Venous Thromboembolism Outcomes Research Articles

Reduced- versus full-dose anticoagulants for the extended treatment of cancer-associated venous thromboembolism in Thai patients

BackgroundReduced dose anticoagulant therapy for the extended treatment of cancer-associated venous thromboembolism (VTE) has been used to avoid bleeding. However, it may increase the risk of recurrent VTE. AimsTo study the rate of recurrent VTE and bleeding complications in Thai patients with cancer-associated VTE who were treated with full-dose or reduced-dose anticoagulants. MethodsA retrospective cohort study was conducted in a single-center academic hospital. Electronic medical records were reviewed from 2016-2023. Patients with cancer-associated VTE who received anticoagulants for at least 3 months were evaluated. Reduced-dose anticoagulant was defined as a dose that was lower than the recommended standard dosage. The primary outcome was recurrent VTE. The secondary outcomes were major bleeding and clinically relevant non-major bleeding. ResultsA total of 229 patients were included. The median age was 65 years (interquartile range [IQR] 54-72). In the reduced-dose group, age and history of previous bleeding were higher than in the full-dose group. There were 169 (74%) patients and 60 (26%) patients who received full- and reduced-dose anticoagulants. The median time to reduce the dose was 3.6 months ([IQR] 0.7 – 5.5). Of a total of 7 (3.1%) recurrent VTE, 4 (2.4%) occurred in the full-dose and 3 (5.0%) in the reduced-dose groups (p=0.4), respectively. The median time to recurrent VTE was 7.2 months ([IQR] 3.5-12.4). There were 8 (3.5%) bleeding events, 7 (4.1%) and 1 (1.7%) in the full and reduced-dose anticoagulant groups (p=0.35), respectively. The median follow-up time was 1.5 years (IQR 1-3.1). ConclusionOlder age and a history of previous bleeding were associated with the use of reduced-dose anticoagulants. Patients with cancer-associated VTE receiving reduced-dose anticoagulants had a numerically higher risk of recurrent VTE and lower bleeding outcomes compared with those receiving full-dose anticoagulants.

Association between tumour somatic mutations and venous thromboembolism in the 100,000 Genomes Project cancer cohort: a study protocol

Venous thromboembolism (VTE) is a common cause of morbidity and mortality in patients with cancer. There is evidence that specific aberrations in tumour biology contribute to the pathophysiology of this condition. We plan to examine the association between tumour somatic mutations and VTE in an existing cohort of patients with cancer, who were enrolled to the flagship Genomics England 100,000 Genomes Project. Here, we outline an a-priori analysis plan to address this objective, including details on study cohort selection, exposure and outcome definitions, annotation of genetic variants and planned statistical analyses. We will assess the effect of 1) deleterious somatic DNA variants in each gene; 2) tumour mutational burden and 3) tumour mutational signatures on the rate of VTE (outcome) in a pan-cancer cohort. Sensitivity analyses will be performed to examine the robustness of any associations, including adjustment for potentially correlated co-variates: tumour type, stage and systemic anti-cancer therapy. We hope that results from this study may help to identify key genes which are implicated in the development of cancer associated thrombosis, which may shed light on related mechanistic pathways and/or provide data which can be integrated into genetic risk prediction models for these patients.

Association of prolonged emergency department length of stay and venous thrombo-embolism prophylaxis and outcomes in trauma: A nation-wide secondary analysis.

The impact of prolonged emergency department length of stay (EDLOS) on appropriately timed pharmacological venous thromboembolism prophylaxis (VTEp) and VTE outcomes is unknown in trauma. Retrospective cohort study of adult patients admitted to civilian trauma centers participating in the American College of Surgeons' TQIP (2019-2021). Patients with severe solid organ, head, or spine injury, early hemorrhage control intervention, pre-existing home anticoagulation or bleeding disorder, inter-facility transfer or early discharge, and injury severity score ≤9 were excluded. Primary exposure was prolonged EDLOS ≥12 h from ED arrival to physical transfer to the wards. Primary outcome was time to first pharmacological VTEp, censored at 24 and 48 h. A total of 191,031 patients were included, 3,827 remained in the ED ≥12 h. The median time to VTEp was 25 h (IQR 12-43). Prolonged EDLOS was associated with a 34 % and 21 % decrease in timely administration of VTEp at 24 (aHR 0.66, 95 % CI 0.61-0.72, P < 0.001) and 48 h (aHR 0.79, 95 % CI 0.74-0.84, P < 0.001), respectively. After propensity score matching, associations persisted at 24 (aHR 0.69, 95 % CI 0.61-0.77, P < 0.001) and 48 h (aHR 0.80, 95 % CI 0.74-0.86, P < 0.001). Absent VTEp by 24 h was associated with increased VTE odds (aOR 1.84, 95 % CI 1.62-2.08, P < 0.001). Prolonged EDLOS delayed pharmacological VTEp in a nation-wide cohort of trauma patients. Absent VTEp, consequently, increased risk of in-hospital VTE, although future study is needed to validate these findings. Timely transfer of stable trauma patients to the floor may improve outcomes by facilitating appropriately timed VTEp administration and decreasing ED overcrowding.

