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Patient safety during fluoroscopically guided medical procedures A. Kyle Jones, Ph.D., DABR Assistant Professor MD Anderson Cancer Center

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Page 1: Patient safety during fluoroscopically guided medical ... · Patient safety during fluoroscopically ... National Library of ... not be connected by patient or care providers 3/15/2012

Patient safety during fluoroscopically guided medical procedures

A. Kyle Jones, Ph.D., DABRAssistant Professor

MD Anderson Cancer Center

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A brief history

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 2

Physician viewing fluorescent screen in a direct‐view fluoroscopy system.   National Library of Medicine

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A brief history

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 3

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Background and definitions

• Interventional reference point (IRP)• FDA reference point• Reference point air kerma (Ka,r)

– Cumulative dose– Reference point dose

• Kerma area product– Dose area product

• Peak skin dose• 95% area load

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 4

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3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 5

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Relative merits of each

Balter, S, Methods for measuring fluoroscopic skin dose, Pediatr Radiiol, 36:136‐140, 2006.

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 6

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RISKS OF FLUOROSCOPICALLY GUIDED PROCEDURES

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 7

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Who is at risk?

• Physicians• Nurses• Technologists• Anesthesiologists• Patient• Facility

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 8

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Risks to the operator and staff

• Radiation‐induced cataracts• Radiation‐induced cancer• Infection• Back injury• Falls• Heavy objects• Litigation

3/15/2012 9A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Risks to the patient

• Death• Puncture of vessel• Contrast reaction• Hematoma• Infection• Radiation‐induced cancer

– Solid tumor– Leukemia

• Deterministic skin injury• Radiation‐induced epilation

3/15/2012 10A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Classification of biological effects

Biological effects from ionizing radiation can be broadly classified into two types:

Deterministic effects:  Effects where the severity of the outcome increases with radiation dose past a certain threshold.  Radiation doses below the threshold will not result in an effect. 

Stochastic effects:  An effect where the probability of occurrence increases with increasing dose.  If the effect occurs, its severity will not depend on dose.  No threshold exists for stochastic effects. 

3/15/2012 11A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Stochastic vs. deterministic

Winning the lotteryWinning the lottery is an example of 

a stochastic effect– Buying more tickets 

increases your chances of winning

– You cannot buy enough tickets to guarantee a win

– You have a chance of winning, albeit very small, with a single ticket

– The amount of money you win is not related to the number of tickets you buy –you win all or nothing

Burning your hand on a stoveBurning your hand on a stove is an 

example of a deterministic effect– You can leave your hand on for 

a very short time and not injure yourself

– If you leave your hand on long enough, you will be burned

– The longer your hand remains on the stove, the more severe the resulting burn

3/15/2012 12A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Classification of biological effects

Examples of the deterministic effects of exposure to ionizing radiation include cataract formation and radiation induced skin changes

– Skin changes do not occur below some threshold dose. However, once this threshold has been exceeded, the severity of the injury increases with increasing dose.

Cancer is an example of a stochastic effect of exposure to ionizing radiation

– Cancer may occur with any exposure to ionizing radiation or may not occur with exposure to large amounts of ionizing radiation. The severity of the effect is constant regardless of the total exposure i.e., one either develops cancer or does not develop cancer.

3/15/2012 13A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Radiation induced cancer

• Stochastic effect – risk ↑ linearly with dose• Risk depends on 

1. Volume of tissue irradiated2. Type of tissue irradiated3. Total dose delivered to tissue4. Age of patient5. Patient genetics

• There is always a risk of stochastic effects if we use ionizing radiation, but we can minimize

3/15/2012 14A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Stochastic effects• Stochastic effects, most notably cancer, can also be induced by (but not linked to) prolonged fluoroscopic procedures

• In some cases the risk to the patient can be reduced

Vañó E, Arranz L, Sastre JM, et al. Dosimetric and radiation protection considerations based on some cases of patient skin injuries in interventional cardiology. Br J Radiol 1998;71:510‐516

3/15/2012 15A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Radiation induced skin injury

• Deterministic effect– Risk = 0 below a certain dose, risk = 1 above*– Severity increases with increasing dose above Dth

• In most cases, can be prevented– Training of operators– Safety program– QC of equipment

3/15/2012 16A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Thresholds

• For many years, hard thresholds for various types of deterministic skin injuries were quoted

• It has become apparent that these “thresholds” vary widely between patients

• Depends on1. Patient genetics2. Prior skin irradiation3. Disease state/treatment

3/15/2012 17A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Balter et al. Fluoroscopically guided interventional procedures:  A review of radiation effects on patients’ skin and hair. Radiology 254:326‐341, 2010.

