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Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population

Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population

Gregory S Matte ccp Lp FppCo-ChiefClinical Coordinator for PerfusionBoston Childrenrsquos HospitalBoston MA USA

Copyright copy 2015 by John Wiley amp Sons Inc All rights reserved

Published by John Wiley amp Sons Inc Hoboken New JerseyPublished simultaneously in Canada

No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise except as permitted under Section 107 or 108 of the 1976 United States Copyright Act without either the prior written permission of the Publisher or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center Inc 222 Rosewood Drive Danvers MA 01923 (978) 750-8400 fax (978) 750-4470 or on the web at wwwcopyrightcom Requests to the Publisher for permission should be addressed to the Permissions Department John Wiley amp Sons Inc 111 River Street Hoboken NJ07030 (201) 748-6011 fax (201) 748-6008 or online at httpwwwwileycomgopermissions

The contents of this work are intended to further general scientific research understanding and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method diagnosis or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research equipment modifications changes in governmental regulations and the constant flow of information relating to the use of medicines equipment and devices the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine equipment or device for among other things any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation andor a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom

For general information on our other products and services or for technical support please contact our Customer Care Department within the United States at (800) 762-2974 outside the United States at (317) 572-3993 or fax (317) 572-4002

Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products visit our web site at wwwwileycom

Library of Congress Cataloging-in-Publication DataMatte Gregory S author Perfusion for congenital heart surgery notes on cardiopulmonary bypass for a complex patient population Gregory S Matte p cm Includes bibliographical references and index ISBN 978-1-118-90079-6 (cloth)I Title [DNLM 1 Heart Defects Congenitalndashsurgery 2 Infant 3 Cardiopulmonary Bypassndashinstrumentation 4 Cardiopulmonary Bypassndashmethods 5 Child 6 Perfusionndashmethods WS 290] RD59835C67 6174prime12ndashdc23 201404632610 9 8 7 6 5 4 3 2 1

1 2015

Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population

Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population

Gregory S Matte ccp Lp FppCo-ChiefClinical Coordinator for PerfusionBoston Childrenrsquos HospitalBoston MA USA

Copyright copy 2015 by John Wiley amp Sons Inc All rights reserved

Published by John Wiley amp Sons Inc Hoboken New JerseyPublished simultaneously in Canada

No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise except as permitted under Section 107 or 108 of the 1976 United States Copyright Act without either the prior written permission of the Publisher or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center Inc 222 Rosewood Drive Danvers MA 01923 (978) 750-8400 fax (978) 750-4470 or on the web at wwwcopyrightcom Requests to the Publisher for permission should be addressed to the Permissions Department John Wiley amp Sons Inc 111 River Street Hoboken NJ07030 (201) 748-6011 fax (201) 748-6008 or online at httpwwwwileycomgopermissions

The contents of this work are intended to further general scientific research understanding and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method diagnosis or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research equipment modifications changes in governmental regulations and the constant flow of information relating to the use of medicines equipment and devices the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine equipment or device for among other things any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation andor a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom

For general information on our other products and services or for technical support please contact our Customer Care Department within the United States at (800) 762-2974 outside the United States at (317) 572-3993 or fax (317) 572-4002

Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products visit our web site at wwwwileycom

Library of Congress Cataloging-in-Publication DataMatte Gregory S author Perfusion for congenital heart surgery notes on cardiopulmonary bypass for a complex patient population Gregory S Matte p cm Includes bibliographical references and index ISBN 978-1-118-90079-6 (cloth)I Title [DNLM 1 Heart Defects Congenitalndashsurgery 2 Infant 3 Cardiopulmonary Bypassndashinstrumentation 4 Cardiopulmonary Bypassndashmethods 5 Child 6 Perfusionndashmethods WS 290] RD59835C67 6174prime12ndashdc23 201404632610 9 8 7 6 5 4 3 2 1

1 2015

Perfusion for congenital heart surgeryNotes on cardiopulmonary bypass for a complex patient population

Gregory S Matte ccp Lp FppCo-ChiefClinical Coordinator for PerfusionBoston Childrenrsquos HospitalBoston MA USA

Copyright copy 2015 by John Wiley amp Sons Inc All rights reserved

Published by John Wiley amp Sons Inc Hoboken New JerseyPublished simultaneously in Canada

No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise except as permitted under Section 107 or 108 of the 1976 United States Copyright Act without either the prior written permission of the Publisher or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center Inc 222 Rosewood Drive Danvers MA 01923 (978) 750-8400 fax (978) 750-4470 or on the web at wwwcopyrightcom Requests to the Publisher for permission should be addressed to the Permissions Department John Wiley amp Sons Inc 111 River Street Hoboken NJ07030 (201) 748-6011 fax (201) 748-6008 or online at httpwwwwileycomgopermissions

The contents of this work are intended to further general scientific research understanding and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method diagnosis or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research equipment modifications changes in governmental regulations and the constant flow of information relating to the use of medicines equipment and devices the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine equipment or device for among other things any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation andor a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom

For general information on our other products and services or for technical support please contact our Customer Care Department within the United States at (800) 762-2974 outside the United States at (317) 572-3993 or fax (317) 572-4002

Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products visit our web site at wwwwileycom

Library of Congress Cataloging-in-Publication DataMatte Gregory S author Perfusion for congenital heart surgery notes on cardiopulmonary bypass for a complex patient population Gregory S Matte p cm Includes bibliographical references and index ISBN 978-1-118-90079-6 (cloth)I Title [DNLM 1 Heart Defects Congenitalndashsurgery 2 Infant 3 Cardiopulmonary Bypassndashinstrumentation 4 Cardiopulmonary Bypassndashmethods 5 Child 6 Perfusionndashmethods WS 290] RD59835C67 6174prime12ndashdc23 201404632610 9 8 7 6 5 4 3 2 1

1 2015

Copyright copy 2015 by John Wiley amp Sons Inc All rights reserved

Published by John Wiley amp Sons Inc Hoboken New JerseyPublished simultaneously in Canada

No part of this publication may be reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying recording scanning or otherwise except as permitted under Section 107 or 108 of the 1976 United States Copyright Act without either the prior written permission of the Publisher or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center Inc 222 Rosewood Drive Danvers MA 01923 (978) 750-8400 fax (978) 750-4470 or on the web at wwwcopyrightcom Requests to the Publisher for permission should be addressed to the Permissions Department John Wiley amp Sons Inc 111 River Street Hoboken NJ07030 (201) 748-6011 fax (201) 748-6008 or online at httpwwwwileycomgopermissions

The contents of this work are intended to further general scientific research understanding and discussion only and are not intended and should not be relied upon as recommending or promoting a specific method diagnosis or treatment by health science practitioners for any particular patient The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties including without limitation any implied warranties of fitness for a particular purpose In view of ongoing research equipment modifications changes in governmental regulations and the constant flow of information relating to the use of medicines equipment and devices the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine equipment or device for among other things any changes in the instructions or indication of usage and for added warnings and precautions Readers should consult with a specialist where appropriate The fact that an organization or Website is referred to in this work as a citation andor a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make Further readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read No warranty may be created or extended by any promotional statements for this work Neither the publisher nor the author shall be liable for any damages arising herefrom

For general information on our other products and services or for technical support please contact our Customer Care Department within the United States at (800) 762-2974 outside the United States at (317) 572-3993 or fax (317) 572-4002

Wiley also publishes its books in a variety of electronic formats Some content that appears in print may not be available in electronic formats For more information about Wiley products visit our web site at wwwwileycom

Library of Congress Cataloging-in-Publication DataMatte Gregory S author Perfusion for congenital heart surgery notes on cardiopulmonary bypass for a complex patient population Gregory S Matte p cm Includes bibliographical references and index ISBN 978-1-118-90079-6 (cloth)I Title [DNLM 1 Heart Defects Congenitalndashsurgery 2 Infant 3 Cardiopulmonary Bypassndashinstrumentation 4 Cardiopulmonary Bypassndashmethods 5 Child 6 Perfusionndashmethods WS 290] RD59835C67 6174prime12ndashdc23 201404632610 9 8 7 6 5 4 3 2 1

1 2015

To Bridget Nicholas and Justin for their love support and regular reminders that we are all lifelong students

vii

Foreword x

Preface xi

Acknowledgments xii

1 Equipment for bypass 1Oxygenators 1Arterial line filters 12Tubing packs 13Cardioplegia systems 16The heartndashlung machine 17The heater-cooler system 19Cannulae 20

2 Priming the bypass circuit 27Prime constituents 27Steps for priming 28

3 The bypass plan 33Communication agreement for case 33Anticoagulation management 35Blood gas management 40

Carbon dioxide management 40Oxygenation strategy 42

Hematocrit management 45Blood pressure management 47Temperature management 49Flow rates regional perfusion and hypothermic circulatory arrest 52Methods of ultrafiltration 55

Before bypass 55On bypass 55After bypass 56

SMUF specifications 59Standard and augmented venous return 60

Standard venous return with gravity siphon drainage 60Augmented venous return 60

The prebypass checklist 63The surgical safety checklist for congenital heart surgery 65

4 Typical phases of cardiopulmonary bypass 72Commencement of bypass 72Standard support phase of bypass 74Termination of bypass 76Post bypass 78

5 Additional notes based on bypass tasks 79Prebypass 79

Heartndashlung machine (HLM) 79Reoperations 79Cannulation 79Transfusion during cannulation 80

On bypass 80Verification of adequate drainage when caval tapes are used 80Blood gas management 80Cardioplegia delivery 81Planned circulatory arrest 81Induced ventricular fibrillation 82Administration of blood products 82Atrial line placement 82LV vent placement 83Bed rotation during bypass 83

6 Bypass considerations based on diagnosis 85Anomalous coronary arteries 86Aortic regurgitationinsufficiency 89Aortic stenosis 91Aortopulmonary collaterals 93Aortopulmonary window 95Atrial septal defect 96Cardiomyopathy requiring orthotopic heart transplantation 99

