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Techniques in
extracorporeal
circulation
This page intentionally left blank
Techniques in
extracorporeal
circulation
FOURTH EDITION


                 Edited by

                 PHILIP H KAY MA DM FRCS

                 Consultant Cardiothoracic Surgeon,
                 Yorkshire Heart Centre,
                 The General Infirmary,
                 Leeds, UK

                 and


                 CHRISTOPHER M MUNSCH ChM FRCS (C/Th)

                 Consultant Cardiothoracic Surgeon,
                 Yorkshire Heart Centre,
                 The General Infirmary,
                 Leeds, UK




                 A member of the Hodder Headline Group
                 LONDON
First published in 1976 by Butterworth-Heinemann Ltd,
Linacre House, Jordan Hill, Oxford, OX2 8DP.
This edition published in Great Britain in 2004 by
Arnold, a member of the Hodder Headline Group,
338 Euston Road, London NW1 3BH

http://www.arnoldpublishers.com

First published 1976
Second edition 1981
Reprinted 1982
Third edition 1992
Reprinted 1993
Fourth edition 2004

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accurate at the date of going to press, neither the author[s] nor the publisher
can accept any legal responsibility or liability for any errors or omissions
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Contents




     Contributors                                                                      vii

     Foreword                                                                          xi

     Preface to Fourth Edition – 50 years on                                          xiii

     Preface to Third Edition                                                         xiv

     Preface to Second Edition                                                         xv

     Preface to First Edition                                                         xvi

     Acknowledgements                                                                 xvii

1    A brief history of bypass                                                          1
     Anil Kumar Mulpur and Christopher M Munsch

2    Design and principles of the extracorporeal circuit                                7
     Medtronic, Inc., A Manufacturer of Technologies for Extracorporeal Circulation

3    Physiology and pathophysiology of extracorporeal circulation                      23
     Jonathan AJ Hyde and Ralph E Delius

4    Anaesthesia for cardiopulmonary bypass                                            57
     Linda Nel and John WW Gothard

5    Monitoring and safety in cardiopulmonary bypass                                   76
     Jonathan M Johnson, Stephen Robins and Jonathan A J Hyde

6    Priming fluids for cardiopulmonary bypass                                          99
     Piet W Boonstra and Y John Gu

7    Filters in cardiopulmonary bypass                                                108
     Farah NK Bhatti and Timothy L Hooper

8    The inflammatory response to cardiopulmonary bypass                               117
     Saeed Ashraf

9    Pulsatile cardiopulmonary bypass                                                 133
     Terry Gourlay and Kenneth M Taylor

10   Cardiopulmonary bypass and the brain                                             148
     G Burkhard Mackensen, Hilary P Grocott and Mark F Newman
vi Contents


11     Cardiopulmonary bypass in children with congenital heart disease                      177
       Carin van Doorn and Martin Elliott

12     Intraoperative myocardial protection                                                  184
       John WC Entwistle III and Andrew S Wechsler

13     Blood conservation                                                                    210
       Mike Cross

14     Mechanical circulatory support                                                        236
       Stephen Westaby and Satoshi Saito

15     Extracorporeal membrane oxygenation                                                   254
       Scott K Alpard, Dai H Chung and Joseph B Zwischenberger

16     The extended use of the extracorporeal circuit                                        292
       Philip H Kay, Anil Kumar Mulpur, Dumbor Ngaage, Samir Shah, Kieran Horgan,
       John Pollitt and Stephen D Hansbro

17     Cardiopulmonary bypass during Port-access™ and robotic surgery                        298
       Alan P Kypson and W Randolph Chitwood Jr

18     Cardiac surgery without cardiopulmonary bypass                                        315
       Joseph P McGoldrick

19A    The development of clinical perfusion education and standards in the UK and Ireland   332
       Michael Whitehorne

19B    Standards, guidelines and education in clinical perfusion: the European perspective   337
       Ludwig K Von Segesser

19C    Perfusion education in the USA at the turn of the twentieth century                   341
       Alfred H Stammers

       Index                                                                                 345
Contributors




Scott K Alpard MD                                         Mike Cross
Surgical Research Fellow,                                 Consultant Anaesthetist,
Division of Cardiothoracic Surgery,                       Yorkshire Heart Centre,
University of Texas Medical Branch,                       The General Infirmary at Leeds,
Galveston, TX, USA                                        Leeds, UK

Saeed Ashraf FRCS(CTh) MD                                 Ralph E Delius MD
Consultant Cardiothoracic Surgeon,                        Children’s Hospital of Michigan,
Regional Cardiothoracic Centre,                           Detroit, MI, US
The Morriston Hospital, and Honorary Senior Lecturer,
University of Swansea,
                                                          Carin van Doorn
Swansea, UK
                                                          Senior Lecturer in Cardiothoracic Surgery,
Farah NK Bhatti                                           University College London,
Specialist Registrar in Cardiothoracic Surgery,           and Honorary Consultant Cardiothoracic Surgeon,
Wythenshawe Hospital,                                     Cardiothoracic Unit,
Manchester, UK                                            Great Ormond Street Hospital for Children,
                                                          London, UK
Piet W Boonstra
Department of Cardiothoracic Surgery,                     Martin Elliott
University Hospital,                                      Consultant Cardiothoracic Surgeon,
Groningen, The Netherlands                                Cardiothoracic Unit,
                                                          Great Ormond Street Hospital for Children,
Walt Carpenter                                            London, UK
Director of Cardiopulmonary R&D,
Medtronic Perfusion Systems,                              John WC Entwistle III MD PhD
Minneapolis, MN, USA                                      Assistant Professor of Cardiothoracic Surgery,
                                                          Department of Cardiothoracic Surgery,
W Randolph Chitwood Jr MD
                                                          Drexel University College of Medicine,
Senior Associate Vice Chancellor and Director,
                                                          Philadelphia, PA, USA
North Carolina Cardiovascular Institute,
Professor and Chairman,
Professor of Surgery,                                     John WW Gothard FRCA
Chief, Division of Cardiothoracic and Vascular Surgery,   Consultant Anaesthetist,
The Brody School of Medicine,                             Royal Brompton Hospital,
East Carolina University,                                 London, UK
Greenville, NC, USA
                                                          Terry Gourlay PhD BSc (Hons) CBiol MIBiol ILTHE FRSH
Dai H Chung MD                                            British Heart Foundation Perfusion Specialist,
Assistant Professor of Surgery,                           Department of Cardiothoracic Surgery,
Chief, Section of Pediatric Surgery,                      NHLI,
Department of Surgery,                                    Imperial College Medical School,
University of Texas Medical Branch,                       Hammersmith Hospital Campus,
Galveston, TX, USA                                        London, UK
viii Contributors


Hilary P Grocott MD FRCPC               G Burkhard Mackensen MD
Associate Professor,                    Assistant Professor,
Department of Anesthesiology,           Klinik für Anaesthesiologie,
Duke Heart Center,                      Technische Universität München,
Duke University Medical Center,         Klinikum rechts der Isar,
Durham, NC, USA                         München, Germany

                                        Joseph P McGoldrick MD FRCS
Y John Gu
                                        Consultant Cardiothoracic Surgeon,
Department of Cardiothoracic Surgery,
                                        The Yorkshire Heart Centre,
University Hospital,
                                        The General Infirmary at Leeds,
Groningen, The Netherlands
                                        Leeds, UK

Stephen D Hansbro                       Anil Kumar Mulpur MS MCh FRCS (Edin)
Department of Clinical Perfusion,       FRCS (Glasgow) FRCS C/Th (Edin) FETCS
Leeds General Infirmary,                 Consultant Cardiothoracic Surgeon,
Leeds, UK                               Sri Sathya Sai Institute of Higher Medical Sciences,
                                        Whitefield, Bangalore, India
Timothy L Hooper
                                        Christopher M Munsch ChM FRCS (C/Th)
Consultant Cardiac Surgeon,
                                        Consultant Cardiothoracic Surgeon,
Wythenshawe Hospital,
                                        Department of Cardiothoracic Surgery,
Manchester, UK
                                        The Yorkshire Heart Centre,
                                        The General Infirmary,
Kieran Horgan                           Leeds, UK
Department of General Surgery,
Leeds General Infirmary,                 Linda Nel FRCA
Leeds, UK                               Consultant Anaesthetist,
                                        Southampton University Hospitals Trust,
Jonathan AJ Hyde MD FRCS(CTh)           Southampton, UK
Consultant Cardiac Surgeon,             Mark F Newman MD
Royal Sussex County Hospital,           Professor and Chairman,
Brighton, UK                            Department of Anesthesiology,
                                        Duke Heart Center,
Jonathan M Johnson BSc ACP              Duke University Medical Center,
Chief Clinical Perfusionist,            Durham, NC, USA
Royal Sussex County Hospital,
Brighton, UK                            Dumbor Ngaage
                                        Department of Cardiothoracic Surgery,
                                        Leeds General Infirmary,
Bruce Jones
                                        Leeds, UK
Cardiopulmonary Product Manager,
Medtronic Perfusion Systems,            John Pollitt
Minneapolis, MN, USA                    Department of General Surgery,
                                        Leeds General Infirmary,
Philip H Kay MA DM FRCS                 Leeds, UK
Consultant Cardiothoracic Surgeon,
                                        Stephen Robins PgDip AACP
The Yorkshire Heart Centre,
                                        Chief Clinical Perfusionist,
The General Infirmary,
                                        New Cross Hospital,
Leeds, UK
                                        Wolverhampton, UK

Alan P Kypson MD                        Satoshi Saito MD PhD
Assistant Professor of Surgery,         Senior Clinical Research Fellow,
Division of Cardiothoracic Surgery,     Department of Cardiothoracic Surgery,
Brody School of Medicine,               Oxford Heart Centre,
East Carolina University,               John Radcliffe Hospital,
Greenville, NC, USA                     Oxford, UK
Contributors ix


Ludwig K Von Segesser                              Andrew S Wechsler MD
Service de Chirurgie Cardio-Vasculaire,            Professor and Chairman,
Centre Hospitalier Universitaire Vaudois (CHUV),   Department of Cardiothoracic Surgery,
Lausanne, Switzerland                              Drexel University College of Medicine,
                                                   Philadelphia, PA, USA
Samir Shah
Department of Cardiothoracic Surgery,              Stuart Welland
Leeds General Infirmary,                            European Marketing Manager,
Leeds, UK                                          Medtronic Europe Sàrl,
                                                   Tolochenaz, Switzerland
Alfred H Stammers MSA CCP
Chief Perfusionist,                                Stephen Westaby PhD FETCS MS
Department of Surgery,                             Consultant Cardiac Surgeon,
Geisinger Medical Center,                          Department of Cardiothoracic Surgery,
Danville, PA, USA                                  Oxford Heart Centre,
                                                   John Radcliffe Hospital,
Editor, Journal of Extracorporeal Technology
                                                   Oxford, UK
Jeanne Stanislawski                                Michael Whitehorne MSC ACP FCCPS
Cardiopulmonary Product Manager,
                                                   Consultant Clinical Perfusion Scientist,
Medtronic Perfusion Systems,
                                                   Department of Cardiothoracic Surgery,
Minneapolis, MN, USA
                                                   King’s College Hospital,
Wendy Svee                                         London, UK
Cardiopulmonary Product Manager,                   Joseph B Zwischenberger MD
Medtronic Perfusion Systems,                       Professor of Surgery, Medicine, and Radiology,
Minneapolis, MN, USA                               Director, General Thoracic Surgery and ECMO Programs,
Kenneth M Taylor                                   Division of Cardiothoracic Surgery,
Professor of Cardiac Surgery,                      University of Texas Medical Branch,
Department of Cardiothoracic Surgery,              Galveston, TX, USA
NHLI,
Imperial College Medical School,
Hammersmith Hospital Campus,
London, UK
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Foreword




I am most grateful to the editors for their invitation to       preference for medical revascularisation (percutaneous
write the foreword for this – the fourth edition of             transluminal coronary angioplasty, stents, the expanding
Techniques of Extracorporeal Circulation. My office book-        range of percutaneous coronary interventions) at the
case currently contains the three previous editions, and        expense of what we used to consider the unassailable
if I am not considered presumptuous, I look forward to          gold standard: conventional coronary artery bypass graft
adding a copy of this fourth edition.                           surgery.
    John Gibbon received international acclaim for his              For cardiopulmonary bypass and the perfusion pro-
courage and determination on the 50th anniversary of            fessionals, the challenge was different, but no less daunt-
that historic open-heart operation in Philadelphia on           ing: would off-pump coronary bypass render the use of
May 5th 1953 when the heart–lung machine was used               cardiopulmonary bypass in coronary surgery obsolete?
successfully in a patient for the first time. Fifty years does   One might reasonably assume that now is not the time to
not seem to me to be that long, although when I was             invest in cardiopulmonary bypass – far too risky! I beg
younger (i.e. not over 50) my opinions were different. It       to differ, however. I would suggest that now is precisely
is always fascinating to hear graphic personal accounts of      the time for investment in cardiopulmonary bypass.
those early days of cardiopulmonary bypass where the            It should, however, be specifically targeted investment,
challenges seemed almost insuperable.                           a balanced investment portfolio.
    Things are very different 50 years on. The technology           First, the further continual refinement of cardio-
and the practice of cardiopulmonary bypass have been            pulmonary bypass remains as great a challenge and an
refined to an exceptional degree. The benefits to the car-        opportunity now as it was in the 1950s. Developments in
diac surgical patients and the cardiac team of surgeons,        medicine in general (particularly including molecular
anaesthetists, perfusionists and nursing staff have been        science and genetics/genomics) offer great potential to
incalculable. I was asked a few years ago to give a talk on     increase our understanding of the fundamental patho-
the topic: ‘Can cardiopulmonary bypass become more              physiological mechanisms of cardiopulmonary bypass
patient friendly?’ I observed at the start of the talk that     and consequently introduce more effective preventative
cardiopulmonary bypass had been a great friend to cardiac       and therapeutic strategies.
surgical patients and to cardiac surgeons and their col-            Second, we need to broaden our horizons as far as
leagues, and that John Gibbon would be turning over in          extracorporeal circulation is concerned. Its potential roles
his grave at the very thought of the topic I had been given.    in other forms of surgery (both in cardiac and non-
    I was exaggerating of course, and Gibbon and his fellow     cardiac) in local circulations and in systemic circulatory
pioneers would be the very last to encourage complacency        and respiratory support present a wealth of opportunities.
regarding cardiopulmonary bypass. As it so happened, the            Third and finally, to quote the UK Prime Minister Tony
following year I was asked to speak to another question: ‘Is    Blair (who interestingly was born on May 5th 1953 –
cardiopulmonary bypass in 2001 as good as it gets?’ I trust     Gibbon’s historic day) ‘... education, education, education’.
you will already have worked out that I was somewhat            We need to apply ourselves, both individually and in the
negative in my response to that proposition!                    medical and perfusion schools of the future. New science
    They say that things come along in threes – and it fell     brings with it new terminologies – we need to learn the
to me to address another cardiopulmonary bypass                 languages. Then we can communicate with the basic sci-
related question in 2002. ‘Would you invest in cardiopul-       entists, with molecular experts, with geneticists and who
monary bypass in 2002?’ was the title. I found this exer-       knows who else!
cise particularly interesting. By then, cardiac surgery and         It may be a daunting prospect for us, but spare a
cardiopulmonary bypass were each facing major chal-             thought also for the basic scientists – when have they ever
lenges to their future importance. For cardiac surgery,         before been visited by an enthusiastic perfusionist or
the challenge – indeed the threat – was the increasing          cardiac surgical trainee?
xii Foreword


   So these are the challenges, and the opportunities.        honourable tradition of risk-takers. As one of the North
This textbook will help considerably. Philip Kay and          American insurance corporations proclaims in its adver-
Chris Munsch have brought into this book the right            tising: ‘the only risk is not to take one’.
subjects and the right authors. This book contains a lot of       John Gibbon would profoundly agree with that.
information, which can be a launch pad for new ideas
and new questions.                                                             Professor Kenneth M Taylor MD FRCS
   Are there risks? Of course there are! We must never                                      FRCSE FESC FETCS FSA
forget, however, that in cardiac surgery we come from an                            BHF Professor of Cardiac Surgery
Preface to Fourth Edition — 50 years on




In May 1953 Edmund Hilary and Sherpa Tensing became            surgery make the clinical perfusionist obsolete? Whatever
the first men to stand on the summit of Mount Everest.          happens there is no doubt that clinical perfusion will con-
In that same month came John Gibbon’s moment of tri-           tinue to evolve and develop. We believe that this fourth
umph, with the first successful use of mechanical car-          edition of Techniques in Extracorporeal Circulation
diopulmonary bypass in a human patient.                        deserves a place on the bookshelves of all healthcare pro-
   The seed had been sown and it subsequently fell to          fessionals working in the cardiac surgical operating room.
other pioneers to develop the science of extracorporeal        We suspect, in an era of electronic communication, that
circulation.                                                   the bookshelf may well be the first to become obsolete.
   Leeds was at the forefront of this exciting development        Progress in surgery is often compared with moun-
and, in 1957, Geoffrey Wooler used cardiopulmonary             taineering and exploration (and contributors to this
bypass to repair a mitral valve. He then went on to edit the   book have themselves used the analogy). A lot has hap-
first edition of Techniques in Extracorporeal Circulation,      pened in both spheres in the past 50 years. With that in
published in 1976. The change in authorship and content        mind, we would like to follow in John Hunt’s illustrious
of the subsequent three editions reflects the evolution of      footsteps and, as he did in The Ascent of Everest, dedicate
the speciality over a generation of cardiac surgery.           this book … ‘To those who made it possible’.
   Who, reading the first edition, would have predicted
that the fourth edition, 27 years later, would contain chap-                               Philip Kay and Chris Munsch
ters on robotic surgery and off-pump surgery? Will the                                                           Leeds
combined threat of increasing angioplasty and off-pump                                                            2003
Preface to Third Edition