Gender and Racial Disparities in the Impact of Factor V Leiden on Mortality and Venous Thromboembolic Outcomes Among Patients with Liver Cirrhosis: A National Inpatient Sample Analysis

Gender and Racial Disparities in the Impact of Factor V Leiden on Mortality and Venous Thromboembolic Outcomes Among Patients with Liver Cirrhosis: A National Inpatient Sample Analysis

Clinical Outcomes of Cancer-Associated Venous Thromboembolism in Patients with Gastrointestinal or Genitourinary Cancers Treated with Direct Oral Anticoagulant Vs. Low Molecular Weight Heparin

Clinical Outcomes of Cancer-Associated Venous Thromboembolism in Patients with Gastrointestinal or Genitourinary Cancers Treated with Direct Oral Anticoagulant Vs. Low Molecular Weight Heparin

Association between tumour somatic mutations and venous thromboembolism in the 100,000 Genomes Project cancer cohort: a study protocol

Venous thromboembolism (VTE) is a common cause of morbidity and mortality in patients with cancer. There is evidence that specific aberrations in tumour biology contribute to the pathophysiology of this condition. We plan to examine the association between tumour somatic mutations and VTE in an existing cohort of patients with cancer, who were enrolled to the flagship Genomics England 100,000 Genomes Project. Here, we outline an a-priori analysis plan to address this objective, including details on study cohort selection, exposure and outcome definitions, annotation of genetic variants and planned statistical analyses. We will assess the effect of 1) deleterious somatic DNA variants in each gene; 2) tumour mutational burden and 3) tumour mutational signatures on the rate of VTE (outcome) in a pan-cancer cohort. Sensitivity analyses will be performed to examine the robustness of any associations, including adjustment for potentially correlated co-variates: tumour type, stage and systemic anti-cancer therapy. We hope that results from this study may help to identify key genes which are implicated in the development of cancer associated thrombosis, which may shed light on related mechanistic pathways and/or provide data which can be integrated into genetic risk prediction models for these patients.

The Effects of Perioperative Gender-affirming Hormone Therapy on Facial Feminization Surgery Adverse Events, Facial Features Addressed, and Esthetic Satisfaction: A Multimodal Analysis.

Facial feminization surgery (FFS) treats gender dysphoria in transfeminine patients by addressing the facial bony and soft tissue components. Individuals seeking FFS may be taking gender-affirming hormone replacement therapy [gender-affirming hormone therapy (GAHT)]. This study aims to better characterize the GAHT's impact on venous thromboembolism (VTE) risk, surgical planning, and outcomes. A systematic review and meta-analysis of the literature were carried out to assess the effect of perioperative GAHT continuation on VTE. Cochrane Q and I2 statistics measured study heterogeneity with the following meta-regression exploring these results. Simultaneously, a retrospective review of the senior author's FFS cohort was conducted to investigate GAHT duration's impact on FFS revision rate, complication incidence, and facial structures operated on. Eleven articles were included: 602 patients stopped GAHT, of whom 3 VTEs were recorded (0.49%). This is compared with one episode among the 925 who continued GAHT perioperatively (0.11%). Study heterogeneity was low (0%), but limited VTE sample size precluded meta-analytic conclusions. Gender-affirming hormone therapy duration does not impact the incidence of all-cause complications (P = 0.478), wound infection (P = 0.283), hematoma (P = 0.283), or VTE (P = 1). The only procedures significantly less associated with higher GAHT were tracheal shaving (P = 0.002) and mandibuloplasty (P = 0.003). Finally, the FFS revision rate was not associated with GAHT duration (P = 0.06). There is a paucity of data to assess the safety or harm of continuing GAHT in the FFS perioperative period. Thus, a shared provider-patient decision-making process examining the risks and benefits of GAHT perioperative continuation is warranted. As patients seeking gender-affirming care are diverse, a "one-protocol-fits-all" is not appropriate.

