Risk Factors For Thromboembolic Events Research Articles

Atrial high-rate episodes and thromboembolism in patients without atrial fibrillation: The West Birmingham Atrial Fibrillation Project

BackgroundPatients with cardiac implantable electronic device (CIED) developing atrial high-rate episodes (AHRE) have a significant risk of thromboembolic events (TEs), but risk factors have been scarcely investigated. ObjectivesTo analyze risk factors for TEs in a contemporary cohort of patients with CIED. MethodsConsecutive non-AF patients without anticoagulation at baseline were followed up after the CIED implantation. The role of newly-developed AHRE and other risk factors for TEs were analyzed using a time-dependent Cox regression model and Kaplan-Meier analysis with log-rank tests. ResultsA total of 594 CIED patients were followed up for a mean of 4.2 years: 175 developed AHRE (29.5%; incident rate [IR] 8.80% per patient-year). Of those, 33 experienced TEs (5.5%; IR 1.38% per patient-year). Incidence of TEs was low in patients with a CHA2DS2-VASc score < 2 (male)/<3 (female) (AHRE vs. no-AHRE, 0.60% vs. 0.00% per patient-year, p = 0.469) and high in those with score ≥ 2 (male)/≥3 (female) (AHRE vs. no-AHRE, 2.12% vs. 1.36% per patient-year, p = 0.209), regardless of the AHRE presence. AHRE was not significantly associated with TEs (hazard ratio [HR], 1.46 [0.64–3.33]). There was no temporal relationship between AHRE and TEs. Baseline CHA2DS2-VASc score was independently associated with TEs (HR, 1.41 [1.13–1.75]) on multivariate analysis, but not AHRE. ConclusionsThromboembolic risk in patients with CIED is mainly driven by comorbidity burden, i.e., CHA2DS2-VASc score, rather than AHRE per se. Decision-making on stroke prevention needs to focus on comorbidity burden and not merely on the presence or absence of AHRE in CIED patients.

Direct Oral Anticoagulants: An Evaluation of the Safety and Efficacy in Cardiothoracic Transplant Recipients

Purpose The use of direct oral anticoagulants (DOACs) has not been fully adopted by the solid organ transplant (SOT) community due to several transplant-specific factors including, fluctuating renal function, drug-drug interactions, routine biopsies, and the limited availability of reversal agents. In addition, there is limited data evaluating the safety and efficacy of using DOACs in SOT recipients. The purpose of this study is to assess the safety and efficacy of apixaban versus non-apixaban DOAC (NA-DOAC) therapy in cardiothoracic transplant recipients (CTRs). Methods A single center, retrospective chart review of heart, heart-kidney, and lung transplant recipients who received DOAC therapy between 1/1/2011-6/31/2018. Patients lost to follow-up or receiving a DOAC for less than one month were excluded. Results A total of 38 CTRs were included in the study with 26 (68.4%) receiving apixaban and 12 (31.6%) receiving NA-DOAC therapy (dabigatran n=2; rivaroxaban n=10). Baseline demographics were similar between the two cohorts (Table 1). There were numerically lower bleeding (12% vs. 25%, p = 0.35) and thromboembolic (15% vs. 33%, p=0.23) events in the apixaban vs. the NA-DOAC group. Potential risk factors for bleeding events in CTRs included age ≥72 (p=0.02), single-lung transplant recipients (p=0.006), and a HAS-BLED score ≥3 (p=0.03). There were no statistically significant risk factors for thromboembolic events, however, patients with events (n=8) were dosed below the recommended package insert dosing (50% vs. 27%, p=0.71). Conclusion Apixaban appears to be the more favorable DOAC in SOT patients due to decreased rates of bleeding and thromboembolic events. Patient-specific characteristics should be taken into consideration when initiating DOAC therapy in SOT patients.

Abstract WP528: Safety and Effectiveness of Rivaroxaban Among Japanese Elderly Patients With Nonvalvular Atrial Fibrillation in Everyday Clinical Practice

