Blood Works: An Owner's Guide: What Every Person Needs to Know BEFORE They Are a Patient

By Shannon L. Farmer, Irwin Gross and Aryeh Shander

 

Much has been published on heart health, kidney health, and gut health. But how many of us are aware of our blood health? Is your blood as healthy as it should be? How would you even know? Blood Works is a fascinating new blood owners’ guide to help you care for the health of your most precious fluid—your blood.

About 2 billion people globally are anemic, and almost as many suffer from iron deficiency without anemia. Many don’t even know they have it, just feeling tired, lethargic, and “foggy-headed.” Sound familiar? Over 600 million more suffer from acute or sometimes unrecognized chronic blood loss from causes such as heavy menstrual bleeding, obstetric hemorrhage, gastrointestinal bleeding, surgery, and trauma. Anemia, iron deficiency, and bleeding are signs of “blood failure” and have major negative health effects. Blood Works, with contributions from 48 leading international medical experts, is a must have book for all who want to look after their blood health.

Your blood is the essential fluid that keeps you alive. Yet, while many of us know our cholesterol level and blood pressure, few of us are aware of our blood count. What we don’t know can affect our everyday quality of life and put us at risk if we have bleeding, an injury, or require hospitalization.

Blood, and the vessels that contain it, make up the largest organ system in the body. Its balance and health must be maintained. For many decades, the treatment of first resort for anemia and blood loss has been blood transfusion, which is essentially a “liquid organ” transplant from another person. In heart failure or kidney failure, organ transplantation is not first-line treatment. In blood failure, blood “transplantation” should not be the first thing we reach for. Since the 1990s, scientific research has shown that the common use of blood transfusion is not the most effective treatment in many medical situations. It has been identified as one of the most overused treatments in modern medicine, costing billions of dollars, while causing changes in the recipient’s immune system that may increase the risk of complications and death. In October 2021, the World Health Organization called for the urgent global implementation of Patient Blood Management (PBM), stating “our own blood is still the best thing to have in our veins.”

Blood Works is one of the most exciting books on blood health you will read. The book zooms in on why medical experts from around the world now recognize the need for fundamental change in the way a patient’s blood is managed. Known as PBM, Patient Blood Management places the person receiving treatment at the center of decisions involving their lifeblood. Its aim is to improve general health and treatment outcomes by managing and preserving a patient’s own blood while empowering them to share in making decisions.

Meticulously researched and referenced, masterfully illustrated, and featuring personal stories from patients and their families, Blood Works is a compelling read. It will have a profound impact on your health and the health of your loved ones and is an invaluable resource for health care professionals.

• Language: English
• Publisher: City Point Press
• Release date: Nov 29, 2022
• ISBN: 9781947951570

Shannon L. Farmer

Dr. Shannon L. Farmer, DHSc, is an academic researcher and a consultant and pioneer in Patient Blood Management, having been in the field for over 30 years. He is a Doctor of Health Science and has appointments as Adjunct Associate Professor, Discipline of Surgery, Medical School, The University of Western Australia, and Honorary Research Fellow in Haematology, Department of Haematology, Royal Perth Hospital, Western Australia. He is a medical journal peer-reviewer, and serves on several PBM committees and guidelines expert working groups. In 2021 he was invited to serve on the World Health Organization External Working Group to develop a WHO Policy Brief and Guidelines for the implementation of PBM. He has published numerous peer-reviewed research papers, is a regularly invited lecturer, and has consulted to national and international health authorities. In 2014 he received the Dr Kathleen J Sazama Award (USA) “For Outstanding Leadership in Advancing Patient Rights and Patient Blood Management.”

Book preview

INTRODUCTION

You’ve heard about heart health, liver and kidney health, and gut health. Have you heard about blood health?

This book is about the fascinating and complex fluid that keeps you alive and healthy – your blood. It looks at how blood is made, what it contains, and what it does. Blood carries life-giving oxygen from the lungs to all the cells, tissues, and organs of your body. It carries metabolic wastes from cells for elimination as it passes through the kidneys, and carbon dioxide for removal through the lungs. As an important part of the immune system, it helps protect your body from disease. And blood contains an elaborate system to repair any breaches in the blood vessels to limit and stop bleeding and blood loss. It really is your lifeblood – an indispensable part of the infrastructure of your body’s systems and life processes. In fact, the circulatory system, and the blood it contains, is the largest organ system in the body. Like any other organ or system in the body, its balance and health must be maintained.

If blood fails – and because it is so complex it can fail in many ways – it results in reduced physical and mental function and increases your risk of health complications and death. Blood failure can be mild or severe. Even mild blood failure requires investigation and treatment. You have a role both in maintaining your blood health and in making treatment choices if it fails.

One of the most common forms of blood failure is anemia – failure to maintain normal levels of the blood component called red blood cells (and the hemoglobin molecules within them) that carry oxygen to sustain the health and life of your body’s cells, tissues, and organs. Of all health disorders, anemia is the one that affects the greatest number of people around the globe – an estimated 1.95 to 2.4 billion individuals. This means one in every three to four people globally. Anemia is associated with adverse health outcomes including reduced quality of life, impaired cognitive function, decreased physical and working capacity, increased psychiatric disorders, heart failure, impaired immune function, and adverse outcomes of pregnancy for both mothers and babies, to name a few. The leading cause of anemia is iron deficiency, called iron deficiency anemia, with an estimated 1.2 billion people affected globally.

Infants, children, women of childbearing age, women during pregnancy, and the elderly are most affected by the burden of iron deficiency and anemia. The disability that results from anemia is greater than that owing to asthma, diabetes, and cardiovascular disease combined. In 2017, anemia was identified as the leading cause of years lived with disease¹ in females. In addition to these are patients who develop anemia when admitted to a hospital either for medical illness or surgical procedures. Both can result in blood loss and impaired red blood cell production, leading to what is referred to as hospital-acquired anemia. This has been called a danger of modern medical care.

The effects of anemia can range from feeling tired and foggy-headed all the time to more serious, even life-threatening consequences. If you need surgery and are anemic prior to your operation, you are almost three times more likely to die and four times more likely to suffer kidney damage. You have a 2-fold increased risk of developing an infection, a 1.3-fold increased risk of a stroke, and a 5-fold increased risk of receiving a red blood cell transfusion. Clearly, recognizing and managing anemia should be a high priority.

"Almost every individual can benefit from PBM during their lifetime.

