Use and Interpretation of Home Blood Pressure Monitoring

Use and Interpretation of Home Blood Pressure Monitoring BLOOD PRESSURE in year 2015 PARAMETERS TODAY Gianfranco Parati University of Milano-Bicocca & Ospedale S.Luca, IRCCS, Istituto Auxologico Italiano Milan, Italy

OFFICE OR OUT-OF-OFFICE BP? The ESH current position: Need of out-of-office BP

2013 ESH/ESC Hypertension Guidelines Blood pressure management, history, and physical examination Recommendations Class Level It is recommended that all hypertensive patients undergo palpation of the pulse at rest to determine heart rate and to search for arrhythmias, especially atrial fibrillation. I B Out-of-office BP should be considered to confirm the diagnosis of hypertension, identify the type of hypertension, detect hypotensive episodes, and maximize prediction of CV risk. IIa B For out-of-office BP measurements, ABPM or HBPM may be considered depending on indication, availability, ease, cost of use and, if appropriate, patient preference IIb C

UNTREATED PATIENTS Home BP Clinic Pressure 140/90 White Coat Hypertension True Normotension Sustained Hypertension Masked Hypertension 135/85 Daytime Ambulatory Pressure

BP REACTIVITY TO AUTOMATED OR SEMI-AUTOMATED (TRIGGERED BY THE PATIENT) BP MEASUREMENTS Parati G et al. Hypertension 1985

BP REACTIVITY TO AUTOMATED OR SEMI-AUTOMATED (TRIGGERED BY THE PATIENT) BP MEASUREMENTS Parati G et al. Hypertension 1998

HBPM should be used routinely in all treated hypertensive patients Journal of Hypertension 2008, 26:1505 1530

NEW WITH THE CONTRIBUTION OF GENERAL PRACTITIONERS. Journal of Human Hypertension (2010), 1 7

BP MONITORING AT HOME DIFFERENT OSCILLOMETRIC DEVICES ARM CUFF WRIST CUFF FINGER CUFF Recommended if validated Not recommended. Cautious use as BP measure at distal site affected by hand position vs heart level Not recommended

Validazion of BP measuring devices according to ESH International Protocol Validation Procedure Operator Operator Supervisor Investigated Subjects Double Binaural Stethoscope

Details of devices and their validation status can be obtained on www.dableducational.org www.pressione arteriosa.net websites devoted to blood pressure measurement.

ESH. J Hypertens 2008;26:1505-26 AHA. Hypertension 2008;52:1-9. DIAGNOSTIC SCHEDULE: US + EUROPEAN CONSENSUS 7 days of measurements Duplicate measurements per occasion Morning and evening per day Discard 1st day readings Calculate average.(hypertension: 135/85 mmhg)

HBPM DEVICE with MEMORY and Graphic Display Omron HEM-5001 Graphic display of weeklymonthly-average BP

Home Monitor with Weekly-Monthly- Average BP Graphic Display Omron HEM-5001 display

Proportion of patients (%) Home Monitor with Average BP Graphic Display Accelerates BP Control 40 Proportion of patients with home BP <135/85 mmhg GRAPHIC DISPLAY WITH WITHOUT 30 20 10 0 1 2 3 4 5 6 (months)

Microlife WatchBP Home USUAL mode Self BPM at anytime DIAGNOSTIC mode ESH/AHA Monitoring Schedule 7 days Duplicate morning and evening readings Average after discarding 1 st day before each visit PC link

Microlife WatchBP Home

Guidelines-Based Report (ESH/AHA 2008)

Omron s Home Monitor with Nocturnal Reading 22 Prior to HEM-7252G-HP, Omron launched 3 home monitors with nocturnal measurement function all of which were for only research use. HEM-747IC-N HEM-5041 HEM-7080IC HEM-7252G-HP 2000-2012 2007-2012 2012-2014 - Serial cable USB USB 3G 300 memory 600 memory 300 memory 90 memory 5 auto readings Only in Japan 20 auto readings Only in Japan 8 auto readings Only in Japan Unlimited auto reading

ROLE OF SELF BP MONITORING AT HOME ACKNOWLEDGEMENT OF PROGNOSTIC VALUE

Mancia G, Parati G. Hypertension 2011; 57:21-23

Studies assessing HBPM and prognosis Sheikh S, et al. Curr Hypertens Rep (2011) 13:192 199

Niiranen, et al. Office, Home, and Ambulatory Blood Pressures as Predictors of Cardiovascular Risk. Hypertension. 2014;64:00-00.

