Anticoagulant Treatment Research Articles

Direct oral anticoagulants in the treatment of chronic thromboembolic pulmonary hypertension patients: A retrospective cohort study

IntroductionDirect oral anticoagulants (DOACs) are increasingly prescribed for life-long anticoagulation in chronic thromboembolic pulmonary hypertension (CTEPH) patients, despite not being recommended in the guidelines. This study aims to evaluate the efficacy and safety of DOACs in CTEPH patients. MethodsFrom May 2013 to December 2022, patients who were first diagnosed with CTEPH in Fuwai Hospital and started long-term anticoagulation treatment with warfarin or DOACs were retrospectively included and followed up until (1) death, (2) transition to other kinds of anticoagulants, or (3) discontinuation of anticoagulation. Propensity score matching was used to balance confounding bias of baseline characteristics. All-cause death, major bleeding, clinically relevant nonmajor bleeding and venous thromboembolism (VTE) recurrence were obtained and analysed. ResultsAfter propensity score matching, 115 patients taking warfarin and 206 patients taking DOACs were included in our study and followed up for 5.5 [3.4, 7.1] years. There was no significant difference of survival between the warfarin and the DOAC group (p = 0.77). The exposure adjusted event rate of major bleeding (0.3 %/person-year vs 0.4 %/person-year, p = 0.705) and clinically relevant nonmajor bleeding (3.1 %/person-year vs 3.2 %/person-year, p > 0.999) was similar between two groups. The exposure adjusted rate of VTE recurrence was significantly higher in the DOAC group (1.5 %/person-year vs 0.3 %/person-year, p = 0.030). ConclusionIn anticoagulation of CTEPH patients, DOACs have similar survival rate, similar risk of bleeding but higher risk of VTE recurrence than warfarin.

Ultrasound elastography predicts anticoagulation in lower extremity deep vein thrombosis.

To investigate predictors of anticoagulation efficacy in deep venous thrombosis (DVT) by ultrasound elastography (UE). The basic clinical, laboratory and ultrasound treatment data of fifty-eight patients with DVT were collected and analyzed. Then the results of ultrasound after 3-month anticoagulation treatment were compared among different groups. Multiple logistic regression analysis was used to identify independent risk factors that affected anticoagulation efficacy. The predictive efficacy of each independent risk factor was accessed by drawing operating characteristic (ROC) curves. According to the regression analysis, the elastic modulus (OR = 0.631, P = 0.001) and strain rate ratio (OR = 0.332, P = 0.006) were identified as independent risk factors for the effectiveness of anticoagulation therapy in patients with DVT. According to the ROC curves, elastic modulus and strain rate ratio could predict effective anticoagulation therapy for DVT, and the optimal threshold values were 22.10 kPa and 1.80 respectively. The corresponding AUC values were 0.879 and 0.854, with a sensitivity of 71.4% and 59.5%, a specificity of 93.7%, and a Youden index of 65.1% and 62.7%, respectively. The elastic modulus (≤22.10 kPa) or strain rate ratio (≤1.80) of the thrombus were independent predictors for the effectiveness of anticoagulation therapy.

Analysis of the Effect of High-Dose Segmental Citrate Anticoagulation in High Flux Hemodialysis

Objective: To analyze the clinical effect of high-dose citrate in segmental extracorporeal anticoagulation for high-throughput hemodialysis. Methods: The subjects included in this study were admitted to the hospital for maintenance hemodialysis treatment from January 2021 to January 2023. All patients had a high risk of bleeding and received 4% trisodium citrate anticoagulant treatment, administered at a rate of 200 mL/h before and after the dialyzer. The anticoagulant effects achieved by the patients were observed and analyzed. Results: The total number of patients who received high-dose segmented citrate extracorporeal anticoagulation dialysis treatment was 50, with each patient undergoing 100 treatments. During the treatment, 2 patients had to end the treatment early due to transmembrane pressure exceeding 30 mmHg and an increase in venous pressure exceeding 250 mmHg; the treatment times for these patients were 20 minutes and 200 minutes, respectively. The remaining patients successfully completed the 4-hour treatment. Blood pH and calcium ion concentration in the venous pot were monitored. It was observed that before dialysis, after 2 hours of dialysis, and at the end of dialysis, the blood pH of the patients remained within a relatively normal range. Although some patient levels changed after dialysis, they remained within the normal range. No adverse reactions (such as numbness of the limbs or convulsions) were observed during the anticoagulant treatment. Conclusion: Administering 4% trisodium citrate at a rate of 200 mL/h before and after the dialyzer achieves a good anticoagulant effect, maintains the patient’s blood gas levels within the normal range at the end of dialysis, and causes no adverse reactions.

