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Saving blood, saving money, saving lives
Dr. David Guzick, M.D., Ph.D.
December 22, 2008
Imagine a clinical procedure performed in hospitalized patients that, in 17 of 18 studies reviewed, was found to be an independent predictor of death with a pooled relative risk estimate of 1.7. Further imagine that this same procedure increased the risk of an infectious complication in all studies, with a relative risk of 1.8, and was associated with an increased risk of developing multi-organ dysfunction syndrome and acute respiratory distress syndrome. (Crit Care Med 2008; 36:2667–2674)
This procedure, performed about 30 million times per year in U.S. hospitals at a cost of $25 billion, is blood transfusion. It is the single most commonly coded procedure for hospital discharges in the United States according to the AHRQ. (http://www.ahrq.gov/data/hcup/factbk7/fbk7tab3.htm)
Surprised? Perhaps, you might be thinking, there are risks associated with blood transfusion, but these must be outweighed, on average, by the benefits. Not so. The recent review referenced above in Critical Care Medicine classified 45 studies including 272,596 patients as (i) risks outweigh benefits, (ii) neutral risk, and (iii) benefits outweigh risks. In 42 of the 45 studies the risks of red blood cell (RBC) transfusion outweighed the benefits; the risk was neutral in two studies; and the benefits outweighed the risks in a single subgroup of a single study (elderly patients with an acute myocardial infarction and a hematocrit < 30%).
Blood transfusion can be a life-saving procedure for many patients in specific situations involving hemorrhage from trauma or surgery, or in many cases of severe anemia in patients who are critically ill. The above data, which have been accumulating in recent years, are quite sobering, however. As suggested in an editorial by Drs. Howard Corwin and Jeffrey Carson (NEJM 2007;356:1667-8): "Red-cell transfusion should no longer be regarded as ‘may help, will not hurt' but, rather, should be approached as ‘first, do no harm'."
Let's look at some of the issues in a little more detail and then consider how the findings can be applied to Strong Memorial and Highland Hospitals, where new transfusion protocols are being championed by Neil Blumberg, MD, Professor of Pathology and Laboratory Medicine and Director of the Blood Bank, and Paul Levy, MD, Professor of Medicine and Associate Chairman for the Department of Medicine.
The history of blood transfusion is intertwined with the history of medicine generally, and is one of the great examples of true translational science. The first successful transfusion of human blood was performed by Dr. James Blundell, a British Obstetrician; he treated a woman who developed postpartum hemorrhage using her husband's blood. Through the 1800s, transfusions were only infrequently performed (e.g., to treat conditions like hemophilia), as many recipients died due to what we now know were hemolytic reactions from blood group incompatibility. The ABO blood group system was discovered by the Austrian Karl Landsteiner, MD, in 1901 (for which he won the Nobel Prize in Medicine or Physiology in 1930), providing the scientific basis for improving the safety of blood transfusion. In 1939, Drs. Landsteiner, Levine and Weiner discovered the Rh blood group system. In 1961, Rh immune globulin was commercially introduced to prevent Rh disease in newborns of Rh-negative women. Since then, advances have occurred in the system of infection screening, storage, distribution, and processing of blood products. Currently accepted blood transfusion practices evolved prior to the concepts of randomized trials and clinical outcomes studies, however, and developed all the sanctity expected of time- honored therapies.
Over the past several decades, with the exception of concern about transfusion-related infection that has been largely eliminated due to effective Hepatitis and HIV testing, the practice of transfusion has grown dramatically under the "may help, can't hurt" mindset. In 1999, however, the results of an important clinical trial, Transfusion Requirements in Critical Care (TRICC), were reported (NEJM 1999;340:409-17). In this randomized, controlled study involving critically ill adults, a liberal transfusion strategy (target hemoglobin level, 10.0g/dL to 12.0 g/dL, with a transfusion trigger of 10.0 g/dL) was compared with a restrictive transfusion strategy (target hemoglobin level, 7.0g/dL to 9.0g/dL, with a transfusion trigger of 7.0 g per deciliter). Patients randomized to restrictive management received 54% fewer red-cell units than did the liberal group, and the restrictive strategy was found to be at least as effective as the liberal strategy with respect to mortality. In patients who were less acutely ill (with a score of < 20 on the Acute Physiology and Chronic Health Evaluation [APACHE II]) or under 55 years of age, the restrictive strategy was actually superior, in that it was associated with a lower mortality than the liberal strategy.
