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PubMed2005

Oral direct thrombin inhibitor ximelagatran compared with warfarin for the prevention of venous thromboembolism after total knee arthroplasty.

BACKGROUND: Warfarin, which requires coagulation monitoring, is associated with relatively high rates of thromboembolism despite providing adequate prophylaxis. This study compared an oral direct thrombin inhibitor, ximelagatran, with warfarin in order to evaluate the safety and efficacy of the medication for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty. METHODS: Following surgery, patients were randomly assigned to fixed-dose oral ximelagatran (36 mg twice daily) or warfarin (target international normalized ratio, 2.5), both administered for seven to twelve days in a double-blind, double-dummy design. Warfarin was initiated on the evening of the day of surgery, and ximelagatran, on the morning after surgery. The primary efficacy end point was the incidence of asymptomatic deep-vein thrombosis determined by bilateral venography, objectively confirmed symptomatic deep-vein thrombosis or pulmonary embolism, and death from all causes during treatment. RESULTS: Adequate venograms or confirmed symptomatic events (efficacy population) were obtained for 1949 patients. Venous thromboembolism and death from all causes occurred in 22.5% (221) of 982 ximelagatran-treated patients and in 31.9% (308) of 967 warfarin-treated patients (p < 0.001). Proximal deep-vein thrombosis and pulmonary embolism were observed in 3.1% (thirty) and 0.2%, respectively, of the patients in the ximelagatran group and in 3.4% (thirty-three) and 0.4%, respectively, of the patients in the warfarin group. The six deaths from all causes included 0.3% (four) of the ximelagatran-treated patients and 0.2% (two) of the warfarin-treated patients. Major bleeding was noted in 1% (twelve) of the ximelagatran-treated patients and in 0.4% (five) of the warfarin-treated patients (p = 0.09). CONCLUSIONS: Oral ximelagatran (36 mg twice daily), administered without coagulation monitoring or dose adjustment and started the day after total knee arthroplasty, demonstrates superior efficacy compared with warfarin prophylaxis, with no wound complications and no significant difference with respect to bleeding events, although the rate of major bleeding events was greater with ximelagatran than with warfarin. LEVEL OF EVIDENCE: Therapeutic Level I.

Aged↗
PubMed2005

Extended anticoagulation therapy for the primary and secondary prevention of venous thromboembolism.

Extending the period of anticoagulation is an active area of investigation in both primary and secondary prevention of venous thromboembolic disease. In orthopaedic surgery, particularly in patients undergoing hip surgery, there is a growing interest in using extended anticoagulation beyond that traditionally given in the postoperative period using low-molecular weight heparin, oral anticoagulants, or newer agents such as fondaparinux sodium. Most studies show a benefit to extending anticoagulation without a considerable increase in major bleeding. There have been several large clinical trials addressing the question of extending oral anticoagulation in secondary prevention of venous thromboembolism (VTE). Just how long anticoagulation should be given in the treatment of venous thromboembolic disease remains an open question, depending on the nature of the initial VTE, associated patient risk factors and the risks of major bleeding. Future directions include the use of newer agents for anticoagulation as well as methods of better defining who will benefit most from extended anticoagulation based on an identification of risk factors with the aid of markers such as D-dimer or residual vein thrombosis.

Anticoagulants↗
PubMed1995

Pulmonary thromboembolic hypertension in systemic lupus erythematosus with lupus anticoagulant: histopathological analysis of localization and distribution of thromboemboli in pulmonary vasculature.

We report a systemic lupus erythematosus patient with lupus anticoagulant accompanied by pulmonary thromboembolic hypertension possibly due to large vegetation of the tricuspid valve of the heart. Histopathological analysis of localization and distribution of thromboemboli in pulmonary vasculature revealed that the organized thromboembolic occlusion of multiple blood vessels (99 out of 222 arteries), might be responsible for the pulmonary hypertension both in quality and quantity. The contribution of lupus anticoagulant to the pathogenesis of Libman-Sacks endocarditis in systemic lupus erythematosus, and its possible relationship to pulmonary thromboembolic hypertension are discussed.

