Previous Venous Thromboembolism Research Articles

Secondary prophylaxis of venous thromboembolism (VTE) with low dose apixaban or rivaroxaban in major-thrombophilia carriers.

Direct oral anticoagulants (DOACs) are widely used for treatment and secondary prophylaxis of venous thromboembolism (VTE) and represent the gold standard for VTE secondary prophylaxis, with low-intensity DOACs administration becoming increasingly used worldwide in such scenario. Albeit widespread DOACs usage there are few literature data regarding their efficacy and safety in major thrombophilia carriers and almost no data is available for low intensity apixaban and rivaroxaban as secondary VTE prophylaxis in such patients. The aim of our study is to evaluate and confront the efficacy and safety of low-dose DOACs for VTE secondary prophylaxis, in major thrombophilia carriers vs patients at high risk of VTE recurrence for other reasons. We retrospectively evaluated patients who required long-term anticoagulant secondary prophylaxis to prevent recurrent VTE, treated with apixaban 2.5mg BID or rivaroxaban 10mg daily and that were screened for thrombophilia. The examined patients were 339. Baseline characteristics such as sex, age, obesity rate, smoking, number of previous VTEs and comorbidities (such as cardiovascular diseases, diabetes, mild CKD) were equally distributed in either group. The median low-dose DOACs administration time was 19.20months (IQR 12.17-35.67). During low-dose DOACs treatment, 13 (3.8%) VTE recurrences were observed; 14 bleeding events were registered (4,1%), with no major bleeding (MB), 6 clinically relevant non major bleeding (CRNMB) (1.8%) and 8 minor bleeding (2.3%). No statistically significant difference in the rate of VTE recurrence and/or bleeding events emerged between major thrombophilia carriers and non-major thrombophilia carriers. In multivariate analysis increased risk of VTE recurrence was found for patients with cardiovascular comorbidities (HR 4.00 - p = 0.034) and for patients with more than one previous VTE episode (HR 5.14-p = 0.034). Our data suggest that low-dose DOACs may be effective and safe in secondary VTE prophylaxis for carriers of major thrombophilia with no increase in VTE recurrence and/or bleeding risk.

Development and internal validation of a simple clinical score for the estimation of the probability of deep vein thrombosis in outpatient emergency department patients.

BackgroundWells score comprises subjective elements, which can lead physicians reluctant to use Wells score or use it incorrectly. ObjectivesTo develop and internally validate a prediction score that is objective and simple for evaluating suspected deep vein thrombosis (DVT), with a safety comparable to Wells score. MethodsWe performed a post-hoc analysis using data from the Ri-Schedule study (NCT02486445), involving suspected DVT patients at Østfold Hospital’s Emergency Department, Norway (2015-2018). Candidate variables were identified through bootstrapping technique, with a confirmed DVT diagnosis as the outcome variable. Sensitivity, specificity, negative and positive predictive values (NPV and PPV) were estimated and compared to the two-tier Wells score. ResultsAmong 1312 patients (median age: 64 years (IQR 52-73), 55% women), 19.9% were diagnosed with DVT. Exploration of 30 variables identified tenderness along deep veins and previous venous thromboembolism as significant predictors (selection frequency>60% in 1000 bootstrapping samples). The derived score categorized 450 patients with zero items as unlikely to have DVT, in whom 8.0% were diagnosed with DVT, compared to 8.2% in DVT-unlikely category according to Wells score. Compared to Wells score, the derived score demonstrated sensitivity of 86.2 (81.4-90.2) vs 80.1 (74.7-84.8), specificity of 39.4 (36.4–42.4) vs 55.3 (52.2-58.3), NPV of 92.0 (89.4–94.0) vs 91.8 (89.7-93.5) and PPV of 26.1 (24.8-27.5) vs 30.8 (28.9-32.8). When incorporating D-dimer cut-off <0.5, the derived score had sensitivity of 99.6 (97.9-99.9), specificity of 16.1 (13.1–18.4), NPV of 99.4 (96.0-99.9) and PPV of 22.8 (22.3-23.3). ConclusionsThe derived DVT score, with two objective variables, had a comparable safety to that of the Wells score. However, an external validation is mandated prior to clinical use.

Rate and predictors of thromboprophylaxis in internal medicine wards: Results from the AURELIO study

