acr–asnr–assr–sir–snis practice guideline for the performance of ...

any new methods for achieving the same end: vertebralaugmentation.A thorough review of the literature was performed. Whenpublished data were felt to be inadequate, data from theexpert panel members’ own quality assurance programswere used to supplement. Thresholds for qualityassurance have been updated in accordance with availabledata in the literature.Introduced by Galibert and Deramond et al in France in1987 [1], vertebroplasty entails injection of material intothe weakened vertebra. Radiologic imaging has been acritical part of vertebroplasty from its inception. Mostprocedures are performed using fluoroscopic guidance forneedle placement and material injection or placement.The use of computed tomography (CT) has also beendescribed for these purposes [2-3].Vertebral augmentation is an established and safeprocedure [1-2,4-21]. Two blinded, randomizedcontrolled trials failed to demonstrate an advantage intheir study populations for vertebroplasty over a controlintervention for either pain reduction or disabilityimprovement [22-23]. However, larger, non-blinded,prospective randomized controlled studies and otherstudies of vertebral augmentation have shown its efficacy[24-36]. As with any invasive procedure, the patient ismost likely to benefit when the procedure is performed inan appropriate environment by qualified physicians.These guidelines are intended to be used in qualityimprovement programs to assess vertebral augmentationprocedures. The most important processes of care are 1)patient selection, 2) performing the procedure, and 3)monitoring the patient. The outcome measures orindicators for these processes are indications, successrates, and complication rates. Outcome measures areassigned threshold levels.Use of other technologies to treat patients for the sameindications should yield similar or better success rates andcomplication profiles.II.DEFINITIONSVertebral augmentation includes all percutaneoustechniques used to achieve internal vertebral bodystabilization.Vertebroplasty is a minimally invasive surgical orinterventional procedure, performed by percutaneouslyinjecting radiopaque bone cement into a painfulosteoporotic or neoplastic compression fracture or apainful vertebral body weakened by any other etiology.Kyphoplasty is an image-guided percutaneous procedurethat creates a cavity within the bone that is then filledwith material.Failure of medical therapy is defined as:III.1. For a patient rendered nonambulatory due to painfrom weakened or fractured vertebral body, painpersisting at a level that prevents ambulationdespite 24 hours of analgesic therapy.or2. For a patient with sufficient pain from weakenedor fractured vertebral body that physical therapyis intolerable, pain persisting at that level despite24 hours of analgesic therapy.or3. For any patient with weakened or fracturedvertebral body, unacceptable side effects such asexcessive sedation, confusion, or constipationdue to the analgesic therapy necessary to reducepain to a tolerable level.OVERVIEWVertebral compression fractures are a common and oftendebilitating complication of osteoporosis [37-41].Although most fractures heal within a few weeks ormonths, a minority of patients continue to suffer pain thatdoes not respond to conservative therapy [42-44].Vertebral compression fractures are a leading cause ofnursing home admission. Open surgical fixation is rarelyused to treat these fractures. The poor quality of bone atthe adjacent unfractured levels does not provide a goodanchor for surgical hardware, and the advanced age ofmost affected patients increases the morbidity andmortality risks of major surgery.Initial success with vertebroplasty for treating aggressivehemangiomas [1,12] and osteolytic neoplasms [10,21] ledto extension of the indications to include osteoporoticcompression fractures refractory to medical therapy [2,4-9,11,13-19]. Vertebral augmentation is currently beingused to treat a wide variety of osteolytic metastases andmultiple myelomas.Perioperative imaging that identifies the painful vertebralbody in concordance with the clinical examination isconsidered essential for the safe and effectiveperformance of vertebral augmentation.IV.INDICATIONS ANDCONTRAINDICATIONSThe major indication for vertebral augmentation is thetreatment of symptomatic osteoporotic vertebral bodyfracture(s) refractory to medical therapy or vertebralbodies weakened due to neoplasia. Currently, there is noindication for the use of vertebral augmentation for2 / Vertebral Augmentation PRACTICE GUIDELINE