The heart is a unique organ, simple in concept as a mus-        The first edition of this book, edited by Mr M. Ionescu
cle pump, but complex in design and function. Heart          and Mr G. Wooller 16 years ago, laid a solid foundation for
failure, from whatever cause, remains the commonest          the student of extracorporeal circulation. It was followed
cause of death in the western world.                         by a second edition five years later and, after a further 11
    It is now almost 100 years since von Reyn contravened    years, by this edition. Yet progress in this field is so fast that
the dictates of Billroth, risked ‘loosing the esteme of      many of the new developments in this book were not even
his colleagues’ and successfully operated on the heart.      contemplated in the final ‘future developments’ chapter of
However, cardiac surgery proceeded at a slow pace until      the second edition, and so I am sure will be the case for the
the development of the extracorporeal circuit. Thereafter    fourth edition. Similarly, much progress has been made
the understanding of the complex anatomy, biochem-           during the three years it has taken to produce this book.
istry, pharmacology and physiology of the heart has          Nevertheless, this edition, like the original, provides a firm
enabled us to take great strides in the complex repair       basis for doctors, nurses, perfusionists and physicians’
work that is now so common place in the operating            assistants alike, all students of the extracorporeal circula-
room. Concomitantly, advances in rheology and material       tion and its ever increasing number of applications.
science have provided a wider safety margin and there-          I hope that it will stimulate its readers to continuing
fore expanded the number of patients able to benefit          the pioneering interface between the lone surgeon and
from cardiac surgery. It is these advances that form the     the increasingly complex machinery that surrounds him.
basis of the third edition of Techniques in Extracorporeal
Circulation.                                                                                                        P.H. Kay
Preface to Second Edition




The preface to the first edition of this book was preceded      theoretical aspects of extracorporeal circulation but does
by Michelangelo’s humble remark ‘ancora imparo’. Even          not necessarily provide final answers.
for the contents of this small book on techniques in              In an effort to keep abreast of the many advances
extracorporeal circulation it proved its timeless veracity     which have occurred, a number of additional topics have
as we ‘continue to learn’.                                     been included in this present edition. Several new, out-
   The first edition, however, despite many short-com-          standing contributors have participated, whilst the great
ings, has fulfilled its role.                                   majority of those chapters which appeared in the first
   During the past few years the energetic clinical and        edition have been updated or augmented.
research activities have led to many advances and have            Despite the awareness of discontinuity and reitera-
further broadened the concept of artificial circulation         tion, this second edition of Techniques in Extracorporeal
and oxygenation so that an increasing number of sub-           Circulation retains the structure of most modern books
specialties are now attaining a certain contour.               by being comprised of a series of individual chapters.
   In recent years, several areas of extracorporeal circula-      I wish to express my enthusiasm for the privilege of
tion have assumed increasing importance. The progress          editing this text and gratefully acknowledge the out-
made in the field of ischaemic heart disease and the            standing contributions of the authors who have joined in
major impact of myocardial protection through cardio-          this endeavour.
plegia are only two of the most obvious examples.                 I should like to thank Miss Wendy Lawrence for the
Refinements in the construction and performance of              complex and seemingly endless secretarial work.
bubble oxygenators and the introduction of disposable             My sincere appreciation is extended to Messrs
membrane oxygenating systems have changed the tech-            Butterworths for their unfailing attention to detail and
niques of heart–lung bypass and broadened its scope.           for the maintenance of the high standards for which they
   Many pioneers in these fields have discovered and redis-     are known.
covered noteworthy features of great clinical significance.
   This second edition attempts to summarize the major
technical problems and touches on some of the more                                                    Marian I. Ionescu
Preface to First Edition



ancora imparo                                                  single volume standard current techniques in extracorpor-
Michelangelo Buonarotti                                        eal circulation along with the more recent developments
                                                               in this field. This is an attempt to answer some of the
Extracorporeal circulation with an artificial heart-lung        innumerable practical problems associated with the rou-
machine has established itself as the routine adjunct to       tine use of artificial circulation and oxygenation and to
intracardiac and vascular surgery. Since its introduction      present some models of standardized techniques.
in 1953, this method has been progressively improved by           A major problem with such a book is to decide what to
development and simplification of the equipment and by          include and what to omit. We are aware that omissions
better understanding of the body response to the alter-        have been made, but we have aimed to keep the subject
ations induced by the use of artificial perfusions.             matter strictly circumscribed in the interest of text size and
   The method, established in the experimental labora-         readability. The esoteric has been omitted on purpose and
tory, has been perfected by clinical use. For many poorly      emphasis is placed on the current practical methodology.
understood aspects the method has continued to be                 Advances in modern surgical and perfusion techniques
investigated in the laboratory, where answers and solu-        have been developed to such a degree that an entirely new
tions have been found for innumerable bewildering and          spectrum of problems evolves with each new develop-
knotty clinical problems.                                      ment. Such rapid changes and improvements will certainly
   A superficial look at today’s methods would give the         call for another publication in the near future, and this is
uninformed the general impression that no substantial          another reason for limiting the size of this book.
progress has been made in the past ten years. For example,        Since this is a multi-authored book and the chapters
the same principle of bubble oxygenation used at the begin-    are designed to be read separately, some reiteration has
ning of the open-heart surgery era is almost universally       been inevitable, although an attempt was made to avoid
employed today. The same may be said for metallic pros-        repetition.
thetic valves with a ball or disc occluder mechanism. The         Major attention has been focused on the cardio-vascular
best method for ‘myocardial preservation’ during open-         system, the lung, the renal function and haematological
heart surgery is yet to be established and the Montagues of    changes. Clearly the brain, liver, gut, muscle masses and
hypothermia still have to convince the Capulets of coronary    reticuloendothelial system are of great importance in the
perfusion of the veracity and superiority of their principle   body response to extracorporeal circulation, but the meas-
just as much as they had to ten years ago.                     urement of their function in the cardiovascular patient is
   On closer examination, one realizes that during the         at the moment largely in the realm of the investigator.
past ten years an enormous wealth of data and knowledge        Although the principles and techniques described have
has been accumulated and the application of this know-         become routine for practical purposes, they are by no
ledge has made clinical perfusions incomparably better         means beyond challenge. As William Hazlitt put it ‘when
and safer. The results of cardiovascular surgery obtained      a thing ceases to be a subject of controversy, it ceases to be
today, whether in the newborn or the elderly, for great        a subject of interest’.
arteries or coronary arteries, in routine cases or in emer-       The Editors join the contributors in hoping that this
gencies, when compared with the results obtained only          volume will be of interest to those active in the field of
ten years ago, are the best proof of progress and continu-     cardiovascular surgery.
ous improvement in extracorporeal circulation.                    We take great pleasure in expressing our thanks to
   During the past few years many new and exciting prin-       Dr Frank Gerbode for kindly writing the Foreword of
ciples and techniques based on extracorporeal circulation      this work. We are grateful to Miss Nancy Evans for her
have been brought into clinical use. Deep hypothermia for      continuous and enthusiastic help.
heart surgery in the newborn, prolonged extracorporeal            Completion of this book within a few months was
oxygenation-perfusion for pulmonary insufficiency and           promised, but it has taken almost two years and we
intra-aortic balloon pumping for circulatory assistance are    appreciate the forbearance and continuous help of our
some of the major achievements of the past decade.             publishers, Butterworth and Co. Ltd.
   The paucity of books devoted exclusively to extracor-
poreal circulation has prompted us to bring together in a                                                      M.I. Ionescu
Acknowledgements




Philip H Kay and Christopher M Munsch would like to          We are also indebted to everyone at Hodder Arnold who
thank the individual chapter authors for their skilful and   worked so hard to make it happen.
patient contributions to this beautifully crafted book.
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1
A brief history of bypass

ANIL KUMAR MULPUR AND CHRISTOPHER M MUNSCH


Introduction                                             1    Hypothermia                                                     4
The first heart–lung machine                              1    Heparin                                                         4
Oxygenation                                              2    Summary                                                         5
Pumping the blood                                        4    Further reading                                                 5
Haemodilution                                            4    References                                                      5




INTRODUCTION                                                  THE FIRST HEART–LUNG MACHINE

The history of cardiopulmonary bypass is, in many ways,       The concept of cardiopulmonary bypass is rightly
a miniature representation of the history of all surgery.     credited to Dr John Heysham Gibbon Jr (1903–1973).
The discoveries and the experiments, the longed-for           Dr Gibbon came from a family of doctors and was work-
triumphs and the all too frequent disasters, the blood        ing with Dr Churchill at Harvard Medical School. In
(especially the blood), the sweat and the tears of years of   October 1930 a female patient, who had undergone
surgical endeavour are all mirrored in the evolution of       a cholecystectomy two weeks before, collapsed due to
cardiac surgery. In 1880 Billroth stated that ‘any surgeon    pulmonary thrombo-embolism. Dr Churchill did under-
who wishes to preserve the respect of his colleagues,         take a pulmonary embolectomy on her, but in that era
would never attempt to suture the heart’. What was once       there were no survivors of this procedure in the USA.
considered hazardous, outrageous or even sacrilegious         Dr Gibbon looked after this patient in her last stages.
has now become routine and commonplace. There is no           This led to the genesis of an idea that Dr Gibbon outlined
doubt that the bravery and determination of the pion-         (Gibbon, 1970):
eers (both doctors and patients) has seen bypass develop
rapidly. Most cardiac surgeons these days prefer their           During that long night, helplessly watching the patient
heart surgery to be, if not boring, then at least not too        struggle for life as her blood became darker and veins
exciting.                                                        more distended, the idea naturally occurred to me that if
   Much has been written about the history of cardio-            it were possible to remove continuously some of the blue
pulmonary bypass and the development of cardiac sur-             blood from the patient’s swollen veins, put oxygen into
gery. The interested reader, particularly one with an eye        that blood and allow carbon dioxide to escape from it,
for the flamboyant, is recommended to study Landmarks             and then to inject continuously the now-red blood back
in Cardiac Surgery (Westaby and Bosher, 1997). This              into the patient’s arteries, we might have saved her life.
chapter could never compete in such exalted company              We would have bypassed the obstructing embolus and
and, in fact, subsequent chapters in the current book            performed part of the work of the patient’s heart and
will cover the historical background to specific areas of         lungs outside the body.
bypass in greater detail. Therefore, this introductory
chapter will simply document some of the major mile-          Dr Gibbon set out to devise a mechanical pump oxy-
stones in the (relatively short) journey from impossible      genator and, with his wife Mary Hopkinson, spent the
to mundane.                                                   next 20 years in pursuit of his goal. The heart–lung
2 A brief history of bypass


machine Model I was built by International Business               carbon dioxide removal. It seemed that what was actually
Machines (IBM) laboratories in 1949, by which time                needed was in fact a lung, either natural or artificial.
Gibbon was able to keep small dogs on bypass with only
10 per cent mortality, and by 1951 a machine for clinical
use was built. In 1953, using Model II, an atrial septal defect   The lungs
was closed successfully on cardiopulmonary bypass, for
the first time in history.                                         In 1956, Campbell reported successful cardiac surgical
   However, this momentous occasion had much of                   procedures in humans on bypass, by use of dog lungs
the feel of a false dawn. Gibbon operated on four further         (Campbell et al., 1956), and Mustard and co-workers
patients, all of whom died. He became disillusioned with          reported the use of scrupulously washed monkey lungs
the technique and critical of his own surgical abilities,         for oxygenation in human cardiac surgery in 1954. These
and called a halt to the programme.                               experiments, although seemingly moderately successful,
   All was not lost though, and John Kirklin, using a             were extremely complicated and soon abandoned
modified Model II, operated on eight patients with intra-          (Mustard et al., 1954; Mustard and Thomson, 1957). In
cardiac defects, with just four deaths, only one of which         1958 Drew used patients’ own lungs as the oxygenator,
he attributed directly to complications of bypass. The            with a combination of right and left heart bypass and
impetus had been regained and further progress in                 profound hypothermia (Drew and Anderson, 1959). With
mechanical cardiopulmonary bypass was stimulated.                 this technique, the time available for surgical repair was
                                                                  increased and more complex abnormalities could be
                                                                  addressed (Westaby and Bosher, 1997).
OXYGENATION

The historical development of oxygenators is summar-              Cross-circulation
ized in Fig. 1.1. Many methods of oxygenating the blood
have been investigated over the years. Early experiments          Andreasen and Watson conducted some canine experi-
involved actually injecting oxygen directly into the blood        ments in Kent, England and published their results
stream, whilst other equally inventive techniques of oxy-         in 1952. If the superior vena caval entry into the heart
genation were attempted and soon abandoned. These                 was snared at the cavo-atrial junction, no dog survived
early experiments focused purely on artificial oxygen-             beyond 10 minutes. If the snare was distal to azygos vein,
ation, without concerning themselves with the need for            allowing azygos venous flow into the right atrium, there


                                  Oxygenators



             Natural                                Artificial
           oxygenators                             oxygenators



  Heterologous                    Homologous
  oxygenators                     oxygenators



    Dog                  Monkey
   lungs                  lungs



                                  Controlled
                               cross-circulation




                                Bubble                Film         Membrane
                                                                                 Figure 1.1 Development of oxygenators for
                              oxygenator           oxygenator      oxygenator
                                                                                 cardiopulmonary bypass.
Oxygenation 3


was adequate flow to prevent cerebral damage for up to           sheet oxygenator, and improved the DeWall–Lillehei
40 minutes. This finding challenged the existing notion          bubble oxygenator further, which meant that the bub-
that flows equivalent to normal cardiac output were nec-         ble oxygenator became available as a sterile sealed unit.
essary to prevent damage to vital centres, and suggested        This development played a significant role in expanding
that in fact only eight to nine per cent of normal flow was      cardiac surgery beyond Minnesota (Gott et al., 1957a,b).
needed (Andreasen and Watson, 1952).                               Naef (1990) wrote:
   Lillehei, at the University of Minnesota, recognized
the significance of these findings for cardiac surgery               the home made helix reservoir bubble oxygenator of
(Lillehei, 2000). After a series of careful experiments            DeWall and Lillehei, first used clinically on May 13, 1955,
(Cohen and Lillehei, 1954), he introduced the technique            went to conquer the world and helped many teams to
of ‘controlled cross-circulation’. As the name suggests,           embark on the correction of malformations inside the
the technique used an adult whose circulation was con-             heart in a precise and unhurried manner. The road to open-
nected to a child patient, the adult subject acting as the         heart surgery had been opened.
oxygenator. In Lillehei’s own words, ‘controlled’ refers to
the use of a pump to precisely control the balance of the       DeWall went on to develop the bubble oxygenator fur-
volume of blood flowing into and out of the donor and            ther and introduced the oxygenator and omnithermic
the patient.                                                    heat exchanger in a disposable and pre-sterilized poly-
   This was a daring and innovative idea. These oper-           carbonate unit (DeWall et al., 1966). With the advent of
ations carried a theoretical 200 per cent mortality. In fact,   better technology, and safer operations under more con-
there was no donor mortality in 45 operations. Of 45            trolled circumstances, surgeons were, for the first time,
patients, 28 survived and were discharged from hospital,        appreciating the intricacies of pathologic anatomy in
many surviving for as long as 30 years (Lillehei et al.,        congenital and acquired heart disease, and leading to the
1986). Controlled cross-circulation, however, was limited       development of surgical techniques in the present form.
in its use and could not fully support the circulation. At
the same time, more conventional forms of extracorporeal
circulation were being developed, and before long Lillihei      Film oxygenators
himself went on to develop a new pump oxygenator.
                                                                Gibbon developed a film oxygenator with a rapidly
                                                                revolving vertical cylinder. The film itself was a thin film
Bubble oxygenators                                              of blood on the metal plate, where the oxygenation took
                                                                place. In the first model, there was no reservoir. Gas flow
Simple measures to bubble oxygen into the blood met             included a 95 per cent oxygen and five per cent carbon
with disastrous results because of air embolism. Clark and      dioxide mixture at 5 L/min. The venous and arterial sides
co-workers had a breakthrough in 1950, when they started        of the oxygenators had roller pumps and blood passed
to use small glass beads or rods coated with DC Antifoam        through tubing, which was immersed in a waterbath
A, made by the Dow Corning Company in Michigan                  to maintain a constant temperature throughout the per-
(Clark et al., 1950). This concept was further developed by     fusion. Flows of up to 500 mL/min were generated with
Lillehei and DeWall, who used a spiral settling tube with a     the initial model (Gibbon, 1937). Next, a wire mesh was
helical system that largely eliminated bubbles. The initial     introduced to produce a turbulent blood–gas interface
models were sterilized and re-used. Later on, disposable        to improve oxygenation (Gibbon, 1954). This was fur-
bubble oxygenators were developed. The first clinical use        ther improvised at the Mayo Clinic, with 14 wire meshes
of the DeWall–Lillehei bubble oxygenator was on 13 May          enclosed in a lucite case. Blood flowed onto the screens
1955, for a three-year-old child with a ventricular septal      through a series of 0.6 micron slots. Gas flow was 10 L of
defect and pulmonary hypertension. By use of normo-             oxygen, and the carbon dioxide flow was varied depend-
thermia, a Sigmamotor pump and flows of 25–30 mL/kg,             ing on the pH of the blood (Kirklin et al., 1955). However,
Lillehei reported the first success story with the bubble        compared with the DeWall–Lillehei bubble oxygenator,
oxygenator (Lillehei et al., 1956).                             the Mayo Clinic Gibbon film oxygenator, although impres-
    Bubble oxygenators were later refined to serve adult         sive, was handcrafted and expensive, and difficult to use
patients. The Rygg–Kyvsgaard bag (Rygg and Kyvsgaard,           and maintain.
1956) combined the bubbling and settling chambers                   Kay and Cross developed a rotating disk film oxygena-
with a reservoir, all in one plastic bag. Sponges made of       tor in Cleveland, USA. Although this device did become
polyethylene and coated with antifoam agent were used           commercially available, it had serious drawbacks in
for bubble removal. This model was manufactured in              terms of ease of use, massive priming volumes, and diffi-
Denmark. Up to 3 L/min flows were possible. Gott and             culty in cleaning and sterilizing (Cross et al., 1956; Kay
co-workers developed a self-contained unitized plastic          et al., 1956).
4 A brief history of bypass


