New Recommendations From the Society for Cardiovascular Angiography and Interventions (SCAI) Regarding Radiation Safety in the Cath Lab

Tell us about the creation of the new guidelines. It was actually in 2006, after completing the 1992 infection control guidelines update, that the SCAI Lab Standards Committee (now the Quality Improvement Committee), looked at renewing the 1992 radiation safety guidelines. Our group was composed of three physicists and three cardiologists, as well as the multiple other people we recruited for opinions. Committee members included Dr. Stephen Balter, a medical physicist in cardiology at Columbia University (also on the 1992 paper), Dr. Ralf Holzer, a pediatric/ structural heart disease cardiologist at Nationwide Children’s Hospital, Dr. Kenneth Fetterly, a PhD at the Mayo Clinic, Dr. Pei Jan-Paul Lin from the Beth Israel Deaconess Medical Center, who has been active in the society for years as a physicist/consultant, Dr. Warren Laskey, a past SCAI president who has been involved in radiation safety for years, and Dr. James Blankenship, Cath Lab Director at the Geisinger Medical Center. As the committee went through the old guidelines, it became evident that something more than just another guidelines review was needed. We decided to provide actual practice recommendations on how to set up a radiation safety program.¹ Would you say there is a greater concern or interest in radiation dosing now, with the advent of CTA, structural heart disease procedures, and so on? I am not sure it is greater, but I think what it has to be is more focused. In the 1992 radiation safety guidelines, we did not address, as we have in the current guidelines, women and pregnancy, and adult congenital heart disease. We also didn’t go through exactly how to set up a radiation safety program. The current guidelines do take note of other papers in the literature, such as the 2004 American College of Cardiology/SCAI fluoroscopic guidelines by Hirshfeld et al, which gives an overview of the physics of imaging and radiation safety.² Quality improvement in the cath lab is entirely different than what it was in the 1990’s. You have much more emphasis on continuous quality improvement, process indicators, and how to set programs up and follow procedures anywhere from the consent form pre-procedure, to in-lab practices and post-procedure follow up. There is an entire thought process that has evolved since the 1992 guidelines, where we were simply discussing topics. Now everyone is focusing on the processes of improving quality/patient care. What does a “process-minded” approach mean for the current recommendations? The key is that as one must create and manage a radiation safety program; it is a mindset, not just an “occurrence.” In other words, you have to manage radiation during a procedure the same way you manage radiographic contrast. As we say in the introduction, the first principle, as was first written in the 1970’s, is that it is essential the procedure is justified. Second, you have to make sure the infrastructure for a program is in place. I won’t say it is the simple things, but rather that it is the mindset of making sure that everybody wears dosimeters, for example. You have to have a radiation safety-conscious environment. Third is radiation dose management. We broke it down into a pre-procedural, procedural, and post-procedural process. The pre-procedure portion, besides making sure the procedure is appropriate, is making sure that the informed consent includes a concept the patient can understand, especially for patients who may be having a complex procedure, like percutaneous coronary intervention for chronic total occlusions. These procedures are ones where patients have to be aware it is going to be a more complex procedure, you may get an excessive dose of radiation, but this is what we are doing to manage it. The guidelines go on to detail ways to manage and decrease radiation exposure: anywhere from better use of the equipment to better use of shielding, better use of overall practice patterns, where you place the table, how you cone, and how you limit the cine images. After management comes follow up, in the off chance that a patient received a high radiation dose. In some of these procedures, where you are trying to get vessels open, there is going to be a significant dose of radiation. As long as the justification for the procedure was there and best dose management practices were applied, then it’s something you have to accept. However, it must be followed up. This is a potential patient scenario: a patient presents to their family physician, a month after their procedure, with this square-shaped “rash” on their back (we include an image in the paper), and they’ll say, what’s this? The physician will look at it, and not appreciate that it is a rash in the same configuration as the x-ray tube used for the procedure. This is why those familiar with the procedure should follow this up themselves, since they know what to expect. Radiation safety must be considered a process, from pre-procedure to procedure and post-procedure, in order to make sure all aspects of exposure are covered and the best patient care is delivered. Many labs often refer to their ‘radiation safety officer’ as the primary person for monitoring radiation safety. It is essential to have a point person in all labs, but radiation best practice is everyone’s responsibility. This is the mindset that we are trying to get out there. Use best practice every day, every case, every member of the staff. The CARE Bill, which was introduced in Congress approximately 5 years ago and ultimately not passed, stressed, among multiple issues, the importance of staff training. How Congress defined “appropriate training” was probably the problem, but that’s a discussion for another time. All staff must have initial training in imaging equipment and radiation safety with mandatory continuing education. This is for the betterment of the patient and the betterment of the staff, including physicians. Safe practice for the patient protects the staff and visa versa. Does this paper address the patient who may be seeking information? The patient education component