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PubMed2004

The predictive characteristics of D-dimer testing in outpatients with suspected venous thromboembolism: a Bayesian approach.

BACKGROUND: Despite the widespread use of quantitative methods to measure D-dimer, clinical decisions commonly are based only on binary test information (positive/negative). This study aimed to determine the significance of quantitative D-dimer results in the evaluation of venous thromboembolism (VTE) by means of a differentiated Bayesian approach. METHODS: Prospective study in 118 outpatients referred for workup of suspected pulmonary embolism (n = 75) or deep vein thrombosis (n = 43). The sensitivity and specificity of D-dimer results obtained by DD VIDAS (Biomerieux, France), STA Liatest (Diagnostica Stago, France), and D-dimer plus (Dade, US) were assessed for five different cut-offs. Further, predictive values and multilevel likelihood ratios were calculated in order to assess the operative test characteristics in excluding or confirming VTE. RESULTS: At a cut-off of 500 ng/ml and pretest probabilities < 47%, the VIDAS provides a negative predictive value (NPV) > 95%, whereas a positive predictive value (PPV) > 95% is obtained in patients with a D-dimer > 10,000 ng/ml and pretest probabilities > 50%. At a cut-off of 500 ng/ml and pretest probabilities < 33%, the Liatest exhibits a NPV > 95%, whereas a PPV > 95% is obtained in patients with a D-dimer >10,000 ng/ml and pretest probabilities > 37%. Finally, with the D-dimer plus, a NPV > 95% is seen at a cut-off of 150 ng/ml and pretest probabilities < 30%, whereas a PPV > 95% is obtained at a cut-off > 1000 ng/ml and pretest probabilities > 67%. CONCLUSIONS: D-dimer measurements in outpatients cannot only allow for exclusion but, in some situations, also for confirmation of venous thromboembolism. It is therefore advisable to conduct a quantitative interpretation of D-dimer results.

Aged↗
PubMed2006

Diagnosis of suspected venous thromboembolic disease in pregnancy.

Venous thromboembolic disease is a leading cause of maternal mortality during pregnancy. Early and accurate radiological diagnosis is essential as anticoagulation is not without risk and clinical diagnosis is unreliable. Although the disorder is potentially treatable, unnecessary treatment should be avoided. Most of the diagnostic imaging techniques involve ionizing radiation which exposes both the mother and fetus to finite radiation risks. There is a relative lack of evidence in the literature to guide clinicians and radiologists on the most appropriate method of assessing this group of patients. This article will review the role of imaging of suspected venous thromboembolic disease in pregnant patients, highlight contentious issues such as radiation risk, intravenous contrast use in pregnancy and discuss the published guidelines, as well as suggesting an appropriate imaging algorithm based on the available evidence.

Algorithms↗
PubMed2006

Venous thromboembolism and cancer: guidelines of the Italian Association of Medical Oncology (AIOM).

Thromboembolic complications represent one of the most important cause of morbidity and mortality in cancer patients. Although several data have been published demonstrating the strong association between cancer and venous thromboembolism (VTE), there is poor perception, among oncologists, of the level of risk of thrombosis and of relevance of managing VTE in these patients. The Associazione Italiana di Oncologia Medica (AIOM) has provided some recommendations to direct clinical practice according to evidence-based data concerning cancer and VTE. In fact, we conducted an extensive literature review (1996-2005) to produce evidence-based recommendations to improve perceptions of the magnitude of this risk among Italian medical and surgical oncologists and alert on the new approaches to prophylaxis and treatment of VTE in cancer patients. Levels of evidence are given according to a five-point rating system, and similarly for each key recommendation a five-point rating system suggests if the evidence is strong and indicate that the benefits do, or do not, outweigh risks and burden.

Anticoagulants↗
PubMed2005

Burden of illness in venous thromboembolism in critical care: a multicenter observational study.

