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Protecting the Provider:  A Reexamination of Cath Lab Radiation Safety

Protecting the Provider: A Reexamination of Cath Lab Radiation Safety

Posted on July 22, 2016 by in Safety with no comments

Protecting the Health of Cath Lab Technicians

Unlike patients who are only exposed to ionized radiation during their procedure, cath lab technicians are exposed during every procedure they perform. This article discusses health effects associated with radiation exposure in the cath lab along with ways to protect the health of those technicians. Two of those ways are wearing a lead-based shield, and keeping a distance between the operator and the radiation source.

Wohns, David, and Ryan Madder. “Protecting the Provider: A Reexamination of Cath Lab Radiation Safety.” Cath Lab Digest. HMP Communications, Feb. 2015. Web. 26 May 2016.

Read the article in full below, or click the link to see the originally published article at Cath Lab Digest:

http://www.cathlabdigest.com/article/Protecting-Provider-Reexamination-Cath-Lab-Radiation-Safety

 


 

Protecting the Provider: A Reexamination of Cath Lab Radiation Safety

Author(s):

David Wohns, MD, Medical Director, and Ryan Madder, MD, 

Kresge Cardiac Cath Labs, Frederik Meijer Heart & Vascular Institute, 

Spectrum Health, Grand Rapids, Michigan

Topics:
Radiation
Safety
Robotic PCI

In the delivery of high-quality healthcare, patient safety is always a major concern of providers and the public. The safety of healthcare workers frequently receives significantly less attention. Recent events have highlighted this issue and are altering this perspective, with greater recognition of the sacrifices and risks that healthcare workers routinely take to perform their jobs. Patient safety remains the number-one concern of healthcare providers. However, the health and safety of providers should receive equal attention, particularly when novel techniques and strategies can be adopted to mitigate provider risk.

During 2014, the Ebola patients treated within U.S. borders caught the attention of the mainstream media and the public. Besides the public’s general concern for the patients, much attention was devoted to the healthcare workers who were exposed to the virus while caring for Ebola patients. These events raised the public’s awareness of healthcare worker safety and also caused many people to ask: “How do we ensure the safety of healthcare providers who put themselves in harm’s way to look after their patients’ health?

Madder

This increased awareness is especially relevant to interventional cardiologists. Unlike patients, who are only exposed to ionizing radiation during their procedure, interventional cardiologists and other members of the cath lab team are repeatedly exposed to ionizing radiation, subjecting them to potentially serious long-term health issues. Additionally, the physical demands of performing their jobs while wearing heavy protective gear can lead to chronic orthopedic conditions that may prematurely end careers or force change into other fields of medicine.

Wohns

With the increased interest in healthcare worker safety, it is an appropriate time to explore the risks associated with cath lab environments and novel technological solutions available to improve safety.

Assessing cath lab risks

Medical procedures performed in the cath lab are a leading source of occupational ionizing radiation exposure for medical personnel1, due to the use of fluoroscopy and cine angiography during these procedures. This occupational radiation exposure is of particular concern because today’s interventional cardiologists are spending significantly greater time in the cath lab doing more complex and lengthy procedures. Further, the performance of percutaneous coronary intervention (PCI) procedures in cath labs has increased more than 50 percent since 20002, potentially exposing interventional cardiologists to additional radiation.

Although research studies have demonstrated substantial variations in the amount of ionizing radiation to which interventional cardiologists are exposed, a look at the literature reveals the following:

  • One study showed that an interventional cardiologist’s head and neck area are generally exposed to approximately 20 to 30 millisieverts (mSv) per year3, which equates to 2 to 3 rems per year.
  • Another demonstrated that cumulative doses for the average interventional cardiologist after 30 years in the cath lab fall between 50 to 200 mSv, equivalent to 5 to 20 rems, or 2,500 to 10,000 chest x-rays.4
  • A third shows that interventionalists receive approximately 1 to 3 sieverts (Sv) to their head during their career (equivalent to 1,000 to 3,000 mSv, or 100 to 300 rems), which corresponds to about 500mSv to the brain5 (equivalent to 50 rems).
  • A separate study showed that interventional cardiologists have a radiation exposure rate documented to be two to ten times higher than that of diagnostic radiologists.4

 

Adverse health effects

Despite the availability and use of personal protective equipment (PPE), such as lead aprons, leaded glasses and thyroid collars, there are significant radiation exposure risks that have the potential to negatively impact the health of interventional cardiologists and their staff. Below are some findings from recent scientific literature:

