draft only the measure of life premium central blood pressure and pulse pressure wave analysis...
TRANSCRIPT
DRAFT ONLY
The Measure of Lifewww.uscom.com.au
Premium central blood pressure
and pulse pressure wave analysis
Uscom BP+
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
USCOM BP+
• BP+ is a clinical and research device for rapid and accurate measures of central aortic blood pressure
• Improves identification of hypertension and prediction of outcomes.
• As easy to use as current cuff based BP measurement devices.
• Calculates in around 60 seconds and requires no additional operator training.
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
KEY BENEFITS
• Ultrafast SupraSystolic measure on inflate BP measurement• In contrast to multiple inflate/deflate cycles required by other
products• Speed is valuable for clinicians • Children struggle to sit still during tonometry
• Significantly more clinically relevant information in the same or less time than regular BP
• Simple one button automatic operation • Familiar to clinicians and patients• Avoids operator dependence• Minimal user training
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
BP+ KEY MEASUREMENTS
• Central Blood PressureSystolic and Diastolic
• Brachial Blood Pressure Systolic and Diastolic
• SupraSystolic rhythm stripEasy identification of arrhythmias
• Pulse Rate
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
• Central Blood Pressure (cBP)• How is it different from
brachial?
• Outcomes• cBP and brachial BP change
independently • cBP responds differently to
Antihypertensive medication• The individual response to
treatment is different
CENTRAL BLOOD PRESSURE
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
CENTRAL BLOOD PRESSURE
“We have known for over half a century that brachial pressure is a poor surrogate for aortic pressure, which is invariably lower than corresponding brachial values. Recent evidence suggests that central pressure is also more strongly related to future cardiovascular events than brachial pressure, and responds differently to certain drugs.”
“We may be treating some subjects with relatively low central pressures, and not treating individuals with elevated central pressures, because they have brachial systolic pressures under current treatment thresholds.”
Carmel M. McEniery, John R. Cockcroft, Mary J. Roman, Stanley S. Franklin, and Ian B. Wilkinson CENTRAL BLOOD PRESSURE: CURRENT EVIDENCE AND CLINICAL IMPORTANCE. European Heart Journal (2014) 35, 1719–1725.
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
CENTRAL BLOOD PRESSURE
What is cBP? • The blood pressure in the aorta near the heart.
How is cBP different from peripheral BP? • BP increases as it gets further from the heart due to the increasing
peripheral resistance of the small arteries. • The degree to which the peripheral BP is higher than cBP is not linear nor
predictable due partly to the varying compliance of the arteries.
Amplification of the pressure waveform moving from the aorta to the radial artery.
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
CENTRAL PULSE PRESSURE WAVE
• The sum of the forward pressure wave, created by ventricular contraction, and of the reflected pressure wave, produce the peak systolic blood pressure in the aorta.
• Time to Reflection is when the reflected pressure wave starts to arrive
• Forward central pressure is augmented by the reflected pressure
• Central Augmentation index is ratio of central Augmentation Pressure over central Pulse Pressure*
* cAIx = AP/cPP (for people under 50 years of age)
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
CENTRAL BLOOD PRESSURE
DRAFT ONLY
www.uscom.com.au The Measure of Life
VALIDATION
Invasive cBP
Uscom BP+ cBP validated as equivalent to invasive cBP
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
VALIDATION
Invasive validation• Aaron C.W. Lin, Andrew Lowe, Karishma Sidhu, Wil Harrison, Peter
Ruygrok, and Ralph Stewart. Evaluation of a novel sphygmomanometer, which estimates central aortic blood pressure from analysis of brachial artery suprasystolic pressure waves. J Hypertens. 2012 Sep;30(9):1743-50. doi: 10.1097/HJH.0b013e3283567b94. http://www.ncbi.nlm.nih.gov/pubmed/22796711
Noninvasive validation to tonometry• Rachel E.D. Climie, Martin G. Schultz, Sonja B. Nikolic, Kiran D.K. Ahuja,
James W. Fell and James E. Sharman. Validity and Reliability of Central Blood Pressure Estimated by Upper Arm Oscillometric Cuff Pressure. Am J Hypertens. 2012 Apr;25(4):414-20. doi: 10.1038/ajh.2011.238. Epub 2012 Jan 5. http://www.ncbi.nlm.nih.gov/pubmed/22223041
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
REPRODUCIBILITY
As reproducible and repeatable as NIBP
pSBP (1
)
PR (1)
pAI (
1)
cSBP (1
)
cSBP (2
)
3 Day
pSB
P (1)
3 Day
pAI (
1)
10 D
ay cSB
P (2)
0.5
0.6
0.7
0.8
0.9
1
ICC
(1) Unpublished data, Otago University(2) Climie et al. P6.05, N=47
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
USCOM BP+
• BP+ is the most clinically applicable cBP monitor!
