Criteria for Outpatient Management of Proximal Lower Extremity Deep Venous Thrombosis

doi:10.1378/chest.115.4.972

Chest

Volume 115, Issue 4, April 1999, Pages 972-979

https://doi.org/10.1378/chest.115.4.972 Get rights and content

Study objectives

To develop and to evaluate selection criteria for outpatient management of deep venous thrombosis (DVT).

Design

We developed outpatient treatment eligibility criteria that incorporated demographic and clinical data. We aimed to exclude patients at high risk for bleeding or recurrent clotting, as well as those with pulmonary embolism, limited cardiopulmonary reserve, or need for hospitalization due to another illness. Then, we retrospectively applied the criteria to hospitalized patients with newly diagnosed proximal lower extremity DVT to determine the fraction of patients eligible for outpatient therapy; patients were classified as eligible, possibly eligible, or ineligible for home treatment based on the selection criteria.

Setting

University hospital.

Patients

One hundred ninety-five hospitalized patients diagnosed as having proximal lower extremity DVT by duplex ultrasound over a 1-year period.

Measurements

Frequency of complications during initial DVT therapy, including major bleeding, symptomatic thromboembolism, and death.

Results

Eighteen (9%) patients were classified as eligible, and 18 (9%) were classified as possibly eligible for outpatient therapy. None of these patients developed complications. Of the 159 (82%) patients classified as ineligible, 13 (8%; 95% confidence interval [CI], 4 to 12%) died or developed serious complications. Therefore, the eligibility criteria had a sensitivity of 100% (95% CI, 92 to 100%) and a negative predictive value of 100% (95% CI, 92 to 100%) for predicting serious complications.

Conclusions

Specific eligibility criteria may identify a subset of patients with acute DVT who can be treated safely at home.

Section snippets

Study Setting and Patients

Using a computerized registry, we identified all patients who underwent lower extremity duplex ultrasound scanning between July 1, 1993, and June 30, 1994, in the vascular laboratory at Jewish Hospital at the Washington University Medical Center in St. Louis, MO. Patients were selected for chart review if they had been hospitalized and had a new proximal lower extremity DVT diagnosed by duplex examination. During duplex evaluation, proximal lower extremity DVT was defined as a constant and

Patients

Twelve hundred patients underwent lower extremity duplex ultrasound scanning during the 1-year period (Fig 1). Of these patients, 203 (17%) were diagnosed as having proximal lower extremity DVT. Of the 199 who had inpatient therapy, 195 had charts available for review, constituting our main study cohort. The mean (± SD) age of the study cohort was 70 (± 16) years with a range of 81 years. Fifty-nine percent of patients were women.

Eligibility for Outpatient Therapy

Thirty percent of patients had the diagnosis of proximal lower

Discussion

This study suggests that objective criteria may be used to select patients for proximal lower extremity DVT home therapy. We showed that complications of bleeding, venous thromboembolism, and death were greater in those patients considered ineligible than in those patients considered eligible for home therapy. The ability of the criteria to identify patients safe for home therapy was demonstrated with the 100% sensitivity and the 100% negative predictive value of the criteria for predicting

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Cited by (39)