Risk factors of epistaxis in rural Denmark: a cross-sectional population-based survey of data from the Lolland-Falster health study.

Epistaxis is a common condition that affects about 60% of the population in their lifetime, with 6% needing medical attention. Little is known about the epidemiology and risk factors of epistaxis outside the health care system. This study aimed to investigate the prevalence and risk factors of epistaxis in a rural Danish population using data from the Lolland-Falster Health Study (LOFUS). We conducted a cross-sectional survey based on data from LOFUS, a household-based, prospective cohort study in the rural provincial area of Lolland-Falster, Denmark. We enrolled 10,065 participants (≥ 50 years) and collected data on demographics, comorbidities, medication, lifestyle factors, and laboratory parameters. Logistic regressions were used to test for correlations between epistaxis and different risk factors. In total 5.3% of the participants had experienced epistaxis within the past 30 days, and 7.9% had sought medical attention for epistaxis at some point in their lives. We identified several factors that were significantly correlated with increased odds of epistaxis, such as male gender, age group 50-59 years, high BMI (> 25), allergy, diabetes, hypertension, atherosclerosis, angina, and anticoagulant treatment. Excellent or good self-reported health was correlated to significantly lower odds of epistaxis. This study provides a comprehensive overview of the prevalence and risk factors of epistaxis outside the health care system. Our study suggests that preventive measures targeting these risk factors may reduce the incidence and severity of epistaxis in this population.

Recurrent Ischemic Stroke in Patients With Atrial Fibrillation While Receiving Oral Anticoagulants

Patients with atrial fibrillation (AF) can have an ischemic stroke (IS) despite oral anticoagulant (OAC) treatment. Knowledge regarding the association between OAC discontinuation and the subsequent risk of recurrent IS in patients with AF is limited. To determine the risk of recurrent IS in patients with AF receiving OAC and to evaluate the association between OAC discontinuation and the risk of recurrent IS. This is a nationwide cohort study of patients aged 50 years or older in Denmark who had AF and an IS (entry IS) and were initiating or restarting subsequent OAC treatment after being discharged between January 2014 and December 2021. Patients were followed up for recurrent IS until June 2022. Within this study cohort, a nested case-control analysis was performed in which patients with recurrent IS were matched to patients receiving OAC who had not yet experienced a stroke. Data were analyzed from May 25, 2023, to April 18, 2024. Use of OAC at the time of recurrent IS or the equivalent date in matched controls based on redeemed prescriptions. The primary outcome was recurrent IS. Crude and adjusted cumulative incidences of recurrent IS and all-cause mortality were calculated in cohort analyses, and adjusted odds ratios (aORs) were determined for recurrent IS associated with OAC discontinuation in nested case-control analyses. The study cohort included 8119 patients (4392 [54.1%] male; mean [SD] age, 78.4 [9.6] years; median (IQR) CHA2DS2-VASc score, 4.0 [3.0-5.0]). Over a mean (SD) follow-up of 2.9 (2.2) years, 663 patients had a recurrent IS, of whom 533 (80.4%) were receiving OAC at the time of their recurrent IS. The crude cumulative incidence of recurrent IS at 1 year was 4.3% (95% CI, 5.9%-7.1%), and the crude cumulative incidence of all-cause mortality was 15.4% (95% CI, 14.7%-16.2%). Adjusted analysis showed similar results. Patients who discontinued OACs had a higher risk of recurrent IS (89 cases [13.4%], 180 controls [6.8%]; aOR, 2.13; 95% CI, 1.57-2.89) compared with patients still receiving OAC. The risks of recurrent IS and mortality were high in patients with AF despite secondary prevention with OAC, and OAC discontinuation doubled the risk of recurrent IS compared with patients who continued OAC. This finding highlights the importance of OAC continuation and the need for improved secondary stroke prevention in patients with AF.

