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Guideline Summary
Guideline Title
ACR–SIR practice guideline for the performance of inferior vena cava (IVC) filter placement for the prevention of pulmonary embolism.
Bibliographic Source(s)
American College of Radiology (ACR), Society of Interventional Radiology (SIR). ACR-SIR practice guideline for the performance of inferior vena cava (IVC) filter placement for the prevention of pulmonary embolism. [online publication]. Reston (VA): American College of Radiology (ACR); 2010. 13 p. [68 references]
Guideline Status

This is the current release of the guideline.

Jump ToGuideline ClassificationRelated Content

Scope

Disease/Condition(s)
  • Pulmonary embolism
  • Deep venous thrombosis

Note: Refer to the "Indications" section of the "Major Recommendations" field for a detailed list of diseases and conditions.

Guideline Category
Management
Prevention
Clinical Specialty
Cardiology
Family Practice
Hematology
Internal Medicine
Preventive Medicine
Pulmonary Medicine
Radiology
Surgery
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Nurses
Physician Assistants
Physicians
Guideline Objective(s)
  • To assist practitioners in providing appropriate radiologic care for patients
  • To describe principles of practice for performance of inferior vena cava (IVC) filter placement for the prevention of pulmonary embolism
Target Population

Patients undergoing inferior vena cava (IVC) filter placement for the prevention of pulmonary embolism

Interventions and Practices Considered
  1. Inferior vena cava (IVC) filter placement
    • Use of qualified personnel
    • Appropriate patient selection
    • Use of appropriate equipment, medications, and emergency support (e.g., physiologic monitoring and resuscitation equipment)
    • Use of appropriate support personnel
    • Preprocedural, procedural, and postprocedural care
  2. Selection criteria for short-term observation
  3. Consideration of relative contraindications to short-term observation and hospitalization when appropriate
  4. Appropriate documentation
  5. Minimizing radiation exposure
Major Outcomes Considered
  • Success rates
  • Complication rates

Methodology

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

The Medline literature search is based on keywords provided by the topic author. The two general classes of keywords are those related to the condition (e.g., ankle pain, fever) and those that describe the diagnostic or therapeutic intervention of interest (e.g., mammography, MRI).

The search terms and parameters are manipulated to produce the most relevant, current evidence to address the Practice Guideline or Technical Standard topic being reviewed or developed. Combining the clinical conditions and diagnostic modalities or therapeutic procedures narrows the search to be relevant to the topic. Exploding the term "diagnostic imaging" captures relevant results for diagnostic topics.

The following criteria/limits are used in the searches.

  1. Articles that have abstracts available and are concerned with humans.
  2. Restrict the search to the year prior to the last topic update or in some cases the author of the topic may specify which year range to use in the search. For new topics, the year range is restricted to the last 5 years unless the topic author provides other instructions.
  3. May restrict the search to Adults only or Pediatrics only.
  4. Articles consisting of only summaries or case reports are often excluded from final results.

The search strategy may be revised to improve the output as needed.

Number of Source Documents

The total number of source documents identified as the result of the literature search is not known.

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence
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

Recommendations are formulated through iterative review by committee, collaborating societies, and membership. Suggested recommendations are reviewed by the committee, and agreement is reached by consensus.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

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

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

Each practice guideline and technical standard, representing a policy statement by the American College of Radiology (ACR), has undergone a thorough consensus process in which it has been subjected to extensive review, requiring the approval of the Commission on Quality and Safety as well as the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council.

Recommendations

Major Recommendations

Many devices have been developed for endoluminal caval interruption and currently several devices designed for permanent placements are commercially available in the United States. In addition to permanent inferior vena cava (IVC) filters, retrievable IVC filters are also available. These filters can be left in place as a permanent implant but also can be removed when the indication for filter placement resolves. Selection of a device requires knowledge of the clinical settings in which filters are used, as well as an evaluation of the clot-trapping efficiency and structural integrity of the device, the occlusion rate of the IVC and access vein, the risk of filter movement and filter embolization, magnetic resonance imaging (MRI) compatibility of the device, and the ease of placement.

Placement of a caval filter can be performed as either an outpatient or inpatient procedure. Practically speaking, however, most filter placements will occur in the inpatient population because of ongoing medical therapy for acute thromboembolic disease or underlying illness.

