High Risk Of VTE Research Articles

Venous thromboembolism in patients hospitalized for hip joint replacement surgery

BackgroundVenous thromboembolism (VTE) is a potentially life-threatening disease. Major transient risk factors include trauma, surgery, and immobilization. Patients undergoing hip joint replacement (HJR) are characterized by a high risk of postoperative VTE, but data on the time trends of VTE rates in this population are sparse. MethodsIn an analysis of the German nationwide inpatient sample, we included all hospitalizations for elective primary HJR in Germany from 2005 to 2016. Time trends of the surgical procedure, overall death rates, and VTE rates were analysed, and predictors of VTE identified. ResultsOverall, 1,885,839 inpatients with elective primary HJR (59.1% women, 51.4% ≥70 years) were included in the analysis. During hospitalization, VTE was documented in 11,554 (0.6%) patients. While total numbers of primary HJR increased from 145,223 in 2005 to 171,421 in 2016 (β-(slope)-estimate 1818 [95%CI 1083 to 2553], P < 0.001), in-hospital VTE decreased from 1288 (0.9%) to 843 (0.5%) cases (β-estimate −0.71 [95%CI -0.77 to −0.65], P < 0.001), and in-hospital death rate from 0.33% (476 deaths) to 0.29% (498 deaths) (β-estimate −0.11 [95%CI -0.20 to −0.02], P = 0.018). Infections during hospitalization were associated with higher VTE risk than cancer and cardiovascular events. VTE events were independently associated with an increased death risk (OR 15.19 [95%CI 14.19–16.86], P < 0.001). ConclusionsWhile total numbers of HJR increased significantly in Germany between 2005 and 2016, in-hospital rates of VTE decreased from 0.9% to 0.5%. Patients with perioperative VTE had a 15-fold increase of in-hospital death. Cancer, cardiovascular disease and perioperative infections were associated with higher risk for VTE.

Prospective evaluation of drug-drug interactions in ambulatory cancer patients initiated on prophylactic anticoagulation.

Drug options for VTE prophylaxis are increasing for ambulatory cancer patients and data regarding anticoagulant-drug interactions and their relationship to VTE and bleeding are needed to improve care. Over one year, 108 cancer patients with high VTE risk were prospectively identified. Potential anticoagulant-drug interactions were ascertained by chart review and graded on need for intervention. Providers selected anticoagulant prophylaxis based on potential drug interactions and patient-provider discussion. A cross-sectional analysis was performed thereafter to evaluate VTE and bleeding endpoints within one year of anticoagulant initiation. The average number of potential drug interactions per patient was higher for warfarin than others (3.04 vs. 1.28 (apixaban), 1.02 (rivaroxaban), and 0.98 (LMWH)). The severity of the interactions based on grade was, for apixaban: 1.6% grade X, 50.8% grade D, and 47.5% grade C; for rivaroxaban: 2.1% grade X, 64.9% grade D, 33.0% grade C; for LMWH, 0% grade X, 66.7% grade D, 33.3% grade C; and for warfarin, 0% grade X, 29.4% grade D, 70.6% grade C. At the end of the investigational period, 11 bleeds and 7 VTEs were reported. Drug combinations significantly associated with an increased bleeding risk were crizotinib with apixaban or rivaroxaban and PPIs with warfarin. The use of sulfamethoxazole-trimethoprim with warfarin was associated with an increased VTE risk. DOACs had fewer DDIs than warfarin, although interaction severity differed between anticoagulants. Some anticoagulant-drug interactions were associated with bleeding or VTE. Although not powered for analysis, DDI severity did not affect bleeding rates and inversely correlated with VTE risk.

Risk of venous thromboembolism in patients undergoing gastric cancer surgery: protocol for a systematic review and meta-analysis

IntroductionVenous thromboembolism (VTE) is a serious life-threatening complication in patients with gastric cancer. Abnormal coagulation function and tumour-related treatment may contribute to the occurrence of VTE. Many guidelines considered that...

