Mr contrast rsna3/31/2023 ![]() It recommended limiting use of these agents only for exams where contrast is needed to clearly diagnose a few specific diseases can cannot be seen without contrast. In March 2017, the European Medicines Agency decided there was enough of evidence to limit the use of gadolinium agents. Increased regulation and limits on the use of these agents is already in play. Sessions on GBCAs were packed, and one session had concerned questions from the audience continue for 45 minutes past the end of the session, which I have never seen in 10 years of covering sessions at medical conferences. Radiologists too are concerned, as evidenced by what I saw at RSNA 2017. This will need to change as public and regulatory concerns continue to rise over the use of both dose and contrast agents. ![]() The idea of recording data on patients who receive contrast agents or even ionizing radiation doses from X-rays was not even on most radiologists’ horizons until just the past few years. So, radiology has not see the wide-spread use of large-scale, multi-center, randomized trials that are now the bread and butter of most specialties. Radiology is a different animal in that they do not treat patients, they look at the pictures and tell other doctors what they see. This idea of evidence-based medicine has been embraced by most medical specialties as a way to use empirical evidence to decide if drug A or B or therapy A or B is better at treating patients. It was taken off the market just a year after it gained FDA clearance because of clear data showing poorer outcomes. The most recent case of this in 2017 was with the first FDA-cleared bioresorable stent. However, this has enabled early warnings for safety events. For this reason, cardiologists document a large amount of data for each patient they treat. This requires a lot of data to be collected to sufficiently power studies or registries to clearly identify safety trends that might otherwise be viewed as one-off events. Often, rare complications are only seen in single digit percentages of specific patient subgroups with various comorbidities or specific anatomy. The safety of devices like drug-eluting stents has gotten so good that adverse events are seen in less 5 percent of patients. When a new cardiovascular implantable device or new drug is approved by the FDA, it includes post-market approval studies or a registry to help identify any trends in major adverse events. Documentation in a systematic effort would also provide the clinical data needed to show any potential cause and effect with these agents and patients reporting problems.Ĭardiology is where I have concentrated most of my coverage over the past 10 years. With the introduction of contrast tracking systems and the potential liability of these agents, knowing that gadolinium is retained in the body, radiology should begin rethinking its documentation efforts. This was the same response I heard at RSNA 2016. The key take away I heard at RSNA 2017 is that there is not enough evidence to conclusively say gadolinium agents do not cause adverse events in at least a subset of patients. However, radiology has by and large failed to even record the exact doses administered or what specific agent was used in the exam. There is also a subset of patients who claim they have experienced adverse events or developed chronic conditions after receiving MRI contrast exams. Radiology only recently identified in 2014 that gadolinium from MRI contrast agents is retained in patients’ tissues. It is my opinion that radiology has failed to treat the contrast agents they use with the same level of concern or thoughtful documentation as with pharmaceuticals or implantable devices I have seen in other medical specialties. What I learned only served to confirm my earlier concerns. At the 2017 Radiological Society of North America (RSNA) meeting, I attended a couple sessions on gadolinium safety, spoke to two MRI contrast vendors and two of the top RSNA experts on MRI. Over the past couple years covering the news about gadolinium-based contrast agent (GBCA) retention in the brain, skin and bones of patients who received contrast magnetic resonance imaging (MRI) exams, a few key safety red flags popped up for me.
0 Comments
Leave a Reply.AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |