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Radiation safety action plan recommendations: Maximize benefits, minimize risk

Issue: October 2012

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Guidelines from professional organizations exist on the judicious and appropriate use of testing using low levels of ionizing radiation in adult CV care, but debate about radiation safety continues.

Radiation exposure has increased sixfold for medical purposes within the past 25 years, with radiation exposure from CV imaging and interventions accounting for about 17% of the total, according to a joint press release from the American College of Cardiology Foundation, Duke University Clinical Research Institute and American Heart Association, the three sponsoring organizations of a think tank conducted in February 2011 in Washington, D.C.

Pamela S. Douglas, MD, Ursula Geller professor of medicine at Duke University, discussed controversy surrounding the risks of radiation in CV care.

Photo provided by: Pamela S. Douglas, MD; reprinted with permission

Patients are benefiting from great medical advancements in imaging, experts interviewed for Cardiology Today said. But, the question remains of how to ensure that a balance between appropriate, necessary testing and radiation exposure for each patient is achieved to best serve the patient as safely as possible. A team of physicians, professional organizations, industry representatives, patient representatives and lawmakers all came together during the think tank to address this complex question in practice now, and in the future.

The conference report, “Developing an Action Plan for Patient Radiation Safety in Adult Cardiovascular Medicine,” which featured proceedings from the think tank, was recently co-published in the Journal of the American College of Cardiology and Circulation.

The concerns of overexposure

Concerns also revolve around using more radiation than necessary and testing performed for inappropriate indications.

The greatest concern is the small minority of patients who may receive more radiation than is necessary, said Pamela S. Douglas, MD, Ursula Geller professor of medicine at Duke University Medical School and chair of the report’s writing committee.

“Then, there is also a concern that in the process of all this minimization, we use a dose so low that we can’t perform high enough quality informative studies for the patients that need them. There has to be a nuanced approach to radiation safety — not just dose reduction,” Douglas said.

Andrew J. Einstein, MD, PhD, Victoria and Esther Aboodi assistant professor of medicine, Herbert Irving assistant professor of medicine (in radiology), director, cardiac CT research co-director, cardiac CT and MRI, Columbia University Medical Center, department of medicine, division of cardiology department of radiology, spoke about the challenge of ensuring that patients benefit from dose reduction.

“We’ve seen great initial strides over the past 5 years in the development of methods that can reduce radiation exposure to patients in nuclear cardiology, cardiac CT, interventional cardiology and electrophysiology. However, what data we have suggest that many patients still have studies performed with techniques that use more radiation than is necessary, and that a sizable minority of procedures involving ionizing radiation are performed for inappropriate indications.

“Ensuring that as many patients as possible benefit from approaches to radiation dose reduction continues to pose a significant challenge. Addressing this challenge is essential to reduce the population burden of radiation from CV imaging and intervention,” Einstein said

Benefits known, risks unknown

Charles E. Chambers, MD, professor of medicine and radiology at Pennsylvania State University, director of the cardiac catheterization laboratory at MS Hershey Medical Center and vice president of the Society for Cardiovascular Angiography and Interventions (SCAI), put the benefits into numbers in a recent interview.

Charles E. Chambers

“In an era of marked advances in CV care resulting in significant reductions in CV mortality, the increasing use of ionizing radiation in diagnostic and therapeutic procedures is significant. In 1950, there were 586 CV deaths per 100,000 [people]. This number has decreased remarkably in the following half-century, to just 188 in 2007. Adjusted for current population growth, this results in approximately 1.2 million lives saved. However, during the period from 1980 to 2006, medical radiation use increased more than 600%,” said Chambers, who also participated at the think tank as a presenter and contributed to the published paper.

The risks remain in controversy. There is a need for large-scale research to quantify the risks of low-dose radiation exposure, according to Allen J. Taylor, MD, FACC, past-chair of the ACC’s Imaging Council and co-author of the scientific paper and chief, cardiology division, department of medicine, Georgetown University.

“The benefits are obvious, but the risks need to be better understood. It is going to take very long-term, very large-scale studies to better understand the risks, and that is an important part to emphasize,” Taylor said.

“There is a lot of controversy about the risks. Much of our information is based on atomic bomb survivors of World War II. The survivors had a single exposure to a large amount of radiation, which may be very different from repeated exposures to a very small amount of radiation,” Douglas said.

