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Expanding eligibility for outpatient treatment of deep venous thrombosis and pulmonary embolism with low-molecular-weight heparin: a comparison of patient self-injection with homecare injection.

BACKGROUND: The outpatient treatment of patients with deep vein thrombosis and pulmonary embolism using low-molecular-weight heparin has the potential to reduce health care costs, but it is unclear if most patients with deep vein thrombosis and pulmonary embolism can be treated as outpatients. In the published studies, more than 50% of patients were excluded from outpatient treatment for reasons such as comorbid conditions, short life expectancy, concomitant pulmonary embolism, and previous deep vein thrombosis, and many patients were not treated entirely at home. We sought to determine if expanding patient eligibility for the outpatient treatment of deep vein thrombosis and pulmonary embolism affects the safety and effectiveness of the treatment, and to determine if patient self-injection compared with injections administered by a homecare nurse affected these outcomes. PATIENTS AND METHODS: We treated as outpatients all patients with deep vein thrombosis and pulmonary embolism, except for those with massive pulmonary embolism, high risk for major bleeding or an active bleed, phlegmasia, and patients hospitalized for reasons that prevented discharge. We compared 2 models of outpatient care to determine feasibility, safety, and efficacy. Both models involved nurse managers who provided daily patient contact and ongoing treatment; however, in one model the patients were taught to inject themselves and in the other model homecare nurses administered the injections. We expanded the population of patients eligible for outpatient treatment by including many patients not treated at home in previous studies. Most patients in our study were treated with dalteparin sodium, 200 U/kg every 24 hours, for a minimum of 5 days. Therapy with warfarin sodium was started on the day of diagnosis or the following day. Patients were followed up for 3 months to determine rates of recurrent venous thromboembolism, bleeding, and death. RESULTS: In this study, 194 (83%) of 233 consecutive patients were deemed eligible and treated as outpatients. Of the 39 patients who did not receive home therapy, 20 had concomitant medical problems responsible for their admission or were already inpatients, 6 had massive pulmonary embolism, 6 refused to pay for the dalteparin therapy, 4 had active bleeding, and 3 had phlegmasia cerulea dolens, which required treatment with intravenous narcotics for pain control. More than 184 (95%) of the 194 patients were treated entirely at home. There was no significant difference (P>.99) in the rate of recurrent venous thromboembolic events between the patients who were injected by homecare nurses (3/95 [3.2%]) and those who injected themselves (4/99 [4.0%]). Combining the 2 models, the overall recurrent event rate was 3.6% (95% confidence interval, 1.5%-7.4%). Similarly, there were no significant differences in rates of major hemorrhage (2/95 vs 2/99; P>.99), minor hemorrhage (8/95 vs 2/99; P = .06), and death (6/95 vs 8/99; P = .63). The overall rate of major hemorrhage was 2.0% (95% confidence interval, 0.6%-5.2%). CONCLUSIONS: We demonstrate that more than 80% of patients at our tertiary care hospital could be treated at home using 1 of the 2 models of care we describe. Our results demonstrate that patients can safely and effectively perform home self-injection under the supervision of a hospital-based nurse. Injections at home by a homecare nurse are similarly effective. Our overall rates of recurrent venous thromboembolism, bleeding, and death are at least as favorable as those previously reported despite using 1 dose per day of dalteparin for most patients.

Adult↗

Alcohol consumption and risk of deep venous thrombosis and pulmonary embolism in older persons.

OBJECTIVES: To assess whether low to moderate alcohol consumption decreases the risk of deep venous thrombosis and pulmonary embolism. DESIGN: Prospective cohort study. SETTING: Three communities of the Established Populations for Epidemiologic Studies of the Elderly. PARTICIPANTS: A total of 7959 persons aged 68 years or older. MEASUREMENTS: The incidence of deep venous thrombosis and pulmonary embolism was assessed by surveying hospital discharge diagnoses and deaths from 1985 through 1992. Those participants who estimated they used alcohol less than 1 time, on average, in the past month, less than 1 ounce per day, and 1 ounce or more per day were compared with those who reported no alcohol intake in the past year. Age, gender, race, body mass index, smoking, education, income, disability, cognitive function, arterial pressure, medication use, baseline chronic conditions, number of hospital admissions in past year, and occurrence of disease during follow-up were examined as possible confounders. RESULTS: During 48,038 person-years of follow-up, 155 events were observed (35 deep venous thromboses and 123 pulmonary emboli). Compared with non-drinkers, after adjusting for potential confounding variables, the relative risks (95% confidence interval) for deep venous thrombosis and pulmonary embolism associated with increasing alcohol consumption levels were 0.7 (0.4-1.1), 0.6 (0.4-0.9), and 0.5 (0.2-1.1), respectively (P for trend = .004). The results were unchanged after stratifying on health status and disability. CONCLUSIONS: Low to moderate alcohol consumption is associated with a decreased risk of deep venous thrombosis and pulmonary embolism in older persons.

