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Research Commentary: CardioGen-82 PET Scan
Research Commentary: CardioGen-82 PET Scan j Mary Myrthil, MS, RN, NE-BC, CRN What is this? A CardioGen-82 positron emission tomography (PET) scan (PET myocardial perfusion imaging) is literally a closed system used to produce rubidium 82 (Rb-82) chloride injection for an intravenous administration. Rb-82 chloride injection is indicated for PET image of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with or suspected existing coronary artery disease (CAD). This type of scan is useful in distinguishing abnormal myocardium from normal myocardium. CAD is a disease that affects the vessels of the heart causing varying degrees of illness in the patient. Diagnosing the degrees of illness comes in many forms.
Electrocardiograms Echocardiograms Stress testing Cardiac magnetic resonance imaging Computerized tomography calcium scoring PET
All the above modalities can assist in the diagnosis of some portion of CAD; however, the gold standard of noninvasive testing is the PET scan. CAD is usually present for many years before the actual diagnosis is made because of its progressive nature and confusing symptomatology. Unfortunately, the usual first significant event occurs as an irreversible incident, such as myocardial ischemia or cardiac arrest from a ruptured intravascular sclerotic plaque (Bateman, 2004; Bateman, 2006; Merhige, 2007; Nandalur, 2008). If someone has the universally identified risk factors, they should be acutely aware of the modalities used to track their disease progression. Of the modalities mentioned above, the PET scan has recently come under the scrutiny of the Food and Drug Administration (FDA) (Federal Drug Administration).
Mary Myrthil, MS, RN, NE-BC, CRN, is a Nursing Consultant in Miami, Florida. Corresponding author: Mary Myrthil, 5540 SW 156th Place, Miami, FL 33185. E-mail: [email protected] J Radiol Nurs 2011;30:172-173 1546-0843/$36.00 Copyright Ó 2011 by the Association for Radiologic & Imaging Nursing. doi: 10.1016/j.jradnu.2011.08.001
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The FDA Safey communication can be summarized as follows: ISSUE FDA notified the public and the medical imaging community about the potential for inadvertent increased radiation exposure in patients who underwent or will be undergoing cardiac PET scans with Rb-82 chloride injection from CardioGen-82 manufactured by Bracco Diagnostics, Inc. BACKGROUND A CardioGen-82 PET scan is one of a variety of nuclear medicine scans and uses the radioactive drug Rb-82 chloride injection to evaluate the heart. FDA has received reports of two patients who received more radiation than expected from CardioGen-82. The excess radiation was because of strontium isotopes that may have been inadvertently injected into the patients because of a strontium breakthrough problem with CardioGen-82. RECOMMENDATION At this time, FDA believes that “the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable. The estimated amount of excess radiation the two patients received is similar to that other patients may receive with cumulative exposure to certain other types of heart scans.” It would take much more radiation to cause any severe adverse health effects in patients. Health care professionals in the imaging department should follow closely the required testing and quality control procedures essential to help detect strontium breakthrough from CardioGen-82. Other types of heart scans provide information very similar to CardioGen-82, and professionals are encouraged to consider these alternatives while FDA completes its investigation of the reported cases of excess radiation exposure. The product Cardio-Gen 82 has been voluntarily recalled by Bracco Diagnostics, Inc. Patients who have recently had heart scans should talk to their health care professional if they have any questions. Patients who are planning to undergo a heart scan should talk to the health care professional if they are unsure of the type of planned heart scan and the
www.radiologynursing.org
DECEMBER 2011
CardioGen-82 PET Scan
JOURNAL OF RADIOLOGY NURSING
radiation risks associated with the scan. The FDA is actively investigating the root cause of this failure with CardioGen-82 and will promptly notify the public with updates. Before the advent of the PET scan to determine the presence of CAD, the patient would need to undergo an invasive cardiac catheterization. This procedure also involves radiation exposure. It will be of interest to see which of these two testing modalities have the least radiation exposure and still be the most beneficial for the patient. The registered nurse should be well versed in the most current information available from the regulatory agencies guiding the daily operation of the department and procedure rooms where they practice. They are to act as a resource for the patient, physician, and fellow coworkers. There are many position statements and documents prepared to guide the actions of the imaging nurse.
VOLUME 30 ISSUE 4
Myrthil
References Bateman, T.M. (2004). Cardiac positron emission tomography and the role of adenosine pharmacologic stress. American Journal of Cardiology, 94, 19-24. Bateman, T.M., Heller, G.V., McGhie, I.A., Friedman, J.D., Case, J.A., & Bryngelson, J.R., et al. (2006). Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. Journal of Nuclear Cardiology, 13, 24-33. Federal Drug Administration. Drug Safety Communication. Retrieved from, www.fda.gov. July 15, 2011. Merhige, M.E., Breen, W.J., Shelton, V., Houston, T., D’Arcy, B.J., & Perna, A.F. (2007). Impact of myocardial perfusion imaging with PET and (82)Rb on downstream invasive procedure utilization, costs, and outcomes in coronary disease management. Journal of Nuclear Medicine, 48, 1069-1076. Nandalur, K.R., Dwamena, B.A., Choudhri, A.F., Nandalur, S.R., Reddy, P., & Carlos, R.C. (2008). Diagnostic performance of positron emission tomography in the detection of coronary artery disease: a meta-analysis. Academic Radiology, 15, 444-451.
