Family History Of Venous Thromboembolism Research Articles

P126 Use of oral contraceptives in females with rheumatoid arthritis is not associated with an increased risk of venous thromboembolism: United Kingdom-population based study

Abstract Background/Aims While the use of oral contraceptives in females with immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) is acknowledged as a risk factor for venous thromboembolism (VTE), the interaction between oral contraceptive use and RA is poorly understood. In a large population-based study, we aimed to estimate RA-attributable VTE risk in females using oestrogen contraceptives and/or on hormone replacement therapy (HRT). Methods Females registered with a general practice from January 1999 to December 2018 were identified from the Royal College of General Practitioners Research (RCGP) and Surveillance Centre (RSC) database. Female RA patients and VTE outcome (composite of pulmonary embolism and deep vein thrombosis) were determined using previously-validated algorithms. Female unaffected controls (UCs) were matched 4:1 with RA patients by current age (per year), calendar time, and years since practice registration using nearest neighbour matching, with replacement. Absolute VTE rates over 20 years were compared in RA patients versus matched UCs, overall and in two different subgroups defined by the use of oestrogen contraceptives or HRT. Relative VTE risk over the same period was estimated using Cox proportional hazards models adjusted for sociodemographic and clinical features and established VTE risk factors (BMI [body-mass index], smoking status, alcohol use, evidence of reduced mobility, thrombophilia, fracture of the lower limb and family history of VTE). Results A total of 82,082 female adults were included in this study, of whom 16,634 were RA patients and 65,448 were UCs. Average study follow-up was 8.3 years (standard deviation [SD]=6.2 years). Female RA patients (mean age 58.3, SD 16.5; mean BMI 27.0, SD 5.9) were similar to matched UCs in their clinical characteristics. Compared to UCs, females with RA were less likely to receive oral contraceptives (RA n = 545 [3.3%], UCs n = 2,542 [3.9], p < 0.001) but more likely to receive HRT (RA n = 752 [4.5%], UCs n = 2,460 [3.8], p < 0.001). Unadjusted VTE events rates were consistently higher in females with RA compared to UCs (430.2 per 100,000 person-years [py], 95% confidence interval [CI]: 396.1, 466.3; UC: 260.5 per 100,000 py, 95%CI: 247.1, 274.4) and in those receiving and not receiving oral contraceptives and HRT. Overall, relative risk of VTE was 52% higher in females with RA compared UCs (adjusted hazard ratio [aHR]= 1.52, 95%CI: 1.36, 1.71, p < 0.001). Compared to UCs, relative risk increases were not statistically significant for females with RA receiving oral contraceptives (aHR 1.43; 95%CI 0.60, 3.63, p = 0.46) and HRT (aHR 2.32; 95%CI 0.92, 5.85, p = 0.08). Conclusion UK data suggest that all women with RA are at a similarly increased risk of VTE irrespective of the use of oestrogen contraceptives or HRT, although larger studies are needed to confirm this finding. It is therefore advisable to conduct routine VTE risk factor assessments for all females with RA. Disclosure J. Galloway: Honoraria; JG has received honoraria from Abbvie, Biovitrum, BMS, Celgene, Chugai, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, Sobi and UC. V. Basey: Corporate appointments; Pfizer employee. A. Barkaway: Corporate appointments; Pfizer employee. S. de Lusignan: Grants/research support; SdeL has received funding through his universities from Eli Lilly, GSK, Astra Zeneca, MSD, Sanofi, Seqirus, Takeda and Moderna. Other; Director of the RCGP RSC. M.H. Buch: Consultancies; M.H.B. has provided expert advice and received/paid to employer consultant fees from AbbVie, Eli Lilly, EMD serono, Gilead, Pfizer and Sanofi. Grants/research support; .H.B. has received research grants paid to her employer from Gilead Ltd, Pfizer Ltd, Roche and UCB.

P052 Rheumatoid arthritis associated risk of venous thromboembolism is not dependent on disease duration: United Kingdom-based population study

