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PubMed1999

Implementation of a national guideline on prophylaxis of venous thromboembolism: a survey of acute services in Scotland. Thromboembolism Prevention Evaluation Study Group.

BACKGROUND: Deep vein thrombosis (DVT) and pulmonary embolism (PE) are major complications for hospital patients in developed countries. In 1995, the Scottish Intercollegiate Guidelines Network (SIGN) published an evidence-based guideline to encourage the appropriate use of prophylaxis for DVT among hospitalised patients at risk. The guideline was widely distributed within the NHS in Scotland; however, it is not clear what actions trusts have taken to implement it. OBJECTIVE: To investigate the type and extent of DVT guideline implementation activities in acute trusts in Scotland. METHOD: A semi-structured telephone interview with senior clinical audit staff in those trusts with acute services in Scotland. RESULTS: Twenty-nine of the 30 trusts approached participated in the survey (97%). A range of responses to the guideline were reported, including development of local protocols (n = 20), audit of DVT prophylaxis (n = 19), patient specific reminders (n = 13) and provision of a specialist DVT adviser (n = 3). Overall, 25 of the trusts had undertaken guideline development and dissemination activities, and 17 were involved in more active guideline implementation strategies. CONCLUSIONS: The majority of acute trusts in Scotland have responded to the SIGN guideline, usually through the development of local protocols. Strategies to implement the guideline or local protocol are less common. Further guidance is needed on this in the next edition of the guideline.

Clinical Protocols↗
PubMed2005

Thromboembolism during hormone therapy in Japanese women.

Japanese women are unaccustomed to taking hormone therapies such as oral contraceptives (OCs) and hormone replacement therapy (HRT); therefore, there are few studies associated with hormone treatment in Japan. This study focused on evaluating thromboembolism during hormone therapy in Japanese women. In February 2002, we mailed questionnaires regarding the monthly average number of patients who had received prescriptions for OCs and HRT, and the incidence of arterial and venous thromboemboli during hormone therapy for the last 10 years. The mailings were sent to hospitals and clinics that are registered as monitoring institutions with the Japan Association of Obstetricians and Gynecologists. Of 1083 institutes, 771 responded (71% response rate). In July 2002, to obtain additional information on hormone therapy, patient history, and outcomes, we sent follow-up questionnaires to 39 institutions that responded as having experienced cases of thromboembolism. Thirty-nine institutions (5.1% of institutions responding to survey) experienced 53 cases of thromboembolism during hormone therapy. The 53 patients included 29 who received OCs (OC patients), 13 who received HRT (HRT patients), and 11 who received other hormone treatment. Among the 29 OC patients, eight had been diagnosed as having arterial thromboembolism (ATE), including two patients with myocardial infarction (MI) and six with ischemic stroke, whereas 20 had venous thromboembolism (VTE), including two with pulmonary embolism (PE) The remaining patient had an unknown thromboembolic event. Of the OC patients, 75.9% had a thromboembolism within the first year, and 58.6% patients were in their 40s. In 13 HRT patients, seven had ATE, including two MI patients and three with ischemic brain stroke, whereas six had VTE, including one PE patient. The duration of HRT varied widely from less than 1 year to more than 3 years; moreover, the HRT type did not affect thromboembolism occurrence. More than 70% of ATE patients and less than one third of VTE patients had to be hospitalized for the treatment of thromboembolism, and more than 75% of VTE patients recovered completely. However, one third of the ATE patients recovered with mild sequelae, one OC patient had severe sequelae due to stroke, and another OC patient died due to an ischemic event. The estimated incidence of thromboembolism in OC patients and HRT patients was 3.6 to 14.4 and 1.7 to 3.4 per 100,000 woman-years, respectively. The risk factors of thromboembolism, which were found consistently in this study, included obesity, smoking, lifestyle, and aging. Approximately 95% of institutions had not experienced thromboembolism in their hormone therapy patients, suggesting the incidence of thromboembolism during hormone therapy might be low. However, according to an analysis of risk factors, screening users of hormone supplements may be essential for providing safe hormone therapy. Moreover, because of the early occurrence of thromboembolism during hormone therapy, especially with OCs, it is important to monitor and instruct patients with caution from immediately after therapy initiation.