  • Cataracts: The Occupational Cataracts and Lens Opacities in Interventional Cardiology (O’CLOC) study revealed that 50 percent of interventional cardiologists and 41 percent of cardiac cath nurses and technologists had significant posterior subcapsular lens changes, a precursor to cataracts, which is typical of ionizing radiation exposure.6
  • Thyroid disease: Studies have reported structural and functional changes of the thyroid as a result of radiation exposure.7 Structural changes such as malignant and benign thyroid tumors develop at a linear rate to dose exposure. Functional changes that would result in hyper- or hypo-thyroidism were noted at elevated doses of external and internal radiation exposure.7
  • Brain tumors and brain disease: A recent study focused on interventionalists who had been diagnosed with a variety of brain tumors. The study revealed that 86% of the brain tumors (where location is known) originated on the left side of the brain.8 This is significant, since interventional cardiologists typically stand with the left side of their body closest to the X-ray source and scattered radiation. In the general population, brain tumors originate with equal frequency on the left and right hemispheres.
  • Cardiovascular changes: Recent studies suggest evidence of a link between low- to moderate-dose radiation exposure and cardiovascular changes, despite personal protective wear.5
  • Reproductive health effects: For males, ionizing radiation has demonstrated a reduction in sperm.9 Additionally, cath lab staff members who may become pregnant while working in the cath lab must also take into consideration the effects that ionizing radiation can have on the developing fetus.

Additionally, there are orthopedic-related consequences from the heavy weight of lead gear worn by interventional cardiologists. The repeated standing and leaning over patients during procedures is fatiguing and commonly leads to chronic orthopedic conditions. A 2006 survey conducted by the Society for Cardiovascular Angiography and Interventions (SCAI) disclosed that interventional cardiologists suffer from a disproportionate amount of back, hip, and knee injuries leading to a significant amount of missed workdays.10 The weight of the personal protective gear is fatiguing, and a physician who is fatigued or experiencing discomfort may be more likely to be distracted or rush through a procedure.

Protecting the health of cath lab employees

There are two traditional techniques used to reduce radiation exposure. One is lead-based shielding, and the second is increasing the distance between the operator and the radiation source.

A relatively new approach to shielding includes devices that support lead aprons that hang from a boom, rather than being worn by clinicians. These hanging aprons provide effective radiation protection with a greater quantity of lead than is traditionally worn by operators. Since the operator is not physically supporting the lead, these devices have the potential to reduce orthopedic injuries and reduce overall operator fatigue.

The advent of robot-assisted percutaneous coronary intervention (PCI) represents another novel approach to reducing radiation exposure to operators. Robotic systems for PCI allow interventional cardiologists to perform procedures remotely, away from the patient’s bedside. Seated in a radiation-protected cockpit, the physician uses digital controls to robotically manage catheters, guide wires, angioplasty balloons, and stents to clear blockages and restore blood flow. These technologies are beneficial in reducing exposure by positioning operators further from the radiation source, but also have the potential to mitigate the impact that wearing PPE has on operators, such as orthopedic pain, missed work and disability.

The robotic-assisted PCI system being used at Spectrum Health is called CorPath (Corindus Vascular Robotics). The CorPath System allows physicians to perform PCI procedures from the comfort of a radiation-shielded cockpit that includes angiographic and hemodynamic monitors. Physicians using the system are able to take measurements, with sub-millimeter accuracy, of relevant anatomy, as well as advance or retract guide wires and/or balloon stent catheters with movements as small as a millimeter. A clinical trial has shown that using the robotic system reduced radiation exposure to the primary operator by more than 95 percent.11

Elevating healthcare worker safety

Interventional cardiology is a uniquely rewarding, highly innovative profession. The bulk of the innovation in our field over the past 3 decades has appropriately been focused on patient care. However, the manner and circumstances with which that care has been delivered in the cath lab has changed little over time. New approaches are now available to begin to mitigate the biomechanical, orthopedic, and radiation risks of working in the cath lab. The CorPath System is an example of a device with tremendous promise to reduce these hazards for interventional cardiologists, contributing to longer, healthier careers. We have been excited to bring this innovative technology to our cath labs as part of the evolution of our environment.

