Implementation of Patient Blood Management in Orthotopic Heart Transplants: A Single Centre Retrospective Observational Review.

BACKGROUND: Blood transfusion in the perioperative cardiothoracic setting has accepted risks including deep sternal wound infection, increased intensive care unit length of stay, lung injury, and cost. It has an immunomodulatory effect which may cause allo-immunisation. This may influence long-term survival through immune-mediated factors. Targeting coagulation defects to reduce unnecessary or inappropriate transfusions may reduce these complications. METHODS: In 2012, an institution-wide patient blood management evidence-based algorithmic bleeding management protocol was implemented at The Prince Charles Hospital, Brisbane, Australia. The benefit of this has been previously reported in our lung transplant and cardiac surgery (excluding transplants) cohorts. This study aimed to investigate the effect of this on our orthotopic heart transplant recipients. RESULTS: After the implementation of the protocol, despite no difference in preoperative haemoglobin levels and higher risk patients (EuroSCORE 20 vs 26; p=0.013), the use of packed red blood cells (13.0 U vs 4.4 U; p=0.046) was significantly lower postoperatively and fresh frozen plasma was significantly lower both intra- and postoperatively (7.4 U vs 0.6 U; p<0.001, and 3.3 U vs 0.6 U; p=0.011 respectively). Concurrently, the use of prothrombin complex concentrate (33% vs 78%; p<0.001) and desmopressin (5% vs 22%; p=0.0028) was significantly higher in the post-protocol group, while there was less use of recombinant factor VIIa (15% vs 4%; p=0.058). Intraoperative units of cryoprecipitate also rose from 0.9 to 2.0 (p=0.006). CONCLUSIONS: We have demonstrated that a targeted patient blood management protocol with point-of-care testing for heart transplant recipients is correlated with fewer blood products used postoperatively, with some increase in haemostatic products and no evidence of increased adverse events.

Patient Blood Management as an Emerging Concept in Quality: The Role of Nurses.

BACKGROUND: Transfusion of blood components has long been considered lifesaving therapy. While blood transfusion may be clinically indicated as a treatment option for some patients, the benefits of transfusion in asymptomatic, hemodynamically stable patients are questionable. PROBLEM: Blood component transfusion is routinely used as a default therapy when not clinically indicated, increasing the risk of poor patient outcomes, adverse events, pressures on blood supply and availability, and increased health care costs. APPROACH: Nurses have the responsibility to advocate for patients and reduce/avoid unnecessary blood transfusion through the implementation of patient blood management (PBM). The PBM paradigm includes treatment of anemia, minimizing blood loss and bleeding, optimization of coagulation, and employing true patient-centered decision making. CONCLUSIONS: PBM should become the standard of care with the goal of improving health care quality and patient outcomes while using the multidisciplinary team for its implementation. As advocates for their patients, nurses can play a major role in the development, implementation, and promotion of PBM.

Determining sex-specific preoperative haemoglobin levels associated with intraoperative red blood cell transfusion in cardiac surgery: a retrospective cohort study.

BACKGROUND: Anaemic cardiac surgery patients are at greater risk of intraoperative red blood cell transfusion. This study questions the application of the World Health Organization population-based anaemia thresholds (haemoglobin <120 g L-1 in non-pregnant females and <130 g L-1 in males) as appropriate preoperative optimisation targets for cardiac surgery. METHODS: A retrospective cohort study was conducted on adults ≥18 yr old undergoing cardiopulmonary bypass surgery. Logistic regression was applied to define sex-specific preoperative haemoglobin concentrations with reduced probability of intraoperative red blood cell transfusion for cardiac surgery patients. RESULTS: Data on 4384 male and 1676 female patients were analysed. Binarily stratified multivariable logistic regression odds of receiving intraoperative red blood cell transfusion increased in cardiac surgery patients >45 yr old (odds ratio [OR] 1.84; 95% confidence interval [CI] 1.33-2.55), surgery urgency <30 days (OR 2.03; 95% CI 1.66-2.48), combined coronary artery bypass grafting and valve surgery, or other surgery types (OR 2.24; 95% CI 1.87-2.67), and female sex (OR 1.92; 95% CI 1.62-2.28). The odds decreased by 8.4% with each 1 g L-1 increase in preoperative haemoglobin (OR 0.92; 95% CI 0.91-0.92). Logistic regression predicted females required a preoperative haemoglobin concentration of 133 g L-1 and males 127 g L-1 to have a 15% probability of intraoperative transfusion. CONCLUSIONS: The World Health Organization female anaemia threshold of haemoglobin <120 g L-1 disproportionately disadvantages female cardiac surgery patients. A preoperative haemoglobin concentration ≥130 g L-1 in adult cardiac surgery patients would minimise their overall probability of intraoperative red blood cell transfusion to <15%.