The IVC should be assessed with imaging prior to placement of a filter, and the current preferred method is by vena cavography. Prior to filter selection and placement, the length and diameter of the infrarenal IVC should be assessed, the location and number of renal veins determined, IVC anomalies defined (e.g., duplication), and intrinsic IVC disease such as pre-existing thrombus or extrinsic compression excluded. If available, prior imaging studies (such as contrast enhanced computed tomography [CT] or MRI of the abdomen) may be used to evaluate the anatomy of the IVC (size, patency, and anatomical variants). The ideal location for filter placement for preventing lower extremity and pelvic venous thromboembolism is the infrarenal IVC. The apex or superior aspect of any filtration device should be at or immediately inferior to the level of the renal veins according to the manufacturer's recommendations. In specific clinical circumstances other target locations may be appropriate.

Placement of a caval filter is commonly accomplished through right femoral or right internal jugular vein approaches; however, other peripheral (e.g., antecubital vein) and central venous access sites can be used. Filters can be placed in veins other than the IVC to prevent thromboembolism (an off-label indication). Implant sites have included iliac veins, subclavian veins, superior vena cava, and IVC (suprarenal and infrarenal). The original guideline document only provides quality improvement guidelines for filter placement within the IVC due to the limited data available for implantation sites other than the IVC. The patient's clinical condition, the type of filter available, the available access sites, and the expertise of the treating physician should always be considered when the decision to place an IVC filter has been made.

IVC filters labeled as retrievable by the U.S. Food and Drug Administration (FDA) are also labeled for permanent placement. Retrievable filters may be placed with the intent of either temporary or permanent filtration. Removal of retrievable IVC filters may be accomplished in those cases where the indication was for prophylaxis and prevention of pulmonary embolism (PE) with temporary contraindication to anticoagulation. Filters placed with the intent of subsequent retrieval may be left in place permanently for any of several reasons (e.g., continuing need for filtration, thrombus on the filter, inability to retrieve the filter). Data for the feasibility of filter retrieval vary widely among devices and centers. Filters that are not retrieved function as permanent filters.

These guidelines are intended to be used in quality improvement programs to assess percutaneous interruption of the IVC to prevent pulmonary embolism. The most important aspects of care are 1) patient selection, 2) performing the procedure, and 3) monitoring the patient. The outcome measures or indicators for these processes are indications, success rates, and complication rates. Outcome measures are assigned threshold levels.

Definitions

For the purpose of this guideline, the following definitions apply:

Permanent placement – deployment in those situations where lifelong protection against thromboembolic episodes is needed

Temporary placement – deployment in those situations where time-limited protection against thromboembolic episodes is needed

Procedural success – deployment of a filter such that the filter is judged suitable for mechanical protection against PE

Recurrent PE – pulmonary embolism occurring after filter placement and documented by pulmonary arteriography, cross-sectional imaging, or significant change in ventilation-perfusion (V/Q) lung scan indicative of recurrent PE, or autopsy

IVC thrombotic occlusion – presence of an occluding thrombus in the IVC occurring after filter insertion and documented by ultrasound, CT, MRI, venography, or autopsy; this may be symptomatic or asymptomatic

IVC penetration – penetration of the vein wall by filter hooks with transmural incorporation. For quality improvement reporting purposes, the definition of IVC penetration is filter strut or anchor devices extending more than 3 mm outside the wall of the IVC as demonstrated by CT, venography, or autopsy. Acute penetration occurring during placement of the filter is considered an insertion problem (see below).

Filter embolization – postdeployment movement of the filter or its components to a distant anatomic site completely out of the target zone

Filter movement – a change in filter position compared to its deployed position (either cranial or caudal) of more than 2 cm as documented by plain film imaging, CT, or venography

Filter fracture – any loss of a filter's structural integrity (i.e., breakage or separation) documented by imaging or autopsy

Insertion problems – malfunctions of the filter or deployment system such as incomplete filter opening, filter tilt more than 15 degrees from the IVC axis (e.g., non-self-centering filters), misplacement of filter outside the infrarenal IVC when the operator's intent is to place the filter in the infrarenal IVC (e.g., when a portion of the filter is within one iliac vein), or prolapse of filter components. Filter malposition requiring surgical/ endovascular removal is considered an insertion problem complication.