Adolescent↗
PubMedDate not supplied

Oral contraceptive use and venous thromboembolism: a consideration of the impact of bias and confounding factors on epidemiological studies.

Recent epidemiological studies have reported an approximately two-fold, significant, increased odds ratio for venous thromboembolism in users of third-generation oral contraceptives (OCs) compared to users of second-generation OCs. However, in each study, this association is of borderline statistical significance, and the studies do not indicate an increase in the absolute risk of venous thromboembolism for users of third-generation OCs compared with the data from prior studies primarily involving second-generation products. The data derived from these recent studies show a lower reported incidence of venous thromboembolism with the use of second-generation OCs over time compared to the prior studies, while the incidence of venous thromboembolism for use of third-generation OCs is approximately equal to that previously reported for second-generation products. Generally, evidence has shown that the risk of venous thromboembolism and the impact on hemostatic parameters are reduced with declining estrogen dose. In addition, there is no evidence of a clinically significant effect of the OC progestogen doses on hemostatic parameters. These inconsistencies point to factors other than a causal relationship to explain the higher risk of venous thromboembolism in users of third-generation OCs. An examination of factors not included in the recent studies has identified at least three potential biases that should be considered: prescription bias, a 'healthy-user' effect and referral bias. Available data on prescription bias come from marketing research surveys, databases of prescribing patterns, epidemiological databases and the recent studies. These data indicate that the recently introduced third-generation OCs have been more extensively used by younger women, for shorter periods of time, and by women with risk factors for venous thromboembolism that have the second-generation OCs. There is also evidence for a healthy-user effect, whereby women who were most susceptible for venous thromboembolism have left the cohort of users of second-generation OCs as a result of a venous thromboembolism during pregnancy or early OC use, and thus were possibly not included in these recent studies. The women remaining in the cohort, who are included in the recent studies, are less susceptible to venous thromboembolic events than are those making up the cohort of women using third-generation OCs. In addition, there are indications that referral bias has occurred because women with risk factors for venous thromboembolism (who disproportionately receive third-generation OCs) are more likely to be referred to a hospital for investigation of possible symptoms of venous thromboembolism, and thus users of third-generation OCs have the potential to be over-represented among cases. These biases act spuriously to increase the observed odds ratio for the first-time occurrence of venous thromboembolism amongst users of third-generation OCs, when compared to users of second-generation OCs. None of the recent epidemiological studies have been able to adjust for the three major biases. These biases are likely to contribute to, or even totally account, for the small increased risk of venous thromboembolism observed for users of third-generation OCs when compared to that for users of second-generation OCs.

Bias↗
PubMed2006

Incidence of venous thromboembolism and its effect on survival among patients with common cancers.

BACKGROUND: The incidence of venous thromboembolism after diagnosis of specific cancers and the effect of thromboembolism on survival are not well defined. METHODS: The California Cancer Registry was linked to the California Patient Discharge Data Set to determine the incidence of venous thromboembolism among cancer cases diagnosed between 1993 and 1995. The incidence and timing of thromboembolism within 1 and 2 years of cancer diagnosis and the risk factors associated with thromboembolism and death were determined. RESULTS: Among 235 149 cancer cases, 3775 (1.6%) were diagnosed with venous thromboembolism within 2 years, 463 (12%) at the time cancer was diagnosed and 3312 (88%) subsequently. In risk-adjusted models, metastatic disease at the time of diagnosis was the strongest predictor of thromboembolism. Expressed as events per 100 patient-years, the highest incidence of thromboembolism occurred during the first year of follow-up among cases with metastatic-stage pancreatic (20.0), stomach (10.7), bladder (7.9), uterine (6.4), renal (6.0), and lung (5.0) cancer. Adjusting for age, race, and stage, diagnosis of thromboembolism was a significant predictor of decreased survival during the first year for all cancer types (hazard ratios, 1.6-4.2; P<.01). CONCLUSIONS: The incidence of venous thromboembolism varied with cancer type and was highest among patients initially diagnosed with metastatic-stage disease. The incidence rate of thromboembolism decreased over time. Diagnosis of thromboembolism during the first year of follow-up was a significant predictor of death for most cancer types and stages analyzed. For some types of cancer, the incidence of thromboembolism was sufficiently high to warrant prospective clinical trials of primary thromboprophylaxis.

