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Vol. 59, No. 20, 2012ed for broad collaboration across a large number of diversekeholders; clarification of the relationship between med-l radiation and stochastic events; required education ofering and providing physicians, and creation of a culturesafety; development of infrastructure to support robustse assessment and longitudinal tracking; continued close

Medical diagnosis and treatment has employed ionizingradiation as an indispensable tool since its introduction byRoentgen in 1895. Advances in medical imaging andprocedural technology and utilization growth have resultedin an increase in radiation exposure in cardiovascular pa-

findings and conclusions in this report are those of the conferenceticipants and do not necessarily reflect the official position of the Americanlege of Cardiology Foundation, the American Heart Association, and theke Clinical Research Institute.his document was endorsed by the American Heart Association, Americaniety of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovasculariography and Interventions, Society of Cardiovascular Computed Tomography,Society of Nuclear Medicine.

ee the Online Appendix for a complete list of conference participants andanizations and corresponding disclosure information.he following companies provided unrestricted educational grants for the meeting:Healthcare, Lantheus Medical Imaging, Inc., and Phillips Healthcare; St. Jude

dical provided partial support for this program.he American College of Cardiology Foundation requests that this document be

adult cardiovascular medicine: proceedings from the Duke University Clinical ResearchInstitute/American College of Cardiology Foundation/American Heart Association ThinkTank held on February 28, 2011. J Am Coll Cardiol 2012;59:183347.

This article has been copublished in Circulation, the Journal of CardiovascularComputed Tomography, and the Journal of Nuclear Cardiology. Copies: This documentis available on the World Wide Web sites of the American College of Cardiology(www.cardiosource.org), American Heart Association (www.heart.org), AmericanSociety of Nuclear Cardiology (www.asnc.org), Heart Rhythm Society (www.hrsonline.org), Society of Cardiovascular Computed Tomography (www.scct.org),and Society of Nuclear Medicine (www.snm.org). For copies of this document, pleasecontact Elsevier Inc. Reprint Department, fax 212-633-3820, e-mail reprints@elsevier.com.

Permissions: Multiple copies, modification, alteration, enhancement, and/or distribu-tion of this document are not permitted without the express permission of the Americanm cardiovascularment and nongoysicists, and patied strategies towaerview of the dd as follows: Douglas PS, Cakherjee D, Taylor AJ. Develoaging societies, private payers, gov-nmental agencies, industry, medicalrepresentatives met to develop goalsthis end; this report provides anssions. This expert think tank

safety inactions npossible urr JJ, Cerqueira MD, Cummings JE, Gerber TC,ping an action plan for patient radiation safety in

College of Cardiohealthpermissionsdiovascular imaging is complex, any proposedto be carefully vetted (and monitored) for

ntended consequences.ONFERENCE REPORT

Developing an Action Plan for PatientRadiation Safety in Adult Cardiovascular MedicineProceedings From the Duke University Clinical Research Institute/American College of Cardiology Foundation/American Heart AssociationThink Tank Held on February 28, 2011Participating societies include the American College of Cardiology Foundation, American College of Radiology,American Heart Association, American Society of Nuclear Cardiology, Heart Rhythm Society,Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography,and Society of Nuclear Medicine

Writing/SteeringCommitteeMembers*

Pamela S. Douglas, MD, MACC, FAHA, Chair

J. Jeffrey Carr, MD, FACC, FAHAManuel D. Cerqueira, MD, FACC, FAHAJennifer E. Cummings, MD, FACC

Thomas C. Gerber, MD, PHD, FACC, FAHADebabrata Mukherjee, MD, FACCAllen J. Taylor, MD, FACC, FAHA

*See Appendix for Writing Committee disclosure information.

stract

chnological advances and increased utilization of medicalting and procedures have prompted greater attention tosuring the patient safety of radiation use in the practice ofult cardiovascular medicine. In response, representatives

attention to patient selection by balancing the benefit ofcardiovascular testing and procedures against carefully min-imized radiation exposures; collation, dissemination, andimplementation of best practices; and robust education, notonly across the healthcare community, but also to patients,the public, and media. Finally, because patient radiation

012 by the American College of Cardiology Foundation; the American Heart Association, Inc.;the Duke University Clinical Research Institutelished by Elsevier Inc.

ISSN 0735-1097/12/$36.00doi:10.1016/j.jacc.2012.01.005imverntrdiscu

ched consensus on several broad directions including: the

careedni

Introductionlogy Foundation. Please contact Elseviers Permission Department at@elsevier.com.

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1834 Douglas et al. JACC Vol. 59, No. 20, 2012nts. This has rekindled the controversy as to whether thedoses of ionizing radiation used in cardiovascular care

y lead to an increased lifetime risk of cancer, and whetherh risks can be justified in light of the established medical

nefits (19). Recently, the discussion has expanded be-nd the medical and physics communities to capture theention of the media, patients, and lawmakers. In Febru-

2010, the House Committee on Energy and Com-rces Subcommittee on Health held a Hearing on Med-l Radiation: An Overview of the Issues (10), which waslowed in March 2010 by a public meeting of the Foodd Drug Administration, Device Improvements to Reducenecessary Radiation Exposure from Medical Imaging,12). Both of these meetings discussed the need toulate radiation exposure in the clinical setting. Despitese intense efforts by multiple stakeholders, many unan-ered questions remain.Radiation is an unavoidable part of our daily lives, withying levels of background exposure from natural sourcesluding radionuclides in our bodies, cosmic rays, groundrces, and radon (13). Although unnecessary radiation ex-

sure is clearly undesirable, the judicious and appropriate uselow levels of ionizing radiation in medical applications isrinsic to the current state of the art of cardiovascular care. Itsplication contributes to many other advances that have

arkably reduced morbidity and mortality from the Amer-s number 1 killer (14). Thus, the effective diagnosis andatment of cardiovascular disease (CVD) often requires someosure to radiation (1517), and the goal should be appro-

ate use rather than the elimination of radiation exposure). The balance between the benefits and risks associated

th ionizing radiation must be evaluated in every clinicalnario in order to provide optimal care. For justified proce-res, exposure should be optimized to give the lowest possiblese while maintaining image quality to give the highestssible accuracy. For example, in older patients and thoseth life-threatening CVDs, the benefits of accurate diagnosisd optimal management that are facilitated by imaging areely to outweigh the minimal or theoretical risks of optimaliation exposure.Defining and accomplishing optimal patient radiationety in adult cardiovascular medicine represents a complexd difficult task. To develop practical approaches to theseategies, in February 2011, the Duke Clinical Researchstitute (DCRI), the American College of Cardiologyundation (ACCF), and the American Heart AssociationHA) convened a meeting of representatives of cardiovas-lar imaging societies, government agencies, industry,dical physicists, safety experts, and patient representa-es. The discussions at the Think Tank, therefore, repre-t the opinions and recommendations of the participants,

d not necessarily the policy of the ACCF or the organi-ions providing representatives.This report provides a review of the discussions and

Cardiovascular Radiation Safety Conference Reportategic recommendations from the Think Tank to en-nce patient radiation safety for cardiovascular imaging

dubewid procedures. Together, these deliberations provide aust and feasible road map for optimizing radiation safety,ucing patient dose, and obtaining diagnostic qualityages while maintaining optimal cardiovascular careough appropriate and best practice use of imaging forgnosis and to guide therapeutic procedures.