Age Distribution↗

Deep vein thrombosis and pulmonary embolism: clinical presentation and pathophysiologic consequences.

Deep vein thrombosis (DVT) and pulmonary embolism (PE) are both characterized by unreliable clinical diagnosis and significant long-term sequelae. In patients with DVT, popliteal valvular insufficiency is associated with increased risk for postphlebitic syndrome. Current data show thrombolytic therapy to be more effective than anticoagulation for DVT, accomplishing significant or complete clearing of the deep venous system in nearly half of all patients treated. Results of investigation show lytic therapy to also be more effective than heparin in treatment of PE, both in terms of acute resolution and long-term function.

Fibrinolytic Agents↗

Thrombosis: the relationship of hemostatic mechanisms to drug therapy.

The mechanism of action and present clinical role of drugs affecting hemostasis in the therapy of spontaneous, postoperative, and posttraumatic arterial thrombosis, arterial embolism, venous thrombosis, pulmonary embolism, and intracranial aneurysm have been reviewed. Both the management of neurosurgical problems and the development of antithrombotic regimens are improving. In regard to the use of drug therapy, discussed herein, each surgeon will reach his own decision based on his findings in the individual patient, and may wisely elect in specific situations not to employ drug therapy. The comments offered in ths analysis are to be construed as suggestions not mandates, as they will undoubtedly undergo modification with time. In closing, it is appropriate to recall a famous Chinese curse: "May you live," it reads, "in a time of transition."

Anticoagulants↗

[Actual state of thrombolytic treatment of recent vein thrombosis and pulmonary embolism (author's transl)].

Recent deep vein thrombosis of the iliofemoral segment often leads to pulmonary embolism and to impaired valve function. Although more common, occlusions in the calf veins are less dangerous, and often a self-limiting disorder as almost half of these thrombi lyse spontaneously. Approximately 70% of fresh deep venous thrombi dissolve under intensive and prolonged thrombolytic treatment with streptokinase and long-term follow-up studies indicate that normal valve function is preserved in those patients in whom thrombus clearance was obtained. Thrombosis with streptokinase or urokinase appears to be the current treatment of choice for most cases of massive and severe, life-threatening pulmonary embolism; those patients surviving more than an hour or so after massive infarction comprise a prognostically better group, in whom the chances of surviving embolectomy is today smaller than the probability of survival without surgery but with thrombolytic treatment. Obviously there are problems in the evaluation but also in the thrombolytic treatment with streptokinase and urokinase of deep venous thrombosis and pulmonary embolism. These problems do not concern the principle of thrombolysis, but are largely due to the fact that the drugs so far used also induce a systemic fibrinogenolysis resulting in a bleeding risk. There is already good evidence that tissue activator of plasminogen is highly specific for fibrin and can induce thrombolysis in experimental animals without inducing systemic fibrinogenolysis.

Animals↗

Adherence to guidelines for oral anticoagulation after venous thrombosis and pulmonary embolism.