Venous Thromboembolism Prophylaxis in Acute Medically Ill Patients: A Retrospective Cohort Study

Background and Aims Venous thromboembolism (VTE) is considered as a preventable cause of death for hospitalized patients. Current guidelines recommend pharmacologic prophylaxis for medical patients considered high risk for VTE, despite failure of studies to show reduction in mortality. We aimed to assess the benefit and safety of VTE prophylaxis in acutely ill medical patients hospitalized in internal medicine wards. Methods Retrospective cohort study of all patients admitted to the internal medicine and acute geriatric departments, with an admission lasting more than 48 hours, during 2012-2018. Patients who received pharmacologic prophylaxis were compared to those who did not. The primary outcome was 30-day mortality. Secondary outcomes were the 90 day incidence of pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), and major bleeding. Propensity-weighted logistic multivariable analysis was performed. Results A total of 18890 patient-unique episodes were included in the analysis. Of them 3206 (17%) received prophylaxis. A total of 1309 (6.9%) died. 540/1309 (41.3%) of those who received VTE prophylaxis died and 769/1309 (58.7%) of those who did not receive prophylaxis died. VTE Prophylaxis was not associated with a reduction in mortality, multivariate-adjusted OR 0.99 (95% CI 0.84-1.14). One hundred and forty two patients (0.7%) developed VTE. The frequency of VTE among patients who received VTE prophylaxis was 31% (44/142) compared with 69% (98/142) in patients who did not receive prophylaxis. The frequency of VTE in patients who had a Padua score ≥4 and received VTE prophylaxis, was 1.9% (30/1573) compared with 1.6% (44/2797) in those with a Padua score ≥4 who did not receive prophylaxis. 74/142 (52.1%) of patients with VTE had a Padua score ≥4, 44/1309 (1.4%) of those who received VTE prophylaxis and 98/15864 (0.6%) of those who did not. VTE Prophylaxis was not associated with reduction in VTE in the whole cohort, multivariable-adjusted OR 1.09 (95% CI 0.52-2.29). VTE prophylaxis was associated with an increase in major bleeding (multivariable-adjusted OR 1.24, 95% CI 1.04-1.48) Conclusion The current practice of routinely administering VTE prophylaxis to medically ill patients considered at high risk for VTE, resulted in a high risk for bleeding a without clear clinical benefit, and should be reassessed. Disclosures No relevant conflicts of interest to declare.

Medical Management of Retained Inferior Vena Cava Filters

Background Venous thromboembolism (VTE) is a common and often fatal medical event. VTE management often includes inferior vena cava filter (IVCF) placement when anticoagulation fails or is contraindicated. Controversial indications for IVCF placement include adjunctive treatment for deep vein thrombosis (DVT) without pulmonary embolism (PE) and VTE prophylaxis for high-risk patients (Deyoung and Minocha, 2016; Ho et al., 2019). Numerous device-associated mechanical and medical complications have been described (Ayad et al., 2019) and guidelines recommend early retrieval (Morales et al., 2013). There is limited evidence, however, to guide anticoagulation practices while IVCFs are retained. We aimed to characterize IVCF placement, retrieval, and interim medical management at our institution. Methods Retrospective chart review was performed for all patients who underwent IVCF placement at the University of Virginia Medical Center from January to December 2016. Data were collected from time of IVCF placement until either IVCF removal or 18 months post-placement, whichever occurred first. Indication for IVCF placement, baseline patient characteristics, IVCF complications, anticoagulation regimens, and bleeding and clotting events were identified. Baseline characteristics were recorded for all patients. Patients who did not survive the admission during which the IVCF was placed, underwent IVCF removal prior to discharge, or lacked adequate outpatient records during the period of IVCF retention were excluded from the event analysis cohort. Results IVCFs were placed in 140 patients during the study period (Table 1). A majority of patients were admitted to a surgical service, frequently following trauma (49 patients, 35%). IVCFs were placed for several indications, most commonly diagnosed VTE with a contraindication to anticoagulation (70 patients, 50%) and prophylaxis for high risk of VTE (44 patients, 31%). By the end of the study period, 88 patients (63%) had confirmed IVCF removal while 35 patients (25%) retained the IVCF for a clinical consideration. 33 patients (24%) lacking an adequately documented period of outpatient IVCF retention were excluded from the event analysis. Of the 107 patients included in the event analysis cohort, 76 patients (71%) underwent IVCF removal. Removal occurred &gt;60 days after placement in 82% of these cases and median time to removal was 95 days (Table 2). Outpatient follow up and anticoagulation management varied widely, though 75 patients (70%) received a therapeutic dose anticoagulant during the period of IVCF retention and only 15 patients (14%) were not exposed to either a prophylactic or therapeutic dose anticoagulant. 50 patients (47%) had at least one regimen change. Bleeding and/or clotting events occurred for 15 patients (14%, Table 3). All 8 bleeding events occurred during anticoagulant exposure. Patients were exposed to a therapeutic dose anticoagulant during 4 of the 6 observed major or clinically relevant non-major bleeding events. Of the 12 observed clotting events, 8 occurred in the absence of anticoagulation. Isolated DVT was the most common clotting event (8 events in 7 patients, 7%) and IVCF thrombus was observed in 2 patients (2%). Bleeding and clotting events were observed in patients with a wide range of indications for IVCF placement, including patients whose IVCFs were placed prophylactically. Conclusions The optimal medical management of retained IVCFs is uncertain. This retrospective study characterizes IVCF placement, removal, and interim medical management for a diverse patient population at a single institution. Outpatient follow up varied widely and anticoagulant exposure during IVCF retention was inconsistent. Despite considerable anticoagulant exposure across the cohort, major bleeding events were infrequent. Thrombotic events, often in the absence of anticoagulation and potentially preventable, were more common. Standardization of medical management during IVCF retention would likely benefit this heterogeneous patient population at high risk of both bleeding and thrombotic complications. Ongoing statistical modeling for the study cohort will seek to inform anticoagulant decision making by assessing for associations between anticoagulant exposure and these clinical events. Disclosures No relevant conflicts of interest to declare.

