Bethesda, MD - Leading clinicians, trialists, and scientists have wrapped up a two-day meeting in Bethesda, MD, convened to figure out what clinical trials are needed to establish a role for emerging cardiovascular imaging modalities. The National Institute of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI), which hosted the meeting, hopes the ideas generated will help them prioritize the NIH research agenda.

"One of the big questions that are being asked right now by many people outside of cardiology—by policy-makers, by payers, by people in other areas of medicine—is: what is the value of CV imaging?" Dr Michael Lauer, one of the NIH leads for the meeting, told heartwire. "There has been a dramatic increase in the utilization of imaging over the past 10 to 15 years, but we don't know to what extent CV imaging results in improvement in patient outcomes. The reason we went into medicine was because we wanted to help people, and therefore everything we do in medicine should be because we want to help people, because we want to make a difference. The imaging technology today is amazing, it's amazing how quickly it's advanced, yet we haven't answered the fundamental question of whether we're actually helping people by doing this."

Meeting cochair Dr Pamela Douglas (Duke University, Durham, NC) called the NIH workshop "a very important initial step" in rethinking how cardiac imaging tests are validated. "The traditional way is to look at sensitivity, specificity, and accuracy, and this is really an opportunity to take those technical and performance characteristics and put them in the context of answering a clinical question," she said. "We're now maturing the science and the field to the point where we're able to get past that technical information and onto the clinical information to test a diagnostic strategy: that's a huge paradigm shift."

Lauer says the specifics of the meeting will be published in a manuscript at some point in the near future but that the overall aims of the meeting were reached. "The specific goal was to say, Let's have a conversation about raising the level of research in imaging so that we're now testing the ability of imaging to improve outcomes. As to the actual specifics of what we discussed, we're not ready to talk about any of that yet; this is a work in progress."

Meeting cochair Dr Allen Taylor (Walter Reed Army Medical Center, Washington, DC) explained that the invited participants ranged from imaging clinicians, to trialists, statisticians, and epidemiologists and focused on different classes of patients ranging from asymptomatic to those with advanced heart disease. The main imaging modalities discussed were echocardiography, nuclear cardiology, cardiac CT, and MRI. These, said Taylor, are "the core imaging technologies that are in need of either outcomes studies themselves or comparative studies."

Taylor also steered clear of implying that the NIH would now move forward with any of the suggestions put forward by the meeting participants. "The goal was to try to define in broad terms a number of clinical trials that would be feasible and would improve our knowledge base with respect to outcomes and to go from there to actually considering those further, in more specific detail, so they can be considered for funding within various funding mechanisms," he said.

By way of examples, Taylor described a hypothetical trial comparing the relationship of detecting subclinical atherosclerosis with refined risk prediction as a means of changing treatment in such a way that outcomes would improve; a study comparing methods of finding myocardial viability in preoperative planning for cardiac surgery in the setting of LV dysfunction; a trial comparing different methods for evaluating mitral-valve morphology in patients undergoing mitral-valve surgery for optimal surgical planning; or an emergency department study comparing different strategies of evaluating acute chest pain.

"In no way was there any commitment to fund anything or a choice made about what would be funded. It was very much a think-tank approach to saying, okay, we need imaging outcomes data, and there's a variety of domains in which we need imaging outcomes data," Taylor explained. "So let's imagine what the priorities are."

Douglas also wouldn't comment on whether one particular imaging strategy or application was given any priority over the others. "The outgrowth of this type of workshop is usually a request for proposals, for somebody to perform research. That's not 100% certain, but usually there is some decision made that something is important and that research is the next step. There was a lot of enthusiasm about possible ways to examine diagnostic strategies in different patient groups, and it's now up to NHLBI to decide what they want to do with those ideas, and hopefully they will be able to fund some really nice research."

Douglas said the NIH may just leave the field open for investigator-initiated proposals, or it may specify one key area where the role of imaging needs to be clarified. "They could say, we really want to understand the role of imaging in screening asymptomatic patients, or when a patient presents to the emergency room with chest pain, or when a patient presents to a physician's office with chest pain, or in a heart-failure patient with known coronary artery disease: what does imaging add? Those were really the four patient scenarios we talked about, and there were discussions of trials that would be very important to do in all of those areas. I don't know, coming out of this, which one, or several, NIH will go with."

Both Taylor and Lauer emphasized that there was no squabbling among participants at the meeting to mirror the growing rift between imaging proponents and naysayers in the wider cardiology community. "This was a group that was all of like mind that these sorts of imaging trials are pivotal at this moment and that we need to move forward to make sure that there's a return on investment for imaging," Taylor said.

Taylor also acknowledged broad recognition of the "funding crisis for imaging" driven by the explosion in imaging utilization coupled with overall limits on Medicare funding and healthcare spending generally.

"So there was the recognition that imaging is growing, we're spending more on imaging, and it's growing disproportionate to other healthcare costs," Taylor explained. "And while that might be because we're delivering better care, it's not a straightforward connection that more imaging improves outcomes. That hasn't been demonstrated. . . . I think everyone realizes that the funding crisis for imaging can't be ignored and that we can't just stick our heads in the sand and think that we have certain beliefs about imaging and its relationship with outcomes; we have to demonstrate it."

Lauer also praised the "very high, very serious level" of discussions, among what he described as medical "all-stars."

These included Drs Marvin Konstam, Philip Greenland, James Udelson, Frank Peacock, Robert Bonow, Robert Califf, Roger Blumenthal, Mathew Budoff, Leslee Shaw, Fred Masoudi, Mario Garcia, Ralph Brindis, Daniel Berman, Paul Heidenreich, Pamela Woodard, Daniel Sullivan, Gil Raff, Eric Peterson, Manuel Cerqueira, Paul Chan, and Manesh Patel.