Complicaciones tromboembólicas y hemorrágicas en pacientes portadores de prótesis valvulares del corazón en un centro de tercer nivel. ¿Qué hemos aprendido? / Thromboembolic and hemorrhagic complications in patients with prosthetic heart valves at third level care center. What have we learned?

Resumen Antecedentes: El reemplazo valvular por prótesis mecánicas o biológicas implica riesgo de tromboembolismo y complicaciones hemorrágicas. Objetivo: Determinar las complicaciones relacionadas con la terapia de anticoagulación complementaria y la probabilidad de riesgo en pacientes portadores de prótesis valvulares del corazón. Métodos: Se estudiaron 163 pacientes entre 2002 y 2016, portadores de prótesis mecánicas y biológicas, quienes recibieron antagonistas de la vitamina K posterior al egreso hospitalario. La terapia de anticoagulación se categorizó en óptima y no óptima conforme a los valores de INR previos a las complicaciones. Fueron excluidos los pacientes con comorbilidades y otros factores de riesgo de trombosis y/o sangrado. Resultados: a 68.7 % de los pacientes se les colocó prótesis mecánica y a 31.3 %, biológica (p ≤ 0.001); 25.2 % presentó las complicaciones motivo de estudio (p ≤ 0.001), hemorrágicas en 48.8 %, tromboembólicas en 26.8 % y de ambos tipos en 24.4 % (riesgo relativo = 4.229); a 95.1 % de los pacientes con complicaciones se les colocó prótesis mecánica y a 4.9 %, biológica (p = 0.005); 49.7 % presentó INR no óptimo (p ≤ 0.001). Conclusiones: Ante riesgo alto de complicaciones tromboembólicas y hemorrágicas, la elección de las prótesis valvulares, la prevención y el seguimiento son prioridades, principalmente en quienes requieren terapia de anticoagulación.

Abstract Background: Heart valve replacement surgery with mechanical or biological prostheses entails a risk of thromboembolism and bleeding complications. Objective: To determine the complications related to complementary anticoagulation therapy and the probability of risk. Methods: One-hundred and sixty-three patients who underwent heart valve replacement between 2002 and 2016 with either mechanical or biological prostheses, and who received vitamin K antagonists after hospital discharge, were studied. Anticoagulation therapy was categorized into optimal and non-optimal according to INR values prior to the development of complications. Patients with comorbidities and other risk factors for thrombosis and/or bleeding were excluded. Results: In total, 68.7 % of patients received mechanical prostheses, and 31.3 %, biological prostheses (p ≤ 0.001); 25.2 % experienced the complications that motivated the study (p ≤ 0.001), which were hemorrhagic in 48.8 %, thromboembolic in 26.8 %, and of both types in 24.4 % (relative risk = 4.229). Among the patients with complications, 95.1 % received mechanical prostheses, and 4.9 %, biological (p = 0.005); non-optimal INR was identified in 49.7 % (p ≤ 0.001). Conclusions: Given the high risk of thromboembolic and hemorrhagic complications, valve prostheses must be carefully chosen, and care priorities should include prevention and follow-up, especially in those patients who require anticoagulation therapy.

The safety and efficiency of left atrial appendage closure combined delayed anticoagulant therapy in atrial fibrillation patients combined with cardiogenic stroke during anticoagulant therapy / 中国医师进修杂志

Objective:To assess the safety and efficiency of left atrial appendage closure (LAAC) combined delayed anticoagulant therapy in atrial fibrillation (AF) patients combined with cardiogenic stroke during anticoagulant therapy.Methods:Using prospective research methods, 35 AF patients combined with cardiogenic stroke during anticoagulant therapy from September 2020 to June 2022 in Xuanwu Hospital, Capital Medical University were selected. All patients were treated with LAAC and delayed anticoagulant therapy. The endpoints were the safety and efficacy of LAAC combined with delayed anticoagulant therapy. The primary endpoint of efficacy was the composite endpoint of postoperative death, myocardial infarction, hemorrhagic stroke and systemic embolism. The safety endpoint was major bleeding as defined by the International Society for Thrombosis and Hemostasis and clinically relevant non-major bleeding.Results:Among 35 patients, 21 were males and 14 were females; the age was (68.5 ± 9.3) years old; the CHA 2DS 2-VASc score was 5 (4, 6) scores; the time to the last stroke was 95 (42, 98) d; the National Institutes of Health stroke scale score at the time of stroke was 3 (1, 6) scores. All patients successfully completed LAAC without perioperative instrument-surface thrombosis, death, new stroke or bleeding events. Thirty-two patients continued oral anticoagulant therapy 45 d after LAAC. The patients were followed up for (12.6 ± 4.3) months, 1 patient experienced recurrent ischemic stroke, 2 patients endured mucosal bleeding, there were no adverse events such as all-cause death, cardiovascular death, systemic embolism and hemorrhagic stroke. Conclusions:The LAAC combined delayed anticoagulant therapy is efficient and safe in patients with AF. For AF patients combined with cardiogenic stroke during anticoagulant therapy, LAAC combined with delayed anticoagulation therapy may be considered to further prevent ischemic stroke events.