Contents

viii Contents

Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114

Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119

Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129

Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130

Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146

7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152

Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161

8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171

9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176

Contents ix

Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178

Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179

10 Abbreviations for congenital heart surgery 180

11 Recommended reference books 186

12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187

Index 190

x

The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself

There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an

essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients

James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School

Chief Division of Cardiac Anesthesia

Francis X McGowan Jr MDChair in Cardiac Anesthesia

Boston Childrenrsquos Hospital

Foreword

xi

Preface

There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run

The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most

common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings

Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass

Gregory S Matte CCP LP FPP

Disclaimer

Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk

xii

Acknowledgments

A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago

I am also deeply indebted to the following individuals who provided feedback regarding the content of this book

andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers

Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc

1

The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass

Oxygenators

The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system

The oxygenator membranebull Membrane oxygenators allow for diffusion of gas

oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)

bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates

bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity

bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions

bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion

bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended

bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection

bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas

Equipment for bypassChapTEr 1

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

vii

Foreword x

Preface xi

Acknowledgments xii

1 Equipment for bypass 1Oxygenators 1Arterial line filters 12Tubing packs 13Cardioplegia systems 16The heartndashlung machine 17The heater-cooler system 19Cannulae 20

2 Priming the bypass circuit 27Prime constituents 27Steps for priming 28

3 The bypass plan 33Communication agreement for case 33Anticoagulation management 35Blood gas management 40

Carbon dioxide management 40Oxygenation strategy 42

Hematocrit management 45Blood pressure management 47Temperature management 49Flow rates regional perfusion and hypothermic circulatory arrest 52Methods of ultrafiltration 55

Before bypass 55On bypass 55After bypass 56

SMUF specifications 59Standard and augmented venous return 60

Standard venous return with gravity siphon drainage 60Augmented venous return 60

The prebypass checklist 63The surgical safety checklist for congenital heart surgery 65

4 Typical phases of cardiopulmonary bypass 72Commencement of bypass 72Standard support phase of bypass 74Termination of bypass 76Post bypass 78

5 Additional notes based on bypass tasks 79Prebypass 79

Heartndashlung machine (HLM) 79Reoperations 79Cannulation 79Transfusion during cannulation 80

On bypass 80Verification of adequate drainage when caval tapes are used 80Blood gas management 80Cardioplegia delivery 81Planned circulatory arrest 81Induced ventricular fibrillation 82Administration of blood products 82Atrial line placement 82LV vent placement 83Bed rotation during bypass 83

6 Bypass considerations based on diagnosis 85Anomalous coronary arteries 86Aortic regurgitationinsufficiency 89Aortic stenosis 91Aortopulmonary collaterals 93Aortopulmonary window 95Atrial septal defect 96Cardiomyopathy requiring orthotopic heart transplantation 99

Contents

viii Contents

Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114

Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119

Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129

Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130

Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146

7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152

Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161

8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171

9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176

Contents ix

Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178

Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179

10 Abbreviations for congenital heart surgery 180

11 Recommended reference books 186

12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187

Index 190

x

The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself

There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an

essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients

James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School

Chief Division of Cardiac Anesthesia

Francis X McGowan Jr MDChair in Cardiac Anesthesia

Boston Childrenrsquos Hospital

Foreword

xi

Preface

There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run

The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most

common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings

Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass

Gregory S Matte CCP LP FPP

Disclaimer

Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk

xii

Acknowledgments

A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago

I am also deeply indebted to the following individuals who provided feedback regarding the content of this book

andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers

Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc

1

The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass

Oxygenators

The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system

The oxygenator membranebull Membrane oxygenators allow for diffusion of gas

oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)

bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates

bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity

bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions

bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion

bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended

bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection

bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas

Equipment for bypassChapTEr 1

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

viii Contents

Coarctation of the aorta 100Common atrioventricular canal defect 102Cor triatriatum 104Corrected transposition of the great arteries (L-TGA Levo-TGA or C-TGA) or congenitally corrected TGA 105Critical aortic stenosis 107Double chambered right ventricle 109Double inlet left ventricle 110Double outlet left ventricle 111Double outlet right ventricle 112Ebsteinrsquos anomaly 113Hypoplastic left heart syndrome 114

Stage 1 (Norwood) procedure 115Hybrid stage 1 palliation 117Stage 2 or bidirectional Glenn shunt 117Fontan procedure (total cavopulmonary anastomosis) 119

Interrupted aortic arch 121Left superior vena cava 123Lung transplantation 124Mitral regurgitationinsufficiency 125Mitral stenosis 126Patent ductus arteriosus 127Pulmonary artery abnormalities 128Pulmonary atresia 129

Pulmonary atresia with an intact ventricular septum 129Pulmonary atresia with ventricular septal defect 130

Pulmonary regurgitationinsufficiency 132Pulmonary stenosis 133Pulmonary vein stenosis or pulmonary venous obstruction 134Tetralogy of Fallot 136Total anomalous pulmonary venous return and partial anomalous pulmonary venous return 138d-Transposition of the great arteries 140Tricuspid atresia 142Tricuspid regurgitationinsufficiency 143Truncus arteriosus 144Ventricular septal defect 146

