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Thromboembolic and bleeding complications after mitral valve replacement.

One thousand six hundred and sixty-eight consecutive patients who underwent isolated mitral valve replacement (MVR) from 1963 to 1984 were evaluated retrospectively. Thromboembolism occurred with a linearised rate of 2.5% +/- 0.2%/patient-year (PY) for Starr-Edwards disc prosthesis Model 6520, 2.4% +/- 0.3%/PY for Bjørk-Shiley plane prosthesis, 3.0% +/- 0.8%/PY for Bjørk-Shiley convexo-concave 60 degrees prosthesis, 3.0% +/- 0.8%/PY for St. Jude Medical prosthesis and 3.4% +/- 0.5%/PY for Carpentier-Edwards tissue valve without the differences reaching significance. In the SJM group, the incidence of thromboembolism was significantly higher (P less than 0.025) in smaller sizes (less than M29) probably due to a more turbulent flow. The linearised rate for major haemorrhage was 1.6% +/- 0.1%/PY. Twenty-three percent of the thromboembolic and 18% of the bleeding events were fatal. Sixty-eight percent of the emboli involved the central nervous system and bleeding apart from fatalities was predominantly non-cerebral (81%). Whereas thromboembolism was a time-related event with more than twice as high a risk in the first postoperative year (4.2% +/- 0.5% vs. 1.7% +/- 0.8%, P less than 0.01), bleeding occurred with a constant rate over time (0.9% +/- 0.4%). Adequacy of anticoagulation was an important risk factor for postoperative embolism with the prothrombin time (PT) exceeding the therapeutic range in 65% of all events. A preoperative history of embolism was the only additional patient-related risk factor for postoperative embolism (18.3% vs. 9.6%, P less than 0.001). In 30% of all haemorrhage, the PT was below 15%.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Cardiovascular and thromboembolic events following hypertensive pregnancy.

BACKGROUND: Hypertension is a common complication of pregnancy. Previous evidence has linked pregnancy-related hypertension to maternal cardiovascular disease. We conducted a population-based cohort study to estimate the risks for cardiovascular and thromboembolic events in women with pregnancy-related hypertension. METHODS: We analyzed data from all singleton births recorded in Washington State from 1987 to 1998. Mothers were classified as having gestational hypertension, preeclampsia, or chronic hypertension based on hospital discharge and birth record information. Birth records were linked to subsequent hospitalizations within Washington State. Proportional hazards models were used to estimate the relationship between each form of pregnancy-related hypertension and subsequent risk for cardiovascular and thromboembolic events. RESULTS: We identified 31,239 eligible hypertensive pregnancies from 807,010 births. During follow-up, there were 118 hospitalizations for a first acute cardiovascular event and 172 hospitalizations for a first thromboembolic event. Gestational hypertension, mild preeclampsia, and severe preeclampsia were associated with 2.8-fold (95% confidence interval [CI], 1.6 to 4.8), 2.2-fold (95% CI, 1.3 to 3.6), and 3.3-fold (95% CI, 1.7 to 6.5) greater risks for cardiovascular events, respectively. Severe preeclampsia was associated with a 2.3-fold (95% CI, 1.3 to 4.2) greater risk for thromboembolic events. CONCLUSION: Preeclampsia and gestational hypertension are associated with increased risk for cardiovascular events. Pregnancy-induced hypertension appears to be an important risk factor for the development of future cardiovascular disease in young women.

Adult↗

Risk of serious upper gastrointestinal and cardiovascular thromboembolic complications with meloxicam.