prophylaxis against future fracture. The indications andcontraindications for vertebral augmentation may changein the future as more research and information becomeavailable.A. Indication Threshold 95%1. Painful osteoporotic vertebral fracture(s)refractory to medical therapy.2. Vertebral bodies weakened by neoplasm.3. Symptomatic vertebral body microfracture (asdocumented by magnetic resonance imaging[MRI] or nuclear imaging, and/or lytic lesionseen on computed tomography (CT) withoutobvious loss of vertebral body height.When fewer than 95% of vertebral augmentations in aninstitution are performed for the above indications, itshould prompt a review of practices related to selection ofpatients for this procedure.B. Absolute Contraindications1. Septicemia.2. Active osteomyelitis of the target vertebra.3. Uncorrectable coagulopathy.4. Allergy to bone cement or opacification agent.C. Relative Contraindications1. Radiculopathy in excess of local vertebral pain,caused by a compressive syndrome unrelated tovertebral collapse. Occasionally preoperativevertebroplasty can be performed before a spinaldecompressive procedure.2. Retropulsion of a fracture fragment causingsevere spinal canal compromise.3. Epidural tumor extension with significantencroachment on the spinal canal.4. Ongoing systemic infection.5. Patient improving on medical therapy.6. Prophylaxis in osteoporotic patients (unlessbeing performed as part of a research protocol).7. Myelopathy originating at the fracture level.V. QUALIFICATIONS ANDRESPONSIBILITIES OF PERSONNELA. PhysicianIn general, the requirements for physicians performingvertebral augmentation may be met by adhering to therecommendations listed below:1. Certification in Radiology or DiagnosticRadiology by the American Board of Radiology,the American Osteopathic Board of Radiology,the Royal College of Physicians and Surgeons ofCanada, or the Collège des Médecins du Québec,and must include performance of successfulvertebral augmentation procedures in at least 5patients as the primary operator, under thesupervision of a qualified physician, and withoutmajor complications.or2. Completion of an approved residency orfellowship program by the Accreditation Councilfor Graduate Medical Education (ACGME), theRoyal College of Physicians and Surgeons ofCanada (RCPSC), the Collège des Médecins duQuébec, or an American Osteopathic Association(AOA) approved residency program thatincluded 6 months of training in cross-sectionalimaging, including CT and MR imaging, and 4months of training in image-guidedinterventional radiological techniques, includingvertebral augmentation, biopsy and drainageprocedures, and vascular embolization. Thismust include performance of successful vertebralaugmentations in at least 5 patients as theprimary operator, under the supervision of aqualified physician, and without majorcomplications.or3. A physician who did not successfully completean ACGME approved radiology residency orfellowship program that included the above maystill be considered qualified to perform vertebralaugmentation provided the following can bedemonstrated: the physician must have at least 1year of experience in performing percutaneousimage-guided spine procedures, during which thephysician was supervised by a physician withactive privileges in these spine procedures.During this year he or she must have performed aminimum of 5 vertebral augmentations asprimary operator with outcomes within thequality improvement thresholds of this guideline.and4. Physicians meeting any of the qualifications in 1,2, or 3 above must have written substantiationthat they are familiar with all of the following:a. Indications and contraindications forvertebral augmentation.b. Periprocedural and intraproceduralassessment, monitoring, and management ofthe patient, and particularly the recognitionand initial management of proceduralcomplications.c. Appropriate use and operation offluoroscopic and radiographic equipment,digital subtraction systems, and otherelectronic imaging systems.d. Principles of radiation protection, hazards ofradiation exposure to the patient and thePRACTICE GUIDELINE Vertebral Augmentation / 3

