Posted on May 6, 2016 by RADPAD
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We would like to share a compelling piece from CX about the endovascular pioneers who moved the field forward, but also illuminated the dangers of X-ray scatter radiation.
CX acknowledges “huge debt” owed to endovascular pioneers affected by radiation
Since its introduction in the late 80s, endovascular therapy has become increasingly widespread and important. A mini-symposium held yesterday brought to the fore the radiation damage that has occurred to pioneering operators in the field. It also focused on currently available methods to reduce radiation exposure during endovascular procedures.
The list of names reads like a who’s who of pioneers in the endovascular world, and you would surely have read about and heard about these legends whose work has broken new ground, time and time again. Yesterday at CX, Roger Greenalgh, London, UK, read out that list of names for a very different reason; he was outlining how these pioneers had personally been affected by working with ionising radiation.
First on the list was renowned cardiovascular surgeon, Edward Diethrich. After being diagnosed with cataracts in both eyes, calcified plaque in a carotid artery, a brain tumour (oligodendroglioma), he has been instrumental in taking the message of the dangers of radiation exposure to the medical community. Working in collaboration with The Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF), he has released a documentary film focusing on the impact that chronic, low-level exposure to ionising radiation has on physicians that practice interventional medicine in fluoroscopy labs.
Then, Allan Reid, consultant interventional radiologist, Glasgow, UK, and a disciple of Ted Diethrich was remembered. Sadly, Reid died of a brain tumour (glioblastoma) in September 2015. His brother, Donald Reid, a consultant vascular surgeon, Edinburgh, UK, was seated in the front row.
The list of eminents goes on: Krassi Ivancev, who has led the way in interventional radiology procedures in Sweden and Bulgaria and is a member of the CX Advisory Board, has been diagnosed with cataracts, as has world-class interventional radiologist Lindsay Machan from Vancouver, Canada, a frequent speaker at CX.
Greenhalgh’s presentation ended in remembering Roy Greenberg, pioneering vascular surgeon from Cleveland Clinic, USA, and a disciple of Krassi Ivancev. Greenberg is remembered as a physician who was instrumental in pushing forward the field of endografting for complex aortic disease. He died of widespread malignant tumour of the peritoneum in December 2013, aged 49.
It is important to note that when the endovascular revolution began, the dangers of working with radiation were not the first concern in physicians’ minds; they set out to help their patients using every new tool and procedure at their disposal including performing long procedures of endovascular abdominal aneurysm repair, and thoracic endovascular aortic repair. Yet, this meant that they were often putting themselves at risk in the process, and this is why, Greenhalgh emphasised, that we owe these pioneers a huge debt of gratitude.
The message resonated with physicians practising in the endovascular field.
Timothy Resch, Malmo, Sweden, explained that EVAR and TEVAR are now well-established for infrarenal aortic aneurysms and descending thoracic aortic pathologies.
“Endovascular repair of areas including aortic branch vessels, such as iliac bifurcation, visceral aorta, and the aortic arch is evolving rapidly. The proper use and evaluation of preoperative imaging for planning is vital to minimise contrast and radiation exposure during complex cases. It is important that X-ray equipment and X-ray protection are properly used and understanding fundamental principles of minimising radiation exposure is critical to minimising the risk. Advanced imaging using fusion technology and intraoperative cone beam CT has the possibility of reducing exposure and improving outcome,” he said.
Reducing radiation during endovascular procedures
There is increasing awareness developing regarding occupational hazards of endovascular therapy, most importantly long-term radiation exposure, said Barry Katzen, Miami, USA.
“A number of very practical steps can be taken to reduce radiation exposure to patients, operator and staff. Awareness itself can be an effective first step in reducing exposure as operators and teams start paying attention to this important topic. Radiation reduction can be focused on reducing the amount of radiation being produced (flouroscopy dose, time, X-ray dose times and frame rates), as well as steps to provide protection to operators and staff including the use of lead aprons, eye protection, and maintaining distance. Simple methods can be surprisingly effective, such as reducing frame rates. In our institution, robotic catheterisation has been very effective at reducing dose, by both positioning operators and staff further from the source, and by reducing fluoroscopy and procedure time,” he said.
Training oneself to apply the ALARA principle
Stephan Haulon, Lille, France, then told delegates that every effort is being made to reduce radiation exposure whilst doing complex aortic endovascular reconstruction.
“Complex aortic endovascular repair procedures can be technically challenging and require fluoroscopy guidance with sometimes prolonged exposure. This has an important effect on vascular physicians, who perform these procedures each day, and are therefore at risk of exposure to high doses X-rays. However, X-rays are well-known for the biological hazards they can induce, such as skin/lenses injuries or cancer occurrence. As the benefit/risk ratio must prevail in medicine, it is mandatory to carefully evaluate the risk of radiation exposure, for the patients, but also for the medical staff—this is known as the As Low As Reasonably Achievable (ALARA) principle,” he said.
Haulon shared some tips and tricks that should be implemented in routine practice to reduce radiation exposure. For example, it is highly recommended to work with the “half or low dose modes”, available in most of the imaging systems, or to use the “pulse mode” rather than the continuous fluoroscopy. All imaging controls should be available to scrubbed physicians at the tableside. “Digital Subtraction Angiography (DSA) mode should be avoided and limited to diagnostic purposes, every time this is possible, and fluoroscopy should be preferred. Collimation must be optimised, distance between the captor and the patient minimised and distance between the tube and the patient maximised. Magnification should be avoided if not necessary, as lateral or cranio-caudal angulations.