ntemporary Cardiovascular Therapyd Increasing Radiation Exposure

D is responsible for 33.6% or 1 of every 3 deaths in theited States, more than any other cause of death. Animated 82,600,000 American adults (1 in 3) have somem of CVD, and the lifetime risk for any CVD is 2 in 3men and 1 in 2 for women (14). Given the high

valence and mortality associated with CVD, timelygnosis and treatment are crucial.The development and clinical application of imaging mo-lities, such as radionuclide myocardial perfusion imaging,ocardiography, computed tomography (CT), magnetic res-

ance imaging, fluoroscopy, and angiography have signifi-tly enhanced the diagnostic and therapeutic approach toD by improving diagnosis and procedural guidance and

abling less invasive treatments. These advances in earlygnosis and management, coupled with improved treatmentCVD, have contributed to a remarkable reduction inrbidity and mortality; from 1997 to 2007 the death ratem CVD declined 27.8% (14). Substantial growth in cardiacaging occurred concurrently with, and may have influenced,

declining cardiovascular morbidity and mortality (19,20).wever, the increased demand generated in response to the

going technological evolution has resulted in a significantrease in the general populations exposure to ionizingiation for medical purposes. A recent report from thetional Council on Radiation Protection and Measurementsimated that the collective dose received from medical uses ofiation in the United States increased by 600% between

80 and 2006 (13).

erview of Patient Radiation ProtectionCardiovascular Care

e biological effects of ionizing radiation fall into 2 broadegories. Deterministic effects predictably occur above cer-n thresholds of absorbed dose to a specific tissue andlude skin erythema, epilation, and possibly even directdiac toxicity. Stochastic effects are those in which radiationses damage that may result in a malignancy, usually at ach later time. The risk and frequency of malignanciessed by the levels of radiation used in medical imagingains undetermined and controversial. However, given

s uncertainty, it is critical to educate providers to mini-ze dose by performing only diagnostic exams and proce-res that are appropriate and necessary, considering the

May 15, 2012:183347nefits and risks of alternative examinations or proceduresthout radiation, and by using the best possible combina-

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1835JACC Vol. 59, No. 20, 2012 Douglas et al.Mayn of equipment, dose, and protocols that will still result inurate and diagnostic studies. Such practices are aligned

th fundamental principles of radiation protection indicine (21,22,22a); a procedure is justified if it is the most

propriate means of accomplishing the clinical goal and isimized by using the smallest necessary amount of radia-n that provides diagnostic image quality (ALARA, orng a radiation dose As Low As Reasonable Achievable),24).

simetry: Measuring Radiation Exposure

sential to any discussion of radiation safety is the differ-tiation between exposure and dose. Exposure is theount of radiation produced by the device and the subse-ent ionization of air molecules and is typically and simplyasured in air. In comparison, the amount of energy

sorbed per unit tissue, referred to as the absorbed dose, isch more relevant to the discussion of radiation risks.

tient absorbed doses vary by organ and body regionthin a patient. The absorbed dose cannot be measuredectly but can only be estimated for a given exam sincemerous patient- and exam-specific factors dramaticallyer how much radiation is absorbed in different patients for

same imaging protocol from a given device. Thus, evenhe scanner-delivered exposure is constant, the number ofay photons that reach various tissues and organs variesatly between individuals. Additional contributors to vari-

ility in radiation absorption include machine design andability, scanning techniques, and other technical param-rs. Nevertheless, exposure can be a useful parameter fornchmarking between imaging protocols and institutions.In addition to the difficulty in measuring the unique dosetribution for each patient for each test, radiation dosim-y metrics differ by imaging modality, making compari-s of exposures from different tests and assessing cumu-

ive dose for a given individual challenging. Forionuclide studies, the administered activity, expressed inndard international (SI) units of Becquerel (Bq), is thendard measurable dosimetry parameter, and internalsorbed doses to the patient may be calculated by standardthods in milligrays per unit administered activity (2527). Onellicurie, the traditional unit for activity, corresponds to 37Bq. For fluoroscopy and cineangiography, the measurablesimetry parameters include total air kerma at the inter-tional reference point, measured in Grays (Gy), and thekerma-area product (28) measured in Gy cm2. For, the volume computed tomographic dose index (CT-

vol), expressed in SI units of milligrays (mGy) or dose-gth product (DLP) expressed in SI units of mGy/cm arest commonly used (29).

The effective dose (E, reported in SI units of milliSiev-s, mSv) is sometimes used to facilitate comparisons ofiation exposure across modalities and exams. Effective

15, 2012:183347se is a surrogate for risk used in radiation protection thatects a whole-body estimate of the dose value that wouldld the stochastic risk equivalent to that of a given

thabionuniform partial-body exposure to ionizing radiationh as occurs in medical imaging (25). Effective dose is a

neric estimate of risk with a wide margin of error andnot be measured directly, but instead is obtained fromdeling, simulation, and interpolation. Although effective

se can be used to compare different scan protocols orminations performed with different imaging modalitiest use ionizing radiation, it cannot express the biological

k specific to individual patients. However, note thatective dose may be useful in comparisons of the stochastick of different medical procedures in population groupst receive ionizing radiation, against each other or against

ckground radiation, whereas direct organ dose calcula-ns are better suited to optimize radiological procedurest involve multiple organs. Despite these efforts at stan-

rdization, measurement of radiation exposure and risk isntroversial, and there is not universal agreement on thepropriate approach.

deling the Potential Cancer Risksociated With Medical Radiation

e risk of malignancy attributable to low dose (100 mSv)els of ionizing radiation is extrapolated from follow-up ofvivors of the atomic bomb explosions in Hiroshima andgasaki, Japan, in 1945 (30). The appropriateness of thisrapolation is controversial because, in contrast to patientso undergo repeated low-dose medical imaging over decades,se subjects experienced a single episode of whole-bodyosure to different types and qualities of radiation (includingha particles) with higher doses delivered over seconds toys. Nevertheless, the linear no-threshold (LNT) modelrived from these data is currently used as the standard modelpotential radiation risk in radiation protection, including thelogical Effects of Ionizing Radiation (BEIR) VII report). However, there are some concerns with use of LNT as andard. The concept of effective dose and the LNT hypoth-s were developed for occupational radiation protection andt as predictive biological models for patients exposed toiation during medical imaging. Further, the assumptionerent in LNT, that cancer risk increases linearly with dose

d that there is no dose level below which there is no risk, isllenged by other models that are well covered elsewhere (32).ally, stochastic risks are random by definition, and thereforeuld not be linearly related to cumulative exposures.