References

  1. Sun Z, AbAziz A, Yusof AK. Radiation-induced noncancer risks in interventional cardiology: optimisation of procedures and staff and patient dose reduction. Biomed Res Int. 2013; 2013: 976962. doi: 10.1155/2013/976962.
  2. Best PJ, Skelding KA, Mehran R, Chieffo A, Kunadian V, Madan M, et al; Society for Cardiovascular Angiography & Interventions’ Women in Innovations (WIN) Group. SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and technical personnel. Catheter Cardiovasc Interv. 2011 Feb 1; 77(2): 232-241. doi: 10.1002/ccd.22877.
  3. L Renaud. A 5-y follow-up of the radiation exposure to in-room personnel during cardiac catheterization. Health Phys. 1992 Jan; 62(1): 10-15.
  4. Picano E, Andreassi MG, Piccaluga E, Cremonesi A, Guagliumi G. Occupational risks of chronic low dose radiation exposure in cardiac catheterisation laboratory: the Italian Healthy Cath Lab study. EMJ Int Cardiol. 2013; 1: 50-58.
  5. Picano E, Vano E, Domenici L, Bottai M, Thierry-Chef I. Cancer and non-cancer brain and eye effects of chronic low-dose ionizing radiation exposure. BMC Cancer. 2012 Apr 27; 12: 157. doi: 10.1186/1471-2407-12-157.
  6. Vano E, Kleiman NJ, Duran A, Romano-Miller M, Rehani MM. Radiation-associated lens opacities in catheterization personnel: results of a survey and direct assessments. J Vasc Interv Radiol. 2013 Feb; 24(2): 197-204. doi: 10.1016/j.jvir.2012.10.016.
  7. Ron E, Brenner A. Non-malignant thyroid diseases after a wide range of radiation exposures.Radiat Res. 2010 Dec; 174(6): 877-888. doi: 10.1667/RR1953.1.
  8. Roguin A, Goldstein J, Bar O, Goldstein JA.  Brain and neck tumors among physicians performing interventional procedures. Am J Cardiol. 2013 May 1; 111(9): 1368-1372. doi: 10.1016/j.amjcard.2012.12.060.
  9. Burdorf A, Figà-Talamanca I, Jensen TK, Thulstrup AM. Effects of occupational exposure on the reproductive system: core evidence and practical implications. Occup Med (Lond). 2006 Dec; 56(8): 516-520.
  10. Dehmer GJ. Occupational hazards for interventional cardiologists. Catheter Cardiovasc Interv. 2006 Dec; 68(6): 974-976.
  11. Weisz G, Metzger DC, Caputo RP, Delgado JA, Marshall JJ, Vetrovec GW, et al. Safety and feasibility of robotic percutaneous coronary intervention: PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study. J Am Coll Cardiol. 2013 Apr 16; 61(15): 1596-1600. doi: 10.1016/j.jacc.2012.12.045.

Disclosure: Dr. Wohns and Dr. Madder report no conflicts of interest regarding the content herein.

The authors can be contacted via David.Wohns@spectrumhealth.org.

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Cath Lab Workers May Be Harmed by Radiation

Cath Lab Workers May Be Harmed by Radiation

Posted on July 1, 2016 by in Safety with no comments

This article discusses a study comprising 466 hospital staff members, including interventional cardiologists, electrophysiologists, nurses and technicians who are exposed to radiation regularly. Additionally, 280 staffers who were not exposed to radiation in the cath lab were interviewed. This study gathered work-related and lifestyle information, current medications and health status for these workers. Almost three percent of interventional cardiology staff had a history of cancer, compared to less than one percent of the unexposed group. Eight percent of lab workers had experienced skin lesions, 30 percent experienced orthopedic illness and five percent had cataracts, compared to two, five, and less than one percent of the unexposed group.

See the full article below or read the original by clicking the link below:

http://www.newsmax.com/Health/Health-News/cath-lab-workers-healthcare/2016/04/13/id/723656/

Cath Lab Workers May Be Harmed by Radiation
Wednesday, 13 Apr 2016 08:53 AM

Copyright AP Radiation protection
Healthcare workers in labs where patients undergo heart procedures guided by X-rays may be at higher risk for cataracts, skin lesions, bone disorders or cancer than other healthcare workers, according to a new study.

Procedures in the “cath lab” – named for the catheters threaded into the heart – are done for all forms of cardiac disease, like congenital heart defects, ischemic heart disease or heart arrhythmias, said lead author Maria Grazia Andreassi of the CNR Institute of Clinical Physiology in Pisa, Italy.
“These procedures, highly effective and often life-saving, require substantial radiation exposure to patients,” Andreassi told Reuters Health by email.

But staff members, too, are exposed to radiation. In particular, for the cardiologists and electrophysiologists who work near the patient and the radiation source, “the cumulative dose in a professional lifetime is not negligible,” Andreassi said.

The researchers used questionnaires to gather work-related and lifestyle information, current medications and health status for 466 exposed hospital staff, including interventional cardiologists, electrophysiologists, nurses and technicians, half of whom had been working for at least 10 years. They also surveyed 280 staffers who had not been exposed to radiation in the cath lab.

Almost 3 percent of interventional cardiology staff had a history of cancer, compared to less than 1 percent of the unexposed comparison group. Eight percent of lab workers had experienced skin lesions, 30 percent had an orthopedic illness and five percent had cataracts, compared to two percent, five percent and less than one percent of the unexposed group, respectively.

Doctors had higher risks than nurses or technicians, and risk was higher for those who had been working more than 16 years, as reported in Circulation: Cardiovascular Interventions.