A more recent study of children in a Pediatric Intensive Care Unit (NEJM 2007;365:1609-19) reached similar conclusions. Using multiple organ dysfunction as an endpoint, a restrictive transfusion strategy was at least equivalent to the liberal strategy in this outcome, and was associated with a 44% reduction in the number of red-cell transfusions. These findings come at a time when a quarter of a century of research demonstrates that transfused patients, in general, have much poorer outcomes than similar untransfused patients, and that patients who receive more transfusions do progressively worse in a dose-dependent fashion. (Blumberg N. "Deleterious clinical effects of transfusion immunomodulation—proven beyond a reasonable doubt." Transfusion 45[Supplement]: 33S-40S (2005).)
Currently, approximately 30,000 units of red blood cells are transfused per year at SMH, at a total direct cost of about $1,000 per unit (only a minority of which is accounted for by reimbursement to the Red Cross for costs of collection and testing). At Highland hospital, approximately 8,000 units are transfused annually. Thus, a 10% reduction in the number of transfused units would results in a savings to our hospitals of about $3.8 million.
Currently, under the leadership of Drs. Levy and Blumberg, a team of physicians, nurses, and laboratory staff are developing new protocols to achieve this goal. In addition to employing a more restrictive policy regarding the trigger-point for transfusion, we will increase the utilization of blood-management, blood-conservation programs, and non-transfusion modalities of treatment to correct anemia before planned surgery. One of the lessons learned by nephrologists and oncologists has been that attempts to correct anemia with erythropoietin in patients with life threatening illnesses should not have the goal of restoring normal or near-normal red cell mass, as the result is increased thrombosis, disease progression or other unfavorable clinical outcomes. Transfusion may have similar or worse risks for thrombotic events. (Khorana A, Francis CW, Blumberg N, Culakova E, Refaai M, Lyman G. "Blood transfusions, thrombosis and mortality in hospitalized cancer patients." Archives of Internal Medicine 2008;168:2377-81.)
Dr. Blumberg has been in the forefront nationally in spurring the growing recognition that while transfusion of stored blood is a powerful, life saving therapy in dire clinical circumstances, it can also carry serious, even fatal, risks. Thus, he counsels that routine prophylactic use to treat numbers (e.g., hematocrit, platelet count) rather than life-threatening clinical findings, largely in a prophylactic mode, is fraught with unnecessary risk and cost. These risks can be reduced in part by removing residual white cells, a procedure begun at Strong in 1991 for leukemia patients, in 1998 for cardiac surgery patients and for all patients in 2000. (Blumberg N, Heal JM. "Universal leukoreduction of blood transfusions." Clinical Infectious Diseases 2007;45:1014-5) and possibly by removing the stored supernatant (Blumberg N , Heal JM, Liesveld, J, Phillips, G, Rowe JM. "Platelet transfusion and survival in adults with acute leukemia." Leukemia 2008;22: 631-635.) That said, Dr. Blumberg concludes that the most appropriate, safe and cost effective intervention is simply to refrain from transfusing unless there is a compelling clinical indication.
Dr. Levy adds that we are faced with an important educational challenge across our health care system to drive home two critical points: (1) There is an extensive literature published over the past decade demonstrating that a liberal approach to RBC transfusions is linked to poorer outcomes, and (2) Except in very specific clinical settings, patients managed using a lower, 7 g/dL Hgb threshold trigger for transfusion, have equal or improved outcomes compared with those transfused at a higher threshold.
Consistent with the theme of recent newsletters focused on achieving excellence at a time of financial strain, Dr. Levy points out that "in today's environment it's especially fortuitous that improving the quality of care for our patients also results in cost savings." I would add, wearing my CTSA hat, that research on blood transfusion has progressed through the first two translational stages: from "T1" (discovery of blood groups, fractionation and storage methods, etc. translated to individual patient treatment) to "T2" (defining risk groups and hemoglobin targets for translation to optimal clinical practice). It is now time to progress to the "T3" phase, in which accumulated knowledge on best practices can be disseminated to our physicians, nurses and students, so that known best practices can be achieved across our health care system in a manner that saves blood, saves money and saves lives.
Meliora,
David S. Guzick, MD, PhD
Dean, School of Medicine and Dentistry
University of Rochester
Dean's Newsletter
Posted May 28, 2009:
A Fond Farewell to the University of Rochester
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