For citation purposes: Cei M, Cei F, Mumoli N. Deep vein thrombosis: who still needs to be admitted? OA Case Reports 2013 Feb 28;2(2):15.

Critical Review

 
Cardiovascular Medicine

Deep vein thrombosis: who still needs to be admitted?

M Cei*, F Cei, N Mumoli
 

Authors affiliations

(1) Department of Clinical Medicine, Hospital of Livorno, Viale Alfieri 36, 57124 Livorno, Italy

* Corresponding author Email: marcocei59@gmail.com

Abstract

Introduction

Since the introduction of low-molecular-weight heparins for safely treating deep vein thrombosis, outpatient treatment of this condition became a standard practice worldwide. Certain groups of patients were not represented in clinical trials of home treatment; however, they still need to be admitted. In deciding which patient to admit, physicians should take into account both comorbid clinical conditions and social, geographic and logistic constraints. Extension of venous thromboembolism (i.e., the presence of symptomatic pulmonary embolism, iliofemoral or caval thrombosis) and the risk of bleeding should also be included in the decision pathway. The aim of this critical review is to see if deep vein thrombosis can be treated at home or at hospital.

Conclusion

Deep vein thrombosis can be treated outside a hospital setting safely, but this varies between individuals. Some people need to be admitted into a hospital as there is a high risk of bleeding or relevant comorbidities.

It is advisable to implement clinical pathways to support the decision of safely assigning patients to outpatient management.

Introduction

Until the second half of 1990’s, patients with deep vein thrombosis (DVT) needed to be admitted to a hospital and treated with intravenous unfractionated heparin for at least 5 days along with coumarins; this regimen requires close laboratory monitoring to be both effective and safe. Two landmark trials[1,2] showed that patients could be safely treated at home with low-molecular weight heparins, drugs that have proven effective when administered in fixed, weight-adjusted doses, one or two times a day without laboratory monitoring. Shortly afterwards, home treatment of DVT became a standard practice worldwide.

We recently revised more than 273,000 hospital discharge records across the last 8 years (2005–2012) in our Department, and we found that only a very small proportion of cases (0.083%) were discharged with an ICD-IX-CM code that led to an attribution to the Diagnosis Related Group 128 (Cei M, unpublished data; Figure 1). Even if this exceptionally low value could be underestimated due to attribution of cases to other codes, we regard this as quite surprising. In fact, in clinical trials, many patients were excluded from home treatment, and outside the research context, physicians should have been even more cautious. We were therefore prompted to critically review the reasons that have led to patients being excluded from home treatment in clinical trials and the reasons that still suggest hospital admission for DVT patients. We focused on DVT of the lower limbs only in this review.

Hospital discharges for DTV at the Clinical Medicine Department, Livorno, Italy. Years 2005–2012 (number of cases per 1,000 discharges per year)

Discussion

The problem of exclusion from home treatment

In randomised clinical trials (RCT), a large proportion of eligible patients are excluded from home treatment: 1491/2230 (66.9%) in a study by Levine[1] and 216/692 (31.2%) in a trial by Koopman[2]. The proportion of excluded patients along with partial in-hospital initial treatment of those patients regarded as treated ‘at home’ were already identified as fundamental problems in a Cochrane review from Othieno[3]. This represents a clear lack of generalizability, the proportion of patients excluded from home treatment was not so high in many subsequent non-randomised studies[4][14], and current practices seem to be even more aggressive[15]. This could be due to, at least in part, the fact that study patients were excluded because of a wide range of conditions, some of which are peculiar to experimental context and are not usually considered in clinical practice (Table 1). On the other hand, a carefully designed pathway for outpatient treatment seems to be less permissive; up to 70% of patients were excluded from home treatment in a series from Shapiro[16]. Indeed, other exclusion reasons may include both conditions related to the clinical status of patients and those related to social, geographic and logistic constraints (Table 2). However, cancer (even when metastatic) should not be considered in itself a reason for exclusion from treatment at home[17]. Moreover, Hyers reported that home treatment was more common in suburban and rural areas than in urban settings in a large, multicentric study[18].

