Quality Improvement Guidelines for the Performance of Inferior Vena Cava Filter Placement for the Prevention of Pulmonary Embolism

Abstract

The membership of the Society of Interventional Radiology (SIR) Standards of Practice Committee represents experts in a broad spectrum of interventional procedures from both the private and academic sectors of medicine. Generally Standards of Practice Committee members dedicate the vast majority of their professional time to performing interventional procedures; as such they represent a valid broad expert constituency of the subject matter under consideration for standards production. Technical documents specifying the exact consensus and literature review methodologies as well as the institutional affiliations and professional credentials of the authors of this document are available upon request from SIR, 3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA 22033. SIR produces its Standards of Practice documents using the following process. Standards documents of relevance and timeliness are conceptualized by the Standards of Practice Committee members. A recognized expert is identified to serve as the principal author for the standard. Additional authors may be assigned dependent upon the magnitude of the project. An in-depth literature search is performed by using electronic medical literature databases. Then, a critical review of peer-reviewed articles is performed with regard to the study methodology, results, and conclusions. The qualitative weight of these articles is assembled into an evidence table, which is used to write the document such that it contains evidence-based data with respect to content, rates, and thresholds. When the evidence of literature is weak, conflicting, or contradictory, consensus for the parameter is reached by a minimum of 12 Standards of Practice Committee members by using a Modified Delphi Consensus Method (Appendix A). For purposes of these documents, consensus is defined as 80% Delphi participant agreement on a value or parameter. The draft document is critically reviewed by the Revisions Subcommittee members of the Standards of Practice Committee, either by telephone conference calling or face-to-face meeting. The finalized draft from the Committee is sent to the SIR membership for further input/criticism during a 30-day comment period. These comments are discussed by the Subcommittee, and appropriate revisions made to create the finished standards document. Before its publication, the document is endorsed by the SIR Executive Council. This guideline was revised by the American College of Radiology (ACR) in collaboration with SIR. These guidelines are written to be used in quality improvement programs to assess inferior vena cava (IVC) filter placement procedures. The most important processes of care are (i) patient selection, (ii) performing the procedure, and (iii) monitoring the patient. The outcome measures or indicators for these processes are indications, success rates, and complication rates. Outcome measures are assigned threshold levels. 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 (1Prevention of venous thrombosis and pulmonary embolism NIH Consensus Development.JAMA. 1986; 256: 744-749Crossref PubMed Scopus (176) Google Scholar, 2Clagett G.P. Basic data related to venous thromboembolism.Ann Vasc Surg. 1988; 2: 402-405Abstract Full Text PDF PubMed Scopus (14) Google Scholar, 3Dalen J.E. Alpert J.S. Natural history of pulmonary embolism.Prog Cardiovasc Dis. 1975; 17: 259-270Abstract Full Text PDF PubMed Scopus (948) Google Scholar, 4Goldhaber S.Z. Hennekens C.H. Evans D.A. Newton E.C. Godleski J.J. Factors associated with correct antemortem diagnosis of major pulmonary embolism.Am J Med. 1982; 73: 822-826Abstract Full Text PDF PubMed Scopus (268) Google Scholar). The current preferred treatment for deep vein thrombosis (DVT) and PE is anticoagulation. However, as many as 20% of these patients will have recurrent PE despite adequate anticoagulation (3Dalen J.E. Alpert J.S. Natural history of pulmonary embolism.Prog Cardiovasc Dis. 1975; 17: 259-270Abstract Full Text PDF PubMed Scopus (948) Google Scholar, 5Glenny R.W. Pulmonary embolism: complications of therapy.South Med J. 1987; 80: 1266-1276Crossref PubMed Scopus (9) Google Scholar, 6Silver D. Sabiston Jr, D.C. The role of vena caval interruption in the management of pulmonary embolism.Surgery. 