A Brief Introduction to VaSera and the CAVI Measurement

A Brief Introduction to VaSera and the CAVI Measurement

Introduction to VaSera for Use in the MESA Study Christopher Broadbridge Phone: (425) 241-7396 Clinical Development & Marketing, VaSera Fukuda Denshi USA Redmond, WA Fukuda Denshi 3,000+ employees worldwide (including 300 engineers) Celebrated 75th Year Anniversary ECG leader in Japan First ECG producer in Japan (1939) Reputation for quality engineering Oldest bedside monitoring manufacturer in the world

Makes 300+ medical device products Fukuda Denshis History in Vascular Function Measurement Rolling cart Touch screen Data transfer: Removable USB Data storage: 2 USB, 1 SD, internal 4

6 ultra-sensitive cuffs (brachia, thighs, ankles) 1 heart-sensitive microphone Ankle cushions and wrist cushions Characteristics of VaSera Tests Diagnostic Non-invasive Validated

Reproducible Sensitive to CV risk Reimbursed in USA FDA approved 6 CAVI A heart-to-ankle measurement: Direct, single-path from the point of origin Includes the whole aorta VaSera tests to perform 1. CAVI test (Cardio-Ankle Vascular Index): For arterial stiffness diagnosis ( atherosclerosis; CAD) 2. Thigh-cuff test (Cardio-Thigh Vascular Index):

For arterial stiffness diagnosis ( atherosclerosis; CAD) 3. ABI test: For peripheral artery disease diagnosis (PAD) 8 Why do the measurement? CAVI is a possible predictor of coronary risk; fully automatic. Cardio-thigh stiffness measurements may be as effective as well-measured cfPWV. VaSera ABIs are automated; easier for clinics to perform. Clean brachial waveforms from VaSera may provide data to predict HF For adults, CAVI is an independent risk marker for:

1. 2. 3. 4. Coronary artery disease Future cardiovascular events in people with CAD Atherosclerosis in HTN patients Renal dysfunction (eGFR) / Chronic Kidney Disease (CKD) REFS: 1. Yingchoncharoen T, Limpijankit T, Jongjirasiri S, Laothamatas J, Yamwong S, Sritara P. Arterial stiffness contributes to coronary artery disease risk prediction beyond the traditional risk score (RAMA-EGAT score). Heart Asia. 2012 Feb 21;4(1):77-82. Print 2012. 2. Otsuka K, Fukuda S, Shimada K, Suzuki K, Nakanishi K, Yoshiyama M, Yoshikawa J. Serial assessment of arterial stiffness by cardio-ankle vascular index for prediction of future cardiovascular events in patients with coronary artery disease.

Hypertens Res. 2014 Jul [Epub ahead of print] 3. Okura, T; Watanabe, S; Kurata, M; Manabe, S; Koresawa, M; Irita, J; Miyoshi, K; Fukuoka, T. Relationship between CardioAnkle Vascular Index (CAVI) and Carotid Atherosclerosis in Patients with Essential Hypertension. Hypertens Res; 2007; (30): 335-340 4. Takuro K, Masaaki M, Kiyo U, Aya N, Shuichi H, Ken K, Osamu K, and Chuwa T. Association between Arterial Stiffness and Estimated Glomerular Filtration Rate in the Japanese General Population. J Atheroscler Thromb, 2009; 16:840-845. CAVI Health Subject Data 11 Cardio-Ankle Vascular Index (CAVI) Healthy Subject Study Results (Japan) (Men=3,259; Women=3,534) 10 9.35

9.01 9 8.6 Male 8.71 7.99 8 7.72 7.5 7

6.81 6.37 6.72 6.86 7.04 7.22 8.15 8.21 8.37

7.95 7.74 7.23 7.02 7.38 66.27 AGE (yrs) 70-74 65-69

60-64 55-59 50-54 45-49 40-44 35-39 30-34 25-29

5 20-24 CAVI Value Female VaSera: Become an Expert! (Tips on testing) MESA version Document Number: USRB-0074-00 12

Background What is CAVI? How is it measured? Document Number: USRB-0074-00 13 4 ultra-sensitive cuffs 1 heart-sensitive microphone ECG for gating signals Document Number: USRB-0074-00 14

Document Number: USRB-0074-00 CAVI A heart-to-ankle measurement: Direct, single-path from the point of origin Includes the whole aorta 15 When VaSera detects the second heart sound, we have the time of closure of the aortic valve. A high quality brachial pulse waveform will show, with its dichrotic notch, when that closures effect occurs in the brachium. Time of the second heart sound to dichrotic notch represents, then, a lag time. Applying that lag time to the start of the rise of the brachial pulse wave (the foot of the brachial wave), the time of expulsion of blood at the level of the aortic valve (valve opening time) is extrapolated. Thus, with aortic valveopening time being time zero, we can easily measure the pulses total transit

time to the ankle, where it is measured until the foot of the ankle wave. Transit distance is estimated using the subjects height, or can be done more exactly from manual measurements. Dividing this distance by transit time gives the pulse wave velocity (PWV). The beta stiffness index and scale adjustments are added to give CAVI more independence from blood pressure and make it comparable to heart-tofemoral PWV. The CAVI measurement is that of a pulse movement along a single path, and includes the whole aorta. Document Number: USRB-0074-00 16 Performing the Measurement Before pressing START button: Quiet room