7 Notes on select issues during bypass 148Blood pressure higher than expected 148Blood pressure lower than expected 149Bypass circuit pressure higher than expected 151Bypass circuit pressure lower than expected 152

Central venous pressure elevated 153Heat exchange issue (slow cooling or warming) 154NIRS values lower than expected 155PaCO2 higher than expected 157PaCO2 lower than expected 159PaO2 lower than expected 160Reservoir volume acutely low 161

8 Notes on select emergency procedures during bypass 163Arterial pump failure (roller head) 164Failure to oxygenate 165Massive air embolization 166Acute aortic dissection at the initiation of bypass 168Venous air lock 169Inadvertent arterial decannulation 170Inadvertent venous decannulation 171

9 Brief overview of named procedures and terms 172Alfieri stitch 172Batista procedure 172Bentall procedure 172Bidirectional Glenn shunt 172BlalockndashHanlon procedure 172BlalockndashTaussig shunt (BTS) 173Brock procedure 173Central shunt 173Cone procedure 173Cox maze procedure 173DamusndashKayendashStansel anastomosis 173Double switch procedure 173Fontan procedure 174Gott shunt 174HemindashFontan procedure 174Holmes heart 174Jatene operation 174Kawasaki disease 174Kawashima procedure 175(Diverticulum of) Kommerell 175Konno procedure 175LeCompte maneuver 175LeCompte procedure 175Manougian procedure 175Marfanrsquos syndrome 175Maze procedure 175Mustard procedure 176

Contents ix

Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178

Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179

10 Abbreviations for congenital heart surgery 180

11 Recommended reference books 186

12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187

Index 190

x

The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself

There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an

essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients

James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School

Chief Division of Cardiac Anesthesia

Francis X McGowan Jr MDChair in Cardiac Anesthesia

Boston Childrenrsquos Hospital

Foreword

xi

Preface

There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run

The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most

common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings

Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass

Gregory S Matte CCP LP FPP

Disclaimer

Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk

xii

Acknowledgments

A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago

I am also deeply indebted to the following individuals who provided feedback regarding the content of this book

andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers

Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc

1

The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass

Oxygenators

The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system

The oxygenator membranebull Membrane oxygenators allow for diffusion of gas

oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)

bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates

bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity

bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions

bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion

bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended

bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection

bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas

Equipment for bypassChapTEr 1

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

Contents ix

Nicks procedure 176Nikaidoh procedure 176Noonan syndrome 176Norwood operation 176Pannus 176Pentalogy of Cantrell 176Potts shunt 177Rashkind procedure 177Rastelli operation 177Ross procedure 177Sano shunt 177Scimitar syndrome 177Senning operation 177Shonersquos complex 178Takeuchi procedure 178TaussigndashBing anomaly 178Trusler repair 178

Van Praagh classification 178Warden procedure 178Waterston shunt 178Williams syndrome 178Yasui procedure 179

10 Abbreviations for congenital heart surgery 180

11 Recommended reference books 186

12 Comprehensive experience-based equipment selection chart select medications administered during bypass 187

Index 190

x

The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself

There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an

essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients

James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School

Chief Division of Cardiac Anesthesia

Francis X McGowan Jr MDChair in Cardiac Anesthesia

Boston Childrenrsquos Hospital

Foreword

xi

Preface

There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run

The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most

common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings

Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass

Gregory S Matte CCP LP FPP

Disclaimer

Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk

xii

Acknowledgments

A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago

I am also deeply indebted to the following individuals who provided feedback regarding the content of this book

andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers

Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc

1

The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass

Oxygenators

The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system

The oxygenator membranebull Membrane oxygenators allow for diffusion of gas

oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)

bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates

bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity

bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions

bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion

bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended

bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection

bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas

Equipment for bypassChapTEr 1

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

x

The art and science of providing perfusion for patients undergoing surgical correction of congenital heart lesions has advanced rapidly in the past decade The complex equip-ment the unique acidndashbase management strategies the spe-cialized perfusion and ultrafiltration techniques the wide variation in patientrsquos age size and vulnerability to physio-logic trespass and the wide variety of surgical procedures performed set perfusion for congenital heart surgery apart from that provided for correction of acquired heart disease in adults Consequently provision of cardiopulmonary support for repair of congenital heart lesions has become a specialty unto itself

There is no doubt that perfusionists caring for patients with congenital heart disease will find this manual invalu-able More importantly from the perspective of a pediatric anesthesiologist and intensivist this manual will be an

essential resource for cardiac anesthesiologists and inten-sivists The practical hands-on information contained herein is not currently readily available in any other publi-cation This manual will and should become part of the teaching curriculum for anesthesia and intensive care residents and fellows involved in the care of these complex patients