ONKOTEV Score as a Predictive Tool for Thromboembolic Events in Pancreatic Cancer-A Retrospective Analysis.

Venous thromboembolism (VTE) is a frequent complication in patients with cancer and causes considerable morbidity and mortality. The risk of VTE is higher in patients with pancreatic cancer and is often associated with treatment delays or interruptions. Recently, the ONKOTEV score was proposed as a VTE risk predictor model for patients with cancer, but its validation is still ongoing. We conducted a retrospective study to determine the incidence of VTE and to evaluate the ONKOTEV score as a VTE predictive tool in a population of patients with pancreatic cancer. Between February 2012 and May 2017, 165 patients were included in the study. The median age was 73 years, 45.5% of patients were female, and 55.8% had stage IV disease. Fifty-one patients had a VTE (30.9%); 23.5% had pulmonary embolism, 25.5% had deep venous thrombosis, and 51.0% had visceral VTE (VsT). At a median follow-up time of 6.3 months, cumulative incidence of VTE was less than 10% for ONKOTEV scores 0 or 1 and approximately 40% and 70% for scores 2 and ≥3, respectively. The high VTE incidence observed in this study is consistent with prior reports. Patients at high risk for VTE with no increase in hemorrhagic risk should be considered for primary thromboprophylaxis. The ONKOTEV score may stratify VTE risk in patients with pancreatic cancer, with ONKOTEV score ≥2 being associated with a higher VTE occurrence. Venous thromboembolism (VTE) is a frequent complication of patients with pancreatic cancer and causes considerable morbidity, treatment delays or interruptions, and mortality. Thromboprophylaxis is not used routinely in ambulatory patients. Tools to stratify the risk of VTE are important to help select patients who may benefit from thromboprophylaxis. Recently, the ONKOTEV score was proposed as a VTE risk predictor model for patients with cancer, but its validation is still ongoing. In this patient series, ONKOTEV score ≥2 was associated with high VTE occurrence and may stratify VTE risk in patients with pancreatic cancer, suggesting that ONKOTEV can be considered to select patients with pancreatic cancer for primary thromboprophylaxis.

Antithrombotic prophylaxis for surgery-associated venous thromboembolism risk in patients with inherited platelet disorders. The SPATA-DVT Study.

