evidence-based evaluation of two major arterial stiffness measures in japan: brachial-ankle pwv and...
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Evidence-Based Evaluation of Two Major Arterial Stiffness Measures in Japan:
Brachial-ankle PWV and Cardio-Ankle Vascular Index
Japan Labor health & Welfare Organization
Tohoku Rosai Hospital
MASANORI MUNAKATA M.D.,Ph.D.
2015 Pulse of Asia
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Changes in life expectancy in the world
↑Universal health case system 1961
AgingHypertension DiabetesDyslipidemiaObesitySmoking etc.
Vascular function tests could help our difficult task?
Endothelial dysfunction
Functional and organic changes in arterial system
Abnormal central and peripheral hemodynamics
Cardiovascular events
large and small artery damage
●endothelial function (FMD, plethysmography)●PWV(cfPWV, baPWV, CAVI), Stiffness index β●augmentation index, Central blood pressure, Photoplethysmogram waveform●ABI
Japanese Circulation SocietyGuidelines for non-invasive vascular function test
2013
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Brachial-ankle PWV Cardio Ankle Vascular Index
Device name VP-1000 (Omron colin) VS-1000 (Fukuda denshi)
Sales start years 1999 2002
Number on the Japan market in 2014
14000 14000
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Data on baPWV and CAVI
There have been 8540 hospitals and 100528 clinics in Japan in 2013.
For a vascular biomarker
1.Logical mechanism
2. Reproducibility
3. Validation and generalization
4. Disease specific changes
5. Additional prognostic value
6. Role of surrogate marker6
How to determine path length formula of baPWV?
Length (b) = 0.2195×height -2.0734Length (c) = 0.5643×height -18.381Length (d) = 0.2486×height +30.709
b :Heart-Brachialc :Heart-Femorald :Femoral-Ankle
Distance(ba) = 1.3×c + d - b
d
b
c
Sternoclavicular joint
Femoral position
Middle point of sensor cuff
Middle point of Cuff
Height
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Copyright © 2014 Journal of Hypertension. Published by Lippincott Williams & Wilkins.
FIGURE 1 Estimation errors of key arterial path lengths
Lhb = path length from the heart to the brachial arterial pressure recording site; Lha = path length from the heart to the ankle arterial pressure recording site; Lba = Lha – Lhb. Data are mean ± SD. P < 0.05 ∗vs. 19–34 years age group,
P < 0.05 vs. 35–49 years ∗∗age group, P < 0.05 vs. ∗∗∗men.
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Sugawara J et al. 32(4):881-889, 2014
Copyright © 2014 Journal of Hypertension. Published by Lippincott Williams & Wilkins.
FIGURE 2 A relation between brachial-ankle pulse wave velocity values derived from the height-based formulas (baPWVHt) and those recalculated using the MRI-based measurements of actual arterial path lengths (baPWVMRI)
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Sugawara J et al. 32(4):881-889, 2014
B
B
A
A
A’
Brachial-radial PWVFemoral-tibial PWV
Carotid-femoral PWVBrachial-ankle PWV
T
D
AB
AB
PWVAB=DAB/TAB
PWVAB=DAB/TAB=DAB/TA’B
Munakata M Current Hypertens Rev 2014
a
b
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Figure 1
Artery Research 2011 5, 91-96DOI: (10.1016/j.artres.2011.03.005) Copyright © 2011 Association for Research into Arterial Structure and Physiology Terms and Conditions
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Limitations and strength of each methodology
Limitations
baPWV: assumption that pulse wave velocity to aorta and that to brachium is nearly equal.
CAVI: assumption that systolic and diastolic blood pressures are nearly equal in all arterial portions.
Strength
Generality is guaranteed for both measures because only one formula is available to calculate baPWV and CAVI.