BackgroundRandomized controlled trials suggest that prophylactic doses of anticoagulants effectively prevent venous thromboembolism (VTE) in hospitalized medical patients with high thromboembolic risk. However, no prospective studies exist regarding the real-world prevalence of prophylactic anticoagulant use. This prospective study aimed to determine the rate and predictors of thromboprophylaxis in an unselected population of patients hospitalized in medical departments. MethodsWe conducted a multicenter prospective observational study (AURELIO – rAte of venous thrombosis in acutely iLl patIents hOspitalized) to assess the rate of deep vein thrombosis (DVT) in unselected acutely ill patients hospitalized in medical wards using compression ultrasound (CUS) at admission and discharge. Additionally, we evaluated the rate of pharmacological thromboprophylaxis administration in this population and analyzed the thrombotic risk by assessing RAMs (Risk Assessment Models) such as the IMPROVE-VTE and PADUA scores following the clinician's decision to administer thromboprophylaxis. Patients with IMPROVE-VTE scores ≥3 and/or PADUA scores ≥4 were classified as high thrombotic risk; those with IMPROVE-VTE scores <3 and/or PADUA scores <4 were classified as low risk. ResultsWe recruited 2371 patients (1233 males [52 %] and 1138 females [48 %]; mean age 72 ± 16 years). The median length of hospitalization was 13 ± 12 days. Overall, 442/2371 (18.6 %) patients received prophylactic parenteral anticoagulants (subcutaneous low weight molecular heparin or fondaparinux once daily) at admission. Assessing the thrombotic risk of the population recruited 1016 (42.9 %) patients were classified as high risk and 1354 (57.1 %) were low risk. Among high-risk patients, 339/1016 (33.4 %) received anticoagulant prophylaxis compared to 103/1354 (7.6 %) low-risk patients. During hospitalization, 9 patients developed DVT, comprising 7 asymptomatic and 2 symptomatic cases of proximal DVT. Of these, 3 patients were on anticoagulant prophylaxis, while 6 were not. Among the high-risk population, 7 out of 1016 patients (0.7 %) experienced proximal DVT during hospitalization, with 2 out of these 7 (28 %) receiving anticoagulant thromboprophylaxis. In the low-risk population, 2 out of 1354 patients (0.2 %) developed DVT, with 1 out of these 2 (50 %) receiving anticoagulant thromboprophylaxis. Age, heart or respiratory failure, pneumonia, active neoplasia, previous VTE, reduced mobility, and absence of kidney failure were more frequent in patients receiving prophylaxis. Multivariable logistic regression identified age (RR 1.010; CI 95 % 1002–1019; p = 0.015), heart/respiratory failure (RR 1.609; CI 95 % 1248–2075; p < 0.0001), active neoplasia (RR 2.041; CI 95 % 1222–2141; p < 0.0001), pneumonia (RR 1.618; CI 95 % 1557–2676; p < 0.0001), previous VTE (RR 1.954; CI 95 % 1222–3125; p < 0.0001), and reduced mobility (RR 4.674; CI 95 % 3700–5905; p < 0.0001) as independent predictors of thromboprophylaxis. ConclusionsThis study, conducted without pre-established thromboembolic risk scores, offers a comprehensive view of venous thromboembolism prophylaxis in medical patients with acute conditions hospitalized in internal medicine departments. It reveals that advanced age, heart or respiratory failure, active cancer, pneumonia, previous VTE, and reduced mobility are predictors that may influence the decision to administer thromboprophylaxis in these patients.

Cohort study of prediction of venous thromboembolism in emergency department patients with extremity symptoms.

Despite diagnostic algorithms, identification of venous thromboembolism (VTE) in emergency departments (ED) remains a challenge. We evaluated symptoms, background, and laboratory data in 27,647 ED patients presenting with pain, swelling, or other symptoms from the extremities, and identified predictors of VTE diagnosis within one year. Predictors of a clinical decision to perform phlebography, ultrasound, or computer tomography (CT) angiography of pelvic, lower, or upper extremity veins, CT of pulmonary arteries, or pulmonary scintigraphy at the ED or within 30days, and the results of such investigations were also evaluated. A total of 3195 patients (11.6%) were diagnosed with VTE within one year. In adjusted analysis of patients in whom all laboratory data were available, a d-dimer value ≥ 0.5mg/l (odds ratio [OR]: 2.602; 95% confidence interval [CI] 1.894-3.575; p < 0.001) at the ED and a previous diagnosis of VTE (OR: 6.037; CI 4.465-8.162; p < 0.001) independently predicted VTE within one year. Of diagnosed patients, 2355 (73.7%) had undergone imaging within 30days after the ED visit and 1730 (54.1%) were diagnosed at this examination. Lower age (OR: 0.984; CI 0.972-0.997; p = 0.014), higher blood hemoglobin (OR: 1.023; CI 1.010-1.037; p < 0.001), C-reactive protein (OR: 2.229; CI 1.433-3.468; p < 0.001), d-dimer (OR: 8.729; CI 5.614-13.574; p < 0.001), and previous VTE (OR: 7.796; CI 5.193-11.705; p < 0.001) predicted VTE on imaging within 30days, whereas female sex (OR 0.602 [95% CI 0.392-0.924]; p = 0.020) and a previous diagnosis of ischemic heart disease (OR 0.254 [95% CI 0.113-0.571]; p = 0.001) were negative predictors of VTE. In conclusion, analysis of 27,647 ED patients with extremity symptoms confirmed the importance of well-established risk factors for VTE. Many patients developing VTE within one year had initial negative imaging, highlighting the importance of continued symptom vigilance.

Identifying pulmonary embolism - high risk patients after total knee replacement: systematic review.