adiologic personnel, and radiationmonitoring requirements.e. Anatomy, physiology, and pathophysiologyof the spine, spinal cord, and nerve roots.f. Pharmacology of contrast agents andimplanted materials and recognition andtreatment of potential adverse reactions tothese substances.g. Technical aspects of performing thisprocedure.The written substantiation should come from thechief of interventional radiology, the chief ofneuroradiology, the chief of interventionalneuroradiology, or the chair of the department ofthe institution in which the physician will beproviding these services 1 . Substantiation couldalso come from a prior institution in which thephysician provided the services, but only at thediscretion of the current interventional,Neurointerventional, or neuroradiology chief, orthe chair who solicits the additional input.and5. Physicians must possess certain fundamentalknowledge and skills that are required for theappropriate application and safe performance ofvertebral augmentation:a. In addition to a basic understanding ofspinal anatomy, physiology, andpathophysiology, the physician must havesufficient knowledge of the clinical andimaging evaluation of patients with spinaldisorders to determine those for whomvertebral augmentation is indicated.b. The physician must fully appreciate thebenefits and risks of vertebral augmentationand the alternatives to the procedure.c. The physician is required to be competent inthe use of fluoroscopy, CT, and MRI orinterpretation of images in the modalitiesused to evaluate potential patients and guidethe vertebral augmentation procedure.d. The physician should be able to recognize,interpret, and act immediately on imagefindings.e. The physician must have the ability, skills,and knowledge to evaluate the patient’sclinical status and to identify those patientswho might be at increased risk, who mayrequire additional perioperative care, or whohave relative contraindications to theprocedure.1 At institutions in which there is joint (dual) credentialingacross departments doing like procedures, this substantiation ofexperience should be done by the chairs of both departments toensure equity of experience among practitioners when theirtraining backgrounds differ [43].f. The physician must be capable of providingthe initial clinical management ofcomplications of vertebral augmentation,including administration of basic lifesupport, treatment of pneumothorax, andrecognition of spinal cord compression.g. Training in radiation physics and safety is animportant component of these requirements.Such training is important to maximize bothpatient and physician safety. It is highlyrecommended that the physician haveadequate training in and be familiar with theprinciples of radiation exposure, the hazardsof radiation exposure to both patients andradiologic personnel, and the radiationmonitoring requirements for the imagingmethods listed above.Some methods of vertebral augmentation may requirespecialized training and experience, and such needsshould be assessed before a physician contemplates usingany method.Maintenance of CompetencePhysicians should perform a sufficient number ofvertebral augmentation procedures to maintain their skills,with acceptable success and complication rates as laid outin this guideline. Continued competence depends onparticipation in a quality improvement program thatmonitors these rates. Regular attendance at postgraduatecourses that provide continuing education on diagnosticand technical advances in vertebral augmentation isnecessary.Continuing Medical EducationThe physician’s continuing education should be inaccordance with the ACR Practice Guideline forContinuing Medical Education (CME).B. Nonphysician PractitionersPhysician assistants and nurse practitioners can bevaluable members of the interventional radiology teambut not as primary operator. These nonphysicianpractitioners can function as independent members of theteam but not as primary operator. See the ACR–SIR–SNIS Practice Guideline for Interventional ClinicalPractice.C. Qualified Medical PhysicistA Qualified Medical Physicist is an individual who iscompetent to practice independently one or more of thesubfields in medical physics. The American College ofRadiology (ACR) considers certification, continuingeducation, and experience in the appropriate subfield(s) to4 / Vertebral Augmentation PRACTICE GUIDELINE