Membrane oxygenators                                          priming of the cardiopulmonary bypass circuits. DeWall
                                                              and Lillehei subsequently confirmed the benefits of
By 1944, Kolff had refined a cellophane membrane appar-        haemodilution on cardiopulmonary bypass (DeWall and
atus for dialysis as an artificial kidney. He later tried to   Lillehei, 1962; DeWall et al., 1962; Lillehei, 1962). Despite
use this as a membrane oxygenator, but found it to be         abundant literature, the actual degree of acceptable
inefficient (Kolff and Berk, 1944; Kolff and Balzer, 1955).    haemodilution remains controversial even today.
However, Clowes and Neville developed a teflon mem-
brane oxygenator for human usage in 1957. The mem-            HYPOTHERMIA
brane area was 25 m2, but the oxygenator was bulky with
problems of sterilization and assembly (Clowes and
Neville, 1957). Once silicone became available as a mem-      Historically, it is interesting to note that hypothermia
brane with satisfactory permeability to both oxygen and       usage in cardiac surgery precedes the development of
carbon dioxide, Bramson and colleagues (Bramson et al.,       cardiopulmonary bypass. Following his earlier work on
1965) reported a new disposable membrane oxygenator           the treatment of frostbite, William Bigelow had already
with integral heat exchanger. This model had 14 cells,        done extensive experimental work on dogs on the physio-
each having a silicone rubber membrane across which           logical effects of hypothermia (Bigelow et al., 1950). He
diffusion took place. Bodell et al. (1963) proposed the       predicted the possible use of hypothermia in cardiac
use of tubular capillary membranes instead of film, and        surgery thus:
this notion led to the hollow-fibre membrane oxygen-              The use of hypothermia as a form of anesthetic could
ators. Not to be outdone, Lillehei was also associated with      conceivably extend the scope of surgery in many new
the availability of the first compact, disposable and             directions. A state in which the body temperature is low-
commercially manufactured membrane oxygenator for                ered and the oxygen requirements of tissue are reduced to
clinical use (Lande et al., 1967).                               a small fraction of normal would allow exclusion of organs
                                                                 from the circulation for prolonged periods. Such a technic
                                                                 might permit surgeons to operate upon the ‘bloodless
PUMPING THE BLOOD                                                heart’ without recourse to extra corporal pumps, and
                                                                 perhaps allow transplantation of organs.
A critical component of the heart bypass apparatus is         These experiments soon led to the use of hypothermia
some form of efficient atraumatic mechanical pump. A           alone, with inflow occlusion but without cardiopul-
variety of pumping devices was developed before the dou-      monary bypass, for the treatment of atrial septal defects.
ble roller pump became widely used. Dale and Schuster         On 2 September, 1952 Dr F. John Lewis and his team
(1928) developed a diaphragm pump with valved inlet           closed an ostium secundum atrial septal defect in a five-
and outlet ports, but a single pump could not generate        year-old girl on inflow occlusion and moderate total
sufficient flow, so Jongbloed used six pumps of this type in    body hypothermia.
parallel to conduct cardiopulmonary bypass (Jongbloed,           Gollan should be given the credit of working on
1949). In Minnesota, Lillehei’s group initially used a mul-   the concept of combining hypothermia and cardiopul-
ticam activated sigmamotor pump.                              monary bypass, before either actually became clinically
    However, as early as 1934, DeBakey had modified a          applicable (Gollan et al., 1955). Sealy, of Duke University,
previously available Porter–Bradley roller pump for rapid     North Carolina, USA, subsequently employed a combin-
blood transfusion (DeBakey, 1934). This pump was applied      ation of cardiopulmonary bypass and hypothermia for
to cardiopulmonary bypass, and rapidly became – and           the first time in a clinical situation for closure of atrial
remains – the most common type of pump in use for             septal defect and this operation lasted for seven hours
clinical perfusion.                                           and 15 minutes! By 1958, Sealy reported a series of 49
                                                              patients operated on by the combined technique (Sealy
                                                              et al., 1958). As mentioned previously, Drew took the
HAEMODILUTION
                                                              temperature down to 12–15°C and pioneered the con-
                                                              cept of circulatory arrest for cardiac surgery (Drew and
Two major problems were identified in patients after car-      Anderson, 1959).
diopulmonary bypass, namely ‘post-perfusion syndrome’
and ‘homologous blood syndrome’. In the early days
the oxygenators and the circuit were primed with donor
                                                              HEPARIN
blood. Zuhdi et al. (1961a, 1961b), however, developed
the concept of haemodilution with five per cent dextrose       It is almost impossible to imagine the conduct of
and thus began the usage of clear priming or crystalloid      cardiopulmonary bypass without the use of heparin.
References 5


The discovery of heparin is an interesting story (Jaques,       REFERENCES
1978), and in the history of medicine is quoted as a classi-
cal example of ‘serendipity’. Horace Well coined this term
                                                                Andreasen, A.T., Watson, F. 1952: Experimental cardiovascular
in 1754; ‘The Three Princes of Serendip’, was the title of a
                                                                    surgery. British Journal of Surgery 39, 548–51.
fairy tale in which the heroes were always making fortu-        Bigelow, W.G., Lindsay, W.K., Greenwood, W.F. 1950: Hypothermia:
nate discoveries (Concise OED, 2002). McLean was a med-             its possible role in cardiac surgery. An investigation of factors
ical student working with W. H. Howell in 1916, on the              governing survival in dogs at low body temperatures. Annals of
nature of ether soluble procoagulants, and by chance dis-           Surgery 132, 849–66.
covered a phospholipid anti-coagulant. Some years later         Bodell, B.R., Head, J.M., Head, L.R. 1963: A capillary membrane
a water-soluble mucopolysaccharide was identified by                 oxygenator. Journal of Thoracic and Cardiovascular Surgery 46,
Howell, and this proved to be heparin (McLean, 1959).               639–50.
Even today, except in very rare circumstances, where it         Bramson, M.L., Osborn, J.J., Main, F.B. et al. 1965: A new
cannot be used, because of genuine hypersensitivity or              disposable membrane oxygenator with integral heat
                                                                    exchanger. Journal of Thoracic and Cardiovascular Surgery 50,
heparin-induced thrombocytopenias, heparin and car-
                                                                    391–400.
diopulmonary bypass are inseparable.
                                                                Campbell, G.S., Crisp, N.W., Brown, E.B. Jr. 1956: Total cardiac
                                                                    bypass in humans utilising a pump and heterologous lung
                                                                    oxygenator (dog lung). Surgery 40, 364–71.
SUMMARY                                                         Clark, L.C., Gollan, F., Gupta, V.B. 1950: The oxygenation of blood by
                                                                    gas dispersion. Science III, 85–7.
                                                                Clowes, G.H.S., Neville, W.E. 1957: Further development of a blood
The history of cardiopulmonary bypass is a truly fascinat-
                                                                    oxygenator dependent upon the diffusion of gases through
ing story. Against many difficulties, with a combination
                                                                    plastic membranes. Transactions of the American Society for
of perseverance, intellect and skill, the early pioneers            Artificial Internal Organs 3, 53–8.
developed the art of cardiopulmonary bypass as we see           Cohen, M., Lillehei, C.W. 1954: A quantitative study of the ‘azygos
it today. A large range of congenital and acquired heart            factor’ during vena caval occlusion in the dog. Surgery,
diseases can be treated surgically with the aid of cardiopul-       Gynecology and Obstetrics 98, 225–32.
monary bypass. With advancing technology, cardiopul-            Concise Oxford English Dictionary (Tenth edition). 2002: Oxford:
monary bypass continues to develop. Advances such as                Oxford University Press.
heparin-bonded circuits, methods minimizing systemic            Cross, F.S., Berne, R.M., Hirose, Y. et al. 1956: Description and
inflammatory response, percutaneous applications of                  evaluation of a rotating disc type reservoir oxygenator.
bypass, port access surgery, continued improvement in               Surgical Forum 7, 274–8.
                                                                Dale, H.H., Schuster, E.A. 1928: A double perfusion pump. Journal
oxygenators and ventricular assist devices; all these and
                                                                    of Physiology 64, 356–64.
others will change the picture of cardiopulmonary bypass
                                                                DeBakey, M.E. 1934: A simple continuous flow blood transfusion
beyond recognition, and the present day will then become            instrument. New Orleans Med Surg J 87, 386–9.
the history.                                                    DeWall, R., Lillehei, C.W. 1962: Simplified total body perfusion-
                                                                    reduced flows, moderate hypothermia and hemodilution.
Key early events in the development of                              Journal of the American Medical Association 179, 430–4.
                                                                DeWall, R., Lillehei, C.W., Sellers, R. 1962: Hemodilution perfusion
extracorporeal circulation
                                                                    for open heart surgery. New England Journal of Medicine 266,
                                                                    1078–84.
•   1916: McLean; discovery of heparin.                         DeWall, R.A., Bentley, D.J., Hirose, M. et al. 1966: A temperature
•   1930: Gibbon; initial idea of cardiopulmonary bypass.           controlling (omnithermic) disposable bubble oxygenator for
•   1934: DeBakey; concept of roller pump for                       total body perfusion. Diseases of the Chest 49, 207–11.
    extracorporeal circulation.                                 Drew, C., Anderson, I.M. 1959: Profound hypothermia in cardiac
•   1950: Bigelow; profound hypothermia for open-                   surgery. Lancet April 11: 748–50.
    heart surgery.                                              Gibbon, J.H. Jr. 1937: Artificial maintenance of circulation during
•   1953: Gibbon; first successful clinical use of                   experimental occlusion of pulmonary artery. Archives of Surgery
                                                                    34, 1105–31.
    cardiopulmonary bypass.
                                                                Gibbon, J.H. Jr. 1954: Application of mechanical heart and
•   1954: Lillehei; use of controlled cross-circulation.
                                                                    lung apparatus to cardiac surgery. Minnesota Medicine 37,
                                                                    171–80.
                                                                Gibbon, J.H. Jr. 1970: The development of the heart–lung
FURTHER READING                                                     apparatus. Rev Surg 27, 231–44.
                                                                Gollan, F., Phillips, R., Grace, J.T. et al. 1955: Open left heart
• General reading: Westaby, S., Bosher, C. 1997: Landmarks in       surgery in dogs during hypothermic asystole with and without
    cardiac surgery. Oxford: ISIS Medical Media, 1997. A very       extracorporeal circulation. Journal of Thoracic Surgery 30,
    well-written book on the history of cardiac surgery.            626–30.
6 A brief history of bypass

Gott, V.L., DeWall, R.A., Paneth, M. et al. 1957a: A self contained,      Lillehei, C.W., DeWall, R.A., Read, R.C. et al. 1956: Direct vision
     disposable oxygenator of plastic sheet for intracardiac surgery.          intracardiac surgery in man using a simple, disposable artificial
     Thorax 12, 1–9.                                                           oxygenator. Diseases of the Chest 29, 1–8.
Gott, V.L., Sellers, R.D., DeWall, R.A. et al. 1957b: A disposable        Lillehei, C.W., Varco, R.L., Cohen, M. et al. 1986: The first open heart
     unitized plastic sheet oxygenator for open heart surgery.                 repairs of ventricular septal defect, atrioventricular communis,
     Diseases of the Chest 32, 615–25.                                         and tetralogy of Fallot using extracorporeal circulation by cross
Jaques, L.B. 1978: Addendum: the discovery of heparin. Seminars in             circulation: a 30 year follow up. Annals of Thoracic Surgery
     Thrombosis and Hemostasis 4, 350–3.                                       41, 4–21.
Jongbloed, J. 1949: The mechanical heart/lung system. Surgery,            McLean, J. 1959: The discovery of heparin. Circulation XIX, 75–78.
     Gynecology and Obstetrics 89, 684–91.                                Mustard, W.T., Thomson, J.A. 1957: Clinical experience with the
Kay, E.B., Zimmerman, H.A., Berne, R.M. et al. 1956: Certain clinical          artificial heart–lung preparation. Journal of the Canadian
     aspects in the use of the pump oxygenator. Journal of the                 Medical Association 76, 265–9.
     American Medical Association 162, 639–41.                            Mustard, W.T., Chute, A.L., Keith, J.D. et al. 1954: A surgical
Kirklin, J.W., Dushane, J.W., Patrick, R.T. et al. 1955: Intracardiac          approach to transposition of the great vessels with
     surgery with the aid of a mechanical pump oxygenator system               extracorporeal circuit. Surgery 36, 39–51.
     (Gibbon type): report of eight cases. Proceedings of Staff           Naef, A.P. 1990: The story of thoracic surgery. Toronto: Hografe &
     Meetings of the Mayo Clinic 30, 201–7.                                    Huber, 113–19.
Kolff, W.J., Balzer, R. 1955: The artificial coil lung. Transactions       Rygg, H., Kyvsgaard, E. 1956: A disposable polyethylene oxygenator
     of the American Society for Artificial Internal Organs 1,                  system applied in the heart/lung machine. Acta Chirurgica
     39–42.                                                                    Scandinavica 112, 433–7.
Kolff, W.J., Berk, H.T.J. 1944: Artificial kidney: dialyser with a great   Sealy, W.C., Brown, I.W., Young, W.G. 1958: A report on the use of
     area. Acta Medica Scandinavica 117, 121–34.                               both extracorporeal circulation and hypothermia for open-heart
Lande, A.J., Dos, S.J., Carlson, R.G. et al. 1967: A new membrane              surgery. Annals of Surgery 147, 603–13.
     oxygenator–dialyser. Surgical Clinics of North America 47,           Westaby, S., Bosher, C. 1997: Landmarks in cardiac surgery. Oxford:
     1461–70.                                                                  ISIS Medical Media.
Lillehei, C.W. 1962: Hemodilution perfusion for open heart surgery.       Zuhdi, N., McCollough, B., Carey, J. et al. 1961a: Hypothermic
     Use of low molecular weight dextran and five per cent dextrose.            perfusion for open heart surgical procedures – report of the use
     Surgery 52, 30–31.                                                        of a heart–lung machine primed with five per cent dextrose in
Lillehei, C.W. 2000: Historical development of cardiopulmonary                 water inducing hemodilution. J Int Coll Surg 35, 319–26.
     bypass in Minnesota. In: G.P. Gravlee et al. (eds),                  Zuhdi, N., McCollough, B., Carey, J. et al. 1961b: Double helical
     Cardiopulmonary bypass: principles and practice                           reservoir heart–lung machine designed for hypothermic
     (second edition). Baltimore, MD: Lippincott Williams &                    perfusion primed with five per cent glucose in water inducing
     Wilkins, 3–21.                                                            hemodilution. Archives of Surgery 82, 320–5.
2
Design and principles of the extracorporeal circuit

MEDTRONIC, INC., A MANUFACTURER OF TECHNOLOGIES FOR EXTRACORPOREAL CIRCULATION


History of cardiopulmonary bypass                        7   Heat exchangers                                           14
Bubble oxygenators                                       8   Tubing                                                    15
Membrane oxygenators                                     8   Myocardial protection                                     15
Components of the extracorporeal circuit                 9   Biocompatibility                                          16
Pumps                                                    9   Adequacy of perfusion                                     21
Venous reservoir                                        12   Acknowledgements                                          21
Cardiotomy reservoirs                                   13   References                                                21