Abstract Background/Aims Risk of venous thromboembolism (VTE) is higher in patients with rheumatoid arthritis (RA) compared to the general population; however, whether this risk changes with RA disease duration remains poorly understood. Acknowledging potential heterogeneity in risk by RA duration could support more tailored screening and effective preventive approaches. In a large population-based study, we aimed to characterise the RA-attributable VTE risk in patients with varying disease durations. Methods Adults registered with a general practice from January 1999 to December 2018 were identified from the Royal College of General Practitioners Research (RCGP) and Surveillance Centre (RSC) primary care database. RA patients (diagnosed prior to and during the study period), VTE outcome (as a composite of pulmonary embolism [PE] or deep vein thrombosis [DVT]) and individual PE and DVT outcomes were determined using previously validated algorithms. RA-unaffected controls (UCs) were matched 4:1 with RA patients by current age, sex, calendar time, and years since practice registration using nearest neighbour matching with replacement. Absolute VTE, PE and DVT rates over 20 years were compared in RA patients versus matched UC across four subgroups defined by disease duration (0-2, 2-5, 5-10 and ≥10 years since diagnosis). Across the same subgroups, relative risks over the same period were estimated using Cox proportional hazards models adjusted for sociodemographic and clinical features and established VTE risk factors (body-mass index [BMI], smoking status, alcohol use, evidence of reduced mobility, thrombophilia, fracture of the lower limb and family history of VTE). Results 117,050 individuals were included, of whom 93,640 were UCs and 23,410 were RA patients. Among those with RA, 63.9% were included at or within two years of diagnosis, 7.8% within two to five years of diagnosis, 9.8% within five to ten years of diagnosis, and 18.5% more than 10 years after diagnosis. Average study follow-up for the primary outcome (VTE) was 8.2 years (standard deviation [SD]=6.6 years). RA patients (mean age 59.0, SD 15.5; 28.9% male [n = 6776]; mean BMI 27.1, SD 5.6) were similar to matched UCs in clinical characteristics. Unadjusted VTE events rates were consistently higher in RA patients compared to UCs across all subgroups. Relative risk of VTE was similarly increased in RA patients compared to the general population regardless of the time elapsed since RA diagnosis (adjusted hazard ratios [aHR] range: 1.49-1.63, all p < 0.001). The results obtained when PE (aHR range 1.46-2.02, all p < 0.001) and DVT (aHR range 1.43-1.89, all p < 0.001) were analysed separately were similar to those observed in the composite outcome. Conclusion Healthcare professionals should recognize that individuals with RA face a consistently elevated VTE risk compared to the general population, irrespective of disease duration. This highlights the need for vigilant monitoring and assessment of VTE risk factors even in early-stage cases. Disclosure J. Galloway: Honoraria; JG has received honoraria from Abbvie, Biovitrum, BMS, Celgene, Chugai, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, Sobi and UC. V. Basey: Corporate appointments; Pfizer employee. S. Rana: Corporate appointments; Pfizer employee. S. de Lusignan: Grants/research support; SdeL has received funding through his universities from Eli Lilly, GSK, Astra Zeneca, MSD, Sanofi, Seqirus, Takeda and Moderna. Other; Director of the RCGP RSC. M.H. Buch: Consultancies; M.H.B. has provided expert advice and received/paid to employer consultant fees from AbbVie, Eli Lilly, EMD serono, Gilead, Pfizer and Sanofi. Grants/research support; M.H.B. has received research grants paid to her employer from Gilead Ltd, Pfizer Ltd, Roche and UCB.

OA38 Venous thromboembolism risk is consistently increased in people with rheumatoid arthritis across different ages, sexes and obesity status: United Kingdom population-based study

Abstract Background/Aims Risk of venous thromboembolism (VTE) is increased in people with rheumatoid arthritis (RA) when compared to the general population, but the variation of this risk among patients is not well understood. Acknowledging the heterogeneity in RA-attributable VTE risk could support tailoring of treatment plans and screening protocols based on an individual’s specific risk profile. In a large population-based study, we aimed to evaluate for variation in RA-attributable VTE risk by age, sex and body-mass index (BMI). Methods Adults registered with a general practice from January 1999 to December 2018 were identified from the Royal College of General Practitioners Research (RCGP) and Surveillance Centre (RSC) primary care database. RA patients and VTE outcome (composite of pulmonary embolism and deep vein thrombosis) were determined using previously validated algorithms. RA-unaffected controls (UCs) were matched 4:1 with RA patients by current age, sex, calendar time, and years since practice registration using nearest neighbour matching with replacement. Absolute VTE rates over 20 years were compared in RA patients versus matched UCs, overall and by age category (18-49, 50-69, ≥70), sex, and BMI category (BMI <25, 25-29.9, ≥30). Across the same subgroups, relative VTE risk over the same period was estimated using Cox proportional hazards models adjusted for sociodemographic and clinical features and established VTE risk factors (BMI, smoking status, alcohol use, evidence of reduced mobility, thrombophilia, fracture of the lower limb and family history of VTE). Results 117,050 individuals were included, of whom 23,410 were RA patients and 93,640 were UCs. Average follow-up was 8.2 years (standard deviation [SD]=6.6 years). RA patients (mean age 59.0, SD 15.5; 28.9% male [n = 6776]; mean BMI 27.1, SD 5.6) were similar to matched UCs in clinical characteristics. Unadjusted VTE events rates were consistently higher in RA patients compared to UCs overall and across all subgroups (overall rates RA: 442.4 per 100,000 person-years [py], 95% confidence interval [CI]: 413.0, 473.2; UC: 262.2 per 100,000 py, 95%CI: 251.9, 273.9); subgroup rates). Similarly, overall relative VTE risk was 46% higher in people with RA compared to UCs (adjusted hazard ratio [aHR]= 1.46, 95%CI: 1.36, 1.56; p < 0.001), and was consistently higher across age-, sex- and BMI-defined subgroups (aHR range: 1.34-2.13, all p < 0.001). Although relative risk was highest in RA patients under 50 years (aHR= 2.13, 95%CI: 1.62-2.79; p < 0.001), this patient subgroup had the lowest absolute risk of VTE (approximately 2.2- and 3.4-fold lower than that observed in those aged 50-69 and ≥70, respectively). Conclusion Clinicians should be aware that risk of VTE is consistently higher in people with RA compared to the general population, regardless of age, sex and BMI. Findings suggest close monitoring and assessment of VTE risk factors is required even in younger individuals with RA. Disclosure J. Galloway: Honoraria; JG has received honoraria from Abbvie, Biovitrum, BMS, Celgene, Chugai, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, Sobi and UC. V. Basey: Corporate appointments; Pfizer employee. M. Mclean: Corporate appointments; Pfizer employee. S. de Lusignan: Grants/research support; SdeL has received funding through his universities from Eli Lilly, GSK, Astra Zeneca, MSD, Sanofi, Seqirus, Takeda and Moderna. Other; Director of the RCGP RSC. M.H. Buch: Consultancies; M.H.B. has provided expert advice and received/paid to employer consultant fees from AbbVie, Eli Lilly, EMD serono, Gilead, Pfizer and Sanofi. Grants/research support; M.H.B. has received research grants paid to her employer from Gilead Ltd, Pfizer Ltd, Roche and UCB.