Based on the LNT model, the average lifetime risk of cancerrtality in the general population attributable to an effective

se of 1,000 mSv (an exposure equal to 50 to 500 typicalonary CT angiograms or radionuclide perfusion studies) isimated at 5% to 7.9% (31). However, prospective, long-termservational studies (33,34) have not unequivocally confirmedincreased risk of solid cancers related to medical or occu-

tional low-dose radiation (100 mSv) delivered over manyrs, thereby neither confirming nor refuting the LNT model.is may be because the cancer risk is so small at this dose level

Cardiovascular Radiation Safety Conference Reportt accurate detection of excess risk of over those conveyed bylogical factors and other known carcinogens would require

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1836 Douglas et al. JACC Vol. 59, No. 20, 2012cking5,000,000 adults over their lifetimes (32). Epidemi-gical studies of radiation as a carcinogen are further com-cated by the long latency period of most radiation-inducedcers. Despite this uncertainty, stochastic radiation risks

ely decrease with increasing age and are lower in men thanwomen; findings that are particularly germane to the

pulation of patients with coronary artery disease.

proaches to Radiation Safety

proaches to patient radiation safety must be lifelong andt confined to simply reducing the exposure during a singlet or procedure. From a patient standpoint, the Americanllege of Radiology and the National Council on Radia-n Protection and Measurements suggest that efforts candivided into those that occur before the imaging orcedure, during the test or procedure to ensure thatosure is minimized, and then afterwards to ensurelong safety (35,36). The Joint Commission uses an

alogous construct in dividing the requirements for its11 Sentinel Event Alert into right test, effective processes,e technology, and safety culture (25,3741).Before imaging or procedures: Tests and procedureslizing radiation should be performed in the right patient,the right reason, at the right time, and alternatives toiation should be considered. Thus, the issue of radiationtection is relevant for every clinician making imaging

d procedural decisions. The ACCF appropriate use cri-ia (16,4247) offer an important framework to ensurepropriate use, whereas concomitant consideration of rel-ve radiation dose levels may be helpful in balancingcacy and potential radiation exposure to the patient totermine whether the procedure is justified (35). This stephighly important since the increase in population expo-e has occurred in the setting of decreased radiation fromh individual test and therefore has resulted entirely fromreased use. The International Commission on Radiolog-l Protection (22,48) and AHA (25) have developederence levels for use as benchmarking and quality assur-ce tools that may be helpful in estimating anticipatedosure from proposed procedures.

Creation of a safe environment and education of orderingd rendering providers must also occur before imaging isrformed. The increased attention to the importance ofiation protection has led to both professional society andreditation body recommendations in these areas (41).During imaging: Each rendering physician, laboratory,d hospital must be responsible for optimizing the doselivered for each test or procedure. The need for greaterndardization is demonstrated by significant variations (up13-fold) in radiation doses for similar types of imagingcedures, within and across institutions for both coronaryangiography and nuclear imaging (3,4,49). Professional

Cardiovascular Radiation Safety Conference Reportieties have addressed these challenges through the cre-on of robust procedural and safety guidelines, including

ideradse from the American Society of Nuclear Cardiology, theciety for Cardiovascular Angiography and Interventions,Society for Cardiovascular Computed Tomography, andSociety of Nuclear Medicine (25,3740,50). Newer

hnology has already enabled dramatic dose reductions fordiac computed tomography angiography (e.g., prospec-e electrocardiogram-triggered axial imaging) and nuclearg., use of technetium instead of thallium, reduced-doseaging using high-sensitivity cameras) and holds promiseadditional future dose reduction. Additional attention to

se management and optimization would be facilitated byuipment capable of automatically providing radiationosure estimates for benchmarking, quality improvement,

d research, and by ensuring that users understand how toperly operate the equipment.After imaging: Although it is likely that more appropri-utilization and further improvements in technology willuce overall radiation exposure to patients, these necessaryerventions are not sufficient to ensure patient safety acrossltiple episodes of care for multiple diseases delivered byny providers. Although cumbersome and burdensome toviders of imaging services, reporting doses from individ-

l exams using the electronic medical record or alternativethods is essential as a quality improvement tool for therposes of benchmarking and radiation minimization.wever, tracking cumulative dose in a given individual is

th difficult to do accurately and has no clear value forproving long-term patient safety, given the inherentlydom nature of stochastic events. Further, whether or noth information can be used to better inform decisionking on types of diagnostic studies to be performed forh episode of care is unproven. One exception to this iscking exposure during a single episode of care involvingeated or high exposure, such as percutaneous coronaryerventions or ablative treatment of arrhythmias, whichy put a patient at risk for deterministic effects. Similarly,s recommended that short-term follow-up be performeder high-dose fluoroscopic procedures (i.e., 5 Gy) totect and treat any resulting deterministic effects.

veloping an Action Plan forrdiovascular Radiation Safety Stakeholders

e uncertainties surrounding the actual levels of patientse related to cardiovascular care, the assessment of poten-l competing benefits and risks, and the need to developctical approaches to radiation safety and education ofysicians, patients, and the public require the input andertise of many relevant stakeholders. Such collaboration

d cooperation recognizes the unique knowledge, perspec-es, and experiences of each group. Therefore, 1 of thetical strategies in achieving the Think Tank goals was to

May 15, 2012:183347ntify and bring together these stakeholders to join iniation safety improvement:

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1837JACC Vol. 59, No. 20, 2012 Douglas et al.May Research scientists; funding agencies: Radiation bi-ologists and physicists working in both the basic andapplied sciences perform much needed research aboutthe biological effects of radiation exposure and how toquantify radiation dose.

Healthcare professionals; professional and scientificorganizations: Physicians and physician societies areprimary stakeholders as requestors and providers oftesting that has been demonstrated to improve mor-bidity and mortality and as the guarantors of optimumsafety for their patients. These groups are responsiblefor developing and implementing optimal imagingprocedures and educational initiatives and should playa collaborative role in developing standards and regu-lations regarding radiation safety. In addition, they areresponsible for defining the content of undergraduate,graduate, and continuing medical education. Nonphy-sician staff are also critical to development and imple-mentation of standards.

Medical physicists: Although the role of physicists inmany cardiovascular facilities has been limited toquality control testing of equipment and ensuringcompliance with state and federal regulations, theirknowledge base is invaluable in quality improvementand education.

Regulators: Federal agencies, including the Food andDrug Administration and Nuclear Regulatory Com-mission, and the state radiological health agencies areresponsible for creating testing standards and moni-toring and ensuring compliance through regulation,and for responding to proposed changes in protocols/dosing that would minimize radiation exposure. Otherregulators, including accreditation agencies such as theJoint Commission, the American College of Radiol-ogy, and the Intersocietal Accreditation Commission,promote safety and standardization through accredita-tion of imaging and procedural laboratories.

Payers: At a national level, the Centers for Medicareand Medicaid Services (CMS) sets guidelines for anyfacilities (hospital and independent imaging facilities)seeking CMS reimbursement for imaging procedures.Government and private payers are also in a uniqueposition to identify and possibly flag duplicate imagingtests and procedures, especially when care may be providedby multiple caregivers. In addition, payers are able toprovide incentives to providers to improve care andradiation safety on multiple levels and need to be opento rapidly covering and reimbursing/paying for mod-ified procedures that would minimize radiation expo-sure. On a patient level, payers should not use radiationhistory alone as an independent factor in determiningauthorization for a procedure.

Industry: Industry can uniquely advance the develop-ment of new technologies and make these features

15, 2012:183347available to providers and patients. Such featuresinclude the ability to ensure diagnostic accuracy while

whrepcardelivering lower doses of radiation, tracking exposure,and transferring dose values to structured reports andthe electronic health record. Both individually andthrough organizations such as the Medical Imagingand Technology Alliance, industry is able to assist withstandardization of dose measurement across tests,protocols, and healthcare providers and with dissemi-nation through education regarding exposure and pro-motion of facility quality assurance practices.