Office, home, and ambulatory blood pressures as predictors of 16.1-year risk of CV events. Niiranen, et al. Office, Home, and Ambulatory Blood Pressures as Predictors of Cardiovascular Risk. Hypertension. 2014;64:00-00.

Measurement of Nocturnal BP with HBPM 28 HBPM performed in multiple nights has shown better results comparing with ABPM. Home BP Ambulatory BP Urine albumin LVMI Ishikawa J, Kario K, et al. Hypertens 2012: 60: 921-928

Measurement of Nocturnal BP with HBPM 29 Nocturnal BP measured with home monitor which can be used multiple nights and reduces day-to-day variability reflects organ damages more closely than 24h-ABPM. Correlation coefficient with indices of target organ damage 0.4 0.3 24h-ABPM Home monitor 24 時間 A B PM 家庭血圧計 0.311 0.270 0.2 0.1 0.194 0.144 0 Urine 尿中アルブミン albumin/ creatinine / クレアチニン比 ratio Left 左室重量係数 ventricular mass index Ishikawa, Hoshide, Kario, et al. Hypertens 2012, 60:921-928

HBP Values in controlled hypertensive patients with small day-to-day BP variability. Average systolic/diastolic BP values were 125/83 mmhg with standard deviations of 6.2/4.5 mmhg. HBP Values in controlled hypertensive patients with large day-to-day BP variability. Average systolic/diastolic BP values were 125/ 82 mmhg, with standard deviations of 12.8/ 8.1 mmhg. Ohkubo T et al. Clinical and Experimental Pharmacology and Physiology (2014), 41, 54 57

Day-by-Day Variability of Blood Pressure and Heart Rate at Home Kikuya et al. Hypertension. 2008

32

33

ROLE OF SELF BP MONITORING AT HOME TOOL FOR BETTER PATIENTS COOPERATION AND MORE EFFECTIVE BP CONTROL

Standardised Relative Risk of BP Below Target in People Monitoring BP at Home Compared with People Whose BP was Monitored by Health Professionals in Clinical Settings 5488 P Cappuccio FP et al., BMJ 2004; 329: 145

HBPM and BP control rates RR of BP response in "home BP group" compared with the "clinic BP group." Type of BP refers to whether the outcome BP was measured by ambulatory or clinic measurements. Agarwal R, et al. Role of HBPM in overcoming therapeutic inertia and improving HT control: a systematic review and meta-analysis. Hypertension. 2011 Jan;57(1):29-38. Epub 2010 Nov 29.

37

38

OPTIMIZATION OF HBPM IN CLINICAL PRACTICE: -TELEMONITORING OF HBP VALUES

Home (Self) Monitoring Problems with SBPM reporting

SELF BPM AT HOME In 54% of patients GPs draw no conclusions from home BP readings (Krecke et al, J Hypertens 1996, 14:323)

Blood Pressure (mmhg) SBPM REPORTING 180 160 140 120 100 day 1-14 Stored Data Patient Diary Mengden et al. Am. J. Hypertens. 1998, 11: 1413-1417

OPTIMIZATION OF HBPM IN CLINICAL PRACTICE: HBP TELEMONITORING: available services - LIFESTAT (www.lifestat.ca) : trend graphs, pie charts, alert triggers - SHL-Telemedicine (www.shl-telemedicine.com) - VITALCARE Platform, by Vitalsys - BP-TEL, By Aerotel - TENSIOCARE system (www.tensiomed.com)

Does Home BP Telemonitoring Improve Hypertension Control? TeleBPCare Study Randomised N=113 Usual Care Office BP N=216 Telemedicine Home BP ABPM: baseline and after 6 ms. Parati G, et al. J Hypertens 2009; 27:198-203.