Efficacy and safety of rivaroxaban versus warfarin in the management of unusual site deep vein thrombosis: a retrospective cohort study.

Unusual site deep vein thrombosis (DVT) was defined as venous thromboembolism (VTE) occurring outside the conventional deep veins of the lower extremity or pulmonary arteries. However, the optimal anticoagulation therapy for unusual site DVT remained unclear. This study aims to evaluate the efficacy and safety of rivaroxaban in unusual site DVT. This retrospective cohort study enrolled consecutive patients at Nanjing Drum Tower Hospital between January 2011 and December 2021 who were diagnosed with unusual site DVT. Patients were divided into two groups based on their ultimate medication choice: the warfarin group and the rivaroxaban group. The demographic characteristics were recorded for all enrolled patients. Clinical outcomes included recurrent VTE, bleeding complications and major bleeding. A total of 1,088 patients were divided into warfarin (n = 514) and rivaroxaban (n = 574) groups. After the stabilized inverse probability of treatment weighting, Hazard Ratios for warfarin vs. rivaroxaban of recurrent VTE, bleeding complications and major bleeding were 0.52(95% CI: 0.25-1.08), 0.30(95% CI: 0.14-0.60), and 0.33 (95% CI, 0.13-0.74), respectively. Risk of clinical outcomes in specified subgroups for age, gender, renal function, thrombosis sites and diagnosis were assessed. The interaction of gender and treatment on major bleeding was significant (P for interaction = 0.062). Otherwise, there was no significant interaction between the other subgroups and the treatment group in terms of clinical outcomes. Compared with warfarin, rivaroxaban exhibited comparable efficacy for the anticoagulant treatment of unusual site DVT, associated with a lower risk of bleeding complications and major bleeding.

Individual participant data analysis comparing acute stroke patients with anterior versus posterior circulation dissections

BackgroundCervical artery dissection (CAD) is a relevant etiology of transient ischemic attacks and strokes. Several trials explored the significance of specific antithrombotic treatments, i.e. oral anticoagulation (OAC) versus antiplatelet treatment (APT), on recurrent ischemic complications and clinical outcomes. As overall incidence rates of complications were low there is still controversy which antithrombotic treatment should be used. However, up to now there has been no systematic investigation among CAD-patients with ischemic stroke specifically comparing clinical course and outcome of patients with anterior versus posterior CAD. MethodsWe performed an individual participant data analysis of patients with CAD and ischemic stroke. Over a five-year period we pooled data from three sites (i.e. West China Hospital, Chengdu, China as well as Erlangen and Giessen University Hospitals, Germany) and enrolled patients with CAD-associated ischemic stroke. Patient demographics, clinical and in-hospital measures as well as radiological data were retrieved from institutional databases. Clinical follow-up was over 6 months and included data on recurrent ischemic strokes and hemorrhages as well as clinical functional outcome assessed by the modified Rankin Scale dichotomized into favourable (mRS=0–2) and unfavourable. ResultsA total of 203 patients with CAD were included of which n=112 had anterior and n=91 had posterior CAD. Patients with posterior CAD were younger (46.0 vs. 41.0 y; p<0.001) than patients with anterior CAD and showed less often arterial hypertension. (42.0 % vs. 28.6 %; p<0.048). Antithrombotic treatment with APT and OAC was similarily distributed among patients with anterior and posterior CAD and not significantly differently related to ischemic or hemorrhagic complications during follow-up (all p=n.s.). Main difference between Chinese and German patients were mode of antithrombotic treatment consisting predominantly of APT in China compared to OAC in Germany. Functional outcome overall was good, yet worse in patients with anterior CAD compared to posterior CAD (80.2 % favorable in anterior CAD vs. 92.2 % in posterior CAD (p=0.014). ConclusionThis study provides evidence that anterior and posterior CAD show baseline imbalances regarding age and comorbidity which may affect clinical outcome. There are no signals of superiority or harm of any specific mode of antithrombotic treatment nor relevant discrepancies in clinical outcome among Chinese and German CAD-associated stroke patients.

Effect of a 3-Month Single-Drug Approach Using Rivaroxaban for Symptomatic Proximal Deep Vein Thrombosis.