1975; 77: 3-10PubMed Google Scholar). Interruption of the IVC for the prevention of PE was first performed in 1893 by using surgical ligation (7Becker D.M. Philbrick J.T. Selby J.B. Inferior vena cava filters Indications, safety, effectiveness.Arch Intern Med. 1992; 152: 1985-1994Crossref PubMed Scopus (364) Google Scholar). Over the years, surgical interruption took many forms (ligation, plication, clipping, or stapling), but IVC thrombosis was a frequent complication after these procedures. Endovascular approaches to IVC interruption became a reality in 1967 after the introduction of the Mobin-Uddin filter (8Mobin-Uddin K. Smith P.E. Martinez L.O. et al.A vena caval filter for the prevention of pulmonary embolus.Surg Forum. 1967; 18: 209-211Google Scholar). Many devices have since 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 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. (Detailed information regarding each of these filters can be found in several reviews [9Asch M.R. Initial experience in humans with a new retrievable inferior vena cava filter.Radiology. 2002; 225: 835-844Crossref PubMed Scopus (192) Google Scholar, 10Dorfman G.S. Percutaneous inferior vena caval filters.Radiology. 1990; 174: 987-992Crossref PubMed Scopus (118) Google Scholar, 11Given M. Lyon S. Foster A. McGrath F. Lee M. Retrievable Gunther-Tulip filter: Experience in 41 Patients.in: Presented at the 2002 Annual Meeting of the Radiological Society of North AmericaDecember 6, 2002Google Scholar, 12Grassi C.J. Inferior vena caval filters: analysis of five currently available devices.AJR Am J Roentgenol. 1991; 156: 813-821Crossref PubMed Scopus (102) Google Scholar, 13Greenfield L.J. DeLucia III, A. Endovascular therapy of venous thromboembolic disease.Surg Clin North Am. 1992; 72: 969-989PubMed Google Scholar, 14Hoppe H. Nutting C.W. Smouse H.R. et al.Günther Tulip filter retrievability multicenter study including CT follow-up: final report.J Vasc Interv Radiol. 2006; 17: 1017-1023Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar, 15Kinney T.B. Update on inferior vena cava filters.J Vasc Interv Radiol. 2003; 14: 425-440Abstract Full Text Full Text PDF PubMed Scopus (311) Google Scholar, 16Le Blanche A.F. Benazzouz A. Reynaud P. et al.The VenaTech LP permanent caval filter: effectiveness and safety in the prevention of pulmonary embolism--a European multicenter study.J Vasc Interv Radiol. 2008; 19: 509-515Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 17Linsenmaier U. Rieger J. Schenk F. Rock C. Mangel E. Pfeifer K.J. Indications, management, and complications of temporary inferior vena cava filters.Cardiovasc Intervent Radiol. 1998; 21: 464-469Crossref PubMed Scopus (103) Google Scholar, 18Millward S.F. Temporary and retrievable inferior vena cava filters: current status.J Vasc Interv Radiol. 1998; 9: 381-387Abstract Full Text PDF PubMed Scopus (91) Google Scholar, 19Millward S.F. Oliva V.L. Bell S.D. et al.Günther Tulip retrievable vena cava filter: results from the Registry of the Canadian Interventional Radiology Association.J Vasc Interv Radiol. 2001; 12: 1053-1058Abstract Full Text Full Text PDF PubMed Scopus (211) Google Scholar, 20Oliva V.L. Perreault P. Giroux M.F. Bouchard L. Therasse E. Soulez G. Recovery G2 inferior vena cava filter: technical success and safety of retrieval.J Vasc Interv Radiol. 2008; 19: 884-889Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar, 21Savader S.J. Inferior vena cava filters.in: Savader S.J. Trerotola S.O. Venous interventional radiology with clinical perspectives. Thieme, New York1996: 367-399Google Scholar, 22Yamagami T. Kato T. Iida S. Tanaka O. Nishimura T. Retrievable vena cava filter placement during treatment for deep venous thrombosis.Br J Radiol. 2003; 76: 712-718Crossref PubMed Scopus (34) Google Scholar, 23Ziegler J.W. Dietrich G.J. Cohen S.A. Sterling K. Duncan J. Samotowka M. PROOF trial: protection from pulmonary embolism with the OptEase filter.J Vasc Interv Radiol. 2008; 19: 1165-1170Abstract Full Text Full Text PDF PubMed Scopus (35) Google Scholar].) 