THE SCIENCE BEHIND CARDIACTION

The information below provides a summary of the evidence-based research and validation that supports the Pulse Wave Analysis and BP+ technology.

Background

Cardiovascular disease encompasses many different conditions, such as heart attacks (Myocardial Infarctions MI), stroke and blood vessel diseases, such as atherosclerosis. High blood pressure—also known as hypertension—is responsible for more deaths and disease worldwide than any other single health risk factor (Lim et al, 2012). High blood pressure is a major risk factor for chronic diseases including stroke, coronary heart disease CHD, heart failure and chronic kidney disease CKD (National Heart Foundation of Australia, 2015).

The traditional approach used for the evaluation, prevention, and treatment of cardiovascular diseases (CVD) and coronary heart diseases (CHD), is to use the top 5 cardiovascular risk factors, that are:

    1. Hypertension
    2. Dyslipidaemia (elevated total or low-density lipoprotein (LDL) cholesterol levels diabetes
    3. Impaired glucose tolerance
    4. Smoking
    5. Obesity

Unfortunately, this approach seems to have reached its limit as it can only identify approximately 50% of people, based on having the 5 risk factors within the so-called ‘normal’ range, who will continue to have CHD (Houston, 2012). This is referred to as the ‘CHD gap’ (Houston, 2010). The stiffness of our arteries is now recognised as a major risk factor for cardiovascular health diseases, such as hypertension (Vlachopoulos et al, 2010).

Over the past two decades, new cardiovascular research, technological advancements, such as central aortic Pulse Wave Analysis (PWA) plus new blood pressure data and assessment concepts have highlighted the importance of central aortic(c-BP) above and beyond the existing clinical value of the traditionally measured brachial BP. The European Society of Hypertension/European Society of Cardiology guidelines for the management of arterial hypertension suggested the measurement of aortic pulse wave velocity (PWV), which is considered the gold standard method for assessing aortic stiffness, as a tool for assessment of subclinical target organ damage (Mancia et al, 2007) for early detection, and aggressive prevention and treat CVD before clinical events occur [Houston, 2012).

Selected References

  •  Houston MC. Nutrition and nutraceutical supplements in the treatment of hypertension. Expert Rev Cardiovasc Ther., (2010), 8: 821-833.
  •  Houston MC. What Your Doctor May Not Tell You About Heart Disease. (2012). Grand Central Life and Style. Hachette Book Group. (2012). 237 Park Ave. New York, USA.
  •  Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet, 380:2224–60.
  •  Mancia G, De Backer G, Dominiczak A, et al. guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2007; 25:1105–87.
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The BP+ PWA device is being used by many researchers around the world

PWA and BP+ Technology

Pulse wave analysis (PWA) is a non-invasive technology for assessing central blood pressure parameters using pressure waveforms recorded from peripheral arteries (typically brachial or radial).


PWA technology is now in use worldwide at major medical institutions, research institutions, and in various clinical trials with leading pharmaceutical companies. This technology is validated by over 1,500 peer-reviewed publications in leading medical and scientific journals. 


In clinical studies, we have shown that PWA is a highly reproducible technique and easy to apply. Assessment of stiffness, perhaps using PWA, may therefore provide better risk assessment and allow treatment to be targeted to those most in need1.


Central Systolic Blood Pressure cSBP variability parameters predict first and recurrent cardiovascular events in 4999 adults aged 50–84 years 2.


A recent study, published in 2020, the largest validation study of non-invasive cSBP measurement PWA techniques so far, has shown that the cSBP values obtained by automated oscillometric cuff-based pulse contour analysis highly correlate to invasive measurements. The authors concluded that ‘Automated oscillometric devices may facilitate the implementation of central blood pressure cBP in daily clinical practice 3.