demonstrate that an individual is competent to practiceone or more of the subfields in medical physics and to bea Qualified Medical Physicist. The ACR stronglyrecommends that the individual be certified in theappropriate subfield(s) by the American Board ofRadiology (ABR), the Canadian College of Physics inMedicine, or the American Board of Medical Physics(ABMP).The appropriate subfield in medical physics for thisguideline is Diagnostic Medical Physics. (Previousmedical physics certification categories includingRadiological Physics, Diagnostic Radiological Physics,and Diagnostic Imaging Physics are also acceptable.)A Qualified Medical Physicist should meet the ACRPractice Guideline for Continuing Medical Education(CME). (ACR Resolution 17, 1996 – revised in 2012,Resolution 42)D. Registered Radiologist AssistantA registered radiologist assistant is an advanced levelradiographer who is certified and registered as aradiologist assistant by the American Registry ofRadiologic Technologists (ARRT) after havingsuccessfully completed an advanced academic programencompassing an ACR/ASRT (American Society ofRadiologic Technologists) radiologist assistant curriculumand a radiologist-directed clinical preceptorship. Underradiologist supervision, the radiologist assistant mayperform patient assessment, patient management andselected examinations as delineated in the Joint PolicyStatement of the ACR and the ASRT titled “RadiologistAssistant: Roles and Responsibilities” and as allowed bystate law. The radiologist assistant transmits to thesupervising radiologists those observations that have abearing on diagnosis. Performance of diagnosticinterpretations remains outside the scope of practice of theradiologist assistant. (ACR Resolution 34, adopted in2006)E. Radiologic TechnologistThe technologist, together with the physician and thenursing personnel, should be responsible for patientcomfort. The technologist should be able to prepare andposition the patient for the vertebral augmentationprocedure and, together with the nurse, monitor thepatient during the procedure. The technologist shouldobtain the imaging data in a manner prescribed by thesupervising physician. The technologist should alsoperform regular quality control testing of the equipmentunder the supervision of the Qualified Medical Physicist.The technologist should have appropriate training andexperience in the vertebral augmentation procedure andbe certified by the American Registry of RadiologicTechnologists (ARRT) and/or have an unrestricted statelicense.F. Nursing ServicesNursing services are an integral part of the team forperioperative patient management and education and mayassist the physician in monitoring the patient during thevertebral augmentation procedure.VI.SPECIFICATIONS OF THE PROCEDUREA. Technical RequirementsVertebral augmentation may be performed with eitherfluoroscopy or CT imaging guidance. The choice is amatter of operator preference and patient characteristics.In either case, there are several technical requirements toensure safe and successful vertebral augmentations. Theseinclude adequate institutional facilities, imaging andmonitoring equipment, and support personnel. Thefollowing are minimum requirements for any institutionin which vertebral augmentation is to be performed:1. A procedural suite large enough to allow safeand easy transfer of the patient from bed toprocedural table with sufficient space forappropriate positioning of patient monitoringequipment, anesthesia equipment, respirators,etc. There should be adequate space for theoperating team to work unencumbered on eitherside of the patient and for the circulation of otherstaff within the room without contaminating thesterile conditions.2. The majority of these procedures are performedunder fluoroscopic guidance. A high-resolutionimage intensifier or flat-panel detector and videosystem with adequate shielding, capable of rapidimaging in orthogonal planes, and withcapabilities for permanent image recording isstrongly recommended. The fluoroscope shouldbe compliant with IEC 601-2-43 [45]. Imagingfindings are acquired and stored either onconventional film or digitally on computerizedstorage media. Imaging and image recordingmust be consistent with the as-low-asreasonably-achievable(ALARA) radiation safetyguidelines.3. Immediate access to CT and rapid (within 30 or45 minutes) access to MRI is necessary toevaluate potential complications. This may beparticularly important if vertebral augmentationis planned in patients with osteolytic vertebralmetastasis and/or with significant pre-existingspinal canal compromise.PRACTICE GUIDELINE Vertebral Augmentation / 5