Background: Factor Xa inhibitors, such as rivaroxaban, are increasing the convenience of treatment for deep vein thrombosis (DVT). Limited evidence exists regarding clot evaluation at 3 months after treatment for DVT. Methods and Results: We retrospectively analyzed the clinical course of symptomatic proximal DVT in patients who received 3 months of anticoagulation treatment at our hospital. Patients treated with the rivaroxaban single-drug approach were classified as group A (n=42). Patients treated with unfractionated heparin (UFH) or subcutaneous fondaparinux followed by vitamin K antagonist comprised group B (n=60) as an historical cohort. The quantitative ultrasound thrombosis (QUT) score was used to quantify clot burden before and after treatment. No significant differences were observed in patient characteristics between the groups. Serum D-dimer levels in both groups significantly improved after treatment. Clot volume assessed using QUT also reduced significantly in both groups. The QUT score in groups A and B improved from 7.5 [4.8, 12.0] to 3.0 [1.8, 5.0; P=0.000] and 7.0 [4.0, 9.8] to 3.0 [2.0, 5.0; P=0.000], respectively. The change in QUT (∆QUT) was significantly greater in group A compared with group B (-4.5 [-8.25, -2.0] vs. -2.0 [-6.0, 0.0]; P=0.005). Conclusions: We were able to demonstrate the effectiveness of DVT treatment using rivaroxaban over a period of 3 months from onset, in terms of clot regression evaluated using the QUT score.

Deep Vein Thrombosis While Still on NOAC

Novel oral anticoagulation treatment has been extensively used for thromboprophylaxis in atrial fibrillation and other clinical conditions because of predicable pharmacokinetic profile and safety. However, rarely plasma drug level variation can occur that can lead to thrombotic and bleeding events. We describe a case of deep vein thrombosis in a compliant patient still on apixaban. Anticoagulation failure with NOAC is concerning and obviously there is growing need of assay in these subsets showing the activity of NOAC. Till the availability of such methods, switching back to conventional therapy with Vitamin K antagonist with accurate monitoring could be appropriate strategy.

Lifestyle counseling in patients with hypertension in primary health care and its association with antihypertensive pharmacotherapy.

The study aimed to investigate differences in hypertensive- and cardio-preventive pharmacotherapy depending on if patients with hypertension received lifestyle counseling or not, including the difference between men and women. Data from the Region Stockholm VAL database was used to identify all patients with a hypertension diagnosis and had visited a primary health care center within the past five years. Data included registered diagnoses, pharmacotherapy, and codes for lifestyle counseling. Logistic regression adjusted for age and comorbidity (diabetes, stroke, coronary heart disease, atrial fibrillation, gout, obesity, heart failure) was used, presenting results as odds ratios (OR) with 99% confidence interval (CI). The study included 130,030 patients with hypertension; 63,402 men and 66,628 women. Patients receiving recommended lifestyle counseling were more frequently treated with three or more hypertensive drugs: women OR 1.38 (1.31, 1.45) and men=1.36 (1.30, 1.43); certain drug classes: calcium antagonists: women 1.09 (1.04, 1.14) and men 1.11 (1.06, 1.16); thiazide diuretics: women 1.26 (1.20, 1.34) and men 1.25 (1.19, 1.32); and aldosterone antagonists: women 1.25 (1.12, 1.41) and men 1.49 (1.34, 1.65). Patients receiving recommended level of lifestyle counseling with concomitant coronary heart disease, atrial fibrillation, diabetes, or stroke were more frequently treated with statins than those who did not. Further, recommended lifestyle counseling was significantly associated with anticoagulant treatment in patients with atrial fibrillation. Lifestyle counseling according to recommendations in national guidelines was significantly associated with a more thorough pharmacological treatment of hypertension, statins, and antithrombotic drugs as well as anticoagulants, in both men and women.

Percutaneous left atrial appendage closure with SeaLA device in non-valvular atrial fibrillation.