Changes of coagulation function and anticoagulant therapy in children with heart failure / 中国小儿急救医学

Thrombosis is a common complication of heart failure, which seriously affects the life quality of patients.At present, anticoagulant therapy in children with heart failure is still not standardized, and the use of anticoagulants depends more on the experience from adults.However, the etiology and coagulation system development of children are different from those of adults.So the anticoagulant treatment strategy for children with heart failure may be different.This review introduced the changes of coagulation function and anticoagulation therapy in children with heart failure, in order to provide reference for the management of coagulation system and anticoagulation therapy in children with chronic heart failure.

Progress on the mechanisms of low molecular weight heparin in treating acute respiratory distress syndrome caused by viral pneumonia / 国际儿科学杂志

Acute respiratory distress syndrome(ARDS) is an important pathological process in patients with severe viral pneumonia.The coagulation disorder is one of the important characteristics of patients with viral pneumonia.In recent years, more and more studies have been exploring the related mechanisms of ARDS caused by viral pneumonia.Although the application of low molecular weight heparin(LMWH) to prevent and treat thrombotic complications in patients with viral pneumonia has become an industry consensus, in addition to anticoagulation, LMWH also has multiple effects such as anti-inflammatory and antioxidant.Therefore, the therapeutic effect of LMWH on ARDS remains to be fully explored.This article focuses on the pathological and clinical characteristics of viral pneumonia, to explore the evidence and clinical mechanisms of LMWH in the treatment of ARDS.

Extracardiac Rupture of Giant Left Valsalva Sinus Aneurysm / 日本心臓血管外科学会雑誌

We report a case of extracardiac rupture of the left Valsalva sinus aneurysm, which is an extremely rare and fatal lesion. The three drugs, clindamycin, ethambutol and rifampicin, had been administered for eleven years because of lung mycobacterium infection. An emergency surgery was performed because of cardiac tamponade. The left Valsalva sinus was entirely enlarged without an aneurysmal neck. The other Valsalva sinuses seemed to be almost normal. The aneurysmal wall adhered the pulmonary artery and the left atrium. The left descending and circumflex arteries independently originated from the aneurysmal wall. The left main trunk seemed to become a part of the aneurysmal wall. Additionally the intraoperative transesophageal echocardiography showed severe aortic regurgitation. The Bio-Bentall procedure was performed. The right coronary artery was reconstructed with the Carrel patch method and the saphenous vein grafts were anastomosed to the proximal portions of the left anterior descending and circumflex arteries, individually. On the thirty-third postoperative day, the patient was discharged uneventfully expect for the delayed sternal closure on the second postoperative day. Five and half years after surgy, the patient is living a normal life and rifampicin has been administered without any anticoagulation drugs.

Early thrombotic risks and prophylactic anticoagulation after liver transplantation / 中华器官移植杂志

In early stage after liver transplantation(LT), coagulation function of recipients stays in a fragile balance. Affected by a variety of complex mechanisms, blood is usually hypercoagulable. An imbalance between coagulation factors and physiological anticoagulants, elevated level of vWF, an occurrence of fibrinolysis inhibition and dosing of immunosuppressive agents cause a hypercoagulable state in an early stage after LT. Blood hypercoagulability may lead to such thrombotic complications as hepatic artery, portal vein and deep vein thromboses. Some studies have demonstrated that postoperative prophylactic anticoagulation has some effect in reducing the risks of early postoperative thrombosis. However, there is still a great lack of high-quality evidence. This review summarized the latest researches on early coagulation dysfunction, thrombosis and preventive anticoagulation after LT.

