TRANSFUSION ALTERNATIVE HEALTH CARE

TRANSFUSION ALTERNATIVE HEALTH CARE

Meeting Patient Needs and Rights

Narrator: Each year in this new millennium, pressures on health-care systems mount. The growing number of patients, particularly the elderly, challenges health-care providers’ ability to meet patient needs with available resources. At the same time, legal and ethical voices increasingly advocate that patients be permitted a greater role in choosing their treatment. These developments especially affect one major sector of health care.

Prof. Neil Blumberg: There’s a growing concern on the part of physicians that our approach to blood transfusion needs to be reevaluated.

Prof. Roland Hetzer: Today at least 80 percent of the patients would strongly favor not to have blood transfusions.

Narrator: News headlines show this, both physicians and patients are faced with transfusion complications, supply shortages, and concerns about blood product safety. As just one example, the world health organization calculates that around the globe unsafe transfusion and injection practices cause some 5,000,000 Hepatitis-C virus infections each year. Increased efforts by national health-care systems to achieve a safer blood supply have caused the cost of blood to spiral upward.

Dr. Guy Turner: Two years ago it cost us about 63 euros per unit of transfused blood. It now costs us 142.

Narrator: Treating transfusion-related side effects has incurred additional costs.

Dr. Aryeh Shander: These costs, which are indirect and delayed, are enormous and clearly would raise the cost of the unit of blood substantially.

Narrator: The same holds true for compensation totaling billions of euros or dollars that have been paid to recipients of tainted blood and to their surviving families. As society faces these issues—transfusion risks and costs—is there a better approach? Might transfusion-alternative health care meet patient needs and rights? Professors Earnshaw and Hetzer and countless other clinicians have responded to the requests of patients and of parents of minors. Consider three examples of complex surgeries performed without transfusion. Open-heart surgery is consistently a major challenge. In Berlin, Professor Roland Hetzer explains why he had to operate on the tiny heart of a ten-month-old baby girl.

Prof. Roland Hetzer: This child has a congenital heart defect, which is relatively rare. It means there is a direct communication between the left ventricle and the right atrium, which creates a continuous abnormal flow between the left heart and the right heart.

Narrator: The defect was corrected with a heart arrest time of only 26 minutes, and the blood flow normalized. No transfusion was given—in fact, there was virtually no blood loss. Another example: Liver surgery usually involves considerable donor transfusion. In Jena, Germany, at the University Clinic, Professor Johannes Scheele here removes the cancerous portion of the liver from an elderly man.

Prof. Johannes Scheele: How much was the blood loss today? ...250 CCs.

Narrator: No donor blood was given, and 18 hours later, the patient is chatting with the doctor in the ICU. Now an example of orthopedic surgery: In London, Royal College fellow Peter Earnshaw successfully performs a total knee replacement on an elderly woman, typically a high-blood-loss operation. All three successful operations were accomplished by surgical teams committed to respecting the patient’s or parent’s preference that donor blood not be given. Were these experimental operations by three pioneering surgeons? There are more than 100,000 physicians and surgeons in 150 countries who routinely treat patients without donor transfusion. Some experts feel…

Dr. Linda Stehling: Every anesthesiologist and surgeon should be interested in blood-conservation strategies because it’s good patient care.

Narrator: When physicians who turn to transfusion-alternative health care are asked why, they often cite as a major reason—respect for their patient’s decision. Professor Blumberg, director of a transfusion medicine unit and blood bank:

Prof. Neil Blumberg: Well, I think there are a growing number of patients who are interested in being treated with either no transfusion or the minimum amount of transfusion possible, and there are some folks who strictly don’t want to be transfused under any circumstances.