PURPOSE: The frequency of clinically diagnosed venous thromboembolism (VTE) including deep venous thrombosis (DVT) and pulmonary embolism (PE) in medical-surgical critically ill patients is unclear. The objectives of this study were to estimate the prevalence and incidence of radiologically confirmed DVT and PE in medical-surgical intensive care unit (ICU) patients and to determine the impact of prophylaxis on the frequency of these events. MATERIALS AND METHODS: In a retrospective observational cohort study in 12 adult ICUs, we identified prevalent cases (diagnosed in the 24 hours preceding ICU admission up to 48 hours post-ICU admission) and incident cases (diagnosed 48 hours or more after ICU admission and up to 8 weeks after ICU discharge) of upper or lower limb DVT or PE. Deep venous thrombosis was diagnosed by compression ultrasound or venogram. Each DVT was classified as clinically suspected or not clinically suspected in that the latter was diagnosed by scheduled screening ultrasonography. Pulmonary embolism was diagnosed by ventilation-perfusion lung scan, computed tomography pulmonary angiography, echocardiography, electrocardiography, or autopsy. RESULTS: Among 12,338 patients, 252 (2.0%) patients had radiologically confirmed DVT or PE and another 47 (0.4%) had possible DVT or PE. Prevalent DVTs were diagnosed in 0.4% (95% confidence interval [CI], 0.3%-0.5%) of patients and prevalent PEs were diagnosed in 0.4% (95% CI, 0.3%-0.6%). Incident DVTs were diagnosed in 1.0% (95% CI, 0.8%-1.2%) of patients, and incident PEs were diagnosed in 0.5% (95% CI, 0.4%-0.6%). Of patients with incident VTE, 65.8% of cases occurred despite receipt of thromboprophylaxis for at least 80% of their days in ICU. The median (interquartile range) ICU length of stay was similar for patients with DVT (7 [3-17]) and PE (5 [2-8]). For all patients with VTE, ICU mortality was 16.7% (95% CI, 12.0%-21.3%) and hospital mortality was 28.5% (95% CI, 22.8%-34.1%). CONCLUSIONS: Venous thromboembolism appears to be an apparently infrequent, but likely underdiagnosed problem, occurring among patients receiving prophylaxis. Findings suggest the need for increased suspicion among clinicians, renewed efforts at thromboprophylaxis, and evaluation of superior prevention strategies.

Anticoagulants↗
PubMed2006

AML M1 presenting with recurrent acute large arterial vessel thromboembolism.

Acute leukemia may be associated with coagulopathy, predominantly severe bleeding diathesis caused by disseminated intravascular coagulation (DIC) and/or hyperfibrinolysis. Disordered hemostasis is characteristic for acute promyelocytic leukemia (APL, FAB M3). However, thromboembolic events such as arterial occlusion localized to the large vessels at presentation is very rare and almost exclusively linked to APL. We report a case of severe recurrent acute arterial thromboembolism at presentation in AML FAB M1. Most likely, the ischemic events in our patient resulted from leukemia as the thrombus material included many leukemic blasts. The thrombotic complications resulted in leg amputation in this patient. Despite leg amputation just a couple of hours before and extremely high infectious risk of the patient, chemotherapy was administered. The clinical course of cessation of the ischemic events and a fast reduction of the blasts in the peripheral blood smear after chemotherapeutic treatment of the patient outlines the importance and life saving role of early chemotherapy even under adverse circumstances.

Adult↗
PubMed2003

Microvascular basal lamina damage in thromboembolic stroke in a rat model.