Stroke and heart attack risk were similar in the radiation and non-radiation exposure groups.

“Compared to healthcare professionals not exposed to radiation, workers with more than 16 years of occupational work are approximately 10 times more likely to experience cataracts and eight times more likely to have cancer after adjusting for other confounders,” like age and smoking status, Andreassi said.

Protective measures like leaded aprons, thyroid collars, leaded glasses, and overhead radiation shields can reduce the radiation dose to the operators, but are still not used regularly in every laboratory, Andreassi said.

Healthcare workers in the cath lab “sort of know there is a risk but it’s typically presented to young people as something to know about and not to worry about,” said Dr. Lloyd Klein of Advocate Illinois Medical Center in Chicago, who coauthored an editorial accompanying the new study.
“Everyone wears lead aprons, and increasingly, lead caps,” Klein told Reuters Health by email. “We are careful about unnecessary exposure.”

But wearing lead creates orthopedic problems and doesn’t completely protect against the effects of radiation, he said.

The Occupational Safety and Health Administration and federal and state agencies probably need to get more involved than they already are, he said.

“Unfortunately, interventional cardiologists are often inadequately trained in radiation safety and radiobiology, and hospitals have few training programs regarding radiation risk and exposure,” Andreassi said.
© 2016 Thomson/Reuters. All rights reserved.

 

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Phone: 913-648-3730
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Radiation Safety for the Interventional Cardiologist

Posted on June 23, 2016 by in Safety with no comments

Protecting Ourselves from the Dangers of Ionizing Radiation:

Patient exposure has significantly decreased over the past decade by reducing procedure time and improved imaging quality and equipment. Despite these improvements, procedure personnel still remain at high risk of radiation exposure. Interventional cardiologists are so commonly concerned with their patient’s safety that they forget they too are at risk. These health care professionals need to know the dangers and risks associated with radiation in order to properly take charge and protect their lives. There are many hazards towards the human body with radiation exposure. These hazards include brain tumors, cataracts, thyroid disease, cardiovascular effects, and reproductive system effects. Along with that, some effects from radiation can be stochastic, like developing a malignancy, and some can be deterministic, like a skin burn. Procedure professional should be aware of their dose limits and way to reduce exposure in the lab.

The following informative article by the American College of Cardiology addresses radiation safety for the Interventional Cardiologist. Read the full text below or link to the article here:

http://www.acc.org/latest-in-cardiology/articles/2015/12/31/10/12/radiation-safety-for-the-interventional-cardiologist

Radiation Safety for the Interventional Cardiologist—A Practical Approach to Protecting Ourselves From the Dangers of Ionizing Radiation

Jan 04, 2016   |  Gautam Kumar, MD, FACC; Syed Tanveer Rab, MBBS, FACC

Editorial Comment From George W. Vetrovec, MD, MACC, Editorial Team Lead for Invasive Cardiovascular Angiography and Intervention Clinical Topic Collection, ACC.org

Radiation safety is the concern of all health care providers who perform procedures associated with radiation imaging, whether for diagnostic purposes or therapeutic procedures. Appropriately, there has been increasing public and societal interest in limiting patient radiation. Likewise, laboratory personnel are at risk for radiation compounded by long procedures and multiyear careers using radiation procedures.

Over the years, there have been various equipment modifications. The initial focus was to improve image quality by increasing radiation intensity. However, there is now a greater focus on limiting patient exposure in the setting of often prolonged procedures, such as complex multivessel and chronic total occlusion (CTO) revascularization procedures. X-ray systems are able to provide excellent image quality with lower X-ray exposure.

However, despite these improvements, radiation remains a risk for procedure personnel. Unfortunately, the focus on the complexity and intensity of the procedure itself often overshadows attention to personal optimal “self-radiation” protection. The following article not only describes these risks but also, importantly, enumerates the specific operator and personnel approaches to minimize radiation risk. A review of these preventive strategies is important to re-emphasize the personnel opportunities and responsibilities for radiation protection. Finally, the authors describe some of the evolving opportunities to more dramatically reduce radiation exposure. This article is an excellent refocus on an important issue for the interventional community.

Ionizing radiation in the form of X-rays is used extensively in the modern cardiac catheterization laboratory. Unlike patients who receive a dose of ionizing radiation during their procedure, interventional cardiologists and cardiac catheterization laboratory personnel are repeatedly exposed to ionizing radiation in the course of their duties. This issue has been magnified with increased exposure in the long duration of structural or complex adult congenital heart disease intervention and CTO cases. Personnel not previously exposed to ionizing radiation such as echocardiographers, ultrasound technologists, cardiac surgeons, and anesthesiologists are frequently close to the X-ray field. Therefore, minimizing radiation exposure is of utmost importance.