Predictive value of early international normalized ratio for Warfarin overanticoagulation in elderly patients with atrial fibrillation / 中华老年医学杂志

Objective:To investigate the relationship between early international normalized ratio(INR)and overanticoagulation in elderly patients with atrial fibrillation(AF)treated with Warfarin, and to evaluate its clinical value in predicting overanticoagulation.Methods:A total of 470 elderly patients with AF treated with Warfarin for anticoagulation were enrolled retrospectively.INR was detected in the morning of the next day after 3 days and 7 days of Warfarin treatment.According to whether INR was greater than 3.0 after 7 days of Warfarin treatment, the patients were divided into over-anticoagulation group(n=107)and non-over-anticoagulation group(n=363). The general clinical data of the two groups were analyzed.The receiver operating characteristic curve(ROC)was used to evaluate the value of 3-day INR(early INR)level in predicting overanticoagulation.Logistic regression was used to analyze the factors related to overanticoagulation in elderly AF patients receiving Warfarin treatment.Results:The age, initial warfarin dose, early INR and serum aspartate transferase level in the over-anticoagulation group were higher than those in the non-over-anticoagulation group( P<0.05 for all). The proportions of patients with initial Warfarin dose≥2.5 mg, age≥70 years old, body weight≤65 kg, valvular atrial fibrillation, hypoproteinemia, abnormal liver function, and combined use of antibiotics were higher in the over-anticoagulation group than those in the non-over-anticoagulation group( P<0.05 for all). The body weight, serum albumin level and the proportion of diabetes mellitus in the over-anticoagulation group were lower than those in the non-over-anticoagulation group( P<0.05). ROC curve showed that the area under the curve(AUC)of early INR in predicting over-anticoagulation was 0.927(95% CI: 0.900-0.949, P<0.0001), the sensitivity was 82.86% and the specificity was 88.43%, the optimal cutoff value for predicting overanticoagulation was INR≥1.66.Multiple Logistic regression analysis showed that early INR level≥1.66( OR=33.871, P<0.001), initial warfarin dose≥2.5 mg( OR=17.062, P=0.011), body weight≤65 kg( OR=2.824, P=0.002), age≥70 years old( OR=2.678, P=0.003), and abnormal liver function( OR=2.091, P=0.022)were related factors for over-anticoagulation in elderly patients with atrial fibrillation. Conclusions:Early INR level is closely related to overuse of anticoagulation in elderly AF patients receiving Warfarin treatment, which can be regarded as a predictor of overuse of anticoagulation.Early INR level in elderly AF patients receiving warfarin treatment should be monitored to reduce the incidence of anticoagulant overuse.

Status quo of anticoagulation therapy for patients with non-valvular atrial fibrillation in community health centers in Beijing / 中华全科医师杂志

Objective:To investigate the status quo of anticoagulant therapy for patients with non-valvular atrial fibrillation (NVAF) in Beijing community health centers and to analyze the affecting factors.Methods:From September to December 2020, 164 patients with NVAF in five community health service centers in Xicheng District of Beijing were selected for a face-to-face questionnaire survey. The questionnaire included basic information of patients, complications, CHA 2DS 2-VASc score, HAS-BLED score and oral anticoagulant therapy, et al. SPSS 23.0 software was used to analyze the status of anticoagulant therapy in patients with different risk stratification of stroke, and chi-square was used to analyze the factors affecting anticoagulant therapy in high-risk patients with stroke. Results:In 161 NVAF patients with indication, 86 received anticoagulation therapy (53.4%), and the utilization rates of rivaroxaban, dabigatran and warfarin were 64.0% (55/86), 26.7% (23/86) and 9.3% (8/86), respectively. In 140 patients (85.4%, 140/164) at high risk of stroke (CHA 2DS 2-VASc score ≥2 points in males or ≥3 points in females), 30.0% (42/140) had never received anticoagulant therapy, and 29.3% (41/140) was treated with antiplatelet therapy, 17.1% (24/140) did not use any antithrombotic medication. Univariate analysis showed that gender, age, symptoms at first diagnosis and complications were not significantly associated with the application of anticoagulant therapy in NVAF patients at high-risk of stoke ( P>0.05). The qualitative study showed that the reasons for not receiving anticoagulant therapy were spontaneous cardioversion or recovery of sinus rhythm after ablation (15 cases), adverse drug reactions (7 cases), self-withdrawal of drugs (10 cases), concern about bleeding (3 cases) and so on. Conclusion:A large proportion of NVAF patients in the community are at high risk of stroke, while the overall rate of anticoagulant treatment is relatively low. Clinician in the community should actively initiate anticoagulant therapy for patients with AF and strengthen the continuous management and compliance management of anticoagulant therapy.