PURPOSE: To assess the risk of serious gastrointestinal and thromboembolic complications with approved doses of meloxicam. METHODS: We pooled data from clinical trials of meloxicam at doses of 7.5 or 15 mg/d. A blinded gastrointestinal adjudication committee used prespecified criteria to identify gastric or duodenal perforation, gastric outlet obstruction, or hemodynamically important upper gastrointestinal bleeding. For analysis of thromboembolic complications, investigator-reported events were analyzed without adjudication. RESULTS: We analyzed data from 24,196 patients from 28 trials, most of whom had been followed for up to 60 days. Of these patients, 13,118 received meloxicam (10,158 received a daily dose of 7.5 mg and 2960 received 15 mg), 5283 were treated with diclofenac 100 mg, 181 received diclofenac 150 mg, 5371 were treated with piroxicam 20 mg, and 243 received naproxen 500 mg twice daily. Patients who received 7.5 mg of meloxicam daily had a 0.03% risk of serious upper gastrointestinal events, which was significantly lower than the risk in those who received diclofenac, naproxen, or piroxicam (P <0.02). With the 15 mg daily dose of meloxicam, this risk was significantly different only when compared with piroxicam (P = 0.03). The risk of thromboembolic events in patients treated with meloxicam at either dose was lower than with diclofenac, but similar to that observed with piroxicam and naproxen. CONCLUSION: This pooled analysis of 24,196 patients demonstrates that meloxicam has a favorable gastrointestinal and thromboembolic safety profile. However, only a small number of patients were followed for more than 60 days, and meaningful comparisons were not possible in this subgroup.

Adolescent↗

Pulmonary artery-to-pulmonary artery anastomoses: angiographic demonstration in patients with chronic thromboembolic pulmonary hypertension.

AIM: To describe direct pulmonary artery-to-pulmonary artery anastomoses seen at pulmonary angiography in patients with chronic thromboembolic pulmonary hypertension and discuss their possible significance. MATERIALS AND METHODS: Between 1 August 2000 and 31 July 2004 43 patients (male-to-female ratio 25:18) with a diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) underwent selective pulmonary angiography to assess the extent of disease and suitability for surgical pulmonary endarterectomy. The mean pulmonary artery pressure ranged from 27-84 mmHg (average of 51 mmHg). Selective bilateral digital subtraction pulmonary angiograms performed in all individuals were reviewed for the presence of intrapulmonary collaterals. RESULTS: In 15 of the 43 patients (male-to-female ratio =7:8) definite (n = 12) or probable (n = 3) pulmonary artery-to-pulmonary artery anastomoses were demonstrated. Of the remaining 28 patients in whom intrapulmonary collaterals were not seen it was felt that in 16 the angiograms were of insufficient diagnostic quality (grades 4-5) to exclude their presence. Twelve patients, eight of whom had angiograms of sufficient diagnostic quality (grades 1-3), demonstrated one or more areas of luxury perfusion but intrapulmonary collaterals were not seen. CONCLUSION: Direct pulmonary artery-to-pulmonary artery anastomoses were demonstrated in patients with chronic thromboembolic pulmonary hypertension, which to our knowledge have not been previously described. The importance of these collateral vessels is unclear but they may play a role in the maintenance of pulmonary parenchymal viability in patients with chronic pulmonary embolic disease. The rate of development of these collaterals and their prognostic significance in patients with chronic thromboembolic pulmonary hypertension are areas worthy of further study.

Adult↗

Triflusal versus oral anticoagulation for primary prevention of thromboembolism after bioprosthetic valve replacement (trac): prospective, randomized, co-operative trial.

OBJECTIVE: Antiplatelet agents are used for prevention of thromboembolism in surgical patients and in patients with chronic atrial fibrillation. Up to date, however, results of randomized studies comparing antiplatelet agents and oral anticoagulation have not been reported. The aim of this study was to compare the efficacy and safety of triflusal (an antiplatelet agent) versus acenocoumarol for primary prevention of thromboembolism in the early postoperative period after implantation of a bioprosthesis. METHODS: In this prospective, multicentric, randomized, open pilot trial, patients were assigned to treatment with triflusal (600mg/d) or acenocoumarol (target INR 2.0-3.0). Study medication was started 24-48h after valve replacement with a bioprosthesis, and continued for 3 months. Four follow-up visits were scheduled: baseline, and at 1, 3 and 6 months thereafter. The primary end-point was a composite of the rate of thromboembolism, severe hemorrhage and valve-related mortality. RESULTS: A total of 193 patients were included (97 received triflusal and 96 acenocoumarol), with a mean age of 72.5 years. Half were men. Aortic valve replacement was performed in 181 patients (93.8%), mitral valve replacement in 10 patients (5.2%) and double valve replacement in 2 (1.0%). Hospital mortality was 11 (5.7%). Primary outcome was recorded in 9 patients with triflusal (9.4%) and in 10 patients with acenocoumarol (11%). There were nine episodes (4.7%) of thromboembolism, six in the triflusal group and three in the acenocoumarol group, and three episodes of permanent neurological deficits, one in the triflusal group and two in the acenocoumarol group. Severe hemorrhage: nine episodes, six in the acenocoumarol group and three in the triflusal group. None of the observed differences in efficacy were statistically significant. Regarding safety, three patients in triflusal group reported at least one hemorrhage, compared to 10 in acenocoumarol group (P=0.048). CONCLUSIONS: There were no significant differences in efficacy between both groups, however, triflusal showed a significantly lower incidence of bleeding episodes.

