Supporting earlier, more accurate heart failure diagnosis1
From 1 November 2024 the NT-proBNP test will be reimbursed under the MBS as an aid to heart failure (HF) diagnosis outside the hospital. This will assist greatly with earlier and more accurate diagnosis1 outside the hospital particularly by GPs, cardiologists, and respiratory specialists.
NT-proBNP is a cardiac biomarker that through a simple blood test, can help clinicians rule-in or rule-out HF as a cause of a patient's signs and symptoms suggestive of HF2.
The MBS listing is as follows:
Quantitation of... NT-proBNP for the exclusion of a diagnosis of heart failure in patients presenting to a non-hospital setting to assist in decision-making regarding the clinical necessity of an echocardiogram, where heart failure is suspected based on signs and symptoms but diagnosis is uncertain.
Applicable not more than once in a 12-month period
Category 6 – Pathology Services
Group P2 - Chemical
MBS item number - 66829
‘This is going to be a really important test because it’s going to change the way we are able to diagnose people with heart failure’ – Prof. Sindone
The CSANZ Guidelines for the Prevention, Detection, and Management of Heart Failure in Australia 2018 has a STRONG recommendation for utilising NT-proBNP for HF diagnosis as it can improve diagnostic accuracy, where the diagnosis is uncertain.
In the case of suspected heart failure due to risk factors, symptoms and/or signs, or an abnormal ECG, NT-proBNP is useful to:
Test results below 125 pg/ml indicate that heart failure is unlikely and physicians should consider another diagnosis. Test results above 125 pg/ml indicate that heart failure is likely and further investigation is required to confirm the diagnosis4.
Major role of Roche NT-proBNP as the initial diagnostic test for the diagnosis of HF
In association with clinical evaluation, natriuretic peptides are recommended as an initial diagnostic test with the highest level of recommendation (IA) in major international guidelines.3,4 Roche NT-proBNP is clinically validated and can support your decision making in heart failure diagnosis in both the non-acute and acute setting5.
The Role of NT-proBNP in Heart Failure Diagnosis in the Non-Hospital Setting
Heart failure (HF) is a complex clinical syndrome with typical symptoms that initially manifest on physical exertion. As the disease progresses, symptoms can occur at a low level of physical activity and in some cases, even at rest. It involves an inability to fill the ventricle with blood or reduced blood ejection to fulfil the requirements of the vital metabolising organs.
HF has heterogenous symptoms, most of which are non-specific. Patients with suspected HF may present to primary care for diagnosis and triage. Due to the non-specificity of symptoms, a definitive diagnosis of HF is difficult. The typical symptoms and signs of chronic HF are listed in Table 1.
Table 1 Typical signs and symptoms of HF (National Heart Foundation of Australia and CSANZ, 2018)
More typical HF symptoms |
More specific HF signs |
Dyspnoea |
Elevated jugular venous pressure |
Orthopnoea |
Hepatojugular reflux |
Paroxysmal nocturnal dyspnoea |
Third heart sound |
Fatigue |
Laterally displaced apex beat |
The diagnosis of HF remains a difficult clinical challenge in all settings. Unlike patients presenting to emergency rooms with symptoms of acute heart failure, patients presenting to primary care settings often have mild or no obvious symptoms, or they present with only risk factors for the condition.
A patient presenting with signs and symptoms suggestive of HF (eg: dyspnoea) should undergo basic investigations including non-invasive measurement of oxygen saturation, 12-lead ECG, chest X-ray, serum biochemistry (electrolytes, renal function, and liver function) and full blood count. Further investigations will depend on clinical circumstances and findings from the initial clinical workup, and may include serum cardiac troponin measurement, plasma natriuretic peptide (including NT-proBNP) levels, thyroid function tests, arterial blood gases, D-dimer, echocardiography, stress testing (assessment for ischaemia or filling pressures), coronary angiography (computed tomography [CT], invasive), right or left heart catheterisation, lung function tests, ventilation/perfusion lung scan, CT pulmonary angiography, high-resolution CT chest, cardiopulmonary exercise testing, and cardiac magnetic resonance (CMR) imaging (National Heart Foundation of Australia and CSANZ 2018)
The role of NT-proBNP
Natriuretic peptides (such as NT-proBNP) are elevated in most forms of HF and are an integral component of making a diagnosis of HF in many clinical settings, especially when the diagnosis is uncertain. The use of these biomarkers has the highest (‘STRONG’) class of recommendation to support a diagnosis or exclusion of HF in contemporary practice guidelines (National Heart Foundation of Australia and CSANZ, 2018).