WORLD HEALTH ORGANIZATION POLICY BRIEF

The Urgent Need to Implement Patient Blood Management 2021

Even less recognized, and estimated to affect double the number of people suffering from iron deficiency anemia, is iron deficiency without anemia. Defined as insufficient iron to meet the body’s needs, iron deficiency, even without anemia, is independently associated with many negative health effects including impaired heart muscle function, defective immune function, cognitive dysfunction, adverse effects for pregnant women and their babies, and increased risk of dying. Some studies have shown that having iron deficiency before major surgery also increases the risk of having a longer stay in hospital, a serious complication, or death.

Another risk to our blood health is bleeding, which can be acute and obvious, but at other times can be chronic and either underestimated or unrecognized. It is estimated that over 600 million people suffer from chronic or acute blood loss from causes such as heavy menstrual bleeding, obstetric hemorrhage, gastrointestinal bleeding, surgery, trauma, and even blood taken for testing during hospitalization.

Since the 1940s, the default treatment for anemia and blood loss has been blood transfusion, essentially a liquid organ transplant from another person. This practice became ingrained in medical culture with little evidence to support its benefit. However, over the last two decades, scientific research has shown that blood transfusion is not the most effective treatment in many medical situations where it has traditionally been used. Also, like any other transplant, it is associated with complications and profound changes in the recipient’s immune system. In addition to the risk of transmitting infectious diseases (and there is a long and growing list), blood transfusion is now connected with worse patient outcomes including increased infection, stroke, heart attack, organ failure, cancer recurrence, and death. While blood transfusion can be an effective option in critical situations, it can have unintended short- and long-term consequences, leading one transfusion medicine expert to state, Allogeneic blood transfusion has the potential for a greater range of serious hazards than probably any other therapeutic intervention. Even in critical situations like massive bleeding and trauma, the transfusion of blood is associated with increased infection, lung injury, organ damage, and death, with the risk of these complications increasing with each unit of blood transfused. This has led to expert guidelines for physicians stating that every effort should be made to minimize exposure to blood transfusion.

As a result of these findings, we now recognize a need for fundamental change in the way a patient’s blood is managed. Your own blood is unique. It is the best and safest blood to have in your veins. Complications are reduced and health outcomes are better when your own blood is viewed as precious, strategies are employed to manage and preserve it, and transfusion of blood from another person is avoided or minimized. Costs of health care are also dramatically reduced.

This new approach is called Patient Blood Management (PBM) with the focus on you, the patient. Its aim is to optimize, manage, and preserve a patient’s own blood to improve general health and health care outcomes. At a time when the global health system is struggling with the challenge of improving people’s health outcomes while facing tighter health budgets, this approach is a win for all: the patient, the community, health care providers and the health care system, insurers, and governments.

PBM is now referred to as the new international standard of care and is seen as a must-have for all modern health care systems. Conversely, failure to implement PBM is regarded as substandard care. However, this disruption in health care requires a re-engineering of the way health care is delivered in communities and in hospitals. In a 2021 World Health Organization (WHO) Policy Brief entitled The Urgent Need to Implement Patient Blood Management, the WHO called for all Member States to act quickly though their ministry or department of health to adopt a national PBM policy, install the necessary governance, and reallocate resources to implement PBM.

PBM places the person receiving care at the center of critical decisions involving their lifeblood. If you or a loved one ever need to see a doctor or are admitted to a hospital, this book will provide you with vital information and enable you to talk with your doctor, understand critical information about the things your doctor will talk about, and become a true partner in your health care. It is information that everyone needs to know before they become a patient. At the same time, this book is a valuable resource for health care providers as it carefully documents and references up-to-date scientific research in this rapidly developing field.

1Years lived with disease(YLD) is a measure of the number of years a person lives with the burden of some disease or disability.

CONTRIBUTORS: Shannon L Farmer, James P Isbister, Irwin Gross, Matteo Bolcato, Christoph A Zenger, Axel Hofmann, Aryeh Shander

"

The fact that patients have access to the same databases as clinicians leads to increased consumer knowledge, which is pushing clinicians to higher quality standards and evidence-based medicine.¹

GUNTHER EYSENBACH ET AL

British Medical Journal 1999

Dr. Louise Phillips is a transfusion scientist from Australia who was diagnosed with cancer. As an informed patient, she asked her surgeon for a treatment she knew would reduce risks and improve her outcome. Her surgeon had not used this approach before. Her story is relevant to all of us as potential patients.

"My story began in 2009 when I went to give my usual blood donation. I had been a blood donor for many years. Pre-donation testing showed that my hemoglobin was low (110 g/L).* An additional blood sample was taken to test my ferritin [iron levels], with instructions to follow up with my doctor. A couple of weeks later the results came back and showed a ferritin of just 6 micrograms per liter (mcg/L), well below a normal range of 30-300 mcg/L.† My doctor knew something was wrong and sent me for a colonoscopy. The colonoscopy and biopsy showed that I had a stage IIB rectal cancer, meaning it had spread through the muscular wall of the rectum and to the lymph nodes. It was quite a serious, advanced stage of cancer. I had no noticeable symptoms apart from persistent tiredness. As a mother of two teenage boys and working full time I had just accepted that fatigue was a part of my life. I was sent to meet the surgeon and it was not quite clear in the early discussion whether I would go straight off to surgery or have some chemotherapy or radiation therapy before that. But I did know what I wanted to happen first.

"I had been involved in transfusion medicine research for a number of years and was aware of the growing medical literature that had been published in recent years indicating that people who had blood transfusion had poorer outcomes, and that the greatest predictor of having a blood transfusion is the hemoglobin level prior to operation. My hemoglobin and iron levels were low, and I wanted my anemia‡ and iron deficiency treated with an iron infusion. I reasoned that the best thing for me to do to avoid transfusion would be to increase my hemoglobin levels, and the quickest and safest way to do that was an iron infusion. So, I asked my surgeon for an intravenous iron infusion.

"My surgeon was a bit taken aback by my proactive patient-centered approach and admitted that he had never given a patient an iron infusion before, but to his credit didn’t dismiss the idea. This was done the next day. Within a week of seeing my general practitioner I’d had an endoscopy, a variety of diagnostic images and blood tests, and an iron infusion. Two weeks later I met the oncologist – I felt better than I had for years! And the irony of that wasn’t lost on me; that I could be diagnosed with rectal cancer and, despite the anxiety around me of my situation, I felt fantastic. I had vitality and energy I hadn’t had in years. In retrospect, I believe that feeling of wellness really helped me face what came after, not just physically, but emotionally and mentally. I could deal with this, I could beat the cancer, because I felt well for the first time.