Major surgery is associated with an increased risk of venous thromboembolism (VTE), thus the application of mechanical or pharmacologic prophylaxis is recommended. The incidence of VTE in patients with inherited platelet disorders (IPD) undergoing surgical procedures is unknown and no information on the current use and safety of thromboprophylaxis, particularly of low-molecular-weight-heparin in these patients is available. Here we explored the approach to thromboprophylaxis and thrombotic outcomes in IPD patients undergoing surgery at VTE-risk participating in the multicenter SPATA study. We evaluated 210 surgical procedures carried out in 155 patients with well-defined forms of IPD (VTE-risk: 31% high, 28.6% intermediate, 25.2% low, 15.2% very low). The use of thromboprophylaxis was low (23.3% of procedures), with higher prevalence in orthopedic and gynecological surgeries, and was related to VTE-risk. The most frequently employed thromboprophylaxis was mechanical and appeared to be effective, as no patients developed thrombosis, including patients belonging to the highest VTE-risk classes. Low-molecular-weight-heparin use was low (10.5%) and it did not influence the incidence of post-surgical bleeding or of antihemorrhagic prohemostatic interventions use. Two thromboembolic events were registered, both occurring after high VTE-risk procedures in patients who did not receive thromboprophylaxis (4.7%). Our findings suggest that VTE incidence is low in patients with IPD undergoing surgery at VTE-risk and that it is predicted by the Caprini score. Mechanical thromboprophylaxis may be of benefit in patients with IPD undergoing invasive procedures at VTE-risk and low-molecular-weight-heparin should be considered for major surgery.

P14.97 High risk of venous thromboembolism in patients with brain metastases from non-small cell lung cancer

Abstract BACKGROUND Venous thromboembolism (VTE) is a common complication in patients with cancer. In general, patients with metastatic disease are at highest risk. Lung cancer belong to those tumor entities with a particularly high risk of VTE, ranging between 3–13.8%. However, little is known about the VTE rate in lung cancer patients with brain metastases. MATERIAL AND METHODS Our study was conducted in the framework of the Vienna Brain Metastasis Registry. Clinical data and VTE events during the course of the disease were recorded via retrospective chart review. In this analysis, non-small cell lung cancer (NSCLC) patients with a resection of brain metastases at the Medical University of Vienna between 2006 and 2010 were included. RESULTS In total, 69 NSCLC patients with brain metastases were analyzed. Overall, 69.6% (48/69) patients had an adenocarcinoma, 13% (9/69) a squamous cell carcinoma, 8.7% (6/69) a large cell carcinoma and 8.7% (6/69) other primary tumor histologies. After cancer diagnosis, 20.3% (14/69) patients developed VTE during the course of the disease. Of those, 85.7% (12/14) thromboembolic events occurred after the diagnosis of brain metastases. CONCLUSION Based on our data, patients with brain metastases from NSCLC have a very high VTE risk. Further investigations are needed in order to identify patients with distinct VTE risk profiles. Patients at high risk might potentially benefit from primary thromboprophylaxis over the high risk of intracerebral bleeding.

Use of the Caprini Score Integrated With a Thrombodynamics Test Reduces the Incidence of Unpredicted, Postoperative Deep Venous Thrombosis

Thrombodynamics (TD) is a global assay for hemostasis that makes it possible to follow changes in parameters such as hypercoagulation and to control an individual’s response to blood thinners. The aim of this study was to compare how well the classic Caprini 2005 score and its modified version, taking into account the results of TD, predict postoperative deep venous thrombosis (DVT) in surgical patients with colorectal cancer. This prospective observational clinical study involved 80 patients (33 men and 47 women; mean age, 73.9 ± 7.2 years) with colorectal cancer who underwent surgery. The patients were at a high risk for postoperative VTE (mean Caprini score, 9.9 ± 2.0) and received combined prophylaxis (antiembolism stockings and enoxaparin 40 mg once daily) until discharge. Enoxaparin was administered at a fixed hour according to the time of blood sampling for TD. Duplex ultrasound was performed to detect postoperative DVT before and 5 to 7 days after surgery. DVT was noted in 21 of the patients. Caprini scores significantly predicted DVT (P < .0001; area under the curve [AUC] = 0.839 ± 0.045). Analysis of receiver operating characteristic (ROC) curve coordinates revealed a cutoff score of 11 points, with a sensitivity of 76.2% and a specificity of 74.6%. The results of the TD test revealed significant hypercoagulation despite administration of enoxaparin to patients with DVT. Regression analysis and ROC curves demonstrated that initial velocity of clot growth and clot size, measured 12 and 24 hours after enoxaparin administration (AUC = 0.697 ± 0.063 and AUC = 0.790 ± 0.059; AUC = 0.847 ± 0.059 and AUC = 0.803 ± 0.069, respectively), best predicted postoperative DVT. The cutoff points for DVT prediction appear to be initial velocity of clot growth >62.5 to 64.5 μm/min (normal range, 35-56 μm/min) and clot size >1351.5 to 1333.5 μm (normal range, 800-1200 μm). The identified thresholds for the TD parameters have been integrated into the Caprini score. The total Caprini scores were recalculated for patients with at least one TD parameter that exceeded the cutoff; we also reanalyzed the ROC curves. The best predictability was found for Caprini score considering the elevation of all four TD parameters together (AUC = 0.924 ± 0.029) and increased cutoff up to 12 points with sensitivity of 85.7% and specificity of 81.4%. Using cutoffs for the original and modified scores, we calculated the number of patients whose values were under the cutoff level but who developed DVT nonetheless: 10.2% and 5.9%, respectively. Integrating TD parameters into the Caprini score increases one’s ability to predict postoperative DVT and to reduce the number of unpredicted complications.

