arterial filter

ROCSafe™ Hybrid Perfusion Systemwith Terumo® Advanced Perfusion System 1

Terumo Products with Features that Address

Controlling Microemboli


Pall Leukoguard Arterial Filters

Gomez, D, et al.

Perfusion, 2009.


Surgery, 2008.

Barak, M, et al.

Chest, 2005.

Control Microemboli

Riley, J, JECT, 2008.

Dickinson, T., et al.

JECT, 2006.

Booke, M, et al.

Anesth Analg, 1997.

Djaiani, G, et al.

Circulation, 2007.

Reduce NeurologicalComplications

Reduce Pulmonary Dysfunction

While the cardiac surgery community concurs that activated leukocytes create an inflammatory response, the means to remove them from the extracorporeal circuit remains controversial.

According to the STS Workforces’ Guidelines on Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery, many of the harmful effects of CPB can be traced to leukocyte activation during extracorporeal perfusion.

However the guidelines do not endorse leukocyte filtration to remove activated leukocytes; while the authors cite evidence that the filters are effective in leukocyte removal and evidence that there are a number of beneficial effects associated with the use of the filters, they note that none of these effects consistently translates into clinical benefit. They also note evidence that leukocyte depletion may activate white cells.

Yet, a number of more recent studies have associated the use of leukocyte reducing filters, particularly among higher risk groups, with a reduction in inflammatory response and other clinical benefits, including a reduction in post-operative atrial fibrillation and platelet preservation.

Reduce Leukocytes

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Terumo Products with Features that AddressReducing Leukocytes

is addressed by is referenced by is associated withStrategies Features Studies Outcomes

Pall Leukoguard Arterial Filters

Reduce ICU/Hosp

LOS

Reduce Renal Complications

Reduce Pulmonary

Dysfunction

Decrease Hospital

Costs

Gunaydin, S, et al.

Perfusion, 2007.

Rubino, et al. Ann

Thorac Surg, 2011.

ReduceLeukocytes

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For more information, contact:

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Terumo®, CAPIOX®, XCoating® are registered trademarks of Terumo Corporation.Optimizing Blood Management™, CDI™, ROCSafe™, and Prescriptive Oxygenation™ are trademarks of Terumo Cardiovascular Systems Corporation.Fresenius C.A.T.S is manufactured by Frensenius Kabi and distributed in the United States by Terumo Cardiovascular Systems.Pall LeukoGuard Filters are manufactured by Pall Corporation, and distributed in the United States by Terumo Cardiovascular Systems.© 2011 Terumo Cardiovascular Systems Corporation821591

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1 Hannon, T. Blood Management: “In 2008, Everyone Was Talking About It. In 2009, Everyone Wants To Do It.” www.terumo-cvs.com/optimizing/ Blood_Management_In_2008_everyone_was_ talking_about_it.shtml 2009.

2 Landro, L. Hospitals Seek to Limit Use of Transfusions. Wall Street Journal, Oct 29, 2010.

3 Adams, PT, et al. Detection of Circulating Donor White Blood Cells in Patients Receiving Multiple Transfusions. Blood 1992; 80:551-5.

4 Blumberg, N, et al. Transfusion-Induced Immunomodulation and its Clinical Consequences. Transfus Med Rev 1990; 4:24-35.

5 Muylle, L. The Role of Cytokines in Blood Transfusion Reactions. Blood Rev 1995; 9:77-83.

6 El-Essawi, A, et al. A Prospective Randomised Multicentre Clinical Comparison Of A Minimised Perfusion Circuit Versus Conventional Cardiopulmonary Bypass. Presented at the 23rd Annual Meeting of the European Society of Cardiothoracic Surgery, October, 2009.

7 Gunaydin, S, et al. Clinical Evaluation of Minimized Extracorporeal Circuit in High-Risk Coronary Revascularization: Impact on Air handling, Inflammation, Hemodilution, and Myocardial Function. Perfusion 2009:24; 153.

8 Kutschka, I, et al. Beneficial Effects of Modern Perfusion Concepts in Aortic Valve and Aortic Root Surgery. Perfusion 2009:24; 37.

9 Barak, M, et al. Microbubbles: Pathophysiology and Clinical Implications. Chest 2005:128; 2918-2932.

10 Ferraris, V, Spiess, B, et al. Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery: The Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists Clinical Practice Guideline. Ann Thorac Surg 2007;83:S27-86.