At the time of surgery, my hemoglobin had risen to 125 g/L, a normal level. Immediately after surgery it had dropped to 107 g/L. Eight days after the operation it had dropped down to 83 g/L, which is quite low. But in consultation with the ward physician again, they were quite happy to let things ride and not transfuse. Instead, I had another iron infusion. Within a couple of weeks, my hemoglobin was back up to normal, and I was able to avoid having a blood transfusion. I felt fortunate to have met with medical professionals who were willing to engage in the conversation, who didn’t dismiss me out of hand as some eccentric who was demanding ‘way out’ therapy.

Dr. Phillips’ story raises some thought provoking questions:

Why would a transfusion scientist want to avoid a blood transfusion?

What is the evidence this transfusion scientist referred to, showing that transfused patients have poorer outcomes?

Are there other strategies and treatments that can reduce your risk of being transfused and improve your health outcomes?

Can you as a patient learn to advocate for your own health like Louise did?

Doctors Choose a Different Approach

A Child with Extreme Anemia

Thirteen-year-old Sofia§ was admitted to a hospital in Italy with vomiting and diarrhea.² She was pale, weak, and lacking energy. Her heart rate and blood pressure were slightly elevated, but her breathing was normal and she was conscious. She was found to be extremely anemic with a hemoglobin level of 33 g/L (normal for her age is 120 g/L or greater). A hemoglobin level this low could be considered life-threatening and most often results in an immediate blood transfusion. However, her doctors did not take that traditional approach. The treating doctors, including pediatricians and transfusion medicine specialists, considered the cause of her extreme anemia,¶ her symptoms, and the short- and long-term risks and hazards of blood transfusion, including the possibility of complications in a future pregnancy and potential risk to the fetus or newborn baby. The doctors felt they should avoid transfusion and proposed to Sofia and her parents that they treat with a different approach. Sofia and her parents consented. Doctors administered supplementary oxygen and gave her intravenous iron and folic acid. Sofia responded well. In 10 days, her hemoglobin was over 60 g/L and at 12 days it was 79 g/L. At the seven-month follow-up her hemoglobin was 144 g/L and she was doing well.

An Older Woman with Extreme Anemia

In a case published in 2020, 79-year-old Anna was found to have a hemoglobin level of 38 g/L when she presented to hospital.³ She also had severe iron deficiency with a ferritin level of 3 mcg/L (normal for her age is at least 45 mcg/L in the absence of inflammation). Anemia may be less well tolerated by older people, and therefore a patient like Anna would ordinarily have been transfused immediately. As Anna discussed her condition with her doctors, it became clear that her extreme anemia had come on gradually due to a long history of bleeding hemorrhoids. Her anemia was severe, yet she was tolerating it well. Although she was pale, her breathing and pulse rate were normal, and she had no history of heart disease. Despite her extremely low hemoglobin level, the doctors decided not to transfuse her, but rather give her some intravenous iron to replace her low iron levels, along with vitamin B12 and folic acid, to help her body make its own new red blood cells. Anna responded well to this treatment. By day seven her hemoglobin was 50 g/L. At follow-up on day 14 her hemoglobin was 74 g/L and on day 28 it was 100 g/L. Despite her age, she responded to intravenous iron so well that her hemoglobin had doubled in just two weeks and nearly tripled in just four weeks! And she avoided a transfusion.

A New Standard of Care

For over 40 years doctors believed that, if a patient’s hemoglobin level dropped to 100 g/L from its normal level, a blood transfusion was necessary to avoid dire consequences for the patient.**†† So why would these doctors recommend avoiding transfusions in these two patients when traditionally it would have been considered necessary, even life-saving? What has changed? And what are the short- and long-term risks and hazards of transfusion the doctors considered when deciding to treat Sofia and Anna differently?‡‡

Blood given by altruistic donors has been referred to as a precious resource. However, this resource, transfused from another person, is like an organ transplant (the oldest and most common form of transplant in current medical practice⁴-⁶) and, like any transplant, it is associated with complications in the recipient. In 1995 Dr Paul Tartter from Mount Sinai Medical Centre wrote, Blood transfusion is the oldest form of transplant - no one would argue that transplantation between unrelated individuals has no influence on the immune system. In organ transplantation the immunologic sequelae are permanent and there is evidence that the same is true following homologous blood transfusion. Because of these complications, transplantation of solid organs from donors is not first-line treatment. Other medical interventions are used first and transplantation is, in most situations, a last resort. Therefore, the new standard of care, illustrated by the care administered to Louise, Sofia, and Anna, involves taking a step back and prioritizing the patient’s own blood as a precious resource, one that should be preserved and managed appropriately, as it was for these three patients.

A GLOBAL DEFINITION

Patient Blood Management

IN 2021 A GROUP OF EXPERTS FROM SIXTEEN INTERNATIONAL PROFESSIONAL MEDICAL SOCIETIES PRODUCED A GLOBAL DEFINITION OF PATIENT BLOOD MANAGEMENT:

Patient Blood Management is a patient-centered, systematic, evidence-based approach to improve patient outcomes by managing and preserving a patient’s own blood, while promoting patient safety and empowerment.

THEY ALSO DEVELOPED A SIMPLIFIED VERSION FOR THE LAYPERSON:

Patient Blood Management is a patient-centered and organized approach in which the entire health care team coordinates efforts to improve results by managing and preserving a patient’s own blood.

Shander A, Hardy JF, Ozawa S, Farmer SL, Hofmann A, Frank SM, Kor DJ, Faraoni D, Freedman J, and Collaborators. A Global Definition of Patient Blood Management. Anesth Analg 2022. DOI 10.1213/ANE.0000000000005873

What Louise had to ask for in 2009 is now referred to in the medical literature as Patient Blood Management.⁷ This refers to managing and preserving the patient’s own blood as a priority, rather than reflexively resorting to transfusing blood from another person. In its definition of Patient Blood Management, or PBM, The Australian Commission on Quality and Safety in Health Care states, The best and safest blood for patients is their own circulating blood. PBM views a patient’s own blood as a valuable and unique natural resource that should be conserved and managed appropriately.⁸ In 2021, 16 international medical organizations developed and endorsed a formal global definition of PBM. This definition appears in the box A Global Definition of Patient Blood Management.⁹

Research has shown that, if PBM strategies are used and transfusion is reduced or avoided, patients experience:¹⁰

better patient care

faster recoveries

reduced mortality

fewer complications

shorter stays in hospital

and all of this with reduced health care costs to governments and the health care system. It is a win-win for all.¹¹ Accordingly, PBM is now viewed as the new standard of care.⁷ In 2021 the World Health Organization (WHO) published a PBM Policy Brief calling for its urgent implementation, stating Delaying the implementation of PBM translates into increased morbidity and mortality.¹²

But why is PBM not more widely known and available? Will you get this new standard of care if you need treatment? Or will you have to ask for it? Is it simply a matter of avoiding transfusion and giving some intravenous iron, vitamin B12, and folic acid? No, seldom are things quite that simple in medicine.