Narrator: Another area motivating physicians and surgeons to change their approach is the growing evidence of inconsistent practices leading to unnecessary transfusions. Everyone concerned with improving health care or protecting the individual patient should consider some revealing studies on blood use. First, the Sanguis Study. As part of a concerted action by the European Commission Medical Research Program, transfusion rates in 43 major teaching hospitals across Europe were analyzed. The ramifications of the Sanguis Study are staggering—for the same type of operation, there were enormous variations in the number of units transfused, depending on the hospital! In 1998 in Brussels, Professor Baele published a follow-up study.

Prof. Philippe Baele: All types of hospitals were included in the Belgium Biomed Transfusion Study for Surgery. And we found exactly the same range of variability.

Prof. Lawrence T. Goodnough: So we are left with the conclusion that variability implies that a lot of these blood transfusion components are being given unnecessarily.

Narrator: A comparison of the two studies revealed another significant fact.

Prof. Philippe Baele: There were two centers which participated both in the Sanguis Study and in the Biomed Study.

Narrator: Based on their findings in the Sanguis Study:

Prof. Philippe Baele: They had somehow managed to reduce their blood consumption for major surgery. The mortality was the same before and after the changes. The hospital stay was shorter. The new procedures they adopted weren’t very difficult to adopt, although they took time and took a considerable educational effort, but they didn’t result in increased costs.

Narrator: Soon after, in Canada, Dr. Hebert did a large-scale study of critically ill patients in intensive care. Professor Spahn evaluates the results.

Prof. Donat R. Spahn: I talk about the Hebert paper, where they showed in more than 800 patients that less transfusion results in an improved outcome.

Narrator: The obvious conclusion is that unnecessary transfusion translates into unnecessary labor and unnecessary cost. Besides patient demand and overtransfusion, many physicians cite as motivation to implement transfusion-alternative health care the desire to avoid medical risks.

Prof. Lawrence T. Goodnough: There’s the risk of bacterial contamination in a stored unit of blood.

Narrator: Bacterial contamination, whether occurring at donation or subsequently from improper storage, can cause infections having fatal consequences. In another arena, despite improved testing viral infections continue to pose a serious threat. Experts are concerned about what the future holds.

Dr. Howard L. Zauder: Will existing viruses mutate and produce disease? There’s no reason to believe that they won’t.

Prof. Peter H. Earnshaw: The problem with contamination of transfusions, it always seems to be one step ahead of us.

Prof. Donat R. Spahn: In addition, blood transfusions induce a immunosuppressive state with the recipient, and that results in increased postoperative infections as well as earlier and more often recurrence of tumors.

Prof. Neil Blumberg: We’ve estimated that, approximately, in the United States, we can expect that 10,000 to 50,000 patients a year may be dying from transfusion-immunomodulation related causes.

Narrator: Likely the most surprising and least recognized medical risk is human error—giving blood of an incompatible type can cause a reaction ranging from mild to fatal. Professor Spence, a director of surgical education, acknowledges:

Prof. Richard K. Spence: We can mix the blood up and cause catastrophe. Patients have died and do die from getting the wrong blood.

Narrator: In fact, reports indicate that human error causes up to one half of all transfusion-triggered deaths! In the light of such realities—patient decision, unnecessary transfusions, medical risks, as well as shrinking blood inventories and soaring blood costs—Professor van der Linden summarizes what many experts have concluded:

Prof. Philippe van der Linden: In view of the potential for a better patient-care and a reduced health-care cost, blood conservation is not an option, it’s a must.

Narrator: The good news is that safe, practical, and cost-effective therapies already exist.

Dr. Aryeh Shander: The best medical care can be delivered without the use of allogeneic blood.

Prof. Peter H. Earnshaw: There are some very simple, very cheap things you can do, which would help the majority of people, and this could be done in the smallest of hospitals.

Prof. Johannes Scheele: Blood conservation is a very simple method, which make things rather smooth, less expensive, and with a better outlook for the patient.