A critical analysis of prophylaxis to avoid venous thromboembolism after cesarean delivery

Aim: The aim of the present study was to analyze the risk factors for VTE in patients who underwent cesarean section. Pregnancy is a thrombogenic condition, and pregnant women have a five-to-six fold higher risk of VTE than non-pregnant women. The incidence of VTE is two-to-four times higher in cesarean deliveries than in vaginal deliveries. Material and Methods: 450 pregnant women who delivered by cesarean section were analyzed. The Turkey Ministry of Health Risk Pregnancy Management Guidelines was used to determine the VTE risk and its factors. After analyses of the data, the number and proportion of high-risk patients, that of medium-risk patients, and that of patients were determined. Results: After analyzing the risk factors we found that 59 (13.1%) pregnant women had a high risk, 351 (78%) had a moderate risk, and 40 (8.9%) had a low risk for VTE. In risk factor analyses, 9 women (2%) in the high-risk group had a history of VTE, 9 (2%) had a high risk of thrombophilia, 9(2%) had a low risk of thrombophilia and a family history of VTE, and 32(7.1%) needed low molecular–weight heparin during the antenatal period. When moderate-risk patients were classified for VTE, we found that 151 (33.6%) had two or more minor risk factors, 117 (26%) required cesarean section during labor, 42 (9.3%) had a hospital stay >3 days or were readmitted after delivery, 32 (7.1%) had a systemic disease, and 9 (2%) had a BMI>40 kg/m2. Conclusion: The results of the study suggest that the majority of pregnant women should be given VTE prophylaxis after cesarean delivery

Risk of Venous Thrombosis in Patients with Sickle Cell Trait after Orthopedic Surgery