New recommendations on cerebral venous and dural sinus thrombosis from the German consensus-based (S2k) guideline

Over the last years, new evidence has accumulated on multiple aspects of diagnosis and management of cerebral venous and dural sinus thrombosis (CVT) including identification of new risk factors, studies on interventional treatment as well as treatment with direct oral anticoagulants. Based on the GRADE questions of the European Stroke Organization guideline on this topic, the new German guideline on CVT is a consensus between expert representatives of Austria, Germany and Switzerland. New recommendations include:• CVT occurring in the first weeks after SARS-CoV-2 vaccination with vector vaccines may be associated with severe thrombocytopenia, indicating the presence of a prothrombotic immunogenic cause (Vaccine-induced immune thrombotic thrombocytopenia; VITT).• D-dimer testing to rule out CVT cannot be recommended and should therefore not be routinely performed.• Thrombophilia screening is not generally recommended in patients with CVT. It should be considered in young patients, in spontaneous CVT, in recurrent thrombosis and/or in case of a positive family history of venous thromboembolism, and if a change in therapy results from a positive finding.• Patients with CVT should preferably be treated with low molecular weight heparine (LMWH) instead of unfractionated heparine in the acute phase.• On an individual basis, endovascular recanalization in a neurointerventional center may be considered for patients who deteriorate under adequate anticoagulation.• Despite the overall low level of evidence, surgical decompression should be performed in patients with CVT, parenchymal lesions (congestive edema and/or hemorrhage) and impending incarceration to prevent death.• Following the acute phase, oral anticoagulation with direct oral anticoagulants instead of vitamin K antagonists should be given for 3 to 12 months to enhance recanalization and prevent recurrent CVT as well as extracerebral venous thrombosis.• Women with previous CVT in connection with the use of combined hormonal contraceptives or pregnancy shall refrain from continuing or restarting contraception with oestrogen–progestagen combinations due to an increased risk of recurrence if anticoagulation is no longer used.• Women with previous CVT and without contraindications should receive LMWH prophylaxis during pregnancy and for at least 6 weeks post partum.Although the level of evidence supporting these recommendations is mostly low, evidence from deep venous thrombosis as well as current clinical experience can justify the new recommendations.This article is an abridged translation of the German guideline, which is available online.

Venous thromboembolism and amyotrophic lateral sclerosis: the Venous Thrombo-Embolism and Sclerosis Lateral Amyotrophic study

BackgroundAmyotrophic lateral sclerosis (ALS) is a severe neurodegenerative disease. Given the inflammatory nature of ALS and the high number of ALS-related clinical circumstances (eg, prolonged immobilization and infections), patients with ALS may have a high risk of venous thromboembolism (VTE). ObjectivesTo determine the annual incidence rate of VTE and the predictors of VTE in patients with ALS. MethodsWe analyzed a prospective cohort of patients with ALS diagnosed between 2009 and 2019 followed in the Brest University Hospital ALS Centre. ResultsAmong 227 patients with ALS, VTE occurred in 19 patients during a median follow-up period of 717 days (IQR, 488-1308), yielding an annual incidence rate of 2.93% (95% CI, 1.88%-4.53%). Predictors for VTE were a family history of VTE (hazard ratio [HR], 15.24; 95% CI, 1.72-134.84; P = .01), the presence of noninvasive ventilation at ALS diagnosis (HR, 6.98; 95% CI, 1.09-44.59; P = .04) and a short time (ie, <213 days) between first symptoms and ALS diagnosis (HR, 5.48; 95% CI, 1.57-19.11; P = .01). Recurrent VTE occurred within 3 months after stopping anticoagulation in 5 patients (26.3%). ConclusionThe annual incidence of VTE in patients with ALS is high. Predictive factors of VTE were a VTE history, noninvasive ventilation, and a short time between first symptoms of ALS and ALS diagnosis.

Comparing U.S. and Canadian treatment patterns on venous thromboembolism outcomes in the GARFIELD-VTE registry

BackgroundEconomically developed countries continue to find that venous thromboembolism (VTE) is a major cause of morbidity and mortality. ObjectiveTo compare baseline risk profiles and patient workflow patterns between the United States (U.S.) and Canadian management of VTE patients from 2014 to 2017. MethodsThe Global Anticoagulant Registry in the FIELD (GARFIELD-VTE) is a prospective, observational study of 10,679 patients with objectively confirmed VTE, followed for 3 years. In total 1101 patients enrolled in the U.S. and Canada were included in this analysis. ResultsMedian age and body mass index were comparable between the U.S. (60.5; 30.2) and Canadian (59.7; 29) patients. A higher percentage of U.S. patients were black (n = 128, 24.1 %; n = 22, 3.9 %) and had a higher VTE-associated risk profile, including immobilization, hospitalization, and recent surgery. U.S. patients had a higher combined DVT and PE primary diagnoses (20.3 %) and were more likely to be treated in hospitals (77.2 %) than Canadians (13.3 %; 48.1 %). Direct oral anticoagulant therapy (DOAC) was nearly two-fold more frequent in Canadian patients (n = 218, 39.2 %) at the end of 3 years in comparison to the U.S. (n = 118, 23.0 %). Adjusted for sex, recent bleed event, heart failure, chronic immobilization, family history of VTE, history of cancer and prior VTE, and renal insufficiency, the risk of all-cause mortality was 51.9 % higher in patients from the U.S. compared to those in Canada after 3 years. Patients from the U.S. also had a higher likelihood of hospitalization, major bleeding, and recurrent VTE after controlling for prior history and comorbid conditions. ConclusionHigher rates of adverse VTE-associated outcomes in the U.S. may be attributed to different baseline risk profiles, facility care, and distribution of specialists and their subsequent treatment strategies. Type of researchGlobal, multicentre, non-interventional, prospective registry titled Global Anticoagulant Registry in the FIELD – Venous Thromboembolism (GARFIELD-VTE). Key findings531 U.S. and 557 Canadians patients included in study. DOAC use more frequent in Canadian patients after 3 years than U.S. (39.2 % vs. 23.0 %, respectively). Adjusted for sex, recent bleed event, heart failure, chronic immobilization, family history of VTE, history of cancer and prior VTE, and renal insufficiency, all-cause mortality risk remained higher in U.S. patients vs. Canadian patients after 3 years. U.S. patients had higher likelihood of hospitalization, major bleeding, and recurrent VTE. Take-home messageHigher rates of adverse VTE-associated outcomes in the U.S. may be attributed to different baseline risk profiles, facility care, and composition of specialists and their subsequent treatment strategies. Table of contents summaryGlobal, multicentre, non-interventional, prospective registry titled Global Anticoagulant Registry in the FIELD – Venous Thromboembolism (GARFIELD-VTE). Higher rates of adverse VTE-associated outcomes were observed in U.S. patients vs Canadian patients, which may be attributed to different baseline risk profiles, facility care, and distribution of specialists and their subsequent treatment strategies.