Relationship between hepatic venous pressure gradient and parameters of Doppler ultrasound in 68 patients with pyrroidine alkaloid-related hepatic sinusoidal obstruction syndrome / 中华消化杂志

Objective:To investigate the relationship between hepatic venous pressure gradient (HVPG) and parameters of Doppler ultrasound in patients with pyrroidine alkaloid-related hepatic sinusoidal obstruction syndrome (PA-HSOS).Methods:From February 17, 2017 to April 22, 2020, the clinical data of 68 patients with PA-HSOS who underwent HVPG manometry and Doppler ultrasound examination at Drum Tower Hospital, the Affiliated Medical College of Nanjing University were retrospectively analyzed, which included HVPG, Drum Tower severity scoring (DTSS), time from PA-HSOS related symptoms appeared to diagnosis after taking pyrroidine alkaloid (hereinafter referred to as diagnosis time), and parameters of Doppler ultrasound induding portal vein trunk diameter (PD), peak portal vein velocity (PPV), splenic vein trunk diameter (SD) and peak splenic vein velocity (PSV). Receiver operating characteristic curve (ROC) was used to determine the optimal cut-off value of HVPG for predicting non-response to anticoagulation therapy. Binary logistic regression was used to analyze the independent risk factors for non-response to anticoagulation therapy, and Kaplan-Meier survival curve was used to analyze the prognostic survival rate of patients with different HVPG levels. Unitary linear regression was applied to analyze the correlation of HVPG with PD, PPV, SD and PSV in patients with different HVPG levels, patients with mild, moderate and severe DTSS, and patients with diagnosis time >1 month or ≤ 1 month. Chi-square test was used for statistical analysis.Results:The results of ROC analysis showed that the optimal cut-off value of HVPG for predicting non-response to anticoagulant therapy was 20.165 mmHg(1 mmHg=0.133 kPa). The result of multivariate analysis indicated that high HVPG (HVPG>20.165 mmHg) was an independent risk factor for predicting non-response to anticoagulant therapy ( OR (95% confidence interval)=6.039(1.466 to 24.869), P=0.013). Kaplan-Meier survival curve demonstrated that prognostic survival rate of patients with high HVPG was lower than that of patients with low HVPG (HVPG≤20.165 mmHg) (78.4% vs.96.8%), and the difference was statistically significant( χ2=4.74, P=0.030). The results of unitary linear regression analysis showed that there was a negative correlation between HVPG and PPV in 68 patients with PA-HSOS( r=-0.330, P=0.006); HVPG was positively correlated with PD and SD in patients with high HVPG ( r=0.540 and 0.341, P=0.001 and 0.039); there was a negative correlation between HVPG and PSV in patients with mild DTSS ( r=-0.519, P=0.019), HVPG was negatively correlated with PPV in patients with moderate DTSS ( r=-0.400, P=0.014). In patients with diagnosis time ≤1 month, there was a negative correlation between HVPG and PPV ( r=-0.391, P=0.010). Conclusions:HVPG can assist in judging the response to anticoagulation therapy and the prognosis of patients with PA-HSOS. Parameters of Doppler ultrasound can help to assess the degree of HVPG elevation in patients with PA-HSOS under certain conditions.

The enlightenment of hemodynamic principleson for prevention and treatment of allograft rejection / 中华器官移植杂志

Antibody mediated rejection (AMR) starts from the binding of donor specific antibody (DSA) to its target antigen on endothelium. Whether or not a circulating DSA would bind to its static target depends on the relative strength between the antigen-antibody attraction potential energy and the kinetic energy of a circulating DSA. The attraction potential energy between antigen & antibody mainly depends on affinity of antibody to its target and is relatively constant. The kinetic energy of antibody depends on its velocity. The faster it moves the higher kinetic energy it possesses (E=mV 2/2). Therefore, the primary endothelial injury has always occurred in capillary which has the lowest blood flow rate. Even though DSA moves at the lowest velocity in capillary (≤1 mm/s), compared to its size (diameter<10 nm), the relative velocity of DSA is very high, which moves a distance of 100, 000 diameter of antibody per second. It is nearly 20, 000 times over the highest relative velocity of Bolt, the world record holder in 100 meters. Therefore, it is not easy for a fast-moving DSA to bind to its static target since the attraction potential energy between antigen and antibody needs to overcome the great kinetic energy of DSA. These basic concepts of hemodynamics and the relative velocity of DSA gives us at least the following inspirations: (1)It is easier for a DSA to bind its antigen in vitro, since there is no relative motion between antigen and antibody in test tube; while it is more difficult for a fast-moving DSA to bind to its static antigen in vivo, since the attraction potential energy between antigen & antibody needs to overcome the great kinetic energy of a fast-moving DSA.(2)A cytotoxic agent usually kills its peripheral blood target with a much higher depletion efficacy than for its target in tissue, since it runs with its circulating target without relative motion, while it is more difficult for a fast-moving agent with a great kinetic energy to bind its static target in tissue.(3)Some patients remain positive for DSA for a long time without the evidence of AMR. This is possibly due to a lower attraction potential energy between antigen-antibody, or due to a higher kinetic energy of a fast-moving DSA in the circumstance without microvascular occlusion.(4)Endothelial injury, resulting from ischemia and reperfusion or others, usually cause microvascular thrombosis, which results in partial or complete occlusion of microvascular system and favors antigen-antibody interaction.(5)Based on the fact that blood flow rate can affect antibody-antigen binding, we can reasonably infer that maintaining a good microcirculation in allograft will help to prevent or treat AMR. The strategies may include prevention of leukocyte adhesion, platelet deposition, red blood cell aggregation, and reduction of blood lipid and viscosity, to have plenty of water, and to do regular exercise. These strategies are equally important for prevention or treatment of cell mediated rejection.