Access site thrombus – occlusive or nonocclusive thrombus developing at the venotomy site after filter insertion, and documented by ultrasound or other imaging

Access site complications with clinical sequelae - arteriovenous fistula, hematoma, or bleeding requiring transfusion, hospitalization (either admission or extended stay), or further treatment

Indications

  1. Therapeutic (Documented Thromboembolic Disease)
    1. Patients with evidence of pulmonary embolus or IVC, iliac, or femoral-popliteal deep vein thrombosis (DVT) and one or more of the following:
      1. Absolute or relative contraindication to anticoagulation
      2. Complication of anticoagulation
      3. Failure of anticoagulation
        1. Recurrent PE despite adequate therapy
        2. Inability to achieve/maintain adequate anticoagulation
        3. Propagation/progression of DVT on therapeutic anticoagulation
    1. Massive pulmonary embolism with residual deep venous thrombus in a patient at risk for further PE
    2. Free-floating iliofemoral or inferior vena cava thrombus
    3. Severe cardiopulmonary disease and DVT (e.g., cor pulmonale with pulmonary hypertension)
  1. Prophylactic (No Current Thromboembolic Disease)
    1. Severe trauma without documented PE or DVT
      1. Closed head injury
      2. Spinal cord injury
      3. Multiple long bone or pelvic fractures
    1. High-risk patients (e.g., immobilized or in an intensive care unit)
  1. Suprarenal Filter Placement

    Suprarenal caval filter placement may be considered when any of the following situations exist in addition to the indications listed above.

    1. Presence of IVC thrombus precluding placement of a filter in the infrarenal IVC
    2. Filter placement during pregnancy. Suprarenal placement is also appropriate in women of childbearing age.
    3. Thrombus extending above previously placed infrarenal filter
    4. Gonadal vein thrombosis
    5. Anatomic variants: duplication of the IVC, low insertion of renal veins
    6. Significant extrinsic compression of the infrarenal IVC
    7. Intrinsic narrowing of the infrarenal IVC
    8. Patients with an intra-abdominal or pelvic mass who will undergo surgery and in whom operative IVC mobilization is contemplated

    The IVC should be assessed with imaging prior to placement of a filter. The current preferred method is by vena cavography. Prior to filter selection and placement, the length and diameter of the suprarenal IVC should be assessed, the location and number of renal veins determined, the location and number of hepatic veins determined, the right atrium should be identified, IVC anomalies defined (e.g., duplication), and intrinsic IVC disease, such as pre-existing thrombus or extrinsic compression, excluded. If available, prior imaging studies (such as contrast enhanced CT or MRI of the abdomen) may be used to evaluate the anatomy of the IVC (size, patency, and anatomical variants). The anatomic considerations should be used in the final planning for filter placement and choice of device.

  1. Filters Placed for Temporary Use and Possible Future Retrieval

    Placement of filters for temporary use and possible future retrieval may be considered when any of the following situations exist in addition to the indications listed above.

    1. PE and/or DVT and transient inability to anticoagulate
    2. Prophylactic prevention of PE in high-risk patients
    3. The use of retrievable filters should also be considered in pediatric and young adult patients, since the long-term effects and durability of the devices are not precisely known. Currently there are no filters specifically designed for use in children. The safety and efficacy of vena cava filters in children have not been firmly established. Case reports and series have described the placement and removal of filters in children, but their long-term effect is unclear.

    The threshold for these indications is 95%. When fewer than 95% of procedures are performed for these indications, the process of patient selection should be reviewed according to institutional policy.

Relative Contraindications

  1. Uncorrectable Severe Coagulopathy
  2. Bacteremia or Untreated Infection

Clinical judgment should be applied in these situations, weighing the theoretical risk of implant infection versus the risk of pulmonary embolism.

Qualification and Responsibilities of Personnel

  1. Physician

    Examinations must be performed under the supervision of and interpreted by a physician who has the following qualifications:

    1. Certification in Radiology or Diagnostic Radiology by the American Board of Radiology, the American Osteopathic Board of Radiology, the Royal College of Physicians and Surgeons of Canada, or the Collège des Médecins du Québec and must have demonstrated competency in vascular procedures under the supervision of an on-site qualified physician during the performance of at least 25 percutaneous vascular procedures of which at least five were as primary operator for IVC filter placement procedures

      or

    2. Completion of a residency program approved by the Accreditation Council for Graduate Medical Education (ACGME), the Royal College of Physicians and Surgeons of Canada (RCPSC), the Collège des Médecins du Québec, or the American Osteopathic Association (AOA) to include a minimum of 6 months training in the performance of percutaneous invasive vascular procedures and interventional radiology or vascular surgery that included the vascular aspects of interventional radiology, including at least 3 months in each of these subspecialty areas with at least 3 months of documented formal training in the performance of invasive catheter angiographic procedures, and must have demonstrated competency in vascular procedures under the supervision of an on-site qualified physician during the performance of at least 25 percutaneous vascular procedures of which at least five were as primary operator for IVC filter placement procedures