Case Report on Challenging Deep Vein Thrombosis

In pregnancy, venous thromboembolism (VTE) remains a leading cause of direct maternal mortality. It is approximatelyfive times more common in pregnant women, with an incidence of 0.5-2 in 1000. The highest risk of deep venous thrombosis(DVT) leading to pulmonary embolism (PE) is during the postnatal period, especially after a cesarean section. A clinician who doesnot treat pregnant women regularly may not routinely identify pregnancy-specific risk factors for VTE. In patients with DVT,treatment with anticoagulation is associated with a high risk of bleeding during the immediate postpartum state, and patients dowell with monitored anticoagulation and proper supportive treatment, as described in this case report. We are reporting a caseof a 20-year-old primigravida who presented with labor pains at 39 (+6) weeks of gestation at Sree Balaji Medical College andHospital, Chrompet, Chennai. The patient had no comorbidities and did not report any past or family history of VTE. An emergencycesarean section was performed due to fetal distress, and on the first postoperative day, she developed swelling pain andtenderness in the left lower limb. Color Doppler ultrasound showed left anterior tibial vein thrombosis, following whichanticoagulant therapy was started with low molecular weight heparin. The patient was closely monitored for signs of bleeding orPE and was eventually discharged on oral anticoagulation. In conclusion, all women should be assessed for the risk factors of DVTduring the antenatal period, and early ambulation in the postoperative period is crucial to prevent such deadly complications.

Features of disorders and methods of correction of the hemostasis system in women with antenatal fetal death

The improvement of the providing medical services quality to pregnant women remains an urgent issue in modern obstetrics. Women with perinatal losses deserve special attention, especially in the second half of pregnancy. Changes in the hemostasis system are an integral part of the development of pregnancy. The tendency to hypercoagulation has significant pathogenetic significance and can be the cause of a number of complications – miscarriage in the I trimester of pregnancy and preeclampsia, premature birth, antenatal fetal death (AFD) – in the II and III trimesters of pregnancy. Also, pregnancy is a background process for the activation of a number of diseases, in particular hereditary thrombophilia.The objective: to evaluate the changes in the hemostasis system in women with antenatal fetal death and the effectiveness of the use of low molecular weight heparins for the correction of disorders in the hemostasis system in this category of patients during childbirth and in the postpartum period.Materials and methods. 72 women were examined, including 42 pregnant women with AFD (main group) and 30 pregnant women with a physiological course of pregnancy, childbirth and the postpartum period (control group). The state of the hemostasis system was studied using a standard coagulogram. D-dimer was determined by immunoturbometric analysis.To assess the state of the hemostasis system, the following biochemical tests were used: procoagulant link – fibrinogen content and indicators: prothrombin index, activated partial thrombin time (APTT), thrombin time (TP), ancistrone time (AT), soluble fibrinogen-monomer complex (SFMC), factor X (FX); to evaluate the antithrombin system, the content of antithrombin-III (AT-III), protein C were determined; to characterize the state of the fibrinolytic system – the amount of plasminogen, α2-antiplasmin, fibrinogen degradation products (FDC).Thrombophilia markers and antiphospholipid antibodies were also determined. The preference was given to vaginal childbirth. During childbirth, mechanical compression of the lower limbs was applied using special compression stockings (compression level 2). In 12 hours after delivery thromboprophylaxis with low molecular weight heparins was started, the drug of choice being enoxaparin sodium. After 48 hours of the postpartum period, a comparative analysis of coagulogram indicators was performed to further determine the timing of thromboprophylaxis.Results. Analysis of family thrombotic anamnesis revealed risk factors in 12 (28.6%) patients of the main group. In close relatives of the first line, the presence of peripheral vein thrombosis was found – 5 (41.7%) cases, myocardial infarction under the age of 45 – 3 (25.0%) cases, pulmonary embolism – 1 (8.3%) case, transient ischemic attack of the brain – 3 (25.0%).In the control group only 2 (6.6%) patients had a family history of venous thromboembolism in first-line relatives. The analysis of the coagulation system shows significantly higher fibrinogen values (the main group – 5.3±0.2 g/l, the control group – 4.3±0.1 g/l; p&lt;0.05), functional FX activity (the main group – 149.3±3.1%, control group – 107.3±2.7%; p&lt;0.05), SFMC (main group – 15.9±1.2 μg/ml, control group – 7.8±0.9 μg/ml; p&lt;0.05) and D-dimer (main group – 4.4±0.25 μg/ml, control group – 0.7±0.2 μg/ml; p&lt; 0.05) in pregnant women of the main group. An increase in these indicators is a predictor of thrombus formation, activation of blood coagulation by the internal pathway with a decrease in the antithrombin reserve due to FX.During the correlation analysis, a strong direct relationship (r=0.8633) was established between the indicators of SFMC and FX in the blood serum of pregnant women of the main group, the combination of which determines the tendency to clot formation. Determination of markers for the most common types of thrombophilia shows the dominance of hereditary forms (prothrombin, Leiden mutation, MTHFR) in 43% of pregnant women of the main group.The implementation of the proposed treatment approach contributed to a significant decrease in the average concentration of fibrinogen 48 hours after delivery in postpartum women of the main group (main group: before delivery – 5.3±0.2 g/l, after 48 hours after delivery – 3.9±0.3 g/l; control group: 48 hours after delivery – 3.2±0.2 g/l; p&lt;0.05) in combination with a synergistic decrease in the average indicators of SFMC (main group: before delivery – 15.9±1.2 μg/ml, 48 hours after delivery – 6.2±0.2 μg/ml; control group: 48 hours after delivery – 5.4±0.3 μg/ml; p&lt;0.05) and FX (main group: before delivery – 149.3±3.1%, after 48 hours after delivery – 103.1±3.6%; control group: after 48 hours after delivery – 117.1±4.1%; p&lt;0.05).Conclusions. Increased coagulation function was confirmed in pregnant women with antenatal fetal death (AFD). Thanks to the proposed method of correcting disorders in the hemostasis system, a decrease in the frequency of postpartum thromboembolism in women with AFD is achieved, as well as an improvement in the main indicators of the hemostasis system. This prevents the emergence of a chronic form of the syndrome of disseminated intravascular blood coagulation which is developed in the cases of AFD.