Patients, public, and media: In the absence of auniversal medical record, the patient may be the onlysource of information regarding prior procedures andradiation exposures. Further, as with all care, patientsshould be educated to make informed decisions,which implies a basic level of knowledge as well asprovider disclosure of potential radiation-associatedrisks related to testing and procedures. In theabsence of a universal medical record, the patientcan take an active role by keeping a record of his/herexams and question the need for tests so they are notrepeated unnecessarily.

itical Areas and Strategies for Action

e Think Tank organizers identified 4 critical areas forich experts were charged with defining 3 to 5 goals andociated strategies required to achieve these includingthods, responsibilities, stakeholders, and implementatione frame. The time frame was meant to convey theency of the issue as well as relative priorities of differentommendations. The topics were

Quantifying the estimated stochastic risks of low-doseradiation associated with cardiovascular imaging andtherapeutic procedures.Measuring and reporting radiation dose in cardiovascularimaging and procedures.Minimizing radiation dose for single episodes of care andacross entire systems of care.Educating and communicating with multiple groups toincrease awareness and achieve goals in minimizingexposure.

oup 1: Quantifying the Estimated Stochasticsks of Low-Dose Radiation Associated Withntemporary Cardiovascular Imaging anderapeutic Procedures

rrent, ongoing radiation biology and epidemiologyearch efforts are robust but still insufficient to fullydress critical questions raised by the need for improvediation safety (51). Identified needs are presented inble 1 and as follows.Basic and translational research into the mechanisms byich radiation-induced cellular DNA damage and cellular

Cardiovascular Radiation Safety Conference Reportair and misrepair mechanisms affect radiation-relatedcinogenesis (52,53) should be encouraged and supported,

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1838 Douglas et al. JACC Vol. 59, No. 20, 2012th particular attention to the low-doseresponse relation-p at the molecular and cellular level. Several areas ofearch were identified as important:

Biological markers of injury. Currently, it is unknownwhich, if any, clinically obtainable biological markers ofradiation injury (such as DNA double-strand breaks orsister chromatid exchanges in blood samples) predictradiation-induced cancer. Identification and clinicallyavailable testing for such markers may allow betterpatient risk stratification.Models of injury. Mechanistic biology-based dose-response models at the level of cellular protein abnor-malities hold the promise of predicting malignancyinduction with better resolution than epidemiologicalstudies. Such new models are being used to studyrecently identified potential confounders of the cur-rent understanding of the dose-response relationshipat low-dose ionizing radiation, such as genomic insta-bility (54), bystander effects (55), or adaptive re-sponses (56). A National Institutes of Health work-shop to further explore the opportunities in this areawould be an important first step toward dedicatingfunding.Because the science and methods of radiation dosimetryare complex, better techniques for modeling and simu-lation are needed to estimate radiation dose and thepotential biological impact. These same methods wouldlikely have relevance to the public secondary to applica-tion related to occupational exposures, nuclear accidents,or acts of war/terrorism.

Implementation: 2014 and ongoing.

Epidemiologic research is required to define the trueg-term risks of exposure, especially in those at high

k (such as children or those with multiple, serialposures). The stochastic risks of serial low-dose expo-

ble 1. Strategies for Quantifying the Estimated Stochastic Riskntemporary Cardiovascular Imaging and Therapeutic Procedure

StrategyPrimary

Responsib

ic and translational research in radiation biology Research sci Physicists Funding age

aluate biological markers of cellular radiation injury asedictors of radiation-induced canceretermine the dose-response relationship betweendiation and molecular and cellular effectstter techniques for modeling and simulation to estimatediation dose

demiological research on population effects of radiation Research sci Physicists Funding age Industry

ng-term studies of patients at high risk (e.g., children,gh exposures due to occupation or accidents)rge prospective registries focused on defining stochasticks of radiation exposureevelop models of risk related to chronic or serialposure to low-dose medical radiation

Cardiovascular Radiation Safety Conference Reportres are inadequately defined; research into statisticald mathematical models should be encouraged. Another

useana for research is how repeated exposure should beded to calculate risk as there are widely varyingommended adjustment factors (dose and dose-rateectiveness factor). Creation of multispecialty registriesth large sample sizes or augmentation of existingistries is a promising prospective approach that would

pport development of novel methods for modelingsorbed dose to provide more accurate patient specificses. However, significant obstacles exist, includingtistical validity and power, incorporation of epidemi-gical expertise, length of follow-up, obtaining accurateimates of relevant organ doses, tracking nonmedicaliation exposure, generalizability of findings, andrces and availability of funding. At present, a numberpopulations with prolonged exposure to higher thanrage levels of radiation (i.e., radiation accidents orited radiation protection) are being studied.

Implementation: 20142015.

oup 2: Measuring and Reporting Radiation Dose inrdiovascular Imaging and Therapeutic Procedures

e accurate estimation of dose for even a single medicalosure requires numerous assumptions and complex mod-

ng performed by medical physicists. Thus, rigorous radi-on dose estimates are typically obtained only in specificuations, when detailed dosimetry is required (such aspected overexposure, equipment malfunction, and expo-e during pregnancy). Despite having significant inherentcertainty and unclear utility and not intended to be usedindividual patients, the radiation protection quantity ofective dose is sometimes used for this purpose in thesence of a better estimate. This is especially true in thege of 50 mSv, a threshold that is rarely crossed bygle exposures for diagnostic imaging purposes. Measur-

and communicating effective dose provides only aited estimate of potential biological risk and should be

Low-Dose Radiation Associated With

StakeholdersImplementation

Time Frame

s Professional and scientificorganizations

Industry

Ongoing; funding foradditional researchby 2014

s Professional and scientificorganizations

Hospitals and testing/procedural labs

Payers

Ongoing; registry by 2014

May 15, 2012:183347Ca

Thexpeliatisitsussurunineffabransininglimd only with great caution to estimate benefit-to-riskalyses. However, given the heightened concern regarding

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1839JACC Vol. 59, No. 20, 2012 Douglas et al.Mayiation exposure and potential deleterious effects onalth, effective dose is an estimate of potential detrimentt can be used to compare biological risk of differentdical procedures against each other or against back-und radiation, as well as to optimize safety of proceduresuiring radiation. Ongoing efforts to develop a better andily obtained measurement for tracking and assessinglogical risk are needed. The following 4 strategies wereommended (see also Table 2).

rategy 1: Establish and Implement Standards tosure Consistent and Complete Recording ofdiation Exposure and Patient Parameters RequiredEstimate Dose

e measures of exposure and patient parameters necessaryaccurately model patient radiation dose (age, sex, height,ight, detailed anthropometry, and part of the bodyosed) are well established for most modalities, althoughbiokinetics of nuclear radiopharmaceuticals are less well

own. When applicable, exposure or dose estimates shouldsystematically and automatically captured at the time ofdical imaging. Properly formatted through a newly de-oped Digital Imaging and Communications in MedicineICOM) standard, this metadata combined with mea-ed procedural dosimetric data could be used to providerce data for population-based studies and research to

prove our understanding of exposure, absorbed dose, andtential biological effects. Resources to define and imple-nt the new standards that would be required to embed

eded patient and technical factors within the practice ofdical imaging should be made a high priority at this time.ce established, collection of these data should be auto-ted and universal. Until this can be accomplished, allorts should document radiation dose in terms of thendard measurable dosimetry parameters that are used tofine diagnostic reference levels. For example, for CT the

ble 2. Strategies for Measuring and Reporting Radiation Expos

Strategy Primary Responsibility

ate standards and mandate recordingelevant radiation exposure andient parameters

Industry Healthcare professionals Radiation physicists

and or develop central registries withiation exposure data to support bestctices

Payers Funding agencies Professional and scientific organ Industry

elop and implement standards andtems for communicating radiationosure beyond effective dose