11 Kirklin, JK, et al. Complement and the damaging effects of cardiopulmonary bypass J. Thorac. Cardiovasc. Surg. Jul 1983; 86: 845-857.

12 Borger, M et al. Cerebral Emboli During Cardiopulmonary Bypass: Effect of Perfusionist Intervention and Aortic Cannulae. JECT 2002;34: 29-33.

13 Meyer, G. Post Arterial Filter Gaseous Microemboli Activity of Four Integrated Cardiotomy Reservoirs During Venting: An In vitro Study. JECT 2009;41:20-27.

14 Stump, D. Triad of Organ Protection. Heart Surgery Forum Reviews 4;2 7-12.

Barak, M, et al. Microbubbles: Pathophysiology and Clinical Implications. Chest 2005. 128: 2918-2932.

Booke, M, et al. Fat elimination during intraoperative autotransfusion: an in vitro investigation. Anesth Analg. 1997. 85: 959-62.

Dickinson, T. In vitro evaluation of the air separation ability of four cardiovascular manufacturer extracorpo-real circuit designs. JECT: 2006; 38:206-213.

Djaiani, G, et al. Continuous-Flow Cell Saver Reduces Cognitive Decline in Elderly Patients After Coronary Bypass Surgery. Circulation. 2007; 116:1888-1895.

El-Essawi, A, et al. A Prospective Randomised Multicentre Clinical Comparison of A Minimised Perfusion Circuit (ROCSafeRX) Versus Conventional Cardiopulmonary Bypass. Eur J Cardiothorac Surg. 2010. 38:91-97.

Ging, AL, et al. Bloodless cardiac surgery and the pediatric patient: a case study. Perfusion. 2008; 23:131-134.

Gomez, D. Evaluation of air handling in a new generation neonatal oxygenator with integral arterial filter. Perfusion 2009; 24: 107-112.

Gunaydin, S. Clinical effects of leukofiltration and surface modification on post-cardiopulmonary bypass atrial fibrillation in different risk cohorts. Perfusion 2007; 22:279-288.

Gunaydin, S. Clinical evaluation of minimized extracorporeal circulation in high risk coronary revascularization: impact on air handling, inflammation, hemodilution and myocardial function. Perfusion 2009. 24(3) 153-162.

Kulat, B, et al. Optimizing Circuit Design Using a Remote-mounted Perfusion System. JECT. 2009; 41:28-31.

Kutschka, I, et al. Beneficial effects of modern perfusion concepts in aortic valve and aortic root surgery. Perfusion. 2009; 24: 37-44.

Leal-Noval, S, et al. Transfusion of Blood Components and Post Operative Infection in Patients Undergoing Cardiac Surgery. Chest. 2001. 119: 1461-1468.

Murphy, G, et al. Increased Mortality, Postoperative Morbidity, and Cost After Red Blood Cell Transfusion in Patients Having Cardiac Surgery. Circulation. 2007. 116: 2544-2552.

Preston, T, et al. Clinical Gaseous Microemboli Assessment of an Oxygenator with Integral Arterial Filter in the Pediatric Population. JECT. 2009; 41: 226-230.

Ranucci, M, et al. Body Size, Gender and Transfusion as Determinants of Outcome After Coronary Operations. Annals of Thoracic Surgery. 2008. 85: 481-486.

Ranucci, M, et al. A Systemic Review of Biocompatible Cardiopulmonary Bypass Circuits and Clinical Outcome. Annals of Thoracic Surgery. 2009. 87: 1311-1319.

Riley, J. Arterial line filters ranked for gaseous micro-emboli separation performance: an in vitro study. JECT. 2008; 40:21-26

Rubino, A, et al. Leukocyte Depletion During Extracorporeal Circulation Allows Better Organ Protection But Does Not Change Hospital Outcomes. Ann Thorac Surg. 2011. 91: 534-540.

Shann, K, et al. An Evidence Based Review of the Practice of Cardiopulmonary Bypass in Adults: A Focus on Neurologic Injury, Glycemic Control, Hemodilution and the Inflammatory Response. Journal of Thoracic and Cardiovascular Surgery. 2006. 132: 283-290.

Shulman, et al. Quality of Processed Blood in Autotransfusion. JECT. 32 (1), March 2000.

Studies Referenced in the Optimizing Blood Management Relationship Browser

References

optimizing blood management - terumo cardiovascular systems

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