James A DiNardo MD FAAPProfessor of AnaesthesiaHarvard Medical School

Chief Division of Cardiac Anesthesia

Francis X McGowan Jr MDChair in Cardiac Anesthesia

Boston Childrenrsquos Hospital

Foreword

xi

Preface

There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run

The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most

common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings

Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass

Gregory S Matte CCP LP FPP

Disclaimer

Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk

xii

Acknowledgments

A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago

I am also deeply indebted to the following individuals who provided feedback regarding the content of this book

andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers

Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc

1

The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass

Oxygenators

The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system

The oxygenator membranebull Membrane oxygenators allow for diffusion of gas

oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)

bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates

bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity

bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions

bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion

bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended

bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection

bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas

Equipment for bypassChapTEr 1

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

xi

Preface

There are numerous excellent textbooks available today on congenital cardiac disease Most congenital cardiac perfu-sion services have at their disposal updated texts regarding the disciplines of cardiology cardiac surgery anesthesia nursing and perfusion The perfusion texts of which I am most interested can be found to have both vague and con-tradictory statements regarding how to actually ldquorun the pumprdquo for congenital cardiac cases It is my hope that this book provides some direction The aim of this book is not to provide a comprehensive textbook for congenital cardiac surgery or cardiopulmonary bypass Nor is it to simply publish clinical practice protocols Rather the aim is to provide easily referenced information and reminders to the pediatric perfusionist and non-perfusionist alike which can influence a bypass plan and perhaps become part of onersquos practice The pediatric perfusionist with at least a general understanding of the other disciplines involved with cardiac surgery should be able to reference this book with its provided notes as I prefer to call them to confidently devise a plan for a pump run

The idea of creating this book stems from over 17 years of practicing perfusion for congenital heart surgery and nearly 25 years of working with critically ill children The academic institutions where I have trained and worked regularly host visitors from around the country and world They include fellows of anesthesia cardiac surgery and the intensive care unit perfusion and nursing students as well as current practitioners in those fields The most

common visitor question a department receives is ldquoCan I get a copy of your protocolsrdquo My standard answer is always a qualified ldquoyesrdquo It is quite simple to pass along perfusion protocols and customized tubing pack specifi-cations Those items are essential and useful Though in isolation they fail to capture much of the thought and consideration put into every cardiopulmonary bypass plan for congenital cardiac cases It is my hope that this book is a step toward filling this gap in currently available offerings

Finally we are all imperfect clinicians and it has been said that no one can harm (or even kill) a patient faster than a perfusionist (or surgeon) With that being said may your clinical errors be minor and preferably off cardiopulmonary bypass

Gregory S Matte CCP LP FPP

Disclaimer

Perfusionists by law provide cardiopulmonary bypass under the supervision of a physician This book contains information and recommendations that should be sanc-tioned by the supervising physician Errors and omissions with the information provided are possible Clinical prac-tice is constantly evolving Use of the information within this book is at your own discretion and risk

xii

Acknowledgments

A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago

I am also deeply indebted to the following individuals who provided feedback regarding the content of this book

andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers

Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc

1

The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass

Oxygenators

The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system

The oxygenator membranebull Membrane oxygenators allow for diffusion of gas

oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)

bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates

bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity

bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions

bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion

bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended

bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection

bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas

Equipment for bypassChapTEr 1

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

xii

Acknowledgments

A special thanks to Willis Gieser former Chief of Perfusion at Boston Childrenrsquos Hospital who accepted my unsolic-ited phone call gave me an interview and hired me many years ago

I am also deeply indebted to the following individuals who provided feedback regarding the content of this book

andor reviewed chapters James DiNardo Frank Pigula Kirsten Odegard Chris Baird Kevin Connor Robert Howe Mark Wesley Robert Groom Robert Wise and Gerard Myers

Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc

1

The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass

Oxygenators

The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system

The oxygenator membranebull Membrane oxygenators allow for diffusion of gas

oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)

bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates

bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity

bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions

bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion

bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended

bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection

bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas

Equipment for bypassChapTEr 1

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

Perfusion for Congenital Heart Surgery Notes on Cardiopulmonary Bypass for a Complex Patient Population First Edition Gregory S Matte copy 2015 John Wiley amp Sons Inc Published 2015 by John Wiley amp Sons Inc

1

The cardiopulmonary bypass plan starts with basics of patient height weight allergy history original diag-nosis previous surgeries and current indications for sur-gery The perfusionist must select and assemble an array of equipment matched to the patientrsquos size expected pump flow rates and other factors related to diagnosis The following is an overview of the major components of a bypass circuit Please refer to Chapter 6 for equipment considerations in addition to patient size Figure 11 is provided as a reference to basic equipment arranged for cardiopulmonary bypass

Oxygenators

The contemporary ldquooxygenatorrdquo is actually several integrated items that in addition to the oxygenating membrane may include the arterial line filter (ALF) venous reservoir and filter cardiotomy filter and heat exchanger Figure 12 depicts the components of the Terumo CAPIOX FX series of ldquooxygenatorsrdquo Figure 13 depicts typical components of an oxygenator system

