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Jul 17, 2015
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Charles BruceProfessor of Medicine, Mayo Clinic
Revolutionizing Heart Care Through
Sensor Technology
charlesbruceCharles Bruce
2 February 13, 2015
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Outline
What got us started?
Addressing the “clinical need”
Developing the solution
Challenges
Lessons learned
Future
3 February 13, 2015
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Vision: Remote Care
Develop integrated adaptable system
“Dashboard” overall health/well-being
Screening
Prevention
Management
Lengthen independence
5 February 13, 2015
Health Dashboard
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Total clinic patients 1,260,000
Hospital admissions 131,000
Hospital days of patient care 608,000
Personnel 59,509
Total revenue (millions) 9,421
Mayo Clinic Facts
6 February 13, 2015
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Population and Disease
7 February 13, 2015
Active disease
Asymptomatic disease
Overt risk factors for disease
Genetic & dietary predisposition
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Dis
Asymp
At risk
Predisp
• Alzheimer’s
• CHF
• AF
• HT
• DM
Person
• Algorithms
• CHF
• AF
• Biofluidics
• Prolonged ECG• Weight scale• Blood Pressure monitor• Accelerometer• Glucometer• Analytes• Other
Intelligent medical cabinet
Device companies
Pharmacy
Health care provider
Sensors
• Unobtrusive• Remote• Pervasive
Relatives
MobileHub
Sessile
• Data storage
• Data management
Infrastructure
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Our Approach
Long-term, unobtrusive monitoring to promote mobility and independence
Focus on emerging epidemics
Atrial fibrillation
Congestive heart failure
Obstructive sleep apnea
Integration of physiological signals
Ensure system non-proprietary, adaptable, integrated
10 February 13, 2015
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Remote Monitoring Platform
CHF Monitor “Proof of Concept”
ECG
Activity
Breathing
Scale
BP
Diagnostic/treatment algorithm
11 February 13, 2015
27 grams
STM32+BT ECG+ACC Battery (18 grams)
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Personal Wireless Health Monitor
12 February 13, 2015
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Remote Patient Care
ECG
Respiration
Physical activity
Symptoms
Wireless BP
and weight
13 February 13, 2015
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7Getting started
At tach BodyGuardian Cont rol Unit to SnapSt rip
Be sure you are using a fully-charged BodyGuardian Control Unit.
1. Line up the BodyGuardian Control Unit and SnapStrip, as shown in Figure 3.
Figure 3. BodyGuardian Control Unit on SnapStrip
Tip: The snaps aren’t evenly spaced. The orientation of the logo on both the BodyGuardian Control Unit and the SnapStrip must be the same.
2. Press firmly so all four snaps are connected.
Prepare your skin
• health care provider, shave the area.
• Clean the area with soap and water or an alcohol wipe.
• Dry your skin completely.
• Do not apply anything to your skin, such as lotions, oils, sprays.
At tach BodyGuardian Cont rol Unit to your chest
1. Peel away the adhesive backing on the SnapStrip patch.
2. Place the BodyGuardian Control Unit on your chest. Your health care provider will select ONE of three placement options for you, as shown in Figure 4.
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Remote Monitoring and AF Recurrence
27 patients undergoing DCCV or AF ablation
Monitored for 26.2 days
20 February 13, 2015
Ave time to AF
recurrence
11:23:18
Days : Hours : Minutes
Vogt et al: ACC, 2014
AF
No AF59%
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Remote Monitoring and AF Recurrence
Physical Activity* significantly increased prior to recurrent AF
Patients with recurrent AF had higher average HR
72.6 ± 7.9 versus 64.1 ± 7.0 (p=0.02)
Average physical activity 5.9 ± 1.3 entire group
Peak activity level 15 min prior to recurrence higher than average
activity level
18.6 ± 10.8 versus 5.7 ± 1.2 (p=0.0002)
21 February 13, 2015
Vogt et al: ACC, 2014* Scale of 0 to 100
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Quantified Self and Remote Care
23 4/17/2015
PreventionAtrial
Fibrillation
Chronic
Disease
Management
Heart Failure
Non BiologicEconomic
GPS
EnvironmentalSmartphone
Smart home
WearablesConsumer
Medical grade
ImplantablesPacemakers
Pressure sensors
Care Continuum
Data
Knowledge
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Prevention: Atrial Fibrillation (AF) and Stroke
78-year-old woman fainted at casino
Palpitations beforehand
Paramedics recorded ECG
HT
24 February 13, 2015
Does she has AF?