The clinical efficacy and safety of a novel left atrial appendage (LAA) occluder of the SeaLA closure system in patients with nonvalvular atrial fibrillation (NVAF) were reported. Patients with NVAF are at a higher risk of stroke compared to healthy individuals. Left atrial appendage closure (LAAC) has emerged as a prominent strategy for reducing the risk of thrombosis in individuals with NVAF. A prospective, multicenter study was conducted in NVAF patients with a high risk of stroke. The LAAC was successfully performed in 163 patients. The mean age was 66.93 ± 7.92 years, with a mean preoperative CHA2DS2-VASc score of 4.17 ± 1.48. One patient with residual flow >3 mm was observed at the 6-month follow-up, confirmed by TEE. During the follow-up, 2 severe pericardiac effusions were noted, and 2 ischemic strokes were observed. Four device-related thromboses were resolved after anticoagulation treatment. There was no device embolism. The LAAC with the SeaLA device demonstrates encouraging feasibility, safety, and efficacy outcomes.

Design and rationale for REVERXaL: A real-world study of patients with factor Xa inhibitor–associated major bleeds

BackgroundThe prevalence of anticoagulation treatment is increasing as an aging global population faces a high burden of cardiovascular comorbidities. Direct oral anticoagulants, including factor Xa inhibitors (FXai), are replacing vitamin K antagonists as the most commonly prescribed treatment for reducing risk of thrombotic events. While the risk of FXai-associated spontaneous bleeds is established, less is understood about their management and the effect of treatment on clinical and patient-reported outcomes. The primary objectives of the REVERXaL study are to describe patient characteristics, health care interventions during the acute-care phase, in-hospital outcomes, and associations between timing of reversal/replacement agent administration and in-hospital outcomes. Secondary/exploratory objectives focus on clinical assessments and patient-reported outcome measures (PROMs) at 30 and 90 days. MethodsREVERXaL is a multinational, observational study of hospitalized patients with FXai-associated major bleeds in Germany, Japan, the United Kingdom, and the United States. The study includes 2 cohorts of approximately 2000 patients each. Cohort A is a historic cohort for whom medical chart data will be collected from hospitalization to discharge for patients admitted for major bleeds during FXai use within 2 years prior to enrollment of Cohort B. Cohort B will prospectively enroll patients administered any reversal/replacement agent during hospitalization to manage FXai-associated major bleeds and will include the collection of clinical outcomes and PROMs data over 3 months. ConclusionsREVERXaL will generate insights on patient characteristics, treatment approaches, and associated outcomes in patients hospitalized with FXai-associated major bleeds. These data may inform clinical practice and streamline treatment pathways in this population. RegistrationURL: https://www.clinicaltrials.gov; unique identifier: NCT06147830.

Enhanced Reendothelialization and Thrombosis Prevention with a New Drug-Eluting Stent.

The objective of the study is to test the efficacy of cyclopentenyl cytosine (CPEC)-coated stents on blocking artery stenosis, promoting reendothelialization, and reducing thrombosis. Scanning electron microscopy was employed to observe the morphological characteristics of stents coated with a mixture of CPEC and poly(lactic-co-glycolic acid) (PLGA) copolymer. PLGA has been used in various Food and Drug Administration (FDA)-approved therapeutic devices. In vitro release of CPEC was tested to measure the dynamic drug elution. Comparison between CPEC- and everolimus-coated stents on neointimal formation and thrombosis formation was conducted after being implanted into the human internal mammary artery and grafted to the mouse aorta. Optimization in stent coating resulted in uniform and consistent coating with minimal variation. In vitro drug release tests demonstrated a gradual and progressive discharge of CPEC. CPEC- or everolimus-coated stents caused much less stenosis than bare-metal stents. However, CPEC stent-implanted arteries exhibited enhanced reendothelialization compared to everolimus stents. Mechanistically, CPEC-coated stents reduced the proliferation of vascular smooth muscle cells while simultaneously promoting reendothelialization. More significantly, unlike everolimus-coated stents, CPEC-coated stents showed a significant reduction in thrombosis formation even in the absence of ongoing anticoagulant treatment. The study establishes CPEC-coated stent as a promising new device for cardiovascular interventions. By enhancing reendothelialization and preventing thrombosis, CPEC offers advantages over conventional approaches, including the elimination of the need for anti-clogging drugs, which pave the way for improved therapeutic outcomes and management of atherosclerosis-related medical procedures.

Thromboembolic and bleeding complications after elective cardioversion of atrial fibrillation: a nationwide cohort study.