Impact of anticoagulant therapy starting at different platelet levels on the incidences of portal vein thrombosis after splenectomy and devascularization / 中华肝胆外科杂志

Objective:To study the impact of anticoagulant therapy starting at different platelet levels on the incidences of portal vein thrombosis (PVT) after splenectomy and devascularization.Methods:From January 2014 to January 2017, 125 patients with liver cirrhosis and portal hypertension underwent splenectomy and pericardial devascularization in Beijing Ditan Hospital, Capital Medical University. All patients routinely received anticoagulant therapy. There were 85 patients who had a platelet count greater than >100×10 9/L (the study group) and 40 patients who had a platelet count greater than >300×10 9/L (the control group). The incidence of PVT was compared between the two groups. Results:A total of 125 patients were included in the study, including 91 males and 34 females, aged 20-59 years. Age, gender, preoperative platelet level, preoperative splenic vein and portal vein width, preoperative coagulation function, preoperative liver function (Child classification), preoperative esophageal and gastric varices, operation time, preoperative bleeding time, preoperative venous blood flow velocity, coagulation function 1 week and 2 weeks after operation between the two groups were not significantly different (all P>0.05). Of 125 patients undergoing splenectomy and pericardial devascularization, PVT was not found in all patients before operation. The incidence of PVT was 39.2% (49/125) within one month after operation. Among the 85 patients in the study group, 28 patients developed PVT, and the incidence of thrombosis was 32.9% (28/85). In the control group, 21 patients developed PVT, and the thrombosis rate was 52.5% (21/40). The difference was significant (χ 2=4.366, P=0.037). After anticoagulant therapy, the incidence of bleeding in the study group was 4.7% (4/85), and that in the control group was 5.0% (2/40), the difference was no significant ( P>0.05). Conclusion:Early anticoagulation (platelet >100×10 9/L) does not increase the risk of postoperative bleeding, but can reduce the incidence of PVT.

Progress in Anticoagulation of Calf Muscle Venous Thrombosis / 中国医学科学院学报

With the wide application of vascular Doppler ultrasound as well as the improvement of instrument precision and personnel operation practice,calf muscular venous thrombosis(CMVT)has been more and more frequently diagnosed among patients,becoming a common clinical disease.However,it is controversial about the anticoagulant therapy for CMVT patients.In this article,we summarize the current research progress of anticoagulation therapy,aiming to provide reference for the treatment of CMVT.

Mechanical heart valve thrombosis during pregnancy under non / 中南大学学报(医学版)

Anticoagulation drugs should be used for patients with mechanical heart valve (MHV) in case of potential risk of thrombosis. Pregnant women with MHV have to change therapies due to teratogenic effect of some anti-coagulation drugs. European Society of Cardiology clinical guidelines for the management of cardiovascular diseases during pregnancy gives specific suggestions for anticoagulation therapy.We have treated 2 patients with mechanical heart valve thrombosis (MVT) during pregnancy: One received low molecular weight heparin (LMWH) throughout the pregnancy and developed MVT at the third trimester of pregnancy; one developed MVT at the first trimester when replacing vitamin K antagonists (VKA) with LMWH. These patients raised secondary reflection on the balance between clinical guideline and personalized medicine. During LMWH therapy, we should dynamically monitor patients' anti-activated factor X (anti-Xa) level to evaluate coagulation function during pregnancy. When a pregnant woman with MHV develops symptoms of acute heart failure, stuck mechanical valve should be paid attention to and surgery should be promptly performed if necessary.

The Urgent Need to Understand Covid-19 Associated Coagulopathies and the Significance of Thrombotic Prophylaxis in Critically Ill Patients.