Early mobilisation of patients with acute deep vein thrombosis does not increase the risk of a symptomatic pulmonary embolism
2006, Angiologia
Principal: evaluar la influencia de la deambulación precoz en pacientes con trombosis venosa profunda (TVP) aguda sobre la incidencia de tromboembolismo pulmonar (TEP) sintomático; secundario: valorar si la localización del trombo y/o el tiempo de evolución influyen en la aparición del TEP sintomático.
Ensayo clínico de observación realizado en dos centros, en el período 2002-2003, con asignación aleatoria 1:1 según sobres cerrados. Se diagnosticaron 650 pacientes con TVP, de los cuales sólo se incluyeron 146, 68 mujeres y 78 hombres (edad media: 60,7 años; rango: 18-83 años). Criterios de inclusión: TVP inferior a 15 días de evolución, consentimiento informado, esperanza de vida mayor de un año y condición clínica sin riesgo vital. Ambos grupos se trataron con heparinas de bajo peso molecular, seguido de anticoagulación oral según protocolo. Grupo A: 67 pacientes, cinco días de reposo. Grupo B: 79 casos, deambulación precoz con contención elástica. Se compararon ambos grupos según el tiempo de evolución y la localización de la trombosis. El análisis estadístico se realizó mediante un estudio descriptivo; se utilizó la prueba de chi al cuadrado o el estadístico exacto de Fisher y análisis multivariante.
Cuatro casos de TEP sintomático (2,7%), sin diferencias estadísticamente significativas entre los dos grupos (p = 0,33). Tampoco hubo diferencias en relación con el tiempo de evolución (p = 0,45) ni localización del trombo (p = 0,37). El análisis multivariante no detectó ninguna variable con significación estadística.
Parece ser que la localización del trombo y el tiempo de evolución no influyen en la incidencia de TEP sintomático.
To evaluate if early mobilization in patients with acute lower limbs deep vein thrombosis (DVT) increases the incidence of symptomatic pulmonary embolism (PE). To evaluate determining factors of PE, like location of the thrombus and/or time of clinical evolution.
Prospective randomised clinical trial. Carried on in two university hospitals, from January 2002 to December 2003. 146 patients with acute lower limbs DVT where included, 68 female and 78 male, with a mean age of 60.7 years. The inclusion criteria were: less that 15 days of initial symptoms, life expectancy greater than one year, no life threatening clinical condition, inform written consent. These patients were randomized into two groups. Group A: 67patients (45.9%) hospital treatment with a 5 days bed rest. Group B: 79 patients (54.1%) home care with early walking and compressive bandage. Primary end point was the presence of symptomatic PE during the first ten days of treatment. The relationships between time of clinical evolution, location of thrombus and symptomatic PE were also analyzed. The statistical analysis was made using the chi-square o Fisher exact test, homogeneity basal and multivariate analysis.
Four cases of symptomatic PE were detected (2.7%), two in each group. There was no significant difference concerning the occurrence of new PE between the two groups (p = 0.33). Also no difference was detected according to time of evolution (p = 0.45) and location of thrombus (p = 0.37). Multivariate analysis did not show any significant difference between groups.
Seemingly location of thrombus and elapse time of symptoms did not increase the incidence of symptomatic PE.
Implementation of outpatient treatment of deep-vein thrombosis in private practices in Germany
2005, European Journal of Vascular and Endovascular Surgery
Citation Excerpt :
Nevertheless, medical enthusiasm to adopt this new strategy seems low. Claims for careful selection of patients were made and warning criteria established but not assessed in clinical studies.26 Clearly, the number of prerequisites deemed necessary for a safe outpatient treatment determines the proportion of eligible patients.
Implementation of outpatient treatment (OT) of deep-vein thrombosis (DVT) is slow despite clear evidence that it is effective, safe and cost-efficient.
An initiative was launched with the help of the Professional Association of Phlebologists of Germany and the industry to familiarize physicians in private practice who had no prior experience with OT of DVT. Data on quality of treatment with the low-molecular-weight heparin tinzaparin and phenprocoumon, compliance, clinical outcome, venous ultrasound, patients' satisfaction and quality of life were collected in a registry, which was open from July 1999 to December 2000. The results were published and their impact on further management of patients was assessed in second survey reported here. Patients of both series were followed-up clinically and with ultrasound over the 1st month of treatment.
Of 67 physicians entering 827 patients into the registry 26 answered a questionnaire on how they treated further patients. Their case load had increased by 450% and data were provided on 540 consecutive patients managed between January and June 2002. OT increased overall from 76 to 92%, that of popliteo-femoral DVT from 71 to 92%, and that of pelvic DVT from 38 to 65%. Medical reasons to decide against OT decreased from 89 to 56% (p<.01). Immediate leg compression was changed from bandaging to medical compression stockings in 20 of the 26 centres (p<.05). In total, data were gathered from OT of 1124 patients. No secondary hospitalisations were required and only one patient had a documented progression of the DVT.
OT was successfully implemented in private practices through the initiative of individual physicians with support of the professional association and sponsoring by the industry—to the benefit of the providers but as much of the patients and their cost bearers.
Deep vein thrombosis
2004, Surgical Decision Making
Effect of Intravenous Heparin Administration on Duration of Hospitalization
2004, Mayo Clinic Proceedings
To determine how frequently hospital discharge is delayed to administer intravenous heparin to patients with diverse indications for oral anticoagulation (OAC) medications and how often these delays are potentially avoidable, as assessed by the prevalence of contraindications to outpatient use of low-molecular-weight heparin (LMWH).
Records were reviewed from a random sample of 309 patients who received at least 1 dose of OAC medication while hospitalized at the Mount Sinai Hospital in New York City between January 1 and December 31, 1997. Medical records were abstracted to determine admission diagnoses; patient demographics and comorbid conditions; indications for anticoagulation; laboratory data; and treatment and discharge medications, including whether LMWH was prescribed. A delay was defined as the continuation of hospitalization solely to administer intravenous heparin. Predefined criteria were used to classify the delay of discharge as appropriate or avoidable on the basis of the patient's potential eligibility for outpatient treatment with LMWH.