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 (MR) imaging compatibility of the device, and the ease of placement. Placement of a caval filter can be performed as 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 before placement of a filter, and the current preferred method is by vena cavography. Before 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 (eg, duplication), and intrinsic IVC disease such as preexisting thrombus or extrinsic compression excluded. If available, earlier imaging studies (eg, contrast-enhanced computed tomography [CT] or MR imaging of the abdomen) may be used to evaluate the anatomy of the IVC (ie, size, patency, and anatomic 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 (eg, 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). This report provides quality improvement guidelines only for filter placement within the IVC because of 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 United States Food and Drug Administration 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 in which the indication was for prophylaxis and prevention of 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 (eg, 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. For the purpose of this guideline, the following definitions apply (24Ferris E.J. McCowan T.C. Carver D.K. McFarland D.R. Percutaneous inferior vena caval filters: follow-up of seven designs in 320 patients.Radiology. 1993; 188: 851-856Crossref PubMed Scopus (306) Google Scholar, 25Ray Jr, C.E. Kaufman J.A. Complications of inferior vena cava filters.Abdom Imaging. 1996; 21: 368-374Crossref PubMed Scopus (105) Google Scholar): Permanent placement is deployment in those situations in which lifelong protection against thromboembolic episodes is needed. Temporary placement is deployment in those situations in which time-limited protection against thromboembolic episodes is needed. Procedural success is the deployment of a filter such that the filter is judged suitable for mechanical protection against PE. Recurrent PE is PE that occurs after filter placement and is documented by pulmonary arteriography, cross-sectional imaging, or significant change in ventilation/perfusion lung scan indicative of recurrent PE, or at autopsy. IVC thrombotic occlusion is the presence of an occluding thrombus in the IVC after filter insertion and documented by ultrasound (US), CT, MR imaging, venography, or autopsy; this may be symptomatic or asymptomatic. IVC penetration is penetration of the vein wall by a filter strut or anchor device 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 or venography, or at autopsy. Acute penetration occurring during placement of the filter is considered an insertion problem (as detailed later). Filter embolization is postdeployment movement of the filter or its components to a distant anatomic site completely out of the target zone. Filter movement is a change in filter position compared with its deployed position (cranial or caudal) of more than 2 cm as documented by plain radiography, CT, or venography. Filter fracture is any loss of a filter's structural integrity (ie, breakage or separation) documented by imaging or at autopsy. Insertion problems refer to malfunctions of the filter or deployment system such as incomplete filter opening, filter tilt more than 15° from the IVC axis (eg, 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 (eg, 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 refers to occlusive or nonocclusive thrombus developing at the venotomy site after filter insertion, and documented by US or other imaging. Access site complications with clinical sequelae include arteriovenous fistula, hematoma, or bleeding requiring a transfusion, hospitalization (admission or extended stay), or further treatment. 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; Appendix B). The complication rates and thresholds herein refer to major complications unless otherwise specified. IVC filter placement has a therapeutic indication (ie, in cases of documented thromboembolic disease) in patients with evidence of PE or IVC, iliac, or femoropopliteal DVT and one or more of the following:•Absolute or relative contraindication to anticoagulation;•Complication of anticoagulation;•Failure of anticoagulation;•Recurrent PE despite adequate therapy;•Inability to achieve/maintain adequate anticoagulation;•Propagation/progression of DVT during therapeutic anticoagulation;•Massive PE with residual DVT in a patient at risk for further PE;•Free-floating iliofemoral or IVC thrombus; and•Severe cardiopulmonary disease and DVT (eg, cor pulmonale with pulmonary hypertension) (24Ferris E.J. McCowan T.C. Carver D.K. McFarland D.R. Percutaneous inferior vena caval filters: follow-up of seven designs in 320 patients.Radiology. 1993; 188: 851-856Crossref PubMed Scopus (306) Google Scholar, 25Ray Jr, C.E. Kaufman J.A. Complications of inferior vena cava filters.Abdom Imaging. 1996; 21: 368-374Crossref PubMed Scopus (105) Google Scholar, 26Kalva S.P. Chlapoutaki C. Wicky S. Greenfield A.J. Waltman A.C. Athanasoulis C.A. Suprarenal inferior vena cava filters: a 20-year single-center experience.J Vasc Interv Radiol. 