Pulmonary Embolism Events Research Articles

Management and outcomes of superficial vein thrombosis: a single-center retrospective study

BackgroundGuidelines suggest but cannot recommend the optimal management of superficial vein thrombosis (SVT). ObjectivesTo identify the prevalence of asymptomatic deep vein thrombosis (DVT) at the time of SVT diagnosis, and to report the treatment and 3-month complications of patients with only SVT more than 3 cm from deep vein junction (or unknown distance). MethodsWe performed a single-center retrospective review of patients referred to the Ottawa Hospital thrombosis unit with ultrasound (US)-diagnosed SVT, and followed patients with only SVT for 3 months. ResultsThree hundred sixteen patients with SVT were included. Of the 218 patients without DVT symptoms at presentation, 19 (8.7%; 95% CI, 5.7%-13.2%) were found to have asymptomatic concomitant DVT (11 proximal and 8 distal), and 45 (20.6%) had SVT within 3 cm of the saphenofemoral or saphenopopliteal junctions. Among the 192 patients diagnosed with SVT only, we observed 3-month thrombotic complications in 56 (29.2%; 95% CI, 23.2%-36.0%) patients, with a total of 69 events: 11 (5.7%) DVTs, 2 (1.0%) pulmonary embolisms, 37 (19.2%) SVT extensions, and 19 (9.8%) SVT recurrences. Eighty-two percent (9/11) of the 3-month DVT and pulmonary embolism events occurred in patients who initially received conservative management. Therapeutic treatment doses were most effective. ConclusionAt the time of SVT diagnosis, many patients had asymptomatic DVT and SVT near the deep venous system, supporting the systematic use of initial US in patients clinically diagnosed with SVT. The observed differences in 3-month complication rates, according to the treatment provided, highlight the need for large-scale randomized controlled trials to establish optimal management.

Abstract 14344: Pitfalls of ICD-10 Codes for Identifying Pulmonary Embolism in Electronic Records: Results From the Multicenter PE-EHR+ Study

Background: Many research studies from electronic databases and even the American Heart Association annual statistics for pulmonary embolism (PE) rely on the International Classification of Disease, 10 th modification (ICD-10) codes. However, the validity of ICD-10 codes for PE remains uncertain. Methods: Using a pre-specified protocol, we identified three groups of patients in the Mass General-Brigham Health system hospitals (MGB, 2016-2021) in equal distribution: Those with ICD-10 Principal discharge codes for PE, those with ICD-10 secondary codes for PE, and those without codes for PE (N=578 each). The accuracy of ICD-10 codes for identification of PE was assessed in reference to review of each chart by two independent physicians who used pre-specified criteria for presence of PE. Weighted estimates were obtained by considering the total of number of hospitalizations at MGB in each group. Results: After excluding duplicates, 1712 entered the analysis (age: 60.6 years, 52.3% female). Using the ICD-10 PEs only in the Principal discharge diagnosis, sensitivity and specificity were 60.3% and 94.6%, respectively. Although use of Principal-or-secondary ICD-10 PE codes had a sensitivity of 99.8% in the study sample, the weighted sensitivity in the parent cohort was reduced to 83.2%. The positive predictive value of Principal ICD-10 discharge codes and Principal-or-secondary ICD-10 codes were 91.9% and 79.2%, respectively (Table). Conclusions: Although the Principal discharge diagnosis codes for PE have an excellent positive predictive value, they miss nearly 40% of new PE events in hospitalized patients. Integration of secondary discharge codes only partially improves the sensitivity at the cost of reducing the positive predictive value, highlighting the need for modified strategies, such as use combination with procedure codes, or use of natural language processing -when feasible -for identification of patients with PE.