Healthcare professionals Radiation physicists Funding agencies Professional and scientific organ Industry

uce exposures that causeerministic effects through enhanced

Industry Hospitals and testing/procedural

15, 2012:183347osure monitoring and warningcedures

Certifying and accrediting organizations RegulatorsDI(vol) is displayed on all scanner consoles manufac-ed after 2006.Implementation: 2012 and ongoing.

rategy 2: Expand or Develop Central Registrieslated to Radiation Exposure and Cardiovascularaging to Support Best Practices and New Research

velopment of an automated, multispecialty national doseistry (and incentives for participation) would collectjective data for research and allow facilities to compareses to national reference levels, which would be a majorprovement to quality assurance practices. The Food andug Administration and other organizations have pro-ted the development of registries for the purposes of

veloping national diagnostic reference levels and bestctices for facility quality assurance (12). The value ofchmarking providers to their peers has been amply dem-

strated to rapidly reduce radiation dose to levels consistentth best practices for a given exam or device (57). Registriesuld help with transparency by providing authoritative andjective data on actual exposures, which in turn would informre meaningful discussions by public, governmental, health

vocacy, scientific. and professional groups. Work to ensuret patient privacy and validity of the data should be sup-rted as part of the process.Implementation: 2013 and ongoing.

rategy 3: Develop and Implement StandardsCommunicating Radiation Exposure and the

stems to Facilitate Adoption Within thealthcare Community

ven the complexity of developing standards in the science andminology of communicating radiation exposure, dose, andtential risk from medical imaging studies to patients, providers,

the broader community, this task will require the resourcesinvestment of many stakeholders. In the short term, available

asures of exposure such as dose-area product should be docu-

nd Dose in Medical Imaging

StakeholdersImplementation

Time Frame

Patients, public, media Regulators Professional and scientific organizations

2012

s

Healthcare professionals Professional and scientific organizations Certifying and accrediting organizations Payers Regulators

2013 and ongoing

s

Patients, public, media Regulators Payers

Ongoing

Patients, public, media Professional and scientific organizations

2012

Cardiovascular Radiation Safety Conference ReportCTtur

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1840 Douglas et al. JACC Vol. 59, No. 20, 2012nted in clinical care and reported as part of all clinical trialsolving radiation use (58). To avoid conflicting language andiable implementation, a standard vocabulary to reduce jargon

the development of systems to support these standards areded to provide consistent and complete information to patients

providers and to promote appropriate utilization. Onceated, use of these standards should be mandatory.Implementation: 2012 and ongoing.

rategy 4: Minimize Deterministic Effects

though much of the concern revolves around late, sto-astic effects, in very rare situations, high exposures tognostic radiation can result in short-term deterministic

ects that may occur when thresholds for biological dam-e are exceeded. Since these deterministic effects aredictable, all healthcare professionals and imaging labo-ories should be aware of them, and the dose activelynaged throughout the procedure. In addition, robustety practices should be instituted to ensure real-timetection if dose thresholds are ever approached, withndated reevaluation of the imaging or therapeutic strat-

y of the particular procedure.Implementation: 2012.

oup 3: Strategies to Minimize Radiation Dose:m Single Episodes of Care Involvingrdiovascular Tests and Procedures,Systems Change

ethods exist to achieve substantial reduction in radiationse. However, gaps in provider knowledge, differences inage acquisition protocols, and limited transparency leaddelays and fragmentation in the implementation of

sting dose-reduction opportunities. Reducing the popu-ion burden of medical ionizing radiation will requirellaboration, interventions, and accountability at the levelindividual patient care episodes, healthcare providers,iation physicists, imagers, and healthcare systems. Thent Commission has recognized the need for such systemsange and provided a strong incentive for compliance withSentinel Event Alert (41).

Appropriate patient selection reinforced through decisionport tools and provider education can reduce the perfor-nce of inappropriate medical imaging procedures (16).e lack of incentives to do the right thing and engrainedctice routines that may reflect medicallegal and eco-mic concerns may hinder the adoption of appropriateaging use. Application of existing ACCF appropriate useteria could reduce these barriers. Tools in developmentlude multimodality appropriate use criteria, which willultaneously assess the appropriateness of testing alterna-

es in specific clinical scenarios, including methods that dot involve ionizing radiation and imaging performanceasures. To fully implement any of these, the healthcaretem should develop incentives for their use.

Cardiovascular Radiation Safety Conference ReportIn performing appropriate studies, substantial radiationse reductions can be achieved by application of existing

levthehnologies. For example, adjustments in cardiac CTuisition protocols can lead to significant dose reductionsough the application of reduced tube potential, and

rformance of prospectively triggered versus retrospectivelyted image acquisition in properly selected patients (59).wever, diagnostic image quality must not be compro-

sed, and the point at which dose minimization mayve an unintended negative consequence on diagnosticuracy remains uncertain. Prospective implementationdies of optimal techniques and protocols suggest thatgnostic image quality can be retained while usingse-reduction techniques (57,60), making inconsisten-s in the application of dose-reduction strategies a lostportunity.There are many opportunities to reduce variability in therformance of procedures that use ionizing radiation foridance, such as patient shielding during fluoroscopiccedures, reduction of fluoroscopy and cineangiographycedural times, and image processing techniques to elim-te unnecessary duplicated images and radiation exposure.llowing existing and future guidelines and implementa-n of robust quality control measures can be accomplishedmediately. In addition, novel complementary stereotaxicd magnetic resonance navigation technologies and non-oroscopic techniques such as optical coherence tomogra-y ultrasound guidance (OCT/US) for anatomical assess-nts are promising (36). Similarly in the area ofionuclide imaging, recommendations have been madethe use of stress-only imaging, positron emission tomog-hy, and adaption of new camera technology that allows amatic reduction in the dose normally administered (39).rther technical refinements will lead to new opportu-ies for dose reduction, and an initial focus on stan-rdizing terminology and harmonizing methods willilitate their implementation across technical platforms,

th avoidance of overly proprietary techniques. Preventing theergence of unproven modalities confused by proprietarygon will require demonstration of benefit/risk during theulatory approval process and be reimbursed such thatviders of services are strongly encouraged to adopt innova-

e protocols.Sustained education and quality improvement programs

lead to meaningful radiation dose reduction (61,62).ch programs should recognize the opportunity to engage,t only imagers, but also ordering physicians in efforts toieve population dose minimization through education on

t and procedure selection. For example, dose administra-n should be a routine part of laboratory quality programs.verage of payment models emphasizing appropriate used quality imaging performance could further bolsterorts at dose minimization.Recommended strategies toward dose minimization that

May 15, 2012:183347erage existing and future technologic advances includefollowing (see also Table 3).