Haulon explained that that new generation imaging systems available in the most recent hybrid rooms provide the newest technologies to successfully achieve good image quality with low exposure. “Old image intensifiers have been replaced by flat panel detectors that achieve a high level of radiographic performance. They are equipped with 3D workstations that allow a fine pre-operative analysis —useful to avoid unnecessary exposures —and advanced imaging applications, such as fusion imaging or cone beam computed tomography that also allow consequent dose savings,” he said.
“Dose awareness and training in radiation protection are also fundamental to optimise dose reduction. One should train oneself to apply the ALARA principle in daily practice by implementing all the tips and tricks to reduce exposure, but this should also be stressed during every vascular surgeon initial formation, as during its whole practice. Radiation awareness can be raised by monitor staff occupational exposure and patients’ exposure in the operating room, and then compare it to reference levels or published evidence. Specific attention must be paid to the application of dose reduction in routine practice to ensure safety and efficiency, for both patients and staff, during EVAR procedures,” Haulon emphasised.
Importance of simulation
Lars Loenn, Copenhagen, Denmark, made the case for radiation protection training in a simulated setting and stated that this makes a difference regarding radiation awareness. “To learn to use radiation exposure wisely, learners should be trained to undertake the task almost without thinking,” Loenn noted. This is a challenge in a classical training situation with radiation exposure to the team and patient in the angiosuite. “The simulated setting is however an incredible learning opportunity since it is radiation free and allows the trainee to try different approaches and learn how to reduce the radiation exposure while receiving dynamic and instant feedback on delivered radiation in the form of a ‘heat map’. In fact, you can train on radiation aspects at the same time as you train on procedural skills in the simulator. Additionally, certain radiation safety skills needed to be obtained in specific procedure related situations can easily be created in a simulator scenario. Simulated radiation protection training could possibly even be used in credentialing new interventional operators based on a proficiency standard in the future,” he said.
“We need a new way of thinking and merge ergonomics, image management and radiation safety training into one package will bring essential value to training. Health professionals should be provided with the means to successfully do their jobs and I strongly believe this is the way to do it,” he said.
Key to safe application of radiation is awareness of potential risks
Then, Fiona Rohlffs, Hamburg, Germany, said that modern hybrid-operating rooms improve the endovascular workflow, but noted that this development is also associated with increased exposure to radiation for staff and patients. That is why, it is vital, she said, that it demands more awareness of, and knowledge about dose and protective measures. Rohlffs set out that this is especially important for complex aortic procedures involving the aortic arch or the thoracoabdominal aorta.
Rohlffs and team compared reported dose values for branched or fenestrated-EVAR and present values for complex TEVAR procedures, while explaining that the comparison of dose values especially for complex procedures still remains challenging because of unequal reporting standards and acquisition system differences.
Data from the team in Hamburg showed that a comparison between fenestrated and branched EVAR shows a significant difference to the personal dose of first operator, which increased for branched procedures and seems to be due to different operating positions.
Rohllfs told delegates that dose reduction is possible if several protective measures are applied. “To achieve this, CT-fusion techniques are increasingly used for complex fenestrated or branched procedures. System improvements can significantly reduce the amount of radiation,” she noted.
Concluding, Rohllfs said that the key to safe application of radiation is the awareness of potential risks and a good knowledge of how to achieve maximal protection for patients and staff.
See the original article here:
CX acknowledges “huge debt” owed to endovascular pioneers affected by radiation
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Posted on April 22, 2016 by RADPAD
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Interventionalists are accustomed to extensive regulations in nearly all aspects of their field, and so are very surprised to discover that the protective quality of their lead aprons is very loosely regulated, resulting in great variation between similarly labeled products. Especially when buying a lightweight non-lead apron, they don’t know what they are getting without complicated laborious in-house testing which is usually beyond their reach. This article outlines the problems and provides some practical tips to avoid the pitfalls that lead to years of silent overexposure.
By Chet R. Rees, MD, Victor Weir, PhD., DABR, Andrew Lichliter, MD, and Evans Heithaus MD
About 40-50% of interventionalists have switched to lightweight “lead” aprons (usually non-lead in reality) to deal with the musculoskeletal problems and fatigue that plague the profession and result in pain, injury, and limitation causing decreased quality of life, and reduction of case-load or disability (1,2). Most are not aware that several studies demonstrate that lightweight aprons don’t fully protect, and they may be receiving radiation exposures several times higher than if wearing standard non-lightweight aprons, despite indistinguishable labels and manufacturer-provided information. For example, one study showed that 73% of 41 aprons tested were outside tolerance levels (4), and there are many others showing the inadequacies of products, standards, and regulations in this industry (3-10). The following example may help frame the problem and its magnitude (Fig 1).
Fig 1. Two aprons are both labeled “0.5 mm Pb equivalent”, with corroboration by their product brochures, websites, and salesmen. They are from different manufacturers but are the same configuration and are almost indistinguishable except by their weights (and color patterns). Yet operator exposure when wearing the lightweight apron on the left was 12 times the operator exposure when wearing the one on the right (appendix A).
