Major Elective Orthopaedic Surgery Research Articles

Integrated Multi-Omics Analysis of Cerebrospinal Fluid in Postoperative Delirium.

Preoperative risk biomarkers for delirium may aid in identifying high-risk patients and developing intervention therapies, which would minimize the health and economic burden of postoperative delirium. Previous studies have typically used single omics approaches to identify such biomarkers. Preoperative cerebrospinal fluid (CSF) from the Healthier Postoperative Recovery study of adults ≥ 63 years old undergoing elective major orthopedic surgery was used in a matched pair delirium case-no delirium control design. We performed metabolomics and lipidomics, which were combined with our previously reported proteomics results on the same samples. Differential expression, clustering, classification, and systems biology analyses were applied to individual and combined omics datasets. Probabilistic graph models were used to identify an integrated multi-omics interaction network, which included clusters of heterogeneous omics interactions among lipids, metabolites, and proteins. The combined multi-omics signature of 25 molecules attained an AUC of 0.96 [95% CI: 0.85-1.00], showing improvement over individual omics-based classification. We conclude that multi-omics integration of preoperative CSF identifies potential risk markers for delirium and generates new insights into the complex pathways associated with delirium. With future validation, this hypotheses-generating study may serve to build robust biomarkers for delirium and improve our understanding of its pathophysiology.

Healthy Eating for Elective Major Orthopedic Surgery: Quality, Quantity, and Timing.

Improvements to enhanced recovery pathways in orthopedic surgery are reducing the time that patients spend in the hospital, giving an increasingly vital role to prehabilitation and/or rehabilitation after surgery. Nutritional support is an important tenant of perioperative medicine, with the aim to integrate the patient's diet with food components that are needed in greater amounts to support surgical fitness. Regardless of the time available between the time of contemplation of surgery and the day of admission, a patient who eats healthy is reasonably more suitable for surgery than a patient who does not meet the daily requirements for energy and nutrients. Moreover, a successful education for healthy food choices is one possible way to sustain the exercise therapy, improve recovery, and thus contribute to the patient's long-term health. The expected benefits presuppose that the patient follows a healthy diet, but it is unclear which advice is needed to improve dietary choices. We present the principles of healthy eating for patients undergoing major orthopedic surgery to lay the foundations of rational and valuable perioperative nutritional support programs. We discuss the concepts of nutritional use of food, requirements, portion size, dietary target, food variety, time variables of feeding, and the practical indications on what the last meal to be consumed six hours before the induction of anesthesia may be together with what is meant by clear fluids to be consumed until two hours before. Surgery may act as a vital "touch point" for some patients with the health service and is therefore a valuable opportunity for members of the perioperative team to promote optimal lifestyle choices, such as the notion and importance of healthy eating not just for surgery but also for long-term health benefit.

Effectiveness and safety of tranexamic acid in total knee arthroplasty: a systematic review and meta-analysis

