Patient Blood Management: a new standard of care to significantly improve outcomes and reduce costs
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1 Patient Blood Management: a new standard of care to significantly improve outcomes and reduce costs Dr. rer. medic. Axel Hofmann, ME Visiting Professor Institute of Anaesthesiology University Hospital Zurich - Switzerland Adjunct Associate Professor School of Surgery Faculty of Medicine Dentistry and Health Sciences University of Western Australia Adjunct Professor Faculty of Health Sciences Curtin University Western Australia
2 Disclaimer In the past 5 years, Dr. Hofmann has received fees, honoraria or travel for consulting or lecturing from the following companies and legal entities: Austrian Institute of Technology, Vienna, Austria CSL Behring GmbH, Marburg, Deutschland IL Werfen, Spain, USA International Foundation for Patient Blood Management MEDahead GmbH, Vienna, Austria MedEd Global Solutions, France Medical Society for Blood Management, Laxenburg, Austria National Blood Authority, Canberra, Australia South African National Blood Service UCB Pharma, PR of China Vifor Fresenius Medical Care Renal Pharma Ltd., Switzerland Vifor International AG,, Switzerland Vision Plus S.r.L., Italy Western Australia Department of Health, Perth, Australia Axel Hofmann Duesseldorf
3 1 The Global Health Care Crisis 3
4 % of GDP Health Care Expenditures All Providers (selected countries) 18,0 16,0 14,0 12,0 10,0 8,0 6,0 4,0 2,0 0,0 Competing with Housing Food Transportation Education Recreation Energy Insurance Social welfare etc. Australia Canada France Germany Italy Japan Korea United Kingdom United States OECD Health Data
5 [T]he era of shifting more and more economic resources toward health care is going to end. The medicine of the future will focus on more efficient use of resources. Kohane, I.S., J.M. Drazen, and E.W. Campion, A glimpse of the next 100 years in medicine. N Engl J Med, (26): p
6 2 The Grey Tsunami: Aggravating the Crisis 6
7
8 From Aging to Hyperaging Adachi M,Ishida R, Oka G. Japan: Lessons from a hyperaging society. McKinsey Quarterly,
9 Population ages 65 and above (% of total) Reproduced from World explorer 26 Population, total Japan Population 60+ Longevity Health care volume Germany Italy U.S China 8 India Life expectancy at birth, total years
10 3 Mitigating the Crisis, but how? 10
11 3.1 Analyze what is going on and wrong in health care 11
12 The financial dimension of what is going wrong 12
13 13
14 Total 2009 health care spending*: France Germany Italy Total $243 Billion $339 Billion $183 Billion $765 Billion *Stats.OECD.org
15 15
16 Cost-Effectiveness Plane Costs ($) $100,000 A No-go Quadrant $50,000 B C 1 2 Outcome E -$50,000 D Prime Quadrant
17 Cost-Effectiveness Plane Costs ($) $100,000 A $50,000 B C 1 2 Outcome E -$50,000 D Prime Quadrant
18 3.2 Focus on one of the bigger issues 18
19 The triad of anaemia, bleeding & transfusion
20 The impairment that affected the greatest number of people in 2015 was anaemia, with 2.36 billion ( billion) individuals affected The prevalence of iron-deficiency anaemia alone was 1.46 billion ( billion).