We investigated microvascular damage in areas with magnetic resonance imaging (MRI)-defined apparent diffusion coefficient reduction (ADC-R) in a rat model of thromboembolic occlusion of the middle cerebral artery. Rats received either intracarotid recombinant tissue plasminogen activator (rt-PA) or saline. Microvascular basal lamina damage was quantified by immunohistochemical staining of collagen type IV and by videoimaging analysis. ADC-R positive basal ganglia (cortical) areas showed a significant reduction of stained microvascular area by 15+/-6% (8+/-7%) and the microvascular density by 13+/-5% (8+/-6%) of that on the non-ischemic control side (P<0.001). There were no significant microvascular differences between rats given rt-PA or saline, or between those with or without angiographically proven recanalization. This study reports for the first time that microvascular basal lamina damage in experimental thromboembolic stroke is confined to regions with ADC-R in MRI.

Angiography↗
PubMedDate not supplied

Inferior vena cava filters in venous thromboembolism.

Vena cava filters have been used for the prevention of pulmonary embolism in patients with venous thromboembolism since the 1930s. Historically, vena cava filters were used in patients with either a contraindication to or a complication of systemic anticoagulation or in those with recurrent pulmonary embolism despite adequate anticoagulation. However, indications for placement have broadened even in the absence of support from randomized controlled trials as the deployment procedure became less complex. With more recently available optional retrievable filters, physicians have another valuable tool to use for the treatment of venous thromboembolism in patients who are not candidates for systemic anticoagulation or, perhaps, more importantly, have only a temporary indication for filtration. As with permanent filters, there is a clinical need for robust clinical studies to establish appropriate indications and define long-term outcomes because there are only case series to guide the current usage of such filters.

Humans↗
PubMed2004

Treatment of venous thromboembolism with low-molecular-weight heparin: a synthesis of the evidence published in systematic literature reviews.

OBJECTIVE: To evaluate the methodology and cumulative evidence presented in systematic reviews of clinical trials comparing low-molecular-weight heparin (LMWH) with unfractionated heparin (UFH) for the treatment of venous thromboembolism. METHODS: We reviewed all systematic reviews of clinical trials published until March 2002. Fourteen systematic literature reviews were published between 1994 and 2000. Deficiencies in methodological quality were common, particularly in the description of search strategies, assessment of clinical trial quality, and methods used to combine results. RESULTS: Results of reviews indicate that LMWH is superior to UFH for the treatment of venous thromboembolism, particularly in reducing mortality. Patients with isolated deep venous thrombosis or deep venous thrombosis with concomitant pulmonary embolism seemed to have similar benefit. However, the benefits of LMWH over UFH were smaller in magnitude in reviews that included more recent clinical trials.

Anticoagulants↗
PubMedDate not supplied

Predictive factors of thromboembolic events in patients undergoing Roux-en-Y gastric bypass.

BACKGROUND: Obesity is a major risk factor for postoperative deep venous thrombosis (DVT) and pulmonary embolism (PE). Identifying those patients at the greatest risk for DVT/PE is essential to prevent thromboembolic events among patients undergoing Roux-en-Y gastric bypass (RYGB) for clinically significant obesity. This aim of the study is to identify factors associated with an increased likelihood of developing DVT/PE after RYGB. METHODS: Prospectively collected data from 660 consecutive patients who underwent RYGB were reviewed. Patients received perioperative prophylaxis with low molecular weight heparin and sequential compression devices. Diagnosis was based on clinical, radiologic, and/or necropsy findings. Patients with and without postoperative DVT/PE were compared using chi(2) and multivariate logistic regression analysis. RESULTS: A total of 23 patients (3.5%) developed postoperative DVT/PE. Age > 50 years (P = .04), previous DVT/PE (P = .02), history of smoking (P < .01), revisional operation (P = .03), open RYGB (P = .02), and anastomotic leak (P < .0001) significantly increased the likelihood of developing DVT/PE. On the other hand, gender, body mass index > 50 kg/m(2) and history of sleep apnea, hypertension, diabetes, or myocardial infarction did not increase the likelihood of DVT/PE. Multivariate analysis revealed that age > 50 years (P = .04), postoperative anastomotic leak (P < .001), smoking (P < .01), and previous DVT/PE (P < .001) increased the likelihood of postoperative DVT/PE. CONCLUSIONS: Age > 50 years, anastomotic leak, smoking, and history of DVT/PE all increase the likelihood of postoperative thromboembolic events in patients undergoing RYGB. Further preoperative screening and/or postoperative prophylaxis may be needed in this subset of high-risk patients.