The oxygenator membranebull Membrane oxygenators allow for diffusion of gas

oxygen and carbon dioxide most importantly across a material separating the blood path from the gas flow path (also called the blood and gas phases)

bull True membrane oxygenators allow for diffusion of gases through a membrane separating the blood and gas phases (see Figure 14) The type and thickness of the membrane as well as blood and gas flow characteristics on opposing sides determines overall diffusion rates

bull Microporous membrane oxygenators allow for diffusion of gases through microscopic holes in the membrane material (see Figure 14) The gas transfers directly through these micropores and is therefore less impacted by the membrane material However blood and gas flow charac-teristics on opposing sides still impact diffusion capacity

bull The vast majority of oxygenators for cardiopulmonary bypass are microporous membrane oxygenators True membrane oxygenators have limited applications today including the use for ECMO at some institutions

bull The membrane oxygenator size chosen for a particular patient should be the smallest which will allow for safe per-fusion with some degree of functional reserve in case of decreasing efficiency during extended bypass runs or to account for markedly increased pump flows due to aorto-pulmonary connections (MAPCAs surgical or other central shunts) or significant aortic regurgitation Increased pump flow rates in these situations may be required to maintain adequate effective systemic perfusion

bull Using an oxygenator above its manufacturer recom-mended maximum flow rate may increase arterial line GME transmission and is not recommended

bull It is recommended to define the patient BSA and select an oxygenator based on the maximum expected pump flows It is important to note that for neonates and infants in particular their relatively higher metabolic requirement may require markedly increased pump flows during normothermic bypass (ie rewarming) Flows of 30ndash35 Lminm2 are not uncommon and should be considered for equipment selection

bull Primary consideration is given to the manufacturer-recommended maximum flow rate that is based on gas

Equipment for bypassChapTEr 1

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

Arterial limbVenous limb

Gas source and13ow meter

Arterial line lterwith bypass loopclamped

Oxygenator withintegrated heatexchanger Angledports are for waterlines

LV vent pump head

Arterial pump head

Integrated cardiotomy venous reservoir (CVR)

Cardiotomy lter

Suction pump head

Field suction

LV vent

Suction pump head

Venous reservoir and lter

Figure 11 Simplified schematic for basic cardiopulmonary bypass equipment (excludes cardioplegia system)

A A A

BB

B

Figure 12 Terumo CAPIOX FX series of oxygenators Left to right Terumo CAPIOX FX05 Terumo CAPIOX FX15-30 Terumo CAPIOX FX25 Amdashcardiotomy venous reservoir and Bmdashoxygenator membrane with integrated arterial line filter and heat exchanger (See insert for color representation of the figure)

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

TOP VIEW

SIDE VIEW

Nonlteredluer lock

Auxiliary port14rdquondash38rdquo

Sampling line

Venous bloodsampling line connection

Two luer lockson venous inlet

Thermistor probe

Venous blood inlet port

Three ltered luer locksto cardiotomy lter

Five suction ports

Quick prime port

Purge line fromthe oxygenator

Vent port

Venous blood inlet port

Cardiotomy lter

Purge line

Guide hole for holder

Clamp

Connecting ring

One way valve

Heat exchanger

Gas inlet port

Arterial lter

Water inlet port

Gas exchangemodule

Water outletport

Luer port (for recirculation or blood cardioplegia)Thermistor probe

Blood outlet portGas outlet portDetachable connector

One-way valve

Blood inletport

Sampling line-arterial side

Reservoiroutlet port

Samplingsystem

Hardshellreservoir

Oxygenatorwith integratedarterial lter

Sampling line-venous side

Venous lter

Detachableconnector

Figure 13 Typical components of an oxygenator system Reproduced with permission from Terumo Cardiovascular Group Ann Arbor MI All rights reserved

Gas ow

Blood ow

Gas ow

Blood ow

Gas transfer only

True membrane oxygenators

Gas diffuses through a solid membrane (shownin gray) There are no directcommunications between the gas and bloodcompartments

Microporous membrane oxygenators

Gases diffuse through tiny holes in themembrane material (shown in gray) There aredirect communications between the gas andblood compartments Microair in the bloodcompartment may pass into the gascompartment to facilitate removal of gaseousmicroemboli in the blood Blood cannot pass

Figure 14 Primary types of oxygenators currently in use

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

4 Chapter 1

exchange and other aspects of oxygenator heat exchanger and reservoir performance The American Association of Medical Instrumentation (AAMI) standard reference values are usually not relied solely upon since they may not take into account additional factors that the manu-facturer evaluates for overall performance

bull Increased oxygenator bundle size does not linearly relate to performance since characteristics of the blood and gas flow paths vary among devices

bull Oxygenators have either radial or axial blood flow paths that affect performance in competing ways in regards to oxygenating efficiency pressure drop microemboli removal and heat exchanger performance (see Figure 15)

bull Microporous oxygenator bundles are important in the removal of air from the blood path Some centers par-ticularly outside of the United States deem the micro-porous oxygenator effective enough at air removal that they do not utilize a standalone ALF

bull One oxygenator on the market the Medtronic Affinity Fusion has taken advantage of the air handling capabil-ities of microporous oxygenators and unique bundle wrapping technology to be FDA approved for use as an ALF as well as an oxygenator

