Radiation Safety Briefing

Imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions, including heart disease. At the same time, these types of exams also expose patients to ionizing radiation. As a result, the U.S. Food and Drug Administration (FDA), Congress and others are increasingly looking at the medical radiation exposure issue and considering policies and/or programs to ensure patient safety

It is important that the cardiovascular community be involved in the creation and implementation of these policies and initiatives, given the increasing use of nuclear imaging, computed tomography (CT) scans and fluoroscopic procedures to facilitate early and accurate diagnosis of heart disease, improve treatment planning, and guide therapeutic interventions necessary to save lives. The ACC supports a pragmatic approach to radiation safety that balances the intended benefits of the procedure against the radiation risk. The ACC is also a strong proponent of the principle of “as low as reasonably appropriate” with respect to radiation levels and has worked with the American College of Radiology (ACR) and other specialties to develop training programs and requirements, appropriate use criteria (AUC), guidelines, and other quality-improvement tools that eliminate unnecessary procedures and ensure patients are receiving the most appropriate –and safe—treatment possible.

Guidelines, Clinical Documents and Appropriate Use Criteria

The ACC has been working jointly with the American Heart Association for decades to develop guidelines that carefully synthesize available evidence to assist physicians in clinical decision-making by recommending a range of generally acceptable approaches for the diagnosis, management or prevention of specific diseases or conditions. Additionally, the College produces clinical competence and expert consensus documents. All of these documents are updated to reflect new data and findings as appropriate. For example, the clinical competence statement for cardiac imaging with CT and magnetic resonance was updated to reflect new evidence in 2009, while a 1998 expert consensus document on radiation safety and cardiology will be updated this year.

In addition to guidelines and other clinical documents, the College has developed AUC for a variety of diagnostic imaging modalities and procedures used by cardiovascular professionals. AUC define “when to do” and “how often to do” a given procedure in the context of scientific evidence, the health care environment, the patient’s profile and a physician’s judgment. In an effort to help imaging providers best use AUC at the point of care and ultimately reduce inappropriate tests, the ACC recently launched “Imaging in FOCUS,” a national quality improvement initiative designed to help physicians self-assess and gain quantitative feedback on their level of appropriate use. The College is also partnering with a nationally recognized information technology vendor to provide an American College of Cardiology Foundation (ACCF)-branded cardiovascular imaging strategies tool to health plans, that will integrate computerized physician decision support with AUC education and quality improvement activities.

Imaging Accreditation

The College also strongly supports mandatory imaging laboratory accreditation programs developed by physicians and other health care providers as a tool to ensure the quality and safety of imaging services.  The ACC is a sponsoring organization of the Intersocietal Accreditation Commission (IAC), whose programs examine three key components of any imaging laboratory: the safety and accuracy of the imaging equipment; the training of the imaging technologists; and the training/certification/experience of the supervising and/or interpreting physician(s). The IAC also requires that information on appropriate use be tracked by the imaging laboratory and furnished as feedback to ordering physicians. The ACC believes this is critical to ensuring appropriate patient selection for therapeutic and diagnostic procedures and ultimately reducing patient medical radiation exposure.

Data Collection and Registry Reporting

The ACC is well-known for its support of efforts to collect and use patient data to learn about best practices and appropriate care. The College’s National Cardiovascular Data Registry (NCDR®) collects data on a wide range of cardiovascular procedures, including:

• coronary catheterization

• percutaneous coronary interventions (PCIs)

• implantable cardiac defibrillators (ICDs)

• carotid artery revascularization and endarterectomy

• percutaneous interventions for adult congenital heart disease

• acute coronary syndromes

•  ambulatory cardiac care

Moving forward, the NCDR is looking to use its registries to learn more about the effects of radiation on patients as a result of cardiovascular procedures tracked through the NCDR. The NCDR CathPCI Registry, which includes information on coronary catheterization and PCIs, has recently begun collecting information on radiation dose. Specifically, CathPCI Registry participants are now required to report either fluoroscopy time to the nearest 0.1 minute and/or fluoroscopy dose to the nearest integer in milligrays for patients undergoing diagnostic cardiac catheterization or PCI. In addition, the ACC is also a participant in the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI). The current plan for the SAFARI Registry calls for the collection of similar information.

Research and Patient Involvement

 

Further research is needed to clearly document the radiation risks to patients with cardiovascular disease, including looking at cancer rates and the appropriateness of tests performed. In addition to more research, the ACC firmly believes that patients must be involved in the decision-making process regarding their care. The more patients are able and willing to be involved, the more they are able to weigh the risks and benefits. Because of this commitment to patient-centered care, the ACC is undertaking two new projects. The first, a physician team/patient shared decision- making project, is being designed to support appropriate use of medical therapy, PCI, and coronary bypass graft surgery for stable coronary heart disease patients. Second, the College is launching a national CardioSmart initiative that will build upon the current CardioSmart website and extend beyond the office visit with community events, web-based education, tracking modules and discounts for heart-healthy products

In both cases, the idea is for physicians and patients to work together to determine the appropriate treatment or test. Such decisions would include a discussion of radiation-related concerns as compared to the benefits of the different diagnosis or treatment options and could lead to better understanding by the patients of potential side effects. Ultimately, these increased patient education efforts could result in the development of a stronger evidence base regarding radiation side effects. Connecting symptoms to radiation exposure could help physicians further comprehend the implications of treatment decisions, as well as increase understanding regarding the effects of radiation exposure.

Finally, in the time fluoroscopy and CT have been available for use, numerous techniques have already been developed to reduce radiation dose. In the case of cardiac catheterization, magnetically steered catheters, such as the Stereotaxis, have been developed to reduce fluoroscopy time by more efficient placement of catheters. Additionally, there are methods of minimizing radiation exposure with the use of “fluoroscopy-save mode” rather than cine when high resolution is not needed. For instance, with new equipment, it is no longer necessary to use cine to document balloon inflations, stent deployments, or for the limited femoral arteriography at the conclusion of most procedures.

The ACC will continue to work closely with the FDA to ensure that any new initiatives reflect the initiatives in which the College is engaged. In addition, the College will continue to monitor Congressional and other government actions to ensure that patients are able to receive the highest quality of care based on science and practice experience, while effectively balancing the use of health care resources and patient safety.