Aortic Blood Pressure Waveform Analysis

The SphygmoCor Px Aortic BP Profile system is a non-invasive, doctor’s office device for obtaining important clinical cardiovascular data. The system does this by analysing the blood pressure profile where it really matters – at the heart. The key to the information the system provides lies in the shape of the aortic pressure wave. This waveform imparts important information about the clinical impact of arterial stiffness on key cardiovascular parameters. The SphygmoCor system has transformed cardiovascular evaluation, enhancing patient assessment and management by providing the following information:

• Evaluation of systemic arterial stiffness (Aortic Augmentation Index) and its clinical impact on the heart in increasing patient risk of heart failure, stroke and myocardial ischaemia.
• Augmentation pressure, which drives left ventricular load (afterload) - a key parameter affecting risk of LV hypertrophy.
• Central Pulse pressure in the ascending aorta (driving cerebral blood flow) giving the true pressure, and hence the risk of stroke.
• Central systolic pressure, often markedly different from the cuff value.
• Ejection duration – a parameter for distinguishing primarily systolic from primarily diastolic dysfunction, and for managing the efficacy of heart failure therapy.
• Diastolic pressure-time index (DPTI), a key determinant of coronary blood supply.
• Systolic pressure-time index (SPTI), a measure of myocardial oxygen demand.
• Subendocardial Viability Ratio – the relationship of DPTI and SPTI, providing a powerful index for risk stratification for myocardial ischaemia.

Clinical Applications

• Evaluation of arterial stiffness and its impact on the heart, giving clinicians an increased ability to assess disease progression and patient risk.
• Hypertension: Improved patient evaluation in hypertension by providing a more comprehensive cardiovascular assessment allowing more effective treatment and patient management decisions.
• Diabetes: Improved patient treatment in diabetes through early identification of "at risk" diabetes patients.
• Heart failure: Differentiation between primarily systolic and primarily diastolic heart failure, and management of the progression of diastolic heart failure.
• Titrating Therapy: Monitoring drug interventions by assessing their effects at the heart and titrating therapy accordingly.
• Renal: Measures of arterial stiffness have been shown to be powerful independent predictors of mortality in end-stage renal disease.

Research Applications

• As a quick, reproducible and non-invasive test, the SphygmoCor Px system provides a tool that can be easily incorporated into clinical trials.
• The versatile nature of the product has lead to its inclusion in clinical trials such as pipeline drug development, discovering early markers for CAD and for ascertaining independent predictors of morbidity and mortality.
• With the addition of pulse wave velocity, provides a complete system to assess arterial stiffness and its effects.

The various research areas SphygmoCor Px has been used in include:

• Diabetes – Type 1, Type 2, Insulin resistance, endothelial function
• Renal – chronic and end-stage renal disease, transplantation, haemodialysis
• Hypertension – ISH, pseudohypertension, etc
• Rheumatology
• Pregnancy and pre-eclampsia
• Preventative and alternative medicine
• Heart failure and heart transplantation

Regulatory Status

• IEC/EN 60601-1 (amendment 1 & 2) & IEC/EN 60601-1-2 (AS/NZS 3200.1.0 AS/NZS 3200.1.2) Electromedical Safety Certification (this is a mandatory requirement for medical equipment to be used in hospitals in some countries). Rating – “Type CF Class 2”

• Device listing with the Australian Therapeutic Goods Administration (TGA)

• CE Mark (MDD Annex II)

• MLHW registration for Japan

• KFDA Approval for Korea

• Import License for China

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