To determine the incidence, onset, risk factors and mortality of pulmonary embolism in total knee replacement patients. The systematic review was conducted in September 2022, and comprised search on PubMed, ScienceDirect, Scopus and Crossref databases for studies published from 1977 till September 7, 2022, in the English language related to the incidence of pulmonary embolism after primary total knee replacement. Cochrane Handbook for Systematic Reviews of Interventions was used to assess risk of bias, and the Newcastle-Ottawa Scale was used to assess the quality of evidence. Of the 3,910 studies initially identified, 66(1.68%) were analysed in detail, which together had 13,258,455 total knee replacement patients. Pulmonary embolism was reported in 76,515(0.58%) cases. The onset of pulmonary embolism ranged 2-150 days post-surgery. Patients with older age, diabetes mellitus, higher body mass index, atrial fibrillation, previous venous thromboembolism, high Charlson Comorbidity Index score, hypertension, arrhythmia and chronic heart failure were at significantly higher risk (p<0.05). The overall mortality rate of pulmonary embolism in such cases ranged 10.53-100%. Pulmonary embolism is a rare complication after orthopaedic surgery, but it has a very high mortality rate. By recognising the risk factors, attending physicians can optimise the use of chemoprophylaxis, thus preventing pulmonary embolism.

The impact of venous thromboembolism before open or minimally-invasive radical cystectomy in the USA: insurance claims data on perioperative outcomes and healthcare costs.

The relationship between venous thromboembolism (VTE) and solid malignancy has been established over the decades. With rising projected rates of bladder cancer (BCa) worldwide as well as increasing number of patients experiencing BCa and VTE, our aim is to assess the impact of a preoperative VTE diagnosis on perioperative outcomes and health-care costs in BCa cases undergoing radical cystectomy (RC). Patients ≥18 years of age with BCa diagnosis and undergoing open or minimally invasive (MIS) RC were identified in the Merative™ Marketscan® Research Databases between 2007 and 2021. The association of previous VTE history with 90-day complication rates, postoperative VTE events, rehospitalization, and total hospital costs (2021 USA dollars) was determined by multivariable logistic regression modeling adjusted for patient and perioperative confounders. Sensitivity analysis on VTE degree of severity (i.e., pulmonary embolism [PE] and/or peripheral deep venous thrombosis [DVT]) was also examined. Out of 8759 RC procedures, 743 (8.48%) had a previous positive history for any VTE including 245 (32.97%) PE, 339 (45.63%) DVT and 159 (21.40%) superficial VTE. Overall, history of VTE before RC was strongly associated with almost any worse postoperative outcomes including higher risk for any and apparatus-specific 90-days postoperative complications (odds ratio [OR]: 1.21, 95% CI, 1.02-1.44). Subsequent incidence of new VTE events (OR: 7.02, 95% CI: 5.93-8.31), rehospitalization (OR: 1.25, 95% CI: 1.06-1.48), other than home/self-care discharge status (OR: 1.53, 95% CI: 1.28-1.82), and higher health-care costs related to the RC procedure (OR: 1.43, 95% CI: 1.22-1.68) were significantly associated with a history of VTE. Preoperative VTE in patients undergoing RC significantly increases morbidity, post-procedure VTE events, hospital length of stay, rehospitalizations, and increased hospital costs. These findings may help during the BCa counseling on risks of surgery and hopefully improve our ability to mitigate such risks.

Machine learning models for prediction of postoperative venous thromboembolism in gynecological malignant tumor patients.

To identify risk factors that associated with the occurrence of venous thromboembolism (VTE) within 30 days after hysterectomy among gynecological malignant tumor patients, and to explore the value of machine learning (ML) models in VTE occurrence prediction. A total of 1087 patients between January 2019 and January 2022 with gynecological malignant tumors were included in this single-center retrospective study and were randomly divided into the training dataset (n = 870) and the test dataset (n = 217). Univariate logistic regression analysis was used to identify risk factors that associated with the occurrence of postoperative VTE in the training dataset. Machine learning models (including decision tree (DT) model and logistic regression (LR) model) to predict the occurrence of postoperative VTE were constructed and internally validated. The incidence of developing 30-day postoperative VTE was 6.0% (65/1087). Age, previous VTE, length of stay (LOS), tumor stage, operative time, surgical approach, lymphadenectomy (LND), intraoperative blood transfusion and gynecologic Caprini (G-Caprini) score were identified as risk factors for developing postoperative VTE in gynecological malignant tumor patients (p < 0.05). The AUCs of LR model and DT model for predicting VTE were 0.722 and 0.950, respectively. The ML models, especially the DT model, constructed in our study had excellent prediction value and shed light upon its further application in clinic practice.

P108 Filgotinib for Rheumatoid Arthritis: an observational cohort to assess clinical effectiveness in a single centre