Adult↗
PubMed2005

Paradoxical peripheral embolism coincident with acute pulmonary thromboembolism.

Paradoxical embolism may occur in patients with acute pulmonary thromboembolism, when patent foramen ovale (PFO) coexists with pulmonary hypertension (right-left shunt). There have been few case reports of paradoxical embolism in peripheral arteries coincident with acute pulmonary thromboembolism. Here, we describe a case of paradoxical peripheral embolism associated with PFO complicated by acute pulmonary thromboembolism. The patient had severe peripheral ischemia due to a massive thrombus and was treated successfully by peripheral thrombectomy, thrombolysis, implantation of a permanent inferior vena cava filter and anticoagulation.

Acute Disease↗
PubMed2002

Bronchopulmonary shunts in patients with chronic thromboembolic pulmonary hypertension: evaluation with helical CT and MR imaging.

OBJECTIVE: The purpose of our study was to compare differences in flow between the pulmonary and systemic circulations by assessing MR phase-contrast flow measurements and CT measurements of dilated bronchial arteries in patients with chronic thromboembolic pulmonary hypertension. MATERIALS AND METHODS: Seventeen patients were included in this study. MR phase-contrast flow measurements were used to calculate the net forward volumes in the right and left pulmonary arteries and in the ascending aorta. Single-detector helical CT scans were assessed for the presence of dilated bronchial arteries that could be delineated from the descending aorta to the mainstem bronchi. Their perpendicular cross-sectional area at the level of the main bronchi was measured using a double-threshold region of interest (> or =100-3072 H). RESULTS: The mean net forward volume in the aorta was 44.6 mL per heartbeat (R-R interval) and in the pulmonary arteries, 30 mL per R-R interval. Thus, the mean difference was 14.6 mL per R-R interval; this value represents the shunt volume between the systemic arterial and pulmonary venous circulations. On CT, dilated bronchial arteries were depicted in all patients (mean, three arteries per patient). The mean cross-sectional area of the bronchial arteries was 0.19 cm(2). Pearson's correlation coefficient (r) between cross-sectional area and shunt volume was 0.86 (p < 0.01). CONCLUSION: MR imaging was able to reveal substantial differences in flow between the systemic arterial and pulmonary venous circulations in patients with chronic thromboembolic pulmonary hypertension. These differences correlated well with the diameters of the bronchial arteries seen on helical CT. Furthermore, these differences resolved after pulmonary thromboendarterectomy. MR imaging enables the accurate estimation of flow in the bronchial arteries in patients with chronic thromboembolic pulmonary hypertension.

Adult↗
PubMedDate not supplied

Thromboembolic infarcts occurring after mild traumatic brain injury in a paediatric patient with Noonan's syndrome.

Noonan's syndrome is a genetic concurrence of multiple morphological abnormalities typified by short stature, webbed neck, cardiovascular abnormalities, and characteristic facies. Numerous neurological conditions have also been associated with Noonan's syndrome, including cerebrovascular pathology. This paper describes the case of a 15-year-old female on our paediatric rehabilitation service who, in a motor vehicle accident, suffered a mild traumatic brain injury (TBI) which was followed by multiple thromboembolic infarcts of the posterior circulation. Full work-up resulted in the diagnosis of Noonan's syndrome and the demonstration of significant posterior circulation congenital anomalies. Traumatic vasculopathy, superimposed on the developmentally hypoplastic posterior vessels, was suggested as an aetiology of this patient's stroke. A review of the limited literature associating thromboembolic infarcts with antecedent TBI, and linking Noonan's syndrome to various neurological problems, is discussed. This paediatric rehabilitation case represents a fascinating new association between thromboembolic infarcts and TBI in the setting of a previously undiagnosed genetic syndrome.

Adolescent↗
PubMed1987

Recombinant human tissue-type plasminogen activator therapy in acute thromboembolic stroke.