The MOREPRESS web-based HBPT System A&d UA-767PC DEVICE & GSM/GPRS INTERFACE PATIENT GENERAL PRACTITIONER WWW.MOREPRESS.NET

Subjects with daytime BP normalisation* (%) Patients who altered their treatment (%) HBPM monitoring may favour BP control and patient compliance versus office BP monitoring, particularly when combined with teletransmission 70 60 50 40 30 20 10 p<0.05 TeleBPCare study 16 14 12 10 8 6 4 2 35.6% reduction p=0.04 0 Control Group (n=111) TELEHBPM (n=187) 0 Control Group (n=111) TELEHBPM (n=187) *SBP <130 mmhg and DBP <80 mmhg Parati et al. J Hypertens 2009:27:198 203

Parati G, Omboni S. Blood Pressure Monitoring 2010, 15:285 295

Self-Measured Blood Pressure Monitoring in the Management of Hypertension A Systematic Review and Meta-analysis Uhlig et al. Self-measured BP monitoring with or without additional support lowers BP compared with usual care Uhlig et al. Ann Intern Med. 2013;159:185-194.

Uhlig et al. Ann Intern Med. 2013;159:185-194.

Home BP Monitoring: US and European Consensus both guidelines say that home BP monitoring should become part of the standard care of hypertensive patients Parati G, Pickering TG. Lancet 2009; 373:876-8.

ABPM or HBPM (Alternative Approaches) vs ABPM and HBPM (Complementary Approaches)?

Comparison of three main methods for BP measurement (Parati et al 2013) Feature OBP ABPM HBPM No. of readings Low High Medium White Coat Effect Yes No No Operator dependency Yes No No Need of device validation (*Yes if oscillometric No* Yes Yes device is used) Daytime BP + + + + + + Night-time BP and dipping (**New HBPM - + + + -/+ ** devices may perform night-time BP measures) Morning BP ± + + + 24 hour BP variability - + + ± Long-term BP variability - ± + + WCH and MH diagnosis - + + + + Placebo effect ++ - - Reproducibility Low High (24-h average values) High (average of several values) Prognostic value + + + + + + Patient involvement - - + + Patient training - ± + + Physician involvement +++ ++ + Patients acceptance ++ ± + + Monitoring of treatment effects Limited information Extensive information on 24h BP profile, cannot be repeated frequently Hypertension control improvement + ++ +++ Cost Low High Low Availability High Low High Appropriate for longterm monitoring, limited information on BP profile

Comparison of three main methods for BP measurement (Parati et al 2013) Feature OBP ABPM HBPM No. of readings Low High Medium White Coat Effect Yes No No Operator dependency Yes No No Need of device validation (*Yes if oscillometric No* Yes Yes device is used) Daytime BP + + + + + + Night-time BP and dipping (**New HBPM - + + + -/+ ** devices may perform night-time BP measures) Morning BP ± + + + 24 hour BP variability - + + ± Long-term BP variability - ± + + WCH and MH diagnosis - + + + + Placebo effect ++ - - Reproducibility Low High (24-h average values) High (average of several values) Prognostic value + + + + + + Patient involvement - - + + Patient training - ± + + Physician involvement +++ ++ + Patients acceptance ++ ± + + Monitoring of treatment effects Limited information Extensive information on 24h BP profile, cannot be repeated frequently Hypertension control improvement + ++ +++ Cost Low High Low Availability High Low High Appropriate for longterm monitoring, limited information on BP profile

Comparison of three main methods for BP measurement (Parati et al 2013) Feature OBP ABPM HBPM No. of readings Low High Medium White Coat Effect Yes No No Operator dependency Yes No No Need of device validation (*Yes if oscillometric No* Yes Yes device is used) Daytime BP + + + + + + Night-time BP and dipping (**New HBPM - + + + -/+ ** devices may perform night-time BP measures) Morning BP ± + + + 24 hour BP variability - + + ± Long-term BP variability - ± + + WCH and MH diagnosis - + + + + Placebo effect ++ - - Reproducibility Low High (24-h average values) High (average of several values) Prognostic value + + + + + + Patient involvement - - + + Patient training - ± + + Physician involvement +++ ++ + Patients acceptance ++ ± + + Monitoring of treatment effects Limited information Extensive information on 24h BP profile, cannot be repeated frequently Hypertension control improvement + ++ +++ Cost Low High Low Availability High Low High Appropriate for longterm monitoring, limited information on BP profile