                                                                  the extracorporeal circuit are adequately perfused
 KEY POINTS                                                       with oxygenated blood by continual monitoring of
                                                                  blood flow rate, perfusion pressure, acid/base
                                                                  state, oxygen consumption, coagulation and renal
 •   The essential components of the clinical
                                                                  function.
     extracorporeal circuit are a pump (artificial heart),
     an oxygenator (artificial lung), a reservoir and the
     tubing to connect these devices, although systems
     are now emerging without traditional reservoirs.
                                                             HISTORY OF CARDIOPULMONARY BYPASS
 •   Additional components include a heat exchanger,
     a system for myocardial protection, and gas and
     emboli filters. Secondary suction circuits may be        The first proposal for artificial circulation was put for-
     added for salvaging shed blood, and venting the         ward by Le Gallois in 1812 when he perfused rabbit
     heart.                                                  brains through carotid arteries. Between 1848 and 1853
 •   The current generation of membrane oxygenators          Brown Sequard showed that dark venous blood, when
     incorporating reservoirs and heat exchangers            exposed to air and shaken, turned bright red. He further
     provide safety, efficacy and ease of use.                demonstrated the feasability of perfusing isolated brain
 •   Centrifugal pumps are compact, durable, easy to         specimens with this ‘arterialized’ blood. The first bubble
     set up and cause minimal haemolysis compared            oxygenator, utilizing the same principle of mixing venous
     with roller pumps. While their cost is certainly        blood with air, was assembled by Shroder in 1882. And
     higher than a simple length of roller pump tubing,      then, two years later, von Frey and Gruber created the first
     it may be more than offset by savings in ventilatory    membrane oxygenator, in which the direct blood–air
     and ICU time, as well as overall hospital stay.         interface of the bubbler design was avoided.
 •   A body of published evidence, as well as extensive         In 1900, Howell and colleagues discovered the anti-
     clinical experience by surgeons and perfusionists,      coagulant properties of heparin. Without the risk of cata-
     supports the value of heparin-based biosurfaces         strophic clotting within the bypass circuit, it was now
     for thrombo-resistance and biocompatibility             possible to expose the blood to extended periods of
     during extracorporeal circulation.                      extracorporeal circulation.
 •   It is the responsibility of the perfusionist to            The first clinical application of extracorporeal circula-
     ensure that the organs of the body supported by         tion was performed by Dr John Gibbon, Massachusetts
8 Design and principles of the extracorporeal circuit


          Table 2.1 Developmental history of oxygenators

          Non-membrane oxygenators
          1937 Gibbon                         Blood filter – pulmonary embolus
          1951 Dennis/Bjork                   Rotating screen and cardiopulmonary bypass rotating disk
          1955 Lillehei/DeWall                First bubble oxygenator with helix reservoir
          1956 Kay/Cross                      Refind disk oxygenator for up to 4000 mL of venous blood
          1956 Rygg/Kyvsgaard                 First disposable plastic bag oxygenator, Polystan (Rygg Bag)
          1962 Cooley/Beall                   Proposed use of commercially available disposable bubble oxygenators
                                              (Travenol Bag)
          1966    DeWall/Najafe/Roden         First disposable hard shell oxygenator (polycarbonate) with built-in heat
                                              exchanger (Bentley Labs)
          Membrane oxygenators
          1955 Kolff/Balzfer                  Oxygenated blood through polyethylene membrane (animals)
          1956 Kolff                          First coiled polyethylene tube oxygenator
          1958 Clowes                         First to test Teflon as membrane plate oxygenator
          1968 Lande                          Methyl silicone folded plate membrane oxygenator (Lande/Edwards)
          1969 Pierce                         Co-polymer of dimethyl siloxan and polycarbonate
          1969 Pierce                         Pierce-GE
          1971 Kolobow                        Silicone rubber reinforced by nylon mesh rolled or coiled (SciMed–Kolobow)
          1972 Eiseman/Spencer                Expanded (Teflon) membrane sheets (Travenol/TMO)
          1975 Travenol Labs                  Polypropylene (expanded) plate or sheets (TMO)
          1985 J& J Cardiopulmonary           First hollowfibre polypropylene oxygenator (Maxima)


General Hospital who, in 1953, successfully repaired an             into the bubble chamber. The early Bentley model has
atrial septal defect in a young female. Despite subsequent          the heat exchanger located within the arterial reservoir.
setbacks, Dr C Walton Lillehei of the University of                    Bubble oxygenators are efficient and easy to use. Unfor-
Minnesota and several others persevered in further                  tunately, the nature of the foaming/defoaming process
developing the techniques and equipment, with Lillehei              causes significant haemolysis, which becomes clinically
using the first bubble oxygenator in 1955.                           significant after only a few hours. Bubble oxygenators also
   The bubble oxygenator, first developed by Rygg, was               present a higher risk of micro- and macro-air embolism:
produced commercially by 1956. The years since have seen            the defoaming process is imperfect, and inadvertent
myriad refinements and improvements in oxygenator and                emptying of the arterial reservoir can lead to massive
other component designs, which unlike the early systems             amounts of air being pumped directly to the patient, at
are now completely disposable. A brief history of the               least when roller pumps are used. Further, because of the
development of oxygenators is summarized in Table 2.1.              bubbling process, it is not considered safe to blend oxy-
                                                                    gen with air (since nitrogen bubbles would be so much
                                                                    less soluble) making independent control of pO2 and
BUBBLE OXYGENATORS
                                                                    pCO2 impossible. This would also necessitate the mixing
                                                                    of small amounts of carbon dioxide with the oxygen to
Bubble oxygenators were the first design to be commer-               prevent the pCO2 from falling too far. For these reasons,
cially available in completely disposable form, and were            bubblers are rarely used today. Several safe, efficient
in wide use throughout the world for more than 46 years.            membrane oxygenators currently dominate the market.
A ‘bubbler’ usually consists of an integrated design, incorp-
orating the oxygenator, heat exchanger, arterial reservoir
                                                                    MEMBRANE OXYGENATORS
and cardiotomy filter in one unit. The unit functions by
passing incoming venous blood over a perforated or
porous sparger plate, through which oxygen is passed,               Membrane oxygenators of various designs have been
turning the venous blood into a foam of variously sized             used sporadically since the mid-1950s, but it was not
bubbles. As oxygen diffuses across the bubble surfaces              until 19 years ago that relatively low-prime volume, easy-
into the blood, and conversely, as excess carbon dioxide            to-use units became commercially available. In the mem-
diffuses from the blood into the bubbles, the blood is              brane oxygenator, the ventilating gas is separated from the
arterialized. The blood is then passed through a silicone-          blood by a semi-permeable membrane fabricated from
based defoaming medium, collects in an arterial reser-              polypropylene, or in one case, silicone rubber. Unlike bub-
voir section and is returned to the patient. The heat               ble oxygenators, there is no direct contact between the
exchanger in most bubble oxygenators was incorporated               blood and ventilating gas. Gas exchange is accomplished
Pumps 9


                                                                  For routine use, the micro-porous polypropylene
                                                               membrane, with its lower blood volume, is considered to
                                                               be more versatile and easier to prime and use. In this
                                                               design, the material is manufactured with tiny holes, too
                                                               small for blood to pass through but large enough to allow
                                                               gas transfer. The material can be fabricated in sheet form
                                                               or more commonly, in tubular or ‘microfibre’ form. In
                                                               most cases, the micro-fibres are arranged – much like the
                                                               relationship between blood and gas in the alveoli – to
                                                               allow blood to flow around the outside of the tubes while
                                                               the ventilating gas passes through the lumen of the tubes.
                                                               Although the arrangement has been reversed in some
                                                               units, this configuration is by far the most common and
                                                               considered by most practitioners to be more physiological
                                                               and less damaging to the formed elements of the blood.
                                                                   Modern membrane oxygenators often incorporate
                                                               an integral heat exchanger where blood can be cooled
                                                               or warmed before being ventilated. The Medtronic
                                                               AFFINITY® oxygenator is an example of the latest in
                                                               membrane/heat exchanger design and can be used with
                                                               or without the integral cardiotomy/venous reservoir
                                                               (Fig. 2.2).


                                                               COMPONENTS OF THE EXTRACORPOREAL
                                                               CIRCUIT

                                                               The extracorporeal system consists of interconnected
                                                               devices for the oxygenation and circulation of the blood,
                                                               temporarily replacing the function of the heart and lungs.
                                                               The main components of the circuit (Fig. 2.3) are a pump
                                                               (artificial heart), an oxygenator (artificial lung), venous
Figure 2.1 Kolobow/SciMed/Medtronic paediatric membrane        and cardiotomy reservoirs (sometimes integrated), a heat
oxygenators. Photo © copyright Medtronic, Inc.                 exchanger (usually integrated with the oxygenator), a sys-
                                                               tem for myocardial protection (cardioplegia), gas and
by diffusion across the membrane, driven by the partial        emboli filters, and the tubing to connect these devices.
pressure gradients of dissolved gases between the blood        Typical secondary circuits include suction, provided by
side of the membrane and the gas side. This same mech-         roller pumps or a vacuum source, for salvaging shed blood,
anism drives respiration in the natural lung, making the       and venting to prevent distension of the left ventricle.
membrane oxygenator a much more physiologic substi-
tute than the bubbler for artificial ventilation. Since there
is no foaming/defoaming process, it is safe to blend air       PUMPS
with the oxygen, making independent control of pO2 and
pCO2 possible.
                                                               While the oxygenator performs the ventilatory task of
   Most commercially available membrane oxygenators
                                                               the lungs on cardiopulmonary bypass, the arterial pump
use silicone rubber or micro-porous polypropylene. The
                                                               takes over for the heart. Its sole function is to provide an
best-known example of a silicone device is the Medtronic/
                                                               adequate flow of oxygenated blood to the patient’s arter-
Kolobow design, in which a long narrow sheet of silicone
                                                               ial circulation. The main technical requirements of an
rubber is wound spirally along with spacer/support
                                                               arterial pump are as follows:
material to form two independent pathways for blood
and gas. These devices are available in various sizes to       1   Wide flow range (up to 7ϩ L/min).
accommodate different patients, from small neonates to         2   Low haemolytic effect.
large adults (Fig. 2.1). They are biocompatible, minimize      3   Minimum turbulence and blood stagnation.
damage to the blood and are the membrane of choice for         4   Simplicity and safety of use.
long-term ventilatory assistance.                              5   Cost-effectiveness.
10 Design and principles of the extracorporeal circuit




                                                                                   Figure 2.2 AFFINITY® adult hollow fibre
                                                                                   oxygenator with integrated CVR. Photo
                                                                                   © copyright Medtronic, Inc.




Of the myriad arterial pump designs that were applied to      order to minimize the inevitable resultant haemolysis,
extracorporeal circulation in the early years, only two are   the rollers are adjusted axially so that the pump is slightly
in widespread use today. Worldwide, just over half of car-    underocclusive. (This is defined as allowing a 1 cm/min
diopulmonary bypass procedures are performed with             drop along a 1 m high saline column in 3/8-inch tubing.)
roller pumps, the remainder use centrifugal pumps.            Flow rate in a roller pump is a derived value, calculated
                                                              from the stroke volume multiplied by the revolutions per
                                                              minute (RPM).
Roller pumps                                                     The roller pump is a simple, inexpensive, easy-to-use
                                                              mechanism. One must keep in mind, however, that it is a
The roller pump (Fig. 2.4) consists of a semi-circular sta-   positive-displacement pump. A line restriction upstream
tor, within which is mounted a rotor with twin rollers        will create an excessive vacuum, leading to degassing of
placed at 180° to each other. The blood tubing is             the blood and generation of a ‘bubble train’ inside the
compressed between the stator and the rotor. Since one        tubing. Conversely, a line restriction downstream will
roller is engaged with the stator just before the other       lead to immediate pressure build-up, with possible dire
roller leaves the semi-circle, flow is unidirectional. In      consequences depending on the source of the obstruction.
Pumps 11




                                                        Arterial cannula     Vent catheter
                                                                                                                        Cardictomy

                                Cardioplegia cannula


  Bio Trend                                                         Sucker
                     Arterial       Venous          Venous
                     SAT            SAT/HCT     return catheter                         MYOtherm XP                                  Autolog


                                                 Affinity CVR
                 Affinity                     Cardiotomy/Venous
                 arterial                          reservoir
                  filter                                                                       Cardioplegia
                                                                                               solution                       Sequestra 1000
                                             Affinity          Bio-
                                           oxygenator          probe




     Heater/cooler                                                                                                                    HMS
                                              Bio-pump




Figure 2.3 Components of the extracorporeal circuit. Schematic © copyright Medtronic, Inc.




                                                                                                      Figure 2.4 Roller pump head. Photo
                                                                                                      © copyright Medtronic, Inc.



A roller pump displaces air as effectively as blood, so that                   Centrifugal pumps
it is possible, for instance in the event of inadvertent
emptying of a hard shell venous reservoir, to pass massive                     The centrifugal pump is essentially a vortex generator.
amounts of air downstream towards the patient. Several                         By spinning an impeller (which may consist of vanes or, in
techniques and systems are utilized to mitigate against                        the case of the Medtronic Bio-Pump® Centrifugal Blood
such a disaster, such as reservoir level sensors, in-line air                  Pump, nested cones) within a housing at high speed, an
detectors, membrane oxygenators and arterial filters.                           area of low pressure is created in the centre, and higher
12 Design and principles of the extracorporeal circuit


                                                                imparted to the blood by the hydrofoil configuration of
                                                                the vanes. This is efficient, but can create turbulence on the
                                                                trailing edges of these vanes. In the Medtronic Bio-Pump®
                                                                design (Fig. 2.5 (a) and (b)) energy is imparted strictly by
                                                                viscous drag inherent in the blood itself, minimizing tur-
                                                                bulence. An inherent safety feature of centrifugal pumps is
                                                                their inability to pump very large amounts of air. When air
                                                                fills the pump chamber, the pump is not able to develop
                                                                sufficient pressure to expel it against the backpressure of
                                                                the extracorporeal circuit.
                                                                    Whatever the impeller design, centrifugal pumps are
                                                                all classified as non-positive displacement pumps – they
                                                                will respond to changes in both pre-load and after-load
                                                                with changes in flow rate, much as the native heart does.
                                                                    Centrifugal pumps require in-line monitoring of the
                                                                flow rate that is accomplished in the Medtronic system,
                                                                for example, by electromagnetic induction. Other sys-
                                                                tems use an ultrasonic probe to detect flow. The in-line
                                                                flow measurement allows accurate adjustment of the
                                                                pump speed when necessary to regulate flow in the case
                                                                of changes in pre-load and after-load.
                                                                    Centrifugal pumps are very practical. They are com-
                                                                pact, durable, easy to set up, and cause minimal
                                                                haemolysis compared with roller pumps. While their cost
                                                                is certainly higher than a simple length of roller pump
(a)                                                             tubing, it may be more than offset by savings in ven-
                                                                tilatory and ICU time, as well as overall hospital stays
                                                                that have been demonstrated in numerous clinical studies
                                                                (Morgan et al., 1998).



                                                                VENOUS RESERVOIR

                                                                The general functions of the venous reservoir are to
                                                                accumulate blood from the patient’s venous system and
                                                                to remove both air and microaggregates present in venous
                                                                blood. Venous reservoirs may be either rigid (hard shell)
                                                                or soft (bag).


                                                                Rigid reservoir

                                                                A rigid reservoir consists of a clear plastic shell, vented
                                                                to the atmosphere either by basic design or integral
(b)                                                             valve, with a provision for defoaming and gross-filtering
                                                                (100– 200 ␮) of incoming venous blood. Typical reservoir
Figure 2.5 (a) The nested cones design within the Medtronic     capacity may range from 1 L to 4.5 L (Fig. 2.6).
Bio-Pump®; (b) BPX-80 adult Bio-Pump®. Photos © copyright
Medtronic, Inc.
                                                                Soft reservoir
pressure is generated along the outside circumference.
Blood is drawn axially into the centre by the vortex and        The soft or ‘bag’ reservoir is constructed of soft PVC with
expelled under pressure through a port oriented tangen-         a 100–200 ␮ filtering screen. Typical reservoir capacity
tial to the axis of rotation. With the vane design, energy is   ranges between 200 mL and 3.0 L (Fig. 2.7).
Cardiotomy reservoirs 13




Figure 2.6 Hard shell reservoir. Photo © copyright
Medtronic, Inc.


