“Is it a heart attack, or something less serious?”
Every day, thousands of symptomatic patients ask emergency department (ED) physicians that very question. Over the years, as diagnostic tools for acute myocardial infarction (AMI), commonly known as a heart attack, have advanced, physicians can provide increasingly accurate answers to that question. Unfortunately, diagnostic gaps still exist that can result in poor patient outcomes.
Diagnostic ambiguity is costing us
There are over 6 million1 ED visits annually in the US for chest pain, resulting in expenditures of $5.5 billion2 for diagnostic testing on these patients. Yet fewer than 4 percent of these patients are ultimately diagnosed as having a heart attack. Our healthcare system is paying a high price for diagnostic uncertainty. Additionally, it is estimated that as many as 2 percent of those with chest pain discharged from the ED are actually having a heart attack and should not have been sent home.3 That could all change with a new lab test that can help bring greater clarity as an aid in diagnosing heart attacks.
The Elecsys® Troponin T Gen 5 STAT (TnT Gen 5 STAT) from Roche Diagnostics is the first highly sensitive Troponin T test cleared by the Food and Drug Administration (FDA) for use in the U.S.,4 and it promises to bring greater confidence to cardiac care. This biomarker revolutionizes cardiac care by identifying lower levels of troponin with excellent precision. Cardiac troponin is released into the bloodstream when cardiac cells are being damaged, and it's the preferred biomarker for the aid in diagnosis of a heart attack in clinical practice.5
World-class accuracy, now within reach
TnT Gen 5 STAT isn't new to the ED. It's been available in the rest of the world for the past seven years, during which time clinicians have rapidly adopted it. However, it's new to the U.S.
Compared to other troponin assays on the market, TnT Gen 5 STAT can detect lower levels of troponin precisely, enabling physicians to more accurately identify patients experiencing a heart attack. In fact, it's the only FDA-approved assay that meets International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) guidelines6 for high sensitivity, and delivers optimal precision per the Third Universal Definition of Myocardial Infarction.7 In addition, the new assay delivers industry-leading speed, with results in nine minutes. What does this mean for the emergency doctor who's on the frontlines of diagnosing heart attacks?
“FDA clearance of this new Roche TnT assay is easily the best news in the last decade for emergency medicine patients presenting with chest pain,” says Frank Peacock, MD, FACEP, FACC, Emergency Medicine Research Director at Baylor College of Medicine in Houston.
Lower troponin levels detected and less wait time in the ED
Historically, troponin assays could detect only higher levels of troponin, says Dr. Peacock, who is a leading ED physician with more than 450 publications on cardiology, emergency medicine and clinical trials.8
With the increased sensitivity, emergency physicians have better help in identifying patients who are experiencing a heart attack, and, according to Dr. Peacock, more confidently identify those who are not.
Cardiologist and Associate Professor of Medicine at UC San Diego Health System Pam R. Taub, MD, FACC, believes that the new assay may help reduce wait time for the patient and speed up triaging in the ED.
“The reason to go with a more high-sensitivity troponin assay is the confidence you get when the result is normal in discharging a patient from the ED,” Dr. Taub says.
Increased sensitivity leads to greater care
More important, with highly sensitive troponin, those patients who need cardiac care who may have previously gone undetected can receive the treatment they need – whether they're having a heart attack or another condition that affects the heart.
“There are a lot of things that can kill heart muscle,” Dr. Peacock says. “As a physician, you have to find out why the troponin is elevated.”
New protocols are good for the heart – and the hospital
It's true that as hospitals adopt this highly sensitive troponin, EDs will need to implement new protocols in diagnosing patients who present chest pain and other symptoms of AMI.
However, it will also mean physicians will be able to triage and treat these patients with greater confidence, so they can provide optimal cardiac care to those patients who need it. By delivering greater accuracy in industry-leading time, the TnT Gen 5 STAT helps enable emergency physicians to focus on the right patient and give the right treatment.
To learn more, visit cardiac.roche.com.
- National Hospital Ambulatory Medical Care Survey: 2013 Emergency Department Summary Tables https://www.cdc.gov/nchs/data/ahcd/nhamcs_emergency/2013_ed_web_tables.pdf. (Accessed April 5, 2017.)
- Slutzman, Jonathan E., Michael Wilson, David Cutler and Jeremiah D. Schuur. University of Massachusetts Medical School, Worcester, MA, Brigham and Women's Hospital, Boston, MA, Harvard University, Cambridge, MA. “Costs Attributable to Emergency Department Care by Diagnosis.” American College of Emergency Physicians; presented October 26, 2015.
- Pope, J. Hector, M.D., Tom P. Aufderheide, M.D., Robin Ruthazer, M.P.H., Roger H Woolard, M.D., James A. Feldman, M.D., Joni R. Beshansky, R.N., M.P.H., John L. Griffith, Ph.D., Harry P. Selker, M.D., M.S.P.H. (April 2000). “Missed Diagnoses of Acute Cardiac Ischemia in the Emergency Department.” New England Journal of Medicine 342:1163–1170.
- U.S. Food and Drug Administration, Department of Health and Human Services. Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 approval letter. January 18, 2017 (accessed March 9, 2017).
- Amsterdam, Ezra A. et al. (2014). AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes, A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 130:e344-e426; originally published September 23, 2014, http://circ.ahajournals.org/content/130/25/e344 (accessed on February 15, 2017).
- Apple, Fred S. et al. (2015). IFCC educational materials on selected analytical and clinical applications of high-sensitivity cardiac troponin assays. Clinical Biochemistry 48:201–203.
- Thygesen, Kristian, Joseph S. Alpert, Allan S. Jaffe, Maarten L. Simoons, Bernard R. Chaitman, Harvey D. White, and the Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. (2012). Circulation 126:2020–2035. Originally published October 15, 2012.
- ResearchGate. https://www.researchgate.net/profile/William_Peacock3 (accessed March 30, 2017).