SAN DIEGO--(BUSINESS WIRE)--Critical Diagnostics announced today the release of a paper titled, “Development of a Novel Heart Failure Risk Tool: The Barcelona Bio-Heart Failure Risk Calculator (BCN Bio-HF Calculator),” published on PLOS ONE, an open-access resource from the Public Library of Science, that introduces a powerful new free online risk calculator designed to help health care professionals better manage patients with heart failure.
What sets this risk calculator apart from existing heart failure risk calculators is the inclusion of cardiac biomarkers, including Critical Diagnostics’ ST2, to improve prediction over clinical variables alone.
For years, health care professionals have used risk calculators, like the popular Seattle Heart Failure Model, to estimate survival rates for patients with heart failure. The Seattle model was developed two decades ago using a cohort of patients carefully selected for a randomized clinical trial. By comparison, the BCN Bio-HF Calculator is derived from a real-world cohort of contemporary treated heart failure patients, and requires half the number of clinical variables and medications to be entered, making it much easier to use — and more accurate.
The BCN Bio-HF Calculator uses only seven clinical variables (age, gender, NYHA functional class, sodium level, renal function, blood pressure and left ventricular ejection fraction), plus four drug treatment options (loop diuretic, statin, beta blocker and ACE inhibitor or ARB).
The other big difference is that at the time the Seattle model was created, cardiac biomarkers for patient risk stratification were not available. Today such cardiac biomarkers are recommended by the ACCF/AHA Guidelines and are a routine part of heart failure patient care. The BCN Bio-HF Calculator supports inclusion of any combination of up to three highly validated cardiac biomarkers reflecting different pathophysiological pathways, to better predict risk.
With the inclusion of the three cardiac biomarkers—high-sensitivity soluble ST2 (ST2) from Critical Diagnostics, which is reflective of myocardial fibrosis and remodeling, plus N-terminal pro B-type natriuretic peptide (NT-proBNP), a marker of myocardial stretch, and high-sensitivity troponin T (hs-cTnT), a marker of myocyte injury, both products of Roche Diagnostics (OTC: RHHBY) — the BCN Bio-HF Calculator outperformed the Seattle Model in this study.
Moreover, while the calculator was designed to be run with none, one, two, or all three biomarkers (depending on availability of data), maximum performance was only possible with inclusion of Critical Diagnostics’ ST2, even for the most robust measures of integrated discrimination improvement (IDI) and net reclassification improvement (NRI). Importantly the combination of hs-cTnT and ST2 showed the best results. Addition of NT-proBNP into the model along with the other two yielded no additional predictive value.
Remarkably, with the inclusion of biomarkers into the model, traditional variables such as ischemic etiology, diabetes, body mass index (BMI), blood systolic pressure, heart rate, atrial fibrillation, chronic obstructive pulmonary disease (COPD), hypertension, iron deficiency, spironolactone or eplerenone treatment, and use of either cardiac resynchronization therapy (CRT) or an implantable cardiac defibrillator (ICD), did not statistically improve risk prediction, and were therefore not included in the BCN Bio-HF Calculator.
“Our company’s core mission has always been about advancing medicine and saving lives by providing clinicians with information tools to improve patient care,” notes David Geliebter, CEO of Critical Diagnostics. “We’re therefore very pleased that ST2 was a valuable contributor to this next-generation risk calculator.”
About The Risk Calculator
The BCN Bio-HF Calculator was derived from 864 patients followed for a median of 3.4 years, during which time there were 305 deaths. The online calculator is available at www.BCNBioHFcalculator.cat
ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis associated with heart failure. ST2 is not adversely affected by confounding factors such as age, body mass index and impaired renal function. Unlike many other cardiac biomarkers, ST2 levels change quickly in response to changes in the patient’s condition — thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust treatment. All this makes ST2 an ideal serial biomarker for monitoring and treating heart failure patients.
The 2013 ACC/AHA Guideline For The Management of Heart Failure, recognizes ST2 as “not only predictive of hospitalization and death in patients with HF but also additive to natriuretic peptide levels in [its] prognostic value.”
The Presage® ST2 Assay from Critical Diagnostics is the only commercially available ST2 biomarker in the world. The Presage ST2 Assay has been CE Marked and cleared by the U.S. FDA for use as in the risk stratification of chronic heart failure patients.
About Critical Diagnostics
Founded in 2004, Critical Diagnostics (www.criticaldiagnostics.com) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. Critical Diagnostics has distribution partners for its Presage ST2 Assay in 45 countries, covering two-thirds of the world’s population.