4. The facility must provide adequate resources forobserving patients during and after vertebralaugmentation. Physiologic monitoring devicesappropriate to the patient’s needs – includingblood pressure monitoring, pulse oximetry, andelectrocardiography – and equipment forcardiopulmonary resuscitation must be availablein the procedural suite.B. Surgical and Emergency SupportAlthough serious complications of vertebral augmentationare infrequent, there should be prompt access to surgical,interventional, and medical management ofcomplications.C. Patient Care1. Preprocedural carea. The clinical history and findings, includingthe indications for the procedure, must bereviewed and recorded in the patient’smedical record by the physician performingthe procedure. Specific inquiry should bemade with respect to relevant medications,prior allergic reactions, and bleeding/clotting status.b. The vital signs and the results of physicaland neurological examinations must beobtained and recorded.c. The indication(s) for the procedure,including (if applicable) documentation offailed medical therapy, must be recorded.d. The indication(s) for treatment of thefracture should have documentation ofimaging correlation and confirmation.2. Procedural carea. Adherence to the Joint Commission’scurrent Universal Protocol for PreventingWrong Site, Wrong Procedure, WrongPerson Surgery is required for proceduresin non-operating room settings includingbedside procedures.The organization should have processes andsystems in place for reconciling differencesin staff responses during the “time out.”b. Vital signs should be obtained at regularintervals during the course of the procedure,and a record of these measurements shouldbe maintained.c. Patients undergoing vertebral augmentationmust have intravenous access in place forthe administration of fluids and medicationsas needed.d. If the patient receives sedation, pulseoximetry must be used. Administration ofVII.sedation for vertebral augmentation shouldbe in accordance with the ACR–SPRPractice Guideline for Sedation/Analgesia.A registered nurse or other appropriatelytrained personnel should be present and haveprimary responsibility for monitoring thepatient. A record of medication doses andtimes of administration should bemaintained.3. Postprocedural carea. A procedural note should be written in thepatient’s medical record summarizing thecourse of the procedure and what wasaccomplished, any immediatecomplications, and the patient’s status at theconclusion of the procedure (see sectionVIII.A.2 below). This note may be brief ifthe formal report will be available within afew hours. This information should becommunicated to the referring physician in atimely manner. A more detailed summary ofthe procedure should be written in themedical record if the formal typed reportwill not be on the medical record within thesame day.b. All patients should be at bed rest andobserved during the initial postproceduralperiod. The length of this period will dependon the patient’s medical condition.c. During the immediate postproceduralperiod, skilled nurses or other appropriatelytrained personnel should monitor thepatient’s vital signs, urinary output,sensorium, and motor strength. Neurologicalstatus should be assessed frequently atregular intervals. Initial ambulation of thepatient must be carefully supervised.d. The operating physician or a qualifieddesignee (another physician or a nurse)should evaluate the patient after the initialpostprocedural period, and these findingsshould be summarized in a progress note onthe patient’s medical record. The physicianor designee must be available for continuingcare during hospitalization and afterdischarge.EQUIPMENT QUALITY CONTROLEach facility should have documented policies andprocedures for monitoring and evaluating the effectivemanagement, safety, and proper performance of imagingand interventional equipment. The quality controlprogram should be designed to maximize the quality ofthe diagnostic information. This may be accomplished aspart of a routine preventive maintenance program.6 / Vertebral Augmentation PRACTICE GUIDELINE

