Correlation Between Anesthesia Methods and Adverse Short-Term Postoperative Outcomes Depending on Frailty: A Prospective Cohort Study.

Purpose: This study aims to investigate how the type of anesthesia used during major orthopedic surgery may impact adverse short-term postoperative outcomes depending on frailty. Methods: To conduct this investigation, we recruited individuals aged 65 years and older who underwent major orthopedic surgery between March 2022 and April 2023 at a single institution. We utilized the FRAIL scale to evaluate frailty. The primary focus was on occurrences of death or the inability to walk 60 days after the surgery. Secondary measures included death within 60 days; inability to walk without human assistance at 60 days; death or the inability to walk without human assistance at 30 days after surgery, the first time out of bed after surgery, postoperative blood transfusion, length of hospital stay, hospital costs, and the occurrence of surgical complications such as dislocation, periprosthetic fracture, infection, reoperation, wound complications/hematoma. Results: In a study of 387 old adult patients who had undergone major orthopedic surgery, 41.3% were found to be in a frail state. Among these patients, 262 had general anesthesia and 125 had neuraxial anesthesia. Multifactorial logistic regression analyses showed that anesthesia type was not linked to complications. Instead, frailty (OR 4.04, 95% CI 1.04 to 8.57, P< 0.001), age (OR 1.05, 95% CI 1.00-1.10, P= 0.017), and aCCI scores, age-adjusted Charlson Comorbidity Index, (OR 1.36, 95% CI 1.12 to 1.66, P= 0.002) were identified as independent risk factors for death or new walking disorders in these patients 60 days after surgery. After adjusting for frailty, anesthesia methods was not associated with the development of death or new walking disorders in these patients (P > 0.05). Conclusion: In different frail populations, neuraxial anesthesia is likely to be comparable to general anesthesia in terms of the incidence of short-term postoperative adverse outcomes.

Compliance status and influencing factors of anticoagulation therapy in outpatient undergoing major orthopedic surgery.

PURPOSE: This study was designed to investigate influencing factors of out-of-hospital anticoagulation therapy compliance among patients undergoing major orthopaedic surgeries. METHODS: A cross-sectional, descriptive study was conducted from July 2022 to February 2023 among outpatients who underwent major orthopedic surgery in our hospital. Patients (n = 200) were surveyed using the General Information Questionnaire, the General Self-Efficacy Scale, the Specificity of Medication-Taking Beliefs Scale, and the Morisky Medication Adherence Scale. Factors that influenced patient compliance were also determined using univariate and multivariate regression analyses. RESULTS: One hundred eighty-three valid questionnaires were returned, the compliance with outpatient anticoagulation therapy among patients undergoing major orthopaedic surgeries was good in 56.3% (103/183) of all cases and poor in 43.7% (80/183). Multivariate logistic regression analysis showed that medication duration, adverse effects, self-efficacy and medication beliefs influenced adherence to out-of-hospital anticoagulation therapy in patients undergoing major orthopedic surgery (P < 0.05). CONCLUSIONS: Poor compliance with out-of-hospital anticoagulation therapy in patients undergoing major orthopedic surgery is mainly associated with a long course of medication, adverse reactions, low self-efficacy and low medication beliefs. Healthcare staff should strengthen post-discharge anticoagulation management based on relevant influencing factors to enhance patient compliance.

Clinical effectiveness and safety of aspirin and other anticoagulants for venous thromboembolism prophylaxis after major orthopedic surgery: a systematic review and meta-analysis of randomized clinical trials.

Purpose: Patients undergoing major orthopedic surgeries, such as total hip replacement (THR), total knee replacement (TKR), and trauma surgery, are at an elevated risk of venous thromboembolism (VTE), causing significant morbidity and mortality. Previous studies have investigated aspirin as a thromboprophylactic agent for arthroplasty, besides trauma surgery. Therefore, we sought to analyze the efficacy of aspirin compared to that of other anticoagulants for VTE prophylaxis in patients undergoing major orthopedic surgeries. Methods: This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The study protocol was registered with the PROSPERO register. Randomized controlled trials that investigated the use of aspirin for thromboprophylaxis in major orthopedic lower limb surgeries were included and analyzed. Quality analysis of the literature and level of evidence were assessed. The primary clinical outcome was VTE. Secondary clinical outcomes included mortality, bleeding events, and wound complications. Results: Eight high-quality studies with level 2 evidence (published within 2006-2021) were included, comprising 6220 patients. The incidence of VTE with aspirin was not found to be more significant than other anticoagulants (risk ratio (RR) = 1.18, 95% CI: 0.89-1.58, P = 0.25). Regarding secondary outcomes, there were no significant differences between aspirin and other anticoagulants (mortality (RR = 1.40, 95% CI: 0.27-7.23, P = 0.69), bleeding events (RR = 0.89, 95% CI: 0.57-1.39, P = 0.61), or wound complications (RR = 0.64, 95% CI: 0.30-1.35, P = 0.24)). Conclusion: The current meta-analysis did not show any difference between aspirin and other anticoagulants as thromboprophylactic agents in preventing VTE in patients who underwent major orthopedic surgeries.