McEniery CM, Cockcroft JR, Roman MJ, Franklin SS, Wilkinson AB. Central blood pressure: current evidence and clinical importance. European Heart Journal (2014) 35, 1719–1725.
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
SUPRASYSTOLIC BEAT
50 100
0.1
0.2
0.3
0.4
0.5
0.6
a
e
b
cd
time (ms)SEP= te - ta
RWTT= tc - ta
dP/dt - Pressure gradient
SEP - Systolic Ejection Period = te - ta
RWTT- Reflected Wave Transit Time = tc - ta
TR - Time to Reflection = td -ta
RWR - Reflection Wave Ratio (AI)=(Pda/Pba)*100%
Pba
Pda
mmHg
150
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
SUPRASYSTOLIC RHYTHM STRIP
PRV - Pulse Rate Variability measures variation in beat duration
dPP – Pulse Pressure Variation measures % variation in beat amplitude
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
MEASUREMENT QUALITY
SNR – Signal to Noise Ratio provides qualitative assessment
Rhythm strip is visual confirmation of measurement quality
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
KEY BENEFITS
• Accurate CBP with Clinical Validation to true Gold Standard of Invasive catheter
• Comfortable Cuff• Supersedes existing BP devices• Sensitive to currently sub-clinical changes• Its disruptive technology (not me too BP!) • Standalone measurements and results display – NO PC!• Internal Measurement Storage and Data Export Facilities• Software for Reporting• Connectivity to Digital Health Records
DRAFT ONLY
www.uscom.com.au The Measure of Life
3
BP+ measures cuff pressure
2
Pressure waves travel to the end of the artery and transferred to the cuff and some pressure reflected
Artery occluded due to SupraSystolic cuff
1
Pressure is generated by the heart in the aorta
SUPRASYSTOLIC TECHNOLOGY
Forward Wave
ReflectedWaves
4
Reflected waves travel back towards the aorta.
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
SUPRASYSTOLIC TECHNOLOGY
• The heart generates a pressure pulse that propagates through aorta into the vascular tree.
• The pressure pulse enters subclavian-brachial artery where it is reflected when it reaches the point where the cuff occludes the artery.
• The pressure pulse travels back towards the aorta and is reflected back down the subclavian and brachial arteries.
• This latter reflection is due to the impedance mismatch between the relatively narrow subclavian and large diameter aorta.
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
• BP+ holds the cuff 30mmg above the measured systolic pressure
• The Supra Systolic pressure wave recorded from the cuff is the sum of these forward and reflected waves.
• BP+ uses a direct physiology based algorithm to model the pressure wave transmission.
• Pulse pressure wave analysis determines central systolic, diastolic BP and other parameters in typically less than 60 seconds!
SUPRASYSTOLIC TECHNOLOGY
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
SUPRASYSTOLIC BENEFITS
• Full occlusion of flow in the brachial artery has several advantages:• Cuff is a deterministic termination impedance which
simplifies the model.• No pooling of the blood below the cuff as would occur at
sub systolic pressures.
This pooling is more uncomfortable than the brief SupraSystolic pressure (+/-12 seconds).
• Removes impact of peripheral vasculature state beyond the cuff (hot/cold, bifurcations, etc.)