INTRODUCTION: Major elective orthopedic surgery is often associated with blood loss, requiring the need for blood transfusion. A possible pharmacological option to reduce surgical blood loss in total arthroplasty is the use of tranexamic acid. The objective of the study was to undertake a meta-analysis investigating the effects of tranexamic acid on knee arthroplasty. MATERIAL AND METHODS: The study was designed as a systematic review and meta-analysis. The PubMed, Central, Web of Science, and Scopus databases were searched up to March 23, 2022, to identify randomized controlled trials concerning tranexamic acid (TXA) administration during knee arthroplasty. Overall and stratified pooled odds ratios (ORs) or mean differences (MDs) with their 95% confidence intervals (Cis) were obtained. RESULTS: Fifty-two articles were included. Pooled analysis showed that hemoglobin changes in TXA group was 3.4 ± 3.1, compared to 4.03 ± 2.62 for non-TXA group (MD = −1.30; 95% CI: –1.57 to –1.03; I2 = 99%; p<0.001). Total blood loss was reported in 31 trials and was statistically significantly lower in the TXA group compared to non-TXA (MD = –391.51; 95% CI: −454.29 to −328.73; p < 0.001). Intraoperative blood loss was lower when using TXA rather than non-TXA (MD = −32.10; 95% CI: −50.63 to −13.58; p < 0.001). 24-hours blood loss from the drain was also lower with TXA than with placebo (MD = −228.68; 95% CI: −293.31 to −164.05; p < 0.001). The above dependencies also applied to the intravenous as well as topical application of TXA. Blood transfusion was performed in 11.2% of patients from TXA group, compared to 34.3% of patients treated with placebo (OR = 0.16; 95% CI: 0.11 to 0.22; p < 0.001). Deep vein thrombosis (DVT) was observed in 4.6% of patients treated with TXA, compared to 5.8% of patients treated with placebo (OR = 0.81; 95% CI: 0.49 to 1.35; p = 0.42) and pulmonary embolism was 0.5% in TXA group and 1.4% in placebo group (OR = 0.44; 95% CI: 0.15 to 1.36; p = 0.15). CONCLUSIONS: Tranexamic acid is effective and safe in reducing blood loss, the requirement for blood transfusion, and drain output in patients undergoing knee arthroplasty.

Introducing NICE guidelines for intravenous fluid therapy into a district general hospital

BackgroundNational Institute for Health and Care Excellence (NICE) guidelines on intravenous fluid prescribing for adults in hospital, issued in 2013, advised less use of 0.9% sodium chloride than current practice,...

165 A Review of The Current Literature on LMWH Administered at Different Times in Relation to MOS (Major Orthopaedic Surgery): Assessment of The Safety and Efficacy of The Different Proposed Strategies

Abstract Nowadays venous VTE represents an important perioperative and postoperative complication in patients undergoing elective Major Orthopedic Surgery (MOS). There are significant discrepancies between clinical practice, international recommendations, and published guidelines. Although thromboembolic events may be less common these days than in the past, they can still lead to serious medical complications. Therefore, most patients undergoing MOS procedures are provided with one of the thromboprophylactic treatments. The optimum timing of LMWH administrations remains debated. Customized structured electronic searches in PubMed and Cochrane database. Meta-Analysis, Randomized Controlled Trials, Systematic Reviews on different strategies of the use of LMWH for MOS. Studies on prophylactic regimens showed that subcutaneous LMWH plays a key role in the management of thromboprophylaxis in MOS. However, some controversies still stand. Among those most relevant, it remains unclear whether to start thromboprophylaxis before or after MOS to better balance the risks of clotting and bleeding. With regards to different times of LMWH administration, there is no convincing evidence that starting prophylaxis 12 hours preoperatively is associated with lower risks of VTE compared to prophylaxis started 12 to 24 hours postoperatively. Furthermore, it seems that the most safe and efficient LMWH regimen is the one called “Just-in-time” (LMWH started 6 hours post-op).

P3 A closed loop audit on pre-operative anaemia in major elective orthopaedic surgery

IntroductionThe international consensus statement on perioperative management of anaemia advises that patients with haemoglobin (Hb) <130 be treated before undergoing elective operations. The advantages include reduced risk of acute kidney injuries, infections and transfusions, and quicker recovery.MethodsData was collected prospectively from 127 consecutive patients undergoing elective arthroplasties at Hinchingbrooke hospital. Baseline compliance with the consensus statement was first assessed in May 2018, and the results presented at a clinical governance meeting. Departmental action plans included early identification of anaemia and treatment to Hb 130, delaying operations where necessary. We then reassessed compliance in May 2019.ResultsThere was a statistically significant change in practice (p = 0.036). The proportion of patients undergoing arthroplasties despite Hb < 130 reduced from 38% to 21%. Those operated with Hb < 120 decreased from 14% to 0%. The proportion of preoperative anaemias that were appropriately investigated during preoperative assessment increased from 11% to 80% (p < 0.001). The increase in attempted treatment of preoperative anaemia prior to surgery however was not significant (7% vs 20%; p = 0.279).DiscussionImplementation of departmental action plans resulted in substantial improvements to clinical practice. For those that underwent arthroplasties despite mild preoperative anaemia, it may have been felt that delays in improvement to quality of life for treatment may be unacceptable, or the causes (e.g. chronic disease) difficult to treat. Further action plans should involve even earlier identification of anaemia, involving primary care at the point of referral.