Efficacy and safety of long-term edoxaban treatment for low body weight cancer patients with isolated distal deep vein thrombosis: a post-hoc subgroup analysis of the ONCO DVT study

Abstract Background Low body weight is known to be a bleeding risk in the anticoagulation treatment. ONCO DVT study revealed that 12-month edoxaban treatment for cancer patients with isolated distal deep vein thrombosis (DVT) reduced a composite outcome of a symptomatic recurrent venous thromboembolism (VTE) or VTE-related death compared with 3-month edoxaban treatment. However, the efficacy and safety of long-term edoxaban treatment for cancer patients with low body weight is unclear. Purpose In this subgroup analysis, we assessed the efficacy and safety of 12-month edoxaban treatment for low body weight cancer patients with isolated distal DVT. Methods We conducted a post-hoc subgroup analysis of the ONCO DVT study in the low body weight patients. ONCO DVT study was a multicenter, open-label, adjudicator-blinded, randomized clinical trial. Cancer patients with isolated distal DVT were assigned to 12-month or 3-month edoxaban treatment. The primary endpoint was a composite outcome of a symptomatic recurrent VTE or VTE-related death at 12 months. The major secondary endpoint was major bleeding at 12 months. We enrolled patients who met low body weight defined in Japanese Version of High Bleeding Risk criteria (&amp;lt;55 kg for men, &amp;lt;50 kg for women) and evaluated the efficacy and safety of 12-month edoxaban treatment using logistic regression models and log-rank test. Results Among 601 patients in the intention-to-treat population of ONCO DVT study, 322 patients (53.6%) met low body weight: 151 patients were in 12-month edoxaban group and 171 patients were in 3-month edoxaban group. The body weight was similar between two group (47.1±5.2 kg in 12-month edoxaban group vs. 46.9±5.4 kg in 3-month edoxaban group; P=0.77). All of them used a lower dose edoxaban (30 mg once daily) following the dose reduction criteria. 12-month edoxaban group had lower rates of the primary endpoint compared with 3-month edoxaban group (2 patients (1.3%) vs. 10 patients (5.8%); Odds ratio 0.22 [95% CI, 0.05–1.00]; Log-rank P=0.036). There was no significant difference in the major secondary endpoint of major bleeding (12 patients (7.9%) in 12-month edoxaban group vs. 16 patients (9.4%) in 3-month edoxaban group; Odds ratio 0.83 [95% CI, 0.38–1.83]; Log-rank P=0.65). All clinically relevant bleeding events occurred in 22 patients (14.6%) in 12-month edoxaban group and in 27 patients (15.8%) in 3-month edoxaban group (Odds ratio 1.40 [0.90–2.19]; Log rank P=0.13), resulting in the comparable risk of bleeding in the 12-month edoxaban group. Conclusions Our study suggests that 12-month edoxaban treatment for low body weight cancer patients with isolated distal DVT prevents recurrent VTE or VTE-related death without increasing the risk of bleeding compared to 3-month edoxaban treatment.primary endpointsecondary endpoint

Intravenous Direct Thrombin Inhibitors for Acute Venous Thromboembolism or Heparin-Induced Thrombocytopenia with Thrombosis in Children: A Systematic Review of the Literature.

Intravenous direct thrombin inhibitors (DTIs) are used for thromboembolic disorders. This systematic review aims to characterize intravenous DTI agents, dosing, monitoring strategies (or use), bleeding, and mortality, in pediatric patients with acute venous thromboembolism (VTE) or heparin-induced thrombocytopenia with thrombosis (HITT). MEDLINE, Embase, and Cochrane's CENTRAL were searched from inception through July 2023. Case series, retrospective studies, and prospective studies providing per-patient or summary data for patients < 18 years of age with VTE or HITT treated with an intravenous DTI were included. Selection and data extraction were conducted independently by two reviewers. Sixteen studies (7 case reports, 1 case series, 5 retrospective studies, 3 prospective studies) with 85 patients were included. Target conditions included acute VTE in 54 (64%) and HITT in 31 (36%) patients. Bivalirudin, argatroban, and lepirudin were used in 52 (61%), 27 (32%), and 6 (7%) patients, respectively. Fifty-two (61%) patients received a bolus dose, and weighted mean infusion rates for bivalirudin, argatroban, and lepirudin were 0.2 mg/kg/hr, 1.2 mcg/kg/min, and 0.15 mg/kg/hr, respectively. The activated partial thromboplastin time was utilized for monitoring in 82 (96%) patients. Complete or partial thrombus resolution was reported in 53 (62%) patients, mortality in 6 (7%) patients, and bleeding complications in 14 (16%) patients. In this systematic review involving 85 pediatric patients treated with an intravenous DTI for acute VTE or HITT, bivalirudin was the most commonly utilized agent, with a rate of resolution over 60% despite a high acuity in the population studied. Prospective collaborative studies are warranted to establish optimal dosing and further characterize VTE and bleeding outcomes.