How can two aprons with the same label differ so remarkably in their protection? It is due to a combination of loose regulations, optional and outdated standards for testing, and the difference in physical properties for lead and non-lead materials which are often not accounted for in the tests. These problems include:
The radiation attenuation (blocking power) of non-lead materials is very energy dependent (fig 2) (3,5,7-9,13,14). Vendor-reported testing is frequently at only one beam quality (related to energy spectrum), while protection at other important unreported energies to which the operator is being exposed may be lower than expected by label interpretation (9). Think of two pairs of sunglasses which both appear equally dark and protective, but one doesn’t block damaging invisible UV rays, whereas the other pair does. If the labels reported only the ability to block visible light, or red light, or blue light, or any color, the user could not know which pair to buy and could receive UV damage with the first pair. Fortunately, consumers are now protected by sunglass labels which report the UV blockage values. But apron labeling is still outdated and paradoxically aprons have gotten less protective overall than the older ones (which contained lead) because the outdated standards worked well for lead, but not for the more recent non-leads which are often used in lightweight aprons.
Fig 2.The intensity of radiation behind a tungsten layer shows the high energy-dependency of its attenuation powers. If tested with a beam quality predominantly above 80keV, its Pb equivalency would be far better than if tested in a beam quality predominating in the lower energies. For this reason such non-leads should not be used alone in a protective garment. Filtration properties of the testing beam importantly affect beam quality and must be known.
Attenuating materials, particularly non-leads of lower atomic number, actually emit secondary radiation (or fluorescence) when exposed to radiation. This new radiation reaches the operator and is of biologically damaging energies (19), however is not well detected with the most commonly used testing methods (narrow beam geometry). Use of more appropriate, but not required, testing methods (broad beam or inverse broad beam) would expose the poor protection of the lightweight aprons, despite their labels (5,8-10,13-15).
Fig 3. Narrow beam geometry (left or top). Fluorescent radiation emitted by non-lead test material is not detected by detector so results are falsely favorable. Broad beam geometry (right or bottom) permits detection of the fluorescent radiation which would expose the wearer of the apron, giving more accurate results.
The methods recommended by standards bodies are not required, and are mostly outdated and inadequate. ASTM does not require broad beam geometry and does not provide for Pb equivalency though used on the label. The effects of somewhat improved IEC-616331-1:2014 are unknown and have yet to be realized in commercial products. Manufacturer’s labels continue to be poorly representative of protection, especially for non-leads.
The labels of some vests and skirts specify lead equivalencies that may correspond only to a double layer (overlap zone) without being clear (3). This creates confusion and may lead the user to believe the entire garment is twice its actual thickness.
Fig 4. Apron vest is only 0.25 mm Pb, but is labeled as “0.5” because it overlaps to 0.5 in the blue shaded area. However most of the area is not overlapped so radiation transmits through the other areas where the user thought the thickness was twice it’s actual.
Fig 5. Cross-section views of 2 overlapping aprons. Very different aprons are labeled the same, confusing the buyer who will purchase the lighter one (A) on the left believing they are equal. In fact A is half as thick in front and sides, and user gets more radiation inside apron. “Front” Pb equivalency on label depends on overlap for apron on left, but not for apron B on the right. Although misleading, it is not illegal to label as on the left (A). Other variations occur such as 0.5 on sides with .25 in front giving 0.5 in overlap and sides. Notice scatter often originates eccentrically, so frontal overlap may be less effective. Apron A is non-lead and B contains lead.
Fig 6. Side-by-side fluoroscopy of the two aprons A and B shown above in Fig 5. Single thickness of apron B attenuates much better than A although both labelled “0.5 mm Pb equiv”.
Fig 7. Aprons A (from Figs 5 and 6) and a new apron C are labeled “0.5 mm Pb” and 0.25 mm Pb” respectively, yet are fairly close in attenuation on a quick fluoroscopy examination. Interestingly, C attenuates slightly better than A, opposite of what one would expect from the labels, and this difference was confirmed on tests performed as described in Fig 6. Both are non-lead. Fluoroscopy of C confirms that is labeled appropriately with regard to “Front” value not relying on overlap.
Substantial weight reductions with equivalent protection have not been achieved for commercial Non-Pb garments, and protection depends largely on weight of the apron for lead and non-lead. Materials that attenuate similarly to Pb over the relevant energy range are still heavy, especially when secondary radiation is measured. Commercial claims of great weight reductions without compromise of protection are made without supporting documentation. This is more recently noted even by manufacturers, such as the statements from one company website that “…there are miniscule differences in the weights of the powders used to produce radiation protection materials…there are no secret formulas…the bottom line here is, it’s lighter weight, it is not offering the same protection levels…Plus or minus a very small percentage, a true 0.5mm [lead equivalent] LE apron is going to weight the same from one manufacturer to the next” (21). Although these facts are becoming more widely understood, under protective aprons are still on the market and need to be avoided.