Comparison of three main methods for BP measurement (Parati et al 2013) Feature OBP ABPM HBPM No. of readings Low High Medium White Coat Effect Yes No No Operator dependency Yes No No Need of device validation (*Yes if oscillometric No* Yes Yes device is used) Daytime BP + + + + + + Night-time BP and dipping (**New HBPM - + + + -/+ ** devices may perform night-time BP measures) Morning BP ± + + + 24 hour BP variability - + + ± Long-term BP variability - ± + + WCH and MH diagnosis - + + + + Placebo effect ++ - - Reproducibility Low High (24-h average values) High (average of several values) Prognostic value + + + + + + Patient involvement - - + + Patient training - ± + + Physician involvement +++ ++ + Patients acceptance ++ ± + + Monitoring of treatment effects Limited information Extensive information on 24h BP profile, cannot be repeated frequently Hypertension control improvement + ++ +++ Cost Low High Low Availability High Low High Appropriate for longterm monitoring, limited information on BP profile

Comparison of three main methods for BP measurement (Parati et al 2013) Feature OBP ABPM HBPM No. of readings Low High Medium White Coat Effect Yes No No Operator dependency Yes No No Need of device validation (*Yes if oscillometric No* Yes Yes device is used) Daytime BP + + + + + + Night-time BP and dipping (**New HBPM - + + + -/+ ** devices may perform night-time BP measures) Morning BP ± + + + 24 hour BP variability - + + ± Long-term BP variability - ± + + WCH and MH diagnosis - + + + + Placebo effect ++ - - Reproducibility Low High (24-h average values) High (average of several values) Prognostic value + + + + + + Patient involvement - - + + Patient training - ± + + Physician involvement +++ ++ + Patients acceptance ++ ± + + Monitoring of treatment effects Limited information Extensive information on 24h BP profile, cannot be repeated frequently Hypertension control improvement + ++ +++ Cost Low High Low Availability High Low High Appropriate for longterm monitoring, limited information on BP profile

Comparison of three main methods for BP measurement (Parati et al 2013) Feature OBP ABPM HBPM No. of readings Low High Medium White Coat Effect Yes No No Operator dependency Yes No No Need of device validation (*Yes if oscillometric No* Yes Yes device is used) Daytime BP + + + + + + Night-time BP and dipping (**New HBPM - + + + -/+ ** devices may perform night-time BP measures) Morning BP ± + + + 24 hour BP variability - + + ± Long-term BP variability - ± + + WCH and MH diagnosis - + + + + Placebo effect ++ - - Reproducibility Low High (24-h average values) High (average of several values) Prognostic value + + + + + + Patient involvement - - + + Patient training - ± + + Physician involvement +++ ++ + Patients acceptance ++ ± + + Monitoring of treatment effects Limited information Extensive information on 24h BP profile, cannot be repeated frequently Hypertension control improvement + ++ +++ Cost Low High Low Availability High Low High Appropriate for longterm monitoring, limited information on BP profile

HBPM and CV prognosis Percentage incidence of CV (gray bars) and all-cause death (white bars) over an average follow-up of 148 months in subjects with various combinations of normality or elevation in office, home and 24-h ambulatory BP. Mancia G, et al. Long-Term Risk of Mortality Associated With Selective and Combined Elevation in Office, Home, and Ambulatory Blood Pressure. Hypertension 2006;47;846-853

OFFICE BP -ABPM - HBPM COMPLEMENTARY NOT ALTERNATIVE APPROACHES

ADEQUATE HYPERTENSION CONTROL AND EFFECTIVE CV RISK REDUCTION REQUIRE BETTER BP ASSESSMENT AND MONITORING