Exhibit D

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PRACTICE PARAMETER Inferior Vena Cava Filter / 1 

 

 

The American College of Radiology, with more than 30,000 members, is the principal organization of radiologists, radiation oncologists, and clinical 

medical physicists in the United States. The College is a nonprofit professional society whose primary purposes are to advance the science of radiology, 

improve radiologic services to the patient, study the socioeconomic aspects of the practice of radiology, and encourage continuing education for 

radiologists, radiation oncologists, medical physicists, and persons practicing in allied professional fields. 

The American College of Radiology will periodically define new practice parameters and technical standards for radiologic practice to help advance the 

science of radiology and to improve the quality of service to patients throughout the United States. Existing practice parameters and technical standards 

will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner, if indicated. 

Each practice parameter and technical standard, representing a policy statement by the College, has undergone a thorough consensus process in which it has 

been subjected to extensive review and approval. The practice parameters and technical standards recognize that the safe and effective use of diagnostic 

and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published 

practice parameter and technical standard by those entities not providing these services is not authorized. 

Revised 2016 (Resolution 18)* 

 

ACR–SIR–SPR PRACTICE PARAMETER FOR THE PERFORMANCE OF 

INFERIOR VENA CAVA (IVC) FILTER PLACEMENT FOR THE 

PREVENTION OF PULMONARY EMBOLISM

PREAMBLE 

This document is an educational tool designed to assist practitioners in providing appropriate radiologic care for 

patients. Practice Parameters and Technical Standards are not inflexible rules or requirements of practice and are 

not intended, nor should they be used, to establish a legal standard of care1. For these reasons and those set forth 

below, the American College of Radiology and our collaborating medical specialty societies caution against the 

use of these documents 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 

practitioner in light of all the circumstances presented. Thus, an approach that differs from the guidance in this 

document, 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 this 

document 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 this document. However, a practitioner who employs an approach substantially different from the 

guidance in this document 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 the guidance in this document will not assure an accurate 

diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable 

 

1 Iowa Medical Society and Iowa Society of Anesthesiologists v. Iowa Board of Nursing, ___ N.W.2d ___ (Iowa 2013) Iowa Supreme Court refuses to find 

that the ACR Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (Revised 2008) sets a national standard for who may 

perform fluoroscopic procedures in light of the standard’s stated purpose that ACR standards are educational tools and not intended to establish a legal 

standard of care. See also, Stanley v. McCarver, 63 P.3d 1076 (Ariz. App. 2003) where in a concurring opinion the Court stated that “published standards or 

guidelines of specialty medical organizations are useful in determining the duty owed or the standard of care applicable in a given situation” even though 

ACR standards themselves do not establish the standard of care. 

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2 / Inferior Vena Cava Filter PRACTICE PARAMETER 

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 this document is to assist practitioners in achieving this objective. 

I. INTRODUCTION 

This practice parameter was revised collaboratively by the American College of Radiology (ACR), the Society of 

Interventional Radiology (SIR), and the Society for Pediatric Radiology (SPR). 

Pulmonary embolism (PE) continues to be a major cause of morbidity and mortality in the United States. 

Estimates of the incidence of nonfatal PE range from 400,000 to 630,000 cases per year, and 50,000 to 200,000 

fatalities per year are directly attributable to PE [1-8]. 

Many devices have been developed for endoluminal caval interruption. Currently, several devices designed for 

permanent placement are commercially available in the United States. In addition to permanent inferior vena cava 

(IVC) filters, retrievable and convertible IVC filters are also available. The retrievable filters can be left in place 

as a permanent implant but also can be removed when the indication for filter placement resolves. (For detailed 

information regarding each of these filters, the reader is referred to several reviews [9-27].) Device selection is 

dependent on many factors, including, but not limited to, clinical indication, anatomy of the iliocaval veins and 

available venous access sites, device-specific outcomes data, magnetic resonance imaging (MRI) compatibility, 

ease of placement, and experience of the operator. 