An excellent study by Pasciak, et al. (22), shows this relationship nicely in their figure 8, where 5 aprons materials were tested along with different thickness of lead foil. Lead foil offered the best protection per weight, and 4 of the 5 aprons fell on a separate line of weight vs. protection which paralleled the pure lead, owing to extra weight due to matrix and fabric. The fifth apron was an outlier; a non-lead with very poor protection per weight. Two aprons met their labels of 0.5 mm equiv (1 non-lead and 1 lead), and the other 3 failed to varying degrees, with as much as ~3X as much exposure to operator. The best protection was provided by the sole lead-based apron. In another study by Lichliter, et al (23), exposure to a phantom operator “wearing” several test aprons was measured while positioned realistically near a phantom patient creating scatter. It had several advantages over previous studies because it tested actual scattered radiation, used a clinically realistic setup, and accounted for differences in the form of the apron (such as open-back vs. closed-back, and differences in how overlap is treated as outlined in Fig 4) rather than just testing scraps of fabric. As seen in Fig 5, weight correlates very well with 1/exposure creating an almost straight line. Data fell along two lines; one for closed-back models and the other for open-back, showing that it is not necessary to cover the back when it is not turned to the patient during fluoroscopy, and that open-back designs are lighter in weight for equivalent protection since they don’t have heavy material in the back. In fact the best protection was provided by an open-back design, Zero-Gravity ™ due to it’s 1.0 mm Pb thickness. Exposures in it were 9.8% of the mean for all aprons, and 37.5% of the best apron. The most protective apron was quite heavy and worn very infrequently in the department.
Fig 6. Exposure-1 (1/operator-exposure) correlates closely with weight of apron, with most protective aprons being higher on Y axis. There are two main lines; one corresponding to closed-back aprons (skirts and vests), and the other to open-backed aprons (butcher style). Note that the open-backed aprons are lighter for equivalent protection, and the most effective model was the open-backed Zero-Gravity ™ which is shown as 0 weight since it is suspended and can’t be weighed. It is also evident that the lead aprons performed better overall than the non-leads in this group, although with some overlap. Test set-up is pictured on the right, with acrylic stack (phantom patient) producing scatter, and phantom operator on a wood frame with dosimeter inside the chest/abdomen region, standing in a typical position for vascular procedure.
HOW TO BUY AN APRON:
The easiest way to safely buy an apron with reasonable assurance of its protection is to buy a lead or lead-composite apron labeled 0.5 mm Pb equiv which does not feel lightweight, and if it is an overlapping design, check it with fluoroscopy to make certain it is not labeled misleadingly as shown in Figs 4-5. This is done in two ways. First, look for transition points between the back panel and the higher attenuating front panel, which if present, means the frontal Pb equivalency may not depend on overlap (e.g. Apron B in figure 5). If the apron is the same all the way around, as in Apron A of Fig 5, and the label suggests the front is twice the thickness of the back, then the apron is labeled misleadingly and it is probably best to avoid the apron and its manufacturer and vendor. Second, place the new apron side by side under fluoroscopy with an old trusty lead apron that has been tested in the past, and is labeled with the same Pb equivalency. They must be side to side due to the automatic brightness control (separate exams will not work). This test is crude and only under one beam quality but can help to distinguish large differences or misleading labeling based on overlap only.
If you need to cut a little weight, consider an open back “butcher” style apron with a good waist band to take weight off the shoulders. Get lead-based material and make sure it does not feel lightweight. Consider the fluoro test against a trusty known apron to look for gross problems.
If you insist on non-lead, insist on a label designating testing using IEC-616331-1: 2014-05 and IEC-616331-3:2014-05 (they must say 2014 in the titles) and look for the following information: Broad beam geometry (or with inverse broad beam, but NOT with narrow beam) indicated on label. Results of tests at 5 energies ranging from 30-150 kVp or wider using the beam qualities specified in Table 1 of the IEC document. The document is vague on exactly what beam qualities must be used and how to report it, so it is important to check carefully. If not on label, request source documentation which specifies the beam qualities in Table 1 of the IEC document. Unfortunately this document is copyrighted and must be purchased in their web store. It may be nearly impossible to obtain all of this information from the vendor, and as of late 2015 most manufacturers can’t provide all of it even on request (24). Ultimately, the garment should be tested in house by a physicist with a copy of the IEC-616331-1:2014 who has the set-up and knowledge to do this. This will be unavailable at most institutions. Until things change considerably with good validation in the literature, this author strongly advises against lead-free materials, especially since they do not save significant weight even when offering similar protection, and are more likely to be poorly represented by their labels.
If your back or neck is killing you and you can’t do your job without a lightweight apron, be aware that you are probably making a trade-off between weight and radiation protection. It would still be wise to test it against other options in-house using acceptable methods to make certain it is not one of the worst. Even a simple side by side fluoroscopic evaluation may be better than nothing, but the value of this has not been established.
Regulations are unlikely to change soon, and the standards are not preventing high variability of products. The only way to remedy these problems are to police the manufacturers and vendors ourselves by demanding copious technical information, making careful choices, and testing and rejecting aprons and vendors who can’t provide information or who provide misleading information.
About the author: Chet R. Rees, MD is a practicing interventional radiologist and Clinical Professor in Dallas, TX at the Baylor Scott and White Hospital. He discloses no conflict of interest in the protective apron industry. He discloses a financial interest with CFI Medical Solutions, who makes shielding products including the Zero-Gravity ™ suspended radiation protection system.
- Q: Do substantially lightweight aprons provide adequate protection? A: No, not even when the label implies they can. There is no miracle material which dramatically cuts weight without making sacrifices in protection. The literature has shown that modest weight reductions may be achieved by mixing metals compared to using pure lead, but substantial weight reductions for same protection has been an elusive goal, despite the appearances of labels and manufacturer’s claims.