Narrator: The transfusion-alternative techniques used by these surgical teams can be grouped within one of three basic principles, or pillars. The first is “tolerance of anemia.” Racing through the arteries, red cells carry life-sustaining oxygen to all parts of the body. The anemic patient has a low number of red cells in relation to his blood volume. If a person suffers extensive blood loss during surgery or as the result of an accident, the body can tolerate anemia to a considerable degree. Professor Moore, an acknowledged pioneer in trauma surgery:

Prof. Ernest E. Moore: Studies have shown, physiologically, that the human being can tolerate much lower hemoglobin levels than previously assumed safe.

Dr. Aryeh Shander: The medical community is starting to realize that tolerance of a significant anemia is doable for patients.

Narrator: However, anemia is tolerable only when the body has sufficient circulatory volume to continue to function.

Prof. Richard K. Spence: We also know that with that anemia, we can compensate with volume, because volume is the critical component here to maintaining blood pressure.

Narrator: With low-cost blood volume expanders being available, current medical opinion increasingly abandons the arbitrary rule, proposed back in 1942, that a hemoglobin level of 10 was the transfusion trigger, or the lowest acceptable figure before administering a transfusion. Thus, Professor Earnshaw notes his first step in implementing a transfusion-alternative program:

Prof. Peter H. Earnshaw: I halved our transfusion rate by simply saying, ‘could we lower our triggers from 10 to 8?’ And just taking a little more control over the decision. That was very easy. That cost nothing.

Narrator: Simply implementing the first pillar would cut out millions of transfusions and save billions of euros or dollars annually! The second important principle in transfusion-alternative strategies involves stimulating red-cell production in the patient’s body. This is important for an anemic patient before surgery, and it can speed recovery after extensive blood loss. Studies directed by Professor of Obstetrics Albert Huch have shown:

Prof. Albert Huch speaking German: Sufficient iron supplementation can already normalize the blood count to a large extent and at relatively little expense.

Narrator: In selected cases, the genetically engineered drug erythropoietin, commonly called epo, can be used. Professor Mercuriali, a director of transfusion services, explains:

Prof. Francesco Mercuriali: Stimulated by the administration of erythropoietin, there is an acceleration of production of new red blood cells.

Narrator: The third principle, or pillar, is to minimize blood loss.

Prof. Johannes Scheele: The most important technique to control bleeding is to avoid bleeding.

Narrator: Meticulous surgery is practical and cost-effective. A variety of tools can be used to assist. For example, electrocautery devices enable surgeons to cut rapidly and to seal blood vessels immediately. There are also modern drugs that can reduce bleeding. Some are applied directly to the bleeding area. Here a fibrin glue pad is used to stop blood from oozing out of a dissected liver. Professor Baron notes about the cost-effectiveness of such agents:

Prof. Jean-François Baron: The decrease in the intraoperative bleeding and the decrease in the use of blood products compensates for the cost of the drug.

Narrator: Another effective technique to minimize loss in instances of heavy bleeding is to salvage the patient’s own blood. Recovery of as much as 50 percent of the blood otherwise lost has become a reality. This technique also meets the ethical needs of many who absolutely refuse donor transfusions. For instance, some of Jehovah’s Witnesses have allowed cell salvage to be used. There are even such machines designed for small children.

Prof. Donat R. Spahn: Cell salvage is a very important technique because when you use cell salvage, the blood lost by the surgeon is not lost for the patient.

Narrator: Many other beneficial strategies are available. All assist in avoiding the risks and societal costs of millions of transfusions. To illustrate the impact of properly combined techniques, consider the task faced by the medical team of four-year-old Luana in Modena, Italy. She was born with a serious heart defect. Her team, headed by Professor Marcelletti, chief of cardiovascular surgery, had to perform a series of complex operations. As requested by Luana’s parents, the first operation was successfully done without donor blood. Once again, for the second procedure, there were both skilled personnel and the appropriate equipment, including a cell-salvage machine. The meticulous surgery, utilizing electrocautery, took two hours, and Luana lost only 100 milliliters of blood! Her parents were delighted, and the medical team was pleased with the outcome.