OBJECTIVE: Guidelines for oral anticoagulation after deep venous thrombosis (DVT) or pulmonary embolism (PE) have recommended that patients be anticoagulated for at least 3 months after hospital discharge. We sought to determine whether this recommendation was being followed and what patient characteristics predict a shorter than recommended duration of therapy. DESIGN: Retrospective cohort study using linked health care claims data. SETTING: Routine clinical practice. PATIENTS: Five hundred seventy-three members of New Jersey's Medicaid or Pharmacy Assistance for the Aged and Disabled programs aged 65 years and older who were hospitalized for DVT or PE between January 1, 1991 and June 30, 1994. RESULTS: Of the 573 patients, 129 (23%) filled prescriptions covering less than 90 days of oral anticoagulant therapy. In multivariate models, African-American race was associated with an increased risk of a shorter than recommended duration of therapy (odds ratio [OR], 1.87; 95% confidence interval [CI], 1.14 to 3.08), but age and gender were not. Patients who used anticoagulants in the year prior to admission were less likely to have a short duration of therapy (OR, 0.30; 95% CI, 0.12 to 0.78), than were patients with PE (OR, 0.58; 95% CI, 0.38 to 0.88). CONCLUSIONS: Nearly a quarter of those anticoagulated following DVT or PE received therapy for less than the recommended length of time after hospital discharge, with African Americans more likely to have a shorter than recommended course of treatment. Further research is needed to evaluate the causes of shorter than recommended duration of therapy and racial disparities in anticoagulant use.

Black or African American↗

The role of venous ultrasonography in the diagnosis of suspected deep venous thrombosis and pulmonary embolism.

This paper describes the role of venous ultrasonography in the diagnosis of suspected deep venous thrombosis and pulmonary embolism. Inability to compress the common femoral or popliteal vein is usually diagnostic of a first episode of deep venous thrombosis in symptomatic patients (positive predictive value of about 97%). Full compressibility of both of these sites excludes proximal deep venous thrombosis in symptomatic patients (negative predictive value of about 98%). In patients with suspected deep venous thrombosis or in those who present with suspected pulmonary embolism but have a nondiagnostic lung scan, the subsequent risk for symptomatic venous thromboembolism is very low (<2% during 6 months of follow-up) provided that ultrasonography of the proximal veins remains normal in the course of 1 week (suspected deep venous thrombosis) or 2 weeks (suspected pulmonary embolism). Anticoagulation and further diagnostic testing can usually be safely withheld in these situations. Venous ultrasonography is much less reliable for the diagnosis of asymptomatic, isolated distal, and recurrent deep venous thrombosis than for the diagnosis of a first episode of proximal deep venous thrombosis in symptomatic patients. Clinical evaluation of the probability of deep venous thrombosis or pulmonary embolism, preferably by using a validated clinical model, complements venous ultrasonographic findings and helps to identify patients who would benefit from additional (often invasive) diagnostic testing. Thus, venous ultrasonography is thought to be a very valuable test for the diagnosis and management of patients with suspected deep venous thrombosis or pulmonary embolism.

Humans↗

Deep venous thrombosis and pulmonary embolism. The importance of heightened awareness.

Left untreated, deep venous thrombosis and pulmonary embolism have a high rate of mortality and long-term morbidity. Physicians therefore must maintain a high index of suspicion for these conditions. Accurate diagnosis is facilitated by knowing the most common sites of thrombus formation, the likelihood of propagation, which patients are at greatest risk, signs and symptoms, and which tests to order. Prompt administration of anticoagulants and, in some cases, thrombolytic agents can minimize the consequences of these diseases. Interruption of the inferior vena cava, thrombectomy, and thromboembolectomy are other treatment options.

Heparin↗

The venous stasis syndrome after deep venous thrombosis or pulmonary embolism: a population-based study.

OBJECTIVES: To estimate the incidence and determine predictors of venous stasis syndrome and venous ulcers after deep venous thrombosis and pulmonary embolism. PATIENTS AND METHODS: This population-based retrospective cohort study reviewed medical records of 1527 patients with incident deep venous thrombosis or pulmonary embolism between 1966 and 1990. We recorded baseline characteristics, event type (deep venous thrombosis with or without pulmonary embolism or pulmonary embolism alone), leg side and site of deep venous thrombosis (proximal with or without distal deep venous thrombosis vs distal deep venous thrombosis alone), and venous stasis syndrome and venous ulcer. RESULTS: Two hundred forty-five patients developed venous stasis syndrome. One-year, 5-year, 10-year, and 20-year cumulative incidence rates were 7.3%, 14.3%, 19.7%, and 26.8%, respectively. By 20 years the cumulative incidence of venous ulcers was 3.7%. Patients with deep venous thrombosis with or without pulmonary embolism were 2.4-fold (95% confidence interval, 1.7-fold-3.2-fold) more likely to develop venous stasis syndrome than patients with pulmonary embolism and no diagnosed deep venous thrombosis. In patients aged 40 years or younger with proximal compared with distal-only deep venous thrombosis, venous stasis syndrome was 3.0-fold more likely (95% confidence interval, 1.6-fold-4.7-fold). In patients with unilateral leg deep venous thrombosis, venous stasis syndrome usually developed in the concordant leg (P < .001). There was a 30% (95% confidence interval, 2%-62%) increased risk for venous ulcer per decade of age at the incident venous thromboembolism. CONCLUSIONS: The cumulative incidence of venous stasis syndrome continues to increase for 20 years after venous thromboembolism. Pulmonary embolism alone is less likely to cause venous stasis syndrome.