3/15/2012 18A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Radiation injuries

• Radiation‐induced skin injuries are particularly troublesome for several reasons– Patient does not experience any sensations– Latent period means that cause and effect may not be connected by patient or care providers

3/15/2012 19A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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6‐8 weeks post procedure 16‐21 weeks post procedure 18‐21 months post procedure

Multiple coronary angiography, angioplasty, and bypass graft on a single day – estimated peak skin dose > 20 Gy

Shope TB . Radiation-induced skin injuries from fluoroscopy. http://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/MedicalImagi

ng/MedicalX-Rays/ucm116682.htm U.S. Food and Drug Administration. Public Domain

3/15/2012 20A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Radiation injuries

• Radiation injuries can be particularly gruesome and, depending on severity, may never completely heal

• Most injuries are entirely preventable

Wagner LK, Archer BR. Minimizing Risks from Fluoroscopic X Rays: Bioeffects, Instrumentation, and Examination, 3rd edition; Houston, TX; R. M. Partnership, 2000

Wagner LK, McNesse MD, Marx MV, Siegel EL. Severe skin reactions from interventional fluoroscopy: case report and review of literature. Radiology 1999;213:773‐776

3/15/2012 21A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Stages of skin injury

1. Initial response2. Main response3. Late effects4. Permanent changes

3/15/2012 22A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Initial response• The initial response of the 

skin to X radiation is much like a sunburn

• Erythema caused by vasodilation and release of histamine and other inflammatory agents by mast cells

• The initial response occurs within a few hours and subsides within a few days– Presence can be indicative of 

high likelihood for severe response

Balter S, et al.  Fluoroscopically guided interventional procedures:  A review of radiation effects on patients’ skin and hair.  Radiology, 254:326‐341, 2010.

3/15/2012 23A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Main response• Main responses include

– Erythema– Dry desquamation– Moist desquamation– Epilation

• Temporary or permanent• Dry and moist 

desquamation are caused by depopulation of clonogenic cells in the stratum basale

• Epilation is caused by damage to hair follicles

Balter S, et al.  Fluoroscopically guided interventional procedures:  A review of radiation effects on patients’ skin and hair.  Radiology, 254:326‐341, 2010.

3/15/2012 24A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Dry desquamation/epilation

Balter S, et al.  Fluoroscopically guided interventional procedures:  A review of radiation effects on patients’ skin and hair.  Radiology, 254:326‐341, 2010.

http://latimes.image2.trb.com/lanews/media/photo/2009‐12/50945817.jpg

3/15/2012 25A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Healing

• Healing of early effects is a result of repopulation  of healthy skin cells 

• Repopulation occurs from 1. Surviving clonogenic cells 

within the irradiated area or 

2. Migration of healthy clonogenic cells from outside the field

Balter S, et al.  Fluoroscopically guided interventional procedures:  A review of radiation effects on patients’ skin and hair.  Radiology, 254:326‐341, 2010.

3/15/2012 26A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Late effects

• Late effects include dermal atrophy, ulceration, telangiectasia, dermatitis, sclerosis, and necrosis

• Occur months to years after main effects

• Caused primarily by vascular damage to the dermis Balter S, et al.  Fluoroscopically guided interventional procedures:  A review of radiation 

effects on patients’ skin and hair.  Radiology, 254:326‐341, 2010.

3/15/2012 27A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Permanent skin changes

• Certain radiation‐induced skin changes can be permanent

• Hyper‐ or hypo‐pigmentation

• Telangiectasia• Scarring• Induration

http://www.uth.tmc.edu/radiology/exhibits/koenig_wagner/index.html3/15/2012 28A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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What can we do?