Improving Patient Blood Management Programs: An Implementation Science Approach.

Organized patient blood management (PBM) programs function in numerous hospitals and health systems around the world contributing to improved patient outcomes as well as increased patient engagement, decreased resource use, and reductions in health care costs. PBM "programming" ranges from the implementation of single strategies/initiatives to comprehensive programs led by dedicated clinicians and PBM committees, employing the use of multiple PBM strategies. Frontline health care professionals play an important role in leading, implementing, operationalizing, measuring, and sustaining successful PBM programs. In this article, we provide practical implementation guidance to support key clinical, administrative, leadership, and structural elements required for the safe and comprehensive delivery of care in PBM programs at the local level.

Patients' Choice, Consent, and Ethics in Patient Blood Management.

The goal of patient blood management (PBM) is to optimize clinical outcomes for individual patients by managing their blood as a precious and unique resource to be safeguarded and managed judiciously. A corollary to successful PBM is the minimization or avoidance of blood transfusion and stewardship of donated blood. The first is achieved by a multidisciplinary approach with personalized management plans shared and decided on with the patient or their substitute. It follows that the physician-patient relationship is an integral component of medical practice and the fundamental link between patient and doctor based on trust and honest communication. Central to PBM is accurate and timely diagnosis based on sound physiology and pathophysiology as the bedrock on which scientifically based medicine is founded. PBM in all disease contexts starts with the questions, "What is the status of the patient's blood?" "If there are specific abnormalities in the blood, how should they be managed?" and "If allogeneic blood transfusion is considered, is there no reasonable alternative therapy?" There are compelling scientific reasons to implement a nontransfusion default position when there is clinical uncertainty and questionable evidence of clinical efficacy for allogeneic blood transfusion due to known potential hazards. Patients must be informed of their diagnosis, the nature, severity and prognosis of the disease, and treatment options along with risks and benefits. They should be involved in decision-making regarding their management. However, as part of this process, there are multifaceted medical, legal, ethical, and economic issues, encompassing shared decision-making, patient choice, and informed consent. Furthermore, variability in patient circumstances and preferences, the complexity of medical science, and the workings of health care systems in which consent takes place can be bewildering, not only for the patient but also for clinicians obtaining consent. Adding "patient" to the concept of blood management differentiates it from "donor" blood management to avoid confusion and the perception that PBM is a specific medical intervention. Personalized PBM is tailoring the PBM to the specific characteristics of each patient. With this approach, there should be no difficulty addressing the informed consent and ethical aspects of PBM. Patients can usually be reassured that there is nothing out of order with their blood, in which case the focus of PBM is to keep it that way. In some circumstances, a hematologist may be involved as a patient's blood advocate when abnormalities require expert involvement while the primary disease is being managed.

Barriers and facilitators to implementing evidence based bleeding management in Australian Cardiac Surgery Units: a qualitative interview study analysed with the theoretical domains framework and COM-B model.