    Hard shell reservoirs are easy to use and offer the
advantage of integration with the cardiotomy function,
simplifying the circuit. They can handle incoming venous
air with ease. With simple modifications, hard shell reser-
voirs can be used for vacuum-assisted venous drainage.
Their principal disadvantage is that it is very possible to
empty the reservoir and pass air to the arterial pump,         Figure 2.7 Soft reservoir bag. Photo © copyright Medtronic, Inc.
which, if it is a roller pump, will pass the air downstream.
This risk can be mitigated somewhat with the use of reser-
voir level sensors and in-line air detectors, which may or
may not shut the arterial pump off automatically.
                                                               CARDIOTOMY RESERVOIRS
    Bag reservoirs can be slightly more cumbersome to
use since incoming venous air does not vent automat-           Blood from the cardiotomy suckers and vents is most
ically and must be actively aspirated from the bag. Also,      often delivered to the cardiotomy reservoir. This serves as
they require a separate hard shell cardiotomy reservoir to     a storage area and also filters the large number of solid
handle returning cardiotomy suction blood and left ven-        and gaseous micro-emboli. The rigid reservoir is made of
tricle vent return. Many practitioners consider them           polycarbonate, with ports that direct incoming blood
safer than hard shell reservoirs since, when maintained        through both defoaming layers and micro-aggregate
properly air-free, bag reservoirs will not allow massive air   filters of between 20 ␮ and 40 ␮ (Fig. 2.8).
embolism, because the soft bag simply collapses upon              Another option with growing acceptance is to
emptying, presenting nothing for the arterial pump to          deliver suction blood to a cell-saving device (Fig. 2.9).
pass. The soft shell system also may be preferable because     Here, the red cells can be separated from the activated
of the elimination of the air–blood interface found in         platelets, white cells and plasma before returning them
open, hard shell systems.                                      to the patient. It is common practice today to integrate
14 Design and principles of the extracorporeal circuit




                                                                                    Figure 2.8 Cardiotomy reservoirs. Photo
                                                                                    © copyright Medtronic, Inc.




these cardiotomy functions with a hard shell venous            which have their strengths and weaknesses. Aluminum
reservoir.                                                     has by far the best heat exchange performance, but is not
                                                               biocompatible unless coated, which degrades its per-
                                                               formance somewhat. Plastic is inexpensive, but has rela-
                                                               tively poor heat transfer properties and requires large
HEAT EXCHANGERS                                                surface areas. Stainless steel seems to be the most popular
                                                               because of its combination of good heat exchange coeffi-
During cardiopulmonary bypass the temperature of the           cient, ease of fabrication in either pleated or tubular
perfusate may be adjusted to improve myocardial protec-        form, and biocompatibility.
tion and optimize the operating conditions for the                To adjust the temperature of the perfusate, water of
patient. This is accomplished within the extracorporeal        variable temperatures is circulated through the heat
circuit by one or more heat exchangers that are com-           exchanger, cooling or warming the perfusate as the clin-
posed of two pathways, one for the perfusate and one for       ical situation dictates. To further enhance efficiency, the
water. These pathways are separated by material that           water flows in the opposite direction relative to the per-
allows efficient thermal exchange between the fluids. The        fusate, maximizing the temperature differential through-
material may be plastic, aluminum or stainless steel, all of   out the transit.
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Techniques in extra corporeal circulation