Systemic fibrinolytic therapy for acute stroke is no longer recommended because of resulting systemic fibrinolysis and the risk of intracerebral hemorrhage. Human tissue-type plasminogen activator (TPA) is a native enzyme that converts plasminogen to plasmin with subsequent clot lysis. The affinity for plasminogen is increased several-fold when the substrate is bound to fibrin. At appropriate dosage, "clot-specific" thrombolysis may be achieved at the surface of the thrombus without creating systemic fibrinolysis. The authors designed a study to evaluate the effect of intravenous TPA administered 2 hours after acute thromboembolic stroke in rats. This time course was chosen to simulate an analogous clinical situation. Middle cerebral artery embolic stroke was caused by intracarotid injection of 0.025 cc of human blood clot in 16 rats. Regional cerebral blood flow, measured by the hydrogen clearance technique, and electroencephalographic (EEG) recordings were obtained every 30 minutes for 5 hours after thromboembolism. Eight rats received a 1-hour infusion of intravenous TPA (1.5 mg/kg) 2 hours after injection of emboli. Ipsilateral blood flow increased significantly within 30 minutes after intravenous TPA and reached preembolic levels within 60 minutes. Blood flow did not improve in the eight control rats throughout the experiment. Power spectral analysis of the EEG recordings showed improvement in the treated group compared to the control group. Postmortem angiography revealed proximal middle cerebral artery occlusion in control animals and patent middle cerebral arteries in TPA-treated animals. Serum fibrinogen and fibrin split products were unchanged in both groups, indicating the absence of systemic fibrinolysis. There were no intracerebral hemorrhages. It is concluded that, in this rat model, TPA increases blood flow with subsequent improvement in the EEG recording after thromboembolic stroke without evidence of systemic fibrinolysis. Intravenous TPA may be useful in the treatment of acute stroke in man.

Animals↗
PubMed2003

Incidence of venous thromboembolism in patients undergoing craniotomy and motor mapping for glioma without intraoperative mechanical prophylaxis to the contralateral leg.

OBJECT: Evidence-based reviews support the use of venous thromboembolism (VTE) prophylaxis in the form of compression devices and/or stockings for patients undergoing craniotomy. In patients undergoing craniotomy with motor mapping for glioma, the contralateral lower extremity should remain visible so that motor responses can be accurately identified. As a consequence, these patients could be placed at a higher risk to develop VTE. The authors have quantified the incidence of VTE in patients undergoing craniotomy with motor mapping and have shown that there is no increased risk of developing a VTE in the contralateral lower extremity when compression devices are not used. METHODS: One hundred eighty consecutive cases (1997-2000) of craniotomy with motor mapping for glioma were retrospectively reviewed to determine the incidence and location of VTEs during the early postoperative course. Intraoperative VTE prophylaxis in all patients consisted of ipsilateral (that is, ipsilateral to the hemisphere being mapped) lower-extremity mechanical prophylaxis (antiembolism stocking plus compression device). Postoperatively, all patients received bilateral mechanical prophylaxis. Patients were observed until discharge and received clinical follow up. Venous thromboembolism, classified as deep venous thrombosis (DVT) or pulmonary embolism (PE) occurring within 6 weeks postoperatively, was confirmed by Doppler ultrasonography, spiral computerized tomography scanning, or both. The average duration of postoperative hospitalization was 5 days (range 2-59 days). Six patients (3.3%) experienced VTE. Of those, in four (2.2%) the DVT was localized to the contralateral (three patients) or ipsilateral (one patient) lower extremity. Two other patients (1.1%) only had PE. There were no deaths from thromboembolic complications and no statistically significant predisposition to VTE in the contralateral lower extremity among patients not receiving intraoperative prophylaxis. CONCLUSIONS: The incidence of VTE in patients undergoing craniotomy with motor mapping is comparable to that in patients receiving bilateral lower-extremity mechanical VTE prophylaxis. The practice of leaving the contralateral lower extremity free from intraoperative prophylaxis does not appear to place patients at a higher risk for developing VTE. There appears to be no preferential distribution of VTE in contralateral lower extremities that do not receive immediate preoperative and intraoperative mechanical prophylaxis.

Adult↗
PubMed2000

Improving detection of venous thromboembolism. New technology holds promise for early, precise diagnosis.