Incidence and Risk Factors for Thrombosis in Cancer Patients with COVID-19

Introduction: Cancer is a leading cause of morbidity and mortality in the United States, and cancer patients infected with COVID-19 are at increased risk of death. Given that cancer and COVID-19 are both risk factors for thrombosis, it has been hypothesized that cancer patients with COVID-19 may be at greater risk for thromboembolic events than patients with COVID-19 alone. This risk could necessitate the need for more vigilant thrombosis prophylaxis. However, studies investigating risk factors for thromboembolic events in this population are limited with mixed results. We aimed to determine the incidence and risk factors for thromboembolic events in patients with cancer and COVID-19. Methods: We performed a retrospective cohort review of all cancer patients hospitalized with COVID-19 at our institution between January 1, 2021 and April 1, 2023. Patients over the age of 18 who had previously been diagnosed with cancer, received treatment within the prior 6 months, and had been hospitalized due to COVID-19 were included in the study. We assessed whether patients had experienced a thromboembolic event during their hospital stay, which included thrombosis of the extracorporeal circuit, distal or proximal lower extremity deep venous thrombosis (DVT), upper extremity DVT, pulmonary embolism, superficial thrombophlebitis, ischemic stroke, or other arterial event. Information regarding comorbidities and clinical course was extracted from the patient's record. Descriptive analysis was performed, and association between qualitative variables was studied with the Chi-squared test and the Fisher Exact test, when appropriate. For quantitative variables, the t-test or the Mann-Whitney U test was performed. Multivariate logistic regression was used to assess variables predictive of thromboembolic events. Results: 456 patients with cancer and COVID-19 were included in the study. The median age was 69 years (IQR 62 - 78) and 55% of patients were male. The majority (85%) of patients were White. Most patients had either lung (19%) or bone marrow (17%) cancer, and 196 (43%) had received chemotherapy in the 6 months prior to hospitalization. 37 patients (8.1%) had thromboembolic events during their hospital stay. Age, race, receipt of chemotherapy, and history of hypertension, heart disease, obesity, and stroke were not predictive of thromboembolic events. Patients with thromboembolic events experienced significantly longer lengths of hospital stay than those without thromboembolic events (9 days vs 12 days, p<0.05). Conclusion: Thromboembolic events affect many cancer patients with COVID-19 and may complicate their treatment course during hospitalization. Patients who experienced a thromboembolic event had prolonged hospital stays, which may lead to increased financial and emotional burden in this patient population. Evidence-based strategies for preventing thrombosis, including pharmacologic and mechanical methods, should be emphasized in hospitalized cancer patients with COVID-19, which may decrease thrombotic complications. Further, methods of secondary thrombosis prophylaxis, such as early detection with screening methods or treatment of subclinical methods, should be encouraged. Future studies should promote risk classification in this patient population and optimal prophylaxis paradigms.

Prevalence and Impact of COVID-19 in Young Women of Reproductive Age [18-44 Years] Hospitalized with Pulmonary Embolism in the US in 2020 Using National Inpatient Sample Dataset, in-Hospital Mortality, Racial Disparity and Predictors of Mortality

Title: Prevalence and Impact of COVID -19 on In-hospital Outcomes and Associated Racial Disparities in Young Women of Reproductive Age Group (18-44 years) Hospitalized with Pulmonary Embolism in the US in 2020 Background: Given the potential of thrombotic events such as pulmonary embolism in COVID-19, it is essential to comprehend the specific risks and effects on young women of reproductive age, a high-risk group for venous thromboembolism. There is a paucity of data regarding the prevalence and impact of COVID-19 in young women within the reproductive age group who were hospitalized with pulmonary embolism (PE) in the United States during the year 2020. Methods: Utilizing the National Inpatient Sample (NIS) 2020 and relevant ICD-10-CM codes, we identified admissions for PE with COVID-19 vs. without COVID-19 among Young Women [18-44 years] hospitalized with PE. We compared the baseline characteristics and comorbidities between the two groups with and without COVID-19. Furthermore, we analyzed the multivariable adjusted odds ratio (OR) of all-cause mortality in COVID-19 with the non-COVID-19 cohort as a referent, subgroup odds for white vs. other races, and effect modification by diabetes mellitus (DM) as a comorbidity. Results: We identified 34,730 hospitalizations in young female patients of the reproductive age group (18 to 44 years) in 2020 with the diagnosis of PE, of which 2345 (6.8%) had COVID-19. The prevalence of PE was higher in COVID-19 cohort (1.6% vs. 0.6%, p<0.001). The majority of the patients with PE were Caucasian (58.9%) and in the lowest median income quartile (36.9%). Analysis of various comorbidities in both cohorts revealed a statistically significant higher prevalence of hypertension (29.6% in those with COVID-19 vs. 24.3% in those without COVID-19, p <0.001), Similarly, hyperlipidemia (11.7% vs. 7.3%, p <0.001), DM (20.9% vs. 12.4%, p <0.001), and obesity (50.3% vs. 32.7%, p <0.001), were more prevalent in COVID-19, indicating that patients who were admitted with PE with concomitant COVID-19 were of poorer overall cardiovascular health than those with COVID-19. Unadjusted all-cause mortality odds ratio was 2.41 (1.71-3.38, p <0.001) in PE with COVID-19 than non-COVID-19. Adjusted all-cause mortality for demographics, hospital level covariates, and pre-existing conditions revealed similar statistically significant findings, with the odds ratio being 2.8 (1.94-4.04, p <0.001). There was no racial disparity observed in all-cause mortality for non-whites compared to white patients admitted with PE and COVID-19 (p=0.064). Furthermore, all-cause mortality in patients with COVID-19 and PE was found to have an odds ratio of 3.04 (1.05-8.81, p=0.041) in a subset of DM compared to non-DM. The results have confirmed a further robust positive association with increasing mortality risk with DM in young women hospitalized with PE and COVID-19. Conclusion and Relevance: There was a nearly three times higher prevalence of PE and 2.5 times higher odds of mortality in Young Women of Reproductive age [18-44 years] hospitalized with PE with COVID-19 as compared to without COVID-19. The effect of PE and a higher risk of mortality are already established with COVID-19; however, there is a paucity of data in young women, which warrants more prospective studies to evaluate the long-term thromboembolic risks of PE and associated events in this population. The findings of this research could have significant implications for understanding the relationship between COVID-19 and PE in this patient population. Special emphasis needs to be laid on improved healthcare strategies, targeted interventions, and patient education in this cohort to establish future research agendas and provide better health care outcomes for this vulnerable group with established risk factors like diabetes. Key Words: COVID-19, Young Women, Pulmonary Embolism, In-Hospital Mortality, Racial Disparity, Predictors of Mortality, Diabetes Mellitus, National Inpatient Sample

Symptoms Suggestive of Postpulmonary Embolism Syndrome and Utilization of Diagnostic Testing.