Development of a predictive model of venous thromboembolism recurrence in anticoagulated cancer patients using machine learning

IntroductionPatients with cancer and venous thromboembolism (VTE) show a high risk of VTE recurrence during anticoagulant treatment. This study aimed to develop a predictive model to assess the risk of VTE recurrence within 6 months at the moment of primary VTE diagnosis in these patients. Materials and methodsUsing the EHRead® technology, based on Natural Language Processing (NLP) and machine learning (ML), the unstructured data in electronic health records from 9 Spanish hospitals between 2014 and 2018 were extracted. Both clinically- and ML-driven feature selection were performed to identify predictors for VTE recurrence. Logistic regression (LR), decision tree (DT), and random forest (RF) algorithms were used to train different prediction models, which were subsequently validated in a hold-out data set. ResultsA total of 16,407 anticoagulated cancer patients with diagnosis of VTE were identified (54.4 % male and median age 70). Deep vein thrombosis, pulmonary embolism and metastases were observed in 67.2 %, 26.6 %, and 47.7 % of the patients, respectively. During the study follow-up, 11.4 % of the patients developed a recurrent VTE, being more frequent in patients with lung cancer. Feature selection and model training based on ML identified primary pulmonary embolism, deep vein thrombosis, metastasis, adenocarcinoma, hemoglobin and serum creatinine levels, platelet and leukocyte count, family history of VTE, and patients' age as predictors of VTE recurrence within 6 months of VTE diagnosis. The LR model had an AUC-ROC (95 % CI) of 0.66 (0.61, 0.70), the DT of 0.69 (0.65, 0.72) and the RF of 0.68 (0.63, 0.72). ConclusionsThis is the first ML-based predictive model designed to predict 6-months VTE recurrence in patients with cancer. These results hold great potential to assist clinicians to identify the high-risk patients and improve their clinical management.

Venous thromboembolism in women of childbearing age: insights from the START registry.

Women of childbearing age are exposed to venous thromboembolic risk mainly for pregnancy and use of oral contraceptives. The impact of risk factors (RF) on venous thromboembolism (VTE) in these circumstances is still unclear. In the context of START registry, we aimed to investigate the weight of a series of RF on the occurrence of pregnancy- or combined oral contraceptive (COC)-associated VTE. We selected all women included in the START for VTE occurred between 18-42 years and compared those with a first or recurrent pregnancy/postpartum- (group A) or COC-VTE (group B) with those who had VTE outside these circumstances (group C). Final analysis included a cohort of 532 women. Follow-up data showed that there were no significant differences between the groups in terms of thrombotic and haemorrhagic complications. As for pregnancy-associated VTE, the overall outcome was good in terms of both maternal and fetal prognosis. In a binary model of logistic regression, correcting for potential confounders, VTE family history conferred a significant and independent higher risk of COC-VTE compared with group C. Similarly, comparison between group A and C documented that family history significantly affected the risk of pregnancy-associated VTE. VTE in the group C was significantly associated with older age. Lastly, smoke was a significant risk factor for pregnancy/postpartum VTE when group A and group B were compared. Present data suggest that in the setting of fertile women, family history of VTE has a greater role in predicting COC- and pregnancy/postpartum- VTE than outside these circumstances.