Sex Disparities Affecting Postoperative Outcomes After Total Elbow Arthroplasty

To investigate sex disparities in 30-day postoperative outcomes of total elbow arthroplasty. The American College of Surgeons-National Surgical Quality Improvement Program files were queried for all patients who underwent a total elbow arthroplasty (TEA) between 2006 and 2020. Sex disparities in preoperative variables were studied using Fisher exact tests. Multivariate logistic regression models were used to determine the adjusted odds ratios (aOR) of postoperative outcomes for women in comparison with men. A total of 788 patients underwent a TEA in the period of 2006-2020. Of those, 180 were men, and 608 were women. We found an increase in TEAs performed each year with a predominance in females compared to males. Additionally, our work demonstrated increased statistically significant odds of a major adverse cardiac event (P < .0001), transfusions required (P < .0001), and return to the operating room (P < .0001) as postoperative outcomes in females compared to males following TEA. Finally, we found no statistically significant difference in mortality between the groups (P = 1). Following a TEA, women had higher adjusted postoperative odds of experiencing a major adverse cardiac event, requiring transfusion, and return to the operating room. No significant differences were found in wound outcomes, pulmonary outcomes, venous thromboembolic outcomes, sepsis, and length of stay. Overall mortality rates were similar between the two groups. Our study warrants further evaluation of the root cause of sex disparities in TEA outcomes and methods to improve care delivery to reduce those disparities. Prognostic 2b.

Elderly patients with venous thromboembolism: Insights from the RIETE registry

Venous thromboembolism (VTE) presents a notable healthcare burden, particularly among the elderly, who experience increased risks and more severe complications. This review aims to use the extensive data from the RIETE registry, a comprehensive database on consecutive patients with VTE. We examine the clinical features, therapeutic approaches, and patient outcomes of VTE in elderly patients, compared to younger patients, offering a comprehensive understanding of management challenges and emphasizing the need for strategies that accommodate the unique challenges of this population.

Incidence, risk factors, and outcomes of patients with monoclonal B-cell lymphocytosis and chronic lymphocytic leukemia who develop venous thromboembolism

BackgroundThe incidence, risk factors, and outcomes of venous thromboembolism (VTE) in patients with chronic lymphocytic leukemia (CLL) and monoclonal B-cell lymphocytosis (MBL) are not well described. ObjectivesWe aimed to determine the clinical characteristics, risk factors, and outcomes of incident VTE in patients with newly diagnosed MBL/CLL and compare the incidence to the age- and sex-matched general population. MethodsUsing the Mayo Clinic CLL Database, we identified 946 patients with newly diagnosed MBL/CLL between 1998 and 2021. Incidence of VTE was identified by querying the electronic health record for VTE-specific International Classification of Diseases-9 and -10 codes and reviewing results of radiographic studies. ResultsEighty patients developed VTE. The incidence of VTE in patients with newly diagnosed MBL/CLL was ∼1% per year. In multivariable analyses, prior history of VTE (hazard ratio [HR]: 5.33; 95% CI: 1.93-14.68, P = .001) and high/very high-risk CLL-International Prognostic Index score (HR: 2.63; 95% CI: 1.31-5.26; P = .006) were associated with an increased risk of VTE; receipt of CLL treatment or occurrence of nonhematologic malignancy was not. Development of VTE was associated with shorter overall survival (HR: 1.82, 95% CI: 1.30-2.55) after adjusting for age, sex, prior history of VTE, and Rai stage. The age- and sex-adjusted VTE incidence rate for patients with MBL/CLL and no prior history of VTE (n = 904) was 1254 per 100 000 person-years compared with 204 per 100 000 person-years in the general population, reflecting a 5.9-fold increase. ConclusionOur study demonstrates a 6-fold increased risk of VTE in patients with MBL/CLL compared with the age- and sex-matched general population.

Impact of COVID-19 in the incidence of venous thromboembolism (VTE) and clinical outcomes in cancer patients: a cohort study.

To determine the incidence of VTE and clinical outcomes in a cohort of cancer patients and COVID-19 infection, and to establish possible predictive factors of VTE. A single-center retrospective cohort study was performed to determine the incidence of VTE and mortality in 118 cancer patients with SARS-CoV-2 infection from March to August 2020. We calculated individual Khorana Risk and CATS-MICA scores in order to evaluate their utility to identify risk of VTE or death. Continuous variables were compared using Wilcoxon or Student's T test, and categorical variables were compared using the Chi-Square or Fisher's exact text among patients with and without VTE. A Log-Rank test was performed to detect mortality differences between the groups. A total of 118 patients were included. VTE global incidence was 4.2% (n = 5), and mortality 25.4% (n = 30). Obesity (p = 0.05), recent chemotherapy (p = 0.049) and use of steroids (p = 0.006) were related to higher risk of VTE in the univariate analysis, although they were not confirmed in the multivariate analysis as independent risk factors. Statistically significant differences in all-cause, COVID-19-related and cancer-related mortality according to the Khorana risk score (KRS) were observed. CATS-MICA score (CMS) also showed statistically significant differences in mortality between low- and high-risk patients. Prediction of risk of VTE development with these scores showed a tendency towards significance. In this cohort, VTE incidence was similar to previously reported in the general population with SARS-CoV-2 infection. KRS was associated with overall and specific-cause mortality, and might be a useful prognostic tool in this setting.