VIII.QUALITY IMPROVEMENT ANDDOCUMENTATIONA. DocumentationResults of vertebral augmentation procedures should bemonitored on a continuous basis. Records should be keptof both immediate and long-term results andcomplications. The number of complications should bedocumented. Any biopsies performed in conjunction withvertebral augmentation should be followed up to detectand record any false negative and false positive results.A permanent record of vertebral augmentation proceduresshould be maintained in a retrievable image storageformat.1. Imaging labeling should include permanentidentification containing:a. Facility name and location.b. Examination date.c. Patient’s first and last names.d. Patient’s identification number and/or dateof birth.2. The initial progress note and final report shouldinclude:a. Procedure undertaken and its purpose.b. Type of anesthesia used (local, moderate,deep or general).c. Listing of level(s) treated and amount ofcement injected at each level.d. Evaluation of injection site and focusedneurologic examination.e. Immediate complications, if any, includingtreatment and outcome.f. Radiation dose estimate (or fluoroscopytime and the number of images obtained onequipment that does not provide directdosimetry information) [46-48].3. Follow up documentation:a. Postprocedure evaluation to assess patientresponse (pain relief, mobilityimprovement). Standardized assessmenttools such as the SF 36 and the Roland-Morris disability scale may be useful forboth preoperative and postoperative patientevaluation.b. Evaluation of injection site and focusedneurologic examination.c. Delayed complications, if any, includingtreatment and outcome.d. Pathology (biopsy) results, if any.e. Record of communications with patient andreferring physician.f. Patient disposition.Reporting should be in accordance with the ACR–SIRPractice Guideline for the Reporting and Archiving ofInterventional Radiology Procedures.B. Informed Consent and Procedural RiskInformed consent or emergency administrative consentmust be obtained and must comply with the ACR–SIRPractice Guideline on Informed Consent for Image-Guided Procedures [49]. Risks cited should includeinfection; bleeding; allergic reaction; rib or vertebralfracture; vessel injury; pneumothorax (for appropriatelevels); and implanted material displacement into theadjacent epidural or paravertebral veins resulting inworsening pain or paralysis, spinal cord or nerve injury,or pulmonary complication. The potential need forimmediate surgical intervention should be discussed. Thepossibility that the patient may not experience significantpain relief should also be discussed.C. Success and Complication Rates and Thresholds [1-2,4-21]Although practicing physicians should strive to achieveperfect outcomes (e.g., 100% success, 0% complications),in practice, all physicians will fall short of this ideal to avariable extent. Therefore, indicator thresholds may beused to assess the efficacy of ongoing qualityimprovement programs. For the purposes of theseguidelines, a threshold is a specific level of an indicatorthat should prompt a review. Procedure thresholds oroverall thresholds refer to a group of indicators for aprocedure, e.g., major complications. Individualcomplications may also be associated with complicationspecificthresholds. When measures such as indications orsuccess rates fall below a minimum threshold, or whencomplication rates exceed a maximum threshold, a reviewshould be performed to determine causes and toimplement changes if necessary. For example, if theincidence of fracture of rib or other bone is one measureof the quality of vertebral augmentation, values in excessof the defined threshold (in this case

therapy (for outpatient procedures), an unplanned increasein the level of care, prolonged hospitalization, permanentadverse sequelae, or death. Minor complications result inno sequelae, but may require nominal therapy or a shorthospital stay for observation (generally overnight; seeAppendix A). The complication rates and thresholdsdescribed herein refer to major complications.Routine periodic review of all cases having less thanperfect outcomes is strongly encouraged. Seriouscomplications of vertebral augmentation are infrequent. Areview is therefore recommended for all instances ofdeath, infection, or symptomatic pulmonary embolus.Table 1: Vertebral Augmentation Success Rates [51-58]Success RatesWhen vertebral augmentation is performed forosteoporosis, procedure outcomes can be defined usingthe criteria by Hodler et al [50] with patients categorizedas worse, same, better, or pain/disability gone. For thepurpose of this document pain/disability