Fondaparinux sodium and low molecular weight heparin for venous thromboembolism prophylaxis in Chinese patients with major orthopedic surgery or trauma: a real-world study.

BACKGROUND: The present real-world study aimed to compare the efficacy and safety between fondaparinux sodium (FPX) and low molecular weight heparin (LMWH) for venous thromboembolism (VTE) prophylaxis in Chinese patients with major orthopedic surgery or trauma. METHODS: A total of 2429 patients, with major orthopedic surgery or trauma, underwent FPX (n = 1177) or LMWH (n = 1252) for VTE prophylaxis and were retrospectively reviewed. Primary outcomes, including in-hospital VTE and in-hospital major bleeding incidences, as well as the secondary outcomes, including in-hospital minor bleeding, in-hospital death, and VTE/bleeding/death within 2 months after discharge, were analyzed. Inverse probability of treatment weighting (IPTW) was conducted. RESULTS: FPX group exhibited lower in-hospital VTE (0.1% vs. 0.8%; P = 0.032, crude OR = 0.11 before IPTW; P = 0.046, weighted OR = 0.12 after IPTW) and in-hospital minor bleeding (17.8% vs. 26.8%; P < 0.001, crude OR = 0.59 before IPTW; P < 0.001, weighted OR = 0.67 after IPTW) compared to LMWH group. Furthermore, no difference of in-hospital major bleeding, in-hospital death, and VTE/bleeding/death within 2 months after discharge was observed between FPX group and LMWH group (all P > 0.05). Further subgroup analyses identified, in specific cluster of patients such as older age, renal function impairment, hypertension and so on, in-hospital VTE was declined in FPX group compared to LMWH group (all P < 0.001). CONCLUSIONS: FPX is probable to exhibit a superior thromboprophylaxis efficacy compared with LMWH in in-hospital patients with major orthopedic surgery or trauma, especially in some special patients such as older age, renal function impairment, hypertension, etc.

Perioperative platelet count in peripheral blood is associated with the early stage of PND after major orthopedic surgery: a prospective observational study.

BACKGROUND: Perioperative neurocognitive disorders (PND) are common complications of major surgery among elderly patients, remarkably decreasing patients' life quality. Platelet count has been proved to be an essential factor in inflammation. However, as far as we know, the relationship between platelet count and PND is not clear yet in the orthopedic area. PND could be a long-term disease, which sometimes lasts for several years, and it is meaningful to find a biomarker of PND at the early stage. Thus, we designed this study to find out the association between perioperative platelet count and occurrence of PND, and determine whether preoperative platelet count could be a biomarker of the early stage of PND. METHODS: A prospective observational study was performed on the patients who would take total knee arthroplasty or total hip arthroplasty. Their peripheral platelets were counted by blood routine examination 1 day before and 3 days after the surgery. And we assessed their neurocognitive functions 1 day before and 3 days after the surgery. These data were recorded and analyzed to find out the relationship between platelet count and the occurrence of PND. RESULTS: Eventually, 70 patients finished the whole process, and 14 of them developed PND. The median preoperative platelet count in the PND group was significantly higher than that in the non-PND group (239 vs 168 × 10^9/L, p = 0.009). Preoperative platelet count was an independent risk factor for PND (odds ratio = 1.014, 95% confidence interval [CI] 1.000-1.027, P = 0.043) in the logistic multivariable regression, while the area under the curve of the receiver operating characteristic curve of the prediction model was 0.796 (95% CI 0.676-0.916). CONCLUSIONS: The higher preoperative and postoperative level of platelet count in the peripheral blood were associated with the early stage of PND, and preoperative platelet count could be a potential predictor of the early stage of PND in patients undergoing major orthopedic surgeries. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000033001 , registration date: 17 May 2020.

Relationship Between Quality of Care and Patient Care Outcomes for Postoperative Pain in Major Orthopedic Surgery: Analytical and Cross-Sectional Study.