Discharge was delayed for 75 of 309 patients (24%; 95% confidence interval [CI], 19%-29%); during analysis of the avoidability of delay, 67 of the 75 medical records were available and showed that 32 of 67 delays (48%; 95% CI, 35%-60%) were avoidable. Of patients taking long-term OAC medications who were admitted for reasons unrelated to thromboembolism or bleeding, discharge was delayed for 18 of 146 (12%; 95% CI, 7%-19%); during analysis of the avoidability of delay, 16 of the 18 medical records were available and showed that 9 of 16 delays (56%; 95% CI, 30%-80%) were avoidable. Of patients admitted for acute venous thromboembolism who were not taking long-term OAC medications, discharge was delayed for 24 of 38 (63%; 95% CI, 46%-78%); during analysis of the avoidability of delay, 22 of the 24 medical records were available and showed that 11 of 22 delays (50%; 95% CI, 28%-72%) were avoidable.
For patients taking OAC medications, hospital discharge is frequently delayed so that intravenous heparin can be administered; approximately half of these delays could be avoided by outpatient use of LMWH. Studies of the safety, efficacy, and feasibility of outpatient use of LMWH for indications other than deep venous thrombosis are needed because timely discharge of these patients could substantially decrease health care costs.
Outpatient treatment of acute venous thromboembolic disease
2003, Clinics in Chest Medicine
Home treatment of patients with venous thrombosis in the lower limbs. Usual practices in a reference hospital
2002, Angiologia
To assess whether patients with deep vein thrombosis (DVT) and without symptoms of pulmonary embolism (PE) can be treated at home with low molecular weight heparin (LMWH), within a health district area. As secondary end point was to assess whether the thrombus location should be an issue to consider ambulatory treatment.
This is an observational prospective study. Along the year 2000 we have been able to diagnose in our Emergency Department, 203 patients with a DVT. All of them were duly diagnosed with duplex (ATL-9 HDI). Only 16 patients were excluded because symptoms of PE and/or thrombosis of the inferior vena cava (IVC). The hospital admission criteria were: 1. Patients thought to be at risk of a PE, 2. Leg pain and oedema, and 3. Patient's refusal to be treated at home. We finally included 187patients (104 men and 83 women, with a mean age of 65 years). Of them 103 (55%) were admitted to hospital for treatment (59 men and 44 women, mean age 63) and 84 (45%) were treated at home (45 men and 39 women, mean age 67 years). Both groups were compared for age, gender, location of thrombosis, and complications. All patients were followed-up at first week, 1 month and a minimum of 6 months.
There were no differences between both groups (hospitalised and ambulatory) as far as gender (p= 0.61), age (p= 0.11), immediate complications (p= 0.25) and the location of the clot (p= 0.12). In the late follow-up all patients improved and only there was a case ofPE detected in an hospitalised patient. Conclusion. The ambulatory treatment with LMWH in patients with the acute phase of a DVT, with no symptoms ofPE or IVC thrombosis has proven as safe and efficacious as the hospital treatment. The location of the thrombus, exception made of the IVC, does not seem to be and important issue for recommending ambulatory LMWH therapy.
Comprobar la aplica-bilidad del tratamiento con heparina de bajo peso molecular (HBPM) en pacientes con trombosis venosa profunda (TVP) de las extremidades inferiores, sin signos de embolismo pulmonar (TEP), de forma ambulatoria en un ámbito asistencial hospitalario. Valorar si la localización de la TVP puede ser un elemento discriminatorio en la recomendación del régimen ambulatorio.
Estudio prospectivo de investigación cualitativa. Durante el año 2000, en el departamento de urgencias de nuestro hospital hemos diagnosticado 203pacientes con TVP. Todos los diagnósticos se efectuaron utilizando el dúplex (ecografía Doppler color). Sólo se excluyeron 16 enfermos por clínica compatible con TEP o por una afectación extensa de la vena cava inferior (VVI). Los criterios de hospitalización fueron: 1) Pacientes que presentaban ‘riesgo’ de TEP; 2) Pacientes con clínica de edema o dolor evidentes; y 3) Rechazo del enfermo al tratamiento ambulatorio (condicionantes personales o económicos). En 187pacientes (104 hombres, 83 mujeres; edad media: 65 años), 103 (55%) fueron ingresos hospitalarios (59 varones, 44 mujeres; edad media: 63 años) y 84 (45%) se trataron a domicilio (45 varones, 39 mujeres; EM67años). Se han comparado ambos grupos por edad, sexo, localización de la trombosis y complicaciones asociadas. Se ha realizado un control clínico de todos los pacientes a la semana, el mesy a los seis meses. Resultados. No hubo diferencias estadísticamente significativas entre los dos grupos (hospitalizados y ambulatorios) en relación con el sexo (p= 0,61), edad (p= 0,11), complicaciones inmediatas (p= 0,25) ni en la localización del trombo (p= 0,12). En el seguimiento todos los enfermos mejoraron y sólo hubo un TEP, en un paciente ingresado. Conclusión. El tratamiento domiciliario con HBPM en enfermos con TVP, sin TEP, diagnosticada por ecografía Doppler se ha mostrado tan eficaz y seguro como el hospitalario. La localización de la TVP (a excepción de la cava) no parece ser un factor pronóstico para recomendar tratamiento hospitalario.
Comprovaraaplicabi-lidade do tratamento com heparina de bai-xopeso molecular (HBPM), em doentes com trombose venosa profunda (TVP) das extremidades inferiores, sem sinais de embolia pulmonar (TEP), deforma ambulatórianum ámbito assistencial hospitalar. Avaliar se a localizacao da TVPpoderá ser um elemento discriminativo na recomendacao do regime ambulatório.
Estudo prospectivo de investigacao qualitativa. Durante o ano de 2000, diagnosticámos nas urgencias do nosso hospital um total de 203 doentes com TVP. Todos os diagnósticos fo-ram efectuados utilizando o Duplex (eco-Doppler color). Foram apenas excluidos 16 doentes por clínica compatível com TEP ou por envolvimento extenso da veia cava inferior (VCI). Os criterios de hospitalizacao foram: 1) Doentes que apresentavam ‘risco’ de TEP; 2) Doentes com sintomatologia de edema e ou dor evidentes e 3) Resistencia do doente ao tratamento ambulatório (condicionantespessoais ou económicas). Em 187 doentes (104 homens e 83 mulheres; idade média de 65 anos), 103 (55%) foram internados (59 homens, 44 mulheres; idade média: 63 anos) e 84 (45%) tratados em ambu-latório (45 homens, 39 mulheres; idade média: 67anos). Os doisgrupos foram comparados com base na idade, sexo, localiza-cao da trombose e complicacoes associa-das. Realizou-se controlo clínico de todos os doentes aos 7dias, ao mes e aos seis meses.
Nao houve diferencas estatisti-camente significativas entre os dois grupos (hospitalizados e ambulatórios) em relacao ao sexo, (p = 0,61), idade (p = 0.11), complicacoes imediatas (p = 0,25) nem na localiza-cao do trombo (p = 0,12). No seguimento todos os doentes melhoraram e houve apenas um TEP, num doente internado. Conclusao. O tratamento domiciliario com HBPM em doentes com TVP sem TEP, diagnosticado por eco-Doppler, demonstrou ser tao eficaz e seguro como no hospitalar. A localizacao da TVP (a excepcao da veia cava) nao parece ser um factor prognóstico para recomendar o tratamento hospitalar.