The IVC should be assessed with imaging prior to placement of a filter. The current preferred method is by vena 

cavography. Intravascular ultrasound (IVUS) has been utilized as an adjunct or primary tool for IVC assessment 

in certain situations. However, the use of IVUS is beyond the scope of this document [28-30]. The length and 

diameter of the IVC should be assessed, the location and number of renal veins determined, IVC anomalies 

defined (eg, duplication), and intrinsic IVC disease such as pre-existing thrombus or extrinsic compression should 

be assessed. If available, prior imaging studies (such as contrast-enhanced computed tomography [CT] or MRI of 

the abdomen and pelvis) should be reviewed to evaluate the anatomy of the IVC (size, patency, and anatomical 

variants) and to determine intrinsic IVC disease and extrinsic compression. The recommended location for filter 

placement for preventing PE from a lower extremity or pelvic venous source thromboembolism is the infrarenal 

IVC. It is a generally accepted belief that 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, such as the suprarenal IVC, iliac veins, or both sides of a duplicated 

IVC, may be appropriate. 

Although retrievable filters are often placed as permanent devices, the long-term safety and efficacy of these 

devices as a class have not been established. However, all retrievable convertible filters are approved for 

permanent placement. When a retrievable filter is placed, the patient should be clinically reassessed periodically 

to weigh the benefits of continued filtration (need for PE prophylaxis) against the associated risks (eg, recurrent 

deep venous thrombosis [DVT], IVC thrombosis, symptomatic penetration, or mechanical failure) and 

uncertainties (given limited data on long-term mechanical stability and integrity of some devices). The current 

recommendation is to consider removal of the IVC filter as soon as mechanical protection against PE is no longer 

needed [31]. Filters placed with the intent of subsequent retrieval may be left in place permanently for any of 

several reasons (eg, continuing need for filtration, thrombus on the filter, or inability to retrieve the filter). Data 

for the feasibility of filter retrieval vary widely among devices and centers. 

These practice parameters are intended to be used in quality improvement programs to assess percutaneous 

interruption of the IVC to prevent PE. 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. 

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II. DEFINITIONS [32,33] 

For the purpose of this practice parameter, the following definitions apply: 

Permanent placement – deployment in those situations where lifelong mechanical protection against 

thromboembolic episodes is needed 

Temporary placement – deployment in those situations where time-limited mechanical protection against 

thromboembolic episodes is needed 

Procedural success – deployment of a filter in the intended location (target zone) such that the filter is judged 

suitable for mechanical protection against PE 

Postfilter recurrent PE – PE occurring after filter placement and documented by pulmonary arteriography, crosssectional imaging, significant change in ventilation-perfusion (V/Q) lung scan indicative of recurrent PE, surgical 

embolectomy, or autopsy 

Postfilter thrombotic occlusion of the IVC – presence of an occluding thrombus in the filter and/or the IVC 

occurring after filter insertion and documented by ultrasound, CT, MRI, venography, or autopsy; this may be 

symptomatic or asymptomatic. 

Filter penetration – penetration of the vein wall by a filter strut with transmural incorporation. For quality 

improvement reporting purposes, the definition of IVC penetration by a filter is filter strut or anchor devices 

extending >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 complication (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 >2 cm 

as documented by plain-film imaging, CT, or venography 

Filter fracture – any loss of a filter’s structural integrity (ie, breakage or separation) documented by imaging or 

autopsy 

Insertion complication – malfunctions of the filter or deployment system such as incomplete filter opening, filter 

tilt >15° from the IVC axis, misplacement of filter outside the infrarenal IVC when the operator’s intent is to 

place the filter in the infrarenal IVC (eg, when a portion of the filter is within one iliac vein), deploying the filter 

in the incorrect orientation (eg, upside down in the IVC), 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 

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III. INDICATIONS [32-43] 

Indications include, but are not limited to: 

A. Therapeutic (Documented Thromboembolic Disease) 

1. Patients with evidence of pulmonary embolus or DVT involving the IVC, iliac, or femoral-popliteal veins 

and 1 or more of the following: 

a. A high risk of a complication from anticoagulation [34,38] 

b. An absolute or relative contraindication to anticoagulation 

c. Failure of anticoagulation [34] 

i. Recurrent symptomatic PE despite adequate anticoagulant therapy 

ii. Inability to achieve/maintain adequate anticoagulation 

iii. Propagation/progression of DVT on therapeutic anticoagulation 

2. Perioperative patients with a history of prior venous thromboembolism (VTE) for whom anticoagulation 

must be interrupted [34] 