BACKGROUND: Bleeding during cardiac surgery is a common complication that often requires the transfusion of blood products. The combination of bleeding and blood product transfusion incrementally increases adverse outcomes including infection and mortality. Following bleeding management guideline recommendations could assist with minimising risk but adherence is not high, and the cause for lack of adherence is not well understood. This study aimed to identify barriers and facilitators to practicing and implementing evidenced-based intra-operative, bleeding management in Australian cardiac surgery units. METHODS: We used a qualitative descriptive design to conduct semi-structured interviews with Australian cardiac surgeons, anaesthetists and perfusionists. The Theoretical Domains Framework (TDF) was utilised to guide interviews and thematically analyse the data. Categorised data were then linked with the three key domains of the COM-B model (capability, opportunity, motivation - behaviour) to explore and understand behaviour. RESULTS: Seventeen interviews were completed. Nine of the 14 TDF domains emerged as significant. Analysis revealed key themes to improving capability included, standardisation, monitoring, auditing and feedback of data and cross discipline training. Opportunity for change was improved with interpersonal and interdepartmental collaboration through shared goals, and more efficient and supportive processes allowing clinicians to navigate unfamiliar business and financial models of health care. Results suggest as individuals, clinicians had the motivation to make change and healthcare organisations have an obligation and a responsibility to partner with clinicians to support change and improve goal directed best practice. CONCLUSION: Using a theory-based approach it was possible to identify factors which may be positively or negatively influence clinicians ability to implement best practice bleeding management in Australian cardiac surgical units.

A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759).

BACKGROUND: Cryopreservation extends platelet (PLT) shelf life from 5 to 7 days to 2 to 4 years. However, only 73 patients have been transfused cryopreserved PLTs in published randomized controlled trials (RCTs), making safety data insufficient for regulatory approval. STUDY DESIGN AND METHODS: The Cryopreserved vs. Liquid Platelet (CLIP) study was a double-blind, pilot, multicenter RCT involving high-risk cardiothoracic surgical patients in four Australian hospitals. The objective was to test, as the primary outcome, the feasibility and safety of the protocol. Patients were allocated to study group by permuted block randomization, with patients and clinicians blinded by use of an opaque shroud placed over each study PLT unit. Up to 3 units of cryopreserved or liquid-stored PLTs were administered per patient. No other aspect of patient care was affected. Adverse events were actively sought. RESULTS: A total of 121 patients were randomized, of whom 23 received cryopreserved PLTs and 18 received liquid-stored PLTs. There were no differences in blood loss (median, 715 mL vs. 805 mL at 24 hr; difference between groups 90 mL [95% CI, -343.8 to 163.8 mL], p = 0.41), but the Bleeding Academic Research Consortium criterion for significant postoperative hemorrhage in cardiac surgery composite bleeding endpoint occurred in nearly twice as many patients in the liquid-stored group (55.6% vs. 30.4%, p = 0.10). Red blood cell transfusion requirements were a median of 3 units in the cryopreserved group versus 4 units with liquid-stored PLTs (difference between groups, 1 unit [95% CI, -3.1 to 1.1 units]; p = 0.23). Patients in the cryopreserved group were more likely to be transfused fresh-frozen plasma (78.3% vs. 27.8%, p = 0.002) and received more study PLT units (median, 2 units vs. 1 unit; difference between groups, 1 unit [95% CI, -0.03 to 2.0 units]; p = 0.012). There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function. No patient had died at 28 days, and postoperative length of stay was similar in each group. CONCLUSION: In this pilot RCT, compared to liquid-stored PLTs, cryopreserved PLTs were associated with no evidence of harm. A definitive study testing safety and hemostatic effectiveness is warranted.

A retrospective explanatory case study of the implementation of a bleeding management quality initiative, in an Australian cardiac surgery unit.