Management of the Gastrointestinal System Bleeding Caused by Direct-Acting Oral Anticoagulants

Direct-acting oral anticoagulants include dabigatran, which is a thrombin inhibitor, and rivaroxaban, apixaban, and edoxaban, which are anti-Xa agents. These are administered in the secondary prophylaxis and treatment of venous thromboembolism (VTE) and pulmonary embolism (PE), in the prophylaxis of VTE that may develop after major elective orthopedic surgery, in reducing stroke and systemic embolism that may occur in non-valvular atrial fibrillation, whereas its use in acute coronary syndrome is still controversial. Although it is specified that direct-acting oral anticoagulants are as effective as heparin therapy and reduce the risk of bleeding due to all causes, many important studies have also reported that they increase the risk of gastrointestinal system (GIS) bleeding.

The Effectiveness and Safety of Direct Oral Anticoagulants Following Lower Limb Fracture Surgery: A Systematic Review and Meta-analysis.

Venous thromboembolism (VTE) is a well-established complication after many orthopaedic injuries, such as hip and lower limb fractures. The use of direct oral anticoagulants (DOACs, previously termed novel oral anticoagulants) is well-established as thromboprophylaxis after major elective orthopaedic surgery, but not in the nonelective setting. The aim of this study was to investigate the effectiveness and safety of DOACs after nonelective lower limb fracture surgery. A systematic literature search of the MEDLINE, EMBASE, CINAHL, and CENTRAL databases was conducted. No limitation was placed on publication date, with only manuscripts printed in English were eligible. Included studies were either randomized controlled trials or prospective and retrospective comparative studies. Included studies compared DOACs to conventional methods of thromboprophylaxis in the postoperative period after surgical management of lower limb fractures. Outcomes included VTE, bleeding, wound complications, mortality, and adverse events. Eight studies met inclusion criteria, of which 7 compared direct factor Xa inhibitors (XaIs) with conventional VTE prophylaxis and one study compared a direct thrombin inhibitor with conventional VTE prophylaxis. Revman 5.3 (Nordic Cochrane Centre, Denmark) was used to complete the meta-analysis and generate forest plots. XaIs were shown to have lower rates of deep vein thrombosis (Odds ratio 0.59; 95% confidence interval, 0.46-0.76; P < 0.0001) and less pharmacologically attributable adverse events (Odds ratio 0.62; 95% confidence interval, 0.46-0.82; P = 0.0007). There was difference between DOACs and conventional VTE prophylaxis regarding mortality, PE, symptomatic deep vein thrombosis, or bleeding events. The results generally support the use of DOACs for VTE prophylaxis after nonelective lower limb fracture surgery, such after hip fracture. The results more strongly support the use of XaIs; however, more evidence is needed to fully assess DOACs' role in clinical practice. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Clinical and Budget Impact of Treating Preoperative Anemia in Major Orthopedic Surgery—A Retrospective Observational Study