Introduction: Nonvalvular atrial fibrillation (AF) is common in elderly patients, who face increased risk of thromboembolism and bleeding during antithrombotic therapy. Xarelto post-authorization safety &amp; effectiveness study in Japanese patients with atrial fibrillation (XAPASS) is a prospective observational post-marketing surveillance study mandated by the Japanese authority. It aims to examine safety and effectiveness of rivaroxaban in everyday clinical practice. This analysis evaluated one-year outcomes and patient characteristics associated with major bleeding or thromboembolic events among elderly patients enrolled in XAPASS. Methods: A total of 11,308 patients with AF newly starting rivaroxaban were enrolled between April 2012 and June 2014. As of September 2017, one year follow-up data were collected from 9578 patients, and 4685 patients (48.9%) were aged ≥75 years. Results: Patients aged ≥75 years had higher rates of major bleeding (2.22 versus 1.35 events per 100 patient-years; p=0.004), and the composite endpoint of stroke, systemic embolism or myocardial infarction (2.41 versus 1.21 events per 100 patient-years; p&lt;0.0001) compared with those aged &lt;75 years. Rates of intracranial hemorrhage were less than 1% in both patient groups aged ≥75 years and &lt;75 years (0.85 versus 0.59 events per 100 patient-years). There was no significant difference in major bleeding or thromboembolism among patients in age groups of 75-79, 80-84, and ≥85 years. Multivariate analysis identified hepatic impairment and concomitant use of acetylsalicylic acid as risk factors of major bleeding events in patients aged ≥75 years (p=0.041 and p&lt;0.0001, respectively). History of stroke was identified as a risk factor of thromboembolic events in the same patient group (p&lt;0.0001). Conclusions: Although elderly patients had higher rates of bleeding and thromboembolic events than younger patients, no significant difference was found in the outcomes between age groups of 75-79, 80-84, and ≥85 years. Benefit and risk of antithrombotic therapy should be thoroughly assessed in elderly patients. Additionally, elderly patients with risk factors of bleeding or thromboembolic events should be carefully monitored while taking anticoagulants.

Hypoalbuminemia as a risk factor for thromboembolic events in inflammatory bowel disease inpatients.

Background/AimsInflammatory bowel disease (IBD) are chronic entities characterized by local and systemic inflammation and may be associated with thrombosis. The aim of this study was to identify the prevalence of thromboembolic events (TEE) in hospitalized IBD patients and identify risk factors for their occurrence. MethodsThis retrospective, single-center study included patients treated at a Brazilian IBD referral unit between 2004 and 2014. Patients hospitalized for more than 48 hours due to active IBD and who did not receive prophylaxis for TEE during hospitalization were included. Patients were allocated to 2 groups: those with TEE up to 30 days or at the time of hospitalization (TEE-group) and patients without TEE (control-group). Clinical and laboratory characteristics were evaluated. ResultsOf 53 patients evaluated, 69,8% with Crohn’s disease (CD) and 30.2% with ulcerative colitis (UC). The prevalence of TEE 30 days before or during hospitalization was 15.1%, with 10.8% in CD and 25% in UC. In the TEE group, mean serum albumin was 2.06 g/dL versus 3.30 g/dL in the control group. Patients with albumin levels below 2.95 g/dL (43.18%) had a higher risk of developing TEE (relative risk, 1.72; 95% confidence interval, 1.17–2.53) (P<0.001). ConclusionsAlbumin levels were significantly lower in patients with TEE, and hypoalbuminemia was considered a risk factor for the development of TEE in this population.

Predictive factors for cancer-associated thrombosis in a large retrospective single-center study.

The relationship between cancer and thrombosis has been studied for years, but reliable guidelines for thromboprophylaxis in that situation are still unclear. We retrospectively reviewed the files of 3159 consecutive patients with newly diagnosed solid tumors at Jules Bordet Institute from January 2008 to December 2011. Among them, 99 developed a symptomatic thromboembolic episode and were matched with 2 controls (nested case control). The aim was to identify risk factors of thromboembolic events and to validate in our setting the Khorana score. In the cohort study, nodal status ≥ 2, presence of metastases, and primary tumor site were found to be the most significant predictive factors of a thromboembolic event (n = 99; 3.1%) in the multivariate analysis. In the nested study (n = 265), hemoglobin < 13g/dL or treatment with a red cell growth factor, CRP ≥ 31.6mg/L, creatinine level > 0.96mg/dL, chronic inflammatory disease, and personal or familial history of thromboembolic events were found to be the most significant predictive factors of a thromboembolic event in the multivariate analysis. In our population, the sensitivity, specificity, positive predictive value, and negative predictive value of the Khorana score were respectively 29%, 93%, 15%, and 96%. We confirm the value of the risk factors identified in the literature with the additional presence of nodal involvement, elevated CRP, and creatinine levels, which may be helpful for patient risk stratification and should be considered in future clinical trials. Our results also suggest that the Khorana score might help to identify patients who can safely be spared of thromboprophylaxis.