In recent years, a number of modalities have been evaluated for the diagnosis of venous thromboembolism. The role of these modalities is still evolving. While ventilation-perfusion scanning is important in the diagnosis of venous thromboembolism, spiral CT scanning, MRI, and D-dimer assays are now being used more often, either exclusively or in combination with ventilation-perfusion scanning. A number of diagnostic algorithms using these modalities are currently being evaluated. Regardless of which diagnostic approach is used, the clinician must be aware of some key limitations. Spiral CT scanning has gained popularity because it is noninvasive and can rapidly identify other cardiopulmonary diseases that mimic pulmonary embolism. Its use has been limited because of its inability to detect subsegmental pulmonary emboli. D-dimer assays offer promise as rapid, inexpensive screening tools. However, the wide variability in assay performance has limited its usefulness. We recommend that if D-dimer assays are to be used in a diagnostic algorithm, the clinician be aware of the details of the assay. At present, lack of data precludes use of MRI as a primary diagnostic tool for detection of venous thromboembolism.

Fibrin Fibrinogen Degradation Products↗
PubMed2000

Thromboembolism during pregnancy. Risks, challenges, and recommendations.

Pregnancy is an important risk factor for venous thrombosis, and venous thromboembolism is a leading cause of preventable death in pregnancy. Diagnosis of venous thromboembolism is complicated in that the symptoms of dyspnea and lower extremity edema are relatively common complaints of pregnant patients. Physicians should maintain an appropriately high index of suspicion and request diagnostic imaging in a timely manner. Diagnosis of deep venous thrombosis with Doppler ultrasonography of the lower extremity poses no health risk to the fetus, but other radiographic studies pose a low radiation risk to the fetus. Because anticoagulant therapy poses a greater health risk to mother and fetus than does the radiation required for the diagnosis of pulmonary embolism, clinicians should aggressively pursue objective evidence of venous thromboembolism. Once the diagnosis is made, anticoagulation with intravenous unfractionated heparin or subcutaneous low-molecular-weight heparin should be used prepartum followed by warfarin therapy after delivery.

Adult↗
PubMed2003

Comparison of 10-mg and 5-mg warfarin initiation nomograms together with low-molecular-weight heparin for outpatient treatment of acute venous thromboembolism. A randomized, double-blind, controlled trial.

BACKGROUND: The optimal means of achieving therapeutic oral anticoagulation in the outpatient setting has not been determined. OBJECTIVE: To compare a 10-mg dosing nomogram with a 5-mg nomogram that has been suggested to be sufficient for warfarin initiation. DESIGN: Randomized, controlled clinical trial. SETTING: Outpatient venous thromboembolism services of four tertiary care hospitals. PATIENTS: 201 of 210 consecutive patients with objectively confirmed diagnoses of acute venous thromboembolism. INTERVENTION: All patients were treated with subcutaneous low-molecular-weight heparin for a minimum of 5 days until a therapeutic international normalized ratio (INR) was achieved. Patients were randomly assigned to initially receive a 10-mg or 5-mg dose of warfarin. MEASUREMENTS: The primary end point was time in days to therapeutic INR. Secondary end points were the proportion of patients who had achieved a therapeutic INR by day 5, the total number of INR assessments, the number of INR measurements greater than 5.0, incidence of recurrent venous thromboembolism and major bleeding, and survival. RESULTS: 210 consecutive patients met the inclusion criteria. Of these, 9 were excluded and 201 were randomly assigned to study groups (104 to the 10-mg group and 97 to the 5-mg group). Demographic characteristics of both groups were similar. Patients in the 10-mg group achieved therapeutic INR 1.4 days earlier than patients in the 5-mg group (P < 0.001). Eighty-three percent of patients in the 10-mg group achieved a therapeutic INR by day 5 versus 46% in the 5-mg group (P < 0.001). Fewer INR assessments were performed in the 10-mg group than in the 5-mg group (8.1 vs. 9.1; P = 0.04). There were no significant differences between the two groups in recurrent events, major bleeding, survival, and number of INR measurements greater than 5.0. CONCLUSION: The 10-mg warfarin initiation nomogram is superior to the 5-mg nomogram because it allows more rapid achievement of a therapeutic INR.

Acute Disease↗
PubMed1998

[Clinical aspects of pulmonary thromboembolism].