Acenocoumarol↗

Arterial thromboembolic complications in critically ill children.

PURPOSE: To evaluate incidence and characteristics of arterial thromboembolic complications in critically ill children. MATERIALS AND METHODS: Hospital records of all consecutive patients with arterial thromboembolic events (ATEs) occurring in the pediatric intensive care unit (PICU) from January 1997 to August 2001 were reviewed. Data collected included demographics and location, treatment modalities and outcome of ATEs. RESULTS: Fifty-four ATEs in 51 children (median age, 14 days) were identified, reflecting an incidence of 1.2% of all PICU patients. Arterial thromboembolic events were located in peripheral arteries in 52 (96%) cases and were associated with indwelling arterial catheters (n=26) or cardiac catheterization (n=26). The remaining 2 ATEs were located in the left ventricle and cerebral arteries, respectively. Therapy consisted of heparin (n=51), thrombolysis (n=22), oral anticoagulation (n=12), and aspirin (n=34). Complete resolution was noted in 33 (70%), partial resolution in 10 (21%), and no resolution in 4 (8.5%) cases. Bleeding complications occurred in 1 patient treated with heparin and in 12 (54%) of the 22 patients receiving thrombolytic therapy. CONCLUSIONS: Arterial thromboembolic events are frequent complications of PICU, particularly affecting neonates, and mostly associated with catheters. Studies to determine safe and effective prophylactic and treatment modalities of ATEs in children are required.

Adolescent↗

The use of abciximab in the treatment of acute cerebral thromboembolic events during neuroendovascular procedures.

BACKGROUND: Recently, a great interest has emerged regarding the use of abciximab for treatment of stroke. Thromboembolic events that occur during neuroendovascular procedures represent a unique subset of stroke patients because definitive angiographic diagnosis and treatment can be performed immediately. The existing literature on this situation suggests excellent results; however, most publications are case reports, and the largest series is 13 cases. We report our experience using abciximab in the treatment of acute thromboembolic events that occur during neuroendovascular procedures. METHODS: We reviewed the last 1373 consecutive patients who underwent neuroendovascular procedures at the University of Florida from our prospectively maintained clinical database. Of these patients, 29 (2.11%) endovascular cases were complicated by acute cerebral thromboembolic events that were treated with abciximab. Abciximab was administered in less than 1 hour after the onset of the occlusion in every patient. The Thrombolysis In Myocardial Infarction (TIMI) scale was used to measure immediate angiographic outcome, and the Modified Rankin Scale (MRS) was used to measure clinical outcome at the time of follow-up. Independent outcome was defined as an MRS of 3 or less at follow-up. RESULTS: Angiographic improvement in the TIMI grade was achieved in 29 (81%) of 36 arteries. Three intracerebral hemorrhages occurred with abciximab when administered with concurrent mechanical clot disruption; in two of these hemorrhages, recombinant tissue plasminogen activator (r-tPA) was also administered. The mean follow-up time for the living cohort was 7.54 months. Twenty-four (83%) patients were independent at follow-up, 3 (10%) were dependent at follow-up, and 2 (7%) died. CONCLUSION: Abciximab appears to be safe and effective in the treatment of acute cerebral thromboembolic complications during neuroendovascular procedures.

Abciximab↗

Epidemiology of venous thromboembolism in neonates and children.