Understanding the Hazards

Significant radiation exposure has the potential to impact the health and well-being of interventional cardiologists in the following ways:

  • Brain Tumors: A case report of brain tumors in 2 Canadian interventional cardiologists1 first raised this concern. There were three additional cases identified in a study from Sweden in physicians who had worked with fluoroscopy.2 The left-sided predisposition of these tumors raised further alarm when four additional cases were reported from France and Israel.3 Active case findings from this group highlighted this concern further when they identified that 22 of 26 cases (85%) had a left-sided distribution of brain tumors, which is a phenomenon that is not noted in the general population.4 In a study of 11 cardiologists performing invasive (diagnostic and interventional) procedures, radiation exposure to the outside left side and outside center of the head was significantly greater than the outside right side of the head (106.1 +/- 33.6 and 83.1 +/- 18.9 vs. 50.2 +/- 16.2 mrad, p < 0.001). This was significantly attenuated by the usage of a radiation protection cap (42.3 +/- 3.5 and 42.0 +/- 3.0 vs. 41.8 +/- 2.9 mrad) and only slightly higher than ambient control (38.3 +/- 1.2 mrad, p = 0.046).5
  • Cataracts: Higher incidence of cataracts (specifically posterior subcapsular) has been reported in interventional cardiologists in a large French multicenter observational study.6 Similar results were also noted in a separate study of both interventional cardiologists and CCL nurses and technicians. Fortunately, this risk appeared to be mitigated in those who wore lead-lined glasses.7
  • Thyroid Disease: Structural and functional changes as a result of radiation exposure have been reported in the thyroid gland. The degree of exposure has been correlated with a linear increase in the development of both benign and malignant thyroid neoplasms.8,9
  • Cardiovascular Effects: Exposure to radiation has been associated with both macrovascular and microvascular abnormalities. The occupational significance of this is not well-identified presently.10
  • Reproductive System Effects: Although exposure to ionizing radiation reduces both sperm count and quality, the occupational effects of this have not been determined.11 A study of 56,436 female radiology technicians in the United States revealed 1,050 cases of breast cancer and concluded that daily low-dose radiation exposure over several years may increase the risk of developing breast cancer.12 It is concerning that in the small series reported by the “Women in Innovation” group for safety, two cardiologists and one nurse with breast cancer had left-sided tumors.13Radiation safety for the pregnant interventional cardiologist and/or cardiac catheterization laboratory nurse/technician is a pressing issue. US federal law prohibits discrimination against the pregnant worker, but pregnancy should be declared to the employer as early as feasible so that adequate fetal protection can be undertaken. Protective garments must provide at least 0.5 mm lead-equivalent protection throughout the entire pregnancy, and an additional monthly fetal dose-monitoring badge should be issued and worn at waist level under the protective garment.14

Understanding Adverse Effects of Radiation Exposure

The adverse risks of radiation exposure may be described in terms of stochastic and deterministic effects.

The stochastic effect is the non-threshold biologic effect of radiation that occurs by chance to a population of persons whose probability is proportional to the dose and whose severity is independent of the dose. Developing malignancy due to radiation exposure is a stochastic risk.

The deterministic effect is a dose-dependent direct health effect of radiation for which a threshold is believed to exist. Developing a skin burn as a result of a prolonged case is a deterministic effect.

Dose exposure is usually described in terms of the following parameters:

  1. Fluoroscopic Time (min): This is the time during a procedure that fluoroscopy is used but does not include cine acquisition imaging. Therefore, considered alone, it tends to underestimate the total radiation dose received.
  2. Cumulative Air Kerma (Gy): The cumulative air kerma is a measure of X-ray energy delivered to air at the interventional reference point (15 cm from the isocenter in the direction of the focal spot). This measurement has been closely associated with deterministic skin effects.
  3. Dose-Area Product (Gy.cm2): This is the cumulative sum of the instantaneous air kerma and the X-ray field area. This monitors the patient dose burden and is a good indicator of stochastic effects.

The annual occupational dose limits for catheterization laboratory personnel are as follows:

Area Maximum Dose/Year
Whole body 50 mSv
Eye lens 150 mSV
Skin or extremities 500 mSv
Fetus 0.5 mSv/month or 5 mSv/pregnancy

Tissue Reactions

Radiation-induced hair loss and injuries of the skin and subcutaneous tissues are collectively termed “tissue reactions” and are rare complications of prolonged fluoroscopic procedures. Tissue reactions may be graded; this is influenced by biological variability. In general, Grade 1 reactions are visible but seldom clinically important, but Grade 2 reactions may be clinically important. Grades 3 and 4 tissue reactions are usually considered to be clinically important.15,16