A look back in history will help us understand this new way forward. Before blood for transfusion became readily available, surgeons were meticulous about preserving the patient’s own blood. For example, at an 1899 medical conference in Brisbane, Australia, speakers advocated 1) treating the patient’s anemia with iron, 2) practicing meticulous surgical techniques to save the patient’s blood, and 3) tolerating anemia while the patient recovered to a normal hemoglobin level on their own.¹³,¹⁴ In effect, the new standard of care is back to the future, advocating the same three principles.

Famous American pioneer surgeon, William Halsted (1852-1922), who established the first surgical school in the United States at Johns Hopkins University, Baltimore, was one of the first proponents of gentle handling of tissue, attention to detail, and meticulous surgical technique to prevent and stop bleeding (hemostasis).§§ This approach became known as Halsted principles. Emphasizing this to surgeons, Halstead quipped, The only weapon with which the unconscious patient can immediately retaliate upon the incompetent surgeon is hemorrhage.¹⁵

Noted English surgeon, Lord Moynihan (1865-1936), exemplified this meticulous surgical care. Of him it was said, He had the same respect for a drop of blood as Halsted and exercised the most punctilious care over haemostasis. Someone in his operating theatre was once heard to remark: ‘Is English blood then so precious?’¹⁶ Lord Moynihan himself said, the perfect surgeon must have the heart of a lion and the hands of a lady, not the claws of a lion and the heart of a sheep. He also stressed, Infinite gentleness, scrupulous care, light handling and purposeful, effective, quiet movements which are no more than a caress, are all necessary if an operation is to be the work of an artist and not merely of a hewer of flesh.¹⁷

With the development of blood transfusion in the early 20th century, and donor blood being collected and stored in blood banks and available on request in the mid-20th century, surgeons had a ready and easy treatment for anemia and blood loss. A degree of complacency developed, resulting in less attention being given to the priority of preserving the patient’s own blood. Transfusion became the default, and at times reflexive, treatment for anemia. The lessons of Halsted and Moynihan were lost and blood loss was seen as an inevitable part of surgery.

With expansion of the blood product supply sector, most blood bankers, often with little direct clinical responsibility for patients, promoted donated blood as one of the safest medical therapies. However, this safety was a misperception due to the potential for transfusion-transmitted infection and the wide-ranging potential hazards of transplanting blood from one human being to another. Diagnosing and correctly treating reversible anemias came to be regarded as a low priority or indeed forgotten. The mistaken belief that blood transfusion is safe, effective, free, and an important common good only supported a perception that blood donation is the gift of life and did little to educate patients and physicians of the risks.

Evidence has emerged that blood transfusion is one of the most overused therapies in medicine and is associated with significant adverse patient outcomes. In 2011, a panel of international experts published the results of the world’s first International Consensus Conference of Transfusion Outcomes (ICCTO).¹⁸ They examined the outcomes of red blood cell transfusion in the medical and surgical scenarios where the vast majority of transfusions are given. Based on evidence from the medical literature, the expert panel concluded that in only 11.8% of the clinical scenarios was transfusion likely to improve patients’ health outcomes. In 59.3% of the scenarios, it was determined that transfusion was not likely to improve health outcomes, and likely to harm the patient. In 28.9% of the scenarios, it was found to be uncertain whether transfusion would be of benefit, of no benefit, or harmful to the patient, with more research required to make definitive conclusions.

RESULTS OF THE INTERNATIONAL CONSENSUS CONFERENCE ON TRANSFUSION OUTCOMES

A multidisciplinary panel of international experts reviewed all the available medical literature to assess the appropriateness of red blood cell transfusion in 450 typical medical, surgical, and trauma scenarios where most transfusions are administered. They rated whether transfusion was:

An article in the prestigious journal Nature entitled Evidence-based medicine: Save blood, save lives stated, Transfusions are one of the most overused treatments in modern medicine at a cost of billions of dollars.¹⁹ This overuse is surprising, since it has been said that blood transfusion has the potential for a greater range of serious hazards than probably any other therapeutic intervention.²⁰

The Challenge of Change

Now that there is greater awareness of the inherent and, in many instances, irreducible risks of transfusion, practice is gradually changing. However, the road to this new standard has been long and challenging, and there is much work still to be done if all patients are to benefit from it. Most patients and many doctors still do not know about Patient Blood Management.

As you will learn in subsequent chapters, blood transfusion was grandfathered into medicine with little scientific evidence to support its use; for many years it was almost exempt from rigorous scrutiny of its risks and potential benefits. In 1996, Dr Robert Winslow, Professor of Medicine at University of California San Diego, said, If one approached regulatory authorities today with a new product with the safety profile of human red blood cells, it probably would not be approved for clinical use.²¹ Despite this, it became ingrained in medical culture. Changing a medical practice that is entrenched has always been challenging (see Chapter 15 Change Begins with Patients). Research has suggested it takes, on average, 17 years (with wide variation) for new evidence published in the medical literature to get into medical practice and benefit patients.²² The effort to change transfusion practice has been particularly long and challenging.

"If one approached regulatory authorities today with a new product with the safety profile of human red blood cells, it probably would not be approved for clinical use.

DR ROBERT WINSLOW, Professor of Medicine University of California San Diego

A 2002 editorial in the British Medical Journal stated that changes in relation to blood transfusion practice will require a cultural shift among clinicians, managers, and policy makers.²³ Changing culture, however, is difficult in any industry. This was noted in a document published by the Treasury Board of Canada Secretariat entitled Changing Management Culture: Models and Strategies to Make It Happen 2003. Culture [involves] feelings, underlying beliefs, values, history, and assumptions … rooted in experiences, stories, and behaviour patterns sometimes decades or centuries old. Culture is enduring, difficult to develop or reshape.

That describes the transfusion culture. In a 2007 review, Drs. Boucher and Hannon stated, the administration of blood products is surrounded by emotions, misconceptions, myths, and prescribing by habit.²⁴

Author Dr. Irwin Gross, who has lectured widely on this subject for many years, likens changing physician behavior to the story of Sisyphus, a character from Greek mythology, who was condemned to an eternity of rolling a boulder uphill, and then watching it roll back down again.

Highlighting the challenge in changing practice, one expert in the earlier referenced article in Nature said, Weaning doctors off their love affair with blood is going to be harder than we think.

Patients as Drivers for Change

Knowledge is power. Information is liberating. Education is the premise of progress, in every society, in every family.