3. Massive PE postsurgical or endovascular thrombolysis/thrombectomy with residual deep venous 

thrombus [44] 

4. Severe cardiopulmonary disease and DVT (eg, cor pulmonale with pulmonary hypertension) [44] 

B. Prophylactic (No Current Thromboembolic Disease) 

Because the risk-benefit ratio for use of IVC filters for primary PE prophylaxis in patients without a documented 

DVT has not been clearly characterized, physicians who place them for this indication are strongly encouraged to 

monitor the actual outcomes achieved and adjust patient selection practices accordingly. All filters placed for 

primary PE prophylaxis should be of retrievable type, with a defined follow-up plan to subsequently retrieve them 

unless clinically contraindicated for retrieval [38]. 

1. Patients at high risk of DVT/PE but cannot receive prophylactic anticoagulation due to underlying risk of 

bleeding. The risk of bleeding may be related to underlying clinical disease (cirrhosis, active 

gastrointestinal ulcer, systemic coagulopathy, etc). Such conditions include, but not limited to: 

a. Severe craniospinal injury resulting in prolonged immobilization or plegic limbs [40] 

b. Pelvic/long-bone fractures [40] 

c. Intra-abdominal mass/hemorrhage compressing pelvic veins or the IVC [40] 

C. Suprarenal Filter Placement [42] 

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 

3. Thrombus extending above a previously placed infrarenal filter 

4. Gonadal vein thrombosis 

5. Anatomic variants: duplication of the IVC, short length of infrarenal IVC 

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 

 

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D. Filters Placed for Temporary Use and Possible Future Retrieval 

The indications for filter placement remain the same as described above, except that the mechanical protection for 

PE is required for short term due to transient inability to anticoagulate a patient [38]. 

The use of retrievable filters should also be considered in pediatric and young adult patients since the long-term 

effects and durability of permanent IVC filters are not precisely known. Currently, there are no filters specifically 

designed for use in children. The safety of vena cava filters in children is unknown [45,46]. 

The threshold for these indications is 95%. When <95% of procedures are performed for these indications, the 

process of patient selection should be reviewed according to institutional policy. 

IV. RELATIVE CONTRAINDICATIONS 

A. Uncorrectable Severe Coagulopathy 

B. Bacteremia or Untreated Infection 

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

the risk of PE. 

V. QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL 

A. 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 (ABR), the 

American Osteopathic Board of Radiology, the Royal College of Physicians and Surgeons of Canada, or 

the Collège des Médecins du Québec and has performed (with supervision) a sufficient number of IVC 

filter procedures to demonstrate competency as attested by the supervising physician(s). 

 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) and has performed (with 

supervision) a sufficient number of IVC filter procedures to demonstrate competency as attested by the 

supervising physician(s). 

 or 

3. Physicians whose residency or fellowship training did not include the above may still be considered 

qualified to perform IVC filter procedures provided that the following can be demonstrated: 

 The physician must have at least 2 years of endovascular procedural experience, during which the 

physician was supervised and during which the physician performed at least 25 percutaneous vascular 

procedures, including a minimum of 5 IVC filter placement procedures with outcomes within the quality 

improvement thresholds of this 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: 

a. Indications and contraindications for the procedure 

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b. Periprocedural and intraprocedural assessment, monitoring, and management of the patient and 

potential complications 

c. Where applicable, pharmacology of moderate-sedation medications and recognition and treatment of 

adverse reactions and complications 

d. Appropriate use and operation of fluoroscopic and radiographic equipment, mechanical injectors, 

digital image capture devices, and electronic imaging systems

e. Where applicable, principles of radiation protection, hazards of radiation, and radiation monitoring 

requirements as they apply to both patients and personnel 

f. Where applicable, pharmacology of contrast agents and recognition and treatment of potential adverse 

reactions 

g. Percutaneous needle and catheter introduction techniques 

h. Technical aspects of performing the procedure, including the use of alternative catheter and guidewire 

systems, contrast materials, and filming sequences 

i. Anatomy, physiology, and pathophysiology of peripheral and central venous vasculature 

j. Postprocedure patient management, especially recognition and initial management of complications 

k. Postprocedure management of puncture sites 

l. 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 section X). 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 ACR Practice Parameter for Continuing 

Medical Education (CME) [47]. 