BackgroundPreoperative anemia (POA) in elective surgery is associated with worse outcome. In this retrospective study, in elective hip and knee arthroplasties, the prevalence of POA and its associations with outcome were analyzed, followed by a model estimating the budget impact of screening and treatment of POA. MethodsAll elective hip/knee arthroplasties performed during the period 2016-2018 were included. Patients with normal hemoglobin and patients with POA (hemoglobin < 13.0 g/dL in men and <12.0 g/dL in women) were compared. Outcome measures were allogeneic blood transfusion (ABT), length of stay (LOS), complications, mortality, and costs. The budget impact of screening for POA and treatment with intravenous iron when relevant was modeled based on the results of the costs related to POA. ResultsIn 881 procedures, the prevalence of POA was 21.5%. POA independently predicted increased risks of ABT (odds ratio [OR]adj, 9.5 [confidence interval—CI, 6.4-13.9]), prolonged LOS (ORadj, 2.8 [CI, 1.8-4.2]), and was associated with increased complications (ORadj, 1.9 [CI, 0.7-4.9]) and mortality (ORadj, 3.2 [CI, 0.8-13.5]). POA resulted in increased costs per patient (P < .001). The budget impact model showed a cost reduction of 254 euros per patient based on the assumption that patients screened and treated for iron-deficient anemia would have the same outcome as non-POA. ConclusionThe prevalence of POA in elective orthopedic surgery in Sweden is at the same level as previously reported by others. Screening and treatment of POA would reduce costs based on less ABT and decreased LOS and may reduce complications in elective major orthopedic surgery.

Blood loss management in major elective orthopaedic surgery

Blood loss is anticipated with all surgical procedures. Within the field of elective orthopaedic surgery it is especially important to reduce bleeding to maintain a patient's haemodynamic balance and ensure a clear surgical field. Complex reconstructive arthroplasty and spinal procedures can be complicated by significant intraoperative blood loss (IBL) and result in the need for allogenic blood transfusion. Patients with higher rates of IBL have increased blood transfusion requirements, resulting in a higher risk of mortality and significant postoperative morbidity. The aim of this review is to outline strategies to manage IBL for both paediatric and adult patients undergoing major elective orthopaedic surgery, and to evaluate the available evidence regarding their efficacy in managing IBL and reducing the need for perioperative allogenic transfusion.

Comparison of Epidural Analgesia Using 0.2% Bupivacaine and 0.2% Ropivacaine for the Management of Postoperative Pain in Major Orthopedic Surgery.

Introduction:Ropivacaine is preferred over racemic bupivacaine for postoperative analgesia as it is less cardiotoxic and has high selectivity for sensory fibers. We aim to compare postoperative epidural analgesia using 0.2% bupivacaine and 0.2% ropivacaine in major lower limb orthopedic surgery.Materials and Methods:In a prospective, randomized, double-blind study, 100 patients, aged 18–70 years, undergoing elective major lower limb orthopedic surgery under spinal anesthesia, were randomly allocated to receive either 7 ml ropivacaine 0.2% (Group R) or 7 ml bupivacaine 0.2% (Group B) for postoperative analgesia through a lumbar epidural catheter. The onset and duration of epidural analgesia, total epidural dose requirement, mean number of epidural topup, rescue analgesia, incidence of motor blockade, and adverse effects were recorded.Results:No differences were noted in demographic data and hemodynamic variables in either group. The onset time of epidural analgesia was 10.46 min ± 0.68 (Group B) and 10.52 min ± 0.71 (Group R). The duration of analgesia was 253.10 ± 17.46 min (Group B) and 251.80 ± 15.77 min (Group R). The total analgesic dose requirement was 78.40 mg ± 6.93 in Group B while in Group R, it was 78.96 mg ± 6.79. Epidural topup requirement and the need for rescue analgesia were similar in both the groups. Motor blockade, hypotension, and nausea were noted more in Group B compared to Group R.Conclusion:In patients undergoing major lower limb orthopedic surgery under subarachnoid block, epidural ropivacaine 0.2% produces effective postoperative analgesia similar to bupivacaine 0.2% with a distinct sensory-motor dissociation resulting in analgesia without motor blockade.

A Systematic Review on the Use of Aspirin in the Prevention of Deep Vein Thrombosis in Major Elective Lower Limb Orthopedic Surgery: An Update from the Past 3 Years.

Introduction Currently there are no consensuses in the national guidance on thromboprophylaxis following major elective lower limb surgery. Emerging clinical evidence suggests that aspirin could be just as effective as anticoagulants with a lower cost. The aim of this study was to provide an update based on literature of the past 3 years for the use of aspirin as thromboprophylaxis after knee and hip arthroplasty. Materials and Methods MEDLINE/EMBASE search was performed with appropriate terms for original articles from 2014 to 2017. Results Eight articles were found. Five articles concluded that aspirin was an effective prophylactic. The collation of results on the deep vein thrombosis rate involved 43,012 patients who were prescribed aspirin, of which 283 (0.66%) suffered from symptomatic deep vein thromboses. Aspirin was noted for its good side effect profile and cost effectiveness. It was noted that anticoagulants had a higher rate of complications, including bleeding and wound-oozing. Conclusion Aspirin is an effective and safe prophylactic against deep vein thrombosis following major elective lower limb arthroplasty surgery.

Effects of thromboprophylactic doses of apixaban and rivaroxaban on coagulation and thrombin generation in association with total hip replacement

Factor Xa inhibitors (FXaI) apixaban and rivaroxaban are used for thromboprophylaxis after major elective orthopaedic surgery. Because few patient sample studies exist, we postoperatively assessed patients undergoing unilateral total hip arthroplasty, including 22 treated with apixaban (2.5mg BID) and 20 treated with rivaroxaban (10mg OD). We collected blood samples before and 3h after drug intake at 4 time points, preoperatively, as well as on day 1, week 1 (day 2-8) and day 28 post-operation. APTT and PT were immediately analysed. Calibrated anti-FXa activity, Russel's Viper Venom Time (RVVT) and thrombin generation (TG; Calibrated Automated Thrombogram®) captured the effects of FXaI on coagulation and TG. APTT and PT remained within the reference interval throughout, and did not correlate with FXaI levels (PT R2 = 0.44, APTT R2 = 0.07). Mean apixaban concentration at the peak varied by eightfold (19-153ng/mL), but rivaroxaban only by 1.5-fold (111-183ng/mL). Rivaroxaban, but not apixaban prolonged RVVT at peak levels. Both FXaIs had a prolonged lag time of TG (p < 0.001). Rivaroxaban decreased ETP peak at all time points and reached a minimum at day 28 (540nM/min at rivaroxaban 184ng/mL, p < 0.001), while rivaroxaban trough levels were low and ETP values normal. However, with apixaban, after an initial decrease, ETP did not differ between peak and trough levels until decreasing on day 28 at peak (990nM/min at apixaban 112ng/mL, p = 0.005). In conclusion, due to different dosing and pharmacology rivaroxaban and apixaban distinctly inhibited TG under postoperative conditions.

Pain after major elective orthopedic surgery of the lower limb and type of anesthesia: does it matter?

Total knee arthroplasty and total hip arthroplasty are associated with chronic pain development. Of the studies focusing on perioperative factors for chronic pain, few have focused on the differences that might arise from the anesthesia type performed during surgery. This was a prospective observational study performed between July 2014 and March 2015 with patients undergoing unilateral elective total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis. Data collection and pain evaluation questionnaires were performed in three different moments: preoperatively, 24hours postoperatively and at 6 months after surgery. To characterize pain, Brief Pain Inventory (BPI) was used and SF-12v2 Health survey was used to further evaluate the sample's health status. Forty and three patients were enrolled: 25.6% men and 74.4% women, 51,2% for total knee arthroplasty and48.8% for total hip arthroplasty, with a mean age of 68 years. Surgeries were performed in 25.6% of patients under general anesthesia, 55.8% under neuraxial anesthesia and 18.6% under combined anesthesia. Postoperatively, neuraxial anesthesia had a better pain control. Comparing pain evolution between anesthesia groups, neuraxial anesthesia was associated with a decrease in "worst", "medium" and "now" pain at six months. Combined anesthesia was associated with a decrease of "medium" pain scores at six months. Of the three groups, only those in neuraxial group showed a decrease in level of pain interference in "walking ability". TKA, "worst" pain preoperatively and general were predictors of pain development at six months. Patients with gonarthrosis and severe pain preoperatively may benefit from individualized pre- and intraoperative care, particularly preoperative analgesia and neuraxial anesthesia.