Elective cardioversion (ECV) is routinely used in atrial fibrillation (AF) to restore sinus rhythm. However, it includes a risk of thromboembolism even during adequate oral anticoagulation treatment. The aim of this study was to evaluate the risk of thromboembolic and bleeding complications after ECV in a real-life setting utilizing data from a large AF population. This nationwide register-based study included all (n = 9625) Finnish AF patients undergoing their first-ever ECV between 2012 and 2018. The thromboembolic and bleeding complications within 30 days after ECV were analysed. The mean age of the patients was 67.7 ± 9.9 years, 61.2% were men, and the mean CHA2DS2-VASc score was 2.6 ± 1.6. Warfarin was used in 6245 (64.9%) and non-vitamin K oral anticoagulants (NOACs) in 3380 (35.1%) cardioversions. Fifty-two (0.5%) thromboembolic complications occurred, of which 62% were ischaemic strokes, 25% transient ischaemic attacks, and 13% other systemic embolisms. Thromboembolic events occurred in 14 (0.4%) NOAC-treated patients and in 38 (0.6%) warfarin-treated patients (odds ratio 0.77; confidence interval: 0.42-1.39). The median time from ECV to the thromboembolic event was 2 days, and 78% of the events occurred within 10 days. Age and alcohol abuse were significant predictors of thromboembolic events. Among warfarin users, thromboembolic complications were more common with international normalized ratio (INR) <2.5 than INR ≥2.5 (0.9% vs. 0.4%, P = 0.026). Overall, 27 (0.3%) bleeding events occurred. The rate of thromboembolic and bleeding complications related to ECV was low without significant difference between NOAC- and warfarin-treated patients. With warfarin, INR ≥2.5 at the time of cardioversion reduced the risk of thromboembolic complications.

Efficacy and safety of DOACs versus LMWH for elderly patients with active cancer: A meta-analysis.

e13776 Background: Anticoagulant treatment in patients with cancer aims to reduce the high risk of thromboembolism. Direct oral anticoagulants (DOACs) and low-molecular-weight heparin (LMWH) are currently approved for the treatment of cancer-related thrombosis. However, there is limited data comparing the efficacy and safety of these two antithrombotic therapies among elderly patients with cancer. Methods: PubMed, Embase, and Cochrane Central Register of Controlled Trials databases were systematically searched for studies comparing DOACs with LMWH in cancer patients with newly diagnosed venous thromboembolism (VTE) or pulmonary embolism (PE). Both solid tumors and hematologic malignancies were included. Outcomes of interest were recurrent VTE and major bleeding. Odds ratio (OR) with 95% confidence intervals (CI) were pooled with a random-effects model. Statistical analysis was performed with Review Manager 5.4.1. Heterogeneity was assessed using the I2 statistic and chi-squared test. Results: Four studies, three randomized controlled trials (RCTs) and one observational, were included. A total of 3,266 patients older than 65 years who underwent anticoagulation with DOACs (35%) or LMWH (65%) were incorporated in the analysis. There was no statistically significant difference between anticoagulation therapies for recurrent VTE (OR, 0.68; 95% CI, 0.41-1.11; p = 0.13; I² = 56%; Table) or major bleeding (OR, 1.18; 95% CI, 0.61-2.25; p = 0.08; I² = 60%; Table). Conclusions: Our findings suggest no statistically significant differences in recurrent VTE or major bleeding between DOACs and LMWH in elderly oncologic patients with newly diagnosed VTE or PE. Given the practical challenges of using LMWH, DOACs may be considered an alternative anticoagulation strategy for these patients. [Table: see text]

Laparoscopic Pancreaticoduodenectomy Combined With Portal-Superior Mesenteric Vein Resection and Reconstruction: Inferior-Posterior "Superior Mesenteric Artery-First" Approach.