In the USA the pulse PWA tests have been set with a CPT code by the American Medical Association making them eligible as reimbursable by small and large payers and Medicare using (CPT code 93050).  https://www.aapc.com/codes/cpt-codes/93050


Uscom with their BP+ PWA device is currently partnering with the University of Tasmania, National Heart Foundation and the Menzies Institute as part of the IDEAL ‘Improved Cardiovascular Delivery’ Study, funded by the National Health and Medical Research Council (NHMRC) to develop better methods for managing heart health in Australia.  Uscom (ASX:UCM) partners with University of Tasmania for IDEAL eHealth study - The Market Herald

The BP+ PWA device is also being used by researchers at the: 

    • School of Population Health, University of Auckland, Auckland, New Zealand 1, 2
    • Institute of Cardiovascular Sciences, University College London, London, UK
    • International Centre for Circulatory Health, Imperial College London, London, UK
    • Institute for Biomedical Technologies, Auckland University of Technology, Auckland, New Zealand
    • Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, USA
    • Health & Environment Department, AIT Austrian Institute of Technology, Vienna, Austria
    • Department of Bioengineering, Imperial College London, London, UK

 

Furthermore, the BP+ PWA unit has CE approval in Europe, TGA approval in Australia, is processing through the Chinese NMPA and is FDA cleared in the USA. 

 

In an article published in the Journal of Hypertension in 2015, researchers concluded that ‘The use of pulse wave analysis may guide the provider in making choices about blood pressure treatment in prehypertensive or hypertensive patients. However, there is little clinical guidance on how to interpret and use pulse wave analysis data in the management of these patients’ 4.


More recently, (March 2022) a person-level meta-analysis of the International Database of Central Arterial Properties for Risk Stratification(n=5576) concluded that.

Despite all the research and citations, PWA has not been widely adopted in clinical practice, and if so only to help practitioners more effectively manage drug interventions. Unfortunately, there does not appear to be much work done regarding using nutrition, exercise of lifestyle (NEL) interventions to reduce the PWA risk parameters apart from the standard ones of reducing BMI, stop smoking, reduce Cholesterol levels etc.


There are two main reasons why PWA technology never proceeded to daily clinical practice, first, because of their high price and second, because the procedure was originally time consuming and required well trained medical staff 3. The PWA technology is now an automated procedure which does not necessitate an intense training of staff, and the results are far less observer-dependent than previous approaches 3. In addition, the price of the new commercial BP+ PWA unit, and with superior technology, is significantly cheaper that the original units. Finally, Cardiaction is a ‘systems biology’ based solution which takes the complex PWA data and simply translates the same into a practical clinical process with actionable insights and interventions; all displayed on a motivational, monitorable dashboard.


For additional evidence of the BP+ device, please visit https://www.uscom.com.au/products/bp/evidence/

Clinicians should become aware that even in the presence of brachial normotension, an assessment of central systolic BP might help in risk stratification and optimizing antihypertensive drug treatment 5.   

Selected References

  1. Sluyter, JD., Hughes, A., Thom, S. et al. Arterial waveform parameters in a large, population-based sample of adults: relationships with ethnicity and lifestyle factors. J Hum Hypertension, 2017, 31, 305-312 2017.  https://doi.org/10.1038/jhh.2016.78
  2. Sluyter JD, Camargo Jr CA, Scragg RK. Ten-second central SBP variability predicts first and recurrent cardiovascular events. Journal of Hypertension. 2019 Mar 1;37(3):530-7.
  3. Gotzmann M, Hogeweg M, Seibert FS, Rohn BJ, Bergbauer M, Babel N, Bauer F, Mügge A, Westhoff TH. Accuracy of fully automated oscillometric central aortic blood pressure measurement techniques. Journal of hypertension. 2020 Feb 1;38(2):235-42.
  4. Townsend RR, Black HR, Chirinos JA, Feig PU, Ferdinand KC, Germain M, Rosendorff C, Steigerwalt SP, Stepanek JA. Clinical use of pulse wave analysis: proceedings from a symposium sponsored by North American Artery. The Journal of Clinical Hypertension. 2015 Jul;17(7):503-13.
  5. Cheng YB, Thijs L, Aparicio LS, Huang QF, Wei FF, Yu YL, Barochiner J, Sheng CS, Yang WY, Niiranen TJ, Boggia J. Risk Stratification by Cross-Classification of Central and Brachial Systolic Blood Pressure. Hypertension. 2022 Mar 2:HYPERTENSIONAHA-121.
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