Tofacitinib Exposure Does Not Increase Postoperative Complications Among Patients With Ulcerative Colitis Undergoing Total Colectomy: A Retrospective Case-Control Study.

Ulcerative colitis, total colectomy, and tofacitinib have all been associated with an increased risk of venous thromboembolism. To determine whether preoperative tofacitinib exposure increases venous thromboembolism or other postoperative complications among patients with ulcerative colitis undergoing subtotal colectomy, total colectomy, or total proctocolectomy. Retrospective, case-controlled study at a single institution. A tertiary referral center. Adult patients with ulcerative colitis undergoing subtotal colectomy, total colectomy, or total proctocolectomy after 2018 who were taking tofacitinib within 30 days of surgery (n = 56) were compared to age- and sex-matched patients with ulcerative colitis undergoing the same surgeries but who were not exposed to tofacitinib (n = 56). The primary outcome was differences in the incidence of venous thromboembolism within 90 days of surgery based on tofacitinib exposure. Secondary outcomes were 90-day postoperative complications. Groups were well matched for age (non-tofacitinib: mean 35.2 years [SD 12.0], tofacitinib: 35.9 [SD 12.1], p = 0.36) and sex (41% women in each group, p = 1.00). Medical characteristics were similar between groups except for biological medication exposure 30 days before surgery (non-tofacitinib: 66%, tofacitinib: 36%, p = 0.004). Surgical characteristics did not differ between groups. Most patients were discharged on extended venous thromboembolism prophylaxis (non-tofacitinib: 80% and tofacitinib: 77%). Adjusted for biological exposure, there were no statistically significant differences in venous thromboembolism (non-tofacitinib exposed: 14%, tofacitinib exposed: 4%, p = 0.09) or other postoperative outcomes. Retrospective, single institutional study. Among patients with ulcerative colitis undergoing total colectomy or proctocolectomy, exposure to tofacitinib was not associated with an increased risk of venous thromboembolism or other postoperative complications. See Video Abstract . ANTECEDENTES:La colitis ulcerosa, la colectomía total y el tofacitinib han sido asociados con un mayor riesgo de tromboembolismo venoso.OBJETIVO:Determinar si la exposición preoperatoria a tofacitinib aumenta la tromboembolia venosa u otras complicaciones posoperatorias entre pacientes con colitis ulcerosa sometidos a colectomía subtotal, colectomía total o proctocolectomía total.DISEÑO:Estudio retrospectivo de casos y controles en una sola institución.AJUSTES:Un centro de referencia terciario.PACIENTES:Los pacientes adultos con colitis ulcerosa sometidos a colectomía subtotal, colectomía total o proctocolectomía total después del año 2018 que se encontraron consumiendo tofacitinib dentro de los 30 días posteriores a la cirugía (n = 56) fueron comparados con pacientes con colitis ulcerosa de la misma edad y sexo sometidos a las mismas cirugías pero que no estuvieron expuestos a tofacitinib (n = 56).MEDIDA DE RESULTADO PRINCIPAL:El resultado primario fueron las diferencias en las incidencias de tromboembolismo venoso dentro de los 90 días posteriores a la cirugía según la exposición a tofacitinib. Los resultados secundarios fueron las complicaciones posoperatorias a los 90 días.RESULTADOS:Los grupos se encontraban bien emparejados por edad (sin tofacitinib: media 35,2 años [DE 12,0], tofacitinib: 35,9 [DE 12,1], p = 0,36) y sexo (41% mujeres en cada grupo, p = 1,00). Las características médicas fueron similares entre los grupos, excepto por la exposición a medicamentos biológicos 30 días antes de la cirugía (sin tofacitinib: 66 %, tofacitinib: 36 %, p = 0,004). Las características quirúrgicas no difirieron entre los grupos. La mayoría de los pacientes fueron dados de alta con profilaxis extendida para tromboembolismo venoso (sin tofacitinib: 80% y tofacitinib: 77%). Ajustado a la exposición biológica, no hubo diferencias estadísticamente significativas en el tromboembolismo venoso (no expuestos a tofacitinib: 14%, expuestos a tofacitinib: 4%, p = 0,09) u otros resultados posoperatorios.LIMITACIÓN:Estudio institucional único, retrospectivo.CONCLUSIÓN:Entre los pacientes con colitis ulcerosa sometidos a colectomía total o proctocolectomía, la exposición a tofacitinib no se asoció con un mayor riesgo de tromboembolismo venoso u otras complicaciones posoperatorias. (Traducción-Dr Osvaldo Gauto ).

Temporal Changes in Long-Term Outcomes of Venous Thromboembolism From the Warfarin Era to the Direct Oral Anticoagulant Era.