IntroductionSickle cell trait (SCT) is considered to confer a hypercoagulable state. Historically, venous thromboembolism (VTE, deep vein thrombosis and PE) rates for untreated patients after major orthopedic surgery (hip or knee replacement or hip fracture surgery) have been close to 4.3%, however with the introduction of post-op anticoagulation, the rates have been as low as 1.15%. Although guidelines exist regarding anticoagulation for up to 35 days after major orthopedic surgery, there are no specific recommendations for patients with SCT. The purpose of this retrospective study is to examine the rates of VTE after major orthopedic surgery in a cohort of patients with SCT. We hypothesize that rates of VTE would be higher in patients with SCT and the risk of VTE would persist beyond 35 days.MethodsA commercial database (Explorys Inc, Cleveland, OH, USA), an aggregate of electronic health record data from 26 major integrated US healthcare systems representing a sixth of the US population, was queried for data, using Systematized Nomenclature of Medicine (SNOMED) clinical terms or codes. Cases were defined as patients with SCT who underwent major knee or hip surgery. Since a majority of the US population with SCT are African American (AA) patients, controls were defined as AA patients without SCT undergoing major orthopedic surgery. For the primary end point of VTE, only adult patients (≥18 years) were selected. Those with previous history of VTE, thrombophilia, malignant disease, antiphospholipid antibody syndrome and other hemoglobinopathies such as sickle cell disease were excluded. 30 and 90-day rates of VTE were recorded for both groups. Logistic regression models were used to adjust of confounding variables (defined a priori as age > 65 or< 65, smoking, gender and presence or absence of body mass index > 30). Of note, SCT is likely under-estimated due to incomplete diagnosis. Rates or proportions were compared using Chi-squared testusing Medcalc software (2018). Logistic regression analysis was done using Statistical Package for Social Sciences (SPSS, version 21, IBM Corp, Armonk, NY). P< 0.05 was considered statistically significant.ResultsA total of 1360 major orthopedic surgeries in patients with SCT and 74040 surgeries in non-SCT patients were identified. 30 and 90-day VTE for SCT patients undergoing major orthopedic surgery was 9.7% each. 30 and 90 day VTE for non-SCT patients undergoing major hip and knee surgery were 5.9 % and 6.4 % respectively. The difference in 30-day and 90-day VTE rates between the SCT and non-SCT group was statistically significant (30 day VTE difference 3.1%, 95% CI 1.6650-4.7569, p < 0.001; 90 day VTE difference=3.6%; 95% CI 2.1658-5.2562, p= <0.001). The rates of anticoagulant dispensation (oral Xa inhibitors, enoxaparin or warfarin) after surgery were 56% and 46% in SCT and non-SCT group respectively (difference = 10%, 95% CI 7.32-12.64, p <0.001). Despite the higher proportion of patients prescribed for anticoagulants in the SCT population, there was still a higher 30 and 90-day VTE rate in that group. Compliance to anticoagulation and mortality from VTE could not be assessed in this study.Logistic regression of risk factors associated with risk of VTE revealed age over 65 years of age, female gender, active smoking status, obesity (BMI >30), and presence of sickle cell trait were all significantly associated with increased risk of both 30 and 90 day VTE post major orthopedic surgery. Please see Table 1 and 2 for further details.ConclusionOur study represents real life data outside of a clinical trial. We found that patients with SCT who underwent major hip and knee surgery had an increased 30 and 90-day VTE rates compared to non-SCT patients undergoing the same procedures. Overall, this cohort of AA patients had VTE rates higher than that were described in literature. Of note, AA patients overall are at a higher risk of VTE than are their Caucasian counterparts. The results from the study seem to suggest a role for extended prophylaxis in people with SCT who are undergoing orthopedic procedures, and warrants further study. [Display omitted] DisclosuresLittle:Doris Duke Charitable Foundations: Research Funding; NHLBI: Research Funding; PCORI: Research Funding; Hemex: Patents & Royalties: Patent, no honoraria.

Low molecular weight heparin versus other anti-thrombotic agents for prevention of venous thromboembolic events after total hip or total knee replacement surgery: a systematic review and meta-analysis

BackgroundVenous thromboembolism (VTE) is an important complication following total hip replacement (THR) and total knee replacement (TKR) surgeries. Aim of this study was to comprehensively compare the clinical outcomes of low-molecular-weight heparin (LMWH) with other anticoagulants in patients who underwent TKR or THR surgery.MethodsMedline, Cochrane, EMBASE, and Google Scholar databases were searched for eligible randomized controlled studies (RCTs) published before June 30, 2017. Meta-analyses of odds ratios were performed along with subgroup and sensitivity analyses.ResultsTwenty-one RCTs were included. In comparison with placebo, LMWH treatment was associated with a lower risk of VTE and deep vein thrombosis (DVT) (P values < 0.001) but similar risk of pulmonary embolism (PE) (P = 0.227) in THR subjects. Compared to factor Xa inhibitors, LMWH treatment was associated with higher risk of VTE in TKR subjects (P < 0.001), and higher DVT risk (P < 0.001) but similar risk of PE and major bleeding in both THR and TKR. The risk of either VTE, DVT, PE, or major bleeding was similar between LMWH and direct thrombin inhibitors in both THR and TKR, but major bleeding was lower with LMWH in patients who underwent THR (P = 0.048).ConclusionIn comparison with factor Xa inhibitors, LMWH may have higher risk of VTE and DVT, whereas compared to direct thrombin inhibitors, LMWH may have lower risk of major bleeding after THR or TKR.