bull The perfusionist must be familiar with the manufacturer recommendations for treating an oxygenator sus-pected of ldquowetting outrdquo These values are listed in Tables 11 to 14

bull Oxygenators are usually qualified for use by the manu-facturer for up to 6 h Use beyond this limit does occur and most often there is not a significant decrease in performance However safe use beyond this limit is not guaranteed Consideration should be given to changing out an oxygenator after a long case in which an addi-tional bypass run is a serious possibility Elective change out while off bypass can be accomplished in a controlled manner and can eliminate several concerns of emer-gently resuming bypass with a product at the end of its rated performance limit

bull Blood proteins coat a membrane oxygenatorrsquos surface area including the micropores through which gas exchange occurs

bull Microporous membranes may experience increased protein coating and subsequent decrease in oxygen transfer during extended bypass runs It is important to note that this protein coating may also decrease the air handling capabilities of the membrane

bull The pressure drop across an oxygenator membrane is frequently listed as a specification It may be measured in real time during bypass A change in this value over time is important to consider during bypass as it can be an indicator of change in function

bull Pressure drop is frequently equated with shear stress where a lower pressure drop is considered beneficial with lower shear stress That is not always the case since

Oxygenator bundle

Oxygenator bundle

Heat exchanger

Heat exchanger

Heat exchanger

Heat exchanger

Oxygenator inlet

Oxygenator inlet

Oxygenator outlet

Oxygenator outlet

Axial blood ow pathBlood travels along the axis of theheat exchanger rst and then alongthe axis of the oxygenator bundlebefore exiting a low point in thedevice

Radial blood ow path Blood enters and radiates through theheat exchanger and oxygenatorbundle before exiting a low point inthe device Some oxygenatorspreferentially have blood exit the heatexchanger top before owing throughthe oxygenator bundle