This paper is a review of the patients with pulmonary thromboembolism hospitalized at General hospital in Teanj starting from the first case recorded in 1980 till now and 172 patients were subjects of this study. Thromboembolism was a direct cause of death in 43.7% (75 patients). Clinical and laboratory records, etiology, chest radiography, ECG data of 89 patients hospitalised and treated in the last five years were analyzed in detail. The most frequent symptoms were dyspnea and tachypnea, often accompanied with other symptoms (84.2%), chest pain (65.2%), cough (52.4%), tachycardia (40.5%), hemoptysis (25.8%). At 74% of patients with pulmonary thromboembolism a significant simultaneous increase of all examined enzymes, except CPK was found. Pulmonary insufficiency (global or partial) was found at 75% of patients. According to our results, in 57.2% of the subjects the pathologic changes on Radiography (infiltrates of the lung, with or without affection of the pleura and changed position of diaphragm) were found, and 70.9% had changes on the ECG.

Humans↗
PubMed1999

[20210A mutation of the prothrombin and venous thromboembolism gene].

PURPOSE: Various genetic disorders interact with environmental factors to cause thrombotic diseases. Recently, a G to A transition at nucleotide 20210 in the prothrombin gene, has been described in association with venous thromboembolism, in Dutch population. Currently, several reports want to know the frequence of this mutation in other ethnic groups and populations. The aim of this work was to assess the prevalence rates of prothrombin mutation in both, thrombotic and healthy Spanish populations, and to estimate the associated relative risks. We described the clinical features in our series of thrombotic carriers and moreover, we compared a routine clotting test versus DNA analysis in the diagnosis of this anomaly. POPULATION, MATERIAL AND METHODS: The design was a non-matched case-control study. The involved populations were: 187 patients of venous thromboembolic diseases and 200 healthy controls. Patients and controls were genotyped and both, carriers and non-carrier patients, were analyzed by a routine prothrombin clotting assay, to determine the sensibility and specificity and optimal cut off level of the test. RESULTS: The 20210 A allele was identified in 17 patients (9.1%) and in 7 controls (3.5%), with a 2.76-fold increased risk (OR 2.76, 95% CI = 1.12-6.81), in carriers. One patient and none of the controls were homozygous. The clinical characteristics (first manifestation age or thrombotic recurrence) are similar in both, carriers and non-carriers, patient groups. The prothrombin level by a routine coagulometric method was 1.31 +/- 0.14 U/ml (95% CI = 1.24-1.38) for the 20210 A carriers, whereas for the non carrier-patients was significantly lower, 1.06 (95% CI = 1.03-1.08) (p < 0.00001). With a cut off level of 1.25 U/ml, 12/16 (75%) carriers and 14/132 (10.6%) non-carriers were positive. Therefore, the sensibility was 75% and the specificity 89.4%. With a cut off level of 1.40 U/ml the diagnostic efficiency was even worse. CONCLUSIONS: 3.5% of healthy subjects and 9.1% of thromboembolic patients carried this prothrombin mutation with a relative risk of 2.76 (95% CI = 1.12-6.81). The relevant clinical features are similar to the rest of the series. The mean prothrombin level was higher (1.31 U/ml) than in the normal patients (1.06 U/ml), but the clotting test seems inappropriate for a diagnostic purpose.

Adult↗
PubMed1999

The risk of early recurrent venous thromboembolism after oral anticoagulant therapy in patients with the G20210A transition in the prothrombin gene.

A G20210A transition in the prothrombin gene is a common risk factor of venous thrombosis. The risk of recurrent venous thromboembolism in carriers of the 20210A allele is unknown and guidelines for secondary thromboprophylaxis in these patients are not available. In a prospective multicenter trial, 492 patients with a history of objectively documented venous thromboembolism were followed for a mean observation time of 24+/-16 months after discontinuation of oral anticoagulants. Forty-two patients (8.5%) were carriers of the 20210A allele. Three of the 42 patients with the G20210A mutation (7%) and 54 of 450 patients without the mutation (12%) experienced recurrent venous thrombosis. At 24 months, the probability of recurrence was 8% (95% CI 0-16.7) in patients with the mutation and was 12.2% (95% CI 8.8-15.6) in patients without the mutation. In conclusion, the risk of early recurrent venous thromboembolism is not higher in patients with the G20210A mutation than in those without the mutation. Therefore, long-term secondary thromboprophylaxis with oral anticoagulants in heterozygous carriers of the 20210A allele is not justified.

