Identification of the haemoglobin level associated with a lower risk of complications after total hip and knee arthroplasty.

BACKGROUND: Preoperative anaemia is associated with poor outcomes in surgical patients, but the preoperative haemoglobin cut-off that determines lower morbidity in total knee arthroplasty (TKA) and total hip arthroplasty (THA) is not well established. METHODS: Planned secondary analysis of data collected during a multicentre cohort study of patients undergoing THA and TKA in 131 Spanish hospitals during a single 2-month recruitment period. Anaemia was defined as haemoglobin <12 g dl-1 for females and < 13 g dl-1 for males. The primary outcome was the number of patients with 30-day in-hospital postoperative complications according to European Perioperative Clinical Outcome definitions and specific surgical TKA and THA complications. Secondary outcomes included the number of patients with 30-day moderate-to-severe complications, red blood cell transfusion, mortality, and length of hospital stay. Binary logistic regression models were constructed to assess association between preoperative Hb concentrations and postoperative complications, and variables significantly associated with the outcome were included in the multivariate model. The study sample was divided into 11 groups based on preoperative Hb values in an effort to identify the threshold at which increased postoperative complications occurred. RESULTS: A total of 6099 patients were included in the analysis (3818 THA and 2281 TKA), of whom 8.8% were anaemic. Patients with preoperative anaemia were more likely to suffer overall complications (111/539, 20.6% vs. 563/5560, 10.1%, p < .001) and moderate-to-severe complications (67/539, 12.4% vs. 284/5560, 5.1%, p < .001). Multivariable analysis showed preoperative haemoglobin ≥14 g dl-1 was associated with fewer postoperative complications. CONCLUSION: Preoperative haemoglobin ≥14 g dl-1 is associated with a lower risk of postoperative complications in patients undergoing primary TKA and THA.

Recommendations From the International Consensus Conference on Anemia Management in Surgical Patients (ICCAMS).

BACKGROUND: Perioperative anemia has been associated with increased risk of red blood cell transfusion and increased morbidity and mortality after surgery. The optimal approach to the diagnosis and management of perioperative anemia is not fully established. OBJECTIVE: To develop consensus recommendations for anemia management in surgical patients. METHODS: An international expert panel reviewed the current evidence and developed recommendations using modified RAND Delphi methodology. RESULTS: The panel recommends that all patients except those undergoing minor procedures be screened for anemia before surgery. Appropriate therapy for anemia should be guided by an accurate diagnosis of the etiology. The need to proceed with surgery in some patients with anemia is expected to persist. However, early identification and effective treatment of anemia has the potential to reduce the risks associated with surgery and improve clinical outcomes. As with preoperative anemia, postoperative anemia should be treated in the perioperative period. CONCLUSIONS: Early identification and effective treatment of anemia has the potential to improve clinical outcomes in surgical patients.

Single-dose intravenous ferric carboxymaltose infusion versus multiple fractionated doses of intravenous iron sucrose in the treatment of post-operative anaemia in colorectal cancer patients: a randomised controlled trial.

BACKGROUND: Recent clinical guidelines suggest that treatment of postoperative anaemia in colorectal cancer surgery with intravenous iron reduces transfusion requirements and improves outcomes. The study aimed at comparing two intravenous iron regimens in anaemic patients after colorectal cancer surgery. MATERIALS AND METHODS: This was a single-centre, open-label, randomised, controlled trial in patients undergoing elective colorectal cancer surgery. Patients with moderate to severe anaemia (haemoglobin [Hb] <11 g/dL) after surgery were randomly assigned 1:1 to receive ferric carboxymaltose (FC; 1,000 mg, single dose) or iron sucrose (IS; 200 mg every 48 hours until covering the total iron deficit or discharge). Randomisation was stratified by Hb level: <10 g/dL (Group A) or ≥10-10.9 (Group B). The primary endpoint was the change in Hb concentration at postoperative day 30. Secondary endpoints included iron status parameters, transfusion requirements, complications, and length of hospital stay. RESULTS: From September 2015 to May 2018, 104 patients were randomised (FC 50, IS 54). The median intravenous iron dose was 1,000 mg and 600 mg in the FC and IS groups, respectively. There were no between-group differences in mean change in Hb from postoperative day 1 to postoperative day 30 (FC: 2.5 g/dL, 95% CI: 2.1-2.9; IS: 2.4 g/dL, 95% CI: 2.0-2.8; p=0.52), in transfusion requirements or length of stay. The infection rate was lower in the FC group compared with the IS group (9.8% vs 37.2%, respectively). DISCUSSION: The administration of approximately 500 mg of IS resulted in an increase in Hb at postoperative day 30 similar to that of 1,000 mg of FC, but it was associated with a higher infection rate. Future research will be needed to confirm the results, and to choose the best regime in terms of effectiveness and side effects to treat postoperative anaemia in colorectal cancer patients.