Venous thromboembolism is an increasingly recognised problem in paediatric practice, particularly in the context of tertiary care paediatric services. In recent years, several national and international registries have helped to define the epidemiology of venous thromboembolism in both neonates and older children. These studies have generated information on the incidence and risk factors associated with venous thromboembolism in different age groups. Data from these and other studies have demonstrated important differences between paediatric and adult practice and highlight the need for specific evidence based guidelines for the prevention and management of venous thromboembolism in neonates and children.

Age Distribution↗

Thromboembolic complications in the nephrotic syndrome: pathophysiology and clinical management.

Patients with the nephrotic syndrome are at increased risk of developing venous and arterial thromboembolism, the most common of which is renal vein thrombosis. There are several unanswered or controversial issues relating to the nephrotic syndrome and thromboembolism, which include the mechanism of thromboembolism, and optimal diagnostic and anticoagulant management strategies. This review will discuss several of these issues: the epidemiology and clinical spectrum of thromboembolic disease occurring in patients with the nephrotic syndrome; the pathophysiology of the hypercoagulable state associated with the nephrotic syndrome; the diagnosis of renal vein thrombosis in the nephrotic syndrome; and the evidence for prophylactic and therapeutic anticoagulation strategies in such patients.

Anticoagulants↗

The treatment of venous thromboembolism in special populations.

Anticoagulant therapy for the typical venous thromboembolism patient is straightforward with predictably favorable outcomes. However, for certain patients with venous thromboembolism, there remains uncertainty and controversy about optimal treatment. These controversial areas include venous thromboembolism patients with: heparin resistance, renal insufficiency, morbid obesity, cancer, antiphospholipid antibody syndrome, recurrent thrombosis despite appropriate anticoagulation, and patients with unprovoked VTE who may or may not benefit from thrombophilia testing. This review summarizes the current data for these special patient populations with venous thromboembolism and provides our recommendations for management.

Anticoagulants↗

Perioperative clinical thromboembolic events after radical or partial nephrectomy.

OBJECTIVES: To evaluate the incidence of, and identify the risk factors for, clinical thromboembolic events after radical/partial nephrectomy. Cancer is an established risk factor for deep vein thrombosis (DVT) and pulmonary embolism (PE); however, their incidence after nephrectomy for renal tumors has been poorly studied. METHODS: We reviewed our prospective institutional renal database and identified 2208 patients who underwent renal tumor surgery from January 1989 to July 2005. The clinical parameters evaluated were age, sex, race, body mass index, smoking history, medical comorbidities, American Society of Anesthesia grade, procedure type, estimated blood loss, and length of hospitalization. Hospital records, discharge "International Classification of Diseases, Ninth Revision" codes, and 30-day postoperative morbidity and mortality data were reviewed to identify patients diagnosed with perioperative DVT or PE. RESULTS: A total of 34 (1.5%, 95% confidence interval 1.1% to 2.1%) thromboembolic events (20 PEs and 14 DVTs) were identified in 33 patients. Patients with a preoperative history of arrhythmia (P = 0.02) or prior DVT (P = 0.053) were more likely to experience PE. The estimated blood loss was directly associated with an increased risk of PE (P = 0.001). Patients with coronary artery disease (P = 0.050) or of advanced age (P = 0.02) were more likely to experience DVT (P = 0.02). CONCLUSIONS: To our knowledge, this is the first study on the incidence of thromboembolic events after nephrectomy. Thromboembolic events are rare but are more likely to occur in patients with coronary artery disease, cardiac arrhythmia, prior DVT, Stage 3 or 4 tumors, or a large estimated blood loss.

Aged↗

Arterial thromboembolic complications in patients with Björk-Shiley and Lillehei-Kaster aortic disc valve prostheses.