Pain after major elective orthopedic surgery of the lower limb and type of anesthesia: does it matter?

Background and objectivesTotal knee arthroplasty and total hip arthroplasty are associated with chronic pain development. Of the studies focusing on perioperative factors for chronic pain, few have focused on the differences that might arise from the anesthesia type performed during surgery. MethodsThis was a prospective observational study performed between July 2014 and March 2015 with patients undergoing unilateral elective total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis. Data collection and pain evaluation questionnaires were performed in three different moments: preoperatively, 24 hours postoperatively and at 6 months after surgery. To characterize pain, Brief Pain Inventory (BPI) was used and SF-12v2 Health survey was used to further evaluate the sample's health status. ResultsForty and three patients were enrolled: 25.6% men and 74.4% women, 51,2% for total knee arthroplasty and48.8% for total hip arthroplasty, with a mean age of 68 years. Surgeries were performed in 25.6% of patients under general anesthesia, 55.8% under neuraxial anesthesia and 18.6% under combined anesthesia. Postoperatively, neuraxial anesthesia had a better pain control. Comparing pain evolution between anesthesia groups, neuraxial anesthesia was associated with a decrease in “worst”, “medium” and “now” pain at six months. Combined anesthesia was associated with a decrease of “medium” pain scores at six months. Of the three groups, only those in neuraxial group showed a decrease in level of pain interference in “walking ability”. TKA, “worst” pain preoperatively and general were predictors of pain development at six months. ConclusionsPatients with gonarthrosis and severe pain preoperatively may benefit from individualized pre- and intraoperative care, particularly preoperative analgesia and neuraxial anesthesia.

Perioperative coagulation assessment of patients undergoing major elective orthopedic surgery.

Traditional coagulative parameters are of limited use in identifying perioperative coagulopathy occurring in patients undergoing major elective orthopedic surgery (MEOS). The aim of our study was to evaluate the coagulation changes in patients undergoing MEOS and to facilitate an early detection of perioperative coagulopathy in patients experiencing major intraoperative bleeding. We enrolled 40 consecutive patients (M/F 10/30, age range 34-90years) who underwent MEOS at the Orthopedic Unit of the Padua University Hospital, Italy, between January 2014 and January 2015. Blood samples were obtained at the following time points: T0-pre: 30min before surgery; T0-post: 30min after the end of the procedure; T1: morning of the first postoperative day; T2: 7±2days after surgery. Patients who experienced an intraoperative blood loss ≥250mL/h were considered as cases. Routine coagulative parameters, thromboelastometry and thrombin generation (TG) profiles were evaluated. At baseline, a significantly lower platelet count and FIBTEM MCF/AUC were observed in patents with excessive bleeding (p<0.05 and 0.02/0.01, respectively). At T0-post and T1 intervals, cases showed hypocoagulation characterized by a significantly low platelet count (p=0.001), prolonged CFT INTEM/EXTEM, reduction of alpha-angle and MaxV INTEM/EXTEM, MCF and AUC INTEM/EXTEM/FIBTEM (p<0.05 in all comparisons). The only TG parameter standing out between study groups was time to peak at T0-pre. A low platelet count and fibrinogen activity were associated with significant intraoperative bleeding in patients undergoing MEOS. Thromboelastometry performed by ROTEM(®) identifies patients with coagulopathy.

Evolution of Patient-Controlled Analgesia: From Intravenous to Sublingual Treatment.