Also, patient-absorbed doses vary by organ and body region within a patient, according to the report. Not all tissues of the body receive radiation doses in the same way, Douglas said. “We need better research on understanding what a certain radiation exposure amounts to in terms of the dose that is seen by various tissues of the body.”

A number of important studies are ongoing. One is the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE), which has already enrolled more than 6,000 patients and will enable the comparison of health care outcomes, as well as radiation burden, between different strategies for the assessment of outpatients with chest pain, said Einstein, a researcher for the trial.

Stakeholders must unite

Representatives from CV imaging societies, private payers, government and nongovernmental agencies, industry, medical physicists and patient representatives — the stakeholders — all participated in the think tank to discuss the common goals of ensuring patient safety with the use of radiation in adult CV care.

“The significance of the published report is that it acknowledges the need for multi-party participation in the important area of radiation safety,” Chambers said.

Andrew J. Einstein

“Engagement and education of the whole spectrum of stakeholders is critical. These include referring physicians and physicians performing tests using radiation, professional societies, medical schools, payers, industry, licensing and accrediting organizations and, of course, patients. Creating an information-rich radiation protection culture that simultaneous eschews undue alarmism by emphasizing all the benefits provided by ionizing radiation, while offering infrastructure that enables a variety of audits that can lead to quality improvement, is part of the solution. Aligning stakeholders’ interests with the best interests of patients in terms of radiation safety is another important piece of the solution,” Einstein said.

Chambers discussed four main topics of radiation safety that were reviewed in the think tank and publication with all stakeholders represented. These included:

• The research aspects of quantification and measuring dose for assessing potential risk.
• Mandatory reporting with standardized methods to provide documentation that is useable and trackable longitudinally.
• Minimizing dose and requirements to address industry standards for equipment, establishment of training programs and modification of clinical practice.
• Educating and communicating these issues heightens public awareness to demand best practice.

“The issue of funding of these programs, implementation and acceptance by the practicing physicians, and assessment of benefit will be the key. It is a good start to have multiple stakeholders recognizing the issues and committing to paper what needs to be done,” Chambers said.

Strategies for the future

The report outlined what should occur in the future as far as strategies to obtain the goal of minimizing radiation exposure and maximizing the benefits (see Timeline). Among them are providing education for test providers, developing measuring and reporting standards and uniform tracking of radiation exposure in laboratories.

“We need education for all the stakeholders to become aware of the issues. And we need training — not just for people who do the imaging, but for those who order the imaging,” Taylor said.

Allen J. Taylor

“It is important to make sure we are doing the right tests for the right patients at the right time,” he said. “We need to see accurate measuring and reporting of radiation exposure.”

Douglas added, “In the future, I would like to see laboratories that are accountable to themselves and to the referring physicians and patients about the appropriateness of the imaging that they do. Labs should also actively follow the recommendations for radiation minimization, including tracking their performance.”

The state-of-the-art best practices from the professional societies are important, Douglas said.

SCAI, the Society of Cardiovascular Computed Tomography (SCCT) and the American Society of Nuclear Cardiology (ASNC) all have documents about radiation minimization and lab best practices and everyone takes it seriously and adheres to them, she said.

“Individual societies such as SCAI have recognized the need for radiation safety for years with repeated publications in this area, the last in 2011 on establishing a radiation safety program for the catheterization laboratory (www.scai.org/Publications/Guidelines.aspx; January 2011),” Chambers said.

“Radiation is a requirement for medical progress, and in most cases, the risks are acceptable. When a knowledgeable clinician trained and supported by research and industry provides the best product in an environment of known risk and benefit, the patient is in good hands,” he said. – by Suzanne Bryla

Charles E. Chambers, MD, can be reached at Penn State Milton S. Hershey Medical Center, 500 University Drive, Hershey, PA 17033; his email is cchambers@hmc.psu.edu.

Pamela S. Douglas, MD, can be reached at 7022 North Pavilion Duke University Medical Center, PO Box 17969, Durham, NC 27715; her email is pamela.douglas@duke.edu.

Andrew J. Einstein, MD, PhD, can be reached at Columbia University Medical Center, Division of Cardiology, 622 W. 168th St. PH 10-203, New York, NY 10032; his email is andrew.einstein@columbia.edu.

Allen J. Taylor, MD, FACC, can be reached at MedStar Health Research Institute, 6525 Belcrest Road, Suite 700, Hyattsville, MD 20782.