B. Qualified Medical Physicist 

For qualifications of the Qualified Medical Physicist, see the ACR–AAPM Technical Standard for Diagnostic 

Medical Physics Performance Monitoring of Fluoroscopic Equipment and the ACR–AAPM Technical Standard 

for Diagnostic Medical Physics Performance Monitoring of Radiographic Equipment. 

C. 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) 

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D. 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 position2 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 policy3 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. 

E. 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. 

VI. 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. 

A. 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. At a minimum, the 

facility should include the following: 

1. A high-resolution image receptor, preferably with a 28-cm 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 1024-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 vena cavagram and IVC placement because these methods 

 

2The 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 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. 

3See the ACR–SPR Practice Parameter for the Use of Intravascular Contrast Media. 

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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 (Patient Care), and there should be immediate access to emergency 

resuscitation equipment. 

B. 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 ACR–SIR Practice Parameter for Sedation/Analgesia [48]). 

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. 

C. 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 

or 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 or 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 ACR–SIR Practice Parameter for Sedation/Analgesia [48]). 

D. 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 

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familiar with the management of patients with complications in the unlikely event of a life-threatening 

complication. 

E. Patient Care 

For additional information see the ACR–SIR–SNIS–SPR Practice Parameter for Interventional Clinical Practice 

and Management [49]. 

1. Preprocedure care 

 For elective filter placement, the following should be documented: 

a. Clinically significant history, including indications for the procedure 

b. Clinically significant physical or diagnostic examination findings, including clinical or medical 

conditions that may necessitate specific care, such as preprocedure antibiotics and other measures 

c. Clinically indicated laboratory evaluation including, but not limited to, coagulation factors, creatinine, 

white blood cell count, and previously obtained cultures 

d. Preprocedure documentation should conform to the requirements of the ACR–SIR–SPR Practice 

Parameter for the Reporting and Archiving of Interventional Radiology Procedures [50] 

Informed consent must be in compliance with all state laws and the ACR–SIR Practice Parameter on 

Informed Consent for Image-Guided Procedures [51]. 

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. 

2. Procedural care 

a. Adherence to the Joint Commission’s Universal Protocol for Preventing Wrong Site, Wrong 

Procedure, Wrong Person SurgeryTM is required for procedures in nonoperating room settings, 

including bedside procedures. The organization should have processes and systems in place for 

reconciling differences in staff responses during the “time-out.” 

b. All patients should have cardiac monitoring continuously during the procedure, with intermittent 

blood pressure monitoring. A record of vital signs should be maintained. 

c. All patients should have intravenous access for the administration of fluids and medications as 

needed. 

d. 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 ACR–SIR Practice Parameter for Sedation/Analgesia [48]. 

3. Postprocedure care 

a. 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. 

b. During the initial postprocedure period, skilled nurses or other appropriately trained personnel should 

periodically monitor the puncture site. 

c. Initial ambulation of the patient must be carefully supervised. The puncture site stability and 

independent patient function and mobility must be assured. 

d. 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 ACR–SIR Practice Parameter for 

Sedation/Analgesia [48]. 

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10 / Inferior Vena Cava Filter PRACTICE PARAMETER 

e. Patients in whom a retrievable IVC filter is implanted should undergo clinical reassessment for the 

appropriateness and timing of filter removal during the first 3 to 6 months after placement (depending 

on the device-specific time window for retrieval). The operating physician should participate in this 

clinical assessment. 

F. 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 (<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 complications. 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. 

G. 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 

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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. 

VII. DOCUMENTATION 

Reporting should be in accordance with the ACR–SIR–SPR Practice Parameter for the Reporting and Archiving 

of Interventional Radiology Procedures [50]. 

VIII. RADIATION SAFETY IN IMAGING 

Radiologists, medical physicists, registered radiologist assistants, radiologic technologists, and all supervising 

physicians have a responsibility for safety in the workplace by keeping radiation exposure to staff, and to society 

as a whole, “as low as reasonably achievable” (ALARA) and to assure that radiation doses to individual patients 

are appropriate, taking into account the possible risk from radiation exposure and the diagnostic image quality 

necessary to achieve the clinical objective. All personnel that work with ionizing radiation must understand the 

key principles of occupational and public radiation protection (justification, optimization of protection and 

application of dose limits) and the principles of proper management of radiation dose to patients (justification, 

optimization and the use of dose reference levels) 

http://www-pub.iaea.org/MTCD/Publications/PDF/Pub1578_web-57265295.pdf. 

