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Pilot trial shows blood test much more effective than current risk stratifications


A researcher at the Cardiovascular Institute (CVI) at Rhode Island, The Miriam and Newport hospitals has found that a simple blood test can predict a person’s risk for sudden cardiac death, enabling physicians to more quickly and accurately assess a patient’s need for an implantable cardiac defibrillator (ICD). 

CVI Dr. Dudley in lab
Samuel C. Dudley, MD, PhD 

That paper by Samuel C. Dudley, MD, PhD, chief of cardiology at the CVI, is published online in advance of print in the Journal of the American College of Cardiology.

“This is the first test of its kind; never before have clinicians been able to accurately assess a patient’s risk of sudden cardiac death by performing a blood test,” Dudley said. “The primary prevention model for at-risk patients in the U.S. is to implant an ICD before a cardiac event happens. While it’s better to be safe, this has led to widespread overuse of ICDs throughout the U.S. and abroad.”

Dudley continued, “With this blood test, we can refine the need for such a device, and instead implant the cardiac defibrillators only in the most severe cases of sudden cardiac death risk.”

Currently, risk assessments are determined by measuring the fraction of blood ejected from the heart in any one heartbeat, the ejection fraction. When the ejection fraction falls below 35 percent, a patient may benefit from an ICD. It is believed that approximately 60 percent of patients who receive defibrillators as a result of these assessments may not actually need one. This blood test will determine more accurately which patients do in fact need the defibrillator.

The new blood test is in a pilot phase and will be validated in a large, multi-site trial led by Dudley and other researchers at Lifespan’s CVI anticipated to start this fall.

“Health care is much more advanced here, but in developing countries, doctors wait until a person has survived a cardiac event before implanting a defibrillator – and only 10 percent survive the initial event,” Dudley said. “But with a blood test, patients could be easily tested before an event and be implanted with an ICD, if appropriate.” 

Dudley continued, “It’s sort of a double-edged sword. With current mechanisms in place, we can’t be sure that a patient needs an ICD, but if we believe the risk to be present, it would be irresponsible not to implant an ICD that could save the patient’s life. If the next trial proves what we believe to be true, this blood test will serve as a much more appropriate and cost-effective tool to measure risk.” 

Sudden cardiac death is an unexpected death caused by loss of heart function, or sudden cardiac arrest. It is the most common cause of natural death in the U.S., resulting in approximately 325,000 adult deaths in the U.S. each year.

Funding for this study include grants from the National Institutes of Health (P01 HL058000), R01 HL1024025, R01 HL106592); Veterans Administration Merit Award; and  a National Institutes of Health R41 HL112355 to 3PrimeDx; and the National Center for Research Resources/National Center for Advancing Translational Sciences (UL 1RR029879). Dudley’s principal affiliation is the Cardiovascular Research Center, Lifespan Cardiovascular Institute.  He also has an academic appointment at The Warren Alpert Medical School of Brown University. Other researchers are Ge Gao M.D., Ph.D; Vikram Brahmanandam, M.D.; Mihai Raicu M.D.; Lianzhi Gu, M.D., Ph.D; Li Zhou, M.D., Ph.D; Srinivasan Kasturirangan, M.D.; Melissa Wood, M.D.; Alan Schwartz, Ph.D, and Ankit A. Desai, M.D., of the University of Illinois, Chicago; Anish Shah of the University of Illinois at Chicago College of Medicine; Smita I. Negi, M.D., of the University of Texas Health Science Center; and Antone Tatooles, M.D., of the Advocate Christ Medical Center, Oak Lawn, Ill.