• Reduce the risk of radiation‐induced cancer for operator, staff, and patient

• Prevent most deterministic effects such as radiation‐induced cataracts and skin injuries

• Recognize situations where a high probability for injury exists so the patient can be appropriately medically managed

3/15/2012 29A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Three‐pronged approach

• Pre‐procedure actions• Intra‐procedure actions• Post‐procedure actions

3/15/2012 30A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 31

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Pre‐Procedure• Consenting process

– Medico‐legal aspects• Patient education

– Requires staff education– Easy‐to‐understand pamphlets

• Identification of high‐risk patients– Certain conditions may pre‐dispose patient to injury

• Diabetes mellitus, connective tissue disorders– Prior high‐CD procedures (JC aspects)– RIS

• Credentialing and privileging of users of fluoroscopic equipment

• Procedure planning

3/15/2012 32A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Intra‐Procedure

• Ka,r thresholds• Ongoing faculty and staff education

– Dose reduction techniques• Removal of grid• Store loop/store monitor, not acquisition

– Be in the room• YDNKWIHUYKWIH

• Reduced dose protocols– Patients identified during pre‐procedure process

• Situational awareness– Prior high‐dose procedure – projection considerations

3/15/2012 33A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Post‐Procedure

• Follow‐up protocol• Record dose descriptors somewhere

– Ka,r/KAP/# of DynaCT/# of exposures/time• RIS• Medical record• PACS• Structured dose reporting is here

• Flag high‐dose cases for f/u– Ka,r = 5 Gy (NCRP 168)– Procedure specific?

3/15/2012 34A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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PRE‐PROCEDURE ELEMENTS

3/15/2012 35A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Informed consent

“Informed consent is a patient's right to be presented with sufficient information, by 

either the physician or their representative, to allow the patient to make an informed decision regarding whether or not to consent to a treatment or procedure.”

http://www.med‐ed.virginia.edu/courses/rad/consent/

3/15/2012 36A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Informed consent

• Lack of informed consent is grounds for malpractice lawsuit

• Ethical considerations

3/15/2012 37A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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3/15/2012 38A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Patient education

• Care providers must have the tools and knowledge to explain the risks to the patient without inducing panic

• One approach to this is a pamphlet/handout– Mechanisms of injury– How we manage radiation– Follow up

• Only for certain patients

3/15/2012 39A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Identify high‐risk patients• Certain conditions are suspected to pre‐dispose patients to radiation induced skin injuries– Diabetes mellitus (microvascular disease)– Connective tissue disorders

• Marfan syndrome– Ataxia telangiectasia– Drug interactions

• Also, a recent high dose procedure can result in the induction of injuries at lower doses in the future

Wagner et al, Severe skin reactions from interventional fluoroscopy: Case report and review of the literature. Radiology;213:773‐776, 1999.

Koenig TR, et al. Skin injuries from fluoroscopically guided procedures: Part I, characteristics of radiation injury. AJR 177:3‐11, 2001.

Balter et al. Fluoroscopically guided interventional procedures:  A review of radiation effects on patients’ skin and hair. Radiology 254:326‐341, 2010.

3/15/2012 40A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Identify high‐risk patients

• Most easily done during the consenting process• The RIS can be a valuable tool for automatically identifying and flagging these patients– Only if the prior procedure was performed in your system or practice

• High risk patients can be routed to a dose sparing protocol, physician can be advised– Fewer acquisition runs, more storing of fluoro– Alternate Ka,r thresholds– Postpone procedure?

3/15/2012 41A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Multiple and repeated procedures

• Two scenarios1. By performing a very complex case in multiple 

sessions, fx can be used to reduce the likelihood of late effects

2. If a procedure is repeated, an unexpected skin reaction may occur as the Biologically Equivalent Dose from the two procedures is greater than the dose from the most recent procedure

3/15/2012 42A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Physician/staff education

• Physicians performing complex procedures should be trained in the safe use of fluoroscopic equipment

• Continuing education is also necessary considering frequent technological advances

• Understand dose saving features of each type of equipment on which they work– Hands‐on component

3/15/2012 43A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Credentialing vs. privileging

• Credentialing:  The process by which providers are certified to practice their specialty– Board certification– State licensure– Specialty boards, CAQ

• Privileging:  The process by which providers are approved to perform specific procedures– Certain credentials may be necessary– Perform certain number of procedures under personal supervision

– Continue to perform minimum number of procedures

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 44

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Continuing education

• Maintenance of Certification and some states require Continuing Medical Education– Certain number of hours specific to fluoroscopy may be required

• Vital to stay current and be aware of advances in your discipline/specialty

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 45

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For example

• ACR looking to require either:– Certain credentials

• Board certification by ABR, etc.

– OR– Privileges to perform specific procedures

• Education requirements• Supervision requirements

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 46

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Education requirements

• Basic radiation physics• Basic fluoroscopic physics• Radiation biology• Radiation protection• Radiation safety• Advanced fluoroscopic physics

– Patient dose management• Hands on training also useful

– Impracticalities– Can applications specialists be trusted to provide this?