Submitral Aneurysm Secondary to Infective Endocarditis: Review of Literature and Case Report

Submitral aneurysm is seldom reported worldwide. It is thought to be caused by weakness in the cardiac musculature due to abnormal embryogenesis. Mostly these aneurysms were reported from Africa in black African population. Apart from congenital cause, many other causes have been put forth as its etiology. Among these endocarditis is a known infective etiology. Submitral aneurysm secondary to left sided infective endocarditis is rare. The definitive diagnostic modality and treatment of submitral aneurysm remains echocardiography and surgical correction of aneurysm respectively. The submitral aneurysms as well as infective endocarditis both are known independent risk factors for thromboembolic events and subsequent stroke increasing both morbidity and mortality. The management of submitral aneurysm includes surgical correction by repair of the aneurysm but it requires careful consideration of surgical resection of diseased paravalvular tissue or diseased mitral valve and correction of mitral regurgitation by preforming mitral valve replacement. The surgical approach reduces the risk of recurrent endocarditis and thromboembolic events, thus reducing the risk of stroke. Prior to surgery, patient should receive prophylactic antibiotics for one to two weeks to control any active infective endocarditis. For us successful treatment of a patient suffering from submitral aneurysm due to infective endocarditis was challenging. We are reporting a case of submitral aneurysm secondary to infective endocarditis along with review of literature on infective endocarditis and submitral aneurysma.

A review and analysis of strategies for prediction, prevention and management of post-operative atrial fibrillation after non-cardiac thoracic surgery.

Atrial fibrillation (AF) is the most common sustained arrhythmia after non-cardiac thoracic surgery and is associated with a significant increase in perioperative morbidity, intensive care unit (ICU) admission, and mortality. Practical guidance is needed to assist clinicians in managing this critical issue and direct further research. Here we aim to provide a synoptic review and analysis of the literature to distil practical recommendations for prediction, prevention and management of post-operative atrial fibrillation (POAF) suitable for clinical application and further evaluation. To predict POAF, risk factors including age, gender, elevated pre-operative heart rate and extent of surgical resection have been reproducibly identified and integrated into scoring systems. To prevent POAF, prophylactic therapy with beta-blockers, amiodarone, or magnesium have demonstrated to be effective, but need further trials in high-risk populations. To manage unstable POAF that precipitates hypotension and hypoperfusion, although rare, requires immediate electrocardioversion to restore cardiac output and adequate oxygen delivery. For hemodynamically stable patients, rate control and prevention of adverse events are the objectives. We propose an individualized approach aimed at rate control using initial incremental low dose beta-blocker or calcium channel blocker (CCB) therapy with close monitoring of a patient's response, and continuation of the drug that they respond to, along with simultaneous identification and reduction of triggers of AF, in order for spontaneous return to sinus rhythm. For patients who persistently fail to respond to rate control therapy, rhythm control may be considered using an agent selected based on the patient's comorbidities and the medications' side effect profile. While controversial and requiring further study, anticoagulation therapy is recommended in patients with risk factors for thromboembolic events after 48 hours of persistent AF. We recommend continuous prospective monitoring of incidence and severity of POAF to track the impact of protocols to predict, prevent and manage POAF.

Thromboembolism and Mortality in the Tasmanian Atrial Fibrillation Study.

Although utilization of anticoagulation in patients with atrial fibrillation (AF) has increased in recent years, contemporary data regarding thromboembolism and mortality incidence rates are limited outside of clinical trials. This study aimed to investigate the impact of the direct oral anticoagulants (DOACs) on the clinical outcomes of patients with AF included in the Tasmanian Atrial Fibrillation Study. The medical records of all patients with a primary or secondary diagnosis of AF who presented to public hospitals in Tasmania, Australia, between 2011 and 2015, were retrospectively reviewed. We investigated overall thromboembolic events (TEs), ischemic stroke/transient ischemic attack (IS/TIA), and mortality incidence rates in patients admitted to the Royal Hobart Hospital, the main teaching hospital in the state. We compared outcomes in 2 time periods: prior to the availability of DOACs (pre-DOAC; 2011 to mid-2013) and following their general availability after government subsidization (post-DOAC; mid-2013 to 2015). Of the 2390 patients with AF admitted during the overall study period, 942 patients newly prescribed an antithrombotic medication (465 and 477 from the pre-DOAC and post-DOAC time periods, respectively) were followed. We observed a significant decrease in the incidence rates of overall TE (3.2 vs 1.7 per 100 patient-years [PY]; P < .001) and IS/TIA (2.1 vs 1.3 per 100 PY; P = .022) in the post-DOAC compared to the pre-DOAC period. All-cause mortality was significantly lower in the post-DOAC period (2.9 vs 2.2 per 100 PY, P = .028). Increasing age, prior stroke, and admission in the pre-DOAC era were all risk factors for TE, IS/TIA, and mortality in this study population. The risk of IS/TIA was more than doubled (hazard ratio: 2.54; 95% confidence interval: 1.17-5.52) in current smokers compared to ex- and nonsmokers. Thromboembolic event and all-cause mortality rates were lower following the widespread availability of DOACs in this population.