Anastomosis, Roux-en-Y↗
PubMed2005

Exclusion of venous thromboembolism: evaluation of D-Dimer PLUS for the quantitative determination of D-dimer.

The objective of this study was to evaluate if D-Dimer PLUS (Dade Behring, USA), a rapid fully automated assay, could be used as an initial screening test in the diagnosis of venous thromboembolism (VTE). Samples from 274 consecutive symptomatic patients with suspected pulmonary embolism (n=229; 79% outpatients, 21% inpatients), deep venous thrombosis (n=37; 84% outpatients, 16% inpatients) or suspected for both complications (n=8) were tested with this D-dimer assay with a Sysmex CA-1500 Coagulation Analyzer. Clinical probability for pulmonary embolism (PE) or deep venous thrombosis (DVT) was staged according to a pretest risk score proposed by Wells. Final diagnosis of PE and/or DVT was established by spiral-computed tomography of the pulmonary arteries or compression ultrasonography, respectively. PE was diagnosed in 13.5% of the patients, whereas DVT was confirmed in 17.7% of the patients. The optimal cut-off value for exclusion of venous thromboembolism was 130 mug/l, and sensitivity, specificity and negative predictive value (NPV) were 95.0% (95% CI: 92.4-97.6), 30.4% (95% CI: 25.0-35.8) and 97.2% (95% CI: 95.2-99.2), respectively. In fact, two patient with PE were missed using D-Dimer PLUS; both cases were outpatients. In conclusion, this assay appears to be safe when implemented in an algorithm based on clinical assessment, D-dimer concentration, and radiological diagnostic techniques to stratify the risk for PE or DVT. However, higher sensitivities and negative predictive values were claimed in the scarce published reports for the D-Dimer PLUS assay than found in this study.

Cohort Studies↗
PubMed2005

Venous thromboembolism prophylaxis in medical patients: future perspectives.

Venous thromboembolism is a common potentially life-threatening complication in acutely ill medical patients. Actually, over 70% fatal episodes of pulmonary embolism during hospitalization occur in non-surgical patients. In the absence of thromboprophylaxis, the incidence of venographically detected deep vein thrombosis is about 15% in medical patients and several trials and meta-analyses have clearly demonstrated the prophylactic role of unfractioned heparin and low-molecular-weight heparins. Although over the last years the knowledge of epidemiology, clinical features and prophylaxis in medical patients has significantly improved, there are still several relevant issues to investigate thoroughly. Scarce data are available on a simple way to stratify patients in order to identify those who should undergo prophylaxis and several studies clearly show that thromboprophylaxis in medical conditions is underused. Moreover, in comparison to surgical settings, very few randomized clinical trials on the efficacy of pharmacologic prophylaxis have been performed and no data at all have been published concerning mechanical prophylaxis in medical conditions. According to previous studies and results of very recently published trials, new data are available to tailor low molecular weight heparin optimal dose, whereas the optimal duration of prophylaxis in medical patients is still a matter of debate. Moreover, the possible role of the new antithrombotic drugs in the venous thromboembolism prevention in medical conditions and the optimal management of thromboprophylaxis in patients with ischaemic stroke have not been fully investigated. Although new evidence represents a significant improvement both in stratification of VTE risk and in decisions about the appropriate type and duration of prophylactic strategies in medical patients, additional data are still needed.

Brain Ischemia↗
PubMed2005

Thromboembolic complications in children with cancer.

Thrombosis is a significant problem in patients with cancer. The impact of thromboembolism in association with childhood cancer is not clearly defined. Similarly the information of prevention and management of thromboembolic events in children receiving cancer-therapy is limited. This review aims to examine current knowledge regarding the epidemiology, pathophysiology and management of thrombosis in association with cancer in children.