Laparoscopic pancreaticoduodenectomy (LPD) with portal-superior mesenteric vein (PV/SMV) resection and reconstruction is increasingly performed. We aimed to introduce a safe and effective surgical approach and share our clinical experience with LPD with PV/SMV resection and reconstruction. We reviewed data for the patients undergoing LPD and open pancreaticoduodenectomy (OPD) combined with PV/SMV resection and reconstruction at the First Hospital of Jilin University between April 2021 and May 2023. The inferior-posterior "superior mesenteric artery-first" approach was used. We compared the preoperative, intraoperative, and postoperative clinicopathological data of the 2 groups to conduct a comprehensive evaluation of LPD with major vascular resection. A cohort of 37 patients with periampullary and pancreatic tumors underwent pancreaticoduodenectomy (PD) with major vascular resection and reconstruction, consisting of 21 LPDs and 16 OPDs. The LPD group had a longer operation time (322 vs. 235 min, P =0.039), reduced intraoperative bleeding (152 vs. 325mL, P =0.026), and lower intraoperative blood transfusion rates (19.0% vs. 50.0%, P =0.046) compared with the OPD group. The LPD group had significantly shorter operation times in end-to-end anastomosis (26 vs. 15 min, P =0.001) and artificial grafts vascular reconstruction (44 vs. 22 min, P =0.000) compared with the OPD group. There was no significant difference in the rate of R0 resection (100% vs. 87.5%, P =0.096). The length of hospital stay and ICU stay did not show significant differences between the 2 groups (15 vs. 18d, P =0.636 and 2.5 vs. 4.5d, P =0.726, respectively). However, the postoperative hospital stay in the LPD group was notably shorter compared with the OPD group (11 vs. 16d, P =0.007). Postoperative complication rates, including postoperative pancreatic fistula (POPF) Grade A/B, biliary leakage, and delayed gastric emptying (DGE), were similar between the two groups (38.1% vs. 43.8%, P =0.729). In addition, 1 patient in each group developed thrombosis, with vascular patency improving after anticoagulation treatment. LPD combined with PV/SMV resection and reconstruction can be easily and safely performed using the inferior-posterior "superior mesenteric artery-first" approach in cases of venous invasion. Further studies are required to evaluate the procedure's long-term outcomes.

The variation of anticoagulation prescribed in foot and ankle surgery in the UK – UK foot and ankle thrombo-embolism audit (UK-FATE)

IntroductionVenous thrombo-embolism (VTE) is a recognised complication of foot and ankle surgery. There are multiple possible anticoagulation treatments available in the UK to mitigate the risk of developing VTE. Our primary objective was to assess the variability of chemical anticoagulation prescribed in patients undergoing foot and ankle procedures. MethodsThis was a UK-based national, multicenter, prospective audit spanning a collection duration of 9 months on all foot and ankle procedures, carried out in 68 UK centers between 1st June 2022 and 30th November 2022, with a further 3-month follow up period. All patients who underwent a foot and ankle surgical procedure (including Achilles tendon rupture treatment) were included in this study. ResultsData on a total of 13,569 patients was submitted. Following data cleansing, 11,363 patients were available for further analysis, with anticoagulation data available for 11,099 patients. There were eleven different chemical anticoagulation treatments recorded across the cohort. A total of 3630 (31.95 %) patients received no chemical anticoagulation. The patients receiving chemical anticoagulation medication could be split into 4 main groups. The most common chemical anticoagulation received was low molecular weight heparin (LMWH) (6303, 84.4 % of patients receiving chemical anticoagulation). Aspirin was given in 4.1 % (308 patients), a Factor Xa inhibitor in 10 % (744 patients) and other anticoagulants (e.g. Warfarin) in 1.5 % (114 patients). The overall VTE rate in this sub analysis of patients receiving chemical anticoagulation, was 1.1 % (83 cases out of 7469). There was no significant difference seen in incidence of VTE between types of anticoagulants, when confounding factors were considered. The duration of post-operative chemical prophylaxis used by participants for most chemical anticoagulants was 6 weeks (64.50 %). ConclusionThere was significant variability of chemical anticoagulants reported in the study, with five different categories of anticoagulants used (including no chemical anticoagulation), and none clearly superior/inferior. The duration of anticoagulation was consistent across types of thromboprophylaxis.