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 47

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www.xraysafety.org

3/15/2012 48A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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INTRA‐PROCEDURE ELEMENTS

3/15/2012 49A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Ka,r thresholds

• All equipment manufactured after June 2006 is required by law to display Ka,r

• Alerting the physician at certain thresholds guarantees there are no surprises at the end of a case

• Decisions can be made based on medical management at each threshold– Pace of procedure– Good practice – YDNKWIHUYKWIH– Continuation of procedure at a later time

3/15/2012 50A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Establishing Ka,r thresholds

3/15/2012 51A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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3/15/2012 52A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Published recommendations

Stecker et al., Guidelines for patient radiation dose management.  J Vasc Interv Radiol 20:S263–S273, 2009. 

Wagner LK and Archer BR, Minimizing Risks from Fluoroscopic X Rays, 2nd ed., R.M. Partnership, The Woodlands, TX.

3/15/2012 53A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Reduced dose protocols

• Many elements of a protocol can be adjusted to reduce radiation dose to the patient– Reduce IAKRD for fluoroscopy– Reduce IAKRD for acquisition– Reduce frame rate for acquisition*– Reduce pulse rate for fluoroscopy*– Use low dose AEC curve– Use additional filtration*

3/15/2012 54A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Situational awareness

• For patients who have undergone a recent high dose procedure, use a different projection to reduce skin dose– Will definitely reduce 95% area load– May not reduce PSD

• May not be able to completely eliminate overlap, but for angled projections can have large benefit– Importance of tight collimation

3/15/2012 55A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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3/15/2012 56A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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3/15/2012 57A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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3/15/2012 58A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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POST‐PROCEDURE ELEMENTS

3/15/2012 59A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Record dose descriptors

• Medical record has been suggested– Perhaps difficult– May not be searchable

• Dictated• Scanned

• DICOM Structured Dose Reporting is here– Just installed our first system (VC14)– Legacy systems may never support

• Manufacturers have agreed to retrofit back to a certain date– Third party options are available

• DICOM headers contain some information

3/15/2012 60A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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3/15/2012 61A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 62

DICOM SR

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Record dose descriptors

• Other possibilities include RIS or logbooks– Would like it to be searchable

• Tracking• Practice improvement• Identify/prevent sentinel events

• We went with the RIS– Manual entry into designated fields– Reports can be generated, already linked with procedure (accession number)

– Automatic analysis of data/entry into database• Now changing to third party solution – PEMNET

3/15/2012 63A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Record dose descriptors

• What we record:– Ka,r– KAP– Number of acquisition runs– Number of rotational angiography runs (DynaCT)– Fluoroscopy time

• Track repeated or multiple procedures

3/15/2012 64A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Flagging and f/u of high dose cases• A high dose case is flagged by the technologist, triggering a follow‐up protocol (PA):– Patient informed that significant dose (>= 5 Gy) was reached

– Patient instruction (pamphlet)• Signs/symptoms (red area the size of your hand)• Instructions (do not scratch or itch)• Actions (call us)

– Telephone or in‐person f/u scheduled for 4 weeks– Print dose report and archive

• Flag = 5 Gy– NCRP 168

3/15/2012 65A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Steele JS, Jones AK, Ninan EP.  Quality initiatives: establishing an interventional radiology patient radiation safety program. Radiographics  32(1):277‐87, 2012.

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Steele JS, Jones AK, Ninan EP.  Quality initiatives: establishing an interventional radiology patient radiation safety program. Radiographics  32(1):277‐87, 2012.

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Peak skin dose (PSD) reconstruction

• Many sources of information are available• A qualified medical physicist can perform a detailed PSD reconstruction

• The process can be automated with server based systems that collect dose information from all systems

• Jones AK, Pasciak AS.  Calculating the peak skin dose resulting from fluoroscopically guided procedures. Part I:  Methods, J Appl Clin Med PhysNov 12(4):3670, 2011

3/15/2012 68A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Dose calc paper

Calculating the peak skin dose resulting from fluoroscopically guided interventions. Part I: Methods. J Appl Clin Med Phys Nov 12(4):3670, 2011.