Arterial thromboembolic complications were studied in 196 patients who had either a single Björk-Shiley or Lillehei-Kaster aortic disc valve implanted. Eight patients suffered from such complications in the course of the first postoperative month and three of them died, two from myocardial infarction and one from cerebral embolism. Nineteen late thromboembolic complications developed in 18 of the 164 patients who survived the postoperative period, the incidence bein 5.9 episodes per 100 patients per year. The two valve types wer found to be equallly thrombogenic, and the rate was not lower than that in patients with Starr-Edwards aortic ball valves of series 2,300 previously studied. Particularly serious was valve malfunction caused by thrombi that limited the movement of the discs. Early recognition of this condition is essential, because the only effective therapy is removal of the thrombus. Three patients with a Björk-Shiley and one with a Lillehei-Kaster valve suffered this complecation and two died, while cerebral embolism caused a third late death. Two of the three patients who had not received anticoagulants developed thromboembolic complications, while most episodes occurred in spite of well-maintained anti-coagulant treatment. It is concluded that arterial thromboembolic complications remain a considerable problem also after aortic disc valve implantation, and that thrombotic valve malfunction is particularly serious and requires special attention.

Adolescent↗

Low-molecular-weight heparins and unfractionated heparin in the treatment of patients with acute venous thromboembolism: results of a meta-analysis.

PURPOSE: To obtain reliable estimates of the relative efficacy and safety of low-molecular-weight heparins (LMWHs) and unfractionated heparin (UFH) in the treatment of patients with venous thromboembolism. METHODS: A literature search of randomized trials evaluating LMWH and UFH for the period from 1980 to 1994 was conducted to obtain data for a meta-analysis. Studies were classified as level 1 if they were double-blind or if there was blinded assessment of outcome measures, and level 2 if they did not provide assurance of blinded outcome assessment. RESULTS: In level 1 studies, the relative risk (RR) of recurrent venous thromboembolism during the first 15 days and over the entire period of anticoagulant therapy was 0.24 (95% confidence intervals [CI] 0.06 to 0.80, P = 0.02) and 0.39 (95% CI 0.30 to 0.80, P = 0.006), respectively, in favor of LMWH treatment. The RR for major bleeding was 0.42 (95% CI 0.2 to 0.9, P = 0.01), in favor of LMWH. In level 2 studies, no significant differences in the rates of recurrent venous thromboembolism or major bleeding were observed. Pooling level 1 and level 2 studies, the RR for overall mortality and mortality in cancer patients was 0.51 (95% CI 0.2 to 0.9, P = 0.01), and 0.33 (95% CI 0.1 to 0.8, P = 0.01), respectively in favor of LMWH. CONCLUSIONS: LMWH are likely to be more effective than UFH in preventing recurrent venous thromboembolism, to produce less major bleeding, and to be associated with a lower mortality rate, particularly in the subgroup of patients with cancer.

Acute Disease↗

Presentation of venous thromboembolism during pregnancy.

OBJECTIVE: We sought to characterize the presentation, recurrence, and outcome of venous thromboembolism during pregnancy. STUDY DESIGN: We performed a 12-year, single-center, retrospective review of 38 patients with venous thromboembolism during pregnancy. The independent variables were subjected to univariate analysis (unpaired t test for normally distributed continuous variables and Fisher exact test for discrete variables). P <.05 was considered significant. RESULTS: There was no significant difference for the following variables according to time of presentation (antepartum vs post partum): gestational age at delivery (37.4 +/- 6.6 wk vs 38.1 +/- 2.4 wk; P =.7), birth weight (3257 +/- 458 g vs 3093 +/- 719 g; P =.3), and mode of delivery (2 vs 4 cesarean deliveries; P =.15). There were 2 maternal deaths. All 3 women with antepartum recurrent venous thromboembolism (despite heparin prophylaxis) had findings of protein C deficiency, protein S deficiency, and lupus anticoagulant-anticardiolipin antibody, respectively. CONCLUSION: The gestational age at presentation appears more equally distributed throughout gestation than previously reported. Notwithstanding limited numbers, the recurrence of venous thromboembolism despite use of prophylactic heparin therapy suggests the need to reexamine the current recommendations for heparin dosing.

Adult↗

[Thromboembolism prevention in acute myocardial infarction].