Level A: Multiple populations evaluated. Data from multiple
randomized clinical trials or meta-analyses
Ranking of evidence
Level B: Limited populations evaluated. Data from a
single randomized trial or nonrandomized studies
Level C: Very limited populations evaluated. Only consensus
opinion of experts, case studies or standard of care
ACCF/AHA Practice Guideline 2010
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Evidence level in disease specific changes
hypertension
diabetes
Mets
dyslipidemia
disease baPWV
Level A
Level B
Level C
ESRD
CKD
CAD
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CAVI
hypertension
diabetes
dyslipidemia
disease CAVIbaPWV
Level A
Level B
Level C
ESRD
CKD
CAD
Mets
Evidence level as a surrogate marker
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CAVI as a sarrogate marker
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Otsuka T et al. Hypertens Res 37:1014-1020, 2014
hypertension
diabetes
Mets
dyslipidemia
disease baPWV
Level A
Level B
Level C
ESRD
CKD
CAD
Evidence level in prognostic value
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CAVI
NO Report Subjects Mean age follow-up Outcome Prognostic value
1 Kitahara T et al.2005
785 hemodialysis patients 60 34 months Total death 131
CV death 85Significant
2 Tomiyama H et al.2005
215 acute coronary syndrome No data 26 month CV events 18 Significant
3 Morimoto S et al.2009
199 hemodialysis patients 61 43.2 month Total death 24
CV death 10Significant
4 Meguro T et al. 2009
72 CHF 68 14 month Readmission due to CHF 17
Cardiac death 9
Significant
5 Miyano I et al. 2010
530 elderly general population 76 3 yrs Total death 30
CV death 10
Significant
6 Nakamura N et al. 2010
191 diabetic patients with CAD No data 25.4 months Composite CV events 59 Significant
7 Turin TC et al. 2010
2480 general population men 61
women 57
6.5 yrs Total death 59 Significant
8 Kato A et al. 2010
194 hemodialysis patients 64 39 months Total death 39
CV events 39
Not significant
9 Tanaka M et al. 2011
445 hemodialysis patients 63 43 months CV events 206CV death 36
Not significant
10 Yoshida M et al.
2012 783 diabetic patients No data 5.4 yrs CV events 85 Not significant
11 Munakata M et al2012
662 hypertensive patients 60 3 yrs CV events 24 Significant
12 Inoue T et al.2012
197 hemodialysis patients 66 69 months CV events 89 Significant
13 Ninomiya T et al. 2013
2916 general population 60 7.1 yrs CV events 126 Significant
14 Takashima N et al.2013
4164 general population 58.9 6.5 yrs CV events 40 Significant
15 Kawai T et al.2013
440 hypertension patients 61 6.3 CV events 62 Significant
16 Ishisone T et al.2013
972 general population 59 7.8 years CV events 37 Significant
17 Maeda Y et al.2014
3628 diabetic patients 61.0 3.2 yrs Total death 207CV events 298
significant
18 Katakami N2014
1040 diabetic patients 59 7.5 years CV events 113 Significant
19 Sugamata W et al.2014
923 CAD patients 65 64 months 116 coronary events Significant
Studies on prognostic significance of baPWV in Japan
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NO Report Subjects Mean age follow-up Outcome Prognostic value
1 Chang LH et al.2014
(Taiwan)
452 diabetic patients 67 5.8 years Total death 17Composite
cardiovascular events 64
Significant
2 Yoon HE at al.(Korea)
241 CKD patients 53 367 days CV events 12 significant
3 Kim J et al.2014
(Korea)
1765 acute ischemic stroke patients
65 3.3 years Total death 228Vascular death 143
significant
4 Sheng C et al. 2014
(China)
3876 general population 68 5.9 years Total death 316 significant
Studies on prognostic significance of baPWV outside Japan
Adjusted hazard ratios (HR; 95% confidence intervals [CIs]) for all-cause mortality according to the decile distributions of brachial-ankle pulse wave velocity in all (left) and hypertensive
subjects (right).
Sheng C et al. Hypertension. 2014;64:1124-1130
Copyright © American Heart Association, Inc. All rights reserved.
Subjects in theTop Decile(n=385)
Top Decile ofBrachial –Ankle PWV vs
Whole Study Population
Outcome No. ofDeaths
Rate per 1000Person-Years
HR (95% CI) P Value
All-cause mortality 75 39.9 1.56 (1.16-2.08) 0.003
Cardiovascularmortality 43 22.9 1.46 (0.90-2.05) 0.15
Stroke mortality 13 6.9 1.49 (0.69-3.20) 0.31
Noncardiovascularmortality
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17.0
1.60 (1.18-2.75) 0.006
Adjusted Analyses on the Risk of Mortality in Subjects in the Top Decile of Brachial-Ankle PWV Relative to the Whole Study Population
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Sheng C et al. Hypertension. 2014;64:1124-1130
Stacked cumulative incidence curves of patients with stroke according to the brachial-ankle pulse wave velocity (baPWV).
Kim J et al. Hypertension. 2014;64:240-246
Copyright © American Heart Association, Inc. All rights reserved.
Table2. Association Between baPWV and Long-Term mortality in Acute Stroke
All –Cause Mortality Vascular Mortality*
baPWV Unadjusted HR (95% Cl)
Adjusted HR(95% Cl)†
Unadjusted HR (95% Cl)
Adjusted HR(95%Cl)‡
As categorical variables
Tertiles of baPWV
T1;<17.79m/s Ref. Ref. Ref. Ref.