The quality of care provided for the management of postoperative pain and patient outcomes are key criteria for healthcare institutions. This study aimed to determine the relationship between the quality of care provided for the alleviation of postoperative pain experienced among patients undergoing major orthopedic surgery and the patient care outcomes. The study was designed as an analytical and cross-sectional study. The rates of pain severity and sleep interference, activity interference, affective experiences, and adverse effects due to postoperative pain were higher in female patients than in male patients. A significant positive correlation was identified between the quality of postoperative pain care and the perception of care (p < .05). Implementing nursing interventions to improve pain management and increase the quality of care appears to be vital elements for reducing adverse effects caused by pain and increasing the satisfaction with postoperative pain care.

Efficacy and Safety of Thromboprophylaxis Post-Orthopedic Surgery.

Given the high risk of venous thromboembolism (VTE) post-orthopedic surgery and the vital role of thromboprophylaxis in preventing VTEs, this meta-analysis aimed to assess the efficacy of thromboprophylaxis post major orthopedic surgery and the relevant safety measures. In this review, we conducted a computer-aided search of Google Scholar, PubMed, CINAHL, Cochrane, Medline, and EMBASE databases. We included all published randomized clinical trials (RCTs) that utilized enoxaparin, fondaparinux, dabigatran, rivaroxaban, apixaban, and aspirin for VTE prophylaxis in patients undergoing total hip arthroplasty (THA), hip fracture surgery, and total knee arthroplasty (TKA) based on primary and secondary outcomes. The Cochrane Collaboration tool was used to evaluate the risk of bias. All statistical analyses were performed using Review Manager Software. A total of 23 RCTs were included with a total sample of 48,424 patients and an overall low risk of bias. The efficacy of enoxaparin in preventing VTEs in the TKA group was significantly better than fondaparinux. In the THA group, the efficacy of enoxaparin was significantly better than apixaban. The efficacies of fondaparinux, dabigatran, rivaroxaban, apixaban, and aspirin were comparable to that of enoxaparin in reducing VTE-associated mortality, major bleeding, and adverse events. In conclusion, we found that all included drugs were non-inferior to enoxaparin in VTE-associated mortality, major bleeding, and adverse events.

Venous Thromboembolism in Major Orthopedic Surgery.

Venous thromboembolism (VTE) is one of the most important complications in orthopedic surgery. Deep-vein thrombosis occurs frequently after surgery but has few clinical symptoms. The emboli formed may cause pulmonary thromboembolism, which is associated with a high mortality rate. The cost of medical care is doubled when VTE develops after surgery. Thus, it is imperative to focus on preventing VTE after major orthopedic surgery. The prevention method should be selected after considering the balance between VTE risk and bleeding risk attributable to drug prophylaxis. Physical prophylaxis, drug prophylaxis, or both should be selected. When performing VTE prophylaxis, the risks and merits of prophylaxis must be made clear to patients.

Effect of the beginning time of intermittent pneumatic compression on hemodynamic and deep vein thrombosis of patients with major orthopedic surgery / 中国实用护理杂志

Objective:To investigate the effects of beginning time of intermittent pneumatic compression (IPC) on hemodynamics and deep vein thrombosis (DVT) of patients with major orthopedic surgery.Methods:A total of 99 patients who underwent major orthopaedic surgery in the Department of Orthopaedics, West China Hospital, Sichuan University from January 2018 to December 2019 were selected as the research objects, which were assigned to ultra-early group, early group and control group, each group contained 33 cases. The IPC were used 3 days before surgery in the ultra-early group, 1 day before surgery in the early group, and after surgery in control group. The incidence of DVT and deep skin pressure injury within 14 days was observed, the blood flow velocity of deep femoral vein and plasma D-dimer in the three groups were also compared.Results:There was no significant difference in the incidence of DVT among the three groups ( P> 0.05), however, the deep tissue injury rate was 18.18% (6/33) in the ultra-early group, significantly higher than 3.03% (1/33) in the early group and 0 in control group, the difference was statistically significant ( χ2 value was 9.531, P<0.05). After 1 day and 3, 5, 7 days of surgery, the blood flow velocity of deep femoral vein in the ultra-early group and the early group were (26.48±2.24), (25.79±2.18), (26.67±3.74), (25.88±2.83) ml/s and (25.76±1.87), (25.39±1.98), (25.45±2.93), (25.48±3.75) ml/s, significantly higher than (23.39±1.75), (23.73±2.61), (23.79±2.30), (22.21±4.42) ml/s in the control group, the difference was statistically significant ( F values were 7.428-22.350, P<0.01). After 3, 5, 7 days of surgery, the levels of plasma D-dimer in the ultra-early group and the early group were (1.11±0.26), (1.03±0.23), (0.98±0.28) mg/L and (1.18±0.32), (1.12±0.24), (1.05±0.31) mg/L, significantly lower than (1.38±0.40), (1.32±0.39), (1.20±0.26) mg/L in the control group, the difference was statistically significant ( F values were 5.809, 8.442, 4.962, P<0.01). Conclusion:Using IPC one day before operation can significantly increase the blood flow velocity of deep femoral vein, reduce the level of plasma D-dimer, and do not increase the incidence of deep skin pressure injury in patients with major orthopedic surgery.

