Author + information
- Ralph Brindis, MD, MPH, FACC, ACC President⁎ ( and )
- Pamela S. Douglas, MD, MACC, Ursula Geller Professor of Research in Cardiovascular Diseases, Duke University Medical Center
- ↵⁎Address correspondence to:
Ralph Brindis, MD, MPH, FACC, American College of Cardiology, 2400 N Street NW, Washington, DC 20037
Diagnostic imaging procedures and fluoroscopically-guided interventions have led to improvements in the diagnosis and treatment of numerous medical conditions, including heart disease. At the same time, many of these procedures also expose patients to ionizing radiation. As a result, the U.S. Food and Drug Administration (FDA) (1), Congress, and others are increasingly looking at medical radiation exposure and considering policies and/or programs to ensure patient and clinician safety (2,3).
The American College of Cardiology (ACC) applauds these efforts and strongly supports a pragmatic approach to radiation safety that balances the intended benefits of the procedure against the radiation risk. It is critical that the cardiovascular community take responsibility for ensuring the safety of imaging and procedures and be involved in the creation and implementation of these policies and initiatives—particularly given the increasing use of nuclear imaging, computed tomography (CT) scans, and fluoroscopic procedures to facilitate accurate diagnosis and prognosis of heart disease, improve treatment planning, and guide therapeutic interventions.
The ACC has taken a multi-pronged approach to ensuring radiation safety, including:
1. Setting standards through laboratory accreditation programs, appropriate use criteria (AUC), clinical practice guidelines, and other standards documents;
2. Developing requirements for training programs and competency, including how to minimize radiation doses during testing and procedures; and
3. Implementing quality improvement programs aimed at lowering the dose for each scan or procedure performed. Approaches to minimizing doses include using AUC to eliminate unnecessary scanning procedures (4); following the principle of “as low as reasonably appropriate” with respect to radiation levels; displaying dose information wherever studies are done; and encouraging facilities to monitor delivered doses and compare them with benchmarks.
Through these efforts, and by working with the American College of Radiology and other specialties, we can ensure that patients are receiving the most appropriate and safe treatment possible.
Guidelines, Clinical Documents, and AUC
When it comes to guidelines, the ACC has been working jointly with the American Heart Association for decades to 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 was updated to reflect new evidence in 2009, while a 1998 expert consensus document on radiation safety and cardiology is being updated this year.
In addition to guidelines and other clinical practice documents, the College has developed AUC for diagnostic imaging modalities and cardiac revascularization. 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. These are updated frequently to stay abreast of rapidly changing technology. Revised AUC for radionuclide imaging were released last year (5), while revised AUC for CT will be released this summer.
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 ACC Foundation-branded cardiovascular imaging strategies tool for health plans. The tool will integrate computerized physician decision support with AUC education and quality improvement activities.
The College also strongly supports mandatory imaging laboratory accreditation programs developed by physicians and other health care providers to ensure the quality and safety of imaging services. The ACC is a sponsoring organization of the Intersocietal Accreditation Commission (IAC). IAC programs examine key components of any imaging laboratory including 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 supporting 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 cardioverter-defibrillators
• carotid artery revascularization and endarterectomy
• percutaneous interventions for adult congenital heart disease
• acute coronary syndromes
• ambulatory cardiac care
Moving forward, NCDR registries will be used to track and learn more about the actual radiation doses used in cardiovascular care and to monitor the effects of radiation on patients as a result of cardiovascular procedures. The NCDR CathPCI Registry, for example, has recently begun collecting information on radiation dose. Specifically, CathPCI Registry participants are now required to report fluoroscopy time to the nearest 0.1 min 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 SAFARI (Safety of Atrial Fibrillation Ablation Registry Initiative). The current plan for the SAFARI Registry calls for the collection of similar information.
Integrated health care systems are also presently looking at methods to actually track cumulative patient radiation exposure. While clearly desirable, this remains a challenging goal in the absence of a common dosimetry across modalities, or a single way to express radiation dose, as well as the lack of a national Unique Patient Identifier to track patient exposures across health systems.
A study that recently published online in the Journalfound that cardiac imaging procedures lead to substantial radiation exposure for many patients in the U.S. (6). The study examined administrative claims to identify cardiac imaging procedures performed from 2005 to 2007 in 952,420 nonelderly insured adults in 5 U.S. health care markets. However, an accompanying editorial piece notes that further research is needed to clearly document the actual health risks of radiation exposure for patients with cardiovascular disease, including looking at cancer rates (7).
In addition to supporting the call for more research, the ACC firmly believes that patients must be involved in the decision-making process regarding their care. The more that 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 2 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 artery bypass graft surgery for stable coronary heart disease patients. The second initiative will build upon the current CardioSmart website and extend cardiovascular providers' reach beyond the office visit with community events, web-based education, tracking modules, and discounts for heart-healthy products, as well as radiation safety information. 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 with the risks and benefits of the different diagnosis or treatment options and could lead to better patient understanding of potential side effects.
Finally, in the time fluoroscopy, nuclear imaging, and CT have been available for use, numerous techniques have already been developed to reduce radiation dose. In the case of cardiac catheterization and invasive electrophysiologic procedures, magnetically-steered catheters, such as the Stereotaxis (Stereotaxis, Inc., St. Louis, Missouri), 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 example, with new equipment, it is no longer necessary to use cine to document balloon inflations or stent deployments, or for the limited femoral arteriography at the conclusion of most procedures. A recent study achieved nearly a 50% reduction in CT angiography radiation dose through a quality improvement initiative (8).
The ACC will continue to work closely with the FDA and other organizations to ensure that the College remains at the forefront of ensuring patient radiation safety. In addition, the ACC is planning a radiation safety summit for early 2011 that will bring together cardiovascular professionals and their societies, regulators, industry, and payers to define a road map for enhancing radiation safety in cardiovascular care. In addition, the College continues 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. For more on the ACC's radiation safety and other quality efforts, go to www.CardioSource.org/focus.
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