Certainty ranges facilitated explicit and transparent judgments regarding evidence credibility

ObjectivesThe Grading of Recommendations Assessment, Development and Evaluation approach to rating certainty of evidence includes five domains of reasons for rating down certainty. Only one of these, precision, is easily amenable—through the confidence interval—to quantitation. The other four (risk of bias, inconsistency, indirectness, and publication bias) are not. Nevertheless, conceptually, one could consider a quantified “certainty range” within which the true effect lies. The certainty range would be at least as wide as the confidence interval and would expand with each additional reason for uncertainty. Study Design and SettingWe have applied this concept to rating the certainty of evidence in the baseline risk of venous thromboembolism (VTE) and bleeding in patients undergoing urological surgery. We considered rating up moderate or low quality evidence when the net benefit of VTE prophylaxis was unequivocally positive, that is, when the smallest plausible value of VTE reduction was greater than the largest plausible value of increased bleeding. To establish whether the net benefit was unequivocally positive, we expanded the range of plausible values by 20% for each of the four nonquantitative domains in which there were serious limitations. ResultsWe present how we applied these methods to examples of open radical cystectomy and laparoscopic partial nephrectomy. In high-VTE risk laparoscopic partial nephrectomy patients and high- and medium-VTE risk open radical cystectomy patients, results proved robust to expanded certainty intervals, justifying rating up quality of evidence. In low-risk patients, the results were not robust, and rating up was therefore not appropriate. ConclusionThis work represents the first empirical application in a decision-making context of the previously suggested concept of certainty ranges and should stimulate further exploration of the associated theoretical and practical issues.

Efficacy of surveillance ultrasound for venous thromboembolism diagnosis in critically ill children after trauma

IntroductionVenous thromboembolism (VTE) is increasingly prevalent in injured children admitted to the intensive care unit (ICU). Few data exist to support VTE pharmacologic prophylaxis or ultrasound (US) surveillance in children with high bleeding risk. After implementation of screening US guidelines, we sought to describe our experience, hypothesizing that screening US of children at highest risk for VTE results in earlier detection and management. Study designA retrospective analysis was conducted on prospectively collected data of injured children admitted to an American College of Surgeons Verified level 1 Pediatric Trauma Center from 2010 to 2015. In patients at high risk for both VTE and bleeding (HRHR), guidelines recommended deferral of pharmacologic prophylaxis and a screening US at ≥7 ICU days if bleeding risk remained. Outcomes analyzed included VTE rates, guideline compliance, and US timing. The rate of deep vein thrombosis (DVT) detection (number of DVT captured/number of US obtained) was examined. ResultsOf 4061 trauma patients, 588 (14.5%) were critically injured including 112 patients who met HRHR criteria. The rate of VTE in the HRHR group ≥7 ICU days was 25% (14/56). Of 23 VTE diagnosed in the ICU, 17 were detected by 49 US performed (34.7%), with the remaining 6 diagnosed by computed tomography. DVT was detected earlier than the US guideline recommended 7 days, independent of symptoms. Guideline compliance was 86%. ConclusionCritically injured children at risk for bleeding frequently develop VTE. Surveillance ultrasound in patients at high risk for both VTE and bleeding allows earlier detection and treatment. Level of EvidenceTherapeutic study, level II.

Risk of venous thromboembolism, survival, and expression of procoagulant genes in neuroendocrine versus castration-resistant prostate cancer.

e17039Background: Neuroendocrine prostate cancer (NEPC) is an aggressive form of PC thought to carry a higher risk of VTE than standard castration resistant prostate cancer (CRPC), though it is unc...

Hemostatic biomarkers levels for the identification of cancer patients at higher VTE risk enrolled in the HYPERCAN study

Hemostatic biomarkers levels for the identification of cancer patients at higher VTE risk enrolled in the HYPERCAN study

Multivariable clinical-genetic risk model for predicting venous thromboembolic events in patients with cancer