Delirium en el perioperatorio de cirugía de cadera en el adulto mayor / Perioperative delirium in hip surgery in the elderly / Delirum na cirurgia de quadril no idoso

El delirium es una de las complicaciones más frecuentes de la cirugía por fractura de cadera. No hay estudios en Uruguay sobre este tema. El objetivo de este trabajo fue determinar la frecuencia de delirium en el perioperatorio de cirugía por fractura de cadera, describir las características sociodemográficas y clínicas de la población y la asociación entre delirium y variables de interés. Se realizó un estudio observacional, analítico, prospectivo, de cohorte única. Se reclutaron 50 adultos mayores ingresados en el Instituto Nacional de Ortopedia y Traumatología, por fractura de cadera, candidatos a cirugía, durante un período de 4 meses. Se evaluaron previo a la cirugía, y en las 24 y 48 horas del postoperatorio. Se seleccionó una muestra no probabilística. Se contó con la aprobación del Comité de Ética del Hospital de Clínicas de Montevideo. La edad media fue de 83 años. La frecuencia de delirium fue de 42%, 28% previo a la cirugía y 14% en el postoperatorio. La frecuencia de delirium en los de 80 años o más fue del 53,3%. Se encontró una asociación estadísticamente significativa entre la edad mayor de 80 años y el estado funcional basal y el desarrollo de delirium. Esta frecuencia coincide con estudios internacionales. El tamaño y la selección de la muestra pueden haber influido en los resultados secundarios. El delirium es frecuente en este contexto y enfatiza la necesidad de un enfoque multidisciplinario y protocolizado para el abordaje de la población mayor que se somete a cirugía ortopédica.

Delirium is one of the most common complications of hip fracture surgery. There are no studies in Uruguay on this subject. The aim of this study was to determine the frequency of delirium in the perioperative period of hip fracture surgery, to describe the sociodemographic and clinical characteristics of the sample and the association between delirium and variables of interest. An observational, analytical, prospective, single cohort study was conducted. 50 older adults admitted to the National Institute of Orthopedics and Traumatology, for hip fracture, candidates for surgery, were recruited over a period of 4 months. They were evaluated before and after surgery. A non-probabilistic sample was selected. The study was approved by the Ethics Committee of the Hospital de Clínicas of Montevideo. Average age was 83 years. The frequency of delirium was 42%, 28% before surgery and 14% in the postoperative period. The frequency of delirium in those aged 80 years or older was 53.3%. A statistically significant association was found between age over 80 years and baseline functional status and the development of delirium. This frequency is similar to that found in international studies. The size and selection of the sample may have influenced secondary outcomes. Delirium is frequent in this context and highlights the need for a multidisciplinary and protocolized approach to the elderly population undergoing orthopedic surgery.

O delirium é uma das complicações mais comuns da cirurgia de fratura do quadril. Não há estudos no Uruguai em cirurgia ortopédica. O objetivo do estudo foi determinar a freqüência de delirium no peri-operatório da cirurgia ortopédica de fratura do quadril, descrever as características sociodemográficos e clínicas da população, e descrever a associação entre o delirium e as variáveis de interesse. Realizou-se um estudo observacional, analítico, prospectivo e de coorte única. 50 pessoas idosas com fratura de quadril candidatos à cirurgia ortopédica foram recrutados do Instituto Nacional de Ortopedia e Traumatologia, por um período de 4 meses. Foi selecionada uma amostra não-probabilística. A coorte foi avaliada antes e depois da cirurgia. O estudo foi aprovado pelo Comitê de Etica do Hospital de Clinicas. Idade média de 83 anos. A freqüência de delirium foi de 42%, 28% antes da cirurgia e 14% no pós-operatório. O percentual de delírio pré-operatório naqueles de 80 anos ou mais foi de 53,3%. Nós encontramos uma associação estatisticamente significativa entre a idade superior a 80 anos e o estatus funcional no desenvolvimento do delirium. Esta frequência encontrada coincide com estudos internacionais. O tamanho e a seleção da amostra podem ter influenciado os secundários. O delirium é comum neste contexto e enfatiza a necessidade de uma abordagem multidisciplinar e protocolada para os idosos que se someten a uma cirurgia ortopédica.