External validation of a bleeding risk assessment model developed with natural language processing and machine learning (PREDICT-AI study) in patients with anticoagulated cancer with venous thromboembolism in the TESEO international prospective registry.

e24123 Background: The risk factors for bleeding during anticoagulation in patients with cancer-associated thrombosis (CAT) remain largely unexplored. The recently developed PredictAI model ( Muñoz Martín AJ et al. JCO 40, e18744-e18744(2022) was aimed to predict major bleeding (MB) in anticoagulant-treated cancer patients within the first 6 months following venous thromboembolism (VTE) diagnosis. The goal was to validate the PredictAI model using an independent cohort of patients from the TESEO international, observational, prospective registry. Methods: The performance of the three predictive models developed in PredictAI were assessed in terms of accuracy, precision, recall, F1-score, and the receiver operating characteristic (ROC) area under the curve (AUC): PredictAI decision tree classifier ROC-AUC 0.66 (confidence interval 95% [CI 95%], 0.63-0.69; P &lt; .0001), random forest classifier ROC-AUC 0.61 (CI 95%, 0.58-0.64; P &lt; .0001), and logistic regression ROC-AUC 0.70 (CI 95%, 0.67-0.73; P &lt; .0001). The outcome was MB within 6 months following VTE diagnosis, whereas the analyzed predictors for MB at baseline comprised those from PredictAI, namely patient’s age, presence of metastasis, hemoglobin levels, platelet count, leukocyte count, and serum creatinine levels. Results: The TESEO cohort used for the external validation comprised 2,179 patients (51.9% male, mean age = 64.72 ± 11.34 years) with active cancer and VTE under anticoagulant treatment. The median (Q1, Q3) follow-up duration across patients was 6 (2, 14) months. Considering the ROC-AUC values for the three tested models (table 1), the results confirm a statistically significant validation and best performance of the logistic regression (ROC-AUC = 0.59; 95% CI = 0.53, 0.65; P = .002) approach. Conclusions: Our results support the first external validation of a risk assessment model of bleeding specifically developed for CAT. This model may guide objective decisions regarding the extension and dosing of anticoagulant therapy in this population. Future steps should involve further validation of the present model in other patient cohorts and the generation of a clinical tool to facilitate its use in healthcare settings. [Table: see text]

Atrial standstill in a young patient treated with left bundle branch area pacing

Abstract Atrial standstill is a rare arrhythmogenic condition characterized by the absence of electrical and mechanical activity in the atria. The therapeutic options for these patients described in the current literature, in which no reversible cause is detected, are permanent cardiac pacing, anticoagulant, and heart failure treatment when the latter exists. We present a case of a young male with no personal or family history of cardiovascular disease, diagnosed with atrial standstill after multiple syncopal episodes, in whom, because of the high expected ventricular pacing percentage, we opted for conduction system pacing with left bundle branch area pacing.

Oral anticoagulant treatment in atrial fibrillation: the AFIRMA real-world study using natural language processing and machine learning

IntroductionOral anticoagulation (OAC) is key in atrial fibrillation (AF) thromboprophylaxis, but Spain lacks substantial real-world evidence. We aimed to analyze the prevalence, clinical characteristics, and treatment patterns among patients with AF undertaking OAC, using natural language processing (NLP) and machine learning (ML). Materials and methodsThis retrospective study included AF patients on OAC from 15 Spanish hospitals (2014–2020). Using EHRead® (including NLP and ML), and SNOMED_CT, we extracted and analyzed patient demographics, comorbidities, and OAC treatment from electronic health records. AF prevalence was estimated, and a descriptive analysis was conducted. ResultsAmong 4,664,224 patients in our cohort, AF prevalence ranged from 1.9% to 2.9%. A total of 57,190 patients on OAC therapy were included, 80.7% receiving Vitamin K antagonists (VKA) and 19.3% Direct-acting OAC (DOAC). The median age was 78 and 76 years respectively, with males constituting 53% of the cohort. Comorbidities like hypertension (76.3%), diabetes (48.0%), heart failure (42.2%), and renal disease (18.7%) were common, and more frequent in VKA users. Over 50% had a high CHA2DS2-VASc score. The most frequent treatment switch was from DOAC to acenocoumarol (58.6% to 70.2%). In switches from VKA to DOAC, apixaban was the most chosen (35.2%). ConclusionsUtilizing NLP and ML to extract RWD, we established the most comprehensive Spanish cohort of AF patients with OAC to date. Analysis revealed a high AF prevalence, patient complexity, and a marked VKA preference over DOAC. Importantly, in VKA to DOAC transitions, apixaban was the favored option.