BACKGROUND: Bleeding management in cardiac surgery is challenging. Many guidelines exist to support bleeding management; however, literature demonstrates wide variation in practice. In 2012, a quality initiative was undertaken at The Prince Charles Hospital, Australia to improve bleeding management for cardiac surgery patients. The implementation of the quality initiative resulted in significant reductions in the incidence of blood transfusion, re-exploration for bleeding; superficial leg and chest wound infections; length of hospital stay, and cost. Given the success of the initiative, we sought to answer the question; "How and why was the process of implementing a bleeding management quality initiative in the cardiac surgery unit successful, and sustainable?" METHODS: A retrospective explanatory case study design was chosen to explore the quality initiative. Analysis of the evidence was reviewed through phases of the 'Knowledgeto Action' planned change model. Data was derived from: (1) document analysis, (2) direct observation of the local environment, (3) clinical narratives from interviews, and analysed with a triangulation approach. The study period extended from 10/2011 to 6/2013. RESULTS: Results demonstrated the complexity of changing practice, as well as the significant amount of dedicated time and effort required to support individual, department and system wide change. Results suggest that while many clinicians were aware of the potential to apply improved practice, numerous barriers and challenges needed to be overcome to implement change across multiple disciplines and departments. CONCLUSIONS: The key successful components of the QI were revealed through the case study analysis as: (1) an appropriately skilled project manager to facilitate the implementation process; (2) tools to support changes in workflow and decision making including a bleeding management treatment algorithm with POCCTs; (3) strong clinical leadership from the multidisciplinary team and; (4) the evolution of the project manager position into a perpetual clinical position to support sustainability.

Targeted Bleeding Management Reduces the Requirements for Blood Component Therapy in Lung Transplant Recipients.

OBJECTIVE: Lung transplantation is associated with high rates of bleeding and frequent blood transfusion. The authors aimed to determine if point-of-care coagulation testing (POCCT) reduced transfusion requirements. DESIGN, SETTINGS, AND PARTICIPANTS: A before-and-after cohort analysis conducted at a single tertiary referral center. Ninety-three sequential adult patients between January 2010 and January 2014 undergoing isolated lung transplant without preoperative extracorporeal support were analyzed. INTERVENTION: ROTEM and multi-plate POCCT were introduced on July 1, 2012, with an associated algorithm based on the results. MEASUREMENTS AND MAIN RESULTS: Statistically significant decreases in the proportion of patients receiving PRBCs (87% v 65%; p = 0.015), FFP (72% v 30%; p<0.0001) and platelets (70% v 37%; p = 0.002) were found after the intervention. There were small decreases in median chest tube blood loss at 2 hours (300 mLs v 215 mLs; p = 0.03) and 4 hours (440 mLs v 350 mLs; p = 0.050) but not at 12 hours postoperatively. There were no changes in reoperation for bleeding (9% v 4%; p = 0.158) or in-hospital mortality (6% v 2%; p = 0.617). The cost of blood products administered decreased from a median of $3,935.00 to $991.00 (p<0.001). CONCLUSIONS: Use of POCCT in lung-transplant surgery is associated with significant reductions in blood product use and cost. There were no detectable changes in outcome aside from a small decrease in early postoperative bleeding.

Long-term outcomes following Medtronic Open Pivot valved conduit.

BACKGROUND AND AIM OF THE STUDY: Aortic root replacement is a complex procedure, though subsequent modifications of the original Bentall procedure have made surgery more reproducible. The study aim was to examine the outcomes of a modified Bentall procedure, using the Medtronic Open PivotTM valved conduit. Whilst short-term data on the conduit and long-term data on the valve itself are available, little is known of the long-term results with the valved conduit. METHODS: Patients undergoing aortic root replacement between February 1999 and February 2010, using the Medtronic Open Pivot valved conduit were identified from the prospectively collected Cardiothoracic Register at The Prince Charles Hospital, Brisbane, Australia. All patients were followed up echocardiographically and clinically. The primary end-point was death, and a Cox proportional model was used to identify factors associated.with survival. Secondary end-points were valve-related morbidity (as defined by STS guidelines) and postoperative morbidity. Predictors of morbidity were identified using logistic regression. RESULTS: A total of 246 patients (mean age 50 years) was included in the study. The overall mortality was 12%, with actuarial 10-year survival 79% and a 10-year estimate of valve-related death of 0.04 (95% CI: 0.004, 0.07). Preoperative myocardial infarction (p = 0.004, HR 4.74), urgency of operation (p = 0.038, HR 2.8) and 10% incremental decreases in ejection fraction (p = 0.046, HR 0.69) were predictive of mortality. Survival was also affected by the valve gradients, with a unit increase in peak gradient reducing mortality (p = 0.021, HR 0.93). Valve-related morbidity occurred in 11 patients. Urgent surgery (p <0.001, OR 4.12), aortic dissection (p = 0.015, OR 3.35), calcific aortic stenosis (p = 0.016, OR 2.35) and Marfan syndrome (p 0.009, OR 3.75) were predictive of postoperative morbidity. The reoperation rate was 1.2%. CONCLUSION: The Medtronic Open Pivot valved conduit is a safe and durable option for aortic root replacement, and is associated with low morbidity and 10-year survival of 79%. However, further studies are required to determine the effect of valve gradient on survival.