      or

    3. In the absence of appropriate ACGME approved residency training as outlined in the section above, formal fellowship training in a Radiology Residency Review Committee (RRC) accredited vascular/interventional radiology fellowship program or other postgraduate training that included comparable instruction and experience in vascular interventional procedures. The physician must have at least 2 years experience with demonstrated competency as the primary operator in vascular interventional procedures under the supervision of an on-site qualified physician during which a minimum of 25 percutaneous vascular procedures, including a minimum of five IVC filter placement procedures, were performed with documented success and complication rates that meet the threshold criteria listed in the "Quality Improvement" section in the original guideline document.
    4. Physicians meeting any of the qualifications in 1, 2, and 3 above must also have written substantiation that they are familiar with all of the following:
      1. Indications and contraindications for the procedure
      2. Periprocedural and intraprocedural assessment, monitoring, and management of the patient and potential complications
      3. Where applicable, pharmacology of moderate sedation medications and recognition and treatment of adverse reactions and complications
      4. Appropriate use and operation of fluoroscopic and radiographic equipment, mechanical injectors, digital image capture devices and electronic imaging systems
      5. Where applicable, principles of radiation protection, hazards of radiation exposure to both patients and radiologic personnel, and monitoring requirements
      6. Where applicable, pharmacology of contrast agents and recognition and treatment of potential adverse reactions
      7. Percutaneous needle and catheter introduction techniques
      8. Technical aspects of performing the procedure, including the use of alternative catheter and guidewire systems, and filming sequences
      9. Anatomy, physiology, and pathophysiology of peripheral and central venous vasculature
      10. Postprocedure patient management, especially recognition and initial management of complications
      11. Postprocedure management of puncture sites
      12. Principles, operation, and imaging findings of vascular ultrasound, where applicable

      The written substantiation should come from the chief of interventional radiology, the chair of the department of radiology, or his or her designee at the institution in which the physician will be providing these services. Substantiation could also come from a prior institution in which the physician provided the services, but only at the discretion of the chair of the department of radiology or his or her designee who solicits the additional input.

    Maintenance of Competence

    Physicians must perform a sufficient number of filter placement procedures to maintain their skills, with acceptable success and complication rates as presented in this document (see the "Quality Improvement" section in the original guideline document). Continued competence should depend on participation in a quality improvement program that monitors these rates.

    Continuing Medical Education

    The physician's continuing education should be in accordance with the American College of Radiology (ACR) Practice Guideline for Continuing Medical Education (CME)" (see the ACR Web site External Web Site Policy for this practice guideline and additional ones mentioned below).

  1. Qualified Medical Physicist

    A Qualified Medical Physicist is an individual who is competent to practice independently in one or more of the subfields in medical physics. The American College of Radiology considers certification and continuing education and experience in the appropriate subfield(s) to demonstrate that an individual is competent to practice one or more of the subfields in medical physics and to be a Qualified Medical Physicist. The ACR recommends that the individual be certified in the appropriate subfield(s) by the American Board of Radiology (ABR), the Canadian College of Physics in Medicine, or for MRI, by the American Board of Medical Physics (ABMP) in magnetic resonance imaging physics.

    The appropriate subfields of medical physics for this guideline are Diagnostic Radiological Physics and Radiological Physics.

    A Qualified Medical Physicist should meet the "ACR Practice Guideline for Continuing Medical Education (CME)." (ACR Resolution 17, 1996 – revised in 2008, Resolution 7)

  2. Registered Radiologist Assistant

    A registered radiologist assistant is an advanced level radiographer who is certified and registered as a radiologist assistant by the American Registry of Radiologic Technologists (ARRT) after having successfully completed an advanced academic program encompassing an ACR/ASRT (American Society of Radiologic Technologists) radiologist assistant curriculum and a radiologist-directed clinical preceptorship. Under radiologist supervision, the radiologist assistant may perform patient assessment, patient management and selected examinations as delineated in the Joint Policy Statement of the ACR and the ASRT titled "Radiologist Assistant: Roles and Responsibilities" and as allowed by state law. The radiologist assistant transmits to the supervising radiologists those observations that have a bearing on diagnosis. Performance of diagnostic interpretations remains outside the scope of practice of the radiologist assistant. (ACR Resolution 34, adopted in 2006)

  3. Radiologic Technologist
    1. The technologist, together with the physician and nursing personnel, should be responsible for patient comfort and safety. The technologist should be able to prepare and position1 the patient for the filter placement procedure and, together with the nurse, monitor the patient during the procedure. The technologist should obtain the imaging data in a manner prescribed by the supervising physician. If intravenous contrast material is to be administered, qualifications for technologists performing intravenous injection should be in compliance with current ACR policy2 and existing operating procedures or manuals at the facility. The technologist should also perform the regular quality control testing of the equipment under the supervision of the physicist.
    2. Technologists should be certified by the American Registry of Radiologic Technologists (ARRT) or have an unrestricted state license with documented training and experience in the imaging modality used for the imaging-guided procedure.