Anticoagulants↗
PubMed2006

Interrelation of hyperhomocysteinemia and inherited risk factors for venous thromboembolism. Results from the E.D.I.TH. study: a hospital-based case-control study.

BACKGROUND: Moderate hyperhomocysteinemia and factor V Leiden mutation are among the most prevalent risk factors for venous thromboembolism (VTE). The hypothesis of an interaction between those risks has been raised and conflicting results were reported. METHODS: We designed a hospital-based case-control study to test the interaction between Factor V Leiden and fasting serum total homocysteine (tHcy). We have also analysed the G20210A prothrombin gene variant. This study enrolled 904 hospitalised patients who had an objectively proven deep vein thrombosis and/or pulmonary embolism as well as 904 hospitalised control patients matched for gender, age and major acquired risk factor for VTE. RESULTS: Our data did not detect any multiplicative interaction between hyperhomocysteinemia (>15 mumol/L) and factor V Leiden mutation or G20210A prothrombin gene variant. Odds ratios (95% CI) were 4.0 (1.5-11) and 6.0 (1.3-27) for the combined effect of hyperhomocysteinemia with either factor V Leiden mutation or G20210A prothrombin gene variant, respectively. CONCLUSIONS: Current data provide further knowledge in relationship between hyperhomocysteinemia and inherited risk factors, such as factor V Leiden mutation and G20210A prothrombin gene variant. As those risk factors are not so rare among Caucasians, a better estimate of the risk related to double exposure might help to optimise venous thromboembolism prevention.

Adolescent↗
PubMedDate not supplied

Venous thromboembolism in renal transplant recipients: high rate of recurrence.

Few data are available on the incidence of venous thromboembolism occurring in renal transplant recipients and optimal duration of oral anticoagulant therapy after thrombotic episode. Our study was performed to evaluate the risk of thrombosis recurrence in patients developing a first episode. Among 484 renal transplant patients 34 (7%) developed a first thromboembolism and were referred to the Thrombosis Centre: 28 patients (group 1) were prospectively studied, after stopping anticoagulants. Group 1 was compared with a group of 84 patients without an history of renal disease who had suffered from a first thrombotic episode and were matched for age, sex, and type of thrombotic event (group 2). During follow-up, 14/28 group 1 patients and 8/84 group 2 patients experienced thrombotic recurrence (P = .0001). Our data outline the high risk of recurrence in renal transplant recipients. Strategies for recurrence prevention are needed taking into account the high bleeding risk of anticoagulants in renal transplant patients.

Adult↗
PubMed2005

Aortic thromboembolism associated with Spirocerca lupi infection.

A 2-year-old male castrated Cavalier King Charles Spaniel was presented with paraplegia, cold caudal extremities and lack of femoral pulses. A 2cm long thrombus occluding the aortic trifurcation and a 3cm long abdominal aortic aneurysm with a thrombus were detected by ultrasonographic examination. The clinical and ultrasonographic findings were consistent with aortic thromboembolism. Anti-thrombotic and vasodilative therapy was not helpful and the dog was euthanized 3 days after the onset of paraplegia. A thrombus in the aortic trifurcation, multiple thoracic and abdominal aneurysms and a distal mediastinal esophageal granuloma containing Spirocera lupi worms were found on necropsy. The abdominal aortic aneurysms formed by S. lupi larval migration are believed to be responsible for the formation of the thrombus that occluded the aortic trifurcation. This is the first report of aortic thromboembolism associated with S. lupi infection.

Animals↗
PubMed2003

Ximelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: Rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V).