3/15/2012 69A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Measuring the PSD

• Radiochromic film can be used to measure PSD

• Dose information can be assessed in two ways:– A calibrated strip can be used to estimate PSD

– The film can be scanned and decalibrated to determine PSD

http://online1.ispcorp.com/_layouts/Gafchromic/content/products/xrr/pdf/doseverstripguide.pdf,10/08

3/15/2012 70A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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http://online1.ispcorp.com/_layouts/Gafchromic/content/products/xrr/pdf/doseverstripguide.pdf,10/08

3/15/2012 71A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Medical management of skin reactions

• Very high skin doses are only seen in the context of long fluoroscopic procedures

• Knowing who to consult regarding skin reactions is tricky

• Dermatologists may never have seen these types of reactions

• Radiation oncologists seem to be the best to discuss these matters with– May not see late/acute effects of same severity

3/15/2012 72A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Practice improvement

• Dose information collected can be used to calculate metrics for data driven practice improvement– Compare dose metrics to national averages

• RAD‐IR study– Identify procedures/physicians/etc. for improvement

– Control charts for identifying exceptional variation• Discuss high dose cases/reactions at M+M

– Limit liability for procedures performed elsewhere

3/15/2012 73A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Hepatic embolization

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 74

Fluoro time DAP CD

MEAN 22 40713 1809MEDIAN 19 34898 1604RAD‐IR MEAN 16.8 28232 1406

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Pelvic embolization

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 75

Fluoro time DAP CD

MEAN 17 39023 1836MEDIAN 19 32309 1964RAD‐IR MEAN 28.4 30284 1846

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Nephrostomy placement

3/15/2012 A. Kyle Jones, Ph.D., DABR     NCHPS 2012 76

Fluoro time DAP CD

MEAN 6 1838 115MEDIAN 4 1024 50RAD‐IR MEAN 10.5 2555 257

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Control charts

61554943373125191371

8000

7000

6000

5000

4000

3000

2000

1000

Procedure

Cum

ulat

ive

Dos

e (m

Gy)

_X=4153

UCL=7164

LCL=1142

111

1

IR procedures over 3000mGy

Steele JS, Jones AK, Ninan EP.  Quality initiatives: establishing an interventional radiology patient radiation safety program. Radiographics  32(1):277‐87, 2012.

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Other areas for concern

• Wound healing– Pre‐surgery spinal embolization

– 8, 10, 12 Gy cases– How do wounds heal after these doses are delivered < 24 hr prior to surgery?

• Damage to fibroblasts• Literature – only a few papers about mouse experiments Gorodetsky et al. Radiation effect in mouse skin:  

Dose fractionation and wound healing, Int J RadiatOnc Biol Phys 18:1077‐81, 1990

3/15/2012 79A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Parameter Level N N Infections OR 95% CI p‐Value

BMI Continuous 99 16 1.04 0.93, 1.16 0.47Prior Spinal Surgery

No 74 10 ‐‐‐‐ ‐‐‐‐0.22Yes 25 6 2.02 0.62, 6.20

Nicotine UseNo 47 6 ‐‐‐‐ ‐‐‐‐

0.26Former 37 8 1.89 0.59, 6.28Yes 15 2 1.05 0.14, 5.24

Estimated Blood Loss Continuous 99 16 1.0002 0.9999, 1.0004 0.09

Spinal Fluid LeakNo 91 15 ‐‐‐‐ ‐‐‐‐

0.77Yes 8 1 0.72 0.04, 4.51

Plastics ClosureNo 66 10 ‐‐‐‐ ‐‐‐‐

0.70Yes 33 6 1.24 0.39, 3.72

PSD Continuous 99 16 1.00002 0.9997, 1.0002 0.81

Number of ACQ Continuous 99 16 1.08 1.02, 1.16 0.02

Total Ka,r Continuous 99 16 1.0001 0.9998, 1.0004 0.39

Frames Continuous 99 16 0.9998 0.998, 1.001 0.81

Number of Levels Embolized Continuous 99 16 1.12 0.83, 1.50 0.44

Number of Levels Angiographed Continuous 99 16 1.10 0.90, 1.35 0.33

ChemotherapyNo 40 6 ‐‐‐‐ ‐‐‐‐

0.80Yes 59 10 1.16 0.39, 3.68

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Parameter Level N N Infections OR 95% CI p‐Value