Prof. Carlo F. Marcelletti: We have performed the operation without the use of a blood transfusion, as we try to perform with all of our children.

Dr. Nicoletta Salviato: I think all these little babies deserve not to be transfused and not to take the risk of a blood transfusion.

Narrator: Further proof of the effectiveness of heart surgery without transfusion is provided by Dr. Rosengart:

Dr. Todd K. Rosengart: When we looked at a series of 50 Jehovah’s Witnesses patients and 100 patients in the general population, we found a shorter length of stay and a lower cost using our blood-conservation strategy.

Narrator: While many clinicians would hold that some situations absolutely require blood, what is the view of those experienced in the use of transfusion alternatives in life-threatening emergencies? First, an anesthesiologist’s perspective:

Dr. Aryeh Shander: The cessation of bleeding, whether surgically or by other means, must be the first principle. It’s important to act quickly, and to keep in mind that modalities are still available even in a trauma situation.

Narrator: Next, a surgeon’s perspective:

Prof. Johannes Scheele: In any trauma patient with a significant blood loss, I would always prepare the cell-saver system.

Narrator: In one of the busiest trauma centers in the United States, Professor Cohn, chief of Trauma and Surgical Critical Care, notes about patients declining donor blood:

Prof. Stephen M. Cohn: We see more than 3,000 patients a year here that are Jehovah’s Witnesses, and we do about 250 to 275 major operations on them each year. And what we have seen in our population is no increased length of stay, no increased mortality. In fact, it appears to be somewhat decreased.

Narrator: On the basis of such experience, many physicians conclude that, overall, transfusion-alternative health care is cost-effective:

Prof. Richard K. Spence: One of the beauties of transfusion alternatives is that the most effective alternatives are generally the cheapest.

Prof. Stephen G. Pollard: There’s no doubt that blood is a costly product. We’ve been able to reduce our blood-transfusion bill for the liver-transplant program here by 70 percent since we started adopting new techniques. And that equates to hundreds of thousands of pounds in a year, and it’s far more than the cost of the drugs and the other therapies we use and the mechanical methods we use for reducing blood loss.

Prof. Philippe Baele: It takes more dedication than technical means. Similar results can be achieved without the use of costly machinery.

Narrator: And transfusion-alternative health care has a benefit beyond saving money and meeting patients’ physical needs. There is an ethical benefit. This care honors the patient’s freedom of choice to accept or reject a certain treatment.

Prof. Neil Blumberg: One of the primary principles of good medical care is being concerned about what the patient wants.

Narrator: Professor Harding, who teaches ethics to medical and law students:

Prof. Timothy W. Harding: Today one would link that ethical duty not to do harm, to seek the best possible outcome for one’s patient, with another duty, which is to respect the autonomy of the patient, to respect the patient’s own views and decisions.

Narrator: At Glasgow University, Professor of Law and Ethics in Medicine Sheila McLean summarizes:

Prof. Sheila A. M. McLean: Doctors have virtually an absolute obligation, both legally and ethically, to respect the patient’s choice.

Narrator: Concerning the advancing legal view generally designated “patient rights,” Professor Guillod, founder of the Health Law Institute at Neuchatel University:

Prof. Olivier Guillod: I believe the basic element of patients’ rights is the right of self-determination, that is, the right of any patient to decide what shall be done with his or her own body.

Prof. Sheila A. M. McLean: Patients have a right to be told that there are alternatives and, more than that there are alternatives, what are the respective risks and benefits expected to be associated with those.

Narrator: Concerning the evolution of patient rights, Professor Weissauer explains:

Prof. Walther Weissauer speaking German: Earlier, the doctor determined how to proceed and thereby shouldered the entire responsibility. In the course of time, the relationship has changed more and more into a partnership, doctor and patient meeting each other with full equal rights.