The role of intraoperative cell salvage system on blood management in major orthopedic surgeries: a cost-benefit analysis.

INTRODUCTION: The aim of this study was to compare the efficiency and cost of cell salvage systems with allogeneic blood transfusions in patients who had major elective orthopedic surgeries. MATERIALS AND METHODS: Consecutive 108 patients who had intraoperative cell saver (CS) performed routinely constitute the study group. In control group, consecutive 112 patients who were operated without intraoperative CS were investigated. Hemoglobin (Hb) level less than 8 mg/dL was regarded as the absolute transfusion indication. The patients were evaluated for age, gender, body mass index, operation period, mean intraoperative estimated blood loss (EBL), postoperative hemovac drainage volume; preoperative, postoperative first day and discharge Hb levels, allogeneic blood transfusion (ABT) volume, hospitalization and cost parameters. RESULTS: The mean intraoperative EBL was 507 mL in the study group and 576 mL in control group. The mean ABT was 300 mL in the study group and 715 mL in control group. In the study group, intraoperative EBL, ABT usage and hospitalization period were significantly lower compared with the control group (p = 0.009, p = 0.000 and p = 0.000; p < 0.05, respectively). The mean cost was 771 Turkish liras (TL) in the study group and 224 TL in control group. In the study group, the cost was significantly higher than the control group (p = 0.000). The postoperative first day Hb level was significantly higher in the study group (p = 0.010). CONCLUSION: Although CS usage was determined to increase the costs in this study, it significantly decreases intraoperative and postoperative ABT requirements. We believe that the increase in cost may be neglected when the complications and prolonged hospitalization due to ABT usage were regarded.

Estrategia restrictiva transfusional en cirugía ortopédica / Restrictive transfusion strategy in orthopedics surgery

Para pacientes que sufren artrosis avanzada o en algunos casos de fractura de cadera, la solución quirúrgica que se propone es la cirugía ortopédica mayor. Alguno de estos pacientes requerirá transfusión de sangre o hemocomponentes, o ambos, antes o después de la intervención. El abordaje de la anemia en el paciente quirúrgico puede hacerse de manera liberal, sujeto a la indicación de cada cirujano, o en el contexto de un protocolo restrictivo de reposición. Con este último el beneficio en el ahorro de recursos se acompaña además de un menor número de complicaciones relacionadas con la administración de sangre alogénica. El objetivo específico de nuestro trabajo fue comparar la estrategia liberal con la terapia restrictiva transfusional. Ingresaron en el estudio 498 pacientes; de estos, 261 (52,4%) en el año 2014 sometidos a terapia liberal y 237 (47,6%) en el año 2015 a quienes se aplicó el protocolo de terapia restrictiva transfusional. Se transfundieron menos individuos y se indicaron 55% menos volúmenes de sangre con la estrategia restrictiva. Se presentaron diez casos de reacción transfusional, todas de tipo febril, ocho en 2014 y dos en 2015. Con respecto a la evolución funcional no se comprobó diferencia entre ambos grupos. En nuestra experiencia y de acuerdo a la literatura consultada, la terapia restrictiva permite alcanzar iguales resultados funcionales, con menor riesgo para el paciente y ahorraría recursos al sistema.

Major orthopedic surgery is the surgical solution proposed for patients who suffer from advanced arthrosis or for some cases of hip fracture. Some of these patients will require blood and/or blood components transfusion before or after surgery. The approach to anemia in surgical patients may involve a liberal or a restrictive transfusion strategy, according to what each surgeon indicates, or observing the context of a restrictive protocol for blood replacement. The latter results in resource savings and in a reduction in the number of complications due to the administration of allogenic blood. The study aims to compare the liberal transfusion strategy to the restrictive strategy. 498 patients were included in the study, 261 of which (52.4%) were treated within the liberal strategy in 2014, and 237 (47.6%) were treated according to a restrictive transfusion protocol in 2015. A smaller number of individuals received blood transfusions and 55% less blood volumes were needed when the restrictive strategy was applied. Ten cases of transfusion reaction arose, all of them involving fever, 8 in 2014 and 2 in 2015. As to the functional evolution, no differences were found between the two groups. According to our study, and according to the global literature consulted, the restrictive therapy strategy enables the same functional results with a lower risk for patients, and it saves resources for the system.