Abstract Background/Aims Filgotinib, a Janus-kinase (JAK) 1 preferential inhibitor, was approved for use in the UK in moderate or severe rheumatoid arthritis (RA) in 2021, as monotherapy or in combination with Methotrexate. Evidence of real-world effectiveness is currently limited. Methods Patients prescribed Filgotinib between December 2021 and August 2022 in NHS Lothian were identified from pharmacy registration data. All underwent clinical efficacy assessment at three months. Electronic patient records (EPR) were reviewed to record baseline data including previous and current treatments. Duration of Filgotinib treatment was recorded, and discontinuation reason if applicable. DAS-28 scores within six months prior to starting Filgotinib were recorded, along with available subsequent scores. Pre-existing interstitial lung disease (ILD), venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy were recorded, along with incident events during treatment. Results 145 patients were prescribed Filgotinib; 106 (73.1%) females and 39 (26.9%) males, with median age 64 years. Median treatment duration was 447 days. 35 (24.1%) were treated with the reduced 100mg dose. 81 (55.9%) received conventional disease-modifying anti-rheumatic drugs (DMARDs) alongside Filgotinib. 41 (28.3%) patients discontinued treatment: 10 (6.9%) due to loss of effect; 16 (11.0%) due to lack of efficacy; six (4.1%) experienced side effects leading to cessation; five (3.4%) stopped for alternative reasons; one (0.7%) experienced a severe allergic drug reaction; three (2.1%) developed lung cancer and treatment was stopped in each case. 12 (8.3%) patients had ILD prior to treatment. 10 (6.9%) had prior major cardiovascular events, eight (5.5%) had previously treated malignancy, and six (4.1%) had previous VTE. During treatment, 1 (0.7%) patient developed ILD and two (1.4%) developed VTE. There were three (2.1%) new malignancies, all lung cancer. No new MACE occurred. 120 (82.8%) patients were previously treated with biologic or targeted synthetic DMARDs. 59 (40.7%) had failed multiple biologic DMARDs of different classes. 19 (13.1%) switched to Filgotinib from another JAK inhibitor. Pre-treatment DAS-28 scores were recorded in 55 (37.9%) patients with mean 5.1, and during treatment in 44 patients (30.3%) with mean 3.5. 17 (11.7%) patients had DAS-28 recorded both before and during treatment, with pre-treatment mean 5.0 and subsequent mean 2.9. Of these, 10 (58.8%) were classified as a good response by EULAR disease activity criteria, and four (23.5%) as a moderate response. Three (17.6%) were non-responders. Conclusion Our cohort includes 40.7% difficult-to-treat RA. Drug survival as a clinical efficacy surrogate was 71.7% at median duration 447 days, demonstrating patient acceptability and clinical effectiveness. Our service is poor at DAS-28 recording in the EPR, which may partly reflect imaging use at response assessment. Since this cohort was established, the European Medicines Agency has issued guidance advising caution using JAK inhibitors in high-risk groups to minimise the chance of serious side effects. Disclosure C.D. Box: None. S. Ramsay: None. N.D. McKay: Other; N.D.M. has received funding for conference registrations from Abbvie, UCB and Novartis, fees for lecturing from Gilead, and has taken part in advisory board meetings for UCB and Gilead.

Primary thromboprophylaxis in cancer outpatients - real-world evidence.

Cancer-associated thrombosis (CAT) is a significant concern among patients with malignant diseases, leading to increased mortality. While current guidelines recommend primary thromboprophylaxis for venous thromboembolism (VTE) in medium-to-high-risk outpatients, this practice remains controversial. A better understanding of primary thromboprophylaxis is crucial, yet there is a lack of Real-World Evidence (RWE) in Portugal. This RWE study aimed to elucidate primary thromboprophylaxis practices among cancer outpatients in Portugal. A five-year observational multicentric study in eight Portuguese health institutions enrolled 124 adult cancer outpatients under primary thromboprophylaxis for VTE. The endpoints were CAT, bleeding, cancer progression and death. High thrombotic risk tumours were prevalent, with 57% (71) of the patients presenting with pancreatic and gastric cancers. Regarding primary thromboprophylaxis, 55% (68) received Low-Molecular-Weight Heparin (LMWH). VTE was presented in 11% (14) of the patients and major bleeding in 2% (2). Vascular compression, elevated D-dimer and previous VTE were significantly associated with VTE occurrence under primary thromboprophylaxis. The Onkotev model was shown to be the best risk assessment model (RAM) in this population (p = 0.007). CAT patients exhibited a lower progression-free survival than non-CAT patients (p = 0.021), while thrombosis did not influence overall survival (p = 0.542). Primary thromboprophylaxis in medium-to-high-risk cancer outpatients is a safe and effective practice in real-world settings. This study is the first Portuguese RWE on primary thromboprophylaxis, highlighting evidence for improving prophylactic strategies in this population.

Caprini versus Padua venous thromboembolism risk assessment scores: A comparative study in hospitalized patients at a tertiary center.

To assess and compare the Caprini and Padua risk assessment models (RAMs) for predicting venous thromboembolism (VTE) in hospitalized patients. We retrospectively reviewed 28 VTE and 450 non-VTE patients hospitalized at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, in 2019. Their baseline medical, demographic, and radiological reports were recorded. We compared Caprini scores (defined at admission) and Padua scores (calculated retrospectively) for their ability to predict VTE. A cumulative risk score was created by adding the individual scores for each risk factor. We also analyzed the sensitivity, specificity, and diagnostic accuracy of the RAM scores. Major differences in risk factors were shown between patients with and without VTE. Previous VTE was significantly associated with a higher risk of VTE (28.6%), as was reduced mobility (57.1%), acute infection (25%), high Caprini score (50%), and high Padua score (64.3%, p<0.05). The sensitivity of the Caprini score (96%) was higher than that of the Padua score (64.3%), as was the specificity (92.1% vs. 46.9%), positive predictive value (93% vs. 7%), and accuracy (94.1% vs. 47.9%). The specificity of the Caprini score was higher than that of the Padua score in Critical Care, Gynecology/Obstetrics, and Surgical departments. The Caprini RAM showed the lowest level of specificity in the medical department. The Caprini RAM demonstrated higher sensitivity, specificity, and predictive accuracy than did the Padua RAM and thus distinguished low and high VTE risk in hospitalized patients.