Maturity Assessment model for Patient Blood Management to assist hospitals in improving patients' safety and outcomes. The MAPBM project.

BACKGROUND: Patient blood management (PBM) is an evidence-based care bundle with proven ability to improve patients' outcomes by managing and preserving the patient's own blood. Since 2010, the World Health Organisation has urged member states to implement PBM. However, there has been limited progress in developing PBM programmes in hospitals due to the implicit challenges of implementing them. To address these challenges, we developed a Maturity Assessment Model (MAPBM) to assist healthcare organisations to measure, benchmark, assess in PBM, and communicate the results of their PBM programmes. We describe the MAPBM model, its benchmarking programme, and the feasibility of implementing it nationwide in Spain. MATERIALS AND METHODS: The MAPBM considers the three dimensions of a transformation effort (structure, process and outcomes) and grades these within a maturity scale matrix. Each dimension includes the various drivers of a PBM programme, and their corresponding measures and key performance indicators. The structure measures are qualitative, and obtained using a survey and structured self-assessment checklist. The key performance indicators for process and outcomes are quantitative, and based on clinical data from the hospitals' electronic medical records. Key performance indicators for process address major clinical recommendations in each PBM pillar, and are applied to six common procedures characterised by significant blood loss. RESULTS: In its first 5 years, the MAPBM was deployed in 59 hospitals and used to analyse 181,826 hospital episodes, which proves the feasibility of implementing a sustainable model to measure and compare PBM clinical practice and outcomes across hospitals in Spain. CONCLUSION: The MAPBM initiative aims to become a useful tool for healthcare organisations to implement PBM programmes and improve patients' safety and outcomes.

Essential Role of Patient Blood Management in a Pandemic: A Call for Action.

The World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19), the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a pandemic. Global health care now faces unprecedented challenges with widespread and rapid human-to-human transmission of SARS-CoV-2 and high morbidity and mortality with COVID-19 worldwide. Across the world, medical care is hampered by a critical shortage of not only hand sanitizers, personal protective equipment, ventilators, and hospital beds, but also impediments to the blood supply. Blood donation centers in many areas around the globe have mostly closed. Donors, practicing social distancing, some either with illness or undergoing self-quarantine, are quickly diminishing. Drastic public health initiatives have focused on containment and "flattening the curve" while invaluable resources are being depleted. In some countries, the point has been reached at which the demand for such resources, including donor blood, outstrips the supply. Questions as to the safety of blood persist. Although it does not appear very likely that the virus can be transmitted through allogeneic blood transfusion, this still remains to be fully determined. As options dwindle, we must enact regional and national shortage plans worldwide and more vitally disseminate the knowledge of and immediately implement patient blood management (PBM). PBM is an evidence-based bundle of care to optimize medical and surgical patient outcomes by clinically managing and preserving a patient's own blood. This multinational and diverse group of authors issue this "Call to Action" underscoring "The Essential Role of Patient Blood Management in the Management of Pandemics" and urging all stakeholders and providers to implement the practical and commonsense principles of PBM and its multiprofessional and multimodality approaches.

Association Between Use of Enhanced Recovery After Surgery Protocol and Postoperative Complications in Total Hip and Knee Arthroplasty in the Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty Study (POWER2).