2008; 19: 1041-1047Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar, 27Kaufman J.A. Geller S.C. When to use an inferior vena cava filter.AJR Am J Roentgenol. 1995; 164: 256-257Crossref PubMed Scopus (18) Google Scholar, 28Kaufman J.A. Rundback J.H. Kee S.T. et al.Development of a research agenda for inferior vena cava filters: proceedings from a multidisciplinary research consensus panel.J Vasc Interv Radiol. 2009; 20: 697-707Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar, 29Norris C.S. Greenfield L.J. Herrmann J.B. Free-floating iliofemoral thrombus A risk of pulmonary embolism.Arch Surg. 1985; 120: 806-808Crossref PubMed Scopus (115) Google Scholar, 30Rutherford R.B. Prophylactic indications for vena cava filters: critical appraisal.Semin Vasc Surg. 2005; 18: 158-165Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar, 31Vaiji K. Vascular and interventional radiology. WB Saunders, Philadelphia1999Google Scholar). IVC filter placement has a prophylactic indication (ie, in cases without current thromboembolic disease) in the following settings:•Severe trauma without documented PE or DVT;•Closed head injury;•Spinal cord injury;•Multiple long-bone or pelvic fractures; and•Patients at high risk (eg, immobilized or in an intensive care unit) (24Ferris E.J. McCowan T.C. Carver D.K. McFarland D.R. Percutaneous inferior vena caval filters: follow-up of seven designs in 320 patients.Radiology. 1993; 188: 851-856Crossref PubMed Scopus (306) Google Scholar, 25Ray Jr, C.E. Kaufman J.A. Complications of inferior vena cava filters.Abdom Imaging. 1996; 21: 368-374Crossref PubMed Scopus (105) Google Scholar, 26Kalva S.P. Chlapoutaki C. Wicky S. Greenfield A.J. Waltman A.C. Athanasoulis C.A. Suprarenal inferior vena cava filters: a 20-year single-center experience.J Vasc Interv Radiol. 2008; 19: 1041-1047Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar, 27Kaufman J.A. Geller S.C. When to use an inferior vena cava filter.AJR Am J Roentgenol. 1995; 164: 256-257Crossref PubMed Scopus (18) Google Scholar, 28Kaufman J.A. Rundback J.H. Kee S.T. et al.Development of a research agenda for inferior vena cava filters: proceedings from a multidisciplinary research consensus panel.J Vasc Interv Radiol. 2009; 20: 697-707Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar, 29Norris C.S. Greenfield L.J. Herrmann J.B. Free-floating iliofemoral thrombus A risk of pulmonary embolism.Arch Surg. 1985; 120: 806-808Crossref PubMed Scopus (115) Google Scholar, 30Rutherford R.B. Prophylactic indications for vena cava filters: critical appraisal.Semin Vasc Surg. 2005; 18: 158-165Abstract Full Text Full Text PDF PubMed Scopus (46) Google Scholar, 31Vaiji K. Vascular and interventional radiology. WB Saunders, Philadelphia1999Google Scholar). Suprarenal caval filter placement may be considered when any of the following situations exist in addition to the indications listed earlier.1Presence of IVC thrombus precluding placement of a filter in the infrarenal IVC;2Filter placement during pregnancy (suprarenal placement is also appropriate in women of childbearing age);3Thrombus extending above previously placed infrarenal filter;4Gonadal vein thrombosis;5Anatomic variants, eg, duplication of the IVC, low insertion of renal veins;6Significant extrinsic compression of the infrarenal IVC;7Intrinsic narrowing of the infrarenal IVC; and8Intraabdominal or pelvic mass in patients who will undergo surgery and in whom operative IVC mobilization is contemplated. The IVC should be assessed with imaging before placement of a filter. The current preferred method is by vena cavography. Before 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 identified, IVC anomalies (eg, duplication) defined, and intrinsic IVC disease, such as preexisting thrombus or extrinsic compression, excluded. If available, previous imaging studies (eg, contrast-enhanced CT or MR imaging of the abdomen) may be used to evaluate the anatomy of the IVC (ie, size, patency, and anatomic variants). The anatomic considerations should be used in the final planning for filter placement and choice of device. 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 earlier.1PE and/or DVT and transient inability to anticoagulate;2Prophylactic prevention of PE in patients at high risk; and3The use of retrievable filters should also be considered in pediatric and young adult patients, as 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 (32Chaudry G. Padua H.M. Alomari A.I. The use of inferior vena cava filters in young children.J Vasc Interv Radiol. 