    1The American College of Radiology approves of the practice of certified and/or licensed radiologic technologists performing fluoroscopy in a facility or department as a positioning or localizing procedure only, and then only if monitored by a supervising physician who is personally and immediately available*. There must be a written policy or process for the positioning or localizing procedure that is approved by the medical director of the facility or department/service and that includes written authority or policies and processes for designating radiologic technologists who may perform such procedures. (ACR Resolution 26, 1987 – revised in 2007, Resolution 12-m)

    *For the purposes of this guideline, "personally and immediately available" is defined in manner of the "personal supervision" provision of the Centers for Medicare and Medicaid Services (CMS)—a physician must be in attendance in the room during the performance of the procedure. Program Memorandum Carriers, DHHS, HCFA, Transmittal B-01-28, April 19, 2001.

    2See the "ACR Practice Guideline for the Use of Intravascular Contrast Media." (ACR Resolution 51, 2001 – revised in 2007, Resolution 38)

  1. Nursing Services

    Nursing services, when deemed appropriate by the performing physician, are an integral part of the team for preprocedure and postprocedure patient management and education and are recommended in monitoring the patient during the procedure.

Specifications of the Examination

There are several technical requirements to ensure safe and successful filter placement procedures. These include adequate angiographic equipment and institutional facilities, physiologic monitoring equipment, and support personnel.

  1. Equipment and Facilities for Filter Placement

    The following are considered the minimum equipment requirements for performing vena cavagrams and filter placement. In planning facilities for IVC placement, equipment and facilities more advanced than those outlined below may be desired to produce higher quality studies with reduced risk and time of study. The facility should include at a minimum:

    1. A high-resolution image receptor, preferably with a 28 to 40 cm field of view, and an imaging chain with either standard angiographic filming capabilities including serial 14-inch film changers, or (preferably) a digital imaging system with a minimum 1,024-image matrix. Digital angiographic systems are preferred, as they allow for reduced volumes of contrast material and reduced examination times. Images are acquired and stored either on conventional film or digitally on computerized storage media. Imaging and image recording must be consistent with the as-low-as-reasonably-achievable (ALARA) radiation safety guidelines. The use of cineradiography or small field mobile image intensifiers is inappropriate for the routine recording of the venacavagram and IVC placement, because these methods cause an unacceptably high patient and operator radiation dose. Use of last image-hold and pulsed fluoroscopy are recommended for dose reduction.
    2. Adequate angiographic supplies such as catheters, guidewires, needles, and introducer sheaths
    3. An angiographic injector capable of varying injection volumes and rates with appropriate safety mechanisms to prevent overinjection
    4. An angiography suite that is large enough to allow easy transfer of the patient from the bed to the table and allow room for the procedure table, monitoring equipment, and other hardware such as intravenous pumps, respirators, anesthesia equipment, and oxygen tanks. Ideally, there should be adequate space for the operating team to work unencumbered on either side of the patient and for the circulation of other technical staff in the room without contaminating the sterile conditions.
    5. An area within the institution appropriate for patient preparation prior to the procedure and for observation of patients after the procedure. This might be within the radiology department, a short-stay unit, a routine nursing unit, or a postanesthesia care unit. At this location, there should be personnel to provide care as outlined below (see "Patient Care" section), and there should be immediate access to emergency resuscitation equipment.
  1. Physiologic Monitoring and Resuscitation Equipment
    1. Equipment should be present in the procedure suite to allow for monitoring the patient's heart rate, cardiac rhythm, and blood pressure. For facilities using moderate sedation, a pulse oximeter monitor should be available (see the National Guideline Clearinghouse [NGC] summary ACR–SIR Practice Guideline for Sedation/Analgesia).
    2. Appropriate emergency equipment and medications must be immediately available to treat adverse reactions associated with administered medications and/or procedural complications. The equipment should be maintained and medications inventoried for drug expiration dates on a regular basis. The equipment, medications, and other emergency support must also be appropriate for the range of ages and sizes in the patient population.
  1. Support Personnel
    1. Radiologic technologists properly trained in the use of the angiographic equipment should assist in performing and imaging the procedure. They should demonstrate appropriate knowledge of patient positioning, angiographic image recording, angiographic contrast injectors, angiographic supplies including IVC filters, and the physiologic monitoring equipment. Certification as a vascular and interventional radiologic technologist is one measure of appropriate training. The technologist should be trained in basic cardiopulmonary resuscitation and in the function of the resuscitation equipment.
    2. If the patient does not receive sedation for the procedure, one of the staff assisting the procedure should be assigned to periodically assess the patient's status. In cases where moderate sedation is used in adults, light or moderate sedation is used in children, or the patient is critically ill, an experienced licensed provider should be present whose primary responsibility is monitoring the patient's vital signs, sedation state, and level of comfort/pain. This person should maintain a record of the patient's vital signs, the time and dose of medications given, and other pertinent information (see the see the NGC summary ACR–SIR Practice Guideline for Sedation/Analgesia).
  1. Acute Care Support

