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Professor Christian Müller (University Hospital Basel, Basel, Switzerland), Chair of the ESC-Heart Failure Association Study Group on Diagnosis and a member of the ESC-Acute Cardiovascular Care Association Biomarker Study Group, knows exactly what constitutes the ideal cardiac biomarker: objective, reproducible, fast, quantitative, inexpensive, widely available and well studied. He uses high-sensitivity cardiac troponin (hs-cTn) as a good example of some of the key features for success.
“hs-cTn is the most important advance in cardiac biomarkers in the last decade due to the conduct of very large diagnostic studies and to extensive clinical development. Because of this, very soon after the first assay became clinically available in 2011, testing was incorporated into ESC Guidelines. Subsequently, many manufacturers were able to launch their own hs-cTn assays. In 2015, ESC Guidelines included a rapid assessment algorithm based on hs-cTn and sampling at 0 and 1 hour to rule-in and rule-out acute myocardial infarction (AMI). Through strong collaborative efforts between assay manufacturers and academic investigators, data were generated so that this scheme universally applies to all available hs-cTn assays.
So, not only did we have detailed information on the biomarker itself, but manufacturers and academic investigators together thoroughly evaluated diagnostic performance and also provided guidance for clinicians on how to use them.
Biomarkers assays are run very successfully in large clinical chemistry platforms operated by hospital central laboratories—they have fantastic standardisation and from an economic perspective, this is the way that most blood tests are run. However, point-of-care biomarker measurement has been important in cardiovascular medicine for the last few years as on-the-spot measurements are needed in some situations, for example, in outpatient settings, in small hospitals or to reduce time delay when results are needed urgently in the emergency department. This highlights another area where progress is being made with hs-cTn testing. Through technical modifications, a point-of-care assay is currently undergoing clinical evaluation, with promising pilot study data, which may substantially broaden the clinical settings in which testing, with all its benefits, can be used.”
Another success story is that of the clinical implementation of B-type natriuretic peptide (BNP) and NT-proBNP into clinical care pathways for patients presenting with shortness of breath. Again, based on solid data obtained from academic collaborations, as well as academic–industry collaborations, current ESC Guidelines recommend, with a class Ia recommendation, the use of BNP/NT-proBNP concentrations as a key element in the early diagnosis of heart failure.
Prof. Müller now explains an area where biomarkers are not so well developed. “There are a multitude of cardiac biomarkers being evaluated in various studies and various disease states, but it is important to add a cautious note, particularly with heart failure, where there has been some over-enthusiasm. There is still a huge unmet need in heart failure management and there was some hope that cardiac biomarkers could help to better phenotype patients and guide improved treatment. However, some biomarkers have been put forward to clinicians where only a very superficial understanding exists on pathophysiology, the cells/organs that produce the biomarkers and how the information provided should be used. Relatively quick and easy studies have been used to show that a certain biomarker concentration is associated with adverse outcomes, but these data are not clinically useful alone and we need to be conservative with what we recommend to clinicians without sufficient evaluation.”
The search for new biomarkers continues in other areas. For example, the recent EU-funded RiskyCAD has helped to identity new biomarkers in the field of lipidology. RiskyCAD examined mechanisms of lipid activity at the molecular level and analysed specific species of lipids linked to inflammation and cardiovascular disease in an attempt to identify novel lipid and small RNA circulating biomarkers. A new diagnostic test involving distinct ceramide species is currently undergoing evaluation for its possible clinical utility. In addition, new human mouse models of coronary artery disease and plaque vulnerability were also developed during RiskyCAD that may support further research in basic research, new biomarkers, new treatment targets and drug screening.
Prof. Müller concludes, “Rigorous studies are needed in the development of new cardiac biomarkers to ensure we have a strong link between mechanisms and measurements, and that an adequate level of evidence and knowledge is reached to ensure we can incorporate the information provided by the biomarker in a way that most benefits patients.”
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