Persistent symptoms of chest pain, dyspnea, fatigue, lightheadedness, and/or syncope more than 3 months after an acute pulmonary embolism (PE) are collectively classified as postpulmonary embolism syndrome (PPES). Although PPES is increasingly recognized as an important long-term sequel of acute PE, its contemporary incidence is unclear. Furthermore, the utilization of diagnostic testing for further phenotypic characterization of these patients is unknown. This study aimed to define the incidence of PPES and evaluate the utilization of diagnostic tests among a national cohort of patients with PE. Retrospective cohort study was performed using the national administrative database, Clinformatics DataMart Database (Optum Insight), and included adult patients (18 years or older) with no history of acute PE or pulmonary hypertension, diagnosed with acute PE between October 1, 2016, and December 31, 2018. With acute PE event as the exposure, the incidence of symptoms consistent with PPES and diagnostic test utilization among patients with PPES were evaluated. Of 21,297 incident patients with acute PE, 11,969 (56.2%) showed ≥1 symptom of PPES, which was new since their pre-PE baseline. New dyspnea was the most common and noted in 3268/15,203 (21.5%) patients, followed by new malaise or fatigue in 2894/15,643 (18.5%) patients. Among the 11,969 patients with PPES, 5128 (42.8%) received ≥1 diagnostic test, with 3242 (27%) receiving a computed tomography pulmonary angiogram, 2997 (25%) receiving an echocardiogram, and 325 (2.7%) received a ventilation-perfusion scan within 3-12 months after PE. Significantly lower use of diagnostic testing was noted in patients older than 65 years (adjusted odds ratio, 0.89; 95% CI, 0.81-0.98). Symptoms consistent with PPES are common after acute PE, occurring in more than half of the patients. Diagnostic imaging for further phenotypic characterization is used in less than half of such patients with PPES.

Non-steroidal anti-inflammatory drugs and risk of pulmonary embolism in patients with inflammatory joint disease-results from the nationwide Norwegian Cardio-rheuma registry.

Patients with inflammatory joint diseases (IJD), including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) have increased rates of pulmonary embolism (PE). Non-steroidal anti-inflammatory drugs (NSAIDs) use is associated with PE in the general population. Our aim was to evaluate the association between NSAIDs use and PE in IJD patients. Using individual-level registry data from the whole Norwegian population, including data from the Norwegian Patient Registry and the Norwegian Prescription Database, we: (1) evaluated PE risk in IJD compared to non-IJD individuals, (2) applied the self-controlled case series method to evaluate if PE risks were associated with use of traditional NSAIDs (tNSAIDs) and selective cox-2 inhibitors (coxibs). After a one-year wash-out period, we followed 4660475 adults, including 74001 with IJD (RA: 39 050, PsA: 20803, and axSpA: 18591) for a median of 9.0 years. Crude PE incidence rates per 1000 patient years were 2.02 in IJD and 1.01 in non-IJD individuals. Age and sex adjusted hazard ratios for PE events were 1.57 for IJD patients compared to non-IJD. Incidence rate ratios (IRR) [95% confidence interval (CI)] for PE during tNSAIDs use were 0.78 (0.64-0.94, P=0.010) in IJD and 1.68 (1.61-1.76, P<0.001) in non-IJD. IRR (95% CI) for PE during coxibs use was 1.75 (1.10-2.79, P=0.018) in IJD and 2.80 (2.47-3.18, P<0.001) for non-IJD. Pulmonary embolism rates appeared to be higher in IJD than among non-IJD subjects in our study. Traditional NSAIDs may protect against PE in IJD patients, while coxibs may associated with increased PE risk.

Venous thromboembolism associated with severe dyspnoea and asthma in 102 792 adults.