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: Supported in part by National Research Service Award F32 HS000124-01 from the Agency for Health Care Policy and Research (Dr. Yusen), and the Norman P. Knowlton, Jr., MD, Incentive for Excellence Fund of Barnes-Jewish Hospital (Dr. Yusen).

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Chest

Clinical InvestigationsPulmonary EmbolismCriteria for Outpatient Management of Proximal Lower Extremity Deep Venous Thrombosis

Study objectives

Design

Setting

Patients

Measurements

Results

Conclusions

Section snippets

Study Setting and Patients

Patients

Eligibility for Outpatient Therapy

Discussion

Lancet

Chest

Am J Med

Am J Med

Thromb Res

Continuous intravenous heparin compared with intermittent subcutaneous heparin in the initial treatment of proximal-vein thrombosis

N Engl J Med

Subcutaneous treatment of deep venous thrombosis: a comparison of unfractionated heparin and low molecular weight heparin

Haemostasis

Treatment of acute venous thromboembolism with low molecular weight heparin (Fragmin): results of a double-blind randomized study

Circulation

Two daily subcutaneous injections of Fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis

Thromb Haemost

A randomized trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis

Thromb Haemost

Subcutaneous low molecular weight heparin compared with continuous intravenous heparin in the treatment of proximal vein thrombosis

N Engl J Med

Subcutaneous low-molecular-weight heparin compared with continuous intravenous unfractionated heparin in the treatment of proximal deep vein thrombosis

Arch Intern Med

Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home

N Engl J Med

A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis

N Engl J Med

Low-molecular-weight heparin in the treatment of patients with venous thromboembolism

N Engl J Med

Clinical Investigations
Pulmonary Embolism
Criteria for Outpatient Management of Proximal Lower Extremity Deep Venous Thrombosis