- Q: Does the “0.5 mm Pb equivalent” label on my apron mean I am protected? A: If your apron contains lead and it is not lightweight, it probably does mean you are getting the protection close to what you were expecting based on the label. But if your apron is non-lead, such labels usually do not guarantee such protection.
- Q: Is there any type of label I can trust for non-leads? A: Maybe, time will tell. The IEC-616331-1:2014 (it must say 2014 in the title) standards have incorporated some improved methods including inverse broad beam geometry and suggestion for multiple energies. However whether these are used, followed as intended, or how the results compare to independent tests are a still unknown. This author has never seen a full IEC-616331-1:2014 label on any product despite frequent checks at vendors booths.
- Q: Are all non-lead aprons terrible? A: No. Some models are not lightweight, use a good mixture of metals to provide attenuation over a spectrum of energies, and include enough to be effective. Based on reports, this seems to be the minority. Current labeling and marketing information are not very helpful, but picking them up and feeling their weight is a pretty good indicator. Unfortunately again, studies have shown that some non-lead aprons provide less protection even on a per weight basis, in addition to the loss of protection due to being lightweight, thereby being especially poor (22,23).
- Q: How do I test my apron to be sure I am okay? A: If your apron contains lead and is not lightweight, it is probably okay, but you can test at a couple beam qualities using narrow or broad beam geometry which may be available to your physicist and compare results to the attenuation tables and Pb equivalency tables, or test against a known standard. Fluoroscope any overlapping models to make sure the labeled attenuation does not correspond to overlap zone only. If your apron is non-lead, it may be difficult or impossible for you to get it done in house. Set up a broad beam geometry, and use 5 beam qualities ranging from 30-150 kVp with the beam filtration values shown in the tables in IEC-616331-1:2014. Compare results to the attenuation tables and Pb equivalency tables. Fluoroscope any overlapping models to make sure the labeled attenuation does not correspond to overlap zone only.
- This stuff scares me. How can we fix this? A: Major changes in regulations could help but will not happen anytime soon. Rapid change is possible through user awareness and demands made upon vendors. If physicians and other workers refuse to buy from vendors whose aprons haven’t been tested in rigorous ways with test values and conditions indelibly attached to the garment, then some vendors will provide the necessary information, it will be more accurate, and the quality of their aprons will have to improve since under-performing models will be exposed. Vendors who don’t do this will probably continue but at least the user will have a choice they do not have right now.
- Q: Why do manufacturers use non-leads to make lightweight aprons if non-leads aren’t really significantly more protective per weight? Why not just use thinner lead preparations? A: We can’t know the intentions, but we can state a couple things which might lead to this. First, commonly used testing such as with narrow beam geometry and use of one or two beam qualities are reasonably accurate for lead but not for non-leads; a poorly protective lightweight non-lead apron could slip through the cracks and get a 0.5 mm Pb label much more easily than a poorly protective lightweight lead apron. Second, lightweight aprons sell, they are in demand, and can command higher prices which may lead to higher profit margins. The buyer may easily believe that non-leads are lighter than lead and so can therefore make lighter aprons (when in fact aprons can easily be made to any weight using any substance in different amounts). Taken all together, the users can easily go down the intuitive, but incorrect, path that lighter materials are more efficient and make protective lightweight aprons which they should pay more money to obtain. And the sellers are simply offering what the people want, without violating any regulations or laws. The cycle can only be broken by user awareness and demands made upon vendors so that profits come to those providing good solid protection with complete and appropriate test results, not from well marketed lightweight aprons which protect worse than evident from label.
- Q: Is there any use for a lightweight apron? A: Probably yes. Some personnel don’t get very close to the patient (source of scatter radiation) during procedures, such as a circulating technologist who is usually behind the control panel. The inverse square law reduces the field in their location enough such that 0.5 mm Pb equivalency is not required. However, they should still be able to assess their purchases by label and brochure without taking wild guesses as to actual protection. For example, settling for 0.25 mm Pb equivalency but getting something less is not acceptable. Interventionalists standing near the patient should be using 0.5 mm Pb equiv without deficiencies.
- Q: Weren’t there studies that showed that non-lead bilayers could substantially lower weight without loss of attenuation? A: Two studies raised hopes of 25% weight reduction with equivalent attenuation, however these were experimental, included non-commercial metals and computer-based simulations (13,15). The authors noted that actual attenuating capabilities must be measured in the final product since it is influenced by the matrix materials and other manufacturing factors which they did not account for. Such findings in commercially available aprons have not been demonstrated to our knowledge.
1. Klein, LW, Tra Y, Garratt KN, et al. Occupational health hazards of interventional cardiologists in the current decade. Catheterization and Cardiovascular Interventions 2015. 86 (5) 913-924, November 1.
2. Ross AM, Segal J, Borenstein D, Jenkins E, Cho S. Prevalence of spinal disc disease among interventional cardiologists. Am J Cardiol. 1997 Jan 1;79(1):68-70.
3. Muir S, McLeod R, Dove R. Light-weight lead aprons—light on weight, protection, or labeling accuracy? Australas Phys Eng Sci Med 2005 Jun;28(2):128-30.
4. Finnerty M, Brennan PC. Protective aprons in imaging departments: manufacturer stated lead equivalence values require validation. Eur Radiol 2005 Jul;15(7):1477-84.