The most recent guideline on acute pulmonary embolism (PE) indicates possible long-term sequelae such as dyspnoea and chronic thromboembolic pulmonary hypertension after a PE event. However, effects on lung function or asthma risk have not been evaluated in the general population. We tested whether individuals with a venous thromboembolism (VTE) encompassing PE and deep vein thrombosis (DVT) have reduced lung function, or greater risks of dyspnoea and asthma using data from 102 792 adults from the Copenhagen General Population Study. Diagnoses of PE, DVT and asthma were collected from the national Danish Patient Registry. Factor V Leiden and prothrombin G20210A gene variants were determined using TaqMan assays. Prevalences of PE, DVT and VTE were 2.2%, 3.6% and 5.2%, respectively. Individuals with VTE had forced expiratory volume in 1 s of 92% predicted compared with 96% pred in individuals without VTE (p<0.001). Individuals with VTE versus those without had adjusted OR (95% CI) for light, moderate and severe dyspnoea of 1.4 (1.2-1.6), 1.6 (1.4-1.8) and 1.7 (1.5-1.9), respectively. Individuals with VTE versus those without had an adjusted OR for asthma of 1.6 (95% CI 1.4-1.8). Factor V Leiden and prothrombin G20210A genotype also associated with increased risk of asthma (p for trend=0.002). Population-attributable fractions of severe dyspnoea and asthma due to VTE were 3.5% and 3.0%, respectively, in the population. Individuals with VTE have worse lung function and higher risks of severe dyspnoea and asthma, and may account for 3.5% and 3.0% of people with severe dyspnoea and asthma, respectively, in the general population.

Enoxaparin versus Placebo to Prevent Symptomatic Venous Thromboembolism in Hospitalized Older Adult Medical Patients

BackgroundAdmission to the hospital is a major risk factor for the development of venous thromboembolism (VTE). Whether thromboprophylaxis with low-molecular-weight heparin prevents symptomatic VTE in medically ill, hospitalized older adults remains debated.MethodsIn a prospective, randomized, placebo-controlled, double-blind, multicenter trial, older adults (>70 years of age) hospitalized for acute medical conditions were randomly assigned to receive 40 mg a day of low-molecular-weight heparin (enoxaparin) or placebo for 6 to 14 days. The primary efficacy outcome was the cumulative incidence of symptomatic VTE (distal or proximal deep vein thrombosis, fatal or nonfatal pulmonary embolism) at 30 days. The primary safety outcome was major bleeding. Secondary outcomes included efficacy and safety outcomes at 90 days.ResultsThe trial was prematurely discontinued in September 2020, 5 years after enrollment began, because of drug supply issues. By the time of trial discontinuation, 2559 patients had been randomly assigned at 47 centers. Median age was 82 years and 60% of patients were female. In the intention-to-treat population, the primary efficacy outcome occurred in 22 out of 1278 (cumulative incidence, 1.8%) patients in the enoxaparin group and in 27 out of 1263 (cumulative incidence, 2.2%) patients in the placebo group (cumulative incidence difference, −0.4 percentage points; 95% confidence interval, −1.5 to 0.7), with no significant difference in time to VTE (P=0.46). The incidence of major bleeding was 0.9% in the enoxaparin group and 1.0% in the placebo group. At 90 days there were 14 symptomatic pulmonary emboli in the enoxaparin group and 25 in the placebo group; all 39 pulmonary embolism events resulted in hospital readmission and/or death, with 5 deaths from pulmonary embolism in the enoxaparin group and 11 deaths in the placebo group.ConclusionsThis trial of thromboprophylaxis in medically ill, hospitalized older adults did not demonstrate that enoxaparin reduced the risk of symptomatic VTE after 1 month. Because the trial was prematurely discontinued, larger trials are needed to definitively address this question. (Funded by the French Ministry of Health Programme Hospitalier de Recherche Clinique, grant number PHRC-N-13-0283; ClinicalTrials.gov number, NCT02379806.)

3830 lead extraction from two patients with left bundle branch area pacing.

3830 lead extraction from two patients with left bundle branch area pacing.

Long-term mortality in patients with pulmonary embolism: results in a single-center registry

BackgroundWhile numerous studies have investigated short-term outcomes after pulmonary embolism (PE), long-term mortality remains insufficiently studied. ObjectivesTo investigate long-term outcomes in an unselected cohort of patients with PE. MethodsA total of 896 consecutive patients with PE enrolled in a single-center registry between May 2005 and December 2017 were followed up for up to 14 years. The observed mortality rate was compared with the expected rate in the general population. ResultsThe total follow-up time was 3908 patient-years (median, 3.1 years). The 1- and 5-year mortality rates were 19.7% (95% CI, 17.2%-22.4%) and 37.1% (95% CI, 33.6%-40.5%), respectively. The most frequent causes of death were cancer (28.5%), PE (19.4%), infections (13.9%), and cardiovascular events (11.6%). Late mortality (after >30 days) was more frequent than expected in the general population, a finding that was consistent in patients without cancer (the 5-year standardized mortality ratios were 2.77 [95% CI, 2.41-3.16] and 1.80 [95% CI, 1.50-2.14], respectively). Active cancer was the strongest risk factor for death between 30 days and 3 years (hazard ratio [HR], 6.51; 95% CI, 4.67-9.08) but was not associated with later mortality. Death after >3 years was predicted by age (HR, 1.86; 95% CI, 1.51-2.29 per decade), chronic heart failure (HR, 1.66; 95% CI, 1.02-2.70), and anemia (HR, 1.62; 95% CI, 1.09-2.41). ConclusionThe risk of mortality in patients with PE remained elevated compared with that in the general population throughout the follow-up period. The main driver of long-term mortality during the first 3 years was cancer. After that, mortality was predicted by age, chronic heart failure, and anemia.