Serum Free Light Chain Difference and β2 Microglobulin Levels Are Risk Factors for Thromboembolic Events in Patients With AL Amyloidosis

BackgroundAL amyloidosis might increase the risk of thromboembolism and other plasma cell dyscrasias; however, only a few reports have described the clinical features of thromboembolism. The present study aimed to elucidate the clinical features of thromboembolic events and to identify the risk factors for these events. Materials and MethodsThe medical records were retrospectively reviewed to define the clinically significant thromboembolic events. ResultsA total of 106 patients with biopsy-proven AL amyloidosis were included. During a median follow-up of 18.1 months (range, 0.4-166.9 months), 13 thromboembolism events were identified in 13 patients. Of the 13 patients, 9 (8.5%) experienced acute cerebral infarction, 2 (1.9%) experienced pulmonary embolism, and 2 (1.9%) experienced deep vein thrombosis. Patients with a higher serum free light chain (FLC) difference (≥ 172.4 mg/L) or β2-microglobulin (β2MG) levels (≥ 2.78 mg/L) experienced significantly more thromboembolic events compared with those with a lower value according to multivariable analysis (for FLC difference: hazard ratio, 4.309; 95% confidence interval, 1.158-16.032; P = .029; for β2MG: hazard ratio, 9.739; 95% confidence interval, 1.127-84.174; P = .039). Most thromboembolic events (11 of 13; 84.6%) occurred within the first year after the AL amyloidosis diagnosis. ConclusionThe incidence of thromboembolism was substantial in those with AL amyloidosis. A greater FLC difference and for β2MG levels were risk factors for thromboembolic events.

Evaluation of hypercoagulability with rotational thromboelastometry in children with iron deficiency anemia

ABSTRACT Objective: Iron deficiency anemia (IDA) has been demonstrated to be a risk factor for thromboembolic events, although the pathogenesis of the development of thromboembolism in IDA is as yet unclear. The likelihood of children with IDA contracting hypercoagulability was evaluated in this cross-sectional study using rotational thromboelastometry (ROTEM). Material and Method: A total of 57 children with IDA (median age 11 years; 37 female, 20 male) and 48 healthy children (median age 9.9 years; 23 female, 25 male) were enrolled in the study. Whole blood count, serum iron, transferrin saturation, ferritin level, prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen levels were ascertained, while ROTEM assays [intrinsic TEM (INTEM) and extrinsic TEM (EXTEM)] were used to measure and analyze coagulation time (CT), clot formation time (CFT), maximum clot firmness (MCF) and rate of maximum lysis (ML60%). This study conforms to ethical standards, has been approved by the appropriate Institutional Review Board. Results: Hemoglobin, serum iron, transferrin saturation and ferritin levels were lower in the IDA group than in the control group (p < 0.001, for all), while the EXTEM and INTEM CT in the two groups were similar (p > 0.05). The EXTEM and INTEM MCF in the IDA group was higher than in the control group, while the INTEM CFT and rate of ML60% were lower than in the control group (p < 0.001, p < 0.001, p < 0.05, p < 0.001, respectively). Conclusion: The ROTEM results suggest that although the platelet count and coagulation tests were within normal ranges in IDA, the tendency to coagulate may have been increased.

Young Investigator: Hypoalbuminemia as Risk Factor for Thromboembolic Events in Hospitalized Inflammatory Bowel Disease Patients: An Observational and Retrospective Analysis

BACKGROUND: Inflammatory bowel diseases (IBD) are chronic entities characterized by local and systemic inflammation that predominantly affects the gastrointestinal tract and may be associated with numerous extraintestinal manifestations including thrombosis. The association between IBD and thromboembolic events (TEE) was first described in 1936 in a study involving more than 1000 patients with IBD followed at the Mayo Clinic. TEE were found in 1.2% of the cases. Since then, several studies have demonstrated such association. The incidence of TEE in patients with IBD ranges from 1.2-6.7%, increasing to 39% in post mortem. Such events occur mostly at a time when IBD is active and (or) with complications such as stenosis, fistulas and abscesses. The aim of this study was to identify the prevalence of TEE in hospitalized IBD patients and find risk factors for its occurrence. METHODS: This was a retrospective single-center longitudinal study carried out by reviewing the medical records of patients with IBD from the gastroenterology and colorectal surgery units at the University of Campinas, Brazil, between 2004 and 2014. Patients hospitalized for more than 48 hours, due to active IBD and who did not use prophylaxis for TEE during hospitalization, were included. Patients with hematopoietic systemic diseases or with coagulopathies, using anticoagulant medications up to 30 days before admission and pregnant women were excluded. Patients were allocated in two groups: those with TEE up to 30 days or at the time of hospitalization (TEE-group) and patients without TEE (control-group). Clinical characteristics (disease duration, medical therapy, extra-intestinal manifestations, disease activity) and laboratorial characteristics (complete blood count, CRP, ESR, albumin, pre albumin, coagulogram) of the patients were evaluated. RESULTS: 45 patients, 23 (51.1%) female were evaluated. 32 patients (71.1%) had Crohn's disease (CD) and 13 (28.9%) ulcerative colitis (UC). At the time of admission, 24.4% of the patients were off treatment due to the recent diagnosis. Only 4.4% of the patients were active smokers and 8.9% were previous smokers. 56.5% of the women used hormonal contraceptive methods. The mean biochemical factors related to the nutritional aspect (albumin and pre-albumin) were reduced (albumin: 3.07±0.94g/dL, pre-albumin: 16.79±10.8mg/dL). Both mean serum albumin and pre-albumin levels were lower in CD (albumin: 2.9±0.93g/dL, pre-albumin: 12.37±8.9mg/dL). The prevalence of TEE, 30 days before or during hospitalization, was 17.7%(n=8), 12.5% in CD and 30.7% in UC. There was no difference between the gender. Patients with TEE presented depletion of the anthropometric status, BMI= 17.6±3.26Kg/m2 in relation to the control group 23.2±3.7Kg/m2. In TEE group, mean serum albumin was 2.06±0.62g/dL vs 3.3±0.85g/dL in the control group. In univariate analysis, only hypoalbuminemia was considered a risk factor for TEE. Individuals with hypoalbuminemia (values below 2.62g/dL) had a 14.8 fold higher chance of developing any TEE (P<0.001). CONCLUSION(S): TEE were identified in 17.7% of admitted IBD patients. Albumin levels were significantly lower in individuals with TEE. Hypoalbuminemia was a risk factor for the development of TEE in IBD. Serum albumin dosage is a simple and accessible test that can be used in the risk stratification of active IBD patients.