  • 1.
  • 4. Techniques in extracorporeal circulation FOURTH EDITION Edited by PHILIP H KAY MA DM FRCS Consultant Cardiothoracic Surgeon, Yorkshire Heart Centre, The General Infirmary, Leeds, UK and CHRISTOPHER M MUNSCH ChM FRCS (C/Th) Consultant Cardiothoracic Surgeon, Yorkshire Heart Centre, The General Infirmary, Leeds, UK A member of the Hodder Headline Group LONDON
  • 5. First published in 1976 by Butterworth-Heinemann Ltd, Linacre House, Jordan Hill, Oxford, OX2 8DP. This edition published in Great Britain in 2004 by Arnold, a member of the Hodder Headline Group, 338 Euston Road, London NW1 3BH http://www.arnoldpublishers.com First published 1976 Second edition 1981 Reprinted 1982 Third edition 1992 Reprinted 1993 Fourth edition 2004 Distributed in the United States of America by Oxford University Press Inc., 198 Madison Avenue, New York, NY10016 Oxford is a registered trademark of Oxford University Press © 2004 Arnold All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronically or mechanically, including photocopying, recording or any information storage or retrieval system, without either prior permission in writing from the publisher or a licence permitting restricted copying. In the United Kingdom such licences are issued by the Copyright Licensing Agency: 90 Tottenham Court Road, London W1T 4LP. Whilst the advice and information in this book are believed to be true and accurate at the date of going to press, neither the author[s] nor the publisher can accept any legal responsibility or liability for any errors or omissions that may be made. In particular (but without limiting the generality of the preceding disclaimer) every effort has been made to check drug dosages; however, it is still possible that errors have been missed. Furthermore, dosage schedules are constantly being revised and new side-effects recognized. For these reasons the reader is strongly urged to consult the drug companies’ printed instructions before administering any of the drugs recommended in this book. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress ISBN 0 340 80723 7 1 2 3 4 5 6 7 8 9 10 Commissioning Editor: Joanna Koster Development Editor: Sarah Burrows Project Editor: Zelah Pengilley Production Controller: Deborah Smith Cover Design: Lee-May Lim Indexer: Laurence Errington Typeset in 10/12 pt Minion by Charon Tec Pvt Ltd, Chennai, India Printed and bound in Great Britain by Butler & Tanner Ltd What do you think about this book? Or any other Arnold title? Please send your comments to feedback.arnold@hodder.co.uk
  • 6. Contents Contributors vii Foreword xi Preface to Fourth Edition – 50 years on xiii Preface to Third Edition xiv Preface to Second Edition xv Preface to First Edition xvi Acknowledgements xvii 1 A brief history of bypass 1 Anil Kumar Mulpur and Christopher M Munsch 2 Design and principles of the extracorporeal circuit 7 Medtronic, Inc., A Manufacturer of Technologies for Extracorporeal Circulation 3 Physiology and pathophysiology of extracorporeal circulation 23 Jonathan AJ Hyde and Ralph E Delius 4 Anaesthesia for cardiopulmonary bypass 57 Linda Nel and John WW Gothard 5 Monitoring and safety in cardiopulmonary bypass 76 Jonathan M Johnson, Stephen Robins and Jonathan A J Hyde 6 Priming fluids for cardiopulmonary bypass 99 Piet W Boonstra and Y John Gu 7 Filters in cardiopulmonary bypass 108 Farah NK Bhatti and Timothy L Hooper 8 The inflammatory response to cardiopulmonary bypass 117 Saeed Ashraf 9 Pulsatile cardiopulmonary bypass 133 Terry Gourlay and Kenneth M Taylor 10 Cardiopulmonary bypass and the brain 148 G Burkhard Mackensen, Hilary P Grocott and Mark F Newman
  • 7. vi Contents 11 Cardiopulmonary bypass in children with congenital heart disease 177 Carin van Doorn and Martin Elliott 12 Intraoperative myocardial protection 184 John WC Entwistle III and Andrew S Wechsler 13 Blood conservation 210 Mike Cross 14 Mechanical circulatory support 236 Stephen Westaby and Satoshi Saito 15 Extracorporeal membrane oxygenation 254 Scott K Alpard, Dai H Chung and Joseph B Zwischenberger 16 The extended use of the extracorporeal circuit 292 Philip H Kay, Anil Kumar Mulpur, Dumbor Ngaage, Samir Shah, Kieran Horgan, John Pollitt and Stephen D Hansbro 17 Cardiopulmonary bypass during Port-access™ and robotic surgery 298 Alan P Kypson and W Randolph Chitwood Jr 18 Cardiac surgery without cardiopulmonary bypass 315 Joseph P McGoldrick 19A The development of clinical perfusion education and standards in the UK and Ireland 332 Michael Whitehorne 19B Standards, guidelines and education in clinical perfusion: the European perspective 337 Ludwig K Von Segesser 19C Perfusion education in the USA at the turn of the twentieth century 341 Alfred H Stammers Index 345
  • 8. Contributors Scott K Alpard MD Mike Cross Surgical Research Fellow, Consultant Anaesthetist, Division of Cardiothoracic Surgery, Yorkshire Heart Centre, University of Texas Medical Branch, The General Infirmary at Leeds, Galveston, TX, USA Leeds, UK Saeed Ashraf FRCS(CTh) MD Ralph E Delius MD Consultant Cardiothoracic Surgeon, Children’s Hospital of Michigan, Regional Cardiothoracic Centre, Detroit, MI, US The Morriston Hospital, and Honorary Senior Lecturer, University of Swansea, Carin van Doorn Swansea, UK Senior Lecturer in Cardiothoracic Surgery, Farah NK Bhatti University College London, Specialist Registrar in Cardiothoracic Surgery, and Honorary Consultant Cardiothoracic Surgeon, Wythenshawe Hospital, Cardiothoracic Unit, Manchester, UK Great Ormond Street Hospital for Children, London, UK Piet W Boonstra Department of Cardiothoracic Surgery, Martin Elliott University Hospital, Consultant Cardiothoracic Surgeon, Groningen, The Netherlands Cardiothoracic Unit, Great Ormond Street Hospital for Children, Walt Carpenter London, UK Director of Cardiopulmonary R&D, Medtronic Perfusion Systems, John WC Entwistle III MD PhD Minneapolis, MN, USA Assistant Professor of Cardiothoracic Surgery, Department of Cardiothoracic Surgery, W Randolph Chitwood Jr MD Drexel University College of Medicine, Senior Associate Vice Chancellor and Director, Philadelphia, PA, USA North Carolina Cardiovascular Institute, Professor and Chairman, Professor of Surgery, John WW Gothard FRCA Chief, Division of Cardiothoracic and Vascular Surgery, Consultant Anaesthetist, The Brody School of Medicine, Royal Brompton Hospital, East Carolina University, London, UK Greenville, NC, USA Terry Gourlay PhD BSc (Hons) CBiol MIBiol ILTHE FRSH Dai H Chung MD British Heart Foundation Perfusion Specialist, Assistant Professor of Surgery, Department of Cardiothoracic Surgery, Chief, Section of Pediatric Surgery, NHLI, Department of Surgery, Imperial College Medical School, University of Texas Medical Branch, Hammersmith Hospital Campus, Galveston, TX, USA London, UK
  • 9. viii Contributors Hilary P Grocott MD FRCPC G Burkhard Mackensen MD Associate Professor, Assistant Professor, Department of Anesthesiology, Klinik für Anaesthesiologie, Duke Heart Center, Technische Universität München, Duke University Medical Center, Klinikum rechts der Isar, Durham, NC, USA München, Germany Joseph P McGoldrick MD FRCS Y John Gu Consultant Cardiothoracic Surgeon, Department of Cardiothoracic Surgery, The Yorkshire Heart Centre, University Hospital, The General Infirmary at Leeds, Groningen, The Netherlands Leeds, UK Stephen D Hansbro Anil Kumar Mulpur MS MCh FRCS (Edin) Department of Clinical Perfusion, FRCS (Glasgow) FRCS C/Th (Edin) FETCS Leeds General Infirmary, Consultant Cardiothoracic Surgeon, Leeds, UK Sri Sathya Sai Institute of Higher Medical Sciences, Whitefield, Bangalore, India Timothy L Hooper Christopher M Munsch ChM FRCS (C/Th) Consultant Cardiac Surgeon, Consultant Cardiothoracic Surgeon, Wythenshawe Hospital, Department of Cardiothoracic Surgery, Manchester, UK The Yorkshire Heart Centre, The General Infirmary, Kieran Horgan Leeds, UK Department of General Surgery, Leeds General Infirmary, Linda Nel FRCA Leeds, UK Consultant Anaesthetist, Southampton University Hospitals Trust, Jonathan AJ Hyde MD FRCS(CTh) Southampton, UK Consultant Cardiac Surgeon, Mark F Newman MD Royal Sussex County Hospital, Professor and Chairman, Brighton, UK Department of Anesthesiology, Duke Heart Center, Jonathan M Johnson BSc ACP Duke University Medical Center, Chief Clinical Perfusionist, Durham, NC, USA Royal Sussex County Hospital, Brighton, UK Dumbor Ngaage Department of Cardiothoracic Surgery, Leeds General Infirmary, Bruce Jones Leeds, UK Cardiopulmonary Product Manager, Medtronic Perfusion Systems, John Pollitt Minneapolis, MN, USA Department of General Surgery, Leeds General Infirmary, Philip H Kay MA DM FRCS Leeds, UK Consultant Cardiothoracic Surgeon, Stephen Robins PgDip AACP The Yorkshire Heart Centre, Chief Clinical Perfusionist, The General Infirmary, New Cross Hospital, Leeds, UK Wolverhampton, UK Alan P Kypson MD Satoshi Saito MD PhD Assistant Professor of Surgery, Senior Clinical Research Fellow, Division of Cardiothoracic Surgery, Department of Cardiothoracic Surgery, Brody School of Medicine, Oxford Heart Centre, East Carolina University, John Radcliffe Hospital, Greenville, NC, USA Oxford, UK
  • 10. Contributors ix Ludwig K Von Segesser Andrew S Wechsler MD Service de Chirurgie Cardio-Vasculaire, Professor and Chairman, Centre Hospitalier Universitaire Vaudois (CHUV), Department of Cardiothoracic Surgery, Lausanne, Switzerland Drexel University College of Medicine, Philadelphia, PA, USA Samir Shah Department of Cardiothoracic Surgery, Stuart Welland Leeds General Infirmary, European Marketing Manager, Leeds, UK Medtronic Europe Sàrl, Tolochenaz, Switzerland Alfred H Stammers MSA CCP Chief Perfusionist, Stephen Westaby PhD FETCS MS Department of Surgery, Consultant Cardiac Surgeon, Geisinger Medical Center, Department of Cardiothoracic Surgery, Danville, PA, USA Oxford Heart Centre, John Radcliffe Hospital, Editor, Journal of Extracorporeal Technology Oxford, UK Jeanne Stanislawski Michael Whitehorne MSC ACP FCCPS Cardiopulmonary Product Manager, Consultant Clinical Perfusion Scientist, Medtronic Perfusion Systems, Department of Cardiothoracic Surgery, Minneapolis, MN, USA King’s College Hospital, Wendy Svee London, UK Cardiopulmonary Product Manager, Joseph B Zwischenberger MD Medtronic Perfusion Systems, Professor of Surgery, Medicine, and Radiology, Minneapolis, MN, USA Director, General Thoracic Surgery and ECMO Programs, Kenneth M Taylor Division of Cardiothoracic Surgery, Professor of Cardiac Surgery, University of Texas Medical Branch, Department of Cardiothoracic Surgery, Galveston, TX, USA NHLI, Imperial College Medical School, Hammersmith Hospital Campus, London, UK
  • 12. Foreword I am most grateful to the editors for their invitation to preference for medical revascularisation (percutaneous write the foreword for this – the fourth edition of transluminal coronary angioplasty, stents, the expanding Techniques of Extracorporeal Circulation. My office book- range of percutaneous coronary interventions) at the case currently contains the three previous editions, and expense of what we used to consider the unassailable if I am not considered presumptuous, I look forward to gold standard: conventional coronary artery bypass graft adding a copy of this fourth edition. surgery. John Gibbon received international acclaim for his For cardiopulmonary bypass and the perfusion pro- courage and determination on the 50th anniversary of fessionals, the challenge was different, but no less daunt- that historic open-heart operation in Philadelphia on ing: would off-pump coronary bypass render the use of May 5th 1953 when the heart–lung machine was used cardiopulmonary bypass in coronary surgery obsolete? successfully in a patient for the first time. Fifty years does One might reasonably assume that now is not the time to not seem to me to be that long, although when I was invest in cardiopulmonary bypass – far too risky! I beg younger (i.e. not over 50) my opinions were different. It to differ, however. I would suggest that now is precisely is always fascinating to hear graphic personal accounts of the time for investment in cardiopulmonary bypass. those early days of cardiopulmonary bypass where the It should, however, be specifically targeted investment, challenges seemed almost insuperable. a balanced investment portfolio. Things are very different 50 years on. The technology First, the further continual refinement of cardio- and the practice of cardiopulmonary bypass have been pulmonary bypass remains as great a challenge and an refined to an exceptional degree. The benefits to the car- opportunity now as it was in the 1950s. Developments in diac surgical patients and the cardiac team of surgeons, medicine in general (particularly including molecular anaesthetists, perfusionists and nursing staff have been science and genetics/genomics) offer great potential to incalculable. I was asked a few years ago to give a talk on increase our understanding of the fundamental patho- the topic: ‘Can cardiopulmonary bypass become more physiological mechanisms of cardiopulmonary bypass patient friendly?’ I observed at the start of the talk that and consequently introduce more effective preventative cardiopulmonary bypass had been a great friend to cardiac and therapeutic strategies. surgical patients and to cardiac surgeons and their col- Second, we need to broaden our horizons as far as leagues, and that John Gibbon would be turning over in extracorporeal circulation is concerned. Its potential roles his grave at the very thought of the topic I had been given. in other forms of surgery (both in cardiac and non- I was exaggerating of course, and Gibbon and his fellow cardiac) in local circulations and in systemic circulatory pioneers would be the very last to encourage complacency and respiratory support present a wealth of opportunities. regarding cardiopulmonary bypass. As it so happened, the Third and finally, to quote the UK Prime Minister Tony following year I was asked to speak to another question: ‘Is Blair (who interestingly was born on May 5th 1953 – cardiopulmonary bypass in 2001 as good as it gets?’ I trust Gibbon’s historic day) ‘... education, education, education’. you will already have worked out that I was somewhat We need to apply ourselves, both individually and in the negative in my response to that proposition! medical and perfusion schools of the future. New science They say that things come along in threes – and it fell brings with it new terminologies – we need to learn the to me to address another cardiopulmonary bypass languages. Then we can communicate with the basic sci- related question in 2002. ‘Would you invest in cardiopul- entists, with molecular experts, with geneticists and who monary bypass in 2002?’ was the title. I found this exer- knows who else! cise particularly interesting. By then, cardiac surgery and It may be a daunting prospect for us, but spare a cardiopulmonary bypass were each facing major chal- thought also for the basic scientists – when have they ever lenges to their future importance. For cardiac surgery, before been visited by an enthusiastic perfusionist or the challenge – indeed the threat – was the increasing cardiac surgical trainee?
  • 13. xii Foreword So these are the challenges, and the opportunities. honourable tradition of risk-takers. As one of the North This textbook will help considerably. Philip Kay and American insurance corporations proclaims in its adver- Chris Munsch have brought into this book the right tising: ‘the only risk is not to take one’. subjects and the right authors. This book contains a lot of John Gibbon would profoundly agree with that. information, which can be a launch pad for new ideas and new questions. Professor Kenneth M Taylor MD FRCS Are there risks? Of course there are! We must never FRCSE FESC FETCS FSA forget, however, that in cardiac surgery we come from an BHF Professor of Cardiac Surgery
  • 14. Preface to Fourth Edition — 50 years on In May 1953 Edmund Hilary and Sherpa Tensing became surgery make the clinical perfusionist obsolete? Whatever the first men to stand on the summit of Mount Everest. happens there is no doubt that clinical perfusion will con- In that same month came John Gibbon’s moment of tri- tinue to evolve and develop. We believe that this fourth umph, with the first successful use of mechanical car- edition of Techniques in Extracorporeal Circulation diopulmonary bypass in a human patient. deserves a place on the bookshelves of all healthcare pro- The seed had been sown and it subsequently fell to fessionals working in the cardiac surgical operating room. other pioneers to develop the science of extracorporeal We suspect, in an era of electronic communication, that circulation. the bookshelf may well be the first to become obsolete. Leeds was at the forefront of this exciting development Progress in surgery is often compared with moun- and, in 1957, Geoffrey Wooler used cardiopulmonary taineering and exploration (and contributors to this bypass to repair a mitral valve. He then went on to edit the book have themselves used the analogy). A lot has hap- first edition of Techniques in Extracorporeal Circulation, pened in both spheres in the past 50 years. With that in published in 1976. The change in authorship and content mind, we would like to follow in John Hunt’s illustrious of the subsequent three editions reflects the evolution of footsteps and, as he did in The Ascent of Everest, dedicate the speciality over a generation of cardiac surgery. this book … ‘To those who made it possible’. Who, reading the first edition, would have predicted that the fourth edition, 27 years later, would contain chap- Philip Kay and Chris Munsch ters on robotic surgery and off-pump surgery? Will the Leeds combined threat of increasing angioplasty and off-pump 2003
  • 15. Preface to Third Edition The heart is a unique organ, simple in concept as a mus- The first edition of this book, edited by Mr M. Ionescu cle pump, but complex in design and function. Heart and Mr G. Wooller 16 years ago, laid a solid foundation for failure, from whatever cause, remains the commonest the student of extracorporeal circulation. It was followed cause of death in the western world. by a second edition five years later and, after a further 11 It is now almost 100 years since von Reyn contravened years, by this edition. Yet progress in this field is so fast that the dictates of Billroth, risked ‘loosing the esteme of many of the new developments in this book were not even his colleagues’ and successfully operated on the heart. contemplated in the final ‘future developments’ chapter of However, cardiac surgery proceeded at a slow pace until the second edition, and so I am sure will be the case for the the development of the extracorporeal circuit. Thereafter fourth edition. Similarly, much progress has been made the understanding of the complex anatomy, biochem- during the three years it has taken to produce this book. istry, pharmacology and physiology of the heart has Nevertheless, this edition, like the original, provides a firm enabled us to take great strides in the complex repair basis for doctors, nurses, perfusionists and physicians’ work that is now so common place in the operating assistants alike, all students of the extracorporeal circula- room. Concomitantly, advances in rheology and material tion and its ever increasing number of applications. science have provided a wider safety margin and there- I hope that it will stimulate its readers to continuing fore expanded the number of patients able to benefit the pioneering interface between the lone surgeon and from cardiac surgery. It is these advances that form the the increasingly complex machinery that surrounds him. basis of the third edition of Techniques in Extracorporeal Circulation. P.H. Kay
  • 16. Preface to Second Edition The preface to the first edition of this book was preceded theoretical aspects of extracorporeal circulation but does by Michelangelo’s humble remark ‘ancora imparo’. Even not necessarily provide final answers. for the contents of this small book on techniques in In an effort to keep abreast of the many advances extracorporeal circulation it proved its timeless veracity which have occurred, a number of additional topics have as we ‘continue to learn’. been included in this present edition. Several new, out- The first edition, however, despite many short-com- standing contributors have participated, whilst the great ings, has fulfilled its role. majority of those chapters which appeared in the first During the past few years the energetic clinical and edition have been updated or augmented. research activities have led to many advances and have Despite the awareness of discontinuity and reitera- further broadened the concept of artificial circulation tion, this second edition of Techniques in Extracorporeal and oxygenation so that an increasing number of sub- Circulation retains the structure of most modern books specialties are now attaining a certain contour. by being comprised of a series of individual chapters. In recent years, several areas of extracorporeal circula- I wish to express my enthusiasm for the privilege of tion have assumed increasing importance. The progress editing this text and gratefully acknowledge the out- made in the field of ischaemic heart disease and the standing contributions of the authors who have joined in major impact of myocardial protection through cardio- this endeavour. plegia are only two of the most obvious examples. I should like to thank Miss Wendy Lawrence for the Refinements in the construction and performance of complex and seemingly endless secretarial work. bubble oxygenators and the introduction of disposable My sincere appreciation is extended to Messrs membrane oxygenating systems have changed the tech- Butterworths for their unfailing attention to detail and niques of heart–lung bypass and broadened its scope. for the maintenance of the high standards for which they Many pioneers in these fields have discovered and redis- are known. covered noteworthy features of great clinical significance. This second edition attempts to summarize the major technical problems and touches on some of the more Marian I. Ionescu