Kofi Annan, Secretary-General of United Nations 1997-2006

In early 2000, an expert group was convened¶¶ in Australia to review the evidence and produce transfusion guidelines.²⁵ They reiterated that it is difficult to change practice and even more difficult to maintain the change. They then highlighted where the patient can play a role, stating, Consumers can also be important drivers of change to practice, if they are aware of the issues surrounding the use of blood components and know about the risks and benefits in their own situation. You, the patient, and the choices you make, can make a difference in promoting progress.

More and more people are turning to the internet for information about their health and treatment options. An article in the British Medical Journal concluded this is a positive development: The fact that patients have access to the same databases as clinicians leads to increased consumer knowledge, which is pushing clinicians to higher quality standards and evidence-based medicine.¹ Patient empowerment can be a powerful driver for change.

"Over himself, over his own body and mind, the individual is sovereign.

JOHN STUART MILL (1806-1873) English philosopher and economist

Patient Autonomy, Informed Consent, and Shared Decision-Making

A key element of Patient Blood Management is patient-centered care. Prior to 1960, medical decision-making and treatment decisions were almost always made in a paternalistic manner – the physician made and conveyed the decisions, and the patient obeyed the doctor’s orders.

The fundamental shift in medicine with regard to patient autonomy and informed consent came as a result of public outrage over the disclosure of the medical experimentation that took place on people preceding, during, and continuing after the Second World War.²⁶ This led in the 1960s to developing the principles of biomedical ethics. These are commonly referred to as:

autonomy(including the right to know, veracity [accuracy and truthfulness], self-determination, and informed consent)

beneficence/non-maleficence***(including fidelity and honesty)

justice(fundamental fairness without discrimination).

In time, these principles were embedded in the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention 1997).²⁷

The shift from a paternalistic doctor-patient relationship to one of shared decision-making has been a slow and problematic one dating as far back as Hippocrates. The traditional view of this relationship became well embedded for two millennia based on the belief that a patient should be protected from knowing the truth about their disease and its likely outcome. Hippocrates stated, Reveal nothing of the patient’s present or future condition. The rationale was that the fully informed patient may not be able to absorb, understand, and psychologically cope with the information. It was implied that appropriately informing the patient might cause stress or, worse, harm the patient. This was tolerated and even accepted by the patient, who was expected to trust their doctor without question.

It was not until the 1970s that the shift towards a fairer, more balanced, and shared decision-making doctor/patient relationship evolved.²⁸ However, prior to this, as medicine became more scientific there were several well-known clinicians who emphasized the importance of involving the patient in understanding diagnosis and treatment. It was gradually being accepted that the patient as a person is the subject of medical diagnosis and treatment, not the object of a disease to be diagnosed and treated.

The following quotes highlight that some early and respected physicians, surgeons, and nurses had the patient as a person forefront in their professional practice and, moreover, felt the patient should know and understand what is going on.

Care more for the individual patient than for the special features of the disease… Put yourself in his place… The kindly word, the cheerful greeting, the sympathetic look – these the patient understands.

The good physician treats the disease; the great physician treats the patient who has the disease.

It is much more important to know what sort of a patient has a disease than what sort of a disease a patient has.

Sir William Osler (1849-1919), Canadian Physician regarded as the Father of Modern Medicine

The patient is the center of the medical universe around which all our works revolve and towards which all our efforts tend.

John Murphy (1857–1916), Chicago professor of surgery

You treat a disease, You win, you lose. You treat a person, I guarantee you win no matter the outcome.

Hunter Patch Adams (1945-), American physician, comedian, social activist, clown

Informed consent is an integral part of modern, quality, patient-centered health care, and a key safety and quality issue. Informed consent is based on the fundamental ethical principle that a competent adult has the right to determine what will and what will not be done to their body. Therefore, no operation, medical treatment, or procedure may be performed without the patient’s consent. From a legal position, in most high-income countries with advanced health systems, a failure to obtain a patient’s consent may result in a charge of assault and battery. If health care providers fail to disclose material risks of a treatment or procedure to a patient, it may result in a legal action of negligence.²⁰

"Apprehension, uncertainty, waiting, expectation, fear of surprise, do a patient more harm than any exertion. Remember he is face to face with his enemy all the time.

FLORENCE NIGHTINGALE (1820-1910)

In simple terms, informed consent means a patient has a right to make informed, voluntary decisions about their care. They need to have their diagnosis/prognosis explained, to know the treatment options available, and the nature, risks, and benefits of the treatment options. Once informed, they have the right to accept or decline treatment(s). Consent/refusal should, where possible, be documented. It is important to recognize that a patient’s refusal of a specific treatment option does not release the physician from their overall duty of care. The physician has an obligation to present other treatment options, if other options are available, or arrange for another physician who is able and willing to provide the treatment.²⁹

These principles apply to transfusion. The International Society of Blood Transfusion (ISBT) in its Code of Ethics Relating to Transfusion Medicine states, the patient has a right to expect that her/his autonomy is respected.³⁰ In relation to autonomy it states, Specific consent must, where feasible, be obtained prior to the transfusion. The consent should be informed and in order to achieve this, information must be provided on the known risks and benefits of blood transfusion and any possible alternative therapies in order to enable a decision whether to accept or refuse the procedure.

The 2021 World Health Organization (WHO) Policy Brief on PBM states that patient education and empowerment, informed consent and shared decision-making is one of the important principles of PBM.¹²

Evidence-Based Medicine – Re-evaluating Practices

A new term in medicine appeared in 1992: evidence-based medicine.³¹,³² Although the philosophical concept had been around since the mid-19th century, the term was introduced to move physicians to a more scientific approach, and to re-evaluate traditional practices, long-held beliefs, and medical dogma. Many commonly accepted treatments were challenged and often came up wanting. In many cases treatments were found to be not only ineffective, but harmful. As we shall see, in many circumstances this has proved to be the case with blood transfusion. As with many things in medicine, the concept of evidence-based medicine was embraced by many, but also attracted widespread criticism and resistance. Many misunderstood the concept. Criticisms included the charge that it was a dangerous innovation, perpetrated by the arrogant to serve cost cutters and suppress clinical freedom.³³ Ironically, almost 20 years after its first appearance it was described as a new approach.³⁴ Clarification of what evidence-based medicine actually meant eventually led to its wide acceptance across all areas of health care and being seen as a vital component to assure safe and effective health care delivery for patients.

Although evidence-based medicine is now a common term in modern medicine, few know its true definition. Many narrowly define it as treatments based on evidence of safety and efficacy from clinical randomized controlled trials, confining it to a treatment. The actual definition is "the integration of best research evidence with clinical expertise and patient values and preferences."³⁵ The patient, with their values and preferences, is at the very core of the definition of evidence-based medicine. Note what each of these three elements involves:

Best research evidence:

Normal and abnormal structure and function of the body

Validity of diagnostic methods

Prognostic†††indicators for disease

Efficacy and safety of therapeutic, rehabilitative, and preventive interventions

Outcome(s) of treated and untreated disease

Clinical expertise:

Best available clinical expertise, with knowledge of and experience with the above criteria being integrated into medical decision-making.