Association Between Thromboelastometry Identified Hypercoagulability and Thromboembolic Complications After Arthroplasty: A Prospective Observational Study in Patients With Obesity.

The prothrombotic state of obesity can increase the risk of thromboembolism. We aimed to investigate if there was an association between baseline hypercoagulable rotational thromboelastometry (ROTEM) profile and thromboembolic complications in arthroplasty patients with obesity. Patients with a body mass index ≥ 25 kg/m2 and/or waist circumference ≥94 cm (M) and 80 cm (F) undergoing hip and knee arthroplasty had pre- and postoperative ROTEM. ROTEM values were compared by outcome status using an independent sample equal-variance t-test. Of the 303 total participants, hypercoagulability defined as extrinsically activated thromboelastometry maximum clot firmness G score ≥ 11 K dyne/cm2, was observed in 90 (30%) of the 300 participants with preoperative ROTEM assays. Clinically significant thromboembolic complications occurred in 5 (1.7%) study participants before discharge and in 10 (3.3%) by 90 days. These included 6 with pulmonary emboli, 3 with deep venous thrombus, and 1 with myocardial infarction. We found no evidence for an association between baseline hypercoagulability and incident thromboembolic events, analysis limited by the number of events. Postoperative decrease in platelets and an increase in fibrinogen were observed. ROTEM parameter changes differed across obesity categories.

Bleeding Management Practices of Australian Cardiac Surgeons, Anesthesiologists and Perfusionists: A Cross-Sectional National Survey Incorporating the Theoretical Domains Framework (TDF) and COM-B Model.

PURPOSE: Excessive bleeding is an acknowledged consequence of cardiac surgery, occurring in up to 10% of adult patients. This clinically important complication leads to poorer patient outcomes. Clinical practice guidelines are available to support best practice however variability in bleeding management practice and related adverse outcomes still exist. This study had two objectives: 1) to gain insight into current bleeding management practice for adult cardiac surgery in Australia and how that compared to guidelines and literature; and 2) to understand perceived difficulties clinicians face implementing improvements in bleeding management. METHODS: A national cross-sectional questionnaire survey was utilized. Perspectives were sought from cardiac surgeons, cardiac anesthesiologists and perfusionists. Thirty-nine closed-ended questions focused on routine bleeding management practices to address pre and intra-operative care. One open-ended question was asked; "What would assist you to improve bleeding management with cardiac surgery patients?" Quantitative data were analysed with SPSS. Qualitative data were categorized into the domains of the Theoretical Domains Framework; the domains were then mapped to the COM-B model. RESULTS: Survey responses from 159 Anesthesiologists, 39 cardiac surgeons and 86 perfusionists were included (response rate 37%). Four of the recommendations queried in this survey were reported as routinely adhered to < 50% of the time, 9 queried recommendations were adhered to 51-75% of the time and 4 recommendations were routinely followed >76% of the time. CONCLUSION: There is a wide variation in peri-operative bleeding management practice among cardiac anaesthesiologists, surgeons and perfusionists in Australian cardiac surgery units. Conceptualizing factors believed necessary to improve practice with the TDF and COM-B model found that bleeding management could be improved with a standardized approach including; point of care diagnostic assays, a bleeding management algorithm, access to concentrated coagulation factors, cardiac surgery specific bleeding management education, multidisciplinary team agreement and support, and an overarching national approach.