was not an integral component of the paper. However, we emphasized that in the consent form, patients be given a paragraph, as much in layman’s terms as possible, which tells them about the radiation aspects of the procedure. This was to make sure the patient understands why they need the procedure, and that in undergoing this procedure, they may get excessive radiation. Tell us about the new sections: you mentioned women and adult congenital heart disease. There are two ways we looked at the pediatrics section. We look at it as structural heart disease as well as pediatrics. Adult congenital is included in this concept of structural heart disease. In other words, patients with congenital abnormalities that survive into adults are also addressed. The big issue that the pediatricians are concerned about, as you can imagine, is the long-term effects of radiation dose. For the elderly, when they receive radiation, the potential delayed effects may be insignificant. However, the younger population obviously has their whole life in front of them, with delayed effects potentially significant. Additionally, it is the potential of not just the one dose, but sequential studies, over a lifetime, and how that may impact the patient’s risk for delayed effect, i.e. cancers. We talk about processes that are in place, like the “Image Gently” campaign from the Alliance for Radiation Safety in Pediatric Imaging. We discuss the importance of understanding the equipment, specific ways of decreasing dose, and address physician responsibility, education and training. There are guidelines for training in structural interventions in pediatric cardiology that have just been recommended by the SCAI Structural Heart Disease Council. Most of the cath lab work for adults is arteries, i.e., coronaries or peripheral work. When you start dealing with structural heart disease, it becomes quite complex: what chamber is attached to what chamber, in regard to some of these congenital abnormalities. Then there are the surgical corrections, the baffles, the conduits. These procedures are quite complicated. You have to understand the potential impact on the patient and obviously, understand your equipment. Regarding the section on “Women and Fluoroscopically-Guided Procedures,” this is a relatively small section, providing an overview of pertinent issues. However, the major issues of women and radiation are addressed in a separate SCAI Consensus Document, just released in January 2011 by the Women in Innovations group.³ This paper provides a more detailed review of the very important issues concerning women and fluoroscopic procedures. What about shielding — have there been developments over time that people may be aware of? Do fellows take practices with them from their training? Or is it that everyone knows the best way and perhaps some don’t apply it? That’s obviously a yes! All of those apply. That’s why no radiation safety paper can go without a section on dosimetry. We review the current thought/policies on how to wear your badge(s). We have a section on shielding that discusses both its importance as well as personal shielding, fixed shielding, and moveable shielding. We do briefly address the issues facing those who are required to wear protective garments long term, regarding the orthopedic side effects. Cardiologists have had to step out of the lab because of cervical compression, for example. These are the potential ramifications of long-term protective garment use. We do reference the Occupational Safety Health Group, which is seeking to address some of these issues.4 We even have a brief discussion on disposable radiation protective drapes. We don’t advocate them and I don’t know how much impact they will have, but we tried to offer as many thoughts and cover as many areas as we could. The key to this is the essential mindset we have been discussing: justification of the procedure, a knowledgeable operator/staff and patient, and appropriate follow up if a high dose is delivered. If you follow this process, even if an adverse event occurs, there should be a reassurance to all that the proper steps were taken to assure the best outcome. Any other points from the guidelines you would like to highlight? We also emphasized the need to partner with a qualified physicist. Support from a physicist will help you not only in equipment maintenance, but also in training and continuing education, setting up all the appropriate policies and, in the odd chance there is a high-dose case, the physicist will be responsible for data interpretation. Additionally, it is essential to remember that dose has to be managed from the beginning of the case, not when high dose has been administered late in the case. Staff has to actively participate in this process. Periodic “gentle reminders” of radiation dose during a complex case assists the operator in dose management. Finally, remember the inverse square law. Do not be near the x-ray source putting oxygen on a patient during fluoroscopy or cine imaging (highest radiation dose). Protect yourself, because while the operators are in the lab frequently and close to the camera, the staff is there all the time. Remember, it is a team effort. Dr. Chambers can be contacted at cchambers@psu.edu ————————————————————

References

1. Chambers CE, Fetterly KA, Holzer R, et al. Radiation Safety Program for the Cardiac Catheterization Laboratory. Catheterization and Cardiovascular Interventions 2011. Available online for download at https://www.scai.org/Publications/Guidelines.aspx. Accessed February 11, 2011.
2. Hirshfeld JW, Balter S, Brinker JA et al. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures. J Am Coll Cardiol 2004; 44:2259-2282.
3. Best PJM, Skelding KA, Mehran R, et al. SCAI Consensus Document on Occupational Radiation Exposure to the Pregnant Cardiologist and Technical Personnel. Catheterization and Cardiovascular Interventions 2011;77:232–241. Available online for download at https://www.scai.org/Publications/Guidelines.aspx. Accessed February 11, 2011.
4. Miller DL, Klein LW, Balter S, et al. J Vasc Interv Radiol 2010 Sep;21(9):1338-1341. Available online at https://www.tinyurl .com/CLDMiller. Accessed February 11, 2011.