How to Evaluate and Choose the Proper Treatments for Patients with Lower Extremity Venous Disease

With an increasing number of interventional and noninterventional treatment options available for venous disorders, it is important that patients undergo a thorough and systematic evaluation. Clinical evaluation should include a personal and family history of venous thromboembolism (VTE), varicose veins, and thrombophilia as these factors affect response and recurrence of disease. Patient should undergo diagnostic and quality of life assessment using validated tools to monitor response to treatment. Duplex ultrasound, both deep and superficial veins, documenting both obstruction and reflux is initial imaging with CT and MRI indicated to document pelvic, iliac vein, and IVC patency and pathology. Conservative therapy including compression, healthy lifestyle with diet, and exercise. New and novel interventional therapies are available for patients with venous disease with recent randomized controlled trials and multisocietal guidelines providing evidence-based recommendations for patients with superficial and deep venous disease. Since the use of anticoagulant and antiplatelet therapies post venous intervention is not well studied nor standardized, patients should routinely undergo evaluation for ongoing risk of recurrent thrombosis and stent occlusion. Finally, patients should be counseled that superficial and deep venous disease is a chronic and often progressive disease, and follow-up at least annually is recommended.

Pregnant and puerperal women's knowledge and awareness of venous thromboembolism: a medical of things survey technique

Pregnant women are at a higher risk of venous thromboembolism (VTE) during pregnancy and postpartum. Coronavirus disease 2019 (COVID-19) infection increases the risk of VTE. This study aimed to assess pregnant and puerperal women’s knowledge and awareness of VTE. The study included 403 females at the maternity hospital in the Al-Ahsa region, Saudi Arabia. All participants were chosen by convenience sampling technique and interviewed about their bio-demographic, clinical, and gynecological data, personal and/or family history of VTE, history of thromboprophylaxis, and knowledge about deep vein thrombosis (DVT) and pulmonary embolism (PE). The results of the study revealed that 284 (70.5%) of the participants had poor knowledge about DVT, and only 119 (29.5%) had a good level of knowledge, with a mean score of 8.7 out of 20. Although VTE prevalence has increased due to COVID-19 and its complications, the study results showed a lack of knowledge and poor awareness of VTE among 70.5% of the study participants. The education of women regarding VTE should be improved, especially among pregnant females. More patient education and public education campaigns are needed to increase public awareness of VTE, especially during the COVID-19 pandemic.

Incidence of VTE in Pregnant Women with Sickle Cell Gene Mutation(s): A Retrospective Database Analysis

Purpose/Objective(s): The leading cause of pregnancy-associated mortality in Western countries is venous thromboembolism (VTE) with an absolute incidence of 0.025 to 0.1 percent in the general pregnant population. Noubiap et al reported that sickle cell disease (SCD) patients had a significantly higher risk for VTE (pooled OR 4.4, 95%CI 2.6-7.5, p < 0.001), deep vein thrombosis (DVT) (OR 1.1, 95% CI 1.1-1.2, p < 0.001) and pulmonary embolism (PE) (pooled OR 3.7, 95% CI 3.6-3.8, p < 0.001) as compared to patients without SCD [1]. Although sickle cell trait (SCT) and SCD have an increased risk for VTE, the incidence of VTE during pregnancy has not been documented. Our primary objective was to record a composite incidence of VTE among pregnant patients with SCT/SCD. Material/Methods: A retrospective, cross-sectional analysis including pregnant patients with SCT and SCD was conducted at our tertiary care academic medical center. Data was collected between January 2011 and December 2020. Adult women up to 51 years old with hemoglobin electrophoresis proven SCT and SCD were included. Risk factors for VTE such as the patient's body mass index (BMI), COVID status, family history of VTE, and smoking history were included in the analysis. ANOVA and Chi-square tests were used for analysis and to calculate a composite incidence, odds ratio, confidence interval, and p-value. A p-value of <0.05 was considered statistically significant. Data was analyzed using the SAS system. Results: A total of 139 pregnant SCT/SCD patients were included for analysis, out of which, the majority of the patients were SCT (84/139, 60.4%). The mean age at pregnancy was 26.42 (standard deviation 5.72). The type of VTE included DVT 58.3% (14/24) and PE 41.7% (10/24). At our facility, the incidence rate of VTE in pregnancy for SCT/SCD was 17% as compared to 0.025 to 0.1% in the general population. There was no statistically significant difference in the odds of developing VTE between SCD and SCT (OR= 1.09, 95% CI [.45, 2.63]). Only 2.16% of patients had positive COVID infection, as most of the collected data predated the pandemic. Almost one-third of the patients were smokers (45/139) and only 2.88% (4/139) had a family history of VTE. BMI was divided into BMI <30 (38.13%, 53/139) and BMI >30 (61.87%, 86/139). Obesity (OR= 1.03, 95% CI [.4166, 2.56]) and COVID status (OR=2.45, 95% CI [.21, 28.23]) were not found to be significant in our population of patients. Patients with a family history of DVT had a greater odd of developing VTE (OR=50.70, 95% CI [2.63, 977.88]), although the sample may not provide a precise representation of the population mean. Conclusion: Currently, ASH guidelines recommend a conservative approach to VTE prophylaxis unless research suggests benefits [2]. Our analysis found a 17% incidence of pregnancy-associated VTE in our SCT/SCD patients, which is drastically higher than the general population. With such a significant increased incidence in this patient population, especially with current racial disparities in African American maternal mortality rates, more research should be conducted to evaluate the need for thromboprophylaxis/treatment. Additionally, evaluation for specific SCT/SCD guidelines and recommendations to decrease pregnancy-related VTE and mortality rates should be discussed.