Improves energy transfer and signal quality
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
• Eliminated noise and artefact in the pressure wave due to:• Reflections of peripheral bifurcations (radial/ulnar etc.)• Individual variance from compressible tissue between cuff and
artery (thin, fat, muscular, etc. arms)• Non-laminar blood flow from induced turbulence by artery walls
• Resulting in:• The most physiologic and superior quality entire central pulse
pressure waveform• Excellent accuracy and reproducibility• BP+ stores all the recorded measurement data in each
measurement file.
Ensuring retrospective calculation of new parameters from previously performed measurements
SUPRASYSTOLIC BENEFITS
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
• RWR reported value is directly off the measured pulse pressure waveform (SupraSystolic) from the cuff, not from a derived waveform.
• RWR is calculated from the average SupraSystolic pulse displayed on the screen of BP+.
SUPRASYSTOLIC BENEFITS
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
• Supra Systolic capture of CBP vs the IEM approach of sub diastolic etc (Richard!)
SUPRASYSTOLIC BENEFITS
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
BRACHIAL vs TONOMETRY
• BP+ has been used on children as it’s quick and simple. Children struggle to sit still for long enough to do accurate tonometry.
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
“Bra-Rad-SBPAmp results in underestimation of central SBP using brachial-BP-calibrated radial tonometry.”
BRACHIAL vs TONOMETRY
RED Climie, DS Picone, MA Keske and JE Sharman. Brachial-to-radial systolic blood pressure amplification in patients with type 2 diabetes mellitus. Journal of Human Hypertension (2015), 1–6
DRAFT ONLY
www.uscom.com.au The Measure of Life
Uscom BP+ TensioMed BPLab AtCor IEM
Australia Hungary Russia Australia Germany
USD 2,950 USD 6,000 USD 7,000 USD 13,000 USD 7,000
60 seconds 2 min 2 min 1 min 2 min
Stand-alone ABP, needs computer
ABP, needs computer
Needs computer ABP, needs computer
CE, FDA, TGA CE CE CE, FDA CE, FDA
Aortic waveform Central systolic BP
Rough waveform Rough waveform Rough waveform
Physical model Statistical regression
Transfer function Transfer function Transfer function
COMPETITION
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
DISTRIBUTOR WEBSITE
• Sales, training, marketing and support material.• White papers and peer-reviewed articles.• Latest news
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
WHAT THE RESEARCH SAYS
• Individual response• Better predictor• Relates better to disease• Better measure of treatment• cBP and BP respond differently to medication• Less medication needed• Central BP goal differs from upper arm BP goal• Useful in pediatrics
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
INDIVIDUAL RESPONSE
• Most classes of antihypertensive agents used as monotherapy lower BP by a similar average amount. However, the individual response to each agent is unpredictable.
• Targets may be difficult to achieve or may not be tolerated in some patients.
Heart Foundation Guide to management of hypertension 2008. Updated December 2010 http://www.heartfoundation.org.au/SiteCollectionDocuments/HypertensionGuidelines2008to2010Update.pdf
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
cBP A BETTER PREDICTOR
• “Central arterial pressure is a better predictor of adverse cardiovascular outcomes than brachial blood pressure”
Evaluation of a novel sphygmomanometer, which estimates central aortic blood pressure from analysis of brachial artery suprasystolic pressure waves Aaron C.W. Lin, Andrew Lowe, Karishma Sidhu, Wil Harrison, Peter Ruygrok, and Ralph Stewart.
jhypertension.com DOI:10.1097/HJH.0b013e3283567b94
• “…central BP can differ greatly between individuals with similar brachial BP.”
Patients with Type 2 diabetes mellitus have an exaggerated brachial and central blood pressure response to exercise: relation to left ventricular hypertrophy. Sharman, J. E., Scott, J. A., Coombes, J. S., Prins, J. B., Leano, R. and Marwick, T. H. (2007). 28th Annual Scientific
Meeting of the High Blood Pressure Research Council of Australia 2006. (1476-1477). 6-8 December, 2006.