Can catheter ablation reduce the incidence of thromboembolic events in patients with atrial fibrillation?: Protocol for a systematic review and meta-analysis.

Atrial fibrillation (AF), the most common cardiac arrhythmia, is a major risk factor for thromboembolic events, especially ischemic stroke. Catheter ablation is an effective method to maintain sinus rhythm in patients with AF. Although some observational studies have shown a relatively lower stroke rate after catheter ablation, whether catheter ablation can reduce the thromboembolic risk in patients with AF remains unclear. We aim to perform a systematic review to determine whether catheter ablation can prevent thromboembolism in patients with AF.PubMed, Embase, the Web of Science, and the Cochrane Library will be searched from January 2000 to the present for randomized controlled trials (RCTs) and non-randomized studies on catheter ablation in patients with AF. Other relevant sources, such as the references and conference proceedings, will also be manually retrieved. All studies will be limited to publication in English. The primary outcome will be thromboembolic events, including stroke, transient ischemic attack, and systemic embolic events. Study screening, data collection, and study quality assessment will be independently performed by 2 researchers. Disagreements will be resolved through team discussion or consultation with a third arbitrator. The risk of bias will be appraised using the Cochrane Collaboration tool and the Newcastle–Ottawa scale according to the different study designs, and a meta-analysis will be performed using RevMan V.5.3 software. The results will be presented as risk ratios and 95% confidence intervals for dichotomous data and continuous outcomes.Catheter ablation is an effective method to cure atrial fibrillation and maintain sinus rhythm. Although it is intuitive that if AF is eliminated, the thromboembolism in the heart would be abolished, and sequently the incidence of thromboembolic events would be decreased, this in fact has not yet been clarified. This systematic review and meta-analysis will be performed with the aim of comprehensively identifying studies that have reported the impact of AF ablation on thromboembolic events in patients with non-valvular AF by comparing an ablation group and non-ablation group. These outcomes will not only produce useful evidence-based data regarding the influence of catheter ablation on thromboembolic events in patients with AF but will also provide some guidance regarding anticoagulation regimens in patients who have undergone catheter ablation.

Bilateral Pulmonary Artery Embolism Following Posterior Spinal Surgery

Introduction: Lumbar spine laminectomy and spinal fixation are common procedures, associated with several recognized complications. Thromboembolic events have been reported during these types of procedures; although their incidence is low, the associated mortality is not. Case Presentation: We present a 53-year-old woman with no medical history or risk factors for thromboembolic events, who underwent lumbar spine laminectomy and posterior spinal fixation. The clinical findings indicated the risk of pulmonary embolism following surgery, which was confirmed via capnography, arterial blood gas, electrocardiography, and computed tomography angiography. Conclusions: Pulmonary embolism may be diagnosed, based on clinical findings and simple data provided by the analysis of vital signs and monitoring in the operating room.

Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer.