COVID-19 is a novel disease caused due to infection from the respiratory pathogen SARS CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). It originated from the city of Wuhan in China in December 2019, and spread to become a pandemic in most of the world. The World Health Organization (WHO) declared COVID-19 to be a ‘public health emergency of international concern’ on January 30, 2020. Since then there have been countless cases and associated fatalities. In this article we focus on one aspect of the underlying conditions that may prove to be fatal in critically ill patients of COVID-19, namely hypercoagulative states and their associated thrombotic complications. We analyse data-driven studies that outline the manifold increase in instances of COVID-19 related thrombotic events and the patient demography that is most affected by it. There are several reflections and critical enumerations of the specific clinical features that patients with COVID-19 associated coagulopathies present with. We analyse and comment on several anecdotal instances of patients presenting with new-onset symptoms of severe large-vessel ischemic strokes and other coagulopathies. We determine how laboratory findings and specific markers can help identify patients most at risk of thrombotic events. These events may range from deep vein thromboses to fatal cerebrovascular accidents. There is an increased stress on how these coagulation problems may relate to other infectious conditions through presentation with similar markers. We also analyse the radiological investigations that such patients yield and identify peculiarities in them. There is further emphasis on the importance and efficacy of thrombotic prophylaxis and anticoagulant therapy in the management and reduction of fatalities. We also attempt to educate clinicians and intensive care providers regarding better management practices to mitigate fatal outcomes, including both pharmacological and supportive interventions.

The Impact of Clinical Pharmacy Services on the Quality of Warfarin Anticoagulation Therapy Management / 中国药学杂志

OBJECTIVE: To evaluate the effects of clinical pharmacy services in patients with warfarin and highlight the important role of clinical pharmacists. METHODS: Patients in need of warfarin were enrolled as intervention group during 2016.9-2017.9 to receive standard anticoagulation management and follow-up provided by clinical pharmacists, and clinical data of patients who meet the inclusion criteria during 2013.7-2015.7 as control group was analyzed retrospectively. International normalized ratio(INR) values, maintenance doses, time to achieve therapeutic range, and etc. were recorded and TTRs (time in therapeutic range) were calculated to compare the outcomes of each group. RESULTS: TTRs in intervention group were significantly higher than those in control group, and so was the percentage of patients with the best quality of warfarin therapy(47.89% vs. 20.09%,P<0.001).Time to achieve therapeutic range was shorter and the frequency of INR test was higher in intervention group compared with those in control group. Patients′ cognitive scores of warfarin therapy were substantially increased after pharmacist′s education. CONCLUSION: Anticoagulation therapy management provided by clinical pharmacists could significantly improve the quality of warfarin therapy.

Application of standardized follow-up protocol in patients with mechanical heart valve replacement / 中国实用护理杂志

Objective@#To evaluate the effect of the standardized follow-up protocol based on telemedicine follow-up system in patients after mechanical heart valve replacement.@*Methods@#A prospective, nonrandomized, controlled clinical trial was performed on 109 patients who underwent mechanical heart valve replacement in the Affiliated Hospital of North Sichuan Medical College from January 2017 to June 2017. They were divided into two groups according to patient's willingness, place of residence and whether have sufficient technical facilities (computer or mobile device connected to the internet), including 56 patients in the control group and 53 patients in the observation group. The control group received routine follow-up guidance, and the observation group received standardized follow-up protocol, which were followed up for 6 months. The patients in the two groups were analyzed with thromboembolism, hemorrhagic event and International normalized ratio (INR) related to anticoagulation therapy during the follow-up period, and the quality of early anticoagulation therapy was evaluated with Time in therapeutic range (TTR), and the satisfaction of the patients with anticoagulation therapy was investigated.@*Results@#There was no significant difference in INR between the two groups during the follow-up period (P >0.05). The TTR of the control group and the observation group was 44.6% (4 516.6 d/10 127.0d) and 54.1% (5 576.1d/10 307 d), respectively, with statistically significant differences (t=-11.273, P < 0.05).There were no significant differences between the two groups in the anticoagulant complications, thromboembolism, hemorrhagic events (P > 0.05). There was significant difference between the observation group and the control group in overall satisfaction with anticoagulation therapy and helpful in answering the patients' questions (Z=6.42, 5.62, P < 0.05), while no statistically significant difference in service attitude to the follow-up period and satisfaction with the guidance that was provided (P > 0.05).@*Conclusion@#Standardized follow-up protocol based on telemedicine follow-up system is applied to patients after MHVR surgery, which is conducive to improving the quality of anticoagulant therapy and improving the satisfaction of patients, and providing reference for the development of "Internet + medical" mode in China.