Patient values and preferences:

Shared decision-making

The individual patient’s unique circumstances, perspectives, priorities, beliefs, expectations, values, preferences, and goals for health and life

The decision-making processes individuals use in considering the potential benefits, harms, costs, and inconveniences of the management options

Ensuring meaningful and documented informed consent

Patient Blood Management is evidence- based.¹⁰,³⁶ So a fundamental principle of PBM is individualized patient- (or person-) focused care and shared decision-making.

The Institute of Medicine named patient-centeredness as one of its six core attributes of a high-quality health care system and encourages dialogue between physicians and patients in the decision-making process. Patient-centeredness is defined as providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions.³⁷

They list ten rules for redesigning and improving care. These include:

Customization based on patient needs and values.The system of care should be designed to meet the most common types of needs but have the capability to respond to individual patient choices and preferences.

The patient as the source of control.Patients should be given the necessary information and the opportunity to exercise the degree of control they choose over health care decisions that affect them.The health care system should be able to accommodate differences in patient preferences and encourage shared decision-making.

"Informed consent is not just the signing of a form. Informed consent is about a thorough process of communication between patient and provider.

AARON FINK, MD

Emory University School of Medicine

Shared knowledge and the free flow of information.Patients should have unfettered access to their own medical information and to clinical knowledge. Clinicians and patients should communicate effectively and share information.

The need for transparency.The health care system should make information available to patients and their families that allows them to make informed decisions when selecting a health plan, hospital, or clinical practice, or choosing among alternative treatments.

Anticipation of needs. The health care system should anticipate patient needs, rather than simply reacting to events.

Cooperation among clinicians. Clinicians and institutions should actively collaborate and communicate to ensure an appropriate exchange of information andcoordination of care.

Entering the Complex Health System

You, as a patient, seek help from modern medical science in the hope that you will be treated as a unique individual in an increasingly convoluted, fragmented, depersonalized, and confusing medical system. However, perhaps you might have some sympathy for the caring health professionals who frequently also struggle, feeling that medicine and the whole of health care is devolving into independent islands of specialty mechanistic practices. To be either a patient entering the health system or a health professional working within it can present challenges in navigating through what can be a disorienting morass. Do not be disheartened, as a close and trusting relationship with your doctor and other health professionals is the both the highest priority and an attainable reality for the informed, and thus empowered, patient. Don’t be shy about asking questions. There is no such thing as a stupid question, and if you can’t understand the answer or want further information, don’t be reluctant to ask.

To fully understand all these issues and how you can be a driver of change and advocate for improving the health outcomes for yourself and those you love, we need to turn to history. Astronomer, cosmologist, and science writer Carl Sagan said, You have to know the past to understand the present. Famous scientist Albert Einstein gave another perspective, saying, "If you want to know the future, look at the past." This book will be a valuable tool in helping you to know the past, understand the present, and help change the future. It will explore the history of transfusion medicine, transfusion itself, and the medical and scientific evidence that has led to the development of this new patient-centered standard of care, Patient Blood Management. Patient choice, combined with other factors, played a role in its early development and will be pivotal in its widespread adoption as a standard of care. Today you, the potential patient, can play an important role in helping improve your own health outcomes and those of your family. Let’s see how patient choice has already contributed to this disruption in health care and the emergence of a new standard of care.

"The best interest of the patient is the only interest to be considered.

DR. WILLIAM J MAYO,

Co-founder of the Mayo Clinic

IN A NUTSHELL 90 SECOND READ

The traditional approach to treating anemia and blood loss is experiencing a much-needed disruption due to the risks associated with blood transfusions and lack of evidence for patient benefit.

Patient Blood Management (PBM) is a new standard of care that places the patient at the center of a systematic, evidence-based approach to improve health outcomes by managing and preserving a patient’s own blood, while promoting patient safety and empowerment.

PBM is associated with fewer complications, faster recoveries, shorter hospital lengths of stay, lower costs, and lower mortality than transfusion-centered care.

Change in health care is often challenging and slow. Patients, empowered by information, are important drivers for change.

*The normal hemoglobin level for a non-pregnant woman is 120-160 g/L. For more information on hemoglobin and iron levels see Chapter 3YourBlood – The River of Lifeand Chapter 7One in Four People are Anemic – Are You?

†Ranges vary between laboratories.

‡Anemia (Greekanaimia, without blood) is lower than normal hemoglobin concentration and is often accompanied by a reduced number of red blood cells.

§Some names have been changed to protect privacy.

¶In Sophia’s case, the cause of her anemia was heavy menstrual bleeding from the time she commenced menstruation, resulting iniron deficiency anemia.See Chapter 10From Periods to Giving Birth – If Anyone Needs to Understand Blood, It’s Women.

**See Chapter 8What You Need to Know When You Need Surgery.

††The hemoglobin level that triggers the decision to transfuse is called the transfusion threshold or trigger.

‡‡See Chapter 4Risky Business Part 1: Direct Hazards of Blood Transfusionand Chapter 5Risky Business Part 2: Indirect Hazards of Blood Transfusion.

§§Hemostasis (Greekhemo, blood +stasis, stopping) – preventing and stopping bleeding.

¶¶This group was convenedunder the auspices of theAustralianNational Health and Medical Research Counciland theAustralasian Society of Blood Transfusion.

***Beneficencerefers to acts and personal qualities of mercy, kindness, generosity, altruism, and the promoting the good of others. In ethics it is the expression of the physician’s commitment to do or promote only good things for patients.Non-maleficencerefers to non-harming or inflicting the least harm possible to reach a beneficial outcome. This concept reminds physicians and other health care providers to take no unnecessary risks with patients, that is, to take no actions for which the long- or short-term benefits may be minimal or in which the short-term effects could cause serious injury and the long-term effects are simply not known.

†††To predict the likely course of a medical condition.

REFERENCES

1. Eysenbach G, Sa ER, Diepgen TL. Shopping around the internet today and tomorrow: towards the millennium of cybermedicine. BMJ 1999;319:1294.

2. Beverina I, Macellaro P, Parola L, Brando B. Extreme anemia (Hb 33 g/L) in a 13-year-old girl: Is the transfusion always mandatory? Transfus Apher Sci 2018;57:512-4.

3. Beverina I, Scalvini R, Brando B. Camel humps-shaped red blood cell histogram in a woman with extreme anemia treated with intravenous iron. Transfusion 2020.