Notification levels are intended to make the operator aware, during the procedure, of the cumulative radiation used. This happens at 3 Gy. The substantial radiation dose level is a trigger level for certain processes and follow-up measures and happens at 5 Gy. It is not an indicator of a tissue reaction or a predictor of the risk of a stochastic effect but is intended to alert providers to the possibility of a tissue reaction. The following process should be followed when a substantial radiation dose level is reached:

  1. At the end of the procedure, the primary operator documents the clinical necessity for exceeding any substantial radiation dose level in the medical record.
  2. Patients are promptly informed when substantial amounts of radiation were used for their procedures and the necessity for this.
  3. Patients receive follow-up to determine whether tissue reactions occurred.
  4. If a tissue reaction is identified, the patient should be referred to an appropriate provider for management. In general, biopsies of these areas must be avoided.
  5. These results are reported to and reviewed by the interventional service quality assurance and peer review committees.

Minimizing X-ray Exposure

This is enshrined in the “as low as reasonably achievable” (ALARA) principle. The level of protection should be the best under the prevailing circumstances, maximizing the margin of benefit over harm. Imaging requirements depend on the specific patient and the specific procedure. Although better-than-adequate image quality subjects the patient to additional radiation dose without additional clinical benefit, reducing patient radiation dose to the point at which images are inadequate is counterproductive and results in radiation dose to the patient without any clinical benefit.17Using an anthropomorphic phantom, significant differences were identified between different manufacturers in terms of radiation doses in comparable views.18

Commonly employed strategies to minimize radiation exposure are summarized below and also in Figures 1 and 2.19

Figure 1

Figure 1

Figure 2

Figure 2

Precautions to Minimize Exposure to Patient and Operator

  • Utilize radiation only when imaging is necessary to support clinical care. Avoid allowing the “heavy foot,” to step on the fluoroscopy pedal while not looking at the image.
  • Minimize use of cine. “Fluoro-save” has a <10% radiation exposure of cineangiography.
  • Minimize use of steep angles of X-ray beam. The left anterior oblique (LAO) cranial angulation has the highest degree of scatter exposure to the operator.
  • Minimize use of magnification modes. Most modern systems have software magnification algorithms that allow for magnification without additional radiation. In modern machines, there is a “Live Zoom” feature without significant degradation of the image. For example, in lieu of magnification, an 8-inch field of view with a zoom factor of 1.2 results in a 6.7-inch field of view without added radiation.
  • Minimize frame rate of fluoroscopy and cine. Ensure that CTOs and other long cases are performed on the 7.5 frames/sec fluoroscopy setting. A reduction of the fluoroscopic pulse rate from 15 frames/sec to 7.5 frames/sec with a fluoroscopic mode to low dose reduces the radiation exposure by 67%.
  • Keep the image detector close to the patient (low subject-image distance).
  • Utilize collimation to the fullest extent possible. In a room with a peripheral-compatible large flat panel detector, ensure that this is collimated to the field of view adequate for coronary procedures.
  • Monitor radiation dose in real time to assess the patient’s risk/benefit ratio during the procedure.

Precautions to Specifically Minimize Exposure to Operator

  • Use and maintain appropriate protective lead garments. We recommend a full protective suit with thyroid collar and additional head protection. However, 49% of active interventional operators report at least one orthopedic injury.20 Consideration should be given to ceiling suspension or floor-mounted personal radiation shielding for enhancing radiation protection and preventing orthopedic issues. For women, we also suggest additional protection to the breast with sleeves, which ensure full coverage of this area, in addition to dedicated breast shields. In view of the concern about brain tumors, protective hats are recommended, especially for the primary operator.
  • Maximize distance of operator from X-ray source and patient.
  • Keep above-table (hanging) and below-table shields in optimal position at all times. A larger ceiling-mounted shield with attached lamellae, used in combination with a drape, decreased exposure to the operator by half.21
  • Use additional disposable shielding material for protection from scatter radiation.
  • Keep all body parts out of the field of view at all times. When it is unavoidable that a body part would be exposed to radiation, consider usage of radiation attenuating gloves (for example, for an echocardiographer imaging during cardiac biopsies) or attenuating cream (for example, for an electrophysiologist attempting to perform device implantation).
  • A robotic percutaneous coronary intervention (PCI) system may be considered as a viable alternative for both radiation protection and occupational hazard mitigation because lead shielding need not be worn when seated in the interventional cockpit during PCI procedures.

Precautions to Specifically Minimize Exposure to Patient

  • Keep table height as high as comfortably possible for the operator.
  • Every 30 minutes, vary the imaging beam angle to minimize exposure to any specific skin area
  • Minimizing steep LAO and anteroposterior cranial angles
  • Keep the patient’s extremities out of the beam.

Conclusion

A radiation safety program is an essential part of the quality administration for the catheterization laboratory. This should be a collaborative effort involving physicians, staff, medical or health physicists, quality assurance personnel, and hospital administration. Interventional cardiologists are an essential part of this process and need to ensure the best possible outcomes for ourselves and for our patients.