Aspirin is as effective as low molecular weight heparins in preventing symptomatic venous thromboembolism following arthroscopic anterior cruciate ligament reconstruction

ObjectiveThe optimal agent for thromboprophylaxis following arthroscopic anterior cruciate ligament reconstruction (ACLR) remains unclear, particularly in patients with a low baseline risk for venous thromboembolism (VTE). This retrospective cohort study aims to compare the effectiveness and safety of aspirin versus low molecular weight heparins (LMWHs) in this specific patient population.MethodsWe analyzed data from patients who underwent ACLR between March 2016 and March 2021, focusing on those with a low risk for VTE. High-risk individuals, identified by factors such as cardiac disease, pulmonary disease, diabetes mellitus, previous VTE, inflammatory bowel disease, active cancer, and a BMI > 40, were excluded (n = 33). Our approach included a thorough review of medical charts, surgical reports, and pre-operative assessments, complemented by telephone follow-up conducted over a 3-month period by a single investigator. We assessed the incidence of symptomatic VTE, including deep vein thrombosis and pulmonary thromboembolism, as the primary outcome. The secondary outcomes included to complications related to the surgery and thromboprophylaxis. Statistical analysis included descriptive statistics, univariate logistic regression models, and calculations of incidence rates.ResultIn our study, 761 patients (761 knees) were included, with 458 (60.18%) receiving aspirin and 303 (39.82%) receiving LMWH. The two groups showed no significant differences in demographic factors except for age. The incidence of VTE was reported at 1.31% (10 individuals). Specifically, five patients in the aspirin group (1.09%) and five patients in the LMWH group (1.65%) developed a symptomatic VTE event (p = 0.53). Additionally, the two groups did not significantly differ in terms of other complications, such as hemarthrosis or surgical site infection (p > 0.05). Logistic regression analysis revealed no statistically significant difference in VTE risk between the two groups.ConclusionThis study, focusing on isolated ACLR in patients with a low baseline risk for venous thromboembolism, demonstrated that aspirin is equally effective as low molecular weight heparins for VTE prophylaxis following this surgery.Level of EvidenceIII

Clinical prediction tool to identify children at risk of pulmonary embolism

IntroductionThe diagnosis of pediatric pulmonary embolism (PE) is often delayed due to non-specific symptoms, and clinical prediction tools designed for adults are unsuitable for children. This study aimed to create a PE predictive model and to evaluate the reported tools in the Thai pediatric population. Materials and methodsA multi-center retrospective study from 4 university hospitals included children ≤18 years of age undergoing computed tomography pulmonary angiogram from 2000 to 2020 with the suspicion of PE. Patients' clinical presentations and risk factors of venous thromboembolism (VTE) were compared between the PE-positive and PE-negative groups. Significant risk factors from univariate and multivariate logistic regression were included to create a clinical prediction tool. The performance of the model was demonstrated by sensitivity, specificity, area under the curve (AUC), Hosmer Lemeshow test, ratio of observed and expected outcomes and bootstrapping. ResultsOf the 104 patients included, 43 (41.3 %) were grouped as PE-positive and 61 (58.7 %) as PE-negative. Five parameters, including congenital heart disease/pulmonary surgery, known thrombophilia, previous VTE, nephrotic syndrome and chest pain showed significant differences between the two groups. Score ≥ 2 yielded a 74.4 % sensitivity and a 75.4 % specificity with an AUC of the model of 0.809. The model performance and validation results were within satisfactory ranges. ConclusionThe study created a clinical prediction tool indicating the likelihood of PE among Thai children. A score ≥2 was suggestive of PE.

Estimating the value of future research into thromboprophylaxis for women during pregnancy and after delivery: a value of information analysis

BackgroundRisk assessment models (RAMs) are used to select women at increased risk of venous thromboembolism (VTE) during pregnancy and the puerperium for thromboprophylaxis. ObjectivesTo estimate the value of potential future studies that would reduce the decision uncertainty associated with offering thromboprophylaxis according to available RAMs in the following groups: high-risk antepartum women (eg, prior VTE), unselected postpartum women, and postpartum women with risk factors (obesity or cesarean delivery). MethodsA decision-analytic model was developed to simulate clinical outcomes, lifetime costs, and quality-adjusted life-years for different thromboprophylaxis strategies, including thromboprophylaxis for all, thromboprophylaxis for none, and RAM-based thromboprophylaxis. The expected value of perfect information analysis was used to determine which factors are associated with high decision uncertainty. The value of future research studies was estimated using expected value of sample information analysis. Costs were assessed from a health and social services perspective. ResultsThe expected value of perfect information analysis identified high decision uncertainty for high-risk antepartum women (£21.8 million) and obese postpartum women (£13.4 million), which was largely attributable to uncertainty regarding the effectiveness of thromboprophylaxis in reducing VTE. A randomized controlled trial of thromboprophylaxis compared with none in obese postpartum women is likely to have substantial value (£2.8 million; 300 participants per arm). A trial in women with previous VTE would have higher value but would be less acceptable. ConclusionFuture research should focus on estimating the effectiveness of thromboprophylaxis in obese postpartum women with additional risk factors who have not had a previous VTE.