Importance: The Enhanced Recovery After Surgery (ERAS) care protocol has been shown to improve outcomes compared with traditional care in certain types of surgery. Objective: To assess the association of use of the ERAS protocols with complications in patients undergoing elective total hip arthroplasty (THA) and total knee arthroplasty (TKA). Design, Setting, and Participants: This multicenter, prospective cohort study included patients recruited from 131 centers in Spain from October 22 through December 22, 2018. All consecutive adults scheduled for elective THA or TKA were eligible for inclusion. Patients were stratified between those treated in a self-designated ERAS center (ERAS group) and those treated in a non-ERAS center (non-ERAS group). Data were analyzed from June 15 through September 15, 2019. Exposures: Total hip or knee arthroplasty and perioperative management. Sixteen individual ERAS items were assessed in all included patients, whether they were treated at a center that was part of an established ERAS protocol or not. Main Outcomes and Measures: The primary outcome was postoperative complications within 30 days after surgery. Secondary outcomes included length of stay and mortality. Results: During the 2-month recruitment period, 6146 patients were included (3580 women [58.2%]; median age, 71 [interquartile range (IQR), 63-76] years). Of these, 680 patients (11.1%) presented with postoperative complications. No differences were found in the number of patients with overall postoperative complications between ERAS and non-ERAS groups (163 [10.2%] vs 517 [11.4%]; odds ratio [OR], 0.89; 95% CI, 0.74-1.07; P = .22). Fewer patients in the ERAS group had moderate to severe complications (73 [4.6%] vs 279 [6.1%]; OR, 0.74; 95% CI, 0.56-0.96; P = .02). The median overall adherence rate with the ERAS protocol was 50.0% (IQR, 43.8%-62.5%), with the rate for ERAS facilities being 68.8% (IQR, 56.2%-81.2%) vs 50.0% (IQR, 37.5%-56.2%) at non-ERAS centers (P < .001). Among the patients with the highest and lowest quartiles of adherence to ERAS components, the patients with the highest adherence had fewer overall postoperative complications (144 [10.6%] vs 270 [13.0%]; OR, 0.80; 95% CI, 0.64-0.99; P < .001) and moderate to severe postoperative complications (59 [4.4%] vs 143 [6.9%]; OR, 0.62; 95% CI, 0.45-0.84; P < .001) and shorter median length of hospital stay (4 [IQR, 3-5] vs 5 [IQR, 4-6] days; OR, 0.97; 95% CI, 0.96-0.99; P < .001). Conclusions and Relevance: An increase in adherence to the ERAS program was associated with a decrease in postoperative complications, although only a few ERAS items were individually associated with improved outcomes.

Principios y deberes en el ejercicio de la dirección médica de los hospitales y centros sanitarios / Principles and duties in the exercise of the medical direction of hospitals and health centers

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Management of Perioperative Iron Deficiency Anemia.

Preoperative anemia affects 30-40% of patients undergoing major surgery and is an independent risk factor for perioperative blood transfusion, morbidity, and mortality. Absolute or functional iron deficiency is its leading cause. Nonanemic hematinic deficiencies are also prevalent and may hamper preoperative hemoglobin optimization and/or recovery from postoperative anemia. As modifiable risk factors, anemia and hematinic deficiencies should be detected and corrected prior to major surgical procedures. Postoperative anemia is even more common (up to 80-90%) due to surgery-associated blood loss, inflammation-induced blunted erythropoiesis, and/or preexisting anemia. Preoperative oral iron may have a role in mild-to-moderate anemia, provided there is sufficient time (6-8 weeks) and adequate tolerance of oral preparations. Postoperative oral iron is of little value and rife with gastrointestinal adverse events. Intravenous iron should preferentially be used in cases of moderate-to-severe iron deficiency anemia, concomitant use of erythropoiesis-stimulating agents, short time to surgery or nonelective procedures, and for postoperative anemia management. Minor infusion reactions to intravenous iron are rare, the incidence of severe anaphylactic reactions is extremely low, and there is no increase in infections with intravenous iron. Currently available intravenous iron formulations allowing administration of large single doses are preferred.

Peri-operative treatment of anaemia in major orthopaedic surgery: a practical approach from Spain.

