Getting Past Turf Issues & FDA Caution
Cardiologist Peter Zwerner spoke recently at a meeting about the “tribal attitudes” that hinder successful cooperation between cardiologists and radiologists. He noted that both disciplines cling to some of these outworn notions. He also said that when both specialties work together they could increase their respective bottom lines, as well as provide better patient care.
Another controversy in cardiac imaging is the use of echo contrast agents. Cardiologists in the U.S. compared to their counterparts in Europe have been hampered by the FDA’s reluctance to approve more than two echo contrast agents and to expand the indications for the two approved agents. In addition, the FDA within the last two years has issued warnings about echo contrast agents only to soften the warnings later. Understandably, many cardiologists are hesitant to use contrast agents despite their proven efficacy.
In our second top story, researchers from Europe showed for the first time that an increase in image quality—gained from the use of contrast—also translates into an increase in accuracy.
What also makes the study noteworthy is that the investigators used fractional flow reserve (FFR) rather than angiography as the reference standard for hemodynamically-relevant stenoses. FFR, you may recall, got a boost in confidence when Nico H.J. Pijls, MD, reported results from the FAME trial at the 2008 TCT meeting. These results showed that FFR was superior to angiography-guided assessment of hemodynamically-relevant stenoses.
Moreover, in an apparent nod to the FDA, the German researchers from the current study wrote that they experienced no adverse reactions from the echo contrast agents.
Among our featured stories are two that I’d like to point out. One of them comes from Walter Huda, PhD, a dean of radiation exposure issues, who says that the cancer risk from cardiac CT is overstated. Cancer risk lexicon sometimes can be difficult to wade through, but the take home message is that rather than a 1 in 114 risk, it is 1 in 1000.
The second featured story of note involves a consensus statement from the American Society of Echocardiography recommending the use of contrast agents. The ASE outlines evidence-based reasons for why, when and how echo contrast agents should be used.
Remember to check out the latest digital issue of Cardiovascular Business. We feature an article that examines in detail the state of contrast-enhanced echocardiography in the U.S. In another article, a cardiovascular physiologist makes the case for practices to set up calcium scoring programs.
On these or any topics, please feel free to send me your comments.
Chris P. Kaiser, Editor