Impact of homelessness on outcomes among pancreatic cancer hospitalization: Insight from the 2016-2020 National Inpatient Sample.

e16264 Background: Homelessness is a major socio-economic issue in the United States, affecting an estimated 171 per 100,000 persons in certain states. While pancreatic cancer (PC) tends to have a poor prognosis, the disease requires an early diagnosis, proper care, and follow-ups. As there is a paucity of data highlighting differences in patient characteristics and outcomes of homeless patients with PC, a retrospective study was conducted via a national database. Methods: We used data from the 2016-2020 National Inpatient Sample (NIS), the most extensive hospital database, to identify patients with a diagnosis of pancreatic cancer. Patients with a status of “homeless” were located via the ICD-10 code “Z590”, per suggestions from HCUP and past studies. Several differences in patient characteristics were explored between homeless cases of PC and non-homeless cases via Pearson’s Chi-Square tests. Finally, the adjusted odds ratio (aOR) and 95% Confidence intervals (CI) of various outcomes such as mortality, pulmonary embolism, septicemia, and hepatic failure were calculated via multivariable logistic regression models. Results: Our study identified 544855 pancreatic cancer cases, including 1380 patients classified as homeless (0.3%). 81.5% of homeless patients were males (vs. 52.1%), and 24.6% were admitted on weekends (vs. 20.6%). Moreover, Medicaid was the prime insurer among homeless patients (47.6% vs. 8.6%) with a higher mean hospital charge ($86796 vs. $70610). Racial differences were also observed as 51.9% of homeless cases were Whites (vs. 71.2%), while 31.6% (vs. 13.8%) were Blacks, and 11.3% (vs. 8.2%) were Hispanics. A higher proportion of homeless cases had palliative care utilization (27.9% vs. 19.1%), a Do-Not-Resuscitate (DNR) order (25.7% vs. 23.1%), and required pancreatic and proximal biliary dilation/stenting (4.0% vs. 2.2%). Homeless patients admitted with pancreatic cancer also expressed higher odds of in-hospital mortality (8.7% vs. 7.4%, aOR 1.625, 95% CI 1.280-2.064, p&lt;0.01). No statistical significance was found for events of pulmonary embolism (aOR 1.231, p=0.160), septicemia (aOR 1.044, p=0.674), and hepatic failure (aOR 0.892, p=0.549). Conclusions: Homeless patients with PC were linked with higher in-patient mortality. Various racial and socio-economic differences were also observed. Several efforts to ameliorate access to care among homeless patients and an early diagnosis may help improve the outcomes.

(035) Risk of Post-Operative Venous Thromboembolism in Patients Undergoing Gender Affirming Surgery: An Assessment of 1,731 Patients

Abstract Introduction Venous thromboembolism (VTE) is a source of significant morbidity and mortality in the post-operative setting. However, poor follow up and the ability for patients to present to other hospital systems for post-operative care, have made assessment of the incidence of post-operative VTE difficult. As a result, previous attempts to assess VTE risk following gender affirming surgery have been limited to small volume, single institution studies. It has been hypothesized that patients undergoing gender affirming surgery may be at increased risk of post-operative VTE given the concomitant use of hormone therapy. Objective To assess the risk of venous thromboembolism and associated risk factors following feminizing and masculinizing gender affirming surgery. Methods Using IBM MarketScan, a commercial claims database, patients undergoing feminizing and masculinizing surgery were identified using Current Procedural Terminology (CPT), ICD-9, and ICD-10 procedure codes between 2011 and 2020. ICD-9 and ICD-10 codes were used to identify healthcare visits associated with lower extremity deep vein thrombosis (DVT) and pulmonary embolism (PE) within 90-days of surgery. Covariates including diabetes, peripheral vascular disease, cardiovascular disease, hypertension, varicose veins, hypercoagulable state, smoking history, and prior VTE were assessed. Given the small cohort size of men undergoing masculinizing surgery, descriptive statistics, including the 90-day incidence, were performed. In patients undergoing feminizing surgery, descriptive and univariate statistics were performed including Kruskal-Wallis tests (continuous variables) or Chi-squared/Fischer’s exact tests (categorical variables). Results 1,731 patients underwent feminizing surgery (1,588) or masculinizing (143) surgery between 2011 and 2020 with a median age (interquartile range) of 34 years (22, 53) and 35 years (26, 46), respectively. A history of DVT or PE events prior to gender affirming surgery was identified in 1.07% (feminizing) and 0.7% (masculinizing). DVT or PE events within 90-days following feminizing surgery and masculinizing surgery occurred in 1.07% and 0.7%, respectively. On univariable analysis, increasing age (p&amp;lt;0.001), bladder cancer (p&amp;lt;0.001), prior cystoprostatectomy (p=0.001), diabetes (p=0.007), cardiovascular disease (p&amp;lt;0.001), hypertension (p=0.04), prior DVT (p&amp;lt;0.001), and prior PE (p&amp;lt;0.001) were associated with increased likelihood of post-operative VTE in patients undergoing feminizing gender affirming surgery. Conclusions In a cohort of patients undergoing gender affirming surgery, the risk of post-operative VTE was low with 1.07% (feminizing) and 0.7% (masculinizing) of patients developing a VTE event within 90 days of surgery. In patients undergoing feminizing gender affirming surgery, increasing age, bladder cancer, cystoprostatectomy, diabetes, cardiovascular disease, hypertension, prior DVT, and prior PE were associated with an increased likelihood of developing a postoperative DVT or PE. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Cooper Medical, Boston Scientific, Acerus, Coloplast, Turtle Health, Maximus, FirmTech, StreamDx, Inherent Bioscience.