Para pacientes com artrose avançada ou em alguns casos de fratura de quadril, a solução cirúrgica que se propõe é a cirurgia ortopédica maior. Algum destes pacientes necessitará transfusão de sangue e/ou hemocomponentes antes ou depois da intervenção. A abordagem da anemia no paciente cirúrgico pode ser feita de maneira liberal, sujeito à indicação de cada cirurgião, ou seguindo um protocolo restritivo de reposição. Utilizando este último se observa um beneficio não só na economia de recursos como também por um menor número de complicações relacionadas com a administração de sangue alogênica. O objetivo específico deste trabalho foi comparar a estratégia liberal com a terapia restritiva transfusional. Foram incluídos no estudo 498 pacientes, sendo 261 (52,4%) em 2014 submetidos à terapia liberal, e 237 (47,6%) em 2015 quando se utilizou o protocolo de terapia restritiva transfusional. Umnúmero menor de pacientes necessitou transfusão sanguínea e foram indicados 55% menos volumes de sangre com a estratégia restritiva. Foram registrados 10 casos de reação transfusional, todas do tipo febril, oito em 2014 e 2 em 2015. Com respeito à evolução funcional, não foram observadas diferenças entre ambos os grupos. Na nossa experiência e de acordo com a literatura consultada, a terapia restritiva permite alcançar resultados funcionais iguais commenos riscos para o paciente e pouparia recursos ao sistema.

Use of direct oral anticoagulants with regional anesthesia in orthopedic patients.

The use of direct oral anticoagulants including apixaban, rivaroxaban, and dabigatran, which are approved for several therapeutic indications, can simplify perioperative and postoperative management of anticoagulation. Utilization of regional neuraxial anesthesia in patients receiving anticoagulants carries a relatively small risk of hematoma, the serious complications of which must be acknowledged. Given the extensive use of regional anesthesia in surgery and the increasing number of patients receiving direct oral anticoagulants, it is crucial to understand the current clinical data on the risk of hemorrhagic complications in this setting, particularly for anesthesiologists. We discuss current data, guideline recommendations, and best practice advice on effective management of the direct oral anticoagulants and regional anesthesia, including in specific clinical situations, such as patients undergoing major orthopedic surgery at high risk of a thromboembolic event, or patients with renal impairment at an increased risk of bleeding.

Budget Impact of Rivaroxaban for the Prevention of Thromboembolic Events after Hip or Knee Replacement in Spain.

Background: Anti-thrombotic prophylaxis is routinely used in patients undergoing elective total hip or knee replacement (THR or TKR) to reduce the risk of venous thromboembolism (VTE). In Spain, pharmacological prophylaxis is performed with low-molecular-weight heparin, enoxaparin being the most commonly used. Rivaroxaban is an oral antithrombotic drug that has shown superior efficacy and similar safety profile compared to enoxaparin regimens in randomized clinical trials. The aim of the study was to estimate the budget impact of increasing the use of rivaroxaban with respect to enoxaparin in the prophylaxis of VTE in patients undergoing elective THR or TKR. Methods: A budget impact analysis was conducted in order to estimate the economic cost from an increase of rivaroxaban use versus enoxaparin by 10%, 20%, and 30% over the 3 years of the time horizon (2015, 2016, and 2017) for the THR and TKR populations. Data related to rate of thromboembolic events, major bleeding events and use of resources (local or general anesthesia and nurse care after surgery) were obtained from the Xarelto® for VTE Prophylaxis After Hip or Knee Arthroplasty (XAMOS) study, an international, non-interventional, observational, open-label study in unselected patients undergoing THR or TKR surgery in routine practice. The study included a total of 17 701 patients from 252 centers in 37 countries, including Spain, Italy, France and United Kingdom, among others. Two cohorts where considered (patients undergoing THR or TKR) with two arms (patients treated with rivaroxaban or enoxaparin). The Spanish patients enrolled in the XAMOS study were 262 with THR and 538 with TKR. Thromboembolic events, major bleeding rates and health care resources were considered from both the international and the Spanish population. Health care resources including pharmacologic prophylaxis, anesthesia and nurse care costs (Euros 2014) were estimated from the Spanish National Healthcare System (NHS) perspective. The annual cost associated with each cohort was estimated based on the mean cost per patient and the estimated distribution of use of rivaroxaban or enoxaparin in the base case scenario and alternative scenario (increase of rivaroxaban use) over the 3 years. A one-way sensitivity analysis was conducted to evaluate the effect that the uncertainty of the input parameters may have on the results of the impact budget. Results: The difference in cost per patient undergoing THR or TKR with rivaroxaban versus enoxaparin was -€140.69 including event rates and resource use from the Spanish XAMOS population, and -€110.54 when considering event rates and resource use from the multinational XAMOS population (including but not limited to European [Spain, France, Italy, United Kingdom, Portugal, etc.], American [Canada, Mexico, Colombia, Venezuela, etc.], Asian [China, etc.] and Australian countries). In the analysis per cohort (THR or TKR), the impact of increasing the use of rivaroxaban in the THR cohort, was -€1106, -€2875, and -€5607 for 2015, 2016, and 2017, considering the data from the Spanish XAMOS population, and -€869, -€2259, and -€4405 considering the data from the multinational population. Considering the TKR cohort, the impact was -€2271, -€5904, and -€11 513, and -€1784, €4639, and -€9046, respectively. Conclusions: The present analysis shows that, according to effectiveness data from the XAMOS study (Spanish and multinational cohorts), an increase in the usage of rivaroxaban in VTE prophylaxis would lead to significant direct cost reduction in elective THR and TKR patients.