5. Eder H, Panzer W, Schofer H. Is the lead-equivalent suited for rating protection properties of lead-free radiation protective clothing? Rofo 2005 Mar;177(3):399-404.
6. Vaiciunaite N, Laurikaitis M, Laurikaitiene J, Cerapaite-Trusinkiene R, Adlys G. Verification of lead equivalent for protective aprons used in radiology. Ninth International Conference & Workshop “Medical Physics in the Baltic States” 2011. Available from: http://www.medphys.lt/medphys2011/images/contributions/MedPhys2011_01_03_Vaiciunaite.pdf.
7. Eder H, Schlatt H, Hoeschen C. X-ray protective clothing: does DIN 6857-1 allow an objective comparison between lead-free and lead-composite materials? Rofo 2010 May;182(5):422-8. doi: 10.1055/s-0028-1110000.
8. Christodoulou EG, Goodsitt MM, Larson SC, Darner KL, Satti J, Chan HP. Evaluation of the transmitted exposure through lead equivalent aprons used in a radiology department, including the contribution from backscatter. Med Phys 2003 Jun;30(6):1033-8.
9. Jones AK, Wagner LK. On the futility of measuring the lead equivalence of protective garments. Med Phys 2013 Jun;40(6):063902-2:063902-9. doi: 10.1118/1.4805098.
10. Pichler T, Schopf T, Ennemoser O. Radiation protection clothing in X-ray diagnostics – comparison of attenuation equivalents in narrow beam and inverse broad-beam geometry. Rofo 2011 May;183(5):470-476. doi: 10.1055/s-0029-1245996.
11. US Food and Drug Administration [Internet]. Silver Springs (MD) [updated 2014 Sept 1; cited 2014 Sept 24]. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.6500.
12. INFAB Corp [Internet]. [cited 2014 Sept 24]. A challenge to BLOX-R and a warning to anyone involved in the use or procurement of flexible radiation materials. Available from: http://www.infabcorp.com/open-letter-to-bloxr/.
13. McCaffrey JP, Mainegra-Hing E, Shen S. Optimizing non-PB radiation shielding materials using bilayers. Med Phys 2009 Dec;36(12):5586-5594.
14. Schlattl H, Zankl M, Eder H, Hoeschen C. Shielding properties of lead-free protective clothing and their impact on radiation doses. Med Phys 2007 Nov;34(11):4270-80.
15. McCaffrey JP, Tessier F, Shen H. Radiation shielding materials and radiation scatter effects for interventional radiology (IR) physicians. Med Phys 2012 Jul;39(7):4537-4546. doi: 10.1118/1.4730504.
16. McCaffrey JP, Shen H, Downton B, Mainegra-Hing E. Radiation attenuation by lead and nonlead materials used in radiation shielding garments. Med Phys 2007 Feb;34(2):530-537. doi: 10.1118/1.2426404.
17. ASTM International (West Conshohocken, PA). Standard test method for determining the attenuation properties in a primary X-ray beam of materials used to protect against radiation generated during the use of X-ray equipment. Designation F2547-06. Available through http://www.astm.org/Standards/F2547.htm.
18. International Electrotechnical Commission [Internet]. c2014. [cited 2014 Sept 24]. Available from: http://webstore.iec.ch/Webstore/webstore.nsf/ArtNum_PK/49622!opendocument&preview=1.
19. Schmid E, Panzer W, Schlattl H, Eder H. Emission of fluorescent x-radiation from non-lead based shielding materials of protective clothing: a radiobiological problem? J Radiol Prot 2012 Sept;32(3):129-139. doi: 10.1088/0952-4746/32/3/N129.
20. Akber SF, Das IJ, Kehwar TS. Broad beam attenuation measurements in lead in kilovoltage X-ray beams. Med Phys 2008;18:197–202. doi: 10.1016/j.zemedi.2008.04.008.
21. http://www.infabcorp.com/is-your-lead-apron-protecting-you/ Access date 2-23-2016.
22. Pasciak AS, Jones AK, Wagner LK. Application of the diagnostic radiological index of protection to protective garments. Med Phys 42 (2), February 2015. 653-662.
23. Lichliter A, Gipson S, Heithaus E, Syed A, Weir V, West J. Clinical evaluation of protective garments with respect to garment characteristics and manufacturer label information. Presentation and poster at the International Symposium on Endovascular Therapy (ISET) 2016, February 6-10, Hollywood Florida. Abstract: J Vasc Interv Radiol 2016;27:e1-e21, page e1-e2. http://www.jvir.org/article/S1051-0443%2816%2900020-8/pdf Abstract and Poster: https://www.eventscribe.com/2016/posters/ISETCIO/SplitViewer.asp?PID=MjYyNjA1MDAyNQ
24. Heithaus RE, Onofrio A, Weir V, Rees CR. Can aprons be properly evaluated for their protective quality without in-house validation? Poster at the International Symposium on Endovascular Therapy (ISET) 2016, February 6-10, Hollywood Florida. Abstract: J Vasc Interv Radiol 2016;27:e1-e21, page e11. http://www.jvir.org/article/S1051-0443%2816%2900020-8/pdf Abstract and Poster: https://www.eventscribe.com/2016/posters/ISETCIO/SplitViewer.asp?PID=MjYyNjg3MDAwOQ
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Posted on February 18, 2016 by RADPAD
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Tumors, Bad Backs, and Cataracts: Interventional Physicians Face a Lifetime of Risk
Hollywood, FL—Under the Florida sunshine, the day after Super Bowl Sunday, interventional physicians attending a “depressing” session devoted to tumors, cataracts, and surgically-repaired backs likened the situation to the concussion problem currently plaguing athletes in the National Football League. According to one expert, many physicians might not want to know about the problem, but the hazards of the catheterization laboratory can no longer be ignored.