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1841JACC Vol. 59, No. 20, 2012 Douglas et al.Mayrategy 1: Education to Create aore Uniform Understanding andproach to Dose Minimization Techniques

ethod 1: Adopt mandatory annual live or online trainingbasic radiation safety techniques for healthcare providersolved in the ordering or performance of medical proce-res using ionizing radiation. A model for this approach isvided by current requirements for training for universalcautions procedures mandated through hospital accred-

tion organizations and current state mandates for fluo-copy training. Topics could include radiation safety,ernatives to use of tests with ionizing radiation, andnciples of patient selection. Because there are few currentuirements for any form of radiation training for providerso order procedures, such education should be integral to

neral as well as procedural cardiology training programsd continuing medical education.Implementation: Before 2014.Method 2: Adopt a professional approach through em-asis on the principles and practice of radiation doseuction as core knowledge within professional educationluding cardiology and subspecialty board certificationterials and examinations.Implementation: Before 2015.

rategy 2: Quality Metricsantitative Reporting of Quality Metrics on Testing

ble 3. Strategies to Minimize Radiation Dose Exposure From S

Strategy Primary Responsib

cation: training Certifying and accrediting or

andatory annual online training onsic radiation safety techniques foralthcare professionals involved ine ordering or performing of medicalocedures using ionizing radiation

cation: professionalism Professional and scientific o Certifying and accrediting orphasize the principles and practice

radiation dose reduction as coreowledge within professionalrtifying education for all healthcareofessionals

lity metrics Professional and scientific o Hospitals and testing/procelaboratories

evelop quality metrics for internalporting within organizations, withadual transition to external reporting

mon industry/technology standards Industry Professional and scientific o Regulators

evelop common protocols,finitions, parameter settings, andvice settings that ensure basicdiation dose minimization standardse met

15, 2012:183347ethod 1: Implement internal reporting of quality metrics,luding appropriateness of testing, use of dose minimization

cochategies, objective image quality assessments, and facility-el radiation exposures for common testing categories.Method 2: Once in place and validated, internal metricsuld be elevated to become national, publically reported

ndards.Implementation: Before 2013.

rategy 3: Common Industry/Technology Standards

ethod 1: Develop common protocols, definitions, param-r settings, and device settings that ensure satisfaction ofsic standards while allowing innovation. From a publicalth standpoint, robust quality control measures whichuce variability may provide more benefit than the latest

vances.Method 2: Continue to reduce exposure through thevelopment and use of improved equipment, technologyd techniques, shielding, and validated uses of contrastents and radiopharmaceuticals.Implementation: Ongoing.

oup 4: Education and Communication forysicians, Patients, the Public, and Media

ightened concerns about the health effects of radiationociated with cardiovascular tests and procedures mandateucation of healthcare professionals and the public about

benefits and risks associated with medical exposures.e ability to accurately assess radiation dose, to correlatedose with biological response, and to communicate these

Episodes of Care to Systems Change

StakeholdersImplementation

Time Frame

tions Healthcare professionals Before 2014

ationstions

Healthcare professionals Before 2015

ations Healthcare professionals Payers Certifying andaccreditingorganizations

Hospitals and testing/procedure laboratories

Before 2013

ations Industry Regulators Physicists

Ongoing

Cardiovascular Radiation Safety Conference Reportshosta

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1842 Douglas et al. JACC Vol. 59, No. 20, 2012ing the balance between the health benefits of cardiovas-lar imaging and the risks to stakeholders, includingtients, physicians, technologists, industry, and the generalblic (see Table 4). This information exists in variousms and is directed to varied audiences that often do notmmunicate with each other, and when they do, under-nding may not occur due to differences in presentationd comprehension.

rategy 1: Identify, Catalog, andvelop Educational Resources

blished scientific and Web-based information on theks and benefits of ionizing radiation provided by profes-nal and medical societies and government agenciesuld be made available to the public, patients, andfessional and medical practitioners. Because accessings information at the appropriate level of understanding

be difficult, it should be modified and cataloged for thepropriate stakeholders so that it remains factual but doest require an advanced knowledge in radiation physics tounderstood. Primary responsibility rests with professionald medical societies and government agencies that haveficient knowledge to provide accurate information. Safe-ards must be put in place to avoid having these organi-ions lobby or market on behalf of their technologies ormbers, but rather to create factual and bias-free material withemphasis on full explanation of risks and benefits. Such efforts

date have included: http://www.imagewisely.org, focused ontting practitioners to avoid unnecessary ionizing radiationdies and to use the lowest optimal radiation dose forcessary studies; http://www.pedrad.org, focused on low-ng radiation doses in the imaging of children; andp://www.radiationanswers.org, focused on explanationsradiation and exploring myths and benefits; and the

ternational Atomic Energy Agencys Radiation Protec-n of Patients (https://rpop.iaea.org/RPOP/RPoP/ntent/About.htm). Once the existing resources have

en identified, it is expected that knowledge gaps willuire the creation of stakeholder-targeted educational

ble 4. Strategies for Education and Communication

Strategy Primary Responsibility

ntify, catalog, and developcation resources

Professional and scientific organizat Regulators

ntify and disseminate best practices Professional and scientific organizat Certifying and accrediting organizati

ghten awareness of radiation Professional and scientific organizat Healthcare professionals Research scientists Hospitals and testing/procedural lab

evelop and test new methods ofmmunicating the risk and risknefit of low-dose medical radiation

oing recognition and minimization All stakeholders above

Cardiovascular Radiation Safety Conference Reportnintended consequencesources by appropriate professional groups. Governmentencies such as the National Institutes of Health, Food andug Administration, and Agency for Healthcare Researchd Quality may have oversight and participatory roles ins effort.Because the majority of the needed material already exists,timeline is relatively short for this effort. The greatest needdevelopment is for simplified material aimed at ordering

ysicians, patients, the general public, and the mass media.anagement and coordination of the effort and the distribu-n process represent another challenge. Although Web-basedess is the fastest and least expensive, accessibility maybeited to many of the stakeholders, and development of

ernative methods such as social media, mailings, radio, andevision should be considered.Implementation: 2012.

rategy 2: Identify and Disseminate Best Practices inagnostic and Procedural Imaging

edical and professional societies have developed guide-es for when and how to perform cardiovascular imagingdies (16,25,3740,4247). This approach first looks atappropriateness of a given study and has been validated

evidence that incorporation of appropriateness guidelineso automated decision support systems limits growth innumbers of medical imaging procedures (63). If a study

inappropriate, there is usually minimal benefit, and eveninimal risk from ionizing radiation is too high. Once a

dy is deemed appropriate, it should be performed usingbest available imaging equipment and protocols for dose

timization to get the most accurate diagnosis. Accredita-n of laboratories providing services is recommended, andts should be performed and images interpreted by certi-d physicians. Both should include requirements for dem-stration of radiation safety knowledge and best practices.ese best-practice methods for imaging using ionizingiation need to be distributed to all the stakeholders and

owledge requirements implemented.Implementation: 20122013.

StakeholdersImplementation

Time Frame

Patients, public, media Healthcare professionals

20112012

Healthcare professionals Industry Professional and scientific organizations Regulators Payers

20122013

dustry Healthcare professionals Funding agencies Industry

Ongoing; 2015

Patients, public, media Ongoing

May 15, 2012:183347resagDranthi

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1843JACC Vol. 59, No. 20, 2012 Douglas et al.Mayrategy 3: Heighten Awareness ofdiation Benefits and Risks

edia reports about radiation accidents engender fear of-level radiation among the general public. Patients with

prehension about radiation may hesitate to receive appro-ate cardiovascular imaging and should be included inversations that recognize both benefits and risks, as befitsneed to ensure true informed consent. Healthcare providers

ed to be cognizant of this fear, as well as of the potential risksd benefits of imaging with ionizing radiation.As part of these communications, it is important tonvey the quantitative uncertainties about the continuousiables of dose and risk estimates. Given these uncertain-s, the American College of Radiology has proposed anproach of categorizing imaging studies by relative radia-n levels that differ by orders of magnitude rather thancise dose estimates. In addition to the difficulties inressing exposure, expressing potential risks can also be

allenging to accomplish in terms that are meaningful totients and clinicians. For example, the concept of attrib-ble lifetime risk of cancer mortality may be difficult toderstand, even if it is compared with hazards of everyday

such as likelihood of dying from a motor vehicleident or the risk of a medical error. Consideration ofchastic radiation risks in cardiovascular care should in-de, in addition to incidence and mortality of cancer,ality of life and cost to society, and should be comparedth the burden of CVD, especially if not appropriatelygnosed or treated. Because decisions on care must beividualized, such potential risks are best communicatedthe setting of a strong physicianpatient relationship.Implementation: 2015 and ongoing.

