Mobile health technology for Atrial Fibrillation
Application screening using smart devices-based PPG
The HUAWEI Heart Study
(Pre-MAFA Study)
Yutao Guo, M.D. Ph.D, Yundai Chen, M.D. Ph.D and Gregory Y H
Lip, M.D
On behalf of the MAFA II Study Investigators
Sep 2,2019 .Paris
Background
• Low detection and nonadherence in AF management
• Photoplethysmography (PPG) and mobile health
(mHealth) technology may enable a screening
approach combined with intervention.
Limit data on AF screening integration with clinical AF care
Objective
To investigate the effectiveness of AF screening in a large population-based
cohort using smart device based photoplethysmography (PPG) technology,
combined with a clinical care AF management pathway using a mHealth
approach
Ø Primary outcome: the incidence of AF identified
Ø Secondary outcome: the anticoagulant use
Independent academic study
PPG algorithm and smart devices have been validated before into
HUAWEI HEART STUDY
Stage 1 Stage 2 Stage 3
Stage 4
2018.3 2018.6 2018.9 2018.10
STAGES
Pilot verified PPG Remodeling& optimization Validation in a real-world setting Pre-MAFA
HUAWEI HEART STUDY
115 Subjects 279 subjects 375 cases
SUBJECTS • AF 52 cases • AF 113 cases • 373 cases with active measurement >100,000
• SR 56 cases • SR 151 cases • 200 cases with continuous detection, Validation of a
• Excluded 7 cases • Excluded 15 • taken 60s every 10 minutes for 14 day
cases
population screening
approach and
integrated AF care
PPG SIGNALS 614 signals 2,654 signals 26,217 signals
*Subjects were excluded if they had a pacemaker or implantable defibrillator, or they were unable to use smart wearable devices.
Fan Y, Guo Y, et al. JMIR Mhealth Uhealth. 2019
Guo Y, et al. Int J Clin Pract. 2019
Guo Y. m-Health in Arrhythmias . 2019 ESC congress
AF screening flow diagram
MAFA: mobile Atrial Fibrillation Application
Individuals with “suspected” AF
by PPG algorithm
MAFA Telecare team
Check and follow up at 24 hour AF confirmed by
clinical evaluation,
Can’t contact ECG, 24 h Holter
Follow up on First week
Individual
s who Can’t contact
refuse
the Follow up on Second week MAFA II cluster
follow-up
Can’t contact
MAFA doctors randomized clinical trial
Follow up for 12 months
Follow up on Fourth week
Can’t contact
Follow up on Sixth week
Can’t contact
Follow up on Eighth week
Can’t contact
The confirmation and follow-up of
Loss of follow-up
individuals with “suspected” AF
Inclusion 246,541 downloaded Screening App Exclusion
Adult ≥18 years (between October 26, 2018 and May 20, 2019)
Adult <18 years
Huawei phone (Android 5.0 or higher)
Inability to use smart phone or devices
Smart devices:
Huawei Watch GT (Version 1.0.3.52 or higher)
187,912 used smart devices
Honor Watch (Version 1.0.3.52 or higher)
Honor Band 4 (Version 1.0.0.86 or higher)
424 (0.2%) with “suspected” AF
262 (61.8%) “suspected” AF followed by
MAFA Telecare team and MAFA doctors
227 (87.0%) “suspected” AF confirmed by doctors with medical
history, physical examine, ECG, 24-H Holter, etc.
216 (95.1%) AF into MAFA with AF integrated care
AF screening, confirmation, and transference into MAFA
Baseline characteristics
Overall Cohort Notification Individuals with Identified AF
clinical evaluation
(n=187,912) (n=424) (n=227)
(n=262)
Suspected AF episodes, n 265,139 265,139 203,985 186,956
Female, n (%) 24938 (13.3) 55(13.0) 43(16.4) 42(18.5)
Age, mean (SD) 34.7(11.5) 54.1(14.3) 54.9(14.0) 56.1(13.7)
≥65, n (%) 3419 (1.8) 95(22.4) 62(23.7) 58(25.5)
55-64, n (%) 7491 (4.0) 112(26.4) 71(27.1) 69(30.4)
40-54, n (%) 44432 (23.6) 136(32.1) 82(31.3) 64(28.2)
20-39, n (%) 132570 (70.5) 81 (19.1) 47(17.9) 36(15.9)
Results: 71% of AF episodes were found within 14 days, but nearly
one third of AF episodes were recorded after two weeks
The rate of AF, %
70.0% 63.9%
61.1%
60.0% Suspected AF (n=424) Identified AF (n=227)
50.0%
40.0%
30.0%
About one third
20.0% 14.9%15.9% of AF episodes
9.7% 7.9% 8.0% 6.2%
10.0% 6.4% 6.2% were recorded
0.0% after two weeks
0-7 days 8-14 days 15-21 days 22-30 days >31 days
Time to first AF
Monitoring time to first detected AF episode
Results: The automatic periodical measurements were much likely to
detect “suspected” AF episodes
The rate of measure,
60.0% 55.4%
50.0%
*
40.0% 37.0%
Automatic periodical
30.0%
%
measurements were
20.0% more likely to identify
7.5%
10.0% AF episodes
0.0%
Active measure (n=32) Automatically periodic Active and periodic
measure (n=157) measure (n=235)
Monitoring method for first “suspected” AF
*Compared to active measure, p<0.001, ** Compared to automatically periodic measure, p<0.001.