In a town hall meeting at the 2016 International Symposium on Endovascular Therapy (ISET), physicians and researchers spoke about the importance of managing the occupational hazards linked with interventional cardiology, radiology, and endovascular surgery, among other fields, discussing everything from the lifetime risks of radiation exposure to the musculoskeletal injuries that slow working physicians at best and, at worst, force an early retirement.
“It was an extraordinarily depressing session,” said Gregg Stone, MD, of Columbia University Medical Center (New York, NY), who participated in the panel discussion. “We give up so much, and we’re so passionate about our specialty and our patients that we do these tremendous personal risks to ourselves and sometimes to our own staff. And I think that does have to change.”
Part of the problem, noted Stone, is that physicians begin their training when they’re young and seemingly indestructible. “You start this specialty as a 20-year-old, and we all feel immortal,” he said. “We’re strong, nothing is happening acutely. Radiation, musculoskeletal effects, cataracts, that’s something so far down the line, and it’s why people aren’t wearing radiation badges or taking this very seriously. It needs to be something that’s really taught early and emphasized in medical school, let alone cardiology training programs.”
William Gray, MD, Lankenau Heart Institute/Main Line Health (Wynnewood, PA), who spoke on the occupational risks of ionizing radiation in interventional procedures, said the issue is similar to the unmasking of lifetime risk that professional football players are exposed to with repetitive hits to the head. “This is a little bit like concussions in the NFL,” said Gray. “People didn’t want to talk about it, but now we’re talking about it. And the more we do, I think, the more relevant it’s going to be for people in their daily lives.”
One of the ISET course directors, Barry Katzen, MD, of the Miami Heart and Vascular Institute in Florida, said the purpose of the session was not meant to be depressing, but rather informative. As a physician who has undergone his “share of back and spine surgery,” Katzen said that if physicians are aware of the risks they’re exposed to throughout their careers, particularly radiation exposure, they can take corrective action. “It’s really more of a Hawthorne effect,” he said. “If you start paying attention to radiation management in your own lab, the reductions can be very dramatic.”
Learning About Radiation Effects From Chernobyl
Image-guided procedures are the leading source of radiation exposure, a problem compounded by the increasing number of interventions performed each year, as well as the by increasing complexity of those procedures, say the experts. Lindsay Machan, MD, of the University of British Columbia (Vancouver, BC), who also presented on the hazards of radiation exposure at ISET, told the audience that while there is “no safe dose” of radiation, individual genetic response to the hazards vary.
“You really don’t know how susceptible you are,” said Machan. “The brain and the eyes are much more radiation-sensitive than were previously thought, and more disturbingly, the person you relied on to tell you how much radiation is safe almost certainly doesn’t know.”
As a competitive squash player, Machan began to notice deterioration in his game after 15 years in clinical practice. “I went from being nationally ranked to where I couldn’t even win my club championship,” he said. He was diagnosed with a posterior cataract, and later suffered a retinal detachment as a complication from the cataract removal. He told the audience the lens of the eye is “just about the most, if not the most, radiation-sensitive tissue in the body” and posterior subcapsular cataracts are not age-related. These cataracts are typically caused by exposure to radiation.
Machan highlighted the research of the late Basil Worgul, PhD, from Columbia University, who studied radiation as a cause of cataracts in the thousands of workers who participated in the cleanup of the 1986 Chernobyl disaster. Even among individuals exposed to less radiation than the yearly allowable limit, the researchers documented the onset of cataracts and other relayed eye conditions, leading the group to conclude the threshold for radiation damage was likely much lower than previously believed.
In addition to the damaging effects of radiation on the eyes, there are concerns about head and neck tumors in interventionalists. In 2013, Ariel Roguin, MD, Rambam Medical Center (Haifa, Israel), published a report in the American Journal of Cardiologyhighlighting such concerns. They identified 23 interventional cardiologists, 2 electrophysiologists, and 6 interventional radiologists with brain and neck tumors. In 85% of cancers, the malignancy was documented on the physician’s left side. Although this doesn’t necessarily mean there is a cause-and-effect relationship, physicians typically stand anteriorly to the patient, with their left side closest to the patient’s chest and closest to the source of the radiation.
According to the Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF), the interventional cardiologist’s head and neck are exposed to approximately 20-30 mSv of ionizing radiation each year. Various regulatory bodies recommend a dose limit of 20 mSv per year up to maximum of 50 mSv while the International Commission on Radiological Protection recommends a annual dose limit of 20 mSv for the lens of the eye, with no single year exceeding 50 mSv.
“Most of us assume we’re going to fall off our career path because of alcohol and apathy, but could this be happening because of our choice of career?” said Machan. “Well, it isn’t destined to happen. We’re not all going to go blind with shrunken testicles. There are things you can do about this.”