Osteopontin alters endothelial and valvular interstitial cell behaviour in calcific aortic valve stenosis through HMGB1 regulation.

OBJECTIVES: Calcific aortic valve stenosis (CAVS) is an important clinical problem predominantly affecting elderly individuals. Studies suggest that the progression of CAVS is actively regulated with valve endothelial injury leading to inflammation, fibrosis and calcification. The aim of this study was to delineate the possible regulatory role of osteopontin (OPN) on high-mobility group box 1 (HMGB1) function and the associated inflammatory and fibrotic response in CAVS. METHODS: Aortic valve leaflets were collected from CAVS patients undergoing aortic valve replacement (n = 40), and control aortic valve leaflets were obtained from heart transplant recipients (n = 15). Valves and plasma were analysed by quantitative real-time polymerase chain reaction (PCR), immunohistochemical staining and Western blot. Recombinant OPN or neutralizing OPN antibody was added to cultured endothelial and valvular interstitial cells (VICs), and cell proliferation scores and HMGB1 expression were assessed. RESULTS: CAVS valves had a decreased total percentage of VICs but increased numbers of infiltrating macrophages relative to control valves. RT-PCR studies showed higher expression of OPN, the inflammatory cytokine tumour necrosis factor-alpha as well as markers of fibrosis, tissue inhibitor of matrix metalloproteinase 1 and matrix metalloproteinase 2 in CAVS valves. Elevated expression of OPN was also observed in plasma of CAVS patients compared with controls. HMGB1 was detected in the secretory granules of cultured valve endothelial and VICs derived from CAVS valves. The addition of exogenous OPN inhibited the proliferation of cultured endothelial and VICs from CAVS valves and was associated with the extracellular expression of HMGB1, whereas neutralizing OPN had the opposite effect. CONCLUSIONS: We conclude that altered OPN expression in CAVS affects cellular HMGB1 function inducing cytoplasmic translocation and secretion of HMGB1 in endothelial cells and VICs, thus indicating a regulatory role for OPN in the progression of CAVS through alteration of HMGB1 function.

Long-term clinical outcomes after aortic valve replacement using cryopreserved aortic allograft.

BACKGROUND: Although the frequency of biological valve use in treating aortic valve disease is increasing, the critical limiting factor, "structural deterioration," remains unresolved. Analysis of long-term outcomes after implantation of cryopreserved aortic allografts will yield further information related to the durability of the aortic allograft, possibly suggesting mechanisms underlying or strategies to prevent or treat the structural deterioration of biological valve substitutes. METHODS: A total of 840 cryopreserved aortic allografts implanted in the last 35 years were reviewed with clinical follow-up completed in 99% of the consecutive series. By June 2010, 285 implanted allografts had been surgically explanted, 288 patients died before allograft removal, and 267 patients are under continued follow-up. RESULTS: Cryopreserved aortic allografts were durable for more than 15 years in the middle-aged and older patient population. The estimated median time until structural deterioration was 20 years post-implantation, and 2 allografts have been functioning well for more than 30 years. Structural deterioration was independently related to the young age of the recipient, elderly age of the donor, severe obesity in the recipient, history of blood transfusion in the recipient, and full-root implantation technique. Infection of the implanted allograft necessitating reintervention rarely occurred. Reintervention for the allograft demonstrated 2% in-hospital mortality. CONCLUSIONS: Cryopreserved aortic allografts were durable for more than 15 years. Structural deterioration of aortic allografts was related to multiple factors. The age of the recipient and the donor, obesity and blood transfusion history of the recipient, and implantation technique were identified as the most important factors contributing to allograft failure.