Venous thromboembolism recurrence among one-and-done direct oral anticoagulant users: a retrospective longitudinal study.

Direct oral anticoagulants (DOACs) are the American Society of Hematology guideline-recommended treatment for venous thromboembolism (VTE) in the United States (US). To compare risk of VTE recurrence between patients who, following the first fill, discontinued ("one-and-done") versus those who continued ("continuers") DOACs. Open source US insurance claims data (04/1/2017 to 10/31/2020) were used to select adult patients with VTE initiated on DOACs (index date). Patients with only one DOAC claim during the 45-day landmark period (starting on the index date) were classified as one-and-done and the remaining as continuers. Inverse probability of treatment weighting was used to reweight baseline characteristics between cohorts. VTE recurrence based on the first post-index deep vein thrombosis or pulmonary embolism event was compared using weighted Kaplan-Meier and Cox proportional hazard models from landmark period end to clinical activity or data end. 27% of patients initiating DOACs were classified as one-and-done. After weighting, 117,186 and 116,587 patients were included in the one-and-done and continuer cohorts, respectively (mean age 60years; 53% female; mean follow-up 15months). After 12months of follow-up, the probability of VTE recurrence was 3.99% and 3.36% in the one-and-done and continuer cohorts; the risk of recurrence was 19% higher in the one-and-done cohort (hazard ratio [95% confidence interval] = 1.19 [1.13, 1.25]). Substantial proportion of patients discontinued DOAC therapy after the first fill, which was associated with significantly higher risk of VTE recurrence. Early access to DOACs should be encouraged to reduce the risk of VTE recurrence.

Sex-Specific Risk Factors for Deep Venous Thrombosis and Pulmonary Embolism in a Population-Based Historical Cohort Study of Middle-Aged and Older Individuals.

Background Whether sex-specific differences exist for risk factors for pulmonary embolism (PE) and deep venous thrombosis (DVT), with the exception of pregnancy and estrogen therapy, has been sparsely studied. We aimed to study whether sex-specific differences of risk factors exist for noncancer-related DVT and PE in middle-aged and older individuals without cardiovascular history or previous diagnosis in a population-based historical (retrospective) cohort. Methods and Results Potential venous thromboembolism (VTE) risk factors were registered at baseline in 15 807 women and 9996 men aged 44 to 74 years, who participated in the Malmö Diet and Cancer study (1991-1996). We excluded subjects with a previous history of VTE, cancer, a diagnosis of cardiovascular disease, or a diagnosis of cancer-associated VTE during follow-up. Patients were followed up from baseline until the first event of PE or DVT, death, or December 31, 2018. During the follow-up period, 365 (2.3%) women and 168 (1.7%) men were affected by first DVT, and 309 (2.0%) women and 154 (1.5%) men were affected by first PE. In the multivariable Cox regression models, the anthropometric obesity markers of weight, body mass index, waist and hip circumference, fat percentage, and muscle weight were in a dose-dependent way associated with DVT and PE among women but not men. In an analysis that included patients with cardiovascular disease and cancer-related VTE, the results were similar for women. For men, several obesity measures became significantly associated with PE or DVT but were weaker than in women, especially for DVT. Conclusions Anthropometric obesity measures are more important risk factors for both DVT and PE among women than men, especially for individuals without cardiovascular history or previous diagnosis or cancer-related VTE.

Venous Thromboembolic Event Following Soft Tissue Sarcoma Diagnosis is Associated with the Development of Pulmonary Metastasis.