BackgroundVenous thromboembolism (VTE) is a leading cause of death among patients with cancer. Outpatients with cancer should be periodically assessed for VTE risk, for which the Khorana score is commonly recommended. However, it has been questioned whether this tool is sufficiently accurate at identifying patients who should receive thromboprophylaxis. The present work proposes a new index, TiC-Onco risk score to be calculated at the time of diagnosis of cancer, that examines patients’ clinical and genetic risk factors for thrombosis.MethodsWe included 391 outpatients with a recent diagnosis of cancer and candidates for systemic outpatient chemotherapy. All were treated according to standard guidelines. The study population was monitored for 6 months, and VTEs were recorded. The Khorana and the TiC-Onco scores were calculated for each patient and their VTE predictive accuracy VTEs was compared.ResultsWe recorded 71 VTEs. The TiC-Onco risk score was significantly better at predicting VTE than the Khorana score (AUC 0.73 vs. 0.58, sensitivity 49 vs. 22%, specificity 81 vs. 82%, PPV 37 vs. 22%, and NPV 88 vs. 82%).ConclusionsTiC-Onco risk score performed significantly better than Khorana score at identifying cancer patients at high risk of VTE who would benefit from personalised thromboprophylaxis.

Inherited thrombophilia in unprovoked venous thromboembolism: Is non 'O' blood group an additional culprit in Indian patients?

BackgroundVenous thromboembolism (VTE) is a known situation of considerable mortality and morbidity and occurs due to the convergence of multiple acquired and genetic risk factors. MethodsIn this study, we have comprehensively analyzed the effect of ABO blood groups and inherited thrombophilia factors [Protein C (PC), Protein S (PS), Antithrombin III (AT III), Activated Protein C Resistance (APCR) and Homocysteine (Hcy)] on 150 unprovoked VTE patients, comparing with normal healthy controls. ABO phenotyping was done using gel cards and thrombophilia workup done using standard kits on coagulation autoanalyzer. ResultsNon O blood group was significantly more frequent among cases than controls (77.3% vs. 62.7%) and had higher odds of VTE (OR=2.03, 95%CI: 1.22–3.37).Positivity for at least one marker of thrombophilia was more in cases (40%) than controls (16%), and led to significantly higher odds (OR=3.5, 95%CI: 2.03–6.04) of VTE. Deficiency of PS was the commonest thrombophilia abnormality.Combination of non O group with positivity for thrombophilia markers was also more among cases (OR=5.67, 95%CI: 2.76–11.65). Highest odds of VTE in cases were associated with non O group in combination with increased Homocystein (OR=10.8, 95%CI: 2.27–51.5). ConclusionThe study results show non O blood group and positivity for factors of inherited thrombophilia in cases impart higher odds of VTE individually. Also combination of both non O blood group and positivity for factors of inherited thrombophilia in cases further increases the odds of VTE. This awareness could assist physicians in identifying those at higher risk of VTE and tailor-made the thromboprophylaxis accordingly.

BSH Guideline: management of thrombotic and haemostatic issues in paediatric malignancy.

BSH Guideline: management of thrombotic and haemostatic issues in paediatric malignancy.

What Impact Does Venous Thromboembolism and Bleeding Have on Cancer Patients’ Quality of Life?

BackgroundVenous thromboembolism (VTE) is common in cancer patients and its treatment is associated with a high risk of recurrent VTE (rVTE) and bleeding. ObjectivesTo analyze data from the Comparison of Acute Treatments in Cancer Hemostasis (CATCH) trial to describe the impact of rVTE and bleeding events on health-related quality of life. MethodsThe three-level EuroQol five-dimensional questionnaire (EQ-5D) data were collected monthly for up to 7 months in patients starting anticoagulation for newly diagnosed VTE. Analyses were designed to describe the impact of rVTE and bleeding on EQ-5D scores while controlling for effects of covariates such as background and clinical variables and longitudinal changes. A repeated-measures model with specification of the variance-covariance matrix to characterize the intrapatient correlation was used to estimate the utility values. The impact of an rVTE or a bleeding event was assumed to be reflected in the utility value when it occurred within 2 weeks from a planned data collection point. ResultsData were available from 883 patients. A total of 76 rVTE and 159 bleeding events occurred during follow-up. rVTE had a significant impact on EQ-5D scores, with a decrement of −0.075 on the basis of our reference case (male, no metastasis, Eastern Cooperative Oncology Group score = 1, Western European), but different patients might have different decrements. Bleeding events had a smaller (nonstatistically significant) impact on EQ-5D scores. ConclusionsThis data set study has quantified the decline in EQ-5D scores associated with experiencing rVTE or bleeding events in cancer patients. These results indicate the net gain in quality of life and impact on cost-effectiveness of secondary VTE prevention.