gone is definedas improved. Therefore patients should be categorized aseither improved, the same, or worse. This categorizationshould be determined with the use of a validatedmeasurement tool.When vertebral augmentation is performed for neoplasticinvolvement, success is defined as achievement ofsignificant pain relief and/or improved mobility asmeasured by validated measurement tools.Published Success Rates Threshold for ReviewNeoplastic, all causes 70% to 92% 10%Permanent neurological deficit (within 30 days ofthe procedure or requiring surgery)OsteoporosisNeoplasm1%>5%Fracture of rib, sternum or vertebra 1% >2%Allergic or idiosyncratic reaction 1%Infection 0%Symptomatic pulmonary material embolus 0%Significant hemorrhage or vascular injury 0%Symptomatic hemothorax or pneumothorax 0%Death 0%The overall procedure threshold for all complications resulting from vertebral augmentation performed for osteoporosis is2%, and when performed for neoplastic indications it is 10%.8 / Vertebral Augmentation PRACTICE GUIDELINE

IX.RADIATION SAFETY IN IMAGINGRadiologists, medical physicists, radiologic technologists,and all supervising physicians have a responsibility tominimize radiation dose to individual patients, to staff,and to society as a whole, while maintaining the necessarydiagnostic image quality. This concept is known as “aslow as reasonably achievable (ALARA).”Facilities, in consultation with the medical physicist,should have in place and should adhere to policies andprocedures, in accordance with ALARA, to varyexamination protocols to take into account patient bodyhabitus, such as height and/or weight, body mass index orlateral width. The dose reduction devices that areavailable on imaging equipment should be active; if not;manual techniques should be used to moderate theexposure while maintaining the necessary diagnosticimage quality. Periodically, radiation exposures should bemeasured and patient radiation doses estimated by amedical physicist in accordance with the appropriate ACRTechnical Standard. (ACR Resolution 17, adopted in2006 – revised in 2009, Resolution 11.)X. QUALITY CONTROL ANDIMPROVEMENT, SAFETY, INFECTIONCONTROL, AND PATIENT EDUCATIONPolicies and procedures related to quality, patienteducation, infection control, and safety should bedeveloped and implemented in accordance with the ACRPolicy on Quality Control and Improvement, Safety,Infection Control, and Patient Education appearing underthe heading Position Statement on QC & Improvement,Safety, Infection Control, and Patient Education on theACR web site (http://www.acr.org/guidelines).ACKNOWLEDGEMENTSThis guideline was revised according to the processdescribed under the heading The Process for DevelopingACR Practice Guidelines and Technical Standards on theACR web site (http://www.acr.org/guidelines) by theGuidelines and Standards Committees of the Commissionon Neuroradiology and the Commission on Interventionaland Cardiovascular Radiology in collaboration with theASNR, the ASSR, the SIR, and the SNIS.Collaborative Committee – members represent theirsocieties in the initial and final revision of this guideline.ACRJoshua A. Hirsch, MD, FACR, ChairJohn E. Jordan, MDPhilip M. Meyers, MDJohn D. Statler, MDASNRDavid F. Kallmes, MDJerry G. Jarvik, MDASSRDmitry Niman, MDDan L. Nguyen, MDR. Sean Pakbaz, MDKent B. Remley, MDMichael I. Rothman, MDSIRJohn D. Barr, MDJ. Kevin McGraw, MDSNISAllan L. Brook, MDMary (Lee) Jensen, MDAlbert J. Yoo, MDGuidelines and Standards Committee – Interventional –ACR Committee responsible for sponsoring the draftthrough the processDonald L. Miller, MD, Chair, FACRAradhana M. Venkatesan, MD, Vice-ChairStephen Balter, PhD, FACRRobert G. Dixon, MDLawrence T. Dauer, PhDJoshua A. Hirsch, MD, FACRSanjoy Kundu, MDPhilip M. Meyers, MDJohn D. Statler, MDMichael S. Stecker, MDTimothy L. Swan, MDRaymond H. Thornton, MDAnne C. Roberts, MD, FACR, Chair, CommissionGuidelines and Standards Committee – Neuroradiology –ACR Committee responsible for sponsoring the draftthrough the processJacqueline A. Bello, MD, FACR, ChairJohn E. Jordan, MD, Vice-ChairMark H. Depper, MDAllan J. Fox, MD, FACRSteven W. Hetts, MDEllen G. Hoeffner, MDThierry A.G.M. Huisman, MDStephen A. Kieffer, MD, FACRSrinivasan Mukundan, MD, PhDEric M. Spickler, MD, FACRAshok Srinivasan, MDKurt E. Tech, MD, MMM, FACRMax Wintermark, MDCarolyn C. Meltzer, MD, FACR, Chair, CommissionPRACTICE GUIDELINE Vertebral Augmentation / 9