Aged↗
PubMed1989

[Postoperative thromboembolism of acquired mitral valve disease--comparison between valve replacement and commissurotomy].

Thromboembolism after mitral commissurotomy (MC) was compared with that after mitral valve replacement (MVR). In 216 surgical cases of acquired mitral valve diseases, including combined operative cases of other valves, thromboembolic complications after MC were observed in 9/137 cases (13 times, 0.94%/patient-year), and those after MVR in 8/70 cases (11 times, 2.55%/patient-year). No thromboembolism occurred in 9 cases of annuloplasty. Thromboembolism-free period after MVR (49 +/- 44 months) was significantly shorter than that after MC (102 +/- 43 months, p less than 0.05). Postoperative CTR of thromboembolic cases (69.5 +/- 8.2%) was significantly larger than that of non-thromboembolic cases (61.4 +/- 9.9%) in MVR group (p less than 0.005), but no significant difference existed between thromboembolic and non-thromboembolic cases in MC group. Thromboembolism after MVR occurred in severe cases, but that after MC often occurred in mild cases. Postoperative echocardiogram of MC group showed significantly lower DDR in thromboembolic cases (1.9 +/- 0.7 cm/sec) than in non-thromboembolic cases (3.2 +/- 1.2 cm/sec, p less than 0.025). Mitral valve area (MVA) of all re-stenotic cases in thromboembolic cases after MC was under 1.5 cm2, comparing that in non-thromboembolic cases there were only two cases that had MVA under 1.5 cm2. After MC, careful management including anticoagulant therapy and reoperation is necessary especially in patients with atrial fibrillation, DDR under 2 cm/sec, and MVA under 1.5 cm2, even though they don't have cardiomegaly.

Adult↗
PubMed1997

Ejection fraction and risk of thromboembolic events in patients with systolic dysfunction and sinus rhythm: evidence for gender differences in the studies of left ventricular dysfunction trials.

OBJECTIVES: The aims of this study were to describe the incidence and spectrum of thromboembolic events experienced by patients with moderate to severe left ventricular systolic dysfunction in normal sinus rhythm and to study the association between ejection fraction and thromboembolic risk. BACKGROUND: The annual incidence of thromboembolic events in patients with heart failure is estimated to range from 0.9% to 5.5%. Previous studies demonstrating a relation between worsening left ventricular systolic function and thromboembolic risk are difficult to interpret because of the prevalence of atrial fibrillation, an independent risk factor for thromboembolism, in the patients with a lower ejection fraction. METHODS: This is a retrospective analysis of the Studies of Left Ventricular Dysfunction prevention and treatment trials data base. Patients with atrial fibrillation were excluded, resulting in 6,378 participants in sinus rhythm at the time of randomization. Thromboembolic events include strokes, pulmonary emboli and peripheral emboli. Separate analyses were conducted in each gender because there was evidence of a significant interaction between ejection fraction and gender on the risk of thromboembolic events (p = 0.04). RESULTS: The overall annual incidence of thromboembolic events was 2.4% in women and 1.8% in men. On univariate analysis, a decline in ejection fraction was [corrected] associated with thromboembolic risk in women (relative risk [RR] per 10% decrease in ejection fraction 1.58, 95% confidence interval [CI] 1.10 to 2.26, p = 0.01), but not in men. On multivariate analysis, a decline in ejection fraction remained independently associated with thromboembolic risk in women (RR per 10% decrease 1.53, 95% CI 1.06 to 2.20, p = 0.02), but no relation was demonstrated in men. CONCLUSIONS: In patients with left ventricular systolic dysfunction and sinus rhythm, the annual incidence of thromboembolic events is low. Ejection fraction appears to be independently associated with thromboembolic risk in women, but not in men.