As a profession, interventional cardiologists need to be conscious of their own radiation safety. Improved wall hanging or floor-mounted personal shielding and robotic cardiac catheterization laboratories need to become a standard of care and not a luxury. The high prevalence of orthopedic issues among catheterization laboratory professionals and subsequent disability should prompt governmental oversight agencies like the Occupational Safety and Health Administration to mandate these types of procedures and equipment. We need to continue pursuing research and development of customized radiation safety equipment for peripheral interventions and structural procedures.

References

  1. Finkelstein MM. Is brain cancer an occupational disease of cardiologists? Can J Cardiol 1998;14:1385-8.
  2. Hardell L, Mild KH, Påhlson A, et al. Ionizing radiation, cellular telephones and the risk for brain tumours. Eur J Cancer Prev 2001;10:523-9.
  3. Roguin A, Goldstein J, Bar O. Brain tumours among interventional cardiologists: a cause for alarm? Report of four new cases from two cities and a review of the literature. EuroIntervention 2012;7:1081-6.
  4. Roguin A, Goldstein J, Bar O, et al. Brain and neck tumors among physicians performing interventional procedures. Am J Cardiol 2013;111:1368-72.
  5. Reeves RR, Ang L, Bahadorani J, et al. Invasive cardiologists are exposed to greater left sided cranial radiation: The BRAIN study (Brain Radiation Exposure and Attenuation during Invasive Cardiology Procedures). JACC Cardiovasc Interv 2015;8:1197-206.
  6. Jacob S, Boveda S, Bar O, et al. Interventional cardiologists and risk of radiation-induced cataract: results of a French multicenter observational study. Int J Cardiol 2013;167:1843-7.
  7. Vano E, Kleiman NJ, Duran A, et al. Radiation-associated lens opacities in catheterization personnel: results of a survey and direct assessments. J Vasc Interv Radiol 2013;24:197-204.
  8. Ron E, Brenner A. Non-malignant thyroid diseases after a wide range of radiation exposures. Radiat Res 2010;174:877-88.
  9. Schneider AB, Ron E, Lubin J, et al. Dose-response relationships for radiation-induced thyroid cancer and thyroid nodules: evidence for the prolonged effects of radiation on the thyroid. J Clin Endocrinol Metab 1993;77:362-9.
  10. Picano E, Vano E, Domenici L, et al. Cancer and non-cancer brain and eye effects of chronic low-dose ionizing radiation exposure. BMC Cancer 2012;12:157-69.
  11. Burdorf A, Figà-Talamanca I, Jensen TK, et al. Effects of occupational exposure on the reproductive system: core evidence and practical implications. Occup Med (Lond) 2006;56:516-20.
  12. Doody MM, Freedman DM, Alexander BH, et al. Breast cancer incidence in U.S. radiologic technologists. Cancer 2006;106:2707-15.
  13. Buchanan GL, Chieffo A, Mehilli J, et al. The occupational effects of interventional cardiology: results from the WIN for Safety survey. EuroIntervention 2012;8:658-63.
  14. Best PJ, Skelding KA, Mehran R, et al. SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and technical personnel. Catheter Cardiovasc Interv 2011;77:232-41.
  15. Balter S, Hopewell JW, Miller DL, et al. Fluoroscopically guided interventional procedures: a review of radiation effects on patients’ skin and hair. Radiology 2010;254:326-41.
  16. National Council on Radiation Protection and Measurements. Radiation Dose Management for Fluoroscopically Guided Interventional Medical Procedures, NCRP Report No. 168. Bethesda: NRCP Publications; 2010.
  17. Cousins C, Miller DL, Bernardi G, et al. ICRP PUBLICATION 120: Radiological protection in cardiology. Ann ICRP 2013;42:1-125.
  18. Christopoulos G, Christakopoulos GE, Rangan BV, et al. Comparison of radiation dose between different fluoroscopy systems in the modern catheterization laboratory: results from bench testing using an anthropomorphic phantom. Catheter Cardiovasc Interv 2015;86:927-32.
  19. Chambers CE, Fetterly KA, Holzer R, et al. Radiation safety program for the cardiac catheterization laboratory. Catheter Cardiovasc Interv 2011;77:546-56.
  20. Klein LW, Tra Y, Garratt KN, et al. Occupational health hazards of interventional cardiologists in the current decade: results of the 2014 SCAI membership survey. Catheter Cardiovasc Interv 2015;86:913-24.
  21. Gilligan P, Lynch J, Eder H, et al. Assessment of clinical occupational dose reduction effect of a new interventional cardiology shield for radial access combined with a scatter reducing drape. Catheter Cardiovasc Interv 2015;86:935-40.