Nationally developed guidelines, such as the ACR Appropriateness Criteria®, should be used to help choose the 

most appropriate imaging procedures to prevent unwarranted radiation exposure. 

Facilities should have and adhere to policies and procedures that require varying ionizing radiation examination 

protocols (plain radiography, fluoroscopy, interventional radiology, CT) to take into account patient body habitus 

(such as patient dimensions, weight, or body mass index) to optimize the relationship between minimal radiation 

dose and adequate image quality. Automated dose reduction technologies available on imaging equipment should 

be used whenever appropriate. If such technology is not available, appropriate manual techniques should be used. 

Additional information regarding patient radiation safety in imaging is available at the Image Gently® for children 

(www.imagegently.org) and Image Wisely® for adults (www.imagewisely.org) websites. These advocacy and 

awareness campaigns provide free educational materials for all stakeholders involved in imaging (patients, 

technologists, referring providers, medical physicists, and radiologists). 

Radiation exposures or other dose indices should be measured and patient radiation dose estimated for 

representative examinations and types of patients by a Qualified Medical Physicist in accordance with the 

applicable ACR technical standards. Regular auditing of patient dose indices should be performed by comparing 

the facility’s dose information with national benchmarks, such as the ACR Dose Index Registry, the NCRP 

Report No. 172, Reference Levels and Achievable Doses in Medical and Dental Imaging: Recommendations for 

the United States or the Conference of Radiation Control Program Director’s National Evaluation of X-ray 

Trends. (ACR Resolution 17, adopted in 2006 – revised in 2009, 2013, Resolution 52). 

Case 2:15-md-02641-DGC Document 8223-4 Filed 10/18/17 Page 12 of 20
12 / Inferior Vena Cava Filter PRACTICE PARAMETER 

IX. 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 website (http://www.acr.org/guidelines). 

These data should be utilized in conjunction with the thresholds described in section X below to assess filter 

placement procedural efficacy and complication rates and to trigger institutional review when these thresholds are 

exceeded. 

X. QUALITY IMPROVEMENT 

A. Success Rates and Thresholds 

Although practicing physicians should strive to achieve perfect outcomes (eg, 100% success, 0% complications), 

in practice all physicians will fall short of this ideal to a variable extent. Thus, indicator thresholds may be used to 

assess the efficacy of ongoing improvement programs. 

For the purpose of these practice parameters, a threshold is a specific level of an indicator that should prompt a 

review. Individual complications may also be associated with complication-specific thresholds. When measures 

such as indications or success rates fall below a minimum threshold or when complication rates exceed a 

maximum threshold, a review should be performed to determine causes and to implement changes, if necessary. 

Thresholds may vary from those listed here; for example, patient referral patterns and selection factors may 

dictate a different threshold value for a particular indicator at a particular institution. Thus, setting universal 

thresholds is very difficult, and each department is urged to alter the thresholds as needed to higher or lower 

values to meet its own quality improvement program needs. 

Complications can be stratified on the basis of outcome. Major complications result in admission to a hospital for 

therapy (for outpatient procedures), an unplanned increase in the level of care, prolonged hospitalization, 

permanent adverse sequelae, or death. Minor complications result in no sequelae; they may require nominal 

therapy or a short hospital stay for observation (generally overnight) (see Appendix A). The complication rates 

and thresholds below refer to major complications. 

It is expected that the technical success for percutaneously placed IVC filters will be 97% or better in experienced 

hands. Therefore, the proposed threshold for review of technical failures should be 3%. 

B. Complication Rates and Thresholds 

1. Complications 

 Each currently available filter has been extensively studied as part of the FDA approval process. Few 

comparative studies have been completed evaluating all filters in one project, and those that have done so 

have been retrospective analyses. Complication rates are highly variable depending on the filter being 

studied. For simplicity, these practice parameters do not suggest threshold rates for each individual filter; 

rather, filtration devices are considered as a group. 