  • 17. Preface to First Edition ancora imparo single volume standard current techniques in extracorpor- Michelangelo Buonarotti eal circulation along with the more recent developments in this field. This is an attempt to answer some of the Extracorporeal circulation with an artificial heart-lung innumerable practical problems associated with the rou- machine has established itself as the routine adjunct to tine use of artificial circulation and oxygenation and to intracardiac and vascular surgery. Since its introduction present some models of standardized techniques. in 1953, this method has been progressively improved by A major problem with such a book is to decide what to development and simplification of the equipment and by include and what to omit. We are aware that omissions better understanding of the body response to the alter- have been made, but we have aimed to keep the subject ations induced by the use of artificial perfusions. matter strictly circumscribed in the interest of text size and The method, established in the experimental labora- readability. The esoteric has been omitted on purpose and tory, has been perfected by clinical use. For many poorly emphasis is placed on the current practical methodology. understood aspects the method has continued to be Advances in modern surgical and perfusion techniques investigated in the laboratory, where answers and solu- have been developed to such a degree that an entirely new tions have been found for innumerable bewildering and spectrum of problems evolves with each new develop- knotty clinical problems. ment. Such rapid changes and improvements will certainly A superficial look at today’s methods would give the call for another publication in the near future, and this is uninformed the general impression that no substantial another reason for limiting the size of this book. progress has been made in the past ten years. For example, Since this is a multi-authored book and the chapters the same principle of bubble oxygenation used at the begin- are designed to be read separately, some reiteration has ning of the open-heart surgery era is almost universally been inevitable, although an attempt was made to avoid employed today. The same may be said for metallic pros- repetition. thetic valves with a ball or disc occluder mechanism. The Major attention has been focused on the cardio-vascular best method for ‘myocardial preservation’ during open- system, the lung, the renal function and haematological heart surgery is yet to be established and the Montagues of changes. Clearly the brain, liver, gut, muscle masses and hypothermia still have to convince the Capulets of coronary reticuloendothelial system are of great importance in the perfusion of the veracity and superiority of their principle body response to extracorporeal circulation, but the meas- just as much as they had to ten years ago. urement of their function in the cardiovascular patient is On closer examination, one realizes that during the at the moment largely in the realm of the investigator. past ten years an enormous wealth of data and knowledge Although the principles and techniques described have has been accumulated and the application of this know- become routine for practical purposes, they are by no ledge has made clinical perfusions incomparably better means beyond challenge. As William Hazlitt put it ‘when and safer. The results of cardiovascular surgery obtained a thing ceases to be a subject of controversy, it ceases to be today, whether in the newborn or the elderly, for great a subject of interest’. arteries or coronary arteries, in routine cases or in emer- The Editors join the contributors in hoping that this gencies, when compared with the results obtained only volume will be of interest to those active in the field of ten years ago, are the best proof of progress and continu- cardiovascular surgery. ous improvement in extracorporeal circulation. We take great pleasure in expressing our thanks to During the past few years many new and exciting prin- Dr Frank Gerbode for kindly writing the Foreword of ciples and techniques based on extracorporeal circulation this work. We are grateful to Miss Nancy Evans for her have been brought into clinical use. Deep hypothermia for continuous and enthusiastic help. heart surgery in the newborn, prolonged extracorporeal Completion of this book within a few months was oxygenation-perfusion for pulmonary insufficiency and promised, but it has taken almost two years and we intra-aortic balloon pumping for circulatory assistance are appreciate the forbearance and continuous help of our some of the major achievements of the past decade. publishers, Butterworth and Co. Ltd. The paucity of books devoted exclusively to extracor- poreal circulation has prompted us to bring together in a M.I. Ionescu
  • 18. Acknowledgements Philip H Kay and Christopher M Munsch would like to We are also indebted to everyone at Hodder Arnold who thank the individual chapter authors for their skilful and worked so hard to make it happen. patient contributions to this beautifully crafted book.
  • 20. 1 A brief history of bypass ANIL KUMAR MULPUR AND CHRISTOPHER M MUNSCH Introduction 1 Hypothermia 4 The first heart–lung machine 1 Heparin 4 Oxygenation 2 Summary 5 Pumping the blood 4 Further reading 5 Haemodilution 4 References 5 INTRODUCTION THE FIRST HEART–LUNG MACHINE The history of cardiopulmonary bypass is, in many ways, The concept of cardiopulmonary bypass is rightly a miniature representation of the history of all surgery. credited to Dr John Heysham Gibbon Jr (1903–1973). The discoveries and the experiments, the longed-for Dr Gibbon came from a family of doctors and was work- triumphs and the all too frequent disasters, the blood ing with Dr Churchill at Harvard Medical School. In (especially the blood), the sweat and the tears of years of October 1930 a female patient, who had undergone surgical endeavour are all mirrored in the evolution of a cholecystectomy two weeks before, collapsed due to cardiac surgery. In 1880 Billroth stated that ‘any surgeon pulmonary thrombo-embolism. Dr Churchill did under- who wishes to preserve the respect of his colleagues, take a pulmonary embolectomy on her, but in that era would never attempt to suture the heart’. What was once there were no survivors of this procedure in the USA. considered hazardous, outrageous or even sacrilegious Dr Gibbon looked after this patient in her last stages. has now become routine and commonplace. There is no This led to the genesis of an idea that Dr Gibbon outlined doubt that the bravery and determination of the pion- (Gibbon, 1970): eers (both doctors and patients) has seen bypass develop rapidly. Most cardiac surgeons these days prefer their During that long night, helplessly watching the patient heart surgery to be, if not boring, then at least not too struggle for life as her blood became darker and veins exciting. more distended, the idea naturally occurred to me that if Much has been written about the history of cardio- it were possible to remove continuously some of the blue pulmonary bypass and the development of cardiac sur- blood from the patient’s swollen veins, put oxygen into gery. The interested reader, particularly one with an eye that blood and allow carbon dioxide to escape from it, for the flamboyant, is recommended to study Landmarks and then to inject continuously the now-red blood back in Cardiac Surgery (Westaby and Bosher, 1997). This into the patient’s arteries, we might have saved her life. chapter could never compete in such exalted company We would have bypassed the obstructing embolus and and, in fact, subsequent chapters in the current book performed part of the work of the patient’s heart and will cover the historical background to specific areas of lungs outside the body. bypass in greater detail. Therefore, this introductory chapter will simply document some of the major mile- Dr Gibbon set out to devise a mechanical pump oxy- stones in the (relatively short) journey from impossible genator and, with his wife Mary Hopkinson, spent the to mundane. next 20 years in pursuit of his goal. The heart–lung
  • 21. 2 A brief history of bypass machine Model I was built by International Business carbon dioxide removal. It seemed that what was actually Machines (IBM) laboratories in 1949, by which time needed was in fact a lung, either natural or artificial. Gibbon was able to keep small dogs on bypass with only 10 per cent mortality, and by 1951 a machine for clinical use was built. In 1953, using Model II, an atrial septal defect The lungs was closed successfully on cardiopulmonary bypass, for the first time in history. In 1956, Campbell reported successful cardiac surgical However, this momentous occasion had much of procedures in humans on bypass, by use of dog lungs the feel of a false dawn. Gibbon operated on four further (Campbell et al., 1956), and Mustard and co-workers patients, all of whom died. He became disillusioned with reported the use of scrupulously washed monkey lungs the technique and critical of his own surgical abilities, for oxygenation in human cardiac surgery in 1954. These and called a halt to the programme. experiments, although seemingly moderately successful, All was not lost though, and John Kirklin, using a were extremely complicated and soon abandoned modified Model II, operated on eight patients with intra- (Mustard et al., 1954; Mustard and Thomson, 1957). In cardiac defects, with just four deaths, only one of which 1958 Drew used patients’ own lungs as the oxygenator, he attributed directly to complications of bypass. The with a combination of right and left heart bypass and impetus had been regained and further progress in profound hypothermia (Drew and Anderson, 1959). With mechanical cardiopulmonary bypass was stimulated. this technique, the time available for surgical repair was increased and more complex abnormalities could be addressed (Westaby and Bosher, 1997). OXYGENATION The historical development of oxygenators is summar- Cross-circulation ized in Fig. 1.1. Many methods of oxygenating the blood have been investigated over the years. Early experiments Andreasen and Watson conducted some canine experi- involved actually injecting oxygen directly into the blood ments in Kent, England and published their results stream, whilst other equally inventive techniques of oxy- in 1952. If the superior vena caval entry into the heart genation were attempted and soon abandoned. These was snared at the cavo-atrial junction, no dog survived early experiments focused purely on artificial oxygen- beyond 10 minutes. If the snare was distal to azygos vein, ation, without concerning themselves with the need for allowing azygos venous flow into the right atrium, there Oxygenators Natural Artificial oxygenators oxygenators Heterologous Homologous oxygenators oxygenators Dog Monkey lungs lungs Controlled cross-circulation Bubble Film Membrane Figure 1.1 Development of oxygenators for oxygenator oxygenator oxygenator cardiopulmonary bypass.
  • 22. Oxygenation 3 was adequate flow to prevent cerebral damage for up to sheet oxygenator, and improved the DeWall–Lillehei 40 minutes. This finding challenged the existing notion bubble oxygenator further, which meant that the bub- that flows equivalent to normal cardiac output were nec- ble oxygenator became available as a sterile sealed unit. essary to prevent damage to vital centres, and suggested This development played a significant role in expanding that in fact only eight to nine per cent of normal flow was cardiac surgery beyond Minnesota (Gott et al., 1957a,b). needed (Andreasen and Watson, 1952). Naef (1990) wrote: Lillehei, at the University of Minnesota, recognized the significance of these findings for cardiac surgery the home made helix reservoir bubble oxygenator of (Lillehei, 2000). After a series of careful experiments DeWall and Lillehei, first used clinically on May 13, 1955, (Cohen and Lillehei, 1954), he introduced the technique went to conquer the world and helped many teams to of ‘controlled cross-circulation’. As the name suggests, embark on the correction of malformations inside the the technique used an adult whose circulation was con- heart in a precise and unhurried manner. The road to open- nected to a child patient, the adult subject acting as the heart surgery had been opened. oxygenator. In Lillehei’s own words, ‘controlled’ refers to the use of a pump to precisely control the balance of the DeWall went on to develop the bubble oxygenator fur- volume of blood flowing into and out of the donor and ther and introduced the oxygenator and omnithermic the patient. heat exchanger in a disposable and pre-sterilized poly- This was a daring and innovative idea. These oper- carbonate unit (DeWall et al., 1966). With the advent of ations carried a theoretical 200 per cent mortality. In fact, better technology, and safer operations under more con- there was no donor mortality in 45 operations. Of 45 trolled circumstances, surgeons were, for the first time, patients, 28 survived and were discharged from hospital, appreciating the intricacies of pathologic anatomy in many surviving for as long as 30 years (Lillehei et al., congenital and acquired heart disease, and leading to the 1986). Controlled cross-circulation, however, was limited development of surgical techniques in the present form. in its use and could not fully support the circulation. At the same time, more conventional forms of extracorporeal circulation were being developed, and before long Lillihei Film oxygenators himself went on to develop a new pump oxygenator. Gibbon developed a film oxygenator with a rapidly revolving vertical cylinder. The film itself was a thin film Bubble oxygenators of blood on the metal plate, where the oxygenation took place. In the first model, there was no reservoir. Gas flow Simple measures to bubble oxygen into the blood met included a 95 per cent oxygen and five per cent carbon with disastrous results because of air embolism. Clark and dioxide mixture at 5 L/min. The venous and arterial sides co-workers had a breakthrough in 1950, when they started of the oxygenators had roller pumps and blood passed to use small glass beads or rods coated with DC Antifoam through tubing, which was immersed in a waterbath A, made by the Dow Corning Company in Michigan to maintain a constant temperature throughout the per- (Clark et al., 1950). This concept was further developed by fusion. Flows of up to 500 mL/min were generated with Lillehei and DeWall, who used a spiral settling tube with a the initial model (Gibbon, 1937). Next, a wire mesh was helical system that largely eliminated bubbles. The initial introduced to produce a turbulent blood–gas interface models were sterilized and re-used. Later on, disposable to improve oxygenation (Gibbon, 1954). This was fur- bubble oxygenators were developed. The first clinical use ther improvised at the Mayo Clinic, with 14 wire meshes of the DeWall–Lillehei bubble oxygenator was on 13 May enclosed in a lucite case. Blood flowed onto the screens 1955, for a three-year-old child with a ventricular septal through a series of 0.6 micron slots. Gas flow was 10 L of defect and pulmonary hypertension. By use of normo- oxygen, and the carbon dioxide flow was varied depend- thermia, a Sigmamotor pump and flows of 25–30 mL/kg, ing on the pH of the blood (Kirklin et al., 1955). However, Lillehei reported the first success story with the bubble compared with the DeWall–Lillehei bubble oxygenator, oxygenator (Lillehei et al., 1956). the Mayo Clinic Gibbon film oxygenator, although impres- Bubble oxygenators were later refined to serve adult sive, was handcrafted and expensive, and difficult to use patients. The Rygg–Kyvsgaard bag (Rygg and Kyvsgaard, and maintain. 1956) combined the bubbling and settling chambers Kay and Cross developed a rotating disk film oxygena- with a reservoir, all in one plastic bag. Sponges made of tor in Cleveland, USA. Although this device did become polyethylene and coated with antifoam agent were used commercially available, it had serious drawbacks in for bubble removal. This model was manufactured in terms of ease of use, massive priming volumes, and diffi- Denmark. Up to 3 L/min flows were possible. Gott and culty in cleaning and sterilizing (Cross et al., 1956; Kay co-workers developed a self-contained unitized plastic et al., 1956).
  • 23. 4 A brief history of bypass Membrane oxygenators priming of the cardiopulmonary bypass circuits. DeWall and Lillehei subsequently confirmed the benefits of By 1944, Kolff had refined a cellophane membrane appar- haemodilution on cardiopulmonary bypass (DeWall and atus for dialysis as an artificial kidney. He later tried to Lillehei, 1962; DeWall et al., 1962; Lillehei, 1962). Despite use this as a membrane oxygenator, but found it to be abundant literature, the actual degree of acceptable inefficient (Kolff and Berk, 1944; Kolff and Balzer, 1955). haemodilution remains controversial even today. However, Clowes and Neville developed a teflon mem- brane oxygenator for human usage in 1957. The mem- HYPOTHERMIA brane area was 25 m2, but the oxygenator was bulky with problems of sterilization and assembly (Clowes and Neville, 1957). Once silicone became available as a mem- Historically, it is interesting to note that hypothermia brane with satisfactory permeability to both oxygen and usage in cardiac surgery precedes the development of carbon dioxide, Bramson and colleagues (Bramson et al., cardiopulmonary bypass. Following his earlier work on 1965) reported a new disposable membrane oxygenator the treatment of frostbite, William Bigelow had already with integral heat exchanger. This model had 14 cells, done extensive experimental work on dogs on the physio- each having a silicone rubber membrane across which logical effects of hypothermia (Bigelow et al., 1950). He diffusion took place. Bodell et al. (1963) proposed the predicted the possible use of hypothermia in cardiac use of tubular capillary membranes instead of film, and surgery thus: this notion led to the hollow-fibre membrane oxygen- The use of hypothermia as a form of anesthetic could ators. Not to be outdone, Lillehei was also associated with conceivably extend the scope of surgery in many new the availability of the first compact, disposable and directions. A state in which the body temperature is low- commercially manufactured membrane oxygenator for ered and the oxygen requirements of tissue are reduced to clinical use (Lande et al., 1967). a small fraction of normal would allow exclusion of organs from the circulation for prolonged periods. Such a technic might permit surgeons to operate upon the ‘bloodless PUMPING THE BLOOD heart’ without recourse to extra corporal pumps, and perhaps allow transplantation of organs. A critical component of the heart bypass apparatus is These experiments soon led to the use of hypothermia some form of efficient atraumatic mechanical pump. A alone, with inflow occlusion but without cardiopul- variety of pumping devices was developed before the dou- monary bypass, for the treatment of atrial septal defects. ble roller pump became widely used. Dale and Schuster On 2 September, 1952 Dr F. John Lewis and his team (1928) developed a diaphragm pump with valved inlet closed an ostium secundum atrial septal defect in a five- and outlet ports, but a single pump could not generate year-old girl on inflow occlusion and moderate total sufficient flow, so Jongbloed used six pumps of this type in body hypothermia. parallel to conduct cardiopulmonary bypass (Jongbloed, Gollan should be given the credit of working on 1949). In Minnesota, Lillehei’s group initially used a mul- the concept of combining hypothermia and cardiopul- ticam activated sigmamotor pump. monary bypass, before either actually became clinically However, as early as 1934, DeBakey had modified a applicable (Gollan et al., 1955). Sealy, of Duke University, previously available Porter–Bradley roller pump for rapid North Carolina, USA, subsequently employed a combin- blood transfusion (DeBakey, 1934). This pump was applied ation of cardiopulmonary bypass and hypothermia for to cardiopulmonary bypass, and rapidly became – and the first time in a clinical situation for closure of atrial remains – the most common type of pump in use for septal defect and this operation lasted for seven hours clinical perfusion. and 15 minutes! By 1958, Sealy reported a series of 49 patients operated on by the combined technique (Sealy et al., 1958). As mentioned previously, Drew took the HAEMODILUTION temperature down to 12–15°C and pioneered the con- cept of circulatory arrest for cardiac surgery (Drew and Two major problems were identified in patients after car- Anderson, 1959). diopulmonary bypass, namely ‘post-perfusion syndrome’ and ‘homologous blood syndrome’. In the early days the oxygenators and the circuit were primed with donor HEPARIN blood. Zuhdi et al. (1961a, 1961b), however, developed the concept of haemodilution with five per cent dextrose It is almost impossible to imagine the conduct of and thus began the usage of clear priming or crystalloid cardiopulmonary bypass without the use of heparin.
  • 24. References 5 The discovery of heparin is an interesting story (Jaques, REFERENCES 1978), and in the history of medicine is quoted as a classi- cal example of ‘serendipity’. Horace Well coined this term Andreasen, A.T., Watson, F. 1952: Experimental cardiovascular in 1754; ‘The Three Princes of Serendip’, was the title of a surgery. British Journal of Surgery 39, 548–51. fairy tale in which the heroes were always making fortu- Bigelow, W.G., Lindsay, W.K., Greenwood, W.F. 1950: Hypothermia: nate discoveries (Concise OED, 2002). McLean was a med- its possible role in cardiac surgery. An investigation of factors ical student working with W. H. Howell in 1916, on the governing survival in dogs at low body temperatures. Annals of nature of ether soluble procoagulants, and by chance dis- Surgery 132, 849–66. covered a phospholipid anti-coagulant. Some years later Bodell, B.R., Head, J.M., Head, L.R. 1963: A capillary membrane a water-soluble mucopolysaccharide was identified by oxygenator. Journal of Thoracic and Cardiovascular Surgery 46, Howell, and this proved to be heparin (McLean, 1959). 639–50. Even today, except in very rare circumstances, where it Bramson, M.L., Osborn, J.J., Main, F.B. et al. 1965: A new cannot be used, because of genuine hypersensitivity or disposable membrane oxygenator with integral heat exchanger. Journal of Thoracic and Cardiovascular Surgery 50, heparin-induced thrombocytopenias, heparin and car- 391–400. diopulmonary bypass are inseparable. Campbell, G.S., Crisp, N.W., Brown, E.B. Jr. 1956: Total cardiac bypass in humans utilising a pump and heterologous lung oxygenator (dog lung). Surgery 40, 364–71. SUMMARY Clark, L.C., Gollan, F., Gupta, V.B. 1950: The oxygenation of blood by gas dispersion. Science III, 85–7. Clowes, G.H.S., Neville, W.E. 1957: Further development of a blood The history of cardiopulmonary bypass is a truly fascinat- oxygenator dependent upon the diffusion of gases through ing story. Against many difficulties, with a combination plastic membranes. Transactions of the American Society for of perseverance, intellect and skill, the early pioneers Artificial Internal Organs 3, 53–8. developed the art of cardiopulmonary bypass as we see Cohen, M., Lillehei, C.W. 1954: A quantitative study of the ‘azygos it today. A large range of congenital and acquired heart factor’ during vena caval occlusion in the dog. Surgery, diseases can be treated surgically with the aid of cardiopul- Gynecology and Obstetrics 98, 225–32. monary bypass. With advancing technology, cardiopul- Concise Oxford English Dictionary (Tenth edition). 2002: Oxford: monary bypass continues to develop. Advances such as Oxford University Press. heparin-bonded circuits, methods minimizing systemic Cross, F.S., Berne, R.M., Hirose, Y. et al. 1956: Description and inflammatory response, percutaneous applications of evaluation of a rotating disc type reservoir oxygenator. bypass, port access surgery, continued improvement in Surgical Forum 7, 274–8. Dale, H.H., Schuster, E.A. 1928: A double perfusion pump. Journal oxygenators and ventricular assist devices; all these and of Physiology 64, 356–64. others will change the picture of cardiopulmonary bypass DeBakey, M.E. 1934: A simple continuous flow blood transfusion beyond recognition, and the present day will then become instrument. New Orleans Med Surg J 87, 386–9. the history. DeWall, R., Lillehei, C.W. 1962: Simplified total body perfusion- reduced flows, moderate hypothermia and hemodilution. Key early events in the development of Journal of the American Medical Association 179, 430–4. DeWall, R., Lillehei, C.W., Sellers, R. 1962: Hemodilution perfusion extracorporeal circulation for open heart surgery. New England Journal of Medicine 266, 1078–84. • 1916: McLean; discovery of heparin. DeWall, R.A., Bentley, D.J., Hirose, M. et al. 1966: A temperature • 1930: Gibbon; initial idea of cardiopulmonary bypass. controlling (omnithermic) disposable bubble oxygenator for • 1934: DeBakey; concept of roller pump for total body perfusion. Diseases of the Chest 49, 207–11. extracorporeal circulation. Drew, C., Anderson, I.M. 1959: Profound hypothermia in cardiac • 1950: Bigelow; profound hypothermia for open- surgery. Lancet April 11: 748–50. heart surgery. Gibbon, J.H. Jr. 1937: Artificial maintenance of circulation during • 1953: Gibbon; first successful clinical use of experimental occlusion of pulmonary artery. Archives of Surgery 34, 1105–31. cardiopulmonary bypass. Gibbon, J.H. Jr. 1954: Application of mechanical heart and • 1954: Lillehei; use of controlled cross-circulation. lung apparatus to cardiac surgery. Minnesota Medicine 37, 171–80. Gibbon, J.H. Jr. 1970: The development of the heart–lung FURTHER READING apparatus. Rev Surg 27, 231–44. Gollan, F., Phillips, R., Grace, J.T. et al. 1955: Open left heart • General reading: Westaby, S., Bosher, C. 1997: Landmarks in surgery in dogs during hypothermic asystole with and without cardiac surgery. Oxford: ISIS Medical Media, 1997. A very extracorporeal circulation. Journal of Thoracic Surgery 30, well-written book on the history of cardiac surgery. 626–30.