4551 Background: Physical activity (PA) is believed to reduce acute side-effects as deconditioning, fatigue and nausea during chemotherapy and enhance post-treatment physical and psychosocial recovery. The national multicenter randomized TAST-trial (clinicaltrial.gov: NCT02577172) aimed to determine the effect of high-intensity training (HIT) during chemotherapy for testicular cancer (TC) on acute and post-treatment physical- and psychosocial outcomes. Methods: Patients aged 18 – 60 years with newly diagnosed metastatic TC, planned for 3 or 4 cisplatin-based chemotherapy cycles in combination with etoposide (EP) or etoposide plus bleomycin (BEP), were randomized to HIT during 9 or 12 weeks of chemotherapy or to one lifestyle counseling session (LCS) during first cycle. The HIT included two supervised endurance interval sessions per week, of which 10-15 minutes per session at 85 – 95 % of peak heart rate. The intensity, duration and number of the intervals were predetermined, but adjusted in accordance to the patients’ daily condition. Thromboembolic (TE) complications were registered consecutively. Results: Among the first 9 patients randomized to HIT, 33% (3 patients aged 22, 30 and 44 years) developed severe TE complications; 2 cases of pulmonary embolism (respectively at day 9 and 7 of BEP cycle 2) and 1 myocardial infarction (at day 7 of BEP cycle 3). Common for these patients were non-seminoma TC, clinical stage IIA, good prognosis group and no known risk factors for TE events. TE complications were not observed among the 10 patients randomized to the LCS. Conclusions: Since TC patients within good prognosis group are expected to have about 5 % risk of TE complications during or shortly after cisplatin-based chemotherapy, we cannot exclude that the HIT may have contributed to the unexpected high number of TE events. Until possible mechanisms explaining our observations have been explored, we discourage high-intensity endurance training during cisplatin-based chemotherapy for TC. These observations led to closure of the TAST-trial after inclusion of 19 of 94 planned patients. Clinical trial information: NCT02577172.

Incidence and impact of thromboembolic events in lung cancer patients treated with nivolumab.

e20624 Background: Lung cancer has one of the highest incidences of thromboembolic events (TEE) ranging from 8.4 to13.2%. Cisplatin-based chemotherapy in lung cancer is a well-established risk factor for TEE (11.8%). The incidence of TEE in lung cancer patients (pts) treated with nivolumab (nivo) is unclear. The objective of this study was to evaluate the incidence of TEE, risk factors and its impact on overall survival in lung cancer pts treated with nivo. Methods: This was a retrospective cohort study that included all lung cancer pts treated with nivo from April 2015 to October 2016 at our institution. Medical records were reviewed for incidence, timing, CTCAE grade, type and site of TEE, risk factors and patient demographics. Cox proportional hazard model was used to identify independent predictive factors for TEE. Risk factors with p &lt;0.15 in univariate analysis were included in multivariate model using a stepwise approach. Kaplan-Meier method was used to estimate overall survival (OS). Results: The cumulative incidence (CI) of TEE over a median follow up of 10.8 months after starting nivo was 18.4% (14/76 pts). Of the 14 pts who had TEE, 8 had deep vein thrombosis (DVT), 7 had pulmonary embolism (PE), 1 had concurrent DVT/PE and 2 had arterial thrombosis (AT). 28.6% (4/14) of pts experienced recurrent TEE resulting in 18 total episodes. Median time to TEE after starting nivo was 2.9 months (95% CI 1.9 - 8.4). Gender was the only covariate included in multivariate analysis that showed a significant association with TEE (Female vs Male HR 3.1, 95% CI 1.02 – 9.5, p= 0.045). At a median follow up of 31.8 months since diagnosis of lung cancer, pts who had TEE before receiving nivo had worse OS. TEE occurring after nivo had no impact on OS. Conclusions: The CI of TEE is significantly high at 18.4% in lung cancer pts treated with nivo. However, it had no impact on OS. Further studies are needed to determine the role of prophylactic anticoagulation in this high-risk population. [Table: see text]

Circulating microparticles and the risk of thromboembolic events in Egyptian beta thalassemia patients.

The presence of elevated numbers of circulating microparticles (MPs) has been hypothesized to be responsible for the occurrence of thromboembolic events (TEEs) in thalassemic patients. Our aim is to evaluate the presence and the thrombotic risk of circulating MPs in thalassemia patients and to determine the difference in MPs between β-thalassemia major (β-TM) and thalassemia intermedia (TI). The percentage of the annexin-labeled MPs, platelet-derived MPs (PMPs), erythrocyte-derived MPs (RMPs), and endothelial-derived MPs (EMPs) was measured by flow cytometry, in 87 thalassemia patients (39 β-TM and 48 TI). By multiple regression analysis, we then assessed the various independent risk factors for the occurrence of TEE. The thalassemic patients who experienced TEE had a significantly higher platelet count, higher percentage of annexin-labeled MPs, and higher percentage of PMPs (p value=0.014, 0.003, and 0.014, respectively). There was no significant difference between β-TM and TI patients at the level of any of the studied MPs. The predictive risk factors for TEE in thalassemic patients were splenectomy, total and direct bilirubin, the RMPs, and the EMPs (OR=10.07 (CI=3.7-27.1), 4.3 (CI=2.1-8.7), 1.4 (CI=1.5-6.2), 1.6 (CI=1.1-2.2), 3.0 (CI=1.9-4.9), respectively). In conclusion, the elevated numbers of circulating MPs is a risk factor for the TEE in thalassemia patients.