 

Case 2:15-md-02641-DGC Document 8223-4 Filed 10/18/17 Page 13 of 20
PRACTICE PARAMETER Inferior Vena Cava Filter / 13 

 

 

TABLE 1 

Complications 

Reported 

Rates (%) 

Threshold 

(%) 

Death [52] 0.12  1 

Filter embolization [9,32,45,46,53-65] 0.1 1 

Deployment outside target area [34,66,67] 1-9 <1% 

Access site thrombosis occlusive [68,69] 3-10 3 

Published rates for individual types of complications are highly dependent on patient selection and are in 

some cases based on series comprising several hundred patients, which is a volume larger than most 

individual practitioners are likely to treat. It is also recognized that a single complication can cause a rate 

to cross above a complication-specific threshold when the complication occurs within a small patient 

volume (eg, early in a quality improvement program). 

2. Other trackable events 

 Because an IVC filter may be implanted as a permanent device (if not retrieved) and can be used in 

relatively young patients, several other trackable parameters are appropriate to record in a quality 

improvement program. The following events may or may not be clinically significant in a particular 

patient. For this reason, thresholds for these events are not included in this document. 

TABLE II 

Other Trackable Events Reported Rates (%) 

IVC penetration* [7,10,12,13,15,16,21,32-

39,42,51,52,58,59,61,63,65,67-76] 

0-100 

Migration of filter/filter components* 

[10,11,13,16,18,19,21,24,31,32,34,36,40-

43,45,52,55,56,63,65,67,70-85] 

0-25 

Filter fracture [9-17,21,32,34,37,39,51,53,54,58,60-

62,66,71-74,76,78,80,81,83-86] 

0-50 

Recurrent PE [32,71,72,78,82] 0.5-6 

Access site thrombus – all types [52,68,83,84,86] 0-25 

IVC occlusion [12,14,15,20,26,27,30,32,34,36,41,43-

46,51,56-58,61,69-77,79,82,85,87,88] 

2-65 

Insertion problems [32,52,61,71,72,78,79,82,84,87,88] 5-23 

Other complications [2,75] 1-15 

The data in the table represents reported outcomes from various publications and not the SIR standard for 

complications. 

* The rate of clinically significant penetration is not precisely known [85]. 

ACKNOWLEDGEMENTS 

This practice parameter was revised according to the process described under the heading The Process for 

Developing ACR Practice Parameters and Technical Standards on the ACR website 

(http://www.acr.org/guidelines) by the Committee on Practice Parameters – Interventional and Cardiovascular 

Radiology of the ACR Commission on Interventional and Cardiovascular Radiology and the Committee on 

Case 2:15-md-02641-DGC Document 8223-4 Filed 10/18/17 Page 14 of 20
14 / Inferior Vena Cava Filter PRACTICE PARAMETER 

Practice Parameters – Pediatric Radiology of the ACR Commission on Pediatric Radiology, in collaboration with 

the SIR and the SPR. 

Collaborative Committee – members represent their societies in the initial and final revision of this practice 

parameter 

ACR SIR SPR 

Drew M. Caplin, MD, Chair Jon C. Davidson, MD Anne M. Cahill, MD, MB BCh 

Timothy L. Swan, MD, FACR, FSIR Suvranu Ganguli, MD Kamlesh U. Kukreja, MD 

Darryl A. Zuckerman, MD, FACR, FSIR Sanjeeva P. Kalva, MD, FSIR Manish N. Patel, DO, FACR 

Committee on Practice Parameters – Interventional and Cardiovascular Radiology 

(ACR Committee responsible for sponsoring the draft through the process) 

Aradhana M. Venkatesan, MD, FSIR, Chair 

Clayton K.Trimmer, DO, FACR, Vice-Chair 

Drew M. Caplin, MD 

Sean R. Dariushnia, MD 

Jeremy L. Friese, MD, MBA 

Joshua A. Hirsch, MD, FACR, FSIR 

Elizabeth A. Ignacio, MD 

Sanjeeva P. Kalva, MD, FSIR 

Minhajuddin S. Khaja, MD, MBA 

Margaret Hsin-Shung Lee, MD 

Susan K. O’Horo, MD, FSIR 

Stephen P. Reis, MD 

Wael Saad, MD, FSIR 

Beth A. Schueler, PhD, FACR, FAAPM 

Timothy L. Swan, MD, FACR, FSIR 

Sanjit Tewari, MD 

Joan C. Wojak, MD, FACR, FSIR 

Committee on Practice Parameters – Pediatric Radiology 

(ACR Committee responsible for sponsoring the draft through the process) 