Safety of limb lengthening after Roux-en-Y gastric bypass: an analysis of the MBSAQIP database

BackgroundRoux-en-Y gastric bypass (RYGB) effectively treats severe obesity, but some patients may require revisional surgery like limb lengthening (LL) for postoperative weight gain. ObjectivesThis study aims to compare 30-day serious complications and mortality rates between LL and primary RYGB, given limited safety data on LL. MethodsPatients who underwent LL and RYGB were identified from the 2020 and 2021 MBSAQIP databases, the only years in which LL data were available. Baseline characteristics and 30-day rates of serious complications and mortality were analyzed. ResultsA total of 86,990 patients underwent RYGB and 455 underwent LL. Patients undergoing RYGB were younger (44.4 versus 49.8 yr, P < .001), had a higher body mass index (BMI) (45.5 versus 41.8 kg/m2, P < .001) and higher rates of comorbidities including diabetes (30.0 versus 13.6%, P < .001). RYGB and LL had similar operative duration (125.3 versus 123.2 min, P = .5). There were no statistical differences between cohorts for length of stay (LOS) (1.6 RYGB versus 1.6 LL d, P = .6). After LL, there were higher 30-day rates of reoperation (3.3 versus 1.9%, P = .03) and deep surgical site infections (1.3 versus .5%, P = .03) compared to RYGB. There were no differences in overall serious complications (5.1 LL versus 5.0% RYGB, P = 1.0) and mortality (.2 LL versus .1% RYGB, P = .5). Multivariable logistic regression adjustment found that previous venous thromboembolism was associated with serious complications after LL. ConclusionsWhen compared to primary RYGB, LL has a favorable safety profile with similar 30-day rates of serious complications and mortality.

Factors Associated with the Evolution of Superficial Vein Thrombosis and Its Impact on the Quality of Life: Results from a Prospective, Unicentric Study

Background: Superficial venous thrombosis (SVT) is a common clinical condition caused by inflammation and the presence of a thrombus inside a superficial vein. It has traditionally been considered a benign and banal disorder, although it can progress or can be associated with thromboembolic disease of deep territories in up to 20%, asymptomatic or symptomatic pulmonary embolism (PE), especially if it affects the main trunk of the internal saphenous vein. The impact of deep vein thrombosis on the quality of life and its sequelae have long been described in the literature; however, they have not been studied in superficial vein thrombosis. Objectives: We aimed to evaluate the risk factors, management, and complications of SVT and its impact on the quality of life of our patients. Methods: Observational, prospective, single-center study to evaluate the management of SVT. The ultrasound (US) was performed initially on symptomatic patients, during treatment with low-molecular-weight heparin (LMWH), at a follow-up, and at the end of 45 days of treatment. A quality-of-life questionnaire was administered to determine the risk factors, management, and complications of SVT at the moment of diagnosis and at the end of treatment. We included patients referred from the emergency department to a monographic consultation for thromboembolic disease, over 18 years of age with a diagnosis of acute SVT symptomatic, without contraindication to initiate anticoagulation. Results: In total, 63 patients were evaluated between October 2020 and April 2022. The mean age was 65.8 years (SD 13.5), of which 35 were women (55.6%), 39 presented cardiovascular risk factors (61.9%), 25 had a history of previous personal venous thromboembolism (VTE) (39.7%), and 10 had obesity (15.9%), 47 had chronic venous insufficiency or varicose veins (74.9%). During follow-up with ultrasound, 39.7% had partial revascularization, and at discharge, 63.5% had permeabilized the thrombosis against 19% who had residual thrombosis or progression of thrombosis. There was a positive correlation between mobility parameters and improvement in the performance of daily activities (rho = 0.35; p = 0.012) and with improvement in pain/discomfort (rho = 0.37; p = 0.007). An improvement in pain parameters was statistically significantly related to a global assessment health perception (rho = 0.48; p &lt; 0.001). Anxiety and depression parameters were related to a global assessment health perception (rho = 0.462; p = 0.001) and to an overall improvement at 12 months (rho = 0.45; p = 0.001). CONCLUSIONS: Superficial venous thrombosis (SVT) is a highly prevalent disease, which is traditionally considered banal and has good evolution, with heterogeneous management in clinical practice and limited information on patient selection for therapies, current treatment routes, and drug use, as well as outcomes. In recent years, the importance of this entity has become evident due to its frequency in clinical practice, its risk of complications, and the impact it has on the quality of life. This study’s results emphasize the importance of the diagnosis, treatment, and follow-up of superficial venous thrombosis.

Incidence of thromboembolism and associated factors in multiple myeloma patients treated with immunomodulatory drugs: a retrospective analysis in Belo Horizonte, Brazil.