Adult↗

[Venous thrombosis and pulmonary embolisms in air travel].

The risk of venal thrombosis and pulmonary embolia during aviation is rather small. The risk markedly rises during long flights (over 7500 km) and namely in elderly persons. Danger of the disease can be lowered by lower limbs exercising, liberal intake of soft drinks, and by elastic calf bandages. Persons of the high risk are candidates for low-molecular heparin administration.

Aerospace Medicine↗

Iliofemoral vein thrombosis and pulmonary embolism associated with a transient ischemic attack in a patient with antiphospholipid syndrome.

Several clinical conditions, such as deep vein thrombosis, cerebral infarct, pulmonary infarct, skin ulcers, renal failure, and habitual abortion, are thought to be associated with the antiphospholipid syndrome. The authors describe a 32-year-old woman who had characteristics of the antiphospholipid syndrome including increased immunoglobulin G-cardiolipin antibody titers, iliofemoral vein thrombosis, pulmonary embolism, headache, visual disturbances, and habitual abortion. During hospitalization, she suddenly experienced right-sided weakness. A Tc-99m HMPAO brain scan showed the probability of a transient ischemic attack in the left frontotemporal cortex.

Adult↗

Prophylaxis of deep venous thrombosis and pulmonary embolism.

Clinically silent deep venous thrombosis (DVT) develops in up to 25% of patients who undergo general surgical procedures. Approximately 10% of these thromboses are complicated by potentially fatal pulmonary embolism. Two recent meta-analyses of more than 70 published trials of DVT prophylaxis in general surgery have demonstrated conclusively that prophylaxis significantly reduces rates of DVT and fatal pulmonary embolism and results in improved overall survival. Physical methods of prophylaxis, including compression stockings and intermittent pneumatic compression, are as effective as pharmacologic prophylaxis (the most common regimen being heparin, 5000 units subcutaneously ever 8 to 12 hours). Bleeding complications are increased with the use of heparin, although they are clinically minor. Deep venous thrombosis prophylaxis should be routinely instituted for all general surgical patients who undergo major operative procedures.

Heparin↗

Deep vein thrombosis and pulmonary embolism in the general population. 'The Study of Men Born in 1913'.

BACKGROUND: Deep vein thrombosis (DVT) and pulmonary embolism (PE) are common public health problems. Still, little is known about the epidemiology and the natural history of venous thromboembolism. METHODS: In the Study of Men Born in 1913, 855 men were followed up prospectively from the age of 50 years to the age of 80 years. Several cross-sectional samples, also of men born in 1913, were studied at the ages of 50, 54, 60, 67, 75, and 80 years. Objective methods were used to ascertain a diagnosis of DVT or PE, and all were confirmed by hospital records or autopsy reports. The follow-up rate in the longitudinal study was 98.2%. RESULTS: In the longitudinal study, the incidence of DVT was 182 per 100,000 observation-years. Corresponding incidence rates were 98 for nonfatal PE, 107 for fatal PE, and 387 for all thromboembolic events. The cumulative probability for a venous thromboembolic event at different ages was estimated to be 0.5% by the age of 50 years and 10.7% by the age of 80 years. In the cross-sectional studies, a history of confirmed venous thromboembolism was found in 0.5% of the men at age 50 years, 0.9% at age 54 years, 1.3% at age 60 years, 2.0% at age 67 years, 4.5% at age 75 years, and 3.8% at age 80 years. CONCLUSIONS: The results indicate a high incidence of DVT and PE in the general population. The incidence of thromboembolic events increases with age. The rate of fatal PE seems to be higher than estimated before, and PE constitutes almost 5% of all deaths during follow-up.

Age Distribution↗