Application of standardized follow-up protocol in patients with mechanical heart valve replacement / 中国实用护理杂志

Objective To evaluate the effect of the standardized follow-up protocol based on telemedicine follow-up system in patients after mechanical heart valve replacement. Methods A prospective, nonrandomized, controlled clinical trial was performed on 109 patients who underwent mechanical heart valve replacement in the Affiliated Hospital of North Sichuan Medical College from January 2017 to June 2017. They were divided into two groups according to patient's willingness, place of residence and whether have sufficient technical facilities (computer or mobile device connected to the internet), including 56 patients in the control group and 53 patients in the observation group. The control group received routine follow-up guidance, and the observation group received standardized follow-up protocol, which were followed up for 6 months. The patients in the two groups were analyzed with thromboembolism, hemorrhagic event and International normalized ratio (INR) related to anticoagulation therapy during the follow-up period, and the quality of early anticoagulation therapy was evaluated with Time in therapeutic range (TTR), and the satisfaction of the patients with anticoagulation therapy was investigated. Results There was no significant difference in INR between the two groups during the follow-up period (P>0.05). The TTR of the control group and the observation group was 44.6% (4 516.6 d/10 127.0d) and 54.1% (5 576.1d/10 307 d), respectively, with statistically significant differences (t=-11.273, P<0.05).There were no significant differences between the two groups in the anticoagulant complications, thromboembolism, hemorrhagic events (P > 0.05). There was significant difference between the observation group and the control group in overall satisfaction with anticoagulation therapy and helpful in answering the patients'questions (Z=6.42, 5.62, P<0.05), while no statistically significant difference in service attitude to the follow-up period and satisfaction with the guidance that was provided (P > 0.05). Conclusion Standardized follow-up protocol based on telemedicine follow-up system is applied to patients after MHVR surgery, which is conducive to improving the quality of anticoagulant therapy and improving the satisfaction of patients, and providing reference for the development of "Internet+medical"mode in China.

Evaluación de costo-efectividad de los nuevos anticoagulantes orales en pacientes con fibrilación auricular no valvular / Cost-effectiveness assessment of new oral anticoagulation drugs in patients with non-valvular atrial fibrillation

Resumen La fibrilación auricular es el trastorno más frecuente del ritmo cardíaco y una de las causas potencialmente tratables de cardioembolia y ataque cerebrovascular. La disponibilidad de nuevos anticoagulantes para pacientes con fibrilación auricular no valvular, plantea retos, derivados principalmente de los costos de su uso, perfiles de eficacia y seguridad, tolerancia y disponibilidad. Se llevó a cabo un análisis de costo-efectividad con base en un modelo de Markov, que permite comparar las estrategias de anticoagulación disponibles para fibrilación auricular no valvular en el país (apixabán, dabigatrán, rivaroxabán). La perspectiva empleada fue la del tercero pagador (sistema de salud colombiano), considerando solo costos médicos directos. Se siguieron las guías metodológicas para este tipo de estudios propuestas por ISPOR (International Society for Pharmacoeconomics and Outcomes Research) e INAHTA (International Network of Agencies for Health Technology Assessment). El horizonte temporal fue de 5 años, 10 años y toda la vida, en tanto que la tasa de descuento fue del 3%. Luego de la evaluación del modelo, con base en los análisis de sensibilidad realizados y el umbral de costo-efectividad para Colombia, se encontró que para el caso base, las diferentes moléculas evaluadas, si bien son costo-efectivas, exceden el umbral propuesto para este trabajo, siendo rivaroxabán y dabigatrán las únicas estrategias costo-efectivas con un horizonte temporal a 10 años con una tasa de descuento del 3% y para un horizonte temporal de toda la vida y tasa de descuento del 3%, las tres moléculas alcanzan el umbral de costo-efectividad establecido para Colombia. Dichas consideraciones son altamente sensibles al costo de los medicamentos.

Abstract Atrial fibrillation is the most common heart rate disorder and one of the potentially treatable causes of cardioembolisms and cerebrovascular events. Availability of new anticoagulation drugs in patients with non-valvular atrial fibrillation poses challenges that mostly derive from usage costs, efficacy and security profiles, tolerance and availability. A cost-effectiveness analysis was conducted based on the Markov model, which allows to compare the available anticoagulation strategies for non-valvular atrial fibrillation in the country (apixaban, dabigatran, rivaroxaban). The third payer perspective (according to Colombian health system) was used, taking into consideration only the direct medical costs. The methodological guides followed were suggested by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Network of Agencies for Health Technology Assessment (INAHTA). The time frame was 5 years, 10 years and a lifetime, whilst the discount rate was 3%. After assessing the model based on the conducted sensitivity analysis and the cost-effectiveness threshold for Colombia, it was revealed that for the baseline case the different molecules assessed, despite being cost effective, exceed the threshold proposed for this study. Rivaroxaban and dabigatran are the only cost-effective strategies in a 10-year time frame with a discount rate of 3% and for a lifetime time frame and discount rate of 3% all three molecules reach the costeffectiveness threshold established for Colombia. These considerations are highly sensitive to the cost of the medications.