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the First Randomized Trial Comparing BalloonKyphoplasty (BKP) to Non-Surgical ManagementAmong Cancer Patients with Vertebral CompressionFractures: Marked Improvement in Back Function,Quality of Life and Pain in the BKP Arm. Paperpresented at: American Society of Hematology:Poster Session: Myeloma-Therapy, ExcludingTransplantaion Poster II; December 6, 2009; NewOrleans, LA.29. Gilula LA. Vertebral Augmentaiton: 2 year ClinicalExperience in a Prospective Randomized ControlledFDA Study in Vertebroplasty Comparing Cortoss [C]to PMMA [P]. Paper presented at: American Societyof Spine Radiology, 2009; Lake Buena Vista,Florida.30. Gilula LA. Subsequent Fractures Post-VertebralAugmentation: Results from a ProspectiveRandomized FDA Trial Comparing Cortoss andPMMA in Osteoporotic Vertebral CompressionFractures (VCF’s). Paper presented at: AmericanSociety of Spine Radiology Annual Symposium; Feb.18-21, 2010; Las Vegas, NV.31. Nunley P. 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Osteoblasticand mixed spinal metastases: evaluation of theanalgesic efficacy of percutaneous vertebroplasty.AJNR Am J Neuroradiol 2007;28:570-574.53. Jensen ME, McGraw JK, Cardella JF, Hirsch JA.Position statement on percutaneous vertebralaugmentation: a consensus statement developed bythe American Society of Interventional andTherapeutic Neuroradiology, Society ofInterventional Radiology, American Association ofNeurological Surgeons/Congress of NeurologicalSurgeons, and American Society of Spine Radiology.AJNR 2007;28:1439-1443.PRACTICE GUIDELINE Vertebral Augmentation / 11

54. McDonald RJ, Trout AT, Gray LA, Dispenzieri A,Thielen KR, Kallmes DF. Vertebroplasty in multiplemyeloma: outcomes in a large patient series. AJNR2008;29:642-648.55. Muto M, Muto E, Izzo R, Diano AA, Lavanga A, DiFuria U. Vertebroplasty in the treatment of back pain.Radiol Med 2005;109:208-219.56. Jha RM, Yoo AJ, Hirsch AE, Growney M, HirschJA. Predictors of successful palliation of compressionfractures with vertebral augmentation: single-centerexperience of 525 cases. J Vasc Interv Radiol2009;20:760-768.57. Lovi A, Teli M, Ortolina A, Costa F, Fornari M,Brayda-Bruno M. Vertebroplasty and kyphoplasty:complementary techniques for the treatment ofpainful osteoporotic vertebral compression fractures.A prospective non-randomised study on 154 patients.Eur Spine J 2009; 18 Suppl 1:95-101.58. McGirt MJ, Parker SL, Wolinsky JP, Witham TF,Bydon A, Gokaslan ZL. Vertebroplasty andkyphoplasty for the treatment of vertebralcompression fractures: an evidenced-based review ofthe literature. Spine J 2009;9:501-508.59. Barragan-Campos HM, Vallee JN, Lo D, et al.Percutaneous vertebroplasty for spinal metastases:complications. Radiology 2006;238:354-362.60. Caudana R, Renzi Brivio L, Ventura L, Aitini E,Rozzanigo U, Barai G. CT-guided percutaneousvertebroplasty: personal experience in the treatmentof osteoporotic fractures and dorsolumbar metastases.Radiol Med (Torino) 2008;113:114-133.61. Layton KF, Thielen KR, Koch CA, et al.Vertebroplasty, first 1000 levels of a single center:evaluation of the outcomes and complications. AJNR2007;28:683-689.62. Murphy KJ, Deramond H. Percutaneousvertebroplasty in benign and malignant disease.Neuroimaging Clin N Am 2000;10:535-545.63. Laredo JD, Hamze B. Complications of percutaneousvertebroplasty and their prevention. Skeletal Radiol2004;33:493-505.Appendix ASociety of Interventional RadiologyStandards of Practice CommitteeClassification of Complications by OutcomeMinor ComplicationsA. No therapy, no consequence.B. Nominal therapy, no consequence; includes overnightadmission for observation only.Major ComplicationsC. Require therapy, minor hospitalization (48 hours).E. Have permanent adverse sequelae.F. Result in death*Guidelines and standards are published annually with aneffective date of October 1 in the year in which amended,revised or approved by the ACR Council. For guidelinesand standards published before 1999, the effective datewas January 1 following the year in which the guidelineor standard was amended, revised, or approved by theACR Council.Development Chronology for this Guideline2000 (Resolution 14)Amended 2004 (Resolution 25)Revised 2005 (Resolution 44)Amended 2006 (Resolution 16g, 17, 34, 35, 36)Revised 2009 (Resolution 25)Revised 2011 (Resolution 40)Revised 2012 (Resolution 6)12 / Vertebral Augmentation PRACTICE GUIDELINE