Apixaban versus enoxaparin in elective major orthopedic surgery: a clinical review.

Despite current guidelines recommendations about anticoagulant prophylaxis, many studies have shown an high venous thromboembolism (VTE) incidence in patients undergoing total hip and knee arthroplasty. A number of anticoagulants are currently available, but they have some limitations that affect their applicability and consequently their effectiveness. Several new oral anticoagulants (NOACs) have been developed in an attempt to overcome these limitations. Apixaban is a NOAC that selectively inhibits the coagulation factor Xa; it is approved for the prevention of VTE after total hip replacement and total knee replacement surgery. This review examines the results of main trials designed to test efficacy and safety of apixaban in major elective orthopedic surgery.

Clinical study on Buyang-huanwu decoction preventing the formation of lower limb deep vein thrombosis after major orthopedic surgery / 国际中医中药杂志

Objective To discuss Buyang-huanwu decoction preventing the formation of lower limb deep vein thrombosis (DVT) after major orthopedic surgery.Methods 60 patients were randomly divided into a treatment group and a control group.The treatment group was treated with oral liquid of Buyang-huanwu,twice a day; while the control group was treated with 5000IU of low molecular heparin through subcutaneous injection,once daily.Prothrombin time (PT),activated partial thromboplatin time (APTT),fibrinogen (FIB),D-dimer,lower limb deep vein color B ultrasonic and the wound flow changes after 48 hours were observed at 1st,7th,and 14th day after medication.Results ①)Comparison on the incidence of DVT:The incidence of DVT in the treatment group was higher than the control group at 7th day after medication,this incidence turn to equal in the two groups at the 14th day after medication,while at the end of therapy,the incidence of DVT in the treatment group was lower than the control group with significant difference (P＜0.05).②Comparison on D-dimer changes:D-dimer at the 1st and 14th day were (0.782 ± 0.472) mg/1 and (0.320 ± 0.102) mg/1 in the treatment group and (0.720±0.421)mg/1 and (0.417 ± 0.217) mg/l in the control group.Comparing with the same group before treatment [the treatment group was(0.548±0.245)mg/1; the control group was (0.560±0.195) mg/l],D-dimer was increased at the 1 st day with obvious difference (P＜ 0.05),but reduced at the 14th day,without statistical difference (P＞0.05).Conclusion Buyang-huanwu decoction did not show good effects as low molecular heparin at the beginning of the treatment,but the its whole therapeutic effects and safety was better in treating lower limb deep vein thrombosis after major orthopedic surgery.

Efficacy and safety of venous thromboembolism prophylaxis with apixaban in major orthopedic surgery.