Oxygenator

Oxygenator bundle

Figure 15 Simplified schematic of blood flow paths through an oxygenator

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

Tab

le 1

1 O

xyge

nato

rs r

ated

up

to ~

2 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce

fact

or

at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed

blo

od

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w r

ang

e (L

PM)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

D10

00

2231

Up

to 0

730

00

6550

0Ye

sN

o10

Up

to 1

4 L

PM

with

a m

ax

VQ

of

21

Up

to 2

8 L

PM

with

a m

ax

VQ

of

41

Sorin

Liili

put

D90

10

3460

08

200

072

675

Yes

No

15U

p to

16

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal

038

380

2ndash1

570

00

6280

0Ye

sN

o15

01ndash

30

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i N

eona

tal w

ith

inte

grat

ed A

LF

038

400

2ndash1

570

00

6280

0Ye

sYe

s33

microm2

0 cm

215

01ndash

30

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX05

05

430

1ndash1

535

00

6510

00Ye

sN

o15

005

ndash5

min

imum

02

V

Q

5 LP

M f

or 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX05

05

430

1ndash1

535

00

6510

00Ye

sYe

s32

microm1

30 c

m2

150

05ndash5

m

inim

um 0

2

VQ

5 LP

M f

or 1

0s

do n

ot r

epea

t

Sorin

D10

10

6187

Up

to 2

560

00

615

00Ye

sN

o30

Up

to 5

LPM

w

ith a

max

V

Q o

f 2

1

Up

to 1

0 LP

M

with

a m

ax

VQ

of

41

Med

tron

icPi

xie

067

480

1ndash2

0N

ot

spec

ified

065

1200

Yes

No

20U

p to

40

LPM

w

ith a

max

V

Q o

f 2

1

Non

e sp

ecifi

ed

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

Tab

le 1

2 O

xyge

nato

rs r

ated

~2

to ~

5 LP

M

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

art

eria

l fi

lter

po

re s

ize

surf

ace

area

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

g

as f

low

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Lilli

put

D90

20

6410

5U

p to

23

200

048

1800

Yes

No

200

Up

to 4

6

LPM

with

a

max

V

Q o

f 21

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-i Pe

diat

ric0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-i Pe

diat

ric

with

inte

grat

ed A

LF0

899

02ndash

28

1500

062

1700

Yes

Yes

33 microm

55

cm2

300

1ndash5

6N

one

spec

ified

Maq

uet

Qua

drox

-iD P

edia

tric

(p

olym

ethy

lpen

tene

)0

881

02ndash

28

1500

062

1700

Yes

No

300

1ndash5

6N

one

spec

ified

Med

tron

icM

inim

ax0

814

90

5ndash2

3N

ot

spec

ified

045

2000

No

No

150

Non

e sp

ecifi

edN

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt1

317

50

5ndash5

030

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i Sm

all

Adu

lt w

ith in

tegr

ated

A

LF

13

295

05ndash

50

3000

062

4200

Yes

with

V

HK

200

1 re

serv

oir

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Sorin

Insp

ire 6

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

14

184

284

w

ith A

LFU

p to

60

4300

06

4500

Yes

Opt

iona

l38

microm6

8 cm

215

0U

p to

12

LPM

not

to

exc

eed

21

VQ

Up

to 1

2 LP

M

not

to e

xcee

d 2

1 V

Q

Teru

mo

Cap

iox

RX15

30

15

135

05ndash

4 5

LPM

w

ith a

ssis

ted

veno

us

drai

nage

1400

06

3000

Yes

No

700

5ndash15

15 L

PM fo

r 10s

do

not

rep

eat

Teru

mo

Cap

iox

RX15

40

15

135

05ndash

50

1400

06

4000

Yes

No

200

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

tTe

rum

oC

apio

x FX

15 3

01

514

40

5ndash4

5 L

PM

with

ass

iste

d ve

nous

dr

aina

ge

1400

06

3000

Yes

Yes

32 microm

360

cm

270

05ndash

1515

LPM

for 1

0s

do n

ot r

epea

t

Teru

mo

Cap

iox

FX15

40

15

144

05ndash

50

1400

053

4000

Yes

Yes

32 microm

360

cm

220

00

5ndash15

15 L

PM fo

r 10s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

Tab

le 1

3 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t I o

f II)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as n

ote

d)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

p

ore

siz

esu

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Sorin

Insp

ire 8

(opt

iona

l in

tegr

ated

art

eria

l fil

ter)

175

219

351

w

ith A

LFU

p to

80

4300

053

4500

Yes

Opt

iona

l38

microm

97 c

m2

150

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QM

aque

tQ

uadr

ox-i

Adu

lt1

821

50

5ndash7

040

000

642

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

No

300

Up

to 1

5N

one

spec

ified

Maq

uet

Qua

drox

-i A

dult

with

inte

grat

ed A

LF1

833

50

5ndash7

060

000

6242

00Ye

s w

ith

VH

K 2

001

rese

rvoi

r

Yes

40 microm

430

cm

230

0U

p to

15

Non

e sp

ecifi

ed

Maq

uet

Qua

drox

-iD A

dult

(pol

ymet

hylp

ente

ne)

18

215

05ndash

70

4000

06

4200

Yes

with

V

HK

200

1 re

serv

oir

No

300

Up

to 1

5N

one

spec

ified

Teru

mo

SX18

18

270

05ndash

70

2200

05

4000

Yes

No

200

05ndash

2020

LPM

for

10

s

do n

ot r

epea

tSo

rinPr

imO

2X1

8725

0U

p to

814

000

4443

00Ye

sN

o25

0U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinA

pex

HP

187

250

Up

to 8

1400

048

4000

Yes

No

200

U

p to

16

LPM

no

t to

exc

eed

21

VQ

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

QSo

rinSy

nthe

sis

250

0 w

ith

inte

grat

ed A

LFU

p to

814

000

3643

00Ye

sYe

s40

microm4

00 c

m2

300

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Up

to 1

6 LP

M

not

to e

xcee

d 2

1 V

Q

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at

Tab

le 1

4 O

xyge

nato

rs r

ated

up

to 8

LPM

(Par

t II

of II

)

Man

ufa

ctu

rer

Oxy

gen

ato

r (m

icro

po

rou

s p

oly

pro

pyl

ene

exce

pt

as

no

ted

)

Oxy

gen

ato

r b

un

dle

(m

2 )O

xyg

enat

or

pri

me

volu

me

Man

ufa

ctu

rer

reco

mm

end

ed

blo

od

flo

w

ran

ge

(LPM

)

Hea

t ex

chan

ger

si

ze (

cm2 )

Hea

t ex

chan

ger

p

erfo

rman

ce f

acto

r at

man

ufa

ctu

rer

max

imu

m

reco

mm

end

ed b

loo

d

flo

w r

ate

Res

ervo

ir

cap

acit

y (m

L)

Co

mp

atib

le

wit

h

vacu

um

as

sist

ed

dra

inag

e

Inte

gra

ted

ar

teri

al f

ilter

po

re

size

su

rfac

e ar

ea

Min

imu

m

op

erat

ing

vo

lum

e

Gas

flo

w

ran

ge

(LPM

)

Max

imu

m

tem

po

rary

gas

fl

ow

fo

r su

spec

ted

w

etti

ng

ou

t o

f o

xyg

enat

or

Med

tron

icA

ffin

ity N

T2

527

01

0ndash7

0N

ot

spec

ified

045

4000

Yes

No

200

10ndash

70

Non

e sp

ecifi

ed

Med

tron

icA

ffin

ity F

usio

n2

526

01

0ndash7

040

000

5545

00Ye

sYe

s25

microm v

ia

oxyg

enat

or b

undl

e20

0N

one

spec

ified

Non

e sp

ecifi

ed

Teru

mo

Cap

iox

RX25

25

250

05ndash

70

2000

053

4000

Yes

No

200

05ndash

2020

LPM

for

10s

do

not

rep

eat

Teru

mo

Cap

iox

FX25

25

260

05ndash

70

2000

053

4000

Yes

Yes

32 microm

600

cm

220

00

5ndash20

20 L

PM f

or 1

0s

do n

ot r

epea

tTe

rum

oSX

252

534

00

5ndash7

022

000

540

00Ye

sN

o20

00

5ndash20

20 L

PM f

or

10 s

do

not

repe

at