The use of immunomodulators in the treatment of multiple myeloma (MM) patients has been associated with venous thromboembolism (VTE). Due to the increase in mortality of cancer patients, venous thromboembolism is an important concern for newly diagnosed multiple myeloma (NDMM) patients. The aim of this study was to determine the incidence of thromboembolic events and evaluate associated risk factors among Brazilian NDMM patients using immunomodulators. Real-life retrospective cohort study in two Brazilian institutions with newly diagnosed multiple myeloma (NDMM) patients treated with immunomodulators from January 2009 to December 2019. Data was collected from patients' medical records for the period of 1 year, and Cox regression was performed to identify risk factors on the development of VTE. We included 131 patients of which there was a mean age of 61.5 years (SD 11.3), 51.9% female, and predominantly using thalidomide (97.7%) as immunomodulator. We found 9 VTE episodes among our patients, with a 12-month cumulative incidence of 6.97% (95% CI 3.41-12.24). Associated factors after multivariate analysis were recent sepsis, recent traumatic injury, previous VTE, and thromboprophylaxis. Our real-life retrospective cohort presented a low incidence of VTE among Brazilian NDMM patients treated with immunomodulators.

Prediction of Venous Thromboembolism in Patients with Cancer Using Neural Network

Background Venous thromboembolism (VTE) is a frequent complication in patients with cancer and can be provoked by the tumor or treatment.An imbalance between coagulation factors and anticoagulant proteinshas been associated with enhanced VTE risk in these patients. Particularly, elevated fibrinogen, FVIII and von Willebrand factor and decreased antithrombin, increase the risk of cancer-associated VTE. Aim To investigate whether artificial intelligence methodologies based on input of patient characteristics and coagulation parameters can predict VTE in patients with cancer. Methods In the ongoing study, all-type of cancer patients with or without previous VTE are enrolledand thrombotic events were followed up over a period of 2 years or until death. Demographics, cancer type and treatment, medications, and VTE events before and during the study were documented. Coagulation factors, antithrombin, fibrinogen, FVIII and Von Willebrand Factor were determined in all samples. The artificial intelligence method neural networks was used to develop a prediction model for VTE in patients with cancer. Final input parameters were age, sex, prior VTE, use of anticoagulants and statins, fibrinogen, antithrombin, FVIII and von Willebrand factor. Results To date, 118 patients were enrolled in the study, and 28 patients completed the follow-up (24%). A neural network was developed in the sub-cohort of patients that had completed the follow-up period (n=28), of which 7 patients had a VTE during the follow-up period. The top-performing neural network was selected. The developed neural network had an overall accuracy of 98%, a sensitivity of 100% and a specificity of 95%. Furthermore, the negative predictive value was 100% and the positive predictive value was 97% (Figure 1A). The most important variables in the neural network were Von Willebrand Factor, age, anticoagulant therapy and history of VTE, contributing 13% each. Sex, antithrombin and fibrinogen contributed 11%, 10% and 10%, respectively, whereas FVIII (6%) , statin use (5%) and antiplatelet therapy (5%) had a minor contribution (Figure 1B). We validated the neural network in the “on-study” sub-cohort, consisting of patients that did not yet complete the follow-up period. Until now, 2 VTE events were recorded in this group; other patients in the sub-cohort remain potentially at risk for VTE. The neural network was able to accurately discern the patients that experienced a VTE during follow-up, resulting in a sensitivity of 100%, and a negative predictive value of 100%. Moreover, the neural network indicated an increased risk of VTE in 37 subjects out of 88 “on-study” patients. The neural network scores the risk of VTE as a value ranging from 0 (no risk) to 1 (high risk). We stratified the neural network VTE risk estimate according to the Khorana and PROTECHT scores for each patient and found a positive association between both the Khorana and PROTECT scores and the neural network VTE estimate (p&amp;lt;0.05). Conclusions A neural network based on patient characteristics, coagulation parameters, and medication use predicts VTE in our cohort of cancer patients. Although the initial validation of the neural network is promising, further clinically validation is needed.

How to recognize pulmonary embolism in syncope patients: A simple rule

BackgroundSyncope can be the presenting symptom of Pulmonary Embolism (PE). It is not known wether using a standardized algorithm to rule-out PE in all patients with syncope admitted to the Emergency Departments (ED) is of value or can lead to overdiagnosis and overtreatment. MethodsWe tested if simple anamnestic and clinical parameters could be used as a rule to identify patients with syncope and PE in a multicenter observational study. The rule's sensitivity was tested on a cohort of patients that presented to the ED for syncopal episodes caused by PE. The clinical impact of the rule was assessed on a population of consecutive patients admitted for syncope in the ED. ResultsPatients were considered rule-positive in the presence of any of the following: hypotension, tachycardia, peripheral oxygen saturation ≤ 93 % (SpO2), chest pain, dyspnea, recent history of prolonged bed rest, clinical signs of deep vein thrombosis, history of previous venous thrombo-embolism and active neoplastic disease. The sensitivity of the rule was 90.3 % (95 % CI: 74.3 % to 98.0 %). The application of the rule to a population of 217 patients with syncope would have led to a 70 % reduction in the number of subjects needing additional diagnostic tests to exclude PE. ConclusionsMost patients with syncope due to PE present with anamnestic and clinical features indicative of PE diagnosis. A clinical decision rule can be used to identify patients who would benefit from further diagnostic tests to exclude PE, while reducing unnecessary exams that could lead to over-testing and over-diagnosis.