NT-proBNP plays a key role in excluding a HF diagnosis. In the non-acute setting (eg: primary care) an NT-proBNP cutoff of <125 pg/mL has a very high negative predictive value (NPV) of between 94% and 98%, and a positive predictive value (PPV) of between 44% and 57% (Ponikowski et al. 2016).
The very high NPV of NT-proBNP testing for HF allows physicians to quickly and reliably exclude HF as a source of each patient’s symptoms, reducing uncertainty and allowing them to focus on other causes (eg: chronic obstructive pulmonary disease - COPD). Those patients with NT-proBNP test results above the 125 pg/mL cutoff can be referred to a Cardiologist or for an echocardiogram for confirmation of a HF diagnosis, and then the appropriate treatment.
Overseas guidelines are evolving and putting NT-proBNP at the start of the diagnostic workup for every suspected HF patient. In the case of the European Society of Cardiology Guidelines in 2021, NT-proBNP testing is recommended for all suspected HF patients with known risk factors, symptoms/signs of HF, and an abnormal ECG, as outlined in the diagram below (ESC HF Taskforce, 2021).
In 2021, the first universal definition of heart failure was published (Bozkurt, et al. 2021). This definition proposed:
“HF is a clinical syndrome with symptoms and or signs caused by a structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels [including NT-proBNP] and or objective evidence of pulmonary or systemic congestion.”
In the ambulatory (non-acute) environment this “elevated” level is stated as >125 pg/mL, and in hospitalised patients >300 pg/mL.
Improvements in the diagnosis and management of HF
In 2023, Roche Diagnostics Australia made a submission to the Medical Services Advisory Committee (MSAC) to improve access to NT-proBNP for HF diagnosis in the non-hospital setting. This submission was accepted, and there will be the creation of a new MBS item (number 66829) from 1 November 2024 for the test to be utilised in this way. Specifically, the MBS item says:
Category 6 - Pathology services
Group P2 Clinical
Quantitation of …. NT-proBNP for the exclusion of a diagnosis of heart failure in patients presenting to a non-hospital setting to assist in decision-making regarding the clinical necessity of an echocardiogram, where heart failure is suspected based on signs and symptoms but diagnosis is uncertain.
Applicable not more than once in a 12-month period
Consultation feedback for the submission was received from many interested parties, and several key organisations provided written support to the application, including:
● Lung Foundation Australia (LFA)
● National Heart Foundation of Australia (The Heart Foundation)
● Royal Australian College of General Practitioners (RACGP)
● Royal College of Pathologists of Australasia (RCPA)
● The Cardiac Society of Australia New Zealand (CSANZ)
(MSAC Application 1740: NT-proBNP to aid in the diagnosis of patients with suspected heart failure in the non-hospital setting)
It is anticipated that physicians will test all suspected HF patients presenting to a non-hospital setting, where diagnosis is uncertain. The Roche NT-proBNP test is widely available in Australia, and can be ordered from pathology service providers (along with other associated blood tests) in the usual way.
Benjamin Smith
Cardiology Disease Area Lead
Roche Diagnostics Australia Pty Ltd
References
Bozkurt, B. (2021). Universal Definition and Classification of Heart Failure. Journal of Cardiac Failure, 27(4), 387-413. https://doi.org/10.1016/j.cardfail.2021.01.022
Chan, Y. K. (2016). Current and projected burden of heart failure in the Australian adult population: a substantive but still ill-defined major health issue. BMC Health Serv Res, 16(1), 501.
ESC HF Taskforce. (2021). 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. European Heart Journal, 00, 1-128. doi:10.1093/eurheartj/ehab368
Mebazza, A. (2022). Safety, tolerability and efficacy of up-titration of guidelinedirected medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. The Lancet, https://doi.org/10.1016/S0140-6736(22)02076-1.
National Heart Foundation of Australia and CSANZ. (2018). Guidelines for the Prevention, Detection, and Management of Heart Failure in Australia 2018. Heart, Lung and Circulation, 27, 1443-9506.
Ponikowski, P. (2016). 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur J Heart Fail, 18(8), 891-975.
Sindone, A. (2021). Consensus statement on the current pharmacological prevention and management of heart failure. MJA, 217(4), 212-217.
Natriuretic Peptides: Role in the Diagnosis and Management of Heart Failure
For further reading on the role of NT-proBNP in the diagnosis and management of heart failure see the Journal of Cardiac Failure article.
References:
1. Taylor, et al. (2017) Br J Gen Pract., 67(655): e94–e102
2. Januzzi, J.L. et al. (2005). Am J Cardiol, 95(8), 948-954
3. Ponikowski et al. (2016). Eur J Heart Fail. 18(8):891 – 975
4. Yancy et al. (2017). Circulation. 136(6):e137 – e161
5. Roche Elecsys proBNP II Method Sheet V4.0