2008; 19: 1103-1106Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar). 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 to IVC filter placement in this setting are (i) uncorrectable severe coagulopathy and (ii) bacteremia or untreated infection. Clinical judgment should be applied in these situations, weighing the theoretical risk of implant infection versus the risk of PE. 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. The following are considered the minimum equipment requirements for performing vena cavograms and filter placement. In planning facilities for IVC placement, equipment and facilities more advanced than those outlined here may be desired to produce higher-quality studies with reduced risk and time of study. The facility should include, at a minimum:1A high-resolution image receptor, preferably with a 28–40-cm field of view, and an imaging chain with 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 on conventional film or digitally on computerized storage media. Imaging and image recording must be consistent with the “As Low As Reasonably Achievable” radiation safety guidelines. The use of cineradiography or small-field mobile image intensifiers is inappropriate for the routine recording of the vena cavogram 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;2Adequate angiographic supplies such as catheters, guide wires, needles, and introducer sheaths;3An angiographic injector capable of varying injection volumes and rates with appropriate safety mechanisms to prevent overinjection;4An 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; and5An area within the institution appropriate for patient preparation before 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 later in the Patient Care section, and there should be immediate access to emergency resuscitation equipment. 1Equipment should be present in the procedure suite to allow for monitoring the patient's heart rate, cardiac rhythm, and blood pressure. For facilities that use moderate sedation, a pulse oximeter monitor should be available, as outlined in the Practice Guideline for Sedation/Analgesia (33Practice Guideline for Sedation/Analgesia.http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/iv.aspxGoogle Scholar).2Appropriate 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. 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 agent 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. 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 in which 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, as outlined in the Practice Guideline for Sedation/Analgesia (33Practice Guideline for Sedation/Analgesia.http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/iv.aspxGoogle Scholar). 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. For additional information on patient care, see the Practice Guideline for Interventional Clinical Practice (34Practice Guideline for Interventional Clinical Practice.http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/iv.aspxGoogle Scholar). For elective filter placement, the following should be documented:aClinically significant history, including indications for the procedure;bClinically significant physical or diagnostic examination findings, including clinical or medical conditions that may necessitate specific care, such as preprocedure antibiotics and other measures;cClinically indicated laboratory evaluation including, but not limited to, coagulation factors, creatinine, white blood cell count, and previously obtained cultures; anddPreprocedure documentation should conform to the requirements of the Practice Guideline for the Reporting and Archiving of Interventional Radiology Procedures (35Practice Guideline for the Reporting and Archiving of Interventional Radiology Procedures.http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/iv.aspxGoogle Scholar). Informed consent must be in compliance with all state laws and the ACR Practice Guideline on Informed Consent for Image-Guided Procedures (36ACR Practice Guideline on Informed Consent for Image-Guided Procedures.http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/iv.aspxGoogle Scholar). 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. Adherence to the Joint Commission's Universal Protocol for Preventing Wrong Site, Wrong Procedure, and 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; and•Be brie