4. Velasquez CA, Singh M, Bin Mahmood SU, Brownstein AJ, Zafar MA, Saeyeldin A, Ziganshin BA, Elefteriades JA. The Effect of Blood Transfusion on Outcomes in Aortic Surgery. Int J Angiol 2017;26:135-42.

5. Bjerkvig CK, Strandenes G, Eliassen HS, Spinella PC, Fosse TK, Cap AP, Ward KR. Blood failure time to view blood as an organ: how oxygen debt contributes to blood failure and its implications for remote damage control resuscitation. Transfusion 2016;56 Suppl 2:S182-9.

6. Tartter PI. Immunologic effects of blood transfusion. Immunol Invest 1995;24:277-88.

7. Spahn DR. Patient Blood Management: the new standard. Transfusion 2017;57:1325-7.

8. ACSQHC. What is Patient Blood Management? Sydney, Australia: Australian Commission on Safety and Quality in Health Care; 2016:Accessed December 31, 2021, athttps://www.safetyandquality.gov.au/national-priorities/pbm-collaborative/what-is-patient-blood-management.

9. Shander A, Hardy JF, Ozawa S, Farmer SL, Hofmann A, Frank SM, Kor DJ, Faraoni D, Freedman J, Collaborators. A Global Definition of Patient Blood Management. Anesth Analg 2022.

10. Leahy MF, Hofmann A, Towler S, Trentino KM, Burrows SA, Swain SG, Hamdorf J, Gallagher T, Koay A, Geelhoed GC, Farmer SL. Improved outcomes and reduced costs associated with a health-system-wide patient blood management program: a retrospective observational study in four major adult tertiary-care hospitals. Transfusion 2017;57:1347-58.

11. Spahn DR, Theusinger OM, Hofmann A. Patient blood management is a win-win: a wake-up call. Br J Anaesth 2012;108:889-92.

12. The urgent need to implement patient blood management: policy brief. World Health Organization. 2021. (Accessed 26 October 2021, athttps://apps.who.int/iris/bitstream/handle/10665/346655/9789240035744-eng.pdfLicense: CC BY-NC-SA 3.0 IGO.)

13. Luther E. Post-Partum Haemorrhage: Its Treatment, Anticipatory and Actual. Transactions of the Intercolonial Medical Congress; 1899; Brisbane, Australiahttps://archive.org/details/b28083593/page/32/mode/2up.

14. Watson A. The Saving of Blood in Gynaecological Operations. Transactions of the 5th session of the Intercolonial Medical Congress 1899; Brisbane, Australiahttps://archive.org/details/b28083593/page/32/mode/2up.

15. Hammond KL, Margolin DA. Surgical hemorrhage, damage control, and the abdominal compartment syndrome. Clin Colon Rectal Surg 2006;19:188-94.

16. Gordon-Taylor G. THE MOYNIHAN TRADITION. The Lancet 1940;236:537-9.

17. Keynes G. Moynihan of Leeds. Ann R Coll Surg Engl 1966;38:1-21.

18. Shander A, Fink A, Javidroozi M, Erhard J, Farmer SL, Corwin H, Goodnough LT, Hofmann A, Isbister J, Ozawa S, Spahn DR, International Consensus Conference on Transfusion Outcomes G. Appropriateness of allogeneic red blood cell transfusion: the international consensus conference on transfusion outcomes. Transfus Med Rev 2011;25:232-46 e53.

19. Anthes E. Evidence-based medicine: Save blood, save lives. Nature 2015;520:24-6.

20. Bolcato M, Russo M, Trentino K, Isbister J, Rodriguez D, Aprile A. Patient blood management: The best approach to transfusion medicine risk management. Transfus Apher Sci 2020;59:102779.

21. Alternatives to transfusion grow in popularity. The Globe and Mail 1996 May 18.

22. Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med 2011;104:510-20.

23. Mortimer PP. Making blood safer. BMJ 2002;325:400-1.

24. Boucher BA, Hannon TJ. Blood management: a primer for clinicians. Pharmacotherapy 2007;27:1394-411.

25. NHMRC/ASBT. Clinical Practice Guidelines on the Use of Blood and Blood Components Commonwealth of Australia; 2001.

26. Sazama K. The ethics of blood management. Vox Sang 2007;92:95-102.

27. Council of Europe ETS No 164 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention 1997). Council of Europe, 1997. (Accessed 22 February 2021, athttps://www.coe.int/en/web/bioethics/oviedo-convention.)

28. Pellegrino ED. The metamorphosis of medical ethics. A 30-year retrospective. JAMA 1993;269:1158-62.

29. Isbister JP, Pearce B, Delaforce A, Farmer SL. Patients’ choice, consent, and ethics in Patient Blood Management. Anesth Analg 2022.

30. Code of Ethics Relating to Transfusion Medicine. International Society of Blood Transfusion, 2017. (Accessed 21 February 2017, athttps://www.isbtweb.org/about-isbt/code-of-ethics.)

31. Guyatt G, Rennie D, Evidence-Based Medicine Working Group., American Medical Association. Users’ guides to the medical literature : essentials of evidence-based clinical practice. Chicago, IL: AMA Press; 2002.

32. Graves RS. Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. J Med Libr Assoc 2002;90:483-.

33. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71-2.

34. Selvaraj S, Kumar Y, Elakiya M, Saraswathi C, Balaji D, Nagamani P, Mohan S. Evidence-based medicine - a new approach to teach medicine: a basic review for beginners. Biology and Medicine 2010;2:1-5.

35. Haynes RB, Devereaux PJ, Guyatt GH. Clinical expertise in the era of evidence-based medicine and patient choice. Vox Sang 2002;83 Suppl 1:383-6.

36. What is Patient Blood Management? International Foundation for Patient Blood Management. (Accessed 22 February 2021, athttps://www.ifpbm.org/index.php.)

37. Institute of Medicine Committee on Quality of Health Care in A. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US) Copyright 2001 by the National Academy of Sciences. All rights reserved.; 2001.

CONTRIBUTORS: Shannon L Farmer, James P Isbister, Irwin Gross, Manuel R Estioko, Aryeh Shander

"

Here is Edward Bear, coming downstairs now, bump, bump, bump, on the back of his head, behind Christopher Robin. It is, as far as he knows, the only way of coming downstairs, but sometimes he feels that there really is another way, if only he could stop bumping for a moment and think of it.

WINNIE-THE-POOH AND SOME BEES, A.A. MILNE

OVERVIEW 90 SECOND READ

Did you know that patient choice often leads to change and progress in medicine?