Over the last 15 years, low-molecular-weight heparins (LMWHs) have been accepted as the "gold standard" for pharmaceutical thromboprophylaxis in patients at high risk of venous thromboembolism (VTE) in most countries around the world. Patients undergoing major orthopedic surgery (MOS) represent a population with high risk of VTE, which may remain asymptomatic or become symptomatic as deep vein thrombosis or pulmonary embolism. Numerous trials have investigated LMWH thromboprophylaxis in this population and demonstrated high efficacy and safety of these substances. However, LMWHs have a number of disadvantages, which limit the acceptance of patients and physicians, especially in prolonged prophylaxis up to 35 days after MOS. Consequently, new oral anticoagulants (NOACs) were developed that are of synthetic origin and act as direct and very specific inhibitors of different factors in the coagulation cascade. The most developed NOACs are dabigatran, rivaroxaban, and apixaban, all of which are approved for thromboprophylaxis in MOS in a number of countries around the world. This review is focused on the pharmacological characteristics of apixaban in comparison with other NOACs, on the impact of NOAC on VTE prophylaxis in daily care, and on the management of specific situations such as bleeding complications during NOAC therapy.

The effect of transdermal scopolamine plus intravenous dexamethasone for the prevention of postoperative nausea and vomiting in patients with epidural PCA after major orthopedic surgery.

BACKGROUND: Postoperative nausea and vomiting (PONV) is common complication of Patient-Controlled Analgesia (PCA) after surgery. The authors sought to determine whether a transdermal scopolamine (TDS) patch in combination with IV dexamethasone is more effective than IV dexamethasone alone or IV dexamethasone plus IV ramosetron for reducing PONV in patients receiving epidural PCA after major orthopedic surgery. METHODS: 120 patients that received epidural PCA with hydromorphone and ropivacaine after major orthopedic surgery under spinal anesthesia were allocated to 3 groups: Group D (n = 40) received IV dexamethasone 8 mg, Group DR (n = 40) received IV dexamethasone 8 mg plus IV ramosetron 0.3 mg, Group DS (n = 40) received IV dexamethasone 8 mg plus a TDS patch (Group DS, n = 40). Nausea and vomiting incidences, VAS for nausea, the use of additional antiemetics, and adverse effects (a dry mouth, blurred vision, drowsiness) during the first 24 hours postoperatively were subjected to analysis. RESULTS: The DS Group had a significantly higher rate of complete remission of PONV than the D and DR groups (82.5% vs 47.5%, and 50.0%, respectively), and had lower rates of nausea (17.5% vs 55.0%, and 50.0%), and vomiting (10.0% vs 50.0%, and 25.0%), and required less antiemetics (5.0% vs 35.0%, 22.5%) than group D and Group DR during the first 24 hours after surgery. Furthermore, no inter-group differences were observed with respect to adverse effects in the three groups. CONCLUSIONS: The prophylactic use of a TDS patch plus dexamethasone was found to be a more effective means of preventing PONV in patients that received epidural PCA after major orthopedic surgery than dexamethasone alone or dexamethasone plus ramosetron without adversely affecting side effects.

The effect of transdermal scopolamine plus intravenous dexamethasone for the prevention of postoperative nausea and vomiting in patients with epidural PCA after major orthopedic surgery / 대한마취과학회지

BACKGROUND: Postoperative nausea and vomiting (PONV) is common complication of Patient-Controlled Analgesia (PCA) after surgery. The authors sought to determine whether a transdermal scopolamine (TDS) patch in combination with IV dexamethasone is more effective than IV dexamethasone alone or IV dexamethasone plus IV ramosetron for reducing PONV in patients receiving epidural PCA after major orthopedic surgery. METHODS: 120 patients that received epidural PCA with hydromorphone and ropivacaine after major orthopedic surgery under spinal anesthesia were allocated to 3 groups: Group D (n = 40) received IV dexamethasone 8 mg, Group DR (n = 40) received IV dexamethasone 8 mg plus IV ramosetron 0.3 mg, Group DS (n = 40) received IV dexamethasone 8 mg plus a TDS patch (Group DS, n = 40). Nausea and vomiting incidences, VAS for nausea, the use of additional antiemetics, and adverse effects (a dry mouth, blurred vision, drowsiness) during the first 24 hours postoperatively were subjected to analysis. RESULTS: The DS Group had a significantly higher rate of complete remission of PONV than the D and DR groups (82.5% vs 47.5%, and 50.0%, respectively), and had lower rates of nausea (17.5% vs 55.0%, and 50.0%), and vomiting (10.0% vs 50.0%, and 25.0%), and required less antiemetics (5.0% vs 35.0%, 22.5%) than group D and Group DR during the first 24 hours after surgery. Furthermore, no inter-group differences were observed with respect to adverse effects in the three groups. CONCLUSIONS: The prophylactic use of a TDS patch plus dexamethasone was found to be a more effective means of preventing PONV in patients that received epidural PCA after major orthopedic surgery than dexamethasone alone or dexamethasone plus ramosetron without adversely affecting side effects.