T2;17.79-22.63m/s 2.15 (1.43-3.24) 1.46 (0.95-2.26 ) 2.42 (1.39-4.20 ) 1.56 (0.88-2.78)
T3;>22.63m/s 4.27 (2.92-6.25 ) 1.97 (1.25-3.08) 5.30 (3.18-8.82 ) 2.39 (1.33-4.29 )
baPWV>optimal cut-off§ 3.87 (2.92-5.15 ) 2.22 (1.59-3.09) 4.44 (3.07-6.40) 2.41 (1.57-3.70)
As continuous variable
baPWV,per10m/s‖ 2.24 (1.95-2.57 ) 1.54 (1.27-1.87) 2.32 (1.97-2.74 ) 1.62 (1.28-2.04)
baPWV indicated brachial–ankle pulse wave velocity ; Cl, confidence interval;and HR, hazard ratio.*Derived from cause-specific Cox hazard regression model (nonvascular death is censored at the event time).†Adjusted for sex, age, National Institutes of Health Stroke Scale (NIHSS) score at admission ,Hypertension , diabetes mellitus, currentsmoking, cardiac disease, peripheral artery disease, cerebral artery atherosclerosis, previous stroke ,stroke subtype, hemoglobin,Cholesterol , low-density lipoprotein, triglyceride ,albumin , glucose, creatinine,and diastolic arterial pressure.‡Adjusted for sex, age,NHSS score at admission ,current smoking, cardiac disease, peripheral artery disease, cerebral arteryAtherosclerosis, previous stroke subtype , white blood cell count,hemoglobin,cholesterol,triglyceride,albumin,creatinine,anddiastolic arterial pressure.‡HR in patients with baPWV above the optimal cut-off point (>27.48m/s for all-cause mortality and>28.56m/s for vascular mortality)compared with those with baPWV less than the cut-off point.‖HR per increase in 10m/s of baPWV.
Kim J et al. Hypertension. 2014;64:240-246
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NO Report Subjects Mean age follow-up Outcome Prognostic value
1 Kubota Y et al.2011
400 patients with lifestyle-related diseases
68.7 27.2 months CV events 47 Significant
Study on prognostic significance of CAVI in Japan
Figure 4
Artery Research 2011 5, 91-96DOI: (10.1016/j.artres.2011.03.005) Copyright © 2011 Association for Research into Arterial Structure and Physiology Terms and Conditions
The cumulative incidence of coronary artery diseases and strokes in 3 groups of CAVIcategory
Kubota Y et al. Artery Res 2011
Group A
Group B
Group C
Hazard ratio for cardiovascular diseases
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Group A Group B Group C P value for trend
<9.0 9.0-10.0 ≤10.0
Person-years of follow-up 154 132 114
Number of cardiovascular diseases 13 16 20
Adjusted HR (95% CI)a 1 1.47 (0.70-3.08) 2.11 (1.02-4.38) 0.04
Multivariate HR (95% CI)b 1 1.38 (0.65-2.97) 2.25 (1.02-4.95) 0.04
CI, confidence interval; HR, hazard ratioaAdjusted for sex and agebAdjusted for sex, age, hypertension, diabetes, dyslipidemia and CKD
Kubota Y et al. Artery Res 2011
Class I: Recommendation that procedure or treatment is
useful/effective (benefit>>>risk).
Classification of recommendation
Class IIa: Recommendation in favor of treatment or
procedure being useful/effective (benefit>>risk).
Class IIb: Recommendation’s usefulness/efficacy less well
established (benefit≥risk).
Class III: Recommendation that procedure or treatment is not
useful/effective and may be harmful.
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ACCF/AHA Practice Guideline 2010
Evidence of classification of recommendation
hypertension
diabetes
Mets
dyslipidemia
disease CAVIbaPWV
ESRD
CKD
CAD
Class I
Class IIa
Class IIb
Class III
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Summary
Prognostic significance has been broadly confirmed in the general population, hypertension, diabetes and other high risk populations for brachial-ankle PWV while only limited evidence exists for CAVI.
We fairly compared all available evidence between brachial-ankle PWV and CAVI, both are most frequently used arterial stiffness measures in Japan.
Cross sectional studies showed that both measures demonstrated an increase in major life style-related diseases and cardiovascular diseases.
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conclusion
Current evidence strongly suggests that brachial-ankle PWV might be a better vascular biomarker than CAVI.