Keywords: Advisory Committees, Biological Products, Biopsy, Brain Neoplasms, Breast Neoplasms, Burns, Cardiac Catheterization, Cataract, Catheterization, Cineangiography, Fetus, Fluoroscopy, Follow-Up Studies, Hair, Health Personnel, Heart Diseases, Heart Rate, Hospital Administration, Laboratory Personnel, Lens, Crystalline, Medical Records, Neoplasms, Percutaneous Coronary Intervention, Prevalence, Protective Devices, Radiation Dosage, Radiation Protection, Risk, Robotics, Sperm Count, Standard of Care, Subcutaneous Tissue, Surgeons, Thyroid Diseases, Thyroid Neoplasms, United States Occupational Safety and Health Administration, X-Rays

 

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New Technique to Cardiac Catheterization Procedure

Posted on June 3, 2016 by in Procedures with no comments

CARDIAC CATH:

Interventional cardiologist Dr. John Wang, chief of the Cardiac Catheterization Lab at MedStar Union Memorial Hospital in Baltimore, Maryland demonstrates a new technique to cardiac catheterization procedure by using transradial access.

Patients may need a cardiac catheterization if they are experiencing cholesterol narrowing’s in the blood vessels which may result in chest pain or even a heartattack. This procedure is typically performed through the femoral artery, but there is sufficient collateral blood flow to the hand to make the wrist an accessible location for catheterization. There is no risk of bleeding complications where the catheter is inserter so this technique is used to increase patient comfort and experience a quicker recovery. If the patient is in need of a stent, this can be placed through the wrist as well.

Link to demonstration video:

Dr. John Wang also discusses the benefits of transradial cardiac catheterization:

https://youtu.be/V_SftPdJUDM

 

WORLDWIDE INNOVATIONS & TECHNOLOGIES, INC. (WIT)
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Lightweight Aprons EXPOSED: Information about radiation safety for interventionalists

Posted on April 22, 2016 by in Safety with no comments

Lightweight Aprons EXPOSED

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).

haith-vs-heit

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.

w-tungsten-curve

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).

 

geometry-narrow-beamgeometry-broad-beam

 

 

 

 

 

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.

overlapFig 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.

overlap-problem

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.

aprons-1Fig 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”.

aprons-2Fig 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.

inv-exp-v-weight

lichliter-setup-photo

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. 

 

FAQ

  1. 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.
  2. 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.
  3. 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.
  4. 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).
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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. 

REFERENCES

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

 

** see the original article here:

http://www.interventco.com/2016/03/06/lightweight-aprons-exposed/

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Lenexa, KS 66215Phone: 913-648-3730
or 1-877-7RADPAD (1-877-772-3723)Fax: 913-648-0131Email: info@radpad.com

RADPAD® Products help Interventional Physicians Manage Occupational Hazards

Posted on February 18, 2016 by in Safety with no comments

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Tumors, Bad Backs, and Cataracts: Interventional Physicians Face a Lifetime of Risk

By Michael O’Riordan 
Wednesday, February 10, 2016

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.


Source:
Presentations at: International Symposium on Endovascular Therapy; February 6-10, 2016; Hollywood, FL.

 

RADPAD® and No Brainer® for Interventional Cardiology

Posted on January 7, 2016 by in Safety with no comments

RADPAD X-Ray Radiation Protection

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)

Organization for Occupational Radiation Safety in Interventional Fluoroscopy (ORSIF) (PRNewsFoto/ORSIF)

WASHINGTONSept. 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.”

Contact RADPAD® anytime for a No Brainer® sample!

Phone: 913-648-3730
or 1-877-7RADPAD (1-877-772-3723)

Fax: 913-648-0131

Email: info@radpad.com

www.radpad.com

 

 

RADPAD SCATTER RADIATION PROTECTION VISITS LISBON

Posted on October 30, 2015 by in Radpad Visits with no comments

RADPAD went to Lisbon, Portugal recently for CIRSE 2015.

RADPAD Scatter Radiation Protection Shields, Drapes and Caps

RADPAD Visits Lisbon

6,600 members attended CIRSE 2015 – a new attendance record!

RADPAD X-Ray Scatter Radiation Protection Shields and Drapes

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) is a non-profit, educational and scientific association aiming to improve patient care through the support of teaching, science, research and clinical practice in the field of cardiovascular and interventional radiology.

RADPAD Scatter Radiation Protection Shields, Drapes and Caps

Interventional radiology is an innovative and ever-expanding specialty that provides minimally invasive treatments for a wide range of diseases, which are performed by trained physicians under appropriate image-guidance. CIRSE aims to support education and further research in this field, as well as ensuring excellent patient safety and timely access to IR therapies.

For more information and to request a free No Brainer Surgical Cap visit www.radpad.com