BACKGROUND: Ximelagatran is a novel, oral direct thrombin inhibitor under investigation as an alternative to warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation (AF). Two long-term studies in patients with AF and at least one additional risk factor for stroke are underway to compare the safety and efficacy of fixed-dose ximelagatran (36 mg bid) without coagulation monitoring with dose-adjusted warfarin (international normalized ratio 2.0-3.0). METHODS: SPORTIF III is a randomized, open-label, parallel-group study with blinded event assessment involving 3407 patients at 259 sites in 23 countries. SPORTIF V is similar, but with double-blind treatment allocation involving 3922 patients at 409 North American sites. The primary end point in each study is the incidence of all strokes and systemic embolic events, and the objective is to establish the noninferiority of ximelagatran relative to warfarin. Secondary end point constellations include (1) death, stroke, systemic embolism, and myocardial infarction; (2) ischemic stroke, transient ischemic attack, and systemic embolism; and (3) bleeding and treatment discontinuation. Blinded central committees adjudicate all end points and monitor patient safety. The studies commenced July 2000; enrollment ended in December 2001. Each study will accrue > or =4000 patient-years and > or =80 primary end points with a minimum per-patient exposure of 12 months. Combined analysis of both studies is also planned. RESULTS: The demographics of the 2 patient populations are similar and should allow the studies to meet the objective. CONCLUSIONS: The program, the largest conducted in this indication, will determine the safety and antithrombotic efficacy of ximelagatran as an alternative to warfarin for prevention of thromboembolism in patients with AF.

Administration, Oral↗
PubMed1999

A randomized, multicenter trial of weight-adjusted intravenous heparin dose titration and point-of-care coagulation monitoring in hospitalized patients with active thromboembolic disease. Antithrombotic Therapy Consortium Investigators.

BACKGROUND: Therapy with intravenous unfractionated heparin improves clinical outcome in patients with active thromboembolic disease, but achieving and maintaining a therapeutic level of anticoagulation remains a major challenge for clinicians. METHODS: A total of 113 patients requiring heparin for at least 48 hours were randomly assigned at 7 medical centers to either weight-adjusted or non-weight-adjusted dose titration. They were separately assigned to either laboratory-based or point-of-care (bedside) coagulation monitoring. RESULTS: Weight-adjusted heparin dosing yielded a higher mean activated partial thromboplastin time (aPTT) value 6 hours after treatment initiation than non-weight-adjusted dosing (99.9 vs 78.8 seconds; P =.002) and reduced the time required to exceed a minimum threshold (aPTT >45 seconds) of anticoagulation (10.5 vs 8.6 hours; P =.002). Point-of-care coagulation monitoring significantly reduced the time from blood sample acquisition to a heparin infusion adjustment (0.4 vs 1.6 hours; P <.0001) and to reach the therapeutic aPTT range (51 to 80 seconds) (16.1 vs 19.4 hours; P =.24) compared with laboratory monitoring. Although a majority of patients participating in the study surpassed the minimum threshold of anticoagulation within the first 12 hours and reached the target aPTT within 24 hours, maintaining the aPTT within the therapeutic range was relatively uncommon (on average 30% of the overall study period) and did not differ between treatment or monitoring strategies. CONCLUSIONS: Weight-adjusted heparin dosing according to a standardized titration nomogram combined with point-of-care coagulation monitoring using the BMC Coaguchek Plus System represents an effective and widely generalizable strategy for managing patients with thromboembolic disease that fosters the rapid achievement of a desired range of anticoagulation. Additional work is needed, however, to improve on existing patient-specific strategies that can more effectively sustain a therapeutic state of anticoagulation.

Adult↗
PubMed1998

Association of mitral annular calcium with new thromboembolic stroke at 44-month follow-up of 2,148 persons, mean age 81 years.

We investigated in a prospective study of 2,148 persons (mean age 81 years), the association between mitral annular calcium and new thromboembolic stroke at 44-month follow-up. Independent risk factors for new thromboembolic stroke were prior stroke (risk ratio 2.4), mitral annular calcium (risk ratio 2.6), atrial fibrillation (risk ratio 3.0), and male gender (risk ratio 1.6).

Aged↗