Opioid administration delivered intravenously (IV) by patient-controlled analgesia (PCA) devices has been an important development in addressing insufficient management of acute pain in the postsurgical setting. However, IV PCA has several disadvantages, including operator error, risk of patient exposure to analgesic gaps, IV line patency issues, and risk of catheter-related infection, all of which contribute to the total cost of care. Morphine, the most commonly used opioid in IV PCA, has a relatively slow onset of analgesia, which may leave patients with inadequate initial pain control and at risk of opioid dose-stacking. Sufentanil is an opioid with no major active metabolites and a rapid onset of analgesia. The sufentanil sublingual tablet system (SSTS) with a 20-minute lockout and other safety features is a novel noninvasive PCA system in development for on-demand relief of moderate to severe acute pain in the hospital setting. Data from phase 3 trials of the use of SSTS after elective major open abdominal and orthopedic surgery show that analgesia is rapidly achieved, with a longer mean interdosing interval compared with IV PCA morphine (81 vs 47 minutes) and a high level of patient and nurse satisfaction. These data suggest that SSTS may also aid in the avoidance of some of the pitfalls inherent with IV PCA, which may help reduce hospital costs associated with IV PCA-related issues. This article describes the evolution, benefits, issues, and costs associated with IV PCA and reviews data from preclinical studies of sufentanil through SSTS phase 3 trials.

Recommendations for the implementation of a Patient Blood Management programme. Application to elective major orthopaedic surgery in adults.

Patient Blood Management (PBM) is a holistic approach to the management of blood as a resource for each, single patient; it is a multimodal strategy that is implemented through the use of a set of techniques that can be applied in individual cases. Indeed, the overall outcome resulting from the implementation of PBM cannot be fully appreciated and explained simply by summing the effects of the single strategies and techniques used, since these can only produce the expected optimal outcome if used in combination1. PBM is, therefore, a patient-centred, multiprofessional, multidisciplinary and multimodal approach to the optimal management of anaemia and haemostasis (also during surgery), to limiting allogeneic transfusion needs in the peri-operative period, and to appropriate use of blood components and, when relevant, plasma-derived medicinal products2. The concept of PBM is not centred on a specific pathology or procedure, nor on a specific discipline or sector of medicine, but is aimed at managing a resource, “the patient’s blood”, shifting attention from the blood component to the patient who, therefore, acquires a central and pre-eminent role3,4. PBM combines the dual purposes of improving the outcomes of patients and reducing costs, being based on the patient rather than on allogeneic blood as the resource. For this reason, PBM goes beyond the concept of appropriate use of blood components and plasma-derived medicinal products, since its purpose is to avoid or significantly reduce their use, managing, in good time, all the modifiable risk factors that can lead to a transfusion being required5. These aims can be achieved through the so-called “three pillars of PBM” (Table I)5, which are crucial for making the paradigmatic shift that characterises the innovative, patient-centred approach: (i) optimising the patient’s erythropoiesis; (ii) minimising bleeding; and (iii) optimising and exploiting an individual’s physiological reserve to tolerate anaemia5. Each of these three key points is a strategic response to clinical circumstances that can cause adverse outcomes and necessitate the use of allogeneic transfusion therapy, namely anaemia, blood loss and hypoxia, respectively. Table I The three pillars of Patient Blood Management (modified from Hofmann A et al.5). PBM is, therefore, intended to guarantee all patients a series of personalised programmes, based on surgical requirements and the characteristics of the patients themselves, with the dual purposes of using allogeneic transfusion support appropriately and reducing the need for this resource. For this reason, PBM requires multidisciplinary and multimodal strategies to systematically identify, evaluate and manage anaemia (boosting, if necessary, individual physiological reserves) and to avoid or minimise blood losses. It seems necessary to produce specific national standards. In fact, in the USA, PBM is the object of attention from the Association for Advancing Transfusions and Cellular Therapies (formerly known as the American Association of Blood Banks - AABB) which recently published the first edition of “Standards for a Patient Blood Management Program” precisely with the aim of supplying healthcare structures with solid elements for the standardisation of procedures and activities for implementing and/or optimising a PBM programme. The Society for the Advancement of Blood Management (SABM), also in the USA, has published a second edition of “Administrative and Clinical Standards for Patient Blood Management Programs”6 and the Joint Commission has published seven parameters for measuring the performance of healthcare structures in the field of PBM7.