The objectives were to identify risk factors for vein thromboembolic disease (VTD) among patients with acute myocardial infarction (AMI) and to analyse both quantitatively and qualitatively the performed thromboembolic prophylaxis. A cross-sectional study was carried out with all inpatients at the Coronary Unit at our hospital during 1998. The risk factors for thromboembolism included: inmobilization (79.2%), heart failure (33.2%) and age over 70 years (31%). VTD prophylaxis was performed in 86.9% of the time. Non-fractioned heparin (NFH) and low molecular weight heparins (LMWH), mostly nadroparine, were the most commonly used drugs at admission and at discharge, respectively. Overdosage and underdosage for NFH and LMWH, respectively, were observed. That patients received or not VTD prophylaxis was not influenced by thromboembolic risk factors.

Adult↗

Characteristics of blood hemostatic markers in a patient with ovarian hyperstimulation syndrome who actually developed thromboembolism.

OBJECTIVE: To investigate whether a patient with ovarian hyperstimulation syndrome (OHSS) demonstrated characteristic changes in the blood hemostatic markers before she developed thromboembolism. DESIGN: Patients with OHSS had blood drawn to determine hemostatic markers and related factors. PATIENTS: Twenty-three OHSS patients, including a case complicated with thromboembolism. SETTING: The IVF-ET program of the Department of Obstetrics and Gynecology, The University of Akita, School of Medicine. MAIN OUTCOME MEASURES: Blood hemostatic markers and related factors. RESULTS: The patient with thromboembolism demonstrated marked leukocytosis and higher levels of activation in the blood markers related to fibrinolytic system, such as alpha 2 plasmin inhibitor, plasmin-alpha 2 antiplasmin complexes, and D-dimers, before the onset of this episode. CONCLUSION: Marked leukocytosis and higher levels of activation of the fibrinolytic system may be the signs of imminent thromboembolism in OHSS patients.

Adult↗

Thromboembolism and resistance to activated protein C in children with underlying cardiac disease.

OBJECTIVES: In the majority of cases, resistance to activated protein C is caused by the point mutation Arg506 to Gln in the factor V gene and has emerged as the most important hereditary cause of thromboembolism. METHODS: To determine to what extent resistance to activated protein C was present in children with thromboembolism and underlying cardiac disease, its occurrence was retrospectively investigated. By using a method based on activated partial thromboplastin time, with DNA technique derived from the polymerase chain reaction, we investigated nine children with underlying cardiac disease in whom thromboembolism had previously occurred. RESULTS: Heterozygous Arg506-to-Gln mutation in the factor V gene was diagnosed in five of the nine children investigated. In addition, protein C type I deficiency w as found in three patients, and two of the nine children showed increased lipoprotein (a) plasma values. Risk factors were present in all children with symptoms. CONCLUSIONS: These data indicate that deficiencies in the protein C anticoagulant pathway are likely to play an important role in the early manifestation of thromboembolism in children with underlying cardiac disease.

Adolescent↗

Risk of thromboembolism in new onset or transient atrial fibrillation.

Atrial fibrillation (AF), potentially serious cardiac arrhythmia, occurs in 2% to 4% of persons greater than 60 years of age. The risk of systemic thromboembolism from chronic AF has long been recognized. Little is known about the thromboembolic risk of new onset AF. However, the results of prior studies support a significant risk of thromboembolism because of recent onset or paroxysmal AF. The mechanism of thrombus formation, embolization, and resolution in AF is ill-defined, particularly that of new onset. The traditional concept holds that atrial thrombus forms only after greater than 2 days of AF and embolizes by dislodgement from increases in shear forces. This prevailing concept further proposes that newly formed atrial thrombus, in the setting of AF, organizes over a span of 14 days. The results of recent transesophageal echocardiographic studies have given insight into the temporal sequence of atrial thrombus formation, embolization, and resolution in AF and have expanded the traditional concept of thromboembolism in AF. Namely, left atrial thrombus may form before the onset of AF in the face of sinus rhythm. Conversion to sinus rhythm may increase the thrombogenic millieu of the left atrium. Importantly, atrial thrombus may form in the acute phase of AF. Lastly, thrombus may require more than 14 days to become immobile or to resolve. On the basis of these emerging insights by transesophageal echocardiography, it appears appropriate to consider anticoagulation in patients presenting with new onset or acute AF.

Anticoagulants↗