Administration, Oral↗
PubMed1999

[Pulmonary thromboembolism in a female with resistance to activated protein C].

Primary or acquired hypercoagulable states favour thrombotic events. The identification of prothrombotic states is of immediate practical usefulness in the orientation, prophylaxis and treatment of pulmonary embolism. Detection of individuals resistant to activated protein C. the most frequent laboratory anomaly in the study of patients with venous thromboembolism, offers a better approach for these patients as well as a better prophylaxis and orientation of their direct relatives concerning thromboembolic events. The authors describe the clinical case of a young woman, previously healthy, who developed serious pulmonary thromboembolism, the resolution of which was difficult and the evolution unusual. Later, a state of resistance to activated protein C (aPCr) was identified. Concerning the case described, the authors reflect on hypercoagulable situations, especially "aPCr" states.

Activated Protein C Resistance↗
PubMed1999

[Chronic pulmonary thromboembolism diagnosed on the basis of characteristic mosaic patterns on lung computed tomograms].

We report on a 59-year-old woman who presented with characteristic findings on lung computed tomographic (CT) scans and was therefore suspected to have chronic pulmonary thromboembolism. She visited our hospital because of worsening exertional dyspnea over the preceding year, and because she was dissatisfied with an earlier diagnosis made by another institution. Chest roentgenograms disclosed nonhomogeneous hyperlucency in both lungs associated with linear and bundle shadows, dullness of the right costophrenic angle, and dilatation of the descending branch of the right pulmonary artery. The patient experienced moderate hypoxemia even at rest. Pulmonary function tests demonstrated a restrictive ventilatory pattern associated with reduced diffusion capacity. The lung CT scans disclosed a mosaic pattern of attenuation in the lung parenchyma, which probably reflected scattered areas of low perfusion. The unique characteristics of such CT findings drew our attention to chronic pulmonary thromboembolism as a possible diagnosis. We eventually confirmed the diagnosis on the basis of enhanced CT scans, pulmonary perfusion and ventilation scintigrams, and digital subtraction angiography. In our view, chronic pulmonary thromboembolism should be kept in mind as a possible differential diagnosis of the mosaic patterns of attenuation on lung CT scans.

Chronic Disease↗
PubMedDate not supplied

[Thromboembolic prophylaxis in patients with head and neck carcinomas: a risk-benefit study].

Thromboembolism is a risk in major surgical procedures on the head and neck for cancer in predisposed patients. This study was designed to determine if preoperative administration of low-molecular-weight heparin is safe or if it increases the risk of postoperative complications. Preoperative administration of low-molecular-weight heparin was the most important factor in complications such as pharyngo-cutaneous fistula, wound infection, suture dehiscence, or seroma. The second most important factor was surgical technique, and the third factor was neck dissection. Low-molecular-weight heparin did not reduce the risk of thromboembolism. In fact, one patient died suddenly from thromboembolism after surgery.

Aged↗
PubMed1999

[Pulmonary thromboembolism accompanied by abnormal plasminogen].

A 38-year-old man was admitted to our hospital because of sudden chest pain and bloody sputum. Lung perfusion scintigraphy disclosed segmental defects in both lungs. An enhanced thin-section computed tomographic scan of the chest showed a low-density area in the right main pulmonary artery. These findings yielded a diagnosis of pulmonary thromboembolism. Serum plasminogen activity was low, not only in the patient but in his elder brother and daughter. Gene analysis revealed a point mutation at exon 15 of the plasminogen gene, suggesting abnormal plasminogen. Abnormal plasminogen is more prevalent in Japan than in the USA or Europe, and is usually asymptomatic. Thromboembolism in patients with abnormal plasminogen is very rare. Further studies are needed to elucidate the relationship between plasminogen abnormalities and pulmonary thromboembolism.

Adult↗