Increased risk of thromboembolic events in adult congenital heart disease patients with atrial tachyarrhythmias

BackgroundAtrial tachyarrhythmias are a major morbidity in patients with adult congenital heart disease (ACHD). However, few studies have investigated risk stratification of thromboembolic events in ACHD patients with atrial tachyarrhythmias. Methods and resultsThis retrospective cohort study reviewed the clinical records of 2314 ACHD patients from 1977 to 2014. We found 242 (10.4%) patients with atrial tachyarrhythmias and excluded 84 patients already being treated with anticoagulant therapy. The remaining 158 patients without anticoagulant therapy were retrospectively followed up from the onset of atrial tachyarrhythmia to the incidence of thromboembolic events. Fourteen thromboembolic events and 5 hemorrhagic events occurred. All patients with thromboembolic events had atrial fibrillation (AF). Thromboembolic events occurred even in the patients with low or intermediate risk as indicated by CHADS2 or CHA2DS2-VASc score. Event rates were higher than those in data from the general adult population in previous studies. Univariate analysis revealed that age≥60years (OR 4.54, 95% CI 1.47–14.06, P=0.009), vascular disease (OR 7.83, 95% CI 1.19–51.53, P=0.032), and persistent AF (OR 5.60, 95% CI 1.73–18.11, P=0.004) were the independent risk factors of thromboembolic events. ConclusionsACHD patients with atrial tachyarrhythmias and even those with low or intermediate risk as indicated by the CHADS2 or CHA2DS2-VASc score had a higher risk of thromboembolic events. Therefore, anticoagulation should be considered earlier than in the general population in patients with risk factors of age≥60years, vascular disease, or persistent AF.

Rates of major complications during neoadjuvant and adjuvant chemotherapy for early breast cancer: An off study population

ObjectivesTo determine the incidence and risk factors for thromboembolic events (TE) and febrile neutropenia (FN) in patients receiving systemic chemotherapy for early breast cancer (EBC). Methods325 patients received FEC75, FEC100-T or ECaP for EBC in 2013. ResultsTE occurred in 7.4% and FN in 19.1% of patients. Risk factors for TE were: central venous catheter (p = 0.011). Risk factors for FN were: FEC100-T treatment versus FEC75 and ECaP (p ≤ 0.001); lower pre-treatment neutrophil count (p = 0.009) and poorer performance status (p = 0.012). Two patients died from treatment-related toxicities. ConclusionIn real-world experience, the majority of patients completed adequate treatment, despite significant complications.

Incidence, Characteristics and Implications of Thromboembolic Events in Patients with Muscle Invasive Urothelial Carcinoma of the Bladder Undergoing Neoadjuvant Chemotherapy

Neoadjuvant chemotherapy and pelvic surgery are significant risk factors for thromboembolic events. Our study objectives were to investigate the timing, incidence and characteristics of thromboembolic events during and after neoadjuvant chemotherapy and subsequent radical cystectomy in patients with muscle invasive bladder cancer. We performed a multi-institutional retrospective analysis of 761 patients who underwent neoadjuvant chemotherapy and radical cystectomy for muscle invasive bladder cancer from 2002 to 2014. Median followup from diagnosis was 21.4 months (range 3 to 272). Patient characteristics included the Khorana score, and the incidence and timing of thromboembolic events (before vs after radical cystectomy). Survival was calculated using the Kaplan-Meier method. The log rank test and multivariable Cox proportional hazards regression were used to compare survival between patients with vs without thromboembolic events. The Khorana score indicated an intermediate thromboembolic event risk in 88% of patients. The overall incidence of thromboembolic events in patients undergoing neoadjuvant chemotherapy was 14% with a wide variation of 5% to 32% among institutions. Patients with thromboembolic events were older (67.6 vs 64.6 years, p = 0.02) and received a longer neoadjuvant chemotherapy course (10.9 vs 9.7 weeks, p = 0.01) compared to patients without a thromboembolic event. Of the thromboembolic events 58% developed preoperatively and 72% were symptomatic. On multivariable regression analysis the development of a thromboembolic event was not significantly associated with decreased overall survival. However, pathological stage and a high Khorana score were adverse risk factors for overall survival. Thromboembolic events are common in patients with muscle invasive bladder cancer who undergo neoadjuvant chemotherapy before and after radical cystectomy. Our results suggest that a prospective trial of thromboembolic event prophylaxis during neoadjuvant chemotherapy is warranted.