Perioperative intravenous fluid prescribing: a multi-centre audit.

BackgroundExcessive or inadequate intravenous fluid given in the perioperative period can affect outcomes. A number of guidelines exist but these can conflict with the entrenched practice, evidence base and prescriber knowledge. We conducted a multi-centre audit of intraoperative and postoperative intravenous fluid therapy to investigate fluid administration practice and frequency of postoperative electrolyte disturbances.MethodsA retrospective audit was done in five hospitals of adult patients undergoing elective major abdominal, gastrointestinal tract or orthopaedic surgery. The type, volume and quantity of fluid and electrolytes administered during surgery and in 3 days postoperatively was calculated, and electrolyte disturbances were studied using clinical records.ResultsData from four hundred thirty-one patients in five hospitals covering 1157 intravenous fluid days were collected. Balanced crystalloid solutions were almost universally used in the operating theatre and were also the most common fluid administered postoperatively, followed by hypotonic dextrose-saline solutions and 0.9 % sodium chloride. For three common uncomplicated elective operations, the volume of fluid administered intraoperatively demonstrated considerable variability. Over half of the patients received no postoperative fluid on day 1, and even more were commenced on free oral fluids immediately postoperatively or on day 1. Postoperative quantities of sodium exceeded the recommended amounts for maintenance in half of the patients who continued to receive intravenous fluids. Potassium administration in those receiving intravenous fluids was almost universally inadequate. Hypokalaemia and hyponatraemia were the common findings.ConclusionsWe documented the current clinical practice and confirmed that early free oral fluids and cessation of any intravenous fluids is common postoperatively in keeping with the aims of enhanced recovery after surgery programmes. Excessive sodium and water and inadequate potassium in those given intravenous fluids postoperatively is common and needs to be investigated. The variation in intraoperative fluid volume administration for three common procedures is considerable and in keeping with other international studies. Future trials of fluid therapy should include the intraoperative and postoperative phases.

Continued commitment to safety: building on the existing rivaroxaban knowledge base: Table 1

Data from post-authorization studies and registries are valuable in establishing the safety and effectiveness of therapies in real-life settings, particularly as physicians may have concerns about the robustness of safety data from randomized controlled trials (RCTs). Furthermore, in routine clinical practice, there may be a potential for increased adverse event reporting with new therapies, and their true safety profile may be difficult to elucidate. The non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) rivaroxaban is a direct factor Xa inhibitor, first approved for the prevention of venous thromboembolism (VTE) following elective hip or knee replacement surgery in 2008, and now licensed for use in five indications in Europe in the venous and arterial thromboembolic space. A number of Phase IV, non-interventional studies, and independent registries are completed or underway that aim to further evaluate safety outcomes with rivaroxaban in everyday clinical practice. These include XAMOS (XArelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of the hip or knee), XANTUS (XArelto on preveNtion of sTroke and non-central nervoUS system systemic emboilism in patients with non-valvular atrial fibrillation), and XALIA (XArelto for Long-term and Initial Anticoagulation in venous thromboembolism). Results to date—from XAMOS—show that rivaroxaban has an acceptable safety profile in real-life, with outcomes that are in line with the RECORD (REgulation of Coagulation in ORthopedic surgery to prevent Deep vein thrombosis and pulmonary embolism) clinical trial programme. International and national registries are also gathering information on rivaroxaban and other NOACs. Together, this breadth of studies illustrates an ongoing commitment to understanding real-life outcomes with NOACs.