Effect of rivaroxaban in preventing deep venous thrombosis after large orthopedic operation of lower extremity / 药物评价研究

Objective To discuss the effect ofrivaroxaban in preventing deep venous thrombosis after large orthopedic operation of lower extremity.Methods Totally 80 patients after lower extremity of large orthopedic operation were selected,they were divided into two groups randomly.The patients in control group (39 cases) were sc injected with enoxaparin through.The patients in observation group (41 cases) were given rivaroxaban orally.The effect of rivaroxaban in preventing deep venous thrombosis after large orthopedic operation of lower extremity were evaluated by hemodynamic indexes,diagnosis index,and complications during 1 months follow-up.Results Before operation,there was no statistical significance on platelet,hemoglobin,and PT values between two groups.Compared with the value before operation,the value ofplatelet and hemoglobin had no significantly change after 3 d of operation.But the PT was increased (P ＜ 0.05).After 3 d of operation,there was no statistical significance on platelet and hemoglobin between two groups.But the PT value of observation was higher than that of control group (P ＜ 0.05).After 1 h operation,there was no statistical significance on D-dimer,Hcy,and hs-CRP between two groups.Compared with the value after 1 h of operation,the values of D-dimer,Hcy,and hs-CRP were decreased significantly (P ＜ 0.05).And the indexes of observation group were lower than those of control group (P ＜ 0.05).After 1 months of operation,although there was no statistical significance on complications between two groups,the incidence rate of secondary bleeding and DVT of control group was higher than that of the observation group.Conclusion The rivaroxaban could prevent DVT well,which is suitable for the anticoagulation therapy after lower extremity of large orthopedic operation with little influence on platelet and hemoglobin.It is worthy of clinical application.

Patrón tromboelastográfico en pacientes anticoagulados con rivaroxabán por fibrilaciónauricular / Thromboelastographic pattern in anticoagulated patients with rivaroxaban due to atrialfibrillation

Resumen Introducción: La fibrilación auricular es la arritmia más frecuente y se asocia con mayor riesgo de eventos tromboembólicos, que requieren tratamiento anticoagulante. En la actualidad no existe un examen que permita monitorizar el rango terapéutico cuando se usan nuevos anticoagulantes. Objetivo: Describir los patrones tromboelastográficos en los pacientes con fibrilación auricular que reciben terapia de anticoagulación con rivaroxabán del servicio de Cardiología del Hospital Universitario Fundación Santa Fe de Bogotá. Materiales y métodos: En este estudio de corte transversal se recolectaron los datos correspondientes a 30 pacientes con fibrilación auricular que recibieron tratamiento anticoagulante con rivaroxabán a partir del 10 de julio de 2013 hasta el 06 de enero de 2015. Se describieron las características generales de la muestra, así como de los parámetros obtenidos por medio del tromboelastograma, y se compararon los patrones de tromboelastografía de acuerdo con la dosis del anticoagulante. Resultados: La edad promedio fue 75,8 a˜nos y la principal indicación de anticoagulación fue la fibrilación auricular paroxística (56,67%). En más del 60% de los pacientes se obtuvo un tiempo de reacción prolongado y un índice de coagulación bajo. El resto de parámetros del tromboelastograma se encontraban dentro del rango normal en la mayoría de los casos. No hubo diferencias estadísticamente significativas en los parámetros del tromboelastograma al comparar la dosis de rivaroxabán de 15 mg versus 20 mg. Conclusión: El patrón tromboelastográfico obtenido en la mayoría de pacientes del estudio se caracterizó por un tiempo de reacción alto y un índice de coagulación bajo, posiblemente debido al efecto del inhibidor del factor Xa.

Abstract Introduction: Atrial fibrillation is the most common arrhythmia, and it is associated with a higher risk of thromboembolic events requiring anticoagulation therapy. Nowadays there is no test that allows monitoring the therapeutic range when using new anticoagulants. Motivation: To describe thromboelastographic patterns in patients with atrial fibrillation who are taking anticoagulants with rivaroxaban in the Cardiology Department at the University Hospital Fundación Santa Fe de Bogotá. Material and methods: The present cross-sectional study collected data relating to 30 patients with atrial fibrillation who received anticoagulation therapy with rivaroxaban between July 10th 2013 and January 6th 2015.General characteristics of the sample, as well as paramametres obtained from the thromboelastography, and they were compared to the thromboelastographic patterns according to the anticoagulant dose. Results: Average age was 75.8 years and the main indication for anticoagulation therapy was paroxysmal atrial fibrillation (56.67%). In more than 60% of patients a prolonged reaction time and low coagulation index was obtained. The remaining parametres from the thromboelastography were located within the normal range in most cases. No statistically significant differences were found in thromboelastographic patterns when comparing the 15 mg versus 20 mg rivaroxaban dose. Conclusion: Thromboelastographic patterns obtained in most study participants were characterized by a high reaction time and low coagulation index, possibly due to the effect of the factor Xa inhibitor.