rategy 4: Identify, Monitor, andinimize Unintended Consequences

althcare providers need to help patients understand thenefits of cardiovascular imaging and minimize situationsere patients avoid potentially life-saving procedures be-se they involve ionizing radiation. Avoidance of cardiac

aging procedures by the elderly or patients with short lifeectancies may ultimately limit access to the benefits oflier diagnosis and optimal management with improve-nt in quality of life. Primary responsibility for avoidingh unintended consequences for all the listed stakeholdersts with all providers of health care who are responsible fortermining whether diagnostic or therapeutic procedures

justified or whether there are other opportunities totain equivalent information/results. Monitoring will be angoing process.Every effort must be made to keep the dose As Low Asasonable Achievable (ALARA) while at the same timeeping the benefit from diagnosis and optimal manage-nt As High As Reasonably Achievable (AHARA). We

15, 2012:183347ognize that implementing best clinical practice usingizing radiation and monitoring and recording radiation

expfloosure are essential steps that must be implemented byse providing the tests as well as by referring physicians.is is an ongoing process.

mmary and Next Steps

e DCRI, ACCF, and AHA Think Tank was convened toter define the issues and needs around patient radiationety in cardiovascular imaging and to develop an action planguide future efforts. As a 1-day meeting, the discussion andommendations are necessarily limited in scope, and shouldseen as exploratory rather than definitive. Nevertheless,eral important lessons can be gleaned.Continuing the progress on improving radiation safety as itates to cardiovascular medicine will require the efforts ofmerous stakeholders in healthcare, government, and patientocacy. Further enhancement of radiation safety will require thebined efforts and continued engagement of multiple and

erse professional groups, industry, and government. At thee time, it is unclear who will be the convener or facilitator for

se efforts in cardiovascular medicine. This is a role that may fallurally to professional societies, such as the ACC, although toe, imaging specialty societies such as the American Society ofclear Cardiology, Society for Cardiovascular Computed To-graphy, Society for Cardiovascular Angiography and Interven-

ns, and Society of Nuclear Medicine, and radiology organiza-ns such as the American College of Radiology and the Healthysics Society have been more active. A first step in uniting therts of multiple organizations and stakeholders is the develop-nt of a glossary of organizations and a clearinghouse forgoing and planned activities. This would allow for less overlap

a more comprehensive and collaborative approach to thees of radiation safety.

The lack of clarity regarding the relationship betweendical radiation and any untoward stochastic events in anividual patient is a significant impediment to setting specific

tient safety exposure standards but does not preclude robustality improvement efforts. Basic and clinical research (and

funding to support it) is needed to understand the risks oflow-dose, multiple exposures that are characteristic of most

diovascular uses. Without accurate risk estimates, it ispossible to assess the benefit-to-risk relationship for anividual patient. However, efforts to better apply the

sic principles of radiation protection and facility-levelcking are eminently feasible, with the collection ofpulation-level dose data already demonstrated to im-ve patient care (18). Nevertheless, funding mecha-m(s) for the many crucial initiatives outlined in thiscument remain a challenge.At present, the infrastructure required to support doseessment for quality improvement purposes is not in place.e needs range from standardization of terminology to

justments in equipment capabilities to automatically track

Cardiovascular Radiation Safety Conference Reportosure, patient parameters, and dose during clinical work-w. Although the primary burden rests with industry, other

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REF

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

1844 Douglas et al. JACC Vol. 59, No. 20, 2012keholders need to support and encourage these improvements,haps by requiring compliance to achieve implementation.Careful patient selection and avoidance of inappropriateting and procedures including use of ACCF appropriate

criteria is an important Think Tank recommendation.other important strategy is balancing the requirement to

ectively guide each episode of care with the need tonimize exposure. Enhancement of patient safety throughherence to the principle of As Low As Reasonablyhievable (ALARA) to guide protocol considerations, thevelopment of lower-dose radiation equipment and com-mentary technology, and widespread application ofven dose-reduction techniques are critical. Recent society

idelines, technology development, and other research haven effective to date, but the collation, dissemination, and

plementation of best practices is a particular need, and mayuire encouragement from governmental and accredita-n agencies. Additional areas in which encouragementy be helpful include reporting of quality metrics andorporation of requirements for professional certificationd maintenance of certification of personnel.Although safety is always paramount, consideration of theefits as well as the risks of medical tests and procedures is inpatients best interest, as is the use of sufficient radiation to

sure diagnostic or therapeutic success. Attention must beid to optimizing patient care and not merely technicalormation. Another unintended consequence of too-tightlytrolled radiation exposure may be the introduction of

warranted fear in the patient/public community leading tousal of necessary test and procedures. Although some of theommendations of this Think Tank may appear onerous toe stakeholders, the most successful change management

tiatives balance carrot and stick approaches.It is only through focused attention on an improved under-nding of the scientific and technical considerations related toiation exposure and practical application of these principlesthe day-to-day care of patients that radiation safety will beproved. For these efforts to be successful, they must beducted by multidisciplinary teams of medical and nonmed-

l scientists, with support from professional societies repre-ting the active commitment of the house of cardiology.nding agencies, payers, and industry must recognize theportance of this work to public health and invest in radiationety. Professional societies and regulators in particular needensure timely implementation of these recommendations,

d monitoring must be implemented to guard against unin-ded consequences. It is hoped that these Think Tankceedings will stimulate and support meaningful continuedrts in the future in this important area.

breviations

CF American College of Cardiology Foundation

Cardiovascular Radiation Safety Conference ReportA American Heart Association computed tomography

20.D cardiovascular diseaseRI Duke Clinical Research InstituteT linear no-threshold model of radiation risk