    Although surgical or other emergency treatment is needed infrequently for serious complications after filter placement procedures, there should be prompt access to surgical and interventional equipment and to specialists familiar with the management of patents with complications in the unlikely event of a life-threatening complication.

  1. Patient Care

    For additional information see the "ACR–SIR–SNIS Practice Guideline for Interventional Clinical Practice."

    1. Preprocedure care

      For elective filter placement, the following should be documented:

      1. Clinically significant history, including indications for the procedure
      2. Clinically significant physical or diagnostic examination findings, including clinical or medical conditions that may necessitate specific care, such as preprocedure antibiotics and other measures
      3. Clinically indicated laboratory evaluation including, but not limited to, coagulation factors, creatinine, white blood cell count, and previously obtained cultures
      4. Preprocedure documentation should conform to the requirements of the "ACR–SIR Practice Guideline for the Reporting and Archiving of Interventional Radiology Procedures."

      Informed consent must be in compliance with all state laws and the "ACR–SIR Practice Guideline on Informed Consent for Image-Guided Procedures."

      For emergency procedures, a note should be written summarizing the indication for the study, the pertinent history and physical findings, if available, and the proposed procedure.

    1. Procedural care
      1. Adherence to the Joint Commission's Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery™ is required for procedures in non-operating room settings, including bedside procedures. "Time out" must be conducted in the location where the procedure will be done, just before starting the procedure and must:
        • Involve the entire operative team
        • Use active communication
        • Be briefly documented, such as in a checklist, and include at least:
          • Correct patient identity
          • Correct site
          • Agreement on the procedure to done

        The organization should have processes and systems in place for reconciling differences in staff responses during the "time out."

      1. All patients should have cardiac monitoring continuously during the procedure with intermittent blood pressure monitoring. A record of vital signs should be maintained.
      2. All patients should have intravenous access for the administration of fluids and medications as needed.
      3. If the patient is to receive sedation for the procedure, pulse oximetry should be used. A registered nurse or other appropriately trained personnel should be present, and his/her primary responsibility should be to monitor the patient. A record should be kept of medication doses and times of administration. See the NGC summary ACR–SIR Practice Guideline for Sedation/Analgesia.
    1. Postprocedure care
      1. All patients should be at bed rest and observed in the initial postprocedure period. The length of this period of bed rest will depend on the site and size of the venotomy and the patient's medical condition.
      2. During the initial postprocedure period, skilled nurses or other appropriately trained personnel should periodically monitor the puncture site.
      3. Initial ambulation of the patient must be carefully supervised. The puncture site stability and independent patient function and mobility must be assured.
      4. The operating physician or a qualified designee should evaluate the patient after the procedure, and these findings should be summarized in a progress note. If moderate sedation was administered prior to and during the procedure, complete recovery from sedation must be documented. The physician or designee should be available for continuing care during hospitalization and after discharge. The designee may be another physician or a nurse. See the NGC summary ACR–SIR Practice Guideline for Sedation/Analgesia.
  1. Selection Criteria for Short-Term Observation

    The duration of postprocedure observation must be individualized. IVC filter placement can be performed on some patients with a short period of postprocedure observation (less than 6 hours) prior to discharge to home; others require overnight care. Short-term observation should only be considered when all the following conditions can be met:

    1. Those patients capable of independent ambulation prior to the procedure demonstrate stable independent ambulation after the procedure. Nonambulatory patients have adequate assistance after discharge to provide care as needed.
    2. The patient is capable of following instructions and detecting changes in symptomatology. Alternatively, patients with impaired mental or neurologic status should have adequate assistance after discharge to provide care as needed.
    3. The patient is provided with instructions on how to recognize potential complications and how to obtain medical assistance in the event of such complication. A responsible adult is also provided with information regarding recognition of potential complications and is available to transport the patient and be in attendance during the initial night after discharge.
    4. The patient is free of concurrent serious medical illness that might contribute to a significantly increased risk of complication.
    5. The patient has recovered from the effects of the sedation.
  1. Relative Contraindications to Short-Term Observation

    Several factors must be considered when determining the length of postprocedure skilled nursing care. Some of the relative contraindications to short-term observation are listed below.