There have been limited data on the changes in clinical outcomes after the introduction of direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) in real clinical practice. We evaluated the changes in management strategies and long-term outcomes from the warfarin era to the DOAC era. We compared the 2 series of multicenter COMMAND VTE (Contemporary Management and Outcomes in Patients With Venous Thromboembolism) registries in Japan enrolling consecutive patients with acute symptomatic VTE: Registry 1: 3027 patients in the warfarin era (2010-2014) and Registry 2: 5197 patients in the DOAC era (2015-2020). The prevalence of DOAC use increased more in Registry 2 than in the Registry 1 (Registry 1: 2.6% versus Registry 2: 79%, P<0.001). The cumulative 5-year incidence of recurrent VTE was significantly lower in Registry 2 than in Registry 1 (10.5% versus 9.5%, P=0.02), and the risk reduction of recurrent VTE in Registry 2 remained significant even after adjusting the confounders (hazard ratio [HR], 0.78 [95% CI, 0.65-0.93]; P=0.005). The cumulative 5-year incidence of major bleeding was not significantly different between the 2 registries (12.1% versus 13.7%, P=0.26), and the risk of major bleeding between the 2 registries was not significantly different even after adjusting the confounders (HR, 1.04 [95% CI, 0.89-1.21]; P=0.63). Along with the shift from warfarin to DOACs, there was a lower risk of recurrent VTE in the DOAC era than in the warfarin era, whereas there was no apparent change in the risk of major bleeding, which might still be an unmet need even in the DOAC era.

Comparative analysis of COVID-19-associated venous thromboembolism outcomes: evolution from 2020 to 2021-2022.

Patients with COVID-19 are at an increased risk for venous thromboembolism (VTE). With the advent of vaccinations and novel treatments from 2020 through 2022, the landscape of COVID-19 has evolved. Notably, the effects of such interventions on the outcomes of COVID-19-associated VTE have not been thoroughly examined. Data from the RIETE registry were analyzed to evaluate 90-day VTE-related outcomes (all-cause mortality, major bleeding, and VTE recurrences) in patients with COVID-19-associated VTE. We compared the periods before and after the widespread introduction of COVID-19 vaccines: March to December 2020 (pre-vaccine period) and March 2021 to December 2022 (post-vaccine period). Statistical analysis included mixed-effects parametric survival-time models. Among 1,620 patients with COVID-19-associated VTE, most (74.1%) were identified during 2020 period. The analysis revealed a more than two-fold increase in the risk of death within 90days (adjusted hazard ratio [HR]: 2.27; 95% confidence interval, CI: 1.18-4.38) and major bleeding (adjusted HR: 2.91; 95%CI: 1.08-7.84) for patients from the 2020 period compared to those from the 2021-2022 period. Inpatient subgroup analysis confirmed the observed mortality differences. The frequency of recurrent VTE was low (1.1 vs. 0.7%, respectively), and did not show significant variation between the two periods. Our research provides a comparative perspective on the clinical outcomes of COVID-19-associated VTE before and after the introduction of vaccines. Our findings reveal a significant decrease in the incidence of 90-day mortality and major bleeding in patients with COVID-19-associated VTE in the 2021-2022 period.

Short term outcome of neonatal venous thromboembolism in anticoagulated versus observed patients

BackgroundAdvancements in the medical field and increased survival of premature infants have led to a rise of venous thromboembolism (VTE) in neonates. Neonatal hemostasis exists in a delicate balance with a propensity towards pro-coagulation. Current recommendations include careful observation, therapeutic anti-coagulation and in some cases thrombolysis. We hypothesize that a sub-group of neonates may not require anti-coagulation and could be safely observed thus reducing their risk of bleeding complications. MethodsWe conducted a retrospective chart review of patients with VTE admitted to the neonatal intensive care unit at the Oklahoma University Children's Hospital from October 2009–October 2019. Patients were selected if they had an ICD-9 or ICD-10 code specific for a VTE or if screening with CPT codes for diagnostic imaging including echocardiogram, venous dopplers and computed topographic/magnetic resonance venogram revealed the word ‘thrombus’, ‘clot’ or ‘venous thromboembolism’. Data were collected about demographics, medical history, co-morbidities, thrombosis characteristics, treatment and outcome. ResultsA total of 211 patients were screened and 119 patients were eligible and included in the study. The majority of patients (85 %) had a central venous catheter (CVC) associated VTE. Two-thirds of patients (n = 81, 68 %) received therapeutic anti-coagulation while one-third (n = 38, 32 %) were observed. The group that received anticoagulation had a significantly older age at diagnosis and had a higher frequency of bacteremia, congenital heart disease and presence of symptoms. There was no difference in the odds of complete resolution between patients who were treated with therapeutic anti-coagulation and those that were observed (OR: 1.37, 95 % CI: 0.59–3.20, p-value: 0.47). Univariate analysis revealed maternal preeclampsia (OR: 0.2, 95 % CI: 0.05–0.82, p-value = 0.025), maternal history of chronic hypertension (OR: 0.17, 95 % CI: 0.04–0.68, p-value = 0.01), and presence of complete occlusion (OR = 0.37, 95 % CI: 0.15–0.91, p-value = 0.03) significantly reduced the odds of complete resolution. Furthermore, having a VTE related to a CVC in an extremity versus an ECMO cannula or cardiac catheterization significantly improved the odds of VTE resolution (OR = 5.94, 95 % CI: 1.30–27.20, p-value = 0.022). Using a stepwise regression model, maternal history of chronic hypertension remained significant for a reduced odds of VTE resolution (OR: 0.14, 95 % CI 0.025–0.73, p-value: 0.02). ConclusionsThe short-term outcome of neonatal VTE does not seem to differ between those that were anticoagulated and those that were observed with serial imaging.