LEAP Pilot: Low Molecular Weight Heparin Vs. Aspirin Postpartum

Background Expert opinion from the American Society for Hematology (ASH), the Royal College of Obstetricians and Gynecologists, UK, as well as the 'Society of Obstetricians and Gynecologists of Canada guidelines recommend a minimum of 6 weeks of prophylactic LMWH for patients with a history of venous thromboembolism (VTE) or high-risk thrombophilia. There are no randomized controlled trials (RCTs) determining the optimal duration of anticoagulation postpartum. A 2014 Cochrane review concluded that there is insufficient evidence on which to base thromboprophylaxis in the pregnancy postpartum setting, and high-quality randomized trials are warranted. Clinical trials and meta-analyses have suggested that ASA administered daily post-operatively may be non-inferior to LMWH for VTE prophylaxis; (RR 0.76; 95% CI, 0.37- 1.56 in one study), with a similar safety profile. Furthermore, in 2018 Anderson et al. demonstrated clinical safety and non-inferiority of a combination of 5 days of rivaroxaban followed by 81mg of ASA for 30 days after total hip arthroplasty and 9 days after total knee arthroplasty. The principal question to be addressed in a large definitive randomized controlled trial (RCT) is whether a combination of prophylactic LMWH for 3 weeks followed by low-dose ASA for the following 3 weeks is non-inferior to the standard of care of prophylactic LMWH for 6 weeks postpartum. This single-center pilot RCT addresses enrollment, adherence and feasibility required prior to conducting a definitive trial. Study Design and Methods Inclusion criteria: 1) Personal history of VTE prior to pregnancy and not prescribed therapeutic anticoagulation 2) Family history of VTE and antithrombin deficiency, protein C or protein S deficiency 3) Combined thrombophilia or homozygous for factor V Leiden mutation or prothrombin gene mutation, regardless of family history. Sample size: 50 patients, 25 patients treated according to each strategy. Primary outcomes: 1) Enrollment/consent rate 2) Adherence to study protocol 3) Loss to follow-up/missing data. Secondary outcomes: 1) VTE rate 2) Bleeding rate three months following delivery 3) Quality of life assessment (QoL) (Duke Anticoagulation Satisfaction Scale). Results The enrollment rate was 69.2%, with 18 of 26 patients agreeing to participate. Of the 18 recruited, one was randomized in error, one had an early pregnancy loss, and one developed a superficial vein thrombosis antenatally due to non-compliance with antepartum anticoagulation, leaving 15 patients satisfying inclusion criteria. 9 patients have completed their 3-month postpartum follow-up, with no patients lost to follow-up. The adherence to treatment at 3 weeks was 96.4% and 94.0% in Group A (LMWH and ASA) and B (LMWH), respectively (p=0.7). At 6 weeks postpartum, there was a trend toward greater treatment compliance in Group A vs Group B (98.2 vs 94.1%); however, this was not statistically significant (p=0.52). With regards to secondary outcomes, there was no VTE documented in either treatment group. One patient in each group reported mild gingival bleeding. No other bleeding events were reported. The QoL assessment score in Group A improved by 56% following the change from LMWH to ASA (39.5 to 16.8), whilst it deteriorated in Group B by 2% (24.5 vs 25.2). At 6 weeks postpartum, the QoL score improved by 33.3% in Group A vs Group B (P=0.01). Conclusion Our data shows promising enrollment, adherence, loss to follow-up and feasibility of our ongoing pilot trial. The results of this study will be used to design first a multicenter pilot study then a large definitive multicentered trial. Demonstration of non-inferiority of ASA and LMWH to LMWH will lead to a shorter course of LMWH postpartum, potentially reducing bleeding risk, need for subcutaneous injections, as well as cost, while improving quality of life. If the definitive trial does not show non-inferiority, the results will provide evidence that six weeks of postnatal thromboprophylaxis with LMWH is warranted.

Immediate and delayed complications of inferior vena cava filters

ObjectiveInferior vena cava (IVC) filter placement has increased dramatically in the past two decades. However, literature supporting the efficacy of these devices has been limited and controversial. In the present study, we have evaluated the predictors and rates of technical complications after IVC filter insertion in a large national database. MethodsThe Vascular Quality Initiative registry was explored (January 2013 to December 2020). Immediate complications were defined as venous injury requiring treatment, filter misplacement (failure to open, deployed >20 mm from intended site or in wrong vein, embolized to the heart), angulation >20°, and insertion site complications. Delayed complications were defined as migration, angulation >15°, fracture, caval and/or iliac thrombosis, filter thrombus, fragment embolization, and perforation. The Pearson χ2 test was used to compare the baseline characteristics between the patients who had developed immediate and/or delayed complications and those who had not. The predictors of these complications were evaluated using multivariable logistic regression, Cox proportional hazard regression, and Kaplan-Meier survival analysis. ResultsA total of 14,784 patients were included in the present analysis, with a median follow-up of 11 months (interquartile range, 4-16 months). The rate of immediate and delayed complications was 1.8% and 3.1%, respectively. Angulation (1.2%) was the most common immediate complication, and filter thrombosis (1.6%) was the most common delayed complication. Compared with the patients with no immediate complications, those with immediate complications were more likely to have had abnormal anatomy (6.0% vs 1.7%; P < .001) and a landing zone other than infrarenal (7.0% vs 4.2%; P = .02). Compared with their counterparts, those with delayed complications were less likely to have received statins (21.0% vs 29.5%; P = .006) and were more likely to have a family history of venous thromboembolism (8.0% vs 5.1%; P = .047). Logistic regression analysis revealed that renal vein visualization was associated a 50% reduction (adjusted odds ratio [aOR], 0.50; 95% confidence interval [CI], 0.27-0.92; P = .027) in the odds of immediate complications and female sex and abnormal anatomy were associated with a 41% (aOR, 1.41; 95% CI, 1.08-1.85; P = .013) and 244% (aOR, 3.44; 95% CI, 1.66-7.16; P < .001) increase in the odds of immediate complications, respectively. Immediate (P = .21) and delayed (P = .51) complications did not result in increased mortality. ConclusionsThe immediate and delayed IVC filter complication rates were 1.8% and 3.1%, respectively, but the occurrence of complications was not associated with increased mortality. Female sex was associated with an increase in the development of immediate complications. The incidence of immediate complications might be mitigated if advanced imaging were used for renal vein visualization before IVC filter deployment. Delayed complications might be avoided if IVC filter retrieval were performed in a timely fashion and institutional retrieval protocols were optimized.