21 patients of 24 studies analyzed 39% of patients were anemic (WHO definition) Anemia was associated with Perioperative mortality - OR 2.90 ( , p< 0.001) Acute kidney injury - OR 3.75 ( , p< 0.001) Infections - OR 1.93 ( , p< 0.01) Stroke in cardiac surgery - OR 1.28 ( , p< 0.01) RBC transfusion - OR 5.04 ( , p< 0.001) Fowler A.J. et al. Br J Surg (2015) 102: 1314
22 Bleeding Uncontrolled hemorrhage is the only defense of the unconscious patient against the incompetent surgeon. William Stewart Halsted Johns Hopkins University
23 Major blood loss associated with increased Mortality (3-fold) Major morbidity (3-fold) ICU and hospital length of stay Likelihood of transfusion Causes On average 75 90% local surgical interruption or vessel interruption 10 25% acquired or congenital coagulopathy Shander A. Surgery 2007 Ranucci M et al. Ann Thorac Surg 2013; 96:478 Vivacqua et al Ann Thorac Surg 2011 Christensen et al J Thorac Cardiovasc Surg 2009 Spence et al Am J Surg 1990 Stokes, M.E., et al BMC Health Serv Res, 2011 Ye, X., et al BMC Health Serv Res, 2013 Alstrom, U., et al Br J Anaesth, 2012
24 Blood transfusion: most common procedure performed during hospitalizations in 2011 (12% of stays with a procedure); rate of hospitalizations with blood transfusion more than doubled since
![[M]ore patients have died in any one year owing to transfusion immunomodulation s side effects than died in the entire transfusion transmitted AIDS](/docs-images/76/73741310/images/25-1.jpg "epidemic Blumberg, N. and J.M. Heal, Immunomodulation by blood transfusion: an evolving scientific and clinical challenge. Am J Med, 1996. 101(3): p.")
25 [M]ore patients have died in any one year owing to transfusion immunomodulation s side effects than died in the entire transfusion transmitted AIDS epidemic Blumberg, N. and J.M. Heal, Immunomodulation by blood transfusion: an evolving scientific and clinical challenge. Am J Med, (3): p
26 The Multi-Billion Dollar Question: of 150 million allogeneic blood components per year Does transfusion do what it is intended to do improve outcome or prevent adverse outcomes? There are few if any articles that support transfusion actually improving patient outcomes. The majority of database papers show associations between transfusion utilization and with immunosuppression, increased infection, increased renal failure, multisystem organ failure, and death. Spiess, B.D., Risks of transfusion: outcome focus. Transfusion, (12 Suppl): p. 4S-14S. 26
27 Adapted from Farmer SL, Hofmann A, Isbister J. Transfusion and Outcomes. Patient Blood Management 2 rd Edition Thieme; Stuttgart, New York: 2015
28 2007 8,500 pts Compared transfused vs non-transfused after multivariable logistic regression and propensity score analysis 30-day mortality was over 6-times higher in the txd patients Increased ICU, high-dependency unit and hospital length of stay RBC transfusion appears to be harmful for almost all cardiac surgery patients Murphy, G.J., et al., Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation, (22): p
29 Outcome Odds ratio C.I. Composite infection Ischaemic events RBC units txd Adjusted OR; CI Infectious Events 0 AOR 1.0; 95% CI, 1 AOR 1.46; 95% CI, AOR 2.36; 95% CI, or 4 AOR 3.82; 95% CI, AOR 10.75; 95% CI, >9 AOR 45.44; 95% CI, Murphy, G.J., et al., Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation, (22): p
30 Adapted from Farmer SL, Hofmann A, Isbister J. Transfusion and Outcomes. Patient Blood Management 2rd Edition Thieme; Stuttgart, New York: 2015
31 Adapted from Farmer SL, Hofmann A, Isbister J. Transfusion and Outcomes. Patient Blood Management 2rd Edition Thieme; Stuttgart, New York: 2015
32 Adapted from Farmer SL, Hofmann A, Isbister J. Transfusion and Outcomes. Patient Blood Management 2rd Edition Thieme; Stuttgart, New York: 2015
33 Marking the paradigm shift
34
35 Induces or exacerbates anemia Anemia & Iron Deficiency Triggers transfusion Blood Loss & Bleeding Triad of Independent Risk Factors for Adverse Outcomes Transfusion Associated with re-bleeding Farmer SL., Towler SC, Leahy MF, Hofmann A. Best Pract Res Clin Anaesthesiol, (1): p
36 4 PBM: Breaking the viscous cycle 36
37 Anemia & Iron Deficiency Blood Loss & Bleeding Triad of Independent Risk Factors for Adverse Outcomes Transfusion Farmer SL., Towler SC, Leahy MF, Hofmann A. Best Pract Res Clin Anaesthesiol, (1): p
38 MODIFYING THE RISK FACTORS Anemia, Optimise Iron Deficiency red cell mass Minimise Blood Loss blood & loss Bleeding & bleeding Harness & optimise Transfusion physiological reserve of anaemia