Results: The highest proportion of AF episodes was among the elderly aged over 65
years, and there was a consistent increases of incident ‘suspected AF’ and ‘identified’ AF over
age
Positive PPG Total PPG PPV of PPG
signals signals signals (95%
CI)
186,956 203,985 91.6%
( 91.5%-91.8%)
Number of Number of Proportion of
cases with cases with positive AF
identified AF suspected (95% CI)
AF
227 262 86.6%
(82.0%-90.2%)
Incident “suspected” and “identified” AF among the screened population (n=187912 )
Results 80% of patients at high-risk were anticoagulated
Oral anticoagulant use in AF patients
Low risk Intermedi High risk
ate risk
N ( %) 91 (42.1) 71(32.9) 54 (25.0) 2007-2009 year
1034 Patients with AF
Anticoagulant use at baseline, n% 5 (5.49) 9 (12.68) 43 (79.63)
OACs: 14%
(Guo Y, et al. Int Card J. 2013)
Anticoagulant use at 3 months, n% 3 (3.30) 29 (40.85) 42 (77.78)
p 0.372 <0.001 0.673
* Low risk: CHA2DS2-VASc of 0 in males, or 1 in females; Intermediate risk: CHA2DS2-VASc of 2 in female, 1 in male; High
risk: CHA2DS2-VASc ≥3 in females, ≥2 in males. McNemar's test was used for testing the difference.
The reasons for patients with or without oral anticoagulants (OACs) on baseline:
Low risk patients with OACs at baseline: 2 patients undergoing AF ablation, with OAC used after discharge, 2 patients with
current onset acute AF episodes, and 1 patient with rheumatic valvular heart disease.
High risk patients without OACs at baseline: six patients who were unwilling to accept anticoagulants, four patients with
antiplatelets (aspirin or clopidogrel), and one patient anticoagulated with traditional Chinese medicine.
Limitations
• Although we had strict follow-up procedures for ‘suspected AF’, there
were 38% of individuals with ‘suspected AF’ who could not be effectively
followed up, which would decrease the proportion of identified AF.
• For the PPV calculation with PPG signals, we did not have real-time 12-lead ECG
data synchronized with PPG-based smart devices.
• Incident AF detection in present study might be impacted by the availability of
smart phones and devices.
Comparison with Apple Heart study
Main Aspects Huawei Heart Study Apple Heart Study
Algorithm
PPG Detecting PPV 91.6% 71.3%
accuracy
Based on PPG,Periodic measurement
Period Based on PPG,Periodic measurement results
results are given, the proportion of
measurement are not given
irregular rhythms is analyzed
Measurement
Period Every 2h for baseline mode,an irregular
measurement Every 10 minutes tachogram initiates a cascade of more
frequency frequent mode (every 16 minutes)
Follow-up by doctor, combined with a
Follow-up mode Follow-up with video visit online
clinical care AF management
Confirmed with medical history, physical
Confirmation mode Confirmed with ePatch
examination, ECG or 24-Holter by doctors
Follow up and
confirmation 44% first study visit * effectively followed up
Follow-up rate 62% with MAFA telecare and doctors
with ePatch returned and analyzed: 21%
Proportion of
confirmed AF by 87% 34%
doctors or ePatch
Summary
Mobile Atrial Fibrillation App
AF screening in
186,956 population
0.2 % received 87% confirmed 95% with MAFA for
the notification of AF by doctors AF integrated care ABC
suspected AF
80% of high-risk patients
were successfully
anticoagulated.
Clinical application
Continuous home-monitoring with smart device-based PPG technology is
a feasible approach for screening and early detection of AF in a large
population.
This could help our efforts at screening and detection of AF, as well as
early interventions to reduce stroke and other AF-related complications.
Acknowledgments
This research project was funded by the National Natural Science
Foundation of China (H2501) and was funded by the Health and Family
Planning Commission of Heilongjiang Province, China (2017-036), and
partly supported by the NIHR Global Health Research Group on Atrial
Fibrillation management at the University of Birmingham, UK.
Thanks to HUAWEI Heart Health Research Team for the development
and optimization of PPG algorithm, headed by Mr. Xiaoxiang He. Team
members include Jiabing Yan, Wenjuan Chen, Qin Chen, Jie Zhang, Xi
Huang, and Hongbao Li.
THANK YOU
JACC. In press
�User reported adverse events
Overall cohort
Total 186
Any device connection and data 123
synchronization issues
Login and experience issues (any) 63
Skin irritation, anxiety, pressure 0