Narrator: Recognizing patient rights accords with the UN’s universal declaration of human rights. In fact, these legal issues have become so important that in 1997 the Council of Europe formulated the Convention on Human Rights and Biomedicine. Article 5 proclaims: “An intervention…may only be carried out after the person concerned has given free and informed consent to it.”

Prof. Olivier Guillod: The doctrine of informed choice says that it is up to the patient to accept or to refuse any kind of medical act, for instance, a blood transfusion.

Narrator: Addressing a sensitive issue, Article 6 states: “The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.”

Prof. Timothy W. Harding: There’s no doubt that minors, in a legal sense, can and very often are able as adolescents to take decisions about their own treatment and their own health.

Narrator: How does freedom of choice for patients and parents work out in practical terms?

Prof. Olivier Guillod: Well, if the physician cannot think of finding a way of accommodating a patient’s desire about alternatives to blood transfusion, he should try to refer the patient to one of his colleagues or to another institution or health-care facility where this alternative is really practiced.

Narrator: But what about emergencies where the victim may not be able to speak, to convey personal conviction?

Prof. Timothy W. Harding: It’s now recognized that people have the right to indicate treatment choices in advance. And this takes the form of a written document where the patient shows that they have considered certain situations and they have taken a clear position about a treatment choice.

Prof. Walther Weissauer speaking German: In an emergency, one would always also search for an advance directive or a durable power of attorney, for instance, in the wallet of the patient.

Narrator: Respecting patient rights also has health-care benefits.

Prof. Sheila A. M. McLean: There is empirical evidence that patients who feel engaged in their treatment are likely to get better quicker.

Narrator: Consider, for example, a case at St. Richard’s Hospital in Chichester in southern England.

Dr. Vipul Patel: Mrs. Whittington had arthritis of her hip, which was so advanced that she required a total hip replacement. She is a Jehovah’s Witness and therefore declined to have a blood transfusion.

Mrs. Whittington: Well, I do believe that God’s word is against taking blood, and we should appreciate that God’s word is the truth. Mr. Patel was quite happy to do it without blood.

Dr. Guy Turner: It is the doctor’s responsibility to listen to patients’ demands, listen to what they have to say, and give them an informed choice of alternatives.

Narrator: In frank dialogue between physician and patient, the question of whether she would accept cell salvage arose:

Mrs. Whittington: When I knew more about the machine and it was explained to me, I said I would accept having the machine.

Jo Light: The relationship between the patients and the medical staff is excellent here. We have a very open culture and a good learning environment.

Narrator: What was the outcome of this cooperative approach?

Dr. Vipul Patel: The strategies that we used intraoperatively during Mrs. Whittington’s operation were meticulous hemostasis, salvage of blood using a cell-saver system, as well as using a cemented hip replacement. She tells me that she is delighted with the operation in terms of the pain relief.

Narrator: As earth’s population continues to grow and age, their medical needs will be a greater challenge to health-care structures, many of which are already struggling. In this regard, transfusion-alternative health care offers a promising direction.

Prof. Philippe van der Linden: A well-adopted blood-conservation program means a decrease in the total cost for the patient but also a decreased cost for society.

Narrator: While all medical interventions involve risks, transfusion-alternative health care uniquely meets both patient needs and rights.

Dr. Vipul Patel: I can foresee that in the future, patients will almost expect that any surgery which is necessary is carried out without blood transfusion.

Prof. Olivier Guillod: Patient empowerment is important, not only to better respect autonomy but to promote good medical treatment.

Prof. Roland Hetzer: The various steps to reduce the need of blood transfusion, nowadays, are very well established, well tested, and they are certainly safe.

Dr. Aryeh Shander: This is universal, can be practiced in any institution, in any part of the world.

Prof. Philippe van der Linden: Blood conservation is safe, effective, and progressive medicine.

Dr. Aryeh Shander: This is the best way of treating patients and clearly should be a standard of care.