Aged↗
PubMed2005

Symptomatic venous thromboembolism in acute leukemia. Incidence, risk factors, and impact on prognosis.

The association between malignant disorders and occurrence of venous thromboembolism is well established. Patients with cancer and venous thromboembolism have adverse prognosis. No systematic study on the incidence and prognostic impact of venous thromboembolism in acute leukemia has been performed as yet. We retrospectively evaluated the incidence of symptomatic venous thromboembolism before chemotherapy in 719 patients (371 males and 348 females, median age of 57.4 years), diagnosed with acute leukemia [534 with acute myelogenous leukemia, 185 with acute lymphoblastic leukemia]. Furthermore, the relationship of venous thromboembolism to clinical and laboratory parameters and its impact on prognosis was assessed. Fifteen patients (2.09%) had venous thromboembolism (objectively confirmed in 13 patients) in close temporal relationship to the onset of acute leukemia. The incidence of venous thromboembolism was the same in acute myelogenous and lymphoblastic leukemia. In five patients, pulmonary embolism was documented. Venous thromboembolism occurred in all subtypes of acute leukemia, but was most common in promyelocytic leukemia. All but one patient were treated with anticoagulants. No patient died from treatment-related bleedings or venous thromboembolism. Overall, survival, disease-free survival, and remission duration did not differ between the patient groups with and without venous thromboembolism. In contrast to solid tumors, venous thromboembolism before or at diagnosis of acute leukemia is not associated with poor prognosis.

Acute Disease↗
PubMed2001

Acquired activated protein C resistance is common in cancer patients and is associated with venous thromboembolism.

PURPOSE: Cancer patients have an increased risk for venous thromboembolism. Because activated protein C resistance is a common risk factor for venous thromboembolism, we prospectively evaluated the activated protein C sensitivity ratio and factor V Leiden mutation in cancer patients with and without venous thromboembolism. SUBJECTS AND METHODS: We studied 55 consecutive cancer patients with deep vein thrombosis, 58 cancer patients with no history of venous thromboembolism, 54 patients with venous thromboembolism without malignancy, and 56 healthy controls. The presence of factor V Leiden mutation was determined by polymerase chain reaction and allele specific restriction digestion. The activated protein C sensitivity ratio was expressed as the ratio of activated partial thromboplastin times measured in the presence and absence of activated protein C; a ratio <2.0 in patients who did not have factor V Leiden was considered to indicate acquired activated protein C resistance. RESULTS: The prevalence of factor V Leiden mutation in cancer patients with thromboembolism (1 of 55, 2%) did not differ significantly from those in cancer patients without thromboembolism (4 of 58, 7%) or normal controls (2 of 56, 4%), but was significantly lower than that of patients with thromboembolism without cancer (18 of 54, 33%, P <0.001). The prevalence of acquired activated protein C resistance was significantly greater in cancer patients with thromboembolism (29 of 54, 54%, P = 0.001) compared with the other groups: 9 of 54 (17%) in cancer patients without thromboembolism, 7 of 36 (19%) in patients with thromboembolism without cancer, and none of the normal controls. CONCLUSION: Although factor V Leiden is not a major risk factor for thrombosis in cancer patients, acquired activated protein C resistance is common and may contribute to the thrombotic tendency in these patients.

Activated Protein C Resistance↗
PubMed1999

Thromboembolism and resistance to activated protein C in patients with inflammatory bowel disease.

