on February 24, 2012 |
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Topics: PET, Imaging, Service Lines, Technology Assessment, Planning, Strategy, Cardiovascular, Capital Planning, Finance
Christopher Pericak
The rubidium generator recall is now over, allowing cardiac imaging administrators to breathe a sigh of relief. The recall had halted cardiac PET services for the past several months after the FDA initiated an investigation in mid-2011 regarding excessive radiation exposure.
Recall aside, the past several years have been difficult for planners of cardiac imaging services, and careful strategic planning is necessary before making an investment in cardiac PET technology.
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Cardiac PET resurgence? Strategic planning required
on July 28, 2011 |
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Topics: Service Lines, Cardiovascular, PET, Imaging
In light of recent incidences of excessive radiation exposure, the FDA has issued an advisory to medical imaging providers to discontinue use of the CardioGen-82 rubidium isotope generator for myocardial PET imaging studies. The CardioGen-82 rubidium chloride injection generator has since been voluntarily recalled by the vendor, Bracco Diagnostics.
This news comes on the heels of recent reports and a public advisory issued by the FDA regarding two incidences of patients receiving radiation exposures in excess of expected thresholds when using the CardioGen-82 generator for myocardial PET imaging studies. According to the FDA's announcements, and coverage in trade websites Health Imaging and AuntMinnie, the risks associated with the excessive exposure are expected to be minimal and on par with cumulative exposure from other cardiac imaging studies; the two patient exposures are estimated to be approximately 90 mSv - approximately 30 times the average exposure for CardioGen-82 myocardial PET imaging procedures. Given the FDA's determination the manufacturing procedures for the CardioGen-82 generator are not sufficient for ensuring the "reliable performance of the generator used to produce the Rb-82 chloride injection," the vendor, Bracco Diagnostics, has since voluntarily recalled the CardioGen-82 generator, and is actively working with the FDA and regulatory agencies to determine the exact cause of the excessive exposure. However, questions still linger regarding whether the excessive exposures are the result of a manufacturing flaw or appropriate quality control techniques at clinical sites using the Rb-82 chloride injection system. In the interim, providers are encouraged to use alternative isotopes or different cardiac imaging studies when clinically appropriate. In a July 15 advisory when the incidences were first identified, the FDA presents a detailed description of steps patients and providers should take in determining and mitigating potential risks associated with CardioGen-82 use.
This comes as a roadblock to the use of myocardial PET imaging for perfusion and viability imaging, which has received a considerable amount of attention over the past 18 months. Rubidium-82 is the principal radiotracer used to evaluate myocardial perfusion with PET. Evidence of superior clinical efficacy for obese patients relative to traditional cardiac nuclear imaging, as well as growing coverage for the use of cardiac PET following equivocal SPECT studies, has led to greater awareness of the value of cardiac PET imaging. But, interest and adoption in cardiac PET has been spurred by market factors, including declining reimbursement for cardiac nuclear imaging (particularly office-based procedures), the worldwide technetium radioisotope shortage, and greater desire to maximize the use of hospital-based PET/CT scanners.
Previously, cardiac PET imaging has been slow to develop given the entrenched practice patterns of cardiologists with standard cardiac nuclear imaging, fluctuating reimbursement, and the hefty price tags associated with monthly rental of the rubidium-82 generator - often upwards of $25,000 - rendering breakeven on the investment challenging. Further, adoption of cardiac PET can both generate new procedure volume and cannibalize from existing cardiac nuclear imaging studies, rendering it a strategic, programmatic investment for hospitals to support comprehensive cardiovascular services.
At this time, it is unclear when the FDA and Bracco Diagnostics will lift the recall of the CardioGen-82 generator system. Providers are encouraged to stay tuned to new developments and communications from the vendor and the FDA regarding future use for Rb-82 PET imaging.
on January 26, 2011 |
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Topics: Service Lines, PET, Imaging
Meeting on January 20th, the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA met to discuss potential approval for Amyvid, a novel radiotracer used to image beta amyloid plaque in the brain. Manufactured by Eli Lilly, Amyvid (florbetapir) is a PET radiotracer which binds to beta amyloid plaque, identified as an indicator of the progression of Alzheimer's disease. The Committee voted not to fully approve the new radiotracer, but rather, to give conditional approval should the manufacturer provide a sufficient training program for readers. Previous studies demonstrated significant variation in readers' ability to extract and interpret data, resulting in a high false-positive rate. The FDA is not calling for more research trials, but rather, that once a training program has been developed, the FDA will likely approve the radiotracer.
To date, the use of PET for neuroimaging has previously been challenging due to the lack of brain-specific radiotracers given existing limitations of using FDG-glucose. High metabolism in the brain renders standard glucose-based imaging unreliable, and PET has thus far been used primarily for oncologic imaging. Amyvid avoids this setback by binding directly to beta amyloid plaque, rather than tracking a specific metabolic process. While Amyvid will not likely be able to definitively diagnose Alzheimer's disease, it can confidently rule it out in favor of other neurodegenerative disorders.
While the availability of Amyvid marks an important step in the evolution of PET imaging to assess myriad neurodegenerative diseases, there is still uncertainty within the medical field regarding the value of detecting precursors to Alzheimer's disease. Without a valid treatment plan, questions remain as to the anxiety placed on the patient and their family in knowing that Alzheimer's is potentially impending. Confidently ruling out Alzheimer's can redirect physician attention to other diseases but detection of beta amyloid plaque does not always indicate Alzheimer's will be present. However, conditional approval of Amyvid and more widespread use of the neuro PET imaging agent can help to further answer these questions and determine an appropriate course of action.