This study aimed to investigate whether venous thromboembolic events (VTEs) are clinically relevant predictors of pulmonary metastatic disease in patients with soft tissue sarcomas (STSs). In this retrospective cohort analysis, we included patients with STS surgically treated for sarcoma between January 2002 and January 2020. The primary outcome of interest was development of pulmonary metastasis after non-metastatic STS diagnosis. Tumor depth, stage, type of surgical intervention, chemotherapy, radiation therapy, body mass index, and smoking status were collected. Episodes of VTEs following STS diagnosis, including deep vein thrombosis, pulmonary embolism, and other thromboembolic events, were also obtained. Univariate analyses and multivariable logistic regression were used to identify potential predictors for pulmonary metastasis. We included 319 patients with mean age of 54.9±16 years. Thirty-seven patients (11.6%) had VTE after STS diagnosis, and 54 (16.9%) developed pulmonary metastasis. Univariate screening revealed pulmonary metastasis, pre- and postoperative chemotherapy, smoking history, and VTE after surgery as potential predictors of pulmonary metastasis. Multivariable logistic regression revealed smoking history [odds ratio (OR) 2.0, confidence interval (CI) 1.1-3.9, P=0.04] and VTE (OR 6.3, CI 2.9-13.6, P<0.001) as independent risk factors for predicting pulmonary metastasis in patients with STS, after adjusting for the factors in the univariate screening as well as age, sex, stage of the tumor, and neurovascular invasion. Patients with VTE after STS diagnosis have an odds ratio of 6.3 for developing metastatic pulmonary disease compared with patients without venous thromboembolic events. Smoking history was also associated with future pulmonary metastases.

Anterior Cervical Discectomy and Fusion Outcomes in Patients With and Without Bariatric Surgery-Weight Loss Does Make a Difference.

A retrospective comparative cohort study. To compare outcomes of elective non-obese anterior cervical discectomy and fusion (ACDF) patients with those that underwent bariatric surgery (BS). Morbid obesity (MO) has been associated with an increased risk of complications following procedures such as elective ACDF. While pre-emptive BS has been considered for those with MO (body mass index [BMI] ≥35kg/m 2 ), the impact of this intervention on BMI and its resultant correlation with surgical outcomes remains limited. The PearlDiver 2010-Q1 2020 MSpine database was used to identify patients undergoing elective isolated ACDF. Three sub-cohorts were defined as follows: (1) Non-obese controls without a history of BS, (2) patients with BS procedure within two years with a BMI <35kg/m 2 (BS+MO-), and (3) patients with BS procedure within the two years with a BMI ≥35kg/m 2 (BS+MO+). Univariate and multivariate regression analyses were performed to compare 90-day adverse event rates adjusting for age, sex, Elixhauser Comorbidity Index, and length of stay. Kaplan-Meier analysis was performed to assess five-year cervical reoperation rates. Of 160,166 elective ACDF patients, prior BS was identified for 479. Of these, 136 patients were BS+MO- and 343 were BS+MO+. On multivariate analysis, BS+MO- were not at increased odds of adverse events, but BS+MO+ were at greater odds of 90-day pulmonary embolism (odds ratio 3.28, P =0.043), wound dehiscence (5.02, P <0.001), hematomas (2.52, P =0.042), and overall minor adverse events (1.61, P =0.011) compared with controls. Five-year reoperation rates were not significantly different between the groups. Twenty-eight percent of those with BS before ACDF fell out of the categorization of MO. Among this group, the odds of adverse events were similar to non-obese patients. These findings suggest that the psychological preparation and BS alone are insufficient to reduce the risk of adverse events after ACDF. Weight reduction must be achieved as well, ideally moving patients out of the BMI range for morbid obesity.

Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture

BackgroundClinical guidelines recommend low-molecular-weight heparin for thromboprophylaxis in patients with fractures, but trials of its effectiveness as compared with aspirin are lacking.MethodsIn this pragmatic, multicenter, randomized, noninferiority trial, we enrolled patients 18 years of age or older who had a fracture of an extremity (anywhere from hip to midfoot or shoulder to wrist) that had been treated operatively or who had any pelvic or acetabular fracture. Patients were randomly assigned to receive low-molecular-weight heparin (enoxaparin) at a dose of 30 mg twice daily or aspirin at a dose of 81 mg twice daily while they were in the hospital. After hospital discharge, the patients continued to receive thromboprophylaxis according to the clinical protocols of each hospital. The primary outcome was death from any cause at 90 days. Secondary outcomes were nonfatal pulmonary embolism, deep-vein thrombosis, and bleeding complications.ResultsA total of 12,211 patients were randomly assigned to receive aspirin (6101 patients) or low-molecular-weight heparin (6110 patients). Patients had a mean (±SD) age of 44.6±17.8 years, 0.7% had a history of venous thromboembolism, and 2.5% had a history of cancer. Patients received a mean of 8.8±10.6 in-hospital thromboprophylaxis doses and were prescribed a median 21-day supply of thromboprophylaxis at discharge. Death occurred in 47 patients (0.78%) in the aspirin group and in 45 patients (0.73%) in the low-molecular-weight–heparin group (difference, 0.05 percentage points; 96.2% confidence interval, −0.27 to 0.38; P<0.001 for a noninferiority margin of 0.75 percentage points). Deep-vein thrombosis occurred in 2.51% of patients in the aspirin group and 1.71% in the low-molecular-weight–heparin group (difference, 0.80 percentage points; 95% CI, 0.28 to 1.31). The incidence of pulmonary embolism (1.49% in each group), bleeding complications, and other serious adverse events were similar in the two groups.ConclusionsIn patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture, thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin in preventing death and was associated with low incidences of deep-vein thrombosis and pulmonary embolism and low 90-day mortality. (Funded by the Patient-Centered Outcomes Research Institute; PREVENT CLOT ClinicalTrials.gov number, NCT02984384.)