In patients undergoing major orthopaedic surgery, pre-operative anaemia, peri-operative bleeding and a liberal transfusion policy are the main risk factors for requiring red blood cell transfusion (RBCT). The clinical and economic disadvantages of RBCT have led to the development and implementation of multidisciplinary, multimodal, individualised strategies, collectively termed patient blood management, which aim to reduce RBCT and improve patients' clinical outcome and safety. Within a patient blood management programme, low pre-operative haemoglobin is one of the few modifiable risk factors for RBCT. However, a survey among Anaesthesia Departments in Spain revealed that, although pre-operative assessment was performed in the vast majority of hospitals, optimisation of haemoglobin concentration was attempted in <40% of patients who may have benefitted from it, despite there being enough time prior to surgery. This indicates that haemoglobin optimisation takes planning and forethought to be implemented in an effective manner. This review, based on available clinical evidence and our experience, is intended to provide clinicians with a practical tool to optimise pre-operative haemoglobin levels, in order to minimise the risk of patients requiring RBCT. To this purpose, after reviewing the diagnostic value and limitations of available laboratory parameters, we developed an algorithm for the detection, classification and treatment of pre-operative anaemia, with a patient-tailored approach that facilitates decision-making in the pre-operative assessment. We also reviewed the efficacy of the different pharmacological options for pre-operative and post-operative management of anaemia. We consider that such an institutional pathway for anaemia management could be a viable, cost-effective strategy that is beneficial to both patients and healthcare systems.

Management of anemia in patients with congestive heart failure.

Anemia is an independent risk factor for adverse patient outcomes. There are no guidelines for management of anemia in patients with congestive heart failure (CHF), despite its high incidence. Four objectives were defined by the International Anemia Management and Clinical Outcomes Expert Panel (AMCO), a multinational group of interdisciplinary experts identified by the Society for the Advancement of Blood Management (SABM) to: determine the prevalence of anemia in outpatients; to determine the prevalence of hospital-acquired anemia; to assess the impact of anemia management on clinical outcomes such as quality of life and functional status; and to provide recommendations for primary care physicians and specialists for the diagnosis, evaluation, and management of anemia in patients with CHF. Anemia and iron deficiency were confirmed to be highly prevalent in patients with CHF. Intravenous iron therapy improves anemia, cardiac function and exercise tolerance, leading to improvement in quality of life. Anemia management has been demonstrated to be cost-effective. Clinical care pathways to manage anemia in patients with CHF are recommended as best practices in order to improve patient outcomes. Am. J. Hematol. 92:88-93, 2017. © 2016 Wiley Periodicals, Inc.

Pillar 2: minimising bleeding and blood loss.

One of the main factors that contributes to the need for transfusion in the surgical patient is excessive blood loss. Pillar 2 of patient blood management (PBM) includes all the strategies to reduce bleeding and preserve the patient's own blood, designed with an aim to reducing or avoiding transfusion. Some of these strategies, such as identifying and planning the management of patients at high risk of bleeding, can be implemented as early as at the preoperative assessment visit. During the intra-operative period, local haemostasis is the most important factor in the control of bleeding; in this context, therefore, surgical technique and meticulous haemostasis are fundamental measures. However, there are also additional anaesthetic techniques that can help reduce blood loss and transfusion requirements, such as the use of pharmacological or haemostatic agents. After surgery, PBM continues in the postoperative recovery unit or on the ward with the monitoring and management of postoperative bleeding. The blood lost via drains can be filtered, washed and reinfused, if needed.

Limit allogeneic blood use with routine re-use of patient's own blood: a prospective, randomized, controlled trial in total hip surgery.