P-752 Association between obesity in women with multiple gestations and adverse obstetric outcomes: a study of an American population database with over 136,000 unique deliveries

Abstract Study question The purpose of this study is to compare obese and non-obese women with multiple pregnancies to determine the effects on pregnancy, delivery, and neonatal outcomes. Summary answer Obesity and multiple gestations are independent risk factors for adverse obstetric outcomes. Combined, obesity in multiple gestation increases risk of maternal, delivery, and neonatal complications. What is known already Obesity is a pandemic and multiple pregnancies are a known consequence of assisted reproductive technologies. Obese women (body mass index [BMI] &amp;gt;30kg/m2) are at higher risk of hypertensive disorders, gestational diabetes, fetal growth complications, stillbirth, preterm birth, labour complications, caesarean deliveries, wound infection, venous thromboembolism, and adverse neonatal outcomes. Multiple gestation is associated with greater obstetric risks, including miscarriage, preterm birth, gestational diabetes, hypertensive disorders, operative delivery, postpartum hemorrhage, congenital anomalies, and fetal growth restriction. The combined effects are not well-established. Study design, size, duration We conducted a retrospective population-based study utilizing data collected between 2004 and 2014 inclusively, from the Healthcare Cost and Utilization Project-Nationwide Inpatient Sample. We evaluated deliveries using the international classification of diseases [ICD], ninth edition, clinical modification codes for delivery-related discharge diagnosis and birth-related procedural diagnosis. All women with a diagnosis of multiple pregnancies were selected. They were subsequently divided based on the ICD-9 code for obesity. A total of 137,303 multiple pregnancies were analyzed. Participants/materials, setting, methods Within the 137,303 multiple pregnancies, 130,542 (95%) were non-obese, while 6,761 (5%) were obese. An initial analysis was performed to identify the prevalence of obesity in women with multiple pregnancies. We then compared baseline clinical and demographic characteristics between women with obesity to those without obesity using chi-squared tests. Subsequently, binary logistic regression analyses were conducted to explore comparisons between the obese and non-obese groups while adjusting for the potential confounding effects. Main results and the role of chance Over the 11-year study period, there was a statistically significant increase in prevalence of obesity for women with multiple gestations (p &amp;lt; 0.0001). The obese group was at higher risk of pregnancy-induced hypertension (adjusted odd’s ratio [aOR]=1.89, 95% confidence interval [CI]=1.77-2.02), gestational hypertension (aOR=1.84, CI = 1.65-2.05), preeclampsia (aOR=1.68, CI = 1.55-1.81), preeclampsia or eclampsia superimposed on pre-existing hypertension (aOR=1.86, CI = 1.58-2.20), gestational diabetes mellitus (aOR=2.65, CI = 2.44-2.87), and placenta previa (aOR=0.57, CI = 0.39-0.85). They were more likely to have preterm premature rupture of membranes (aOR=1.19, CI = 1.06-1.34), chorioamnionitis (aOR=1.24, CI = 1.03-1.51), caesarean sections (aOR=1.28, CI = 1.18-1.38), wound complications (aOR=1.65, CI = 1.31-2.08), and transfusions (aOR=0.77, CI = 0.67-0.89). They were less likely to have small for gestational age neonates (aOR=0.88, CI = 0.79-0.97), though more likely to have neonates with congenital anomalies (aOR=1.56, CI = 1.16-2.10). Conversely, for certain factors, the outcomes were similar between obese and non-obese women with multiple gestation including rates of eclampsia (p = 0.07), abruptio placenta (p = 0.82), hysterectomy (p = 0.36), postpartum hemorrhage (p = 0.08), maternal death (p = 0.98), maternal infection (p = 0.10), deep vein thrombosis (p = 0.17), pulmonary embolism (p = 0.75), venous thromboembolism (p = 0.15), disseminated intravascular coagulation (p = 0.85) and intrauterine fetal demise (p = 0.52). Limitations, reasons for caution The database is retrospective and relies on hospitals reporting elevated body mass index, which may not always be consistently recognized, potentially resulting in an underestimation of the total number of obese women. However, this only stands to support the increased risks detected in this study as being legitimate. Wider implications of the findings We addresses a significant gap in the literature by simultaneously exploring the impacts of multiple pregnancies and maternal obesity on obstetric complications. This can guide clinical practice, encouraging single embryo transfer in obese women undergoing in-vitro fertilization and tailored care for obese patients with multiple pregnancies, anticipating the associated risks. Trial registration number not applicable

Impact of Clinical Decision Support with Mandatory versus Voluntary Venous Thromboembolism Risk Assessment in Hospitalized Patients.