Ensure cuffs correctly wrapped and positioned Patient: Still, Relaxed Supine,Supine, Still, Relaxed Ensure that PCG = distinct 2nd heart sound Brachials = dichrotic notch Ankles = defined starting point to each pulse Thighs = clean, smooth, regular signals Document Number: USRB-0074-00 17 Clean Waveforms and Signals Up-going R-wave; In sinus rhythm

Distinct 2nd heart sound; flatter baseline Noticeable dichrotic notch; no disruptive artifacts on the downslope Sharp and consistent foot, marking the up-slope, with no disruptive artifacts Document Number: USRB-0074-00 18 Always check your PCG signal

If you cant distinguish the 2nd heart sound, VaSera probably cant either. Document Number: USRB-0074-00 19 Look at the Brachial Waveforms Can you distinguish the dichrotic notch from the artifact? Document Number: USRB-0074-00 20 Good Ankle Signal (foot/ trough)?

No Yes Are the troughs or feet of the ankle waveforms at the ends of consistent and regular up-slopes? Document Number: USRB-0074-00 21 Movement Artifact Effect Movement, beyond relaxed breaths, can disrupt signals Document Number: USRB-0074-00 22 Arrhythmia Effect

Arrhythmic heart beats result in irregular pulse waveforms Document Number: USRB-0074-00 23 Measurement Review AFTER CAVI measurement period: Ensure that Blue, data quality-check screen shows pluses + for both sides (R and L) If a minus is shown, press STOP button, and start the test over by adjusting where necessary and pressing START button If there is a minus sign for either side, do not use this test result

Document Number: USRB-0074-00 24 Document Number: USRB-0074-00 You may also review calculation results via the VALUE screen. One column per heartbeat (1-6). These symbols are quality measures: is the same as ++, = +, = , = is the same as ++, = +, = , = = , = . Red values (outliers) are not used in the reported results. 25 Performing Tests with Thigh Cuffs

(See the Thigh Cuff Protocol document) Thigh cuffs are used in this study in order to assess measurements with a heart-to-femur transit (more purely aortic in nature than measurements using a heart-to-ankle transit) Thigh cuffs must be applied as carefully as brachial and ankle cuffs are applied VaSera Data Management for the MESA Study (From the VaSera collection device to MESA central data repository) Please use these site # assignments Site#

Site Name 1 Northwestern University Clinic 2 Columbia University Clinic 3 Johns Hopkins University Field Center 4

University of Minnesota (Epidemiol. Clin.Res. Cntr) 5 UCLA Clinic 6 Wake Forest University Clinic At each site Zip Files VaSera USB data stick 1.

Remove USB drive/Stick from front of VaSera. 2. Use File Manager to copy files from USB drive to a folder you designate for VaSera data on your PC. Name that folder MESA Study VaSera Data. Zip/compress the files in your PC folder to make them ready for transfer. Upload the zipped folder to your MESA central data storage location. 3. 4. 5.

6. Repeat the above steps, on a regular basis, keeping all historical data. ZIPPED For all VaSera data, create consistent, date-sortable, folder-naming format: e.g., 20160915-UCLA MESA Study VaSera Data 20160915-UCLA

Send to Center MESA Central Data Storage Location UCLA-5 ZIPPED ZIPPED 20160915-UCLA 20161030-UCLA upload Unzipped Unzipped

Unzipped Unzipped ZIPPED 20161013-JHU ZIPPED 20161104-UCLA NWU-1 20160915-UCLA 20161030-UCLA

CU-2 CU-2 Unzipped Unzipped ZIPPED 20161028-WFU JHU-3 ZIPPED 20161116-CU

WFU-6 20161116-CU VSS-50 management UCLA-5 20160915-UCLA Aug5 2016_Pennsylvania Import with VSS-50 software JHU-3 Review, Print, or Export

in various data formats 20161224-JHU Inspection Data spreadsheet Wave Data files Graphic files Some Extra Tips 1.Sites not using the AUTO-TRANSFER of data from VaSera to PC: Remove auto transfer option from the system settings 2.Change Site ID # for each site according to table above: MENU SETTINGS PATIENT INFO 3.For Thigh-cuff measurements, make sure to measure to/from the middle of the thigh cuff

4.BP VESSEL LENGTH setting Make sure to input the correct subject HEIGHT information; this is critical to the test result 5.PAUSE the test at the CAVI DATA CHECK SCREEN (SUMMARY SCREEN); this will enable an opportunity to review data quality and decide if to stop and restart the test after adjustments, or to continue with the test to completion. 6.Preview the PDF file Report to see if the CAVI result is reported with a circle (signifying clean data) or no circle (questionable data quality). 7.Data will be saved to USB1, USB3, SD card, and to the VaSera internal memory. 8.A good VaSera test time for each subject is 8 (CAVI test) + 2 (rest between measurements) + 8 (thigh cuff test) = 18 minutes Let us support you Please pose your questions to your local Fukuda Denshi USA representative: Christopher Broadbridge FUKUDA DENSHI USA, Inc.

Tel: (425) 241-7396 Fax: (425) 556-3213 [email protected] Or contact our customer service at: Toll Free : 1-800-365-6668 Local : 425-881-7737 Hours: 8:00 AM to 5:00 PM (PST) Document Number: USRB-0074-00 33

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