BACKGROUND: There are risks related to blood incompatibility and blood-borne diseases when using allogeneic blood transfusion. Several alternatives exist today, one of which, used for autologous blood salvage perioperatively, is the Sangvia Blood Management System. This study was designed to investigate the efficacy of the system and to add data to previously reported safety results. METHODOLOGY/PRINCIPAL FINDINGS: Two hundred sixteen patients undergoing primary or revision total hip arthroplasty (THA) were enrolled in this randomized, controlled, assessor-blinded multicenter study. Randomization was either autologous blood transfusion (Sangvia group) or no use of autologous blood (Control group), both in combination with a transfusion protocol for allogeneic transfusion. Patients were followed during hospital stay and at two months after discharge. The primary outcome was allogeneic blood transfusion frequency. Data on blood loss, postoperative hemoglobin/hematocrit, safety and quality of life were also collected. The effectiveness analysis including all patients showed an allogeneic blood transfusion rate of 14% in both groups. The efficacy analysis included 197 patients and showed a transfusion rate of 9% in the Sangvia group as compared to 13% in the Control group (95%CI -0.05-0.12, p = 0.5016). A mean of 522 mL autologous blood was returned in the Sangvia group and lower calculated blood loss was seen. 1095 mL vs 1285 mL in the Control group (95%CI 31-346, p = 0.0175). No differences in postoperative hemoglobin was detected but a lower hematocrit reduction after surgery was seen among patients receiving autologous blood. No relevant differences were found for safety parameters or quality of life. CONCLUSIONS/SIGNIFICANCE: General low use of allogeneic blood in THA is seen in the current study of the Sangvia system used together with a transfusion protocol. The trial setting is under-powered due to premature termination and therefore not able to verify efficacy for the system itself but contributes with descriptive data on safety. TRIAL REGISTRATION: Clinicaltrials.gov NCT00822588.

Efficacy of intravenous iron for treating postpartum anemia in low-resource African countries: a pilot study in Malawi.

BACKGROUND: Postpartum hemorrhage may lead to maternal morbidity and mortality, increases risks of transfusion, and incurs costs. We report on the feasibility and efficacy of in-hospital intravenous (IV) iron for treating postoperative anemia at Mtengo wa Nthenga, Malawi. PATIENTS AND METHODS: Twenty-eight consecutive women undergoing surgery for complicated pregnancy or complicated childbirth entered the study. Patients with hemoglobin (Hb) <10 g/dL on postoperative day 1 (n = 14) received IV iron sucrose (200 mg/day, 3 consecutive days), and those with Hb ≥10 g/dL (n = 14) received oral iron (ferrous sulfate, 256 mg/day). In-hospital postoperative Hb increase and blood transfusion were recorded. RESULTS: Mean changes in Hb from postoperative day 1 to postoperative day 7 were -0.6 ± 1.2 g/dL and 2.1 ± 1.7 g/dL, for the oral and IV iron groups, respectively (p = 0.001). No side effect was seen with IV iron. Only 1 of 4 women receiving allogeneic blood was transfused after the initiation of IV iron treatment. CONCLUSIONS: Our results suggest that IV iron sucrose is an effective drug for treating puerperal anemia, leading to a rapid recovery of Hb levels. The current availability of generic iron sucrose preparations, with considerably lower acquisition costs, may facilitate in-hospital access to this treatment option in low-resource countries.

[Usefulness of the administration of intravenous iron sucrose for the correction of preoperative anemia in major surgery patients]. / Utilidad de la administración de hierro sacarosa intravenoso para la corrección de la anemia preoperatoria en pacientes programados para cirugía mayor.

BACKGROUND AND OBJECTIVE: There is a high incidence of perioperative anemia among surgical patients (20%-70%). Preoperative anemia has been linked to an increased postoperative morbidity and mortality, as well as a decreased quality of life of surgical patients. In addition, a low preoperative hemoglobin constitutes an important predictive factor of allogeneic blood transfusion in major surgery. We evaluated the efficacy of intravenous iron sucrose (IVIS) administration for correction of anemia in these patient populations. PATIENTS AND METHOD: Data from 84 patients with anemia who were scheduled for major elective surgery (30 colon cancer resections, 33 abdominal hysterectomies, 21 lower limb arthroplasties) and who received preoperative IVIS during 3-5 weeks were propectively collected. RESULTS: Administration of IVIS -mean dose (standard deviation): 1000 (440)mg- caused a significant increase of hemoglobin levels -2.0 (1.6)g/dl (p<0.001)- and anemia was resolved in 58% of patients. No life-threatening adverse effect was witnessed. CONCLUSIONS: Because of the low incidence of side effects and the rapid increase of hemoglobin levels, IVIS emerges as a safe, effective drug for treating preoperative anemia in these patient populations.