Background Venous thromboembolism (VTE) causes significant preventable morbidity and mortality in hospitalized patients. Assessing VTE risk is essential to initiating appropriate prophylaxis and reducing VTE outcomes. Studies show that computerized clinical decision support (CDS) can improve VTE risk assessment (RA), prophylaxis, and outcomes but few examined the effectiveness of specific design features. From 2008 to 2016, University of Michigan Health implemented CDS for VTE prevention in four stages, which alternated between voluntary and mandatory RA using the 2005 Caprini model and generated inpatient orders for risk-appropriate prophylaxis based on CHEST guidelines. This cross-sectional study evaluated the impact of mandatory versus voluntary RA on VTE prophylaxis and outcomes for adult medical and surgical patients admitted to the health system. Methods Interrupted time series analysis was conducted to evaluate the trend in smart order set-recommended VTE prophylaxis by CDS stage. Logistic regression with CDS stage as the primary independent variable was used in pairwise comparisons of VTE during hospitalization and within 90 days post-discharge for mandatory versus voluntary RA. Adjusted odd ratios (ORs) were calculated for total, in-hospital, and post-discharge VTE. Results In this study of 223,405 inpatients over 8 years, smart order set-recommended prophylaxis increased from 65 to 79%; it increased significantly when voluntary RA in Stage 1 became mandatory in Stage 2 (10.59%, p < 0.001) and decreased significantly when it returned to voluntary in Stage 3 (-11.24%, p < 0.001). The rate increased slightly when mandatory RA was reestablished in Stage 4 (0.23%, p = 0.935). Adjusted ORs for VTE were lower for mandatory RA versus adjacent stages with voluntary RA. The adjusted OR for Stage 2 versus Stage 1 was 14% lower ( p < 0.05) and versus Stage 3 was 11% lower ( p < 0.05). The adjusted OR for Stage 4 versus Stage 3 was 4% lower ( p = 0.60). These results were driven by changes in in-hospital VTE. By contrast, the incidence of post-discharge VTE increased in each successive stage. Conclusion Mandatory RA was more effective in improving smart order set-recommended prophylaxis and VTE outcomes, particularly in-hospital VTE. Post-discharge VTE increased despite high adherence to risk-appropriate prophylaxis, indicating that guidelines for extended, post-discharge prophylaxis are needed to further reduce VTE for hospitalized patients.

Incidence, Predictors, and Outcomes of Venous and Arterial Thrombosis in COVID-19: A Nationwide Inpatient Analysis

Coronavirus disease 2019 (COVID-19) is known to increase the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE). However, the incidence, predictors, and outcomes of clinical thrombosis for inpatients with COVID-19 are not well known. This study aimed to enhance our understanding of clinical thrombosis in COVID-19, its associated factors, and mortality outcomes. Hospitalised adult (≥18 years of age) patients with COVID-19 in 2020 were retrospectively identified from the US National Inpatient Sample database. Clinical characteristics, incident VTE, ATE, and in-hospital mortality outcomes were recorded. Multivariable logistic regression was performed to identify clinical factors associated with thrombosis and in-hospital mortality in COVID-19 inpatients. A total of 1,583,135 adult patients with COVID-19 in the year 2020 were identified from the National Inpatient Sample database; patients with thrombosis were 41% females with a mean age of 65.4 (65.1-65.6) years. The incidence of thrombosis was 6.1% (97,185), including VTE at 4.8% (76,125), ATE at 3.0% (47,790), and the in-hospital mortality rate was 13.4% (212,785). Patients with thrombosis were more likely to have respiratory symptoms of COVID-19 (76.7% vs 75%, p<0.001) compared with patients without thrombosis. The main factors associated with overall thrombosis, VTE, and ATE were paralysis, ventilation, solid tumours without metastasis, metastatic cancer, and acute liver failure. Although all thrombosis categories were associated with higher in-hospital mortality for COVID-19 inpatients in univariable analyses (p<0.001), they were not in multivariable analyses-thrombosis (odds ratio [OR] 1.24; 95% confidence interval [CI] 0.90-1.70; p=0.19), VTE (OR 0.70; 95% CI 0.52-1.00; p=0.05), and ATE (OR 1.07; 95% CI 0.92-1.25; p=0.36). The association of COVID-19 with thrombosis and VTE increases with increasing severity of the COVID-19 disease. Risk stratification of thrombosis is crucial in COVID-19 patients to determine the necessity of thromboprophylaxis.