BMI Continuous 99 16 1.04 0.93, 1.16 0.47Prior Spinal Surgery

No 74 10 ‐‐‐‐ ‐‐‐‐0.22Yes 25 6 2.02 0.62, 6.20

Nicotine UseNo 47 6 ‐‐‐‐ ‐‐‐‐

0.26Former 37 8 1.89 0.59, 6.28Yes 15 2 1.05 0.14, 5.24

Estimated Blood Loss Continuous 99 16 1.0002 0.9999, 1.0004 0.09

Spinal Fluid LeakNo 91 15 ‐‐‐‐ ‐‐‐‐

0.77Yes 8 1 0.72 0.04, 4.51

Plastics ClosureNo 66 10 ‐‐‐‐ ‐‐‐‐

0.70Yes 33 6 1.24 0.39, 3.72

PSD Continuous 99 16 1.00002 0.9997, 1.0002 0.81

Number of ACQ Continuous 99 16 1.08 1.02, 1.16 0.02

Total Ka,r Continuous 99 16 1.0001 0.9998, 1.0004 0.39

Frames Continuous 99 16 0.9998 0.998, 1.001 0.81

Number of Levels Embolized Continuous 99 16 1.12 0.83, 1.50 0.44

Number of Levels Angiographed Continuous 99 16 1.10 0.90, 1.35 0.33

ChemotherapyNo 40 6 ‐‐‐‐ ‐‐‐‐

0.80Yes 59 10 1.16 0.39, 3.68

3/15/2012 81A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Parameter Level N N Infections OR 95% CI p‐Value

BMI Continuous 99 16 1.04 0.93, 1.16 0.47Prior Spinal Surgery

No 74 10 ‐‐‐‐ ‐‐‐‐0.22Yes 25 6 2.02 0.62, 6.20

Nicotine UseNo 47 6 ‐‐‐‐ ‐‐‐‐

0.26Former 37 8 1.89 0.59, 6.28Yes 15 2 1.05 0.14, 5.24

Estimated Blood Loss Continuous 99 16 1.0002 0.9999, 1.0004 0.09

Spinal Fluid LeakNo 91 15 ‐‐‐‐ ‐‐‐‐

0.77Yes 8 1 0.72 0.04, 4.51

Plastics ClosureNo 66 10 ‐‐‐‐ ‐‐‐‐

0.70Yes 33 6 1.24 0.39, 3.72

PSD Continuous 99 16 1.00002 0.9997, 1.0002 0.81

Number of ACQ Continuous 99 16 1.08 1.02, 1.16 0.02

Total Ka,r Continuous 99 16 1.0001 0.9998, 1.0004 0.39

Frames Continuous 99 16 0.9998 0.998, 1.001 0.81

Number of Levels Embolized Continuous 99 16 1.12 0.83, 1.50 0.44

Number of Levels Angiographed Continuous 99 16 1.10 0.90, 1.35 0.33

ChemotherapyNo 40 6 ‐‐‐‐ ‐‐‐‐

0.80Yes 59 10 1.16 0.39, 3.68

3/15/2012 82A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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In certain circumstances

• It is necessary and appropriate to administer a high dose of radiation during a fluoroscopically guided procedure

• One must still be conscious of how much radiation has been used

• The risk of injury must be commensurate with the benefits of the procedure

• Medical management after the procedure must be appropriate

3/15/2012 83A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Further reading• Miller et al., Quality improvement guidelines for recording patient radiation dose 

in the medical record. J Vasc Interv Radiol 15:423–429, 2004.– SIR Standards of Practice Committee

• Miller DL, Balter S, Noonan PT, Georgia JD, Minimizing radiation‐induced skin injury in interventional radiology procedures. Radiology 225:329–336, 2002 .

• Stecker et al., Guidelines for patient radiation dose management.  J Vasc IntervRadiol 20:S263–S273, 2009. 

– SIR Safety and Health Committee– Discharge/consenting examples

• Archer BR and Wagner LK, Protecting patients by training physicians in fluoroscopic radiation management. J Appl Clin Med Phys 1:32‐37, 2000.

• Wagner LK and Archer BR, Minimizing Risks from Fluoroscopic X Rays, 2nd ed., R.M. Partnership, The Woodlands, TX.

• Balter S, et al.  Fluoroscopically guided interventional procedures:  A review of radiation effects on patients’ skin and hair.  Radiology, 254:326‐341

• NCRP Report 168• Steele JS, Jones AK, Ninan EP.  Quality initiatives: establishing an interventional 

radiology patient radiation safety program. Radiographics 32(1):277‐87, 2012.

3/15/2012 84A. Kyle Jones, Ph.D., DABR     NCHPS 2012

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Acknowledgements

• Mark Sultenfuss, M.D.• Joseph Steele, M.D.• Alex Pasciak, Ph.D.

3/15/2012 85A. Kyle Jones, Ph.D., DABR     NCHPS 2012