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53.Chambers CE, Fetterly KA, Holzer R, et al. Radiation safety programfor the cardiac catheterization laboratory. Catheter Cardiovasc Interv.2011;77:54656.The Joint Commission Sentinel Event Alert: Radiation risks ofdiagnostic imaging. Available at: http://www.jointcommission.org/assets/1/18/SEA_471.pdf. Accessed September 14, 2011.Hendel RC, Patel MR, Kramer CM, et al. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria forcardiac computed tomography and cardiac magnetic resonance imag-ing: a report of the American College of Cardiology FoundationQuality Strategic Directions Committee Appropriateness CriteriaWorking Group, American College of Radiology, Society of Cardio-vascular Computed Tomography, Society for Cardiovascular MagneticResonance, American Society of Nuclear Cardiology, North AmericanSociety for Cardiac Imaging, Society for Cardiovascular Angiographyand Interventions, and Society of Interventional Radiology. J Am CollCardiol. 2006;48:147597.Taylor AJ, Cerqueira M, Hodgson JM, et al. ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 appropriate use cri-teria for cardiac computed tomography: a report of the AmericanCollege of Cardiology Foundation Appropriate Use Criteria TaskForce, the Society of Cardiovascular Computed Tomography, theAmerican College of Radiology, the American Heart Association, theAmerican Society of Echocardiography, the American Society ofNuclear Cardiology, the North American Society for CardiovascularImaging, the Society for Cardiovascular Angiography and Interven-tions, and the Society for Cardiovascular Magnetic Resonance. J AmColl Cardiol. 2010;56:186494.Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 appropriateness criteria for coronary revas-cularization: a report by the American College of Cardiology Founda-tion Appropriateness Criteria Task Force, Society for CardiovascularAngiography and Interventions, Society of Thoracic Surgeons, Amer-ican Association for Thoracic Surgery, American Heart Association,and the American Society of Nuclear Cardiology. J Am Coll Cardiol.2009;53:53053.Douglas PS, Garcia MJ, Haines DE, et al. ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011 appropriateuse criteria for echocardiography: a report of the American College ofCardiology Foundation Appropriate Use Criteria Task Force, Amer-ican Society of Echocardiography, American Heart Association,American Society of Nuclear Cardiology, Heart Failure Society ofAmerica, Heart Rhythm Society, Society for Cardiovascular Angiog-raphy and Interventions, Society of Critical Care Medicine, Society ofCardiovascular Computed Tomography, and Society for Cardiovascu-lar Magnetic Resonance Endorsed by the American College of ChestPhysicians. J Am Coll Cardiol. 2011;57:112666.Patel MR, Spertus JA, Brindis RG, et al. ACCF proposed method forevaluating the appropriateness of cardiovascular imaging. J Am CollCardiol. 2005;46:160613.Hendel RC, Berman DS, Di Carli MF, et al. ACCF/ASNC/ACR/AHA/ASE/SCCT/SCMR/SNM 2009 appropriate use criteria forcardiac radionuclide imaging: a report of the American College ofCardiology Foundation Appropriate Use Criteria Task Force, theAmerican Society of Nuclear Cardiology, the American College ofRadiology, the American Heart Association, the American Society ofEchocardiography, the Society of Cardiovascular Computed Tomog-raphy, the Society for Cardiovascular Magnetic Resonance, and theSociety of Nuclear Medicine. J Am Coll Cardiol. 2009;53:220129.Diagnostic reference levels in medical imaging: review and additionaladvice. Ann ICRP. 2001;31:3352.Hausleiter J, Meyer T, Hermann F, et al. Estimated radiation doseassociated with cardiac CT angiography. JAMA. 2009;301:5007.Cardiovascular nuclear imaging: balancing proven clinical value andpotential radiation risk. J Nucl Med. 2011;52:11624.Jacob P, Ron E. Late health effects of ionizing radiation: bridging theexperimental and epidemiological divide. Radiat Environ Biophys.2010;49:10910.Preston RJ. Radiation biology: concepts for radiation protection.

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54.

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Heart.org MedscapeGenomicMedicineInstitute AdvisoryBoard/WebMDAdvisor

Pappas Ventures Patient AdvocateFoundation

UniversalOncology

UpToDate

mas C.ber

Mayo ClinicProfessorof Medicine,Radiology

None None Department ofDefense/DefenseAdvancedResearch Agency

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FDA Gates Foundation Ikaria NIH Novartis Pfizer Viacor Walter CoulterFoundation

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AHA AmericanJournal ofRadiology

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None St. Jude fistula,2011

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Key Words: appropriate use y medical radiation y patient safety yquality improvement.

PENDIX. AUTHOR RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIESVELOPING AN ACTION PLAN FOR PATIENT RADIATION SAFETY IN ADULT CARDIOVASCULAR MEDICINE

rticipantName Employment Consultant

SpeakersBureau

Ownership/Partnership/

Principal Personal Research

Institutional,Organizational orOther Financial

BenefitExpert

Witness

ffreyr

Wake Forest UniversitySchool of Medicine,Division ofRadiologicSciencesProfessor& Vice Chair ofClinical Research

None None None None DHHS/NIHGrants andContracts*

NIH/NHLBI SCCT

None

uel D.queira

Cleveland ClinicFoundationChairman,Department ofMolecular &Functional Imaging

Astellas PharmaUS*

Cardinal Health CoreLab Partners GE Healthcare* Lantheus MedicalImaging

AstellasPharma US*

GE Healthcare*

None PerceptiveInformatics*

None None

nifer E.mings

University of ToledoAssociate Professorof Medicine

Boston Scientific CorazonConsulting

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SpeakersBureau

Ownership/Partnership/

Principal Personal Research

Institutional,Organizational orOther Financial

BenefitExpert

Witness

abrataherjee

Texas Tech UniversityHealth SciencesCenterChief,CardiovascularMedicine

None None None None Cleveland ClinicFoundation(DSMB)

None

n J.lor

Washington HospitalCenterCo-Director,Noninvasive Imaging

Abbott* None None None CertificationBoard ofCardiovascularComputedTomography

SAIP SCCT

None

table represents all healthcare relationships of committee members with industry and other entities that were reported by authors, including those not deemed to be relevant to this document,e time this document was under development. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a

iness if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10,000 of the fair market value of the business entity; or if funds receivede person from the business entity exceed 5% of the persons gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency.tionships in this table are modest unless otherwise noted. Please refer to http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/tionships-With-Industry-Policy.aspx for definitions of disclosure categories or additional information about the ACCF Disclosure Policy for Writing Committees.

Significant relationship.No financial benefit.A indicates American Heart Association; AHRQ, Agency for Healthcare Research and Quality; DHHS, Department of Health and Human Services; DSMB, Data Safety Monitoring Board; FDA, Food

Drug Administration; NASCI, North American Society of Cardiovascular Imaging; NHLBI, National Heart, Lung, and Blood Institute; NIH, National Institutes of Health; SAIP, Society for Atherosclerosisging and Prevention; and SCCT, Society of Cardiovascular Computed Tomography.

15, 2012:183347 Cardiovascular Radiation Safety Conference Report

Developing an Action Plan for Patient Radiation Safety in Adult Cardiovascular MedicineAbstractIntroductionContemporary Cardiovascular Therapy and Increasing Radiation Exposure

Overview of Patient Radiation Protection in Cardiovascular CareDosimetry: Measuring Radiation ExposureModeling the Potential Cancer Risk Associated With Medical Radiation

Approaches to Radiation SafetyDeveloping an Action Plan for Cardiovascular Radiation Safety StakeholdersCritical Areas and Strategies for ActionGroup 1: Quantifying the Estimated Stochastic Risks of Low-Dose Radiation Associated With Contem ...Group 2: Measuring and Reporting Radiation Dose in Cardiovascular Imaging and Therapeutic Proced ...Strategy 1: Establish and Implement Standards to Ensure Consistent and Complete Recording of Rad ...Strategy 2: Expand or Develop Central Registries Related to Radiation Exposure and Cardiovascula ...Strategy 3: Develop and Implement Standards for Communicating Radiation Exposure and the Systems ...Strategy 4: Minimize Deterministic Effects

Group 3: Strategies to Minimize Radiation Dose: From Single Episodes of Care Involving Cardiovas ...Strategy 1: Education to Create a More Uniform Understanding andApproach to Dose Minimization Te ...Strategy 2: Quality MetricsQuantitative Reporting of Quality Metrics on TestingStrategy 3: Common Industry/Technology Standards

Group 4: Education and Communication for Physicians, Patients, the Public, and MediaStrategy 1: Identify, Catalog, and Develop Educational ResourcesStrategy 2: Identify and Disseminate Best Practices in Diagnostic and Procedural ImagingStrategy 3: Heighten Awareness of Radiation Benefits and RisksStrategy 4: Identify, Monitor, and Minimize Unintended Consequences

Summary and Next StepsAbbreviationsReferences