39 INTRAOP PREOP POSTOP Hofmann et al. Current Opinions in Anaesthesiology st Pillar Optimise red cell mass 2nd Pillar Minimise blood loss & bleeding 3rd Pillar Harness & optimise physiological reserve of anaemia Detect anaemia Identify underlying disorder(s) causing anaemia Manage disorder(s) Refer for further evaluation if necessary Treat suboptimal iron stores/iron deficiency/anaemia of chronic disease/iron-restricted erythropoiesis Treat other haematinic deficiencies Note: Anaemia is a contraindication for elective surgery Identify and manage bleeding risk Minimise iatrogenic blood loss Procedure planning and rehearsal Assess/optimise patient s physiological reserve and risk factors Compare estimated blood loss with patient-specific tolerable blood loss Formulate patient-specific management plan using appropriate blood conservation modalities to minimise blood loss, optimise red cell mass and manage anaemia Time surgery with haematological optimisation Meticulous haemostasis and surgical techniques Blood-sparing surgical devices Anaesthetic blood conserving strategies Autologous blood options Maintain normothermia Pharmacological/haemostatic agents Optimise cardiac output Optimise ventilation and oxygenation Optimise erythropoiesis Be aware of drug interactions that can increase anaemia Vigilant monitoring and management of post-operative bleeding Avoid secondary haemorrhage Rapid warming / maintain normothermia (unless hypothermia specifically indicated) Autologous blood salvage Minimise iatrogenic blood loss Haemostasis/anticoagulation management Prophylaxis of upper GI haemorrhage Avoid/treat infections promptly Be aware of adverse effects of medication Optimise anaemia reserve Maximise oxygen delivery Minimise oxygen consumption Avoid/treat infections promptly Restrictive transfusion thresholds Perioperative multidisciplinary multimodal patient-specific team approach
40 Anaemia and Bleeding Blood Management Patient Blood Management (managing the patient s own blood) Donor Blood Management (treating the patient with transfusion) because
41 PBM DEFINITION Patient Blood Management (PBM) is an evidence-based bundle of care to optimize patient outcomes by managing and preserving a patient's blood
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43 5 A template for the world: Western Australia PBM Project 43
44 It s a challenge! WA represents one third of the Australian land mass 2.5 million square kilometers for 2.5 million people ~74% live in Perth Fastest growing population and fastest growing older age segment in Australia
45 Results from the world s largest PBM study (n= )
46 Quality, safety, and effectiveness initiative with resource and economic implications. Primary aim: improving medical and surgical patient outcomes while achieving significant cost savings by applying PBM principles Leahy MF, Hofmann A, Towler S, et al. 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
47 Retrospective observational study to assess the impact on key outcome measures in all emergency and elective adult acute-care multi-day stay inpatients (n=605,046) admitted to the 4 major adult tertiary-care hospitals July 2008 June Hospitals perform majority of high-complexity procedures performed in WA including cardiac, major trauma, burns, and obstetrics referral services Multivariate analysis to control for potential confounders and changes in patient case-mix Leahy MF, Hofmann A, Towler S, et al. 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
48 Key program performance indicators Compared to baseline year, implementation was associated in year 6 with: 41% reduction in blood product (P<0.001) RBC txn Hb threshold decreased from 7.9 to 7.3 g/dl (P<0.001) Single-unit RBC txn increased from 33% to 64% (P<0.001) Proportion admitted anemic decreased from 20.8% to 14.4% (P=0.001) Product acquisition cost savings of AU$18.5 million Estimated activity-based cost savings $80 - $100 million A one-time investment of $4.5M to cover 5-year change management and implementation process. Leahy MF, Hofmann A, Towler S, et al. 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
49 Key Patient Outcomes In-hospital mortality: Length of hospital stay: Infection: AMI/Stroke: Readmission: 28% (95% CI, 0.67 to 0.77; P<0.001) 15% (95% CI, 0.84 to 0.87; P<0.001) 21% (95% CI, 0.73 to 0.86; P<0.001) 31% (95% CI, 0.58 to 0.82; P<0.001) 6% (95% CI, 1.02 to 1.10; P<0.001) = additional non-valorized cost savings Leahy MF, Hofmann A, Towler S, et al. 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