Patient empowerment and shared decision-making are keys to helping you get the best care possible. Urgency creates change, and there is a need for change in how we manage your blood.

As long ago as the 1960s, a pioneer surgeon named Dr. Denton Cooley developed techniques to preserve a patient’s own blood instead of transfusing. This enabled him to perform over 1,200 successful open-heart operations on adults and children without transfusing a single drop of blood. It was the beginning of tremendous progress in strategies to preserve and protect a patient’s own blood. Others followed this path and found that patient results were often better than similar treatment with blood transfusions. Despite this, transfusion practice remained the same in most places. But not for long.

In the 1980s, the realization that HIV/AIDS was being transmitted through blood transfusions made headlines around the world and the medical community was forced to re-evaluate how things were being done. Patients wanted answers; patients wanted choice; patients wanted the best care possible. There was an urgent need for change and Patient Blood Management (PBM) led the way.

The journey from Dr. Denton Cooley to our time eventually led in 2021 to the World Health Organization (WHO) publishing a Policy Brief entitled The Urgent Need to Implement Patient Blood Management. This chapter will take you through this exciting medical journey.

A Famous Heart Surgeon Responds to His Patients’ Needs

Experts in change management often refer to the fact that change comes about only with some challenge or crisis that brings with it a sense of urgency.¹,² Without this, the status quo remains.

Dr. Denton Cooley (pictured) is one of the most renowned and awarded heart surgeons in the world.³ From the late 1940s, he developed many of the heart procedures and devices that are now commonly used.⁴ He did early research on the heart-lung machine, developed artificial heart valves and techniques to repair aortic aneurysms, performed the first successful heart transplant in the United States, and was the first to implant an artificial heart in a human. He was an expert in surgical correction of congenital heart defects in infants and children, and was well known for his surgical skill, technical brilliance, and manual dexterity. He founded the Texas Heart Institute in the United States in 1962.

Dr. Denton A Cooley MD.

Reproduced with permission from the Texas Heart Institute, Houston, TX, USA. © TEXAS HEART INSTITUTE 2022.

Dr. Cooley, also generally recognized as the father of bloodless surgery, pioneered open-heart surgery without blood transfusion at the Texas Heart Institute in the early 1960s. At that time, up to 12 units of blood were used just to prime the heart-lung machine! The operations themselves routinely required the transfusion of 20 to 30 units. Cooley and other pioneer heart surgeons noted that priming the heart-lung machine with blood resulted in complications for the patient. Another early heart surgery pioneer, Dr. Robert Litwak, described this as the homologous-blood syndrome.*⁵

"Nothing has ever been achieved by the person who says, ‘It can’t be done.’

ELEANOR ROOSEVELT (1884–1962)

Accordingly, Cooley and others developed a method to prime the heart-lung machine with non-blood fluids and noticed fewer complications for patients.⁶ This became known as a bloodless prime. Then Cooley was presented with a challenge. There was an urgency to this. Patients declining blood transfusion and requesting a bloodless approach came to him for surgery. Other surgeons had declined to treat them because they thought it was impossible to perform heart surgery without blood transfusion. Cooley felt these patients needed to be cared for like any other, and so he developed a different approach, another way, to manage their care. This involved three basic steps⁷ that would later be described as the three pillars of Patient Blood Management (PBM):

Before the operation, he optimized patients’ own blood; that is, he identified and treated anemia, and identified and managed bleeding risk.

During the operation, he refined careful surgical techniques and anesthetic methods to keep blood loss to a minimum.

Following surgery, he and his team tolerated much lower levels of blood hemoglobin than previously thought possible, by providing supportive care until the patients recovered their blood loss by producing their own new blood cells.⁷

Recall from Chapter 1, the general medical belief was that, if a patient’s blood hemoglobin level dropped below 100 g/L, a blood transfusion was necessary. Dr. Cooley disagreed. In an interview when he was 92 years of age,⁸ looking back over his career, Dr. Cooley stated, People have an idea that a surgical patient who has a hemoglobin level of 90 or 100 g/L must immediately have a blood transfusion to bring his hemoglobin up to 120 g/L. That’s not necessary. I think 90% of our patients, even with their blood level down to 50 or 60 g/L, do very well if you modify their life and let their system take over the need for more erythrocytes [red blood cells].†

"Respect for others has resulted in a greater respect of our own profession… I am convinced that what is considered a challenge today will be considered good medical practice tomorrow.

PROFESSOR JACQUES BELGHITI

Ethical Aspects of Bloodless Surgery: The Surgeon’s Viewpoint. Proceedings, Bloodless Surgery International Symposium, Paris, 1996

This was really the beginning of a new way of approaching surgical patient care. Rather than simply relying on transfusion of blood from others, this approach focused on preserving and managing the patient’s own blood.

Cooley had outstanding success. He reported on over 1,200 bloodless surgeries undertaken on children and adults – from one-day-olds to 89-year-olds – saying that such methods avoided the complications often experienced with transfusions.⁷,⁹-¹¹ In the above interview he stated, I always viewed blood as an organ transplant that was associated with similar complications. Cooley was able to compare the results in his large group of patients, in whom he used this combination of bloodless surgery techniques, with other patients receiving conventional donor blood replacement therapy. He said, the results seemed to be better in terms of morbidity [complications] and mortality. Of all Cooley’s outstanding accomplishments, he felt his development of bloodless heart surgery was his most important contribution to open-heart surgery.⁴

In accommodating patient requests, Denton Cooley was applying one of the elements of evidence-based medicine, discussed in Chapter 1: "the integration of best research evidence with clinical expertise and patient values and preferences."¹² To accommodate the preferences and values of these patients who declined blood transfusion at a time when large volumes of blood were routinely transfused in cardiac surgery, Cooley pioneered a different approach, one that would eventually benefit all patients and lead to a new standard of care.

"It is working within limits that the craftsman reveals himself.

JOHANN WOLFGANG VON GOETHE

Others Take up the Challenge

Initially, what Cooley pioneered came to be known as bloodless surgery, because patient blood preservation methods used before, during, and after surgery eliminated the use of transfused blood.¹³ In effect Cooley, all those years ago, employed modern Patient Blood Management and its three-pillar approach.¹⁴

Noting the good patient outcomes and the avoidance of complications he had often observed with transfusion, Cooley recommended that these techniques be applied to every patient.⁷ Dr Cooley was internationally known and respected, with hundreds of surgeons travelling from around the world to observe him and his team. And yet, despite his fame and the fact that he had pioneered a new way that minimized complications and appeared to improve patient outcomes, his recommendation generally fell on deaf ears. Most continued in the traditional way; like Edward Bear, they could not stop bumping downstairs long enough to think of another way. However,