Retrograde venous coil embolization prior to transarterial chemoembolization in hepatocellular carcinoma with arterio-hepatic venous shunts.

PURPOSE This study explored the clinical efficacy of transcatheter retrograde shunt occlusion with coils to prevent pulmonary oil or particle embolization prior to transarterial chemoembolization (TACE) in patients with artero-hepatic venous shunts (AHVS) secondary to hepatocellular carcinoma (HCC). METHODS From July 2017 to January 2021, 6 patients with advanced, unresectable HCC were found to have an AHVS by hepatic arteriography at the time of attempted TACE. The AHVS was embolized ret rogradely with metal coils through a transfemoral or transjugular venous approach. After venous embolization and confirmation of the absence of the AHVS, TACE was performed using an emul sion of iodized oil and doxorubicin or drug-eluting beads. Follow-up computed tomography (CT) was performed within 1 month after the first TACE to evaluate the results and complications. RESULTS Hepatic angiography after venous embolization showed that AHVS had utterly disappeared in all patients during the operation. The immediate technical success of the retrograde venous embo lization was 100%. The AHVS had disappeared entirely during the follow-up period through triple-phase enhancement CT scanning. According to the modified response evaluation criteria in solid tumors, TACE in all 6 patients had a disease control response rate of 100% (6/6) with complete response in 2 patients and partial response in 4 patients. One patient died during the 6-month follow-up, and the other 5 were still alive. No complications related to pulmonary embolism occurred. CONCLUSION Retrograde venous coil embolization of AHVS via the draining hepatic vein appears to be a safe, feasible, and effective treatment to allow TACE treatment without pulmonary embolic events. This approach appears to provide better tumor control and effectively decreases the occurrence of pulmonary embolism.

Systematic Literature Review and Meta-analysis of Venous Thromboembolism Events in Systemic Lupus Erythematosus.

The objective of this work was to conduct a systematic literature review (SLR) and meta-analysis (MA) to evaluate the relative risk (RR) of venous thromboembolism (VTE) events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients with systemic lupus erythematosus (SLE) compared with patients without SLE, as well as the absolute risk (AR) (measured by incidence proportion) and incidence rate (IR) of VTE events in patients with SLE. The SLR was conducted using Embase, MEDLINE, and MEDLINE In-Process to identify observational studies evaluating the risk of VTE, DVT, and PE events in adult patients with SLE compared with the general population, published January 2000 to September 2020. Random-effects models were used as the primary approach in the MA. Heterogeneity was assessed on the basis of the I2 value. Sensitivity analyses were performed to assess the robustness of results to various conditions, and subgroup analysis was performed for the AR of VTE by antiphospholipid status (aPLs) and antiphospholipid syndrome (APS). Of the 50 publications included for data extraction, 44 contained data for consideration in the MA of any one of the measures of interest (RR, AR, or IR) for VTE, DVT, or PE. The pooled RR indicates statistically significantly higher risk of VTE (RR 4.38, 95% confidence interval 2.63-7.29) in patients with SLE compared with the general population. Considerable heterogeneity was present in nearly all MA (I2 = 75-100%). Moreover, a higher pooled AR of VTE was estimated in patients with SLE with aPLs (n/N = 0.13) and APS (n/N = 0.63) compared with patients with SLE without aPLs/APS (n/N = 0.07). Overall, there was evidence of an increased risk of VTE, DVT, and PE in patients with SLE compared with the general population.

Bevacizumab for the Treatment of Patients With Brain Radionecrosis

&#x0D; This review identified limited evidence regarding the clinical effectiveness and safety of bevacizumab for patients with symptomatic brain radionecrosis after radiosurgery. These identified studies had several limitations, most notably due to the limited number of studies with control groups; therefore, the findings related to the effectiveness and safety in this population are uncertain.&#x0D; For adult patients with symptomatic brain radionecrosis, treatment with bevacizumab may be associated with radiographic responses, a reduction in volumetric outcomes, an improvement in overall clinical and neurologic symptoms, an improvement in functional outcomes, and a reduction in corticosteroid use.&#x0D; Limited evidence from 1 study suggests that treatment with bevacizumab may be associated with greater radiographic response, a reduction in volumetric outcomes, and clinical symptom improvement compared to treatment with corticosteroids. The recurrence of brain radionecrosis for patients who received bevacizumab compared to corticosteroids was similar between groups.&#x0D; Commonly reported adverse events after patients with symptomatic brain radionecrosis were treated with bevacizumab included hypertension, proteinuria, edema, pulmonary embolism, and various thromboembolic events.&#x0D;