Table 1

Causes of exclusion from home treatment of DVT because of protocol demands

Table 2

Real-world cause of exclusion from home treatment of DVT

Burden of venous thromboembolism

Approximately one third of DVT patients have some degree of pulmonary involvement[19], and trials have therefore included patients with pulmonary embolism (PE) that was not ‘severe’ or symptomatic. Moreover, the treatment of PE at home has been formally assessed[20]. Nowadays, we have been provided with a validated tool (the Hestia Criteria, Table 3) that safely identifies patients who do not need to be admitted for the management of PE[21]. Patients with extensive iliofemoral DVT or phlegmasia cerulea dolens, which are conditions that carry a high risk of severe post-thrombotic syndrome or those that require parenteral or opioid analgesia, were usually excluded from RCT, although they should been included. It may be reasonable to consider alternative strategies for these patients, including putting them on unfractionated heparin until they have been evaluated for surgical thrombectomy or catheter-directed thrombolysis[22,23]. Bilateral lower limb DVT should raise the suspect of inferior vena cava thrombosis and, in turn, possibly caval atresia[24], especially in the young; these patients should be therefore admitted for extensive evaluation and treatment.

Table 3

The Hestia criteria for PE admission

The fear of bleeding

Many patients in RCT are admitted because of active bleeding or the perceived high risk of bleeding. A miscellanea of clinical conditions have been considered to fulfil this criterion of exclusion, including the presence of bleeding diathesis (defined as thrombocytopenia < 100,000 x 106/L or INR > 1.4), uncontrolled or malignant hypertension, renal or hepatic failure (Figure 2), recent surgery (especially neurologic or ophthalmic) or lumbar puncture, recent gastrointestinal (within 1 month) or intracerebral bleeding (within 6 months) or the concomitant use of antiplatelet agents. To our knowledge, any formal score has never been adopted to exclude such patients from home treatment, and the decision to admit the patient usually relies largely on clinical judgement alone. Indeed, serious bleeding seems to be related more to the patient’s characteristics than to the treatment setting[25], and bleeding risk tools have not been shown to be very accurate, at least in the elderly DVT patients[26].

Large leg haematoma in a woman with bilateral femoral DVT, low-risk PE and renal insufficiency.

Less well-defined causes of exclusion

Other causes of exclusion reported in Table 2 do not deserve specific comments, apart from the presence of comorbidities, which are the most frequently reported cause of hospital admission. As in the case of bleeding, this decision was left at the physician’s discretion. Taken together, these two matters of exclusion lessen the strength of evidence in favour of the safety of home treatment, because the risk of an exclusion bias is not negligible.

Unresolved issues and concerns

It is unknown to what extent the real world follow-up consuetudes differ from the research context. In RCT, patients are more likely to be regularly followed by visiting nurses[27], have facilities to communicate with physicians responsible for the treatment and have the availability of fast-track hospital evaluation in case of symptoms. Clinical pathways should be assured to minimise the risk of outpatient treatment[28]. Standard practices may not be as effective in unrevealing DVT progression or assessing non-overt bleeding. In future, newer anticoagulants not needing laboratory monitoring would further increase the proportion of patients who will not seek medical advice during the period of active treatment.

Conclusion

Outpatient treatment of DVT is generally safe and effective, even when associated with low-risk PE. However, some patients should be admitted because of thromboembolic extension, high risk of bleeding or relevant comorbidities. It is advisable to implement clinical pathways to support the decision to safely assign a patient to outpatient management.

Authors contribution

All authors contributed to conception and design, manuscript preparation, read and approved the final manuscript.

Competing interests

none declared.

Conflict of interests

none declared.

A.M.E

All authors abide by the Association for Medical Ethics (AME) ethical rules of disclosure.

References

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Licensee to OAPL (UK) 2013. Creative Commons Attribution License (CC-BY)

Causes of exclusion from home treatment of DVT because of protocol demands

Lack of informed consent
Age < 18 years
Pregnancy or lactation
Previous venous thromboembolism
Treatment with heparins in the previous few days of enrolment
Reduced life expectancy

Real-world cause of exclusion from home treatment of DVT

Clinical relevant PE
Extensive ilio-caval phlebothrombosis
Phlegmasia cerulea dolens
Active or recent bleeding
High risk of bleeding
Presence of comorbidities that require hospital admission
Allergy to heparin
History of heparin-induced thrombocytopenia
Geographic inaccessibility to follow-up
Likelihood of poor compliance
Hospital inadequate service

The Hestia criteria for PE admission

If any of the following question is ‘yes’, then the patient should be admitted.
Is the patient haemodynamically unstable?
Is thrombolysis or embolectomy necessary?
Is there active bleeding or high risk for bleeding?
Is >24 hours of oxygen supply needed to maintain oxygen saturation >90%?
Is PE diagnosed during anticoagulant treatment?
Is there severe pain requiring intravenous pain medication for >24 hours?
Is there a medical or social reason for treatment in a hospital for >24 hours (infection, malignancy, no support system, etc.)?
Does the patient have a creatinine clearance of <30 mL/minute?
Does the patient have severe liver impairment?
Is the patient pregnant?
Does the patient have a documented history of heparin-induced thrombocytopenia?