  • 25. 6 A brief history of bypass Gott, V.L., DeWall, R.A., Paneth, M. et al. 1957a: A self contained, Lillehei, C.W., DeWall, R.A., Read, R.C. et al. 1956: Direct vision disposable oxygenator of plastic sheet for intracardiac surgery. intracardiac surgery in man using a simple, disposable artificial Thorax 12, 1–9. oxygenator. Diseases of the Chest 29, 1–8. Gott, V.L., Sellers, R.D., DeWall, R.A. et al. 1957b: A disposable Lillehei, C.W., Varco, R.L., Cohen, M. et al. 1986: The first open heart unitized plastic sheet oxygenator for open heart surgery. repairs of ventricular septal defect, atrioventricular communis, Diseases of the Chest 32, 615–25. and tetralogy of Fallot using extracorporeal circulation by cross Jaques, L.B. 1978: Addendum: the discovery of heparin. Seminars in circulation: a 30 year follow up. Annals of Thoracic Surgery Thrombosis and Hemostasis 4, 350–3. 41, 4–21. Jongbloed, J. 1949: The mechanical heart/lung system. Surgery, McLean, J. 1959: The discovery of heparin. Circulation XIX, 75–78. Gynecology and Obstetrics 89, 684–91. Mustard, W.T., Thomson, J.A. 1957: Clinical experience with the Kay, E.B., Zimmerman, H.A., Berne, R.M. et al. 1956: Certain clinical artificial heart–lung preparation. Journal of the Canadian aspects in the use of the pump oxygenator. Journal of the Medical Association 76, 265–9. American Medical Association 162, 639–41. Mustard, W.T., Chute, A.L., Keith, J.D. et al. 1954: A surgical Kirklin, J.W., Dushane, J.W., Patrick, R.T. et al. 1955: Intracardiac approach to transposition of the great vessels with surgery with the aid of a mechanical pump oxygenator system extracorporeal circuit. Surgery 36, 39–51. (Gibbon type): report of eight cases. Proceedings of Staff Naef, A.P. 1990: The story of thoracic surgery. Toronto: Hografe & Meetings of the Mayo Clinic 30, 201–7. Huber, 113–19. Kolff, W.J., Balzer, R. 1955: The artificial coil lung. Transactions Rygg, H., Kyvsgaard, E. 1956: A disposable polyethylene oxygenator of the American Society for Artificial Internal Organs 1, system applied in the heart/lung machine. Acta Chirurgica 39–42. Scandinavica 112, 433–7. Kolff, W.J., Berk, H.T.J. 1944: Artificial kidney: dialyser with a great Sealy, W.C., Brown, I.W., Young, W.G. 1958: A report on the use of area. Acta Medica Scandinavica 117, 121–34. both extracorporeal circulation and hypothermia for open-heart Lande, A.J., Dos, S.J., Carlson, R.G. et al. 1967: A new membrane surgery. Annals of Surgery 147, 603–13. oxygenator–dialyser. Surgical Clinics of North America 47, Westaby, S., Bosher, C. 1997: Landmarks in cardiac surgery. Oxford: 1461–70. ISIS Medical Media. Lillehei, C.W. 1962: Hemodilution perfusion for open heart surgery. Zuhdi, N., McCollough, B., Carey, J. et al. 1961a: Hypothermic Use of low molecular weight dextran and five per cent dextrose. perfusion for open heart surgical procedures – report of the use Surgery 52, 30–31. of a heart–lung machine primed with five per cent dextrose in Lillehei, C.W. 2000: Historical development of cardiopulmonary water inducing hemodilution. J Int Coll Surg 35, 319–26. bypass in Minnesota. In: G.P. Gravlee et al. (eds), Zuhdi, N., McCollough, B., Carey, J. et al. 1961b: Double helical Cardiopulmonary bypass: principles and practice reservoir heart–lung machine designed for hypothermic (second edition). Baltimore, MD: Lippincott Williams & perfusion primed with five per cent glucose in water inducing Wilkins, 3–21. hemodilution. Archives of Surgery 82, 320–5.
  • 26. 2 Design and principles of the extracorporeal circuit MEDTRONIC, INC., A MANUFACTURER OF TECHNOLOGIES FOR EXTRACORPOREAL CIRCULATION History of cardiopulmonary bypass 7 Heat exchangers 14 Bubble oxygenators 8 Tubing 15 Membrane oxygenators 8 Myocardial protection 15 Components of the extracorporeal circuit 9 Biocompatibility 16 Pumps 9 Adequacy of perfusion 21 Venous reservoir 12 Acknowledgements 21 Cardiotomy reservoirs 13 References 21 the extracorporeal circuit are adequately perfused KEY POINTS with oxygenated blood by continual monitoring of blood flow rate, perfusion pressure, acid/base state, oxygen consumption, coagulation and renal • The essential components of the clinical function. extracorporeal circuit are a pump (artificial heart), an oxygenator (artificial lung), a reservoir and the tubing to connect these devices, although systems are now emerging without traditional reservoirs. HISTORY OF CARDIOPULMONARY BYPASS • Additional components include a heat exchanger, a system for myocardial protection, and gas and emboli filters. Secondary suction circuits may be The first proposal for artificial circulation was put for- added for salvaging shed blood, and venting the ward by Le Gallois in 1812 when he perfused rabbit heart. brains through carotid arteries. Between 1848 and 1853 • The current generation of membrane oxygenators Brown Sequard showed that dark venous blood, when incorporating reservoirs and heat exchangers exposed to air and shaken, turned bright red. He further provide safety, efficacy and ease of use. demonstrated the feasability of perfusing isolated brain • Centrifugal pumps are compact, durable, easy to specimens with this ‘arterialized’ blood. The first bubble set up and cause minimal haemolysis compared oxygenator, utilizing the same principle of mixing venous with roller pumps. While their cost is certainly blood with air, was assembled by Shroder in 1882. And higher than a simple length of roller pump tubing, then, two years later, von Frey and Gruber created the first it may be more than offset by savings in ventilatory membrane oxygenator, in which the direct blood–air and ICU time, as well as overall hospital stay. interface of the bubbler design was avoided. • A body of published evidence, as well as extensive In 1900, Howell and colleagues discovered the anti- clinical experience by surgeons and perfusionists, coagulant properties of heparin. Without the risk of cata- supports the value of heparin-based biosurfaces strophic clotting within the bypass circuit, it was now for thrombo-resistance and biocompatibility possible to expose the blood to extended periods of during extracorporeal circulation. extracorporeal circulation. • It is the responsibility of the perfusionist to The first clinical application of extracorporeal circula- ensure that the organs of the body supported by tion was performed by Dr John Gibbon, Massachusetts
  • 27. 8 Design and principles of the extracorporeal circuit Table 2.1 Developmental history of oxygenators Non-membrane oxygenators 1937 Gibbon Blood filter – pulmonary embolus 1951 Dennis/Bjork Rotating screen and cardiopulmonary bypass rotating disk 1955 Lillehei/DeWall First bubble oxygenator with helix reservoir 1956 Kay/Cross Refind disk oxygenator for up to 4000 mL of venous blood 1956 Rygg/Kyvsgaard First disposable plastic bag oxygenator, Polystan (Rygg Bag) 1962 Cooley/Beall Proposed use of commercially available disposable bubble oxygenators (Travenol Bag) 1966 DeWall/Najafe/Roden First disposable hard shell oxygenator (polycarbonate) with built-in heat exchanger (Bentley Labs) Membrane oxygenators 1955 Kolff/Balzfer Oxygenated blood through polyethylene membrane (animals) 1956 Kolff First coiled polyethylene tube oxygenator 1958 Clowes First to test Teflon as membrane plate oxygenator 1968 Lande Methyl silicone folded plate membrane oxygenator (Lande/Edwards) 1969 Pierce Co-polymer of dimethyl siloxan and polycarbonate 1969 Pierce Pierce-GE 1971 Kolobow Silicone rubber reinforced by nylon mesh rolled or coiled (SciMed–Kolobow) 1972 Eiseman/Spencer Expanded (Teflon) membrane sheets (Travenol/TMO) 1975 Travenol Labs Polypropylene (expanded) plate or sheets (TMO) 1985 J& J Cardiopulmonary First hollowfibre polypropylene oxygenator (Maxima) General Hospital who, in 1953, successfully repaired an into the bubble chamber. The early Bentley model has atrial septal defect in a young female. Despite subsequent the heat exchanger located within the arterial reservoir. setbacks, Dr C Walton Lillehei of the University of Bubble oxygenators are efficient and easy to use. Unfor- Minnesota and several others persevered in further tunately, the nature of the foaming/defoaming process developing the techniques and equipment, with Lillehei causes significant haemolysis, which becomes clinically using the first bubble oxygenator in 1955. significant after only a few hours. Bubble oxygenators also The bubble oxygenator, first developed by Rygg, was present a higher risk of micro- and macro-air embolism: produced commercially by 1956. The years since have seen the defoaming process is imperfect, and inadvertent myriad refinements and improvements in oxygenator and emptying of the arterial reservoir can lead to massive other component designs, which unlike the early systems amounts of air being pumped directly to the patient, at are now completely disposable. A brief history of the least when roller pumps are used. Further, because of the development of oxygenators is summarized in Table 2.1. bubbling process, it is not considered safe to blend oxy- gen with air (since nitrogen bubbles would be so much less soluble) making independent control of pO2 and BUBBLE OXYGENATORS pCO2 impossible. This would also necessitate the mixing of small amounts of carbon dioxide with the oxygen to Bubble oxygenators were the first design to be commer- prevent the pCO2 from falling too far. For these reasons, cially available in completely disposable form, and were bubblers are rarely used today. Several safe, efficient in wide use throughout the world for more than 46 years. membrane oxygenators currently dominate the market. A ‘bubbler’ usually consists of an integrated design, incorp- orating the oxygenator, heat exchanger, arterial reservoir MEMBRANE OXYGENATORS and cardiotomy filter in one unit. The unit functions by passing incoming venous blood over a perforated or porous sparger plate, through which oxygen is passed, Membrane oxygenators of various designs have been turning the venous blood into a foam of variously sized used sporadically since the mid-1950s, but it was not bubbles. As oxygen diffuses across the bubble surfaces until 19 years ago that relatively low-prime volume, easy- into the blood, and conversely, as excess carbon dioxide to-use units became commercially available. In the mem- diffuses from the blood into the bubbles, the blood is brane oxygenator, the ventilating gas is separated from the arterialized. The blood is then passed through a silicone- blood by a semi-permeable membrane fabricated from based defoaming medium, collects in an arterial reser- polypropylene, or in one case, silicone rubber. Unlike bub- voir section and is returned to the patient. The heat ble oxygenators, there is no direct contact between the exchanger in most bubble oxygenators was incorporated blood and ventilating gas. Gas exchange is accomplished
  • 28. Pumps 9 For routine use, the micro-porous polypropylene membrane, with its lower blood volume, is considered to be more versatile and easier to prime and use. In this design, the material is manufactured with tiny holes, too small for blood to pass through but large enough to allow gas transfer. The material can be fabricated in sheet form or more commonly, in tubular or ‘microfibre’ form. In most cases, the micro-fibres are arranged – much like the relationship between blood and gas in the alveoli – to allow blood to flow around the outside of the tubes while the ventilating gas passes through the lumen of the tubes. Although the arrangement has been reversed in some units, this configuration is by far the most common and considered by most practitioners to be more physiological and less damaging to the formed elements of the blood. Modern membrane oxygenators often incorporate an integral heat exchanger where blood can be cooled or warmed before being ventilated. The Medtronic AFFINITY® oxygenator is an example of the latest in membrane/heat exchanger design and can be used with or without the integral cardiotomy/venous reservoir (Fig. 2.2). COMPONENTS OF THE EXTRACORPOREAL CIRCUIT The extracorporeal system consists of interconnected devices for the oxygenation and circulation of the blood, temporarily replacing the function of the heart and lungs. The main components of the circuit (Fig. 2.3) are a pump (artificial heart), an oxygenator (artificial lung), venous Figure 2.1 Kolobow/SciMed/Medtronic paediatric membrane and cardiotomy reservoirs (sometimes integrated), a heat oxygenators. Photo © copyright Medtronic, Inc. exchanger (usually integrated with the oxygenator), a sys- tem for myocardial protection (cardioplegia), gas and by diffusion across the membrane, driven by the partial emboli filters, and the tubing to connect these devices. pressure gradients of dissolved gases between the blood Typical secondary circuits include suction, provided by side of the membrane and the gas side. This same mech- roller pumps or a vacuum source, for salvaging shed blood, anism drives respiration in the natural lung, making the and venting to prevent distension of the left ventricle. membrane oxygenator a much more physiologic substi- tute than the bubbler for artificial ventilation. Since there is no foaming/defoaming process, it is safe to blend air PUMPS with the oxygen, making independent control of pO2 and pCO2 possible. While the oxygenator performs the ventilatory task of Most commercially available membrane oxygenators the lungs on cardiopulmonary bypass, the arterial pump use silicone rubber or micro-porous polypropylene. The takes over for the heart. Its sole function is to provide an best-known example of a silicone device is the Medtronic/ adequate flow of oxygenated blood to the patient’s arter- Kolobow design, in which a long narrow sheet of silicone ial circulation. The main technical requirements of an rubber is wound spirally along with spacer/support arterial pump are as follows: material to form two independent pathways for blood and gas. These devices are available in various sizes to 1 Wide flow range (up to 7ϩ L/min). accommodate different patients, from small neonates to 2 Low haemolytic effect. large adults (Fig. 2.1). They are biocompatible, minimize 3 Minimum turbulence and blood stagnation. damage to the blood and are the membrane of choice for 4 Simplicity and safety of use. long-term ventilatory assistance. 5 Cost-effectiveness.
  • 29. 10 Design and principles of the extracorporeal circuit Figure 2.2 AFFINITY® adult hollow fibre oxygenator with integrated CVR. Photo © copyright Medtronic, Inc. Of the myriad arterial pump designs that were applied to order to minimize the inevitable resultant haemolysis, extracorporeal circulation in the early years, only two are the rollers are adjusted axially so that the pump is slightly in widespread use today. Worldwide, just over half of car- underocclusive. (This is defined as allowing a 1 cm/min diopulmonary bypass procedures are performed with drop along a 1 m high saline column in 3/8-inch tubing.) roller pumps, the remainder use centrifugal pumps. Flow rate in a roller pump is a derived value, calculated from the stroke volume multiplied by the revolutions per minute (RPM). Roller pumps The roller pump is a simple, inexpensive, easy-to-use mechanism. One must keep in mind, however, that it is a The roller pump (Fig. 2.4) consists of a semi-circular sta- positive-displacement pump. A line restriction upstream tor, within which is mounted a rotor with twin rollers will create an excessive vacuum, leading to degassing of placed at 180° to each other. The blood tubing is the blood and generation of a ‘bubble train’ inside the compressed between the stator and the rotor. Since one tubing. Conversely, a line restriction downstream will roller is engaged with the stator just before the other lead to immediate pressure build-up, with possible dire roller leaves the semi-circle, flow is unidirectional. In consequences depending on the source of the obstruction.
  • 30. Pumps 11 Arterial cannula Vent catheter Cardictomy Cardioplegia cannula Bio Trend Sucker Arterial Venous Venous SAT SAT/HCT return catheter MYOtherm XP Autolog Affinity CVR Affinity Cardiotomy/Venous arterial reservoir filter Cardioplegia solution Sequestra 1000 Affinity Bio- oxygenator probe Heater/cooler HMS Bio-pump Figure 2.3 Components of the extracorporeal circuit. Schematic © copyright Medtronic, Inc. Figure 2.4 Roller pump head. Photo © copyright Medtronic, Inc. A roller pump displaces air as effectively as blood, so that Centrifugal pumps it is possible, for instance in the event of inadvertent emptying of a hard shell venous reservoir, to pass massive The centrifugal pump is essentially a vortex generator. amounts of air downstream towards the patient. Several By spinning an impeller (which may consist of vanes or, in techniques and systems are utilized to mitigate against the case of the Medtronic Bio-Pump® Centrifugal Blood such a disaster, such as reservoir level sensors, in-line air Pump, nested cones) within a housing at high speed, an detectors, membrane oxygenators and arterial filters. area of low pressure is created in the centre, and higher
  • 31. 12 Design and principles of the extracorporeal circuit imparted to the blood by the hydrofoil configuration of the vanes. This is efficient, but can create turbulence on the trailing edges of these vanes. In the Medtronic Bio-Pump® design (Fig. 2.5 (a) and (b)) energy is imparted strictly by viscous drag inherent in the blood itself, minimizing tur- bulence. An inherent safety feature of centrifugal pumps is their inability to pump very large amounts of air. When air fills the pump chamber, the pump is not able to develop sufficient pressure to expel it against the backpressure of the extracorporeal circuit. Whatever the impeller design, centrifugal pumps are all classified as non-positive displacement pumps – they will respond to changes in both pre-load and after-load with changes in flow rate, much as the native heart does. Centrifugal pumps require in-line monitoring of the flow rate that is accomplished in the Medtronic system, for example, by electromagnetic induction. Other sys- tems use an ultrasonic probe to detect flow. The in-line flow measurement allows accurate adjustment of the pump speed when necessary to regulate flow in the case of changes in pre-load and after-load. Centrifugal pumps are very practical. They are com- pact, durable, easy to set up, and cause minimal haemolysis compared with roller pumps. While their cost is certainly higher than a simple length of roller pump (a) tubing, it may be more than offset by savings in ven- tilatory and ICU time, as well as overall hospital stays that have been demonstrated in numerous clinical studies (Morgan et al., 1998). VENOUS RESERVOIR The general functions of the venous reservoir are to accumulate blood from the patient’s venous system and to remove both air and microaggregates present in venous blood. Venous reservoirs may be either rigid (hard shell) or soft (bag). Rigid reservoir A rigid reservoir consists of a clear plastic shell, vented to the atmosphere either by basic design or integral (b) valve, with a provision for defoaming and gross-filtering (100– 200 ␮) of incoming venous blood. Typical reservoir Figure 2.5 (a) The nested cones design within the Medtronic capacity may range from 1 L to 4.5 L (Fig. 2.6). Bio-Pump®; (b) BPX-80 adult Bio-Pump®. Photos © copyright Medtronic, Inc. Soft reservoir pressure is generated along the outside circumference. Blood is drawn axially into the centre by the vortex and The soft or ‘bag’ reservoir is constructed of soft PVC with expelled under pressure through a port oriented tangen- a 100–200 ␮ filtering screen. Typical reservoir capacity tial to the axis of rotation. With the vane design, energy is ranges between 200 mL and 3.0 L (Fig. 2.7).
  • 32. Cardiotomy reservoirs 13 Figure 2.6 Hard shell reservoir. Photo © copyright Medtronic, Inc. Hard shell reservoirs are easy to use and offer the advantage of integration with the cardiotomy function, simplifying the circuit. They can handle incoming venous air with ease. With simple modifications, hard shell reser- voirs can be used for vacuum-assisted venous drainage. Their principal disadvantage is that it is very possible to empty the reservoir and pass air to the arterial pump, Figure 2.7 Soft reservoir bag. Photo © copyright Medtronic, Inc. which, if it is a roller pump, will pass the air downstream. This risk can be mitigated somewhat with the use of reser- voir level sensors and in-line air detectors, which may or may not shut the arterial pump off automatically. CARDIOTOMY RESERVOIRS Bag reservoirs can be slightly more cumbersome to use since incoming venous air does not vent automat- Blood from the cardiotomy suckers and vents is most ically and must be actively aspirated from the bag. Also, often delivered to the cardiotomy reservoir. This serves as they require a separate hard shell cardiotomy reservoir to a storage area and also filters the large number of solid handle returning cardiotomy suction blood and left ven- and gaseous micro-emboli. The rigid reservoir is made of tricle vent return. Many practitioners consider them polycarbonate, with ports that direct incoming blood safer than hard shell reservoirs since, when maintained through both defoaming layers and micro-aggregate properly air-free, bag reservoirs will not allow massive air filters of between 20 ␮ and 40 ␮ (Fig. 2.8). embolism, because the soft bag simply collapses upon Another option with growing acceptance is to emptying, presenting nothing for the arterial pump to deliver suction blood to a cell-saving device (Fig. 2.9). pass. The soft shell system also may be preferable because Here, the red cells can be separated from the activated of the elimination of the air–blood interface found in platelets, white cells and plasma before returning them open, hard shell systems. to the patient. It is common practice today to integrate
  • 33. 14 Design and principles of the extracorporeal circuit Figure 2.8 Cardiotomy reservoirs. Photo © copyright Medtronic, Inc. these cardiotomy functions with a hard shell venous which have their strengths and weaknesses. Aluminum reservoir. has by far the best heat exchange performance, but is not biocompatible unless coated, which degrades its per- formance somewhat. Plastic is inexpensive, but has rela- tively poor heat transfer properties and requires large HEAT EXCHANGERS surface areas. Stainless steel seems to be the most popular because of its combination of good heat exchange coeffi- During cardiopulmonary bypass the temperature of the cient, ease of fabrication in either pleated or tubular perfusate may be adjusted to improve myocardial protec- form, and biocompatibility. tion and optimize the operating conditions for the To adjust the temperature of the perfusate, water of patient. This is accomplished within the extracorporeal variable temperatures is circulated through the heat circuit by one or more heat exchangers that are com- exchanger, cooling or warming the perfusate as the clin- posed of two pathways, one for the perfusate and one for ical situation dictates. To further enhance efficiency, the water. These pathways are separated by material that water flows in the opposite direction relative to the per- allows efficient thermal exchange between the fluids. The fusate, maximizing the temperature differential through- material may be plastic, aluminum or stainless steel, all of out the transit.