50 Utilization Rate Leahy MF, Hofmann A, Towler S, et al. 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
51 6 PBM as a new standard of care 51
52 WHA63.12 adopted by resolution May 21, 2010: Bearing in mind that patient blood management means that before surgery every reasonable measure should be taken to optimize the patient s own blood volume, to minimize the patient s blood loss and to harness and optimize the patient-specific physiological tolerance of anaemia following WHO s guide for optimal clinical use (three pillars of patient blood management)
53 6.1 Commwealth of Australia 53
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56 Patient Blood Management Why important? Preoperative anaemia is independently associated with an increased risk of morbidity and mortality. In cardiac & non-cardiac surgery, RBC transfusion is independently associated with increased morbidity & mortality. This relationship is dose dependent. Preoperative anaemia is associated with increased hospital length of stay in non-cardiac surgery In cardiac & non-cardiac surgery, RBC transfusion is associated with significantly longer stays in hospital and ICU 1
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59 WHY Patient Blood Management PBM aims to improve clinical outcomes by avoiding unnecessary exposure to blood and blood products. Decisions on whether to transfuse should be carefully considered, taking into account the full range of available therapies, and balancing the evidence for efficacy and improved clinical outcome against the potential risks. PBM improves patient outcomes by improving the patient s medical and surgical management in ways that boost and conserve the patient s own blood. As a consequence of better management, patients usually require fewer transfusions thus avoiding transfusion-associated complications. PBM is a multidisciplinary approach that promotes appropriate care for patients and reduces exposure to unnecessary blood transfusions.
60 6.2 European Union 60
61
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63 PBM - Implementation Guide for Hospitals EUROPEAN COMMISSION Directorate-General for Health and Food Safety Directorate B - Health systems, medical products and innovation Unit B.4 - Medical products: quality, safety, innovation Authors Hans Gombotz, Axel Hofmann, Astrid Nørgaard and Peter Kastner AIT Austrian Institute of Technology GmbH Donau City Straße Vienna, Austria /
64 PBM - Guide for Health Authorities EUROPEAN COMMISSION Directorate-General for Health and Food Safety Directorate B - Health systems, medical products and innovation Unit B.4 - Medical products: quality, safety, innovation Authors Axel Hofmann, Astrid Nørgaard, Johann Kurz, Suma Choorapoikayil, Patrick Meybohm, Kai Zacharowski, Peter Kastner and Hans Gombotz AIT Austrian Institute of Technology GmbH Donau City Straße Vienna, Austria /
65 RBC units issued in EU member states, U.S. and WA (per 1,000 population) U.S Western Australia 2016
66 Gross cost estimate related to the missed opportunity of PBM for the US, EU and Australia (2011) Units of packed blood components Acquisition cost (US$) Activity based cost (ABC) multiplier Activity based cost/unit transfused (US$) Total activity based cost (US$) Additional cost associated w/matched transfused patients United States European Union Australia Total Estimate by Hofmann A. US$185 Billion Trentino K.M., et al., Increased hospital costs associated with red blood cell transfusion. Transfusion 2015 Shander A. et al. Activity-based costs of plasma transfusions in medical and surgical inpatients at a US hospital. Vox Sang 2016 Shander A. et al. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion 2010 Hofmann A. et al. Economic considerations on transfusion medicine and patient blood management. Best Pract Res Clin Anaesthesiol 2013
67 7 Conclusion 67
68 Costs ($) Outcome Prime Quadrant
69 Summary The global health care crisis is real The grey tsunami is aggravating the crisis The current imperative is to improve productivity The cost-effectiveness approach guides to productivity improvements The 3-Pillar-PBM concept targets the burden of anaemia, blood loss and transfusion PBM significantly improves outcome while lowering cost of allogeneic blood product consumption transfusion related clinical services (activity based cost) prevented complications The implementation of PBM is increasingly requested by national health authorities
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