1. From the Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD (R.Z., W.E.S., K.A.S., I.L.P., D.A.C., D.G.S.); Yale School of Medicine, New Haven, CT (E.S.S., J.P.C., H.B.); American College of Cardiology Foundation, Washington, DC (A.P.); VA Eastern Colorado Health Care System, University of Colorado, Denver (P.D.V.); Colorado Cardiovascular Outcomes Research Group, Denver (P.D.V.); and University of Colorado Anschutz Medical Campus, Aurora (F.A.M.).