Research, Innovation, Translation, Advocacy, Standardization

James D. Thomas, MD, FASE, FACC, FAHA, FESC

Have you ever thought about everything that goes into generating an ultrasound picture…all the basic research into ultrasound physics; the applied research to engineer an imaging machine; the regulatory work to get it approved for clinical work? It is a remarkable chain of interlinked events, and ASE is playing a critical role in this process. No, we haven’t built an acoustics laboratory at our headquarters, but we are critically involved in driving the technology forward in many different ways. In this President’s Message, I’d like to let you know about some recent and ongoing initiatives of your Society to drive ultrasound technology forward.

It all starts with basic research. Someone has a crazy idea (usually wrong) about a new way to use ultrasound in understanding pathophysiology, or diagnosing or treating some disease. Years of work may be needed to prove or disprove the idea and may involve researchers with expertise in everything from electrical engineering to epidemiology. The ASE has an admirable record at funding such research, having given $4,033,447 over the past 15 years to deserving projects and individuals. We hope to grow this significantly in upcoming years, largely through your generosity in supporting the ASE Foundation. As important as this funding is to the individuals involved, however, it can never support a large multidisciplinary research group, for which federal funding is clearly needed. For example, the National Institutes of Health (NIH) provided over $17.6M in funding to ultrasound-related projects in 2010 alone, and increasing the size of this pie would greatly enhance echocardiographic research. Unfortunately, ultrasound has traditionally received fewer NIH and NSF dollars than “advanced” imaging techniques like MRI. To improve the visibility of echocardiography in federal funding, ASE paid a visit to the NIH this May. In a full day of discussions with leadership from the National Heart Lung Blood Institute (NHLBI) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), Sanjiv Kaul, Neil Weissman and I, along with ASE CEO, Robin Wiegerink, and VP of Research, Andrea van Hoever, presented recent echo developments, such as strain imaging, molecular contrast imaging, and the use of echocardiographic endpoints in clinical trials. NHLBI Director of Cardiovascular Sciences, Michael Lauer, and his colleagues were most receptive, but made it clear that most NIH funds flow through traditional individual research grants (R01), and strongly encouraged our members to compete actively for these. On’s Research Resources page, we have listed all current ultrasound research grants as well as other information to guide you in the grant application process. In coming years, we hope to continue this conversation, including symposia on federal funding at next year’s scientific session, to push echocardiography as a priority for research support.

A second area of recent ASE activity is in the regulatory realm. Ultrasonic contrast agents have a proven role in improving left ventricular opacification and should be used in up to 20% of resting echoes and even more stress echoes to improve our diagnostic accuracy. Unfortunately, the growth in appropriate contrast use was dealt a blow in 2007 when the FDA issued a black boxed warning for contrast based on a small number of potentially adverse events. Since that time, a host of research studies have better established the safety of contrast agents and shown their further utility, and the FDA has agreed to reconsider the black box. On May 2, they convened an advisory meeting from the Cardiorenal and Drug Safety Panels, to review this new data. I was pleased to have the opportunity to present ASE’s perspective on the safety of contrast agents, the text of which you can read in theContrast Zoneof . While we still await the final outcome of the FDA’s deliberations on this topic, ASE will continue to engage constructively with the Agency to further the appropriate use of contrast.

A final area of ongoing ASE activity is in standardization. While basic and translational research is the means to proving the principle of a new technique, without standardization, it likely won’t lead to widespread clinical use. An example of this is digital echocardiography. In the early 1990’s there was a veritable Tower of Babel of storage formats, with HP, Acuson, ATL, and Vingmed all using their own, mutually incompatible files. With ASE’s strong support and clinical guidance, the digital imaging and communication in medicine (DICOM) committee wrote the standard that now enables exchange of digital echo data between all vendor machines and all archive systems. To have it otherwise would be unthinkable. Today, we face a similar schism in the realm of myocardial mechanics (“strain”). While thousands of papers validate the use of echocardiographic strain (and its kindred spirits, torsion, displacement, strain rate, etc.), these have yet achieved very little penetration into the clinical arena. One barrier to more widespread clinical use of strain is evidence that machines from different vendors may give different results on the same patient, something that we would never accept for a parameter like aortic valve gradient. There are many reasons for this discrepancy, including different “raw” data (tissue Doppler vs. B-mode vs. RF ultrasound signal), different file formats (yes, most vendors have their own, proprietary standard for data storage; sound familiar?), 2D vs 3D, even different definitions for what we call strain (Lagrangian vs. natural strain vs. about 20 even more esoteric offerings from the structural mechanics world). In an effort to de-Babelize the strain world, ASE and our European colleagues in EAE have formed the Strain Standardization Task Force with representatives from our societies as well as all interested vendors. We held our inaugural meeting in Montreal at the ASE Scientific Sessions and work is already underway to standardize and test the agreement for the reporting of global longitudinal strain. We have also engaged the DICOM committee to explore standardizing file formats for this as well as to integrate the reporting of strain parameters into the DICOM Structured Reporting system. There is much more work to be done, and I hope to report back to you later in the year with an update.

These are three examples of how ASE is working to push the field forward and improve our diagnostic capabilities on behalf of our patients. It seems like a slow process, but if you consider that in just a little over 30 years we’ve gone from M-mode squiggles on a strip chart to 3D strain (and compare it to the relatively minor advances in diagnostic angiography in the same time), I think you’ll agree that we’re moving at the speed of sound!

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Jun 11, 2018 | Posted by in CARDIOLOGY | Comments Off on Research, Innovation, Translation, Advocacy, Standardization

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