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
cBP RELATES BETTER TO DISEASE
“central pulse pressure is more strongly related to vascular hypertrophy, extent of atherosclerosis, and cardiovascular events than is brachial blood pressure”
Artery Research 2009;3: 125-7 Hypertension 2007;50:197-203
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
A BETTER MEASURE OF TREATMENT
• “The most important finding of the present study is that central blood pressure responded differently to ergometer and hand-grip exercises.”
• “central systolic blood pressure was increased after isometric hand-grip, but not isotonic ergometer, exercise.”
Differential Response of Central Blood Pressure to Isometric and Isotonic Exercises Satoru Tanaka, Tomonori Sugiura, Sumiyo Yamashita, Yasuaki Dohi, Genjiro Kimura & Nobuyuki Ohte SCIENTIFIC REPORTS | 4 : 5439 | DOI: 10.1038/srep05439
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
cBP AND BP RESPOND DIFFERENTLY TO MEDICATION
• “Moreover, anti-hypertensive drugs can exert differential effects on brachial and central pressure.”
“Central blood pressure: current evidence and clinical importance
Carmel M. McEniery, John R. Cockcroft, Mary J. Roman, Stanley S. Franklin, and Ian B. Wilkinson
European Heart Journal (2014) 35, 1719–1725
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
LESS MEDICATION NEEDED
“We conclude that guidance of hypertension management with cBP resultsin a significantly different therapeutic pathway than conventional cuff BP,with less use of medication to achieve BP control and no adverse effects
on left ventricular mass, aortic stiffness, or quality of life.”
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
cBP GOAL DIFFERS FROM BP GOAL
NEW Central BP goals Hypertension – cBP 130/90, Optimal – cBP 110/80
“cBP of 130/90 mmHg was determined to be the cut off limit fornormality……. This report represents an important step toward the
application of the CBP concept in clinical practice.”
Derivation and Validation of Diagnostic Thresholds for Central Blood Pressure
Measurements Based on Long-Term Cardiovascular Risks
Hao-Min Cheng, MD, PhD∗; Shao-Yuan Chuang, PhD‖; Shih-Hsien Sung, MD‡; Wen-Chung Yu, MD‡; Alan Pearson, AM, PhD∗; Edward G. Lakatta, MD∗∗; Wen-Harn Pan, PhD‖
; Chen-Huan Chen, MD†
J Am Coll Cardiol. 2013;62(19):1780-1787. doi:10.1016/j.jacc.2013.06.029 Hypertension | November 2013
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
USE IN PEDIATRICS
Oscillometric PWA provides valid measures of central blood pressure in children aged 8–10 years.
Original Article Jan 2014Validation of Oscillometric Pulse Wave AnalysisMeasurements in ChildrenLee Stoner, Danielle M. Lambrick, Nicole Westrupp, Joanna Young, and James Faulkner. American Journal of Hypertension 2014, doi:10.1093/ajh/hpt243
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
REGULATORY
• FDA clearance
• CE for Europe
• TGA for Australia
• Reimbursement in the USACPT code 93050, from 1 Jan 2016
• Brachial BP to ISO 81060-2:2014, AAMI SP10, BHS Grade A
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
SUMMARY
• Central Blood Pressure• cBP is different from brachial BP• antihypertensive medication has a different effect on cBP
• Outcomes • central pulse pressure is more strongly related to vascular disease
and cardiovascular events than is brachial
• Innovation• Uscom BP+ uses SupraSystolic technology • cBP with the most physiologic and entire pulse pressure wave
analysis
DRAFT ONLY
www.uscom.com.au The Measure of Life
DRAFT ONLY
In 60 seconds, Uscom BP+ provides:
• Accurate SupraSystolic oscillometry• Non-invasive and operator independent• Affordable and standalone• Clinically significant, actionable measures• Easy to use• Familiar with no extra training
Hypertension. Outcomes. Innovation.
CONCLUSION
The premium Central Blood Pressure and Pulse Pressure Wave Analysis device to improve diagnosis and management of hypertension