Comparison of Khorana Vs. Onkotev Predictive Score to Individualize Anticoagulant Prophylaxis in Ambulatory Patients with Cancer

Background: The current guidelines [ J Clin Oncol. 2020;38(5):496] recommend using the risk assessment model (RAM) Khorana score ≥2 [ Blood. 2008;111(10):4902-4907] for primary anticoagulant prophylaxis (PP) of venous thromboembolism (VTE) in patients treated for cancer in an outpatient setting. Recently, a novel RAM, the ONKOTEV score [ JAMA Network Open 2023;6(2):e230010] has been prospectively externally validated with good predictive performance. Like all other established RAMs, the Khorana Score and ONKOTEV models aim to assess the incidence of VTE accurately but do not integrate the expected benefits and potential harms of treatment to determine the clinical utility of the competing management alternatives. We set out to compare the clinical utility of the Khorana Score vs. the ONKOTEV predictive model to guide the PP of VTE in patients receiving anticancer treatment. Methods: We used the ONKOTEV validation dataset (n=425). The ONKOTEV score included the Khorana Score (dichotomized as Khorana score &amp;gt;2 vs. ≤ 2) and three readily available clinical information (also dichotomized): history of previous VTE, the presence of metastatic disease, and clinical or radiological assessment of vascular or lymphatic compression by tumor. After assessing the models' performance (discrimination, calibration), we applied a generalized decision curve analysis (gDCA) to integrate the effects of treatments with the models' predictive accuracy. This, in turn, allowed us to develop individualized recommendations for using PP for VTE in patients receiving anticancer treatment. We calculated net benefits (NB) to compare three management strategies: don't provide any treatment vs. administer prophylaxis to all patients receiving anticancer treatment for VTE vs. use the Khorana or ONKOTEV model to guide PP of VTE. According to gDCA, the best treatment is the one with the highest NB. We obtained data on treatment effects from the meta-analysis of published randomized trials comparing direct oral anticoagulants (DOAC) and low-molecular-weight heparins (LMWH) vs. placebo [ Annals of Palliative Medicine. 2020;9(5):2970]. We estimated that DOAC reduced the risk of VTE by 57% [relative risk reduction (RRR) =0.57 (95%CI: 0.13 to 0.79)] and LMWH by 48% [RRR=0.48 (95%CI: 0.42 to 0.66)]. We assessed the major bleeding rate on DOAC as 0.01 (95%CI: 0.006 to 0.04) and 0.02 (95%CI: 0.01 to 0.03) for LMWH. Results: Both RAMs had a satisfactory performance. Harell's C discrimination statistics was 0.71 for ONKOTEV and 0.66 for Khorana Score with good calibration properties (with intercept and the slope not statistically significantly different from 0 and 1, respectively). Fig 1A shows the results based on the default assumptions: if the patient values avoiding the morbidity of VTE 1.6 to 5 times more (0.2&amp;lt;RV&amp;lt;0.6) than the major bleeding, then offering DOAC to all patients receiving PP for VTE represents the most optimal management strategy. When the patients would rather avoid the consequences of the major bleeding by &amp;gt;2.5x more than the morbidity of VTE, using the ONKOTEV model to guide the administration of DOAC represents the best treatment strategy. If we assume that RRR ≤ 0.2, relying on the ONKOTEV model to guide the use of DOAC becomes the most optimal approach to PP of VTE in patients receiving anticancer treatment (Fig 1B). Conclusion: ONKOTEV model is superior to Khorana Score in guiding individualized PP for VTE in ambulatory patients with cancer. It is particularly helpful when the patient values avoiding major bleeding more than the morbidity of VTE. Our analysis provides new recommendations for PP of VTE receiving outpatient treatment for cancer, calling for updating the current guidelines for PP of VTE in this setting.

Incidence and Risk Factors for Postoperative Venous Thromboembolism After Gender Affirming Vaginoplasty: A Retrospective Analysis of a Large Insurance Claims Database

To investigate the incidence and associated risk factors of venous thromboembolism (VTE) after gender affirming vaginoplasty. We searched International Business Machines Corporation (IBM) Marketscan, a commercial claims database, for Current Procedural Terminology and International Classification of Diseases (ICD) procedure codes to identify patients who underwent gender affirming vaginoplasty from 2011-2020. We quantified deep venous thrombosis and pulmonary embolism using ICD-9 and ICD-10 codes found within 90days after surgery. Univariate and multivariate analyses were performed to establish association between VTE events and age, residency location, and comorbidities. We identified 1588 patients who underwent gender affirming vaginoplasty. Overall, 1.1% of patients experienced a VTE within 90days following surgery. Patients who experienced postoperative VTE were older, more likely to have had a prior VTE, less likely to be from an urban area, and more likely to have a higher Charlson Comorbidity Index score. Among patients with postoperative VTE, 47.1% had previous VTE. Among patients without a postoperative VTE, 1.3% had previous VTE. In patients undergoing gender affirming vaginoplasty, the incidence of postoperative VTE was 1.1%. Older age, rurality, increased comorbidities, and prior VTE were associated with increased risk of postoperative VTE. Current guidelines do not recommend cessation of gender affirming hormone therapy (GAHT) prior to vaginoplasty. Further research is needed to evaluate if certain high-risk patients would benefit from perioperative adjustment of GAHT or perioperative VTE prophylaxis.