Beverley Newman, MB, BCh, BSc, FACR, Chair

Lorna P. Browne, MB, BCh 

Timothy J. Carmody, MD 

Brian D. Coley, MD, FACR

Lee K. Collins, MD 

Monica S. Epelman, MD 

Lynn Ansley Fordham, MD, FACR 

Kerri A. Highmore, MD 

Sue C. Kaste, DO 

Tal Laor, MD 

Terry L. Levin, MD 

Marguerite T. Parisi, MD, MS 

Sumit Pruthi, MBBS 

Nancy K. Rollins, MD 

Pallavi Sagar, MD 

Philip S. Cook, MD, FACR, FSIR, Chair, Commission on Interventional and Cardiovascular Radiology 

Marta Hernanz-Schulman, MD, FACR, Chair, Commission on Pediatric Radiology 

Case 2:15-md-02641-DGC Document 8223-4 Filed 10/18/17 Page 15 of 20
PRACTICE PARAMETER Inferior Vena Cava Filter / 15 

 

 

Jacqueline A. Bello, MD, FACR, Chair, Commission on Quality and Safety 

Matthew S. Pollack, MD, FACR, Chair, Committee on Practice Parameters and Technical Standards 

Comments Reconciliation Committee 

Ezequiel Silva III, MD, FACR, Chair 

Johnson B. Lightfoote, MD, FACR, Co-Chair 

Jacqueline A. Bello, MD, FACR 

Anne M. Cahill, MD, MB, BCh 

Drew M. Caplin, MD 

Philip S. Cook, MD, FACR, FSIR 

Jon C. Davidson, MD 

Suvranu Ganguli, MD 

Marta Hernanz-Schulman, MD, FACR 

William T. Herrington, MD, FACR 

Sanjeeva P. Kalva, MD, FSIR 

Kamlesh U. Kukreja, MD 

Beverley Newman, MB, BCh, BSc, FACR 

Manish N. Patel, DO 

Matthew S. Pollack, MD, FACR 

Timothy L. Swan, MD, FACR, FSIR 

Clayton K. Trimmer, DO, FACR 

Aradhana M. Venkatesan, MD, FSIR 

Darryl A. Zuckerman, MD, FACR, FSIR 

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deep venous thrombosis. J Vascu Interv Radiol. 2013;24:S87. 

87. Moore BS, Valji K, Roberts AC, Bookstein JJ. Transcatheter manipulation of asymmetrically opened titanium 

Greenfield filters. J Vasc Interv Radiol. 1993;4(5):687-690. 

88. Sweeney TJ, Van Aman ME. Deployment problems with the titanium Greenfield filter. J Vasc Interv Radiol. 

1993;4(5):691-694. 

 

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PRACTICE PARAMETER Inferior Vena Cava Filter / 19 

 

 

APPENDIX A 

Society of Interventional Radiology 

Standards of Practice Committee 

Classification of Complications by Outcome 

Minor Complications 

A. No therapy, no consequence 

B. Nominal therapy, no consequence; includes overnight admission for observation only 

Major Complications 

C. Require therapy, minor hospitalization (<48 hours) 

D. Require major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours) 

E. Permanent adverse sequelae 

F. Death 

*Practice parameters and technical standards are published annually with an effective date of October 1 in the 

year in which amended, revised, or approved by the ACR Council. For practice parameters and technical 

standards published before 1999, the effective date was January 1 following the year in which the practice 

parameter or technical standard was amended, revised, or approved by the ACR Council. 

Development Chronology for This Practice Parameter 

2000 (Resolution 12) 

Amended 2004 (Resolution 25) 

Revised 2005 (Resolution 40) 

Amended 2006 (Resolution 16g, 17, 34, 35, 36) 

Amended 2007 (Resolution 12m, 38) 

Revised 2010 (Resolution 46) 

Amended 2014 (Resolution 39) 

Revised 2016 (Resolution 18) 

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