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Guideline Summary
Guideline Title
Society of Interventional Radiology position statement: treatment of acute iliofemoral deep vein thrombosis with use of adjunctive catheter-directed intrathrombus thrombolysis.
Bibliographic Source(s)
Vedantham S, Millward SF, Cardella JF, Hofmann LV, Razavi MK, Grassi CJ, Sacks D, Kinney TB. Society of Interventional Radiology position statement: treatment of acute iliofemoral deep vein thrombosis with use of adjunctive catheter-directed intrathrombus thrombolysis. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S332-5. [29 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Acute iliofemoral deep vein thrombosis

Guideline Category
Counseling
Evaluation
Management
Prevention
Risk Assessment
Treatment
Clinical Specialty
Family Practice
Hematology
Internal Medicine
Radiology
Intended Users
Advanced Practice Nurses
Hospitals
Nurses
Physicians
Guideline Objective(s)

To provide a position statement for the treatment of acute iliofemoral deep vein thrombosis (DVT) with proper use of adjunctive catheter-directed intrathrombus thrombolysis (CDT)

Target Population

Ambulatory patients with acute iliofemoral deep vein thrombosis (DVT) with reasonable life expectancy and a low expected bleeding risk

Interventions and Practices Considered
  1. Individualized approach and careful selection of patients including imaging studies and assessment of bleeding risk
  2. Patient counseling about risks and benefits of catheter-directed intrathrombus thrombolysis (CDT) and absence of conclusive supportive data for the procedure
  3. CDT as an adjunct to anticoagulant therapy
Major Outcomes Considered
  • Risk and incidence of postthrombotic syndrome (PTS)
  • Health-related quality of life
  • Venous function
  • Symptom resolution

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

An in-depth literature search is performed using electronic medical literature databases. The Medline database was searched from 1980 to 2009.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Not stated
Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

Not stated

Recommendations

Major Recommendations

Statement

The Society of Interventional Radiology (SIR) considers the use of catheter-directed intrathrombus thrombolysis (CDT) as an adjunct to anticoagulant therapy to represent an acceptable initial treatment strategy for carefully selected patients with acute iliofemoral deep vein thrombosis (DVT). The SIR defines acute iliofemoral DVT as complete or partial thrombosis of any part of the iliac vein and/or the common femoral vein with or without associated femoropopliteal DVT, in which symptoms have been present for 14 days or less or for which imaging studies indicate that venous thrombosis has occurred within the past 14 days.

Discussion

The Society of Interventional Radiology (SIR) supports the use of anticoagulant therapy for DVT and the use of adjunctive CDT or surgical thrombectomy for patients with limb-threatening phlegmasia. SIR is aware of the controversy within the medical community regarding the use of adjunctive CDT for patients with acute DVT who do not exhibit signs of impending circulatory compromise. SIR recognizes the methodologic limitations of the studies supporting CDT and strongly believes that the execution of a multicenter randomized trial to conclusively quantify the risk–benefit ratio of CDT in patients with acute proximal DVT should be considered an important national health care priority. In the meantime, physicians are still obligated to carefully consider the short-term and long-term consequences of DVT and to recommend the best possible overall treatment strategy to patients based on the currently available, albeit imperfect, evidence. Although there are no large randomized trials to mitigate for or against CDT, the preponderance of the available evidence favors the existence of a clinical benefit to adjunctive CDT for the subset of patients with acute iliofemoral DVT.

Given the unanswered questions concerning the risk–benefit ratio of CDT, SIR recommends that physicians use an individualized approach to determine which patients should receive adjunctive CDT as initial therapy for acute iliofemoral DVT. Most importantly, a careful assessment should be performed first to detect clinical factors that might increase the risk of bleeding or diminish the importance of any clinical benefit achieved. After this assessment, ambulatory patients with acute iliofemoral DVT with reasonable life expectancy and a low expected bleeding risk should be presented with a balanced discussion of the long-term risks of postthrombotic syndrome (PTS) and the possible benefits of adjunctive CDT. The risks of CDT, the possible lack of long-term benefits, and the absence of conclusive supportive data should be presented as well. SIR believes that these practices will promote proper use of adjunctive CDT in patients who are most likely to attain clinically meaningful benefits and who are least likely to be harmed by the intervention.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Catheter-directed intrathrombus thrombolysis (CDT) has significant potential to prevent postthrombotic syndrome (PTS) and offers distinct advantages compared with surgical venous thrombectomy, systemic thrombolysis, and anticoagulation alone:

  • CDT does not require general anesthesia, a surgical incision, or a prolonged recovery period.
  • Catheter-directed delivery enables a higher intrathrombus drug concentration to be achieved, enhancing thrombus removal and reducing the needed dose.
  • Catheter access into the venous system enables the use of balloon angioplasty and stents to treat underlying venous obstruction that might otherwise predispose to recurrent deep vein thrombosis (DVT).
  • Symptom relief tends to be faster and more complete with adjunctive CDT than with anticoagulant therapy alone.
Potential Harms

The main disadvantage of adjunctive catheter-directed intrathrombus thrombolysis (CDT) is thought to be an increased risk of bleeding. In the studies evaluated, the cumulative major bleeding rate for CDT was 8%, and most bleeding events were confined to the vascular access site. Intracranial bleeding was rare (0.2%).

Qualifying Statements

Qualifying Statements

The Society of Interventional Radiology (SIR) is aware of the controversy within the medical community regarding the use of adjunctive catheter-directed intrathrombus thrombolysis (CDT) for patients with acute deep vein thrombosis (DVT) who do not exhibit signs of impending circulatory compromise. SIR recognizes the methodologic limitations of the studies supporting CDT and strongly believes that the execution of a multicenter randomized trial to conclusively quantify the risk–benefit ratio of CDT in patients with acute proximal DVT should be considered an important national health care priority.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Patient Resources
Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Vedantham S, Millward SF, Cardella JF, Hofmann LV, Razavi MK, Grassi CJ, Sacks D, Kinney TB. Society of Interventional Radiology position statement: treatment of acute iliofemoral deep vein thrombosis with use of adjunctive catheter-directed intrathrombus thrombolysis. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S332-5. [29 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2009 Jul
Guideline Developer(s)
Society of Interventional Radiology - Medical Specialty Society
Source(s) of Funding

Society of Interventional Radiology

Guideline Committee

Standards of Practice Committee

Composition of Group That Authored the Guideline

Committee Members: Suresh Vedantham, MD; Steven F. Millward, MD; John F. Cardella, MD; Lawrence V. Hofmann, MD; Mahmood K. Razavi, MD; Clement J. Grassi, MD; David Sacks, MD; and Thomas B. Kinney, MD

Financial Disclosures/Conflicts of Interest

None of the authors have identified a conflict of interest.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Journal of Vascular and Interventional Radiology Web site External Web Site Policy.

Print copies: Available from the Society of Interventional Radiology, 10201 Lee Highway, Suite 500, Fairfax, VA 22030

Availability of Companion Documents

The following are available:

Patient Resources

The following is available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on August 22, 2011. The information was verified by the guideline developer on September 8, 2011.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

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