OUTCOMES FROM CATHETER-DIRECTED EMBOLECTOMY FOR INTERMEDIATE-RISK AND HIGH-RISK PULMONARY EMBOLISM

OUTCOMES FROM CATHETER-DIRECTED EMBOLECTOMY FOR INTERMEDIATE-RISK AND HIGH-RISK PULMONARY EMBOLISM

DELAYED ASPIRATION THROMBECTOMY OF SADDLE PULMONARY EMBOLISM IN A HEMODYNAMICALLY STABLE PATIENT

DELAYED ASPIRATION THROMBECTOMY OF SADDLE PULMONARY EMBOLISM IN A HEMODYNAMICALLY STABLE PATIENT

Assessment of Venous Thromboembolism Awareness Among Surgical Ward Patients in Makkah, Saudi Arabia: A Cross-Sectional Study

IntroductionVenous thromboembolism (VTE) is the leading source of morbidity and mortality among hospitalized patients in Saudi Arabia. Currently, there is no literature on VTE knowledge and awareness among hospitalized patients in Saudi Arabia’s western region. Consequently, this study aimed to investigate the hospitalized patients’ awareness and perceptions of VTE and associated thromboprophylaxis in surgical wards in Makkah, Saudi Arabia.MethodsA descriptive cross-sectional study was conducted on 301 patients who were admitted to the surgical ward in the Al-Noor Hospital for more than three days, between September and November 2021.ResultsThe study found that patients who had higher education levels, and who were currently or previously receiving pharmacological/non-pharmacological thromboprophylaxis had a significantly higher knowledge score regarding VTE (p = < 0.05). On the other hand, a non-significant relationship was found between knowledge scores and age, gender, the reason for admission, and personal or family history of VTE (p = > 0.05). Spearman’s correlation analysis also revealed a highly significant positive correlation between the patients’ knowledge and attitude scores (r=0.21, p=<0.001).ConclusionThis study revealed a lack of awareness among hospitalized patients about VTE, clinical presentation, and risk factors. Therefore, we encourage health care providers to educate patients about them.

Predicting recurrence of venous thromboembolism in anticoagulated cancer patients using real-world data and machine learning.

e18742 Background: The clinical predictors of venous thromboembolism (VTE) recurrence in patients with cancer are not well known. Our objective was to develop a predictive model for risk of VTE recurrence in anticoagulant-treated cancer patients within the first 6 months following VTE diagnosis. Methods: Using the EHRead technology, based on Natural Language Processing (NLP) and machine learning (ML), the unstructured clinical data in EHRs from 9 Spanish hospitals between 2014 and 2018 was extracted and analyzed. The study population, comprising all adult anticoagulated cancer patients with VTE, was downsampled to prevent bias and class imbalance. A total of 94 patient characteristics were explored, and Random Forest (RF) feature selection was performed to identify the most relevant predictors for VTE recurrence. Multiple algorithms were used to train different prediction models, which were subsequently validated in a hold-out dataset. The model with the best performance metrics (i.e., ROC-AUC) was selected as the final model. Results: From a source population of 2,893,208 patients, 21,227 anticoagulant-treated patients with VTE and active cancer (53.9% male, median age of 70 years) were identified. Across the study period, yearly incidence of VTE remained relatively stable, ranging from 2.7 to 3.9%. The most common type of VTE was deep vein thrombosis (68.2% of patients), followed by pulmonary embolism (28.4%). Regarding primary cancer locations, the most frequent were colorectal (10.1%) and lung cancer (8.5%). Of all trained and validated models, the RF approach yielded the best performance, with a ROC-AUC = 0.72. The following predictors of VTE recurrence were identified: pulmonary embolism, deep vein thrombosis, metastasis, adenocarcinoma, hemoglobin values, serum creatinine values, platelet count, leukocyte count, family history of VTE, and patients’ age. Conclusions: Using NLP and ML, we were able to use the real-world data in EHRs to build a predictive model of VTE recurrence in cancer patients based on individual clinical features. These results may improve the clinical management of VTE recurrence in this population.

A case of pulmonary thromboembolism possibly associated with the use of creatine supplements

Drug administration should be considered a risk factor for venous thromboembolism (VTE) in younger healthy patients. We present a case of new‐onset pulmonary embolism (PE), possibly associated with excessive creatine supplement intake. A 24‐year‐old non‐smoker male presented to the emergency department with sudden‐onset dyspnoea and chest discomfort. Computed tomography pulmonary angiography and venography confirmed PE in the left and right pulmonary artery branches and a thrombus in the left popliteal vein. The patient had no family history of VTE, and other causes of thrombophilia were unlikely. He reported a recent increase in the intensity of his workouts and the dose of his creatine supplements in preparation for a bodybuilding competition. The creatine supplements likely promoted dehydration during intense workouts and profuse sweating. He received anticoagulation therapy, and the creatine supplements were discontinued. Creatine supplements should be used cautiously when there is a higher risk of becoming dehydrated.