OBJECTIVE: Thromboembolic events are serious complications in patients with inflammatory bowel disease (IBD). Resistance of factor V to degradation by activated protein C (APC) is a major cause for venous thrombosis and is found in approximately 30% of patients with thromboembolism. The aim of the present study was to assess the prevalence of APC resistance and clinical risk factors in patients with IBD. METHODS: One-hundred-two patients with IBD (64 women and 38 men; median age, 35 yr; range, 17-77 yr; 77 with Crohn's disease, 25 with ulcerative colitis) and 102 gender- and age-matched healthy control subjects were investigated prospectively for the presence of APC resistance. None of the healthy controls but 16 patients with IBD had a history of thromboembolism. RESULTS: Patients with IBD and thromboembolism were young, with a median age of 37 yr (range, 17-61 yr). Five (31.3%) of them had APC resistance, which was more common than in patients with IBD without thromboembolism (7%) and in controls (5.9%) (p < 0.01). Three patients had two thromboembolic events, the other 13 each had one. Deep vein thrombosis of the leg and pulmonary emboli were the most common thromboembolic complications (84.2%). Active disease, fistula, or bowel stenosis were found in 10 (52.6%) of 19 thromboembolic events; in three (15.8%) cases thromboembolism happened postoperatively. CONCLUSIONS: APC resistance is not associated with IBD but, when present, increases the risk of thromboembolism. Patients with IBD and thromboembolism are mostly young and clinical risk factors can be found in one-half of cases.

Activated Protein C Resistance↗
PubMed1993

Oral contraception and risk of a cerebral thromboembolic attack: results of a case-control study.

OBJECTIVE: To assess the risk of cerebral thromboembolism in women using low dose oral contraceptives. DESIGN: A retrospective case-control study. SETTING: All Danish medical, neurological, neurosurgical, and gynaecological departments. SUBJECTS: All 794 women in Denmark aged 15-44 who had suffered a cerebral thromboembolic attack during 1985-9 and 1588 age matched randomly selected controls. RESULTS: Of 692/1584 case/control questionnaires sent out, 590/1396 (85.3%/88.1%) were returned. Among the cases, 15 refused to participate, 69 had a revised or unreliable diagnosis, 40 had had thromboembolic disease previously, 13 were pregnant, and 152 had a disease predisposing to a cerebral thromboembolic attack. Of the 323 cases without a known predisposition, 320 reported use or non-use of oral contraception. Among the 1396 controls, eight refused to participate, were mentally retarded, or lived abroad; 18 returned an uncompleted questionnaire; 17 had had thromboembolic disease previously; 31 were pregnant; and 130 had a disease predisposing to a cerebral thromboembolic attack. Thus 1198 non-predisposed controls were available, among whom 1197 reported use or non-use of oral contraception. Among the 320 cases, 116 (36.3%) were oral contraceptive users at the time of the cerebral thromboembolic attack. By comparison there were 191 users (16.0%) among the 1197 controls, giving a crude odds ratio of 3.0. After multivariate analysis, including confounder control for age, smoking, years of schooling, and trend in use of different types of oral contraceptives during 1985-90, pills containing 50 micrograms oestrogen were associated with an odds ratio for cerebral thromboembolic attack of 2.9 (95% confidence interval 1.6 to 5.4), those containing 30-40 micrograms oestrogen an odds ratio of 1.8 (1.1 to 2.9), those containing progestogen only an odds ratio of 0.9 (0.4 to 2.4). The odds ratio did not change with increasing age or with duration of oral contraceptive use. A 50% increased risk of a cerebral thromboembolic attacks among cigarette smokers (after confounder control) was independent of oral contraception status and age. CONCLUSION: Low dose oral contraceptives are associated with an increased risk of cerebral thromboembolic attack. Combined or sequential pills containing 30-40 micrograms oestrogen are associated with a one third reduced risk compared with preparations containing 50 micrograms oestrogen. Progestogen only pills did not increase the risk of a cerebral thromboembolic attack.

Adolescent↗