Among safeguards, education remains critical, he said. While radiation scatter is the primary cause of radiation exposure, scatter dose to the operator markedly increases in larger patients. In these bigger individuals, particularly those with a BMI exceeding 30, “we are getting blasted when we’re standing near those patients,” he said.
Wearing protection is important, and physicians should make use of ceiling-suspended or mounted shielding screens, if possible, in addition to wearing appropriate lead glasses, said Machan. He recommends minimizing the use of angulation, as this can increase radiation exposure to the operator, as well as to nursing staff and the anesthetist. Machan also recommends limiting the use of fluoroscopy time for observing objects in motion and lowering the intensity of fluoroscopy to the lowest dosages that yield adequate images. Using stored images and image magnification only when needed is also helpful in reducing exposure.
Finally, Machan recommends physicians “step away from the beam,” noting that radiation dissipates inversely as the distance from the source is squared. This means that tissue twice as far away from the radiation source receives 25% of the dose. Physicians, nurses, and technologists should leave the room if they don’t need to there, he said.
Stopping A Career In Its Tracks
While the focus on radiation is justifiably important given the concerns about cancer, Chet Rees, MD, of Baylor Scott and White (Dallas, TX), said musculoskeletal injuries can also “stop a career in its tracks.” The problem has been documented for some time, with a landmark survey from 1997 showing that while 6% of interventional cardiologists reported a herniated cervical disc, more than half had been previously treated for neck or back pain. Compared with other matched physicians, interventional cardiologists were more likely to miss work because of orthopedic injuries or to pull back on practice.
Based on the results of the survey, the term “interventionalist disk disease” was coined.
Rees said the data also show higher risks of cervical spondylosis—a form of degenerative osteoarthritis—in a large survey of interventional electrophysiologists, with older physicians and those in practice the longest more likely to develop the condition. Another survey, this one undertaken by the Society for Cardiovascular Angiography and Interventions, found that nearly 10% of operators reported taking a health-related leave of absence and one-third had taken an occupational health-related break. Approximately half of respondents reported orthopedic injuries. And finally, a Mayo Clinic survey similarly documented a high rate of work-related pain among techs, nurses, and physicians working in the cath lab.
While physicians should probably try to find comfort wherever they can, Rees stressed they shouldn’t make do with a lightweight vest. Despite claims from manufacturers about safety and protection offered by lighter vests, Rees said such statements don’t hold much water because regulatory standards for protective radiation garments are tremendously lax and inadequate. Lightweight vests have “poor and inconsistent protection, often counter to their labels,” he said. “A safe bet for interventionalists are non-lightweight, lead-based aprons.”
Two studies presented this week at ISET, including one by Rees, cast significant doubt on the protection provided by lightweight vests. Andrew Lichliter, MD, also of Baylor Scott and White Health (Dallas, TX), said that if physicians are worried about protection from radiation, lead is the best option. “And if it feels really lightweight, you’re probably not getting the protection that you think you are. It takes mass to block these X-rays,” he noted.
Presentations at: International Symposium on Endovascular Therapy; February 6-10, 2016; Hollywood, FL.
Posted on January 7, 2016 by RADPAD
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The Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF) has released an article containing the results of a new study that supports the use of RADPAD® and No Brainer®.
See the article here or read below:
Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF) (PRNewsFoto/ORSIF)
WASHINGTON, Sept. 22, 2015 /PRNewswire/ — The results of a research study indicate that interventional cardiologists receive “very high” radiation exposure levels to the left side of the head specifically when performing fluoroscopically guided invasive cardiovascular (CV) procedures. Even with modern imaging equipment and shielding, a significant exposure difference was seen between the two sides of the head. The study was published in JACC: Cardiovascular Interventions, a peer-reviewed journal of the American College of Cardiology. Dr. Ehtisham Mahmud, MD, FACC, FSCAI, chief of Cardiovascular Medicine, director of Sulpizio Cardiovascular Center Medicine and director, Interventional Cardiology at UC San Diego, authored the study.
According to the study, interventionalists received 16 times the ambient radiation level to the left side of the head during an invasive CV procedure. Also, radiation exposure on the left side of the head was 4.7 times higher than exposure on the right side of the head. Interventional cardiologists typically stand anteriorly to the patient, with the left side of their body closest to the patient’s chest and most proximate to the radiation source.
“The implications of this study are significant when considering the subsequent impact ongoing exposure to even low levels of radiation can have on the health of the practitioner over the course of their career,” said Dr. Mahmud.
Michael Seymour, director, Advocacy Programs for the Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF), concurs.
“While it is widely known that exposure to ionizing radiation can cause serious adverse health effects to medical practitioners, the adverse health impact on an individual is determined primarily by the dose to which he or she is exposed. Dr. Mahmud’s study clearly suggests that interventional cardiologists receive a very high level of radiation exposure to the head – specifically, to the left side of the head – creating a greater risk of brain tumors, brain disease and other serious illnesses.”
The study was conducted with eleven operators who wore non-lead, XPF (barium sulphate/bismuth oxide) radiation attenuating protective caps, with dosimeters positioned on the outside and inside of the caps to measure radiation exposure levels. Radiation doses were also measured by dosimeters outside the lab to assess ambient radiation levels.
Seymour noted that, with the large number of fluoroscopically guided procedures performed in the U.S. each year, “hospitals need to investigate technologies that position operators farther from the source of radiation to reduce or eliminate the potential for long-term health risks on medical staff without compromising patient outcomes.”
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