www.radiologynursing.org
173
Electrocardiograms Echocardiograms Stress testing Cardiac magnetic resonance imaging Computerized tomography calcium scoring PET
All the above modalities can assist in the diagnosis of some portion of CAD; however, the gold standard of noninvasive testing is the PET scan. CAD is usually present for many years before the actual diagnosis is made because of its progressive nature and confusing symptomatology. Unfortunately, the usual first significant event occurs as an irreversible incident, such as myocardial ischemia or cardiac arrest from a ruptured intravascular sclerotic plaque (Bateman, 2004; Bateman, 2006; Merhige, 2007; Nandalur, 2008). If someone has the universally identified risk factors, they should be acutely aware of the modalities used to track their disease progression. Of the modalities mentioned above, the PET scan has recently come under the scrutiny of the Food and Drug Administration (FDA) (Federal Drug Administration).
Mary Myrthil, MS, RN, NE-BC, CRN, is a Nursing Consultant in Miami, Florida. Corresponding author: Mary Myrthil, 5540 SW 156th Place, Miami, FL 33185. E-mail: [email protected] J Radiol Nurs 2011;30:172-173 1546-0843/$36.00 Copyright Ó 2011 by the Association for Radiologic & Imaging Nursing. doi: 10.1016/j.jradnu.2011.08.001
172
The FDA Safey communication can be summarized as follows: ISSUE FDA notified the public and the medical imaging community about the potential for inadvertent increased radiation exposure in patients who underwent or will be undergoing cardiac PET scans with Rb-82 chloride injection from CardioGen-82 manufactured by Bracco Diagnostics, Inc. BACKGROUND A CardioGen-82 PET scan is one of a variety of nuclear medicine scans and uses the radioactive drug Rb-82 chloride injection to evaluate the heart. FDA has received reports of two patients who received more radiation than expected from CardioGen-82. The excess radiation was because of strontium isotopes that may have been inadvertently injected into the patients because of a strontium breakthrough problem with CardioGen-82. RECOMMENDATION At this time, FDA believes that “the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable. The estimated amount of excess radiation the two patients received is similar to that other patients may receive with cumulative exposure to certain other types of heart scans.” It would take much more radiation to cause any severe adverse health effects in patients. Health care professionals in the imaging department should follow closely the required testing and quality control procedures essential to help detect strontium breakthrough from CardioGen-82. Other types of heart scans provide information very similar to CardioGen-82, and professionals are encouraged to consider these alternatives while FDA completes its investigation of the reported cases of excess radiation exposure. The product Cardio-Gen 82 has been voluntarily recalled by Bracco Diagnostics, Inc. Patients who have recently had heart scans should talk to their health care professional if they have any questions. Patients who are planning to undergo a heart scan should talk to the health care professional if they are unsure of the type of planned heart scan and the
www.radiologynursing.org
DECEMBER 2011
CardioGen-82 PET Scan
JOURNAL OF RADIOLOGY NURSING
radiation risks associated with the scan. The FDA is actively investigating the root cause of this failure with CardioGen-82 and will promptly notify the public with updates. Before the advent of the PET scan to determine the presence of CAD, the patient would need to undergo an invasive cardiac catheterization. This procedure also involves radiation exposure. It will be of interest to see which of these two testing modalities have the least radiation exposure and still be the most beneficial for the patient. The registered nurse should be well versed in the most current information available from the regulatory agencies guiding the daily operation of the department and procedure rooms where they practice. They are to act as a resource for the patient, physician, and fellow coworkers. There are many position statements and documents prepared to guide the actions of the imaging nurse.
VOLUME 30 ISSUE 4
Myrthil
References Bateman, T.M. (2004). Cardiac positron emission tomography and the role of adenosine pharmacologic stress. American Journal of Cardiology, 94, 19-24. Bateman, T.M., Heller, G.V., McGhie, I.A., Friedman, J.D., Case, J.A., & Bryngelson, J.R., et al. (2006). Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. Journal of Nuclear Cardiology, 13, 24-33. Federal Drug Administration. Drug Safety Communication. Retrieved from, www.fda.gov. July 15, 2011. Merhige, M.E., Breen, W.J., Shelton, V., Houston, T., D’Arcy, B.J., & Perna, A.F. (2007). Impact of myocardial perfusion imaging with PET and (82)Rb on downstream invasive procedure utilization, costs, and outcomes in coronary disease management. Journal of Nuclear Medicine, 48, 1069-1076. Nandalur, K.R., Dwamena, B.A., Choudhri, A.F., Nandalur, S.R., Reddy, P., & Carlos, R.C. (2008). Diagnostic performance of positron emission tomography in the detection of coronary artery disease: a meta-analysis. Academic Radiology, 15, 444-451.
www.radiologynursing.org
173