PD27-09 INCIDENCE AND SIGNIFICANCE OF THROMBO-EMBOLIC EVENTS IN BLADDER UROTHELIAL CARCINOMA PATIENTS UNDERGOING NEO-ADJUVANT CHEMOTHERAPY AND RADICAL CYSTECTOMY: RESULTS FROM MULTI-CENTRE NORTH-AMERICAN AND EUROPEAN CONTEMPORARY DATA

You have accessJournal of UrologyBladder Cancer: Invasive II1 Apr 2016PD27-09 INCIDENCE AND SIGNIFICANCE OF THROMBO-EMBOLIC EVENTS IN BLADDER UROTHELIAL CARCINOMA PATIENTS UNDERGOING NEO-ADJUVANT CHEMOTHERAPY AND RADICAL CYSTECTOMY: RESULTS FROM MULTI-CENTRE NORTH-AMERICAN AND EUROPEAN CONTEMPORARY DATA Wilhelmina Duivenvoorden, Siamak Daneshmand, Daniel Canter, Yair Lotan, Peter Black, Hamidreza Abdi, Bas van Rhijn, Elisabeth Fransen van de Putte, Peter Boström, Ilmari Koskinen, Piotr Zareba, Janet Baack Kukreja, Wassim Kassouf, Samer Traboulsi, and Jehonathan Pinthus Wilhelmina DuivenvoordenWilhelmina Duivenvoorden More articles by this author , Siamak DaneshmandSiamak Daneshmand More articles by this author , Daniel CanterDaniel Canter More articles by this author , Yair LotanYair Lotan More articles by this author , Peter BlackPeter Black More articles by this author , Hamidreza AbdiHamidreza Abdi More articles by this author , Bas van RhijnBas van Rhijn More articles by this author , Elisabeth Fransen van de PutteElisabeth Fransen van de Putte More articles by this author , Peter BoströmPeter Boström More articles by this author , Ilmari KoskinenIlmari Koskinen More articles by this author , Piotr ZarebaPiotr Zareba More articles by this author , Janet Baack KukrejaJanet Baack Kukreja More articles by this author , Wassim KassoufWassim Kassouf More articles by this author , Samer TraboulsiSamer Traboulsi More articles by this author , and Jehonathan PinthusJehonathan Pinthus More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.383AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Neoadjuvant chemotherapy (NAC), in combination with radical cystectomy (RC), is associated with a significant survival advantage for patients with muscle-invasive bladder cancer. Chemotherapy as well as pelvic surgery are significant risk factors for thrombo-embolic events (TEE). The objectives of this study were to investigate the incidence and characteristics of TEE during and after NAC and subsequent RC for urothelial bladder cancer. METHODS A retrospective analysis of 827 patients who underwent NAC and cystectomy for urothelial bladder carcinoma from 2002 to 2014 at ten different tertiary centers across North America and Europe. The median time of follow-up from bladder cancer diagnosis was 13 months (range 1-119 months). The incidence (venous, arterial, port-site or deep vein thrombosis, thrombosis, clinical or incidentally detected pulmonary embolism) and timing of TEE (before or after (< or > 30 days) RC) and Khorana score (established for cancer patients treated with chemotherapy, based on baseline hemoglobin, platelet and leukocyte counts, BMI and tumor site) was determined for all patients. All patients received TEE prophylaxis during the early post-RC period. Multivariate analysis was performed on 827 patients. Kaplan Meier survival curves and log rank test were used to compare survival between patients who developed TEE and those who did not. RESULTS The Khorana criteria indicated intermediate TEE risk in most patients. Khorana risk score was 1 or 2 in 88% of patients. Overall, the incidence of TEE in patients was 15%. 59 TEE were detected pre-operatively (7.1%), 21 early within 30 days of RC (2.5%) and 36 late post-operatively (4.3%). 32% of the TEE events were detected incidentally by imaging, 68% were detected clinically. Median overall survival of patients who developed TEE was 28 months compared to 71 months for those who did not develop TEE (p=0.012). CONCLUSIONS This multi-centre retrospective study suggests that TEE are very common in bladder cancer patients undergoing NAC before and after RC and they associate with poorer survival. Further investigation with a prospective prevention trial for the period of NAC is warranted. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e652-e653 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Wilhelmina Duivenvoorden More articles by this author Siamak Daneshmand More articles by this author Daniel Canter More articles by this author Yair Lotan More articles by this author Peter Black More articles by this author Hamidreza Abdi More articles by this author Bas van Rhijn More articles by this author Elisabeth Fransen van de Putte More articles by this author Peter Boström More articles by this author Ilmari Koskinen More articles by this author Piotr Zareba More articles by this author Janet Baack Kukreja More articles by this author Wassim Kassouf More articles by this author Samer Traboulsi More articles by this author Jehonathan Pinthus More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...