    1. Patients with significant risk of contrast media-associated nephrotoxicity that might be prevented by hospitalization and intravenous hydration
    2. Patients with coagulopathies or electrolyte abnormalities that require correction should be hospitalized until stable.
    3. Insulin-dependent diabetics who have labile serum glucose levels in the periprocedural period should be hospitalized until stable.
    4. Complications occurring during or after IVC filter placement, including large hematoma, anuria, and persistent nausea and vomiting should prompt observation until symptoms resolve.
    5. Patients who exhibit hemodynamic instability or significant dysrhythmia during or after the procedure should be hospitalized until stable.
    6. Patients who live alone
    7. Patients with concurrent serious medical illness that might contribute to a significantly increased risk of complication should be hospitalized until stable.
    8. Patients with impaired mental or neurologic status who do not have adequate assistance to provide care as needed should be hospitalized until appropriate assistance is available or no longer required.

    The decision for short-term or longer-term postprocedure observation must be individualized, and a patient's care may vary from the above criteria for sound clinical reasons. The decision in each case must be made by the physician who performed the procedure and the referring physician after review of all pertinent data.

Documentation

Reporting should be in accordance with the "ACR–SIR Practice Guideline for the Reporting and Archiving of Interventional Radiology Procedures."

Radiation Safety in Imaging

Radiologists, medical physicists, radiologic technologists, and all supervising physicians have a responsibility to minimize radiation dose to individual patients, to staff, and to society as a whole, while maintaining the necessary diagnostic image quality. This concept is known as "as low as reasonably achievable (ALARA)."

Facilities, in consultation with the medical physicist, should have in place and should adhere to policies and procedures, in accordance with ALARA, to vary examination protocols to take into account patient body habitus, such as height and/or weight, body mass index or lateral width. The dose reduction devices should be available; if not, imaging equipment should be active or manual techniques should be used to moderate the exposure while maintaining the necessary diagnostic image quality. Periodically, radiation exposures should be measured and patient radiation doses estimated by a medical physicist in accordance with the appropriate ACR Technical Standard. (ACR Resolution 17, adopted in 2006 – revised in 2009, Resolution 11)

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

Appropriate use of inferior vena cava (IVC) filter placement to prevent pulmonary embolism

Potential Harms
  • Inferior vena cava (IVC) filter placement is associated with the following complications:
    • Recurrent pulmonary embolism (PE)
    • Filter embolization
    • Deployment outside target area
    • Access site thrombus
    • IVC thrombotic occlusion
    • IVC penetration
    • Filter movement
    • Filter fracture
    • Insertion problems
    • Death
    • Other complications (large hematoma, anuria, persistent nausea and vomiting)
  • The safety and efficacy of vena cava filters in children have not been firmly established and their long-term effect is unclear.
  • Angiography exposes patients to radiation.
  • Contrast medium is associated with nephrotoxicity.

Contraindications

Contraindications
  • Relative contraindications to inferior vena cava (IVC) filter placement include uncorrectable severe coagulopathy and bacteremia or untreated infection. Clinical judgment should be applied in these situations, weighing the theoretical risk of implant infection versus the risk of pulmonary embolism.
  • Relative contraindications to short-term observation include:
    • Patients with significant risk of contrast media-associated nephrotoxicity
    • Patients with coagulopathies or electrolyte abnormalities that require correction
    • Insulin-dependent diabetics who have labile serum glucose levels in the periprocedural period
    • Complications occurring during or after IVC filter placement, including large hematoma, anuria, and persistent nausea and vomiting
    • Patients who exhibit hemodynamic instability or significant dysrhythmia during or after the procedure
    • Patients who live alone
    • Patients with concurrent serious medical illness that might contribute to a significantly increased risk of complication
    • Patients with impaired mental or neurologic status who do not have adequate assistance to provide care as needed

Qualifying Statements

Qualifying Statements
  • These guidelines are an educational tool designed to assist practitioners in providing appropriate radiologic care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care. For these reasons and those set forth below, the American College of Radiology cautions against the use of these guidelines in litigation in which the clinical decisions of a practitioner are called into question.
  • The ultimate judgment regarding the propriety of any specific procedure or course of action must be made by the physician or medical physicist in light of all the circumstances presented. Thus, an approach that differs from the guidelines, standing alone, does not necessarily imply that the approach was below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the guidelines when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology subsequent to publication of the guidelines. However, a practitioner who employs an approach substantially different from these guidelines is advised to document in the patient record information sufficient to explain the approach taken.
  • The practice of medicine involves not only the science, but also the art of dealing with the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment. Therefore, it should be recognized that adherence to these guidelines will not assure an accurate diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient to deliver effective and safe medical care. The sole purpose of these guidelines is to assist practitioners in achieving this objective.

Implementation of the Guideline

Description of Implementation Strategy

Quality Control and Improvement, Safety, Infection Control, and Patient Education

Policies and procedures related to quality, patient education, infection control and safety should be developed and implemented in accordance with the ACR Policy on Quality Control and Improvement, Safety, Infection Control, and Patient Education appearing under the heading Position Statement on QC & Improvement, Safety, Infection Control, and Patient Education on the ACR Web site External Web Site Policy.

These data should be utilized in conjunction with the thresholds described in "Quality Improvement" section in the original guideline document to assess filter placement procedural efficacy and complication rates, and to trigger institutional review when these thresholds are exceeded.

Implementation Tools
Audit Criteria/Indicators
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
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
American College of Radiology (ACR), Society of Interventional Radiology (SIR). ACR-SIR practice guideline for the performance of inferior vena cava (IVC) filter placement for the prevention of pulmonary embolism. [online publication]. Reston (VA): American College of Radiology (ACR); 2010. 13 p. [68 references]
Adaptation

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

Date Released
2000 (revised 2010)
Guideline Developer(s)
American College of Radiology - Medical Specialty Society
Society of Interventional Radiology - Medical Specialty Society
Source(s) of Funding

American College of Radiology

Guideline Committee

Guidelines and Standards Committee of the Commission on Interventional and Cardiovascular Radiology, in collaboration with the Society of Interventional Radiology (SIR)

Composition of Group That Authored the Guideline

Collaborative Committee

American College of Radiology (ACR): Drew M. Caplin, MD (Chair); Christine P. Chao, MD; Donald L. Miller, MD, FACR; Timothy L. Swan, MD

Society of Interventional Radiology (SIR): Horacio R. D'Agostino, MD; Clement J. Grassi, MD; Sanjeeva P. Kalva, MD; Darryl A. Zuckerman, MD

ACR Interventional Guidelines and Standards Committee: Donald L. Miller, MD, FACR (Chair); Stephen Balter, PhD, FACR; Drew M. Caplin, MD; Christine P. Chao, MD; John D. Grizzard, MD; John W. Ho, MD; Sanjoy Kundu, MD; Walter S. Lesley, MD, FACR; Philip M. Meyers, MD; Harjit Singh, MD; Timothy L. Swan, MD; Aradhana Venkatesan, MD; Anne C. Roberts, FACR (Chair, Commission)

Comments Reconciliation Committee: Philip S. Cook, MD, FACR (Co-Chair); Richard Duszak Jr., MD, FACR (Co-Chair); Kimberly E. Applegate, MD, MS, FACR; Drew M. Caplin, MD; Christine P. Chao, MD; Horacio R. D'Agostino, MD; Howard B. Fleishon, MD, MMM, FACR; Clement J. Grassi, MD; Sanjeeva P. Kalva, MD; John A. Kaufman, MD; Alan D. Kaye, MD, FACR; Paul A. Larson, MD, FACR; Lawrence A. Liebscher, MD, FACR; Donald L. Miller, MD, FACR; Anne C. Roberts, MD, FACR; Timothy L. Swan, MD; E. Kent Yucel, MD, FACR; Darryl A. Zuckerman, MD

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.

Print copies: Available from the American College of Radiology, 1891 Preston White Drive, Reston, VA 20191. Telephone: (703) 648-8900.

Availability of Companion Documents

The following are available:

  • The process of developing ACR practice guidelines and technical standards. Reston (VA): American College of Radiology. Electronic copies: Available from the American College of Radiology (ACR) Web site External Web Site Policy.
  • Purpose and intended use. Reston (VA): American College of Radiology. Electronic copies: Available from the ACR Web site External Web Site Policy.

In addition, indicator thresholds are available in the original guideline document.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on December 8, 2011.

Copyright Statement

Copyright © by the American College of Radiology, 1891 Preston White Dr., Reston, VA 20191-4397, 703-648-8900. All rights reserved. No reproduction of this material in any format, electronic or otherwise, is permitted except with prior written consent from the American College of Radiology.

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