If so, is she at risk for stroke?
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0
5
10
15
20
0 1 2 3 4 5 6 7 8 9
CHA2DS2VASc Score
25 February 13, 2015
Lip et al: Chest, 2010
Points
Congestive heart failure 1
Hypertension 1
Age >75 years 2
Diabetes 1
Stroke 2
Vascular disease 1
Age 65 to 74 years 1
Sex category (Female) 1S
tro
ke
or
TE
ra
tio
(%
/ye
ar)
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0
5
10
15
20
0 1 2 3 4 5 6 7 8 9
CHA2DS2VASc Score
26 February 13, 2015
Lip et al: Chest, 2010
Points
Congestive heart failure 1
Hypertension 1
Age >75 years 2
Diabetes 1
Stroke 2
Vascular disease 1
Age 65 to 74 years 1
Sex category (Female) 1
Total points 4
Str
oke
or
TE
ra
tio
(%
/ye
ar)
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Prevention: Atrial Fibrillation and Stroke
Under diagnosed
Undertreated
27 February 13, 2015
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Prevention: Atrial Fibrillation and Cryptogenic Stroke
Sanna et al: NEJM, 2014
Implantable Cardiac Monitor versus control: Detection of AF by 36 Months
No at risk
Control 220 194 167 114 72 36 7
ICM 221 191 173 102 57 29 8
Months since randomization
AF
de
tecte
d
(% o
f patients
)
0
20
40
60
80
100
0 6 12 18 24 30 36
0
10
20
30
0 6 12 18 24 30 36
HR 8.8 (95% CI 3.5-22.2)
P<0.001
ICM
Control
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Chronic Disease Management: Heart Failure
Demographics of an Epidemic
29 February 13, 2015
Prevalence>6.6 M over age 18 (2.8%)
~9.5 M by 2030 (3.5%)
Incidence >680,000 new cases/year
Mortality ~57,000 deaths 2008 (more that all cancer combined)
Morbidity diagnosis annual office Most common discharge in patients >65 years; 12 M visits
Lifetime risk 1 in 5 after age 40
Roger et al: Circulation, 2012; Heidenreich et al: Circulation, 2011
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Chronic Disease Management: Heart Failure
30 February 13, 2015
Heart Disease and Stroke Statistics Update: Circulation, 2010
Economic Burden
Total cost 39.2 ($B)
4.1
35.1
Direct expense
Indirect expense (excluding morbidity)
Expenditures ($B)
4.7
20.92.5
3.2
3.8
Hospital cost
Nursing home
Physician
Drugs, etc
Home health
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U.S. Government Response
CMS – HF Outcome Quality Measures
30-day HF mortality and re-admission rates are publicly reported
30-day HF re-admissions will be linked to reimbursement
31 February 13, 2015
http:hospitalcompare.hhs.gov
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Remote Heart Failure Care
33 February 13, 2015
Adapted from Desai, Stevenson: NEJM, 2010
Patient
Patient’s
physiological
indicators
Recommended
therapy plan
Anticipated
change in
status
Patient
receiving
own data
Midlevel team
member
empowered to
make decision
Midlevel team
member who must
wait for MD to
review and make
decision
MD
Most direct path to action Longer paths to action
Repeat measurement
Therapy implemented
Data transmitted by patient
Data received and processed for trends and alerts
Patient contacted
Non BiologicEconomic
GPS
EnvironmentalSmartphone
Smart home
WearablesConsumer
Medical grade
Data
ImplantablesPacemakers
Pressure sensors
WearablesConsumer
Medical grade
ImplantablesPacemakers
Pressure sensors
Knowledge
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The Challenges
Technological
Adherence
Creating a tight feedback loop
Efficacy and proof points
Reimbursement
Regulations
34 February 13, 2015
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Innovation Forces
Agonists
Escalating costs
Declining reimbursement
Aging boom
Increasing chronic disease
Antagonists
Innovator’s dillemma
Fee for service
Regulation
35 February 13, 2015
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Elements Disruptive Innovation
36 February 13, 2015
Christensen: The Innovator’s Prescription
Business
Model Innovation
Technology
Enabler
Regulations
& Standards
Facilitate
Change
Value
Network
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BodyGuardian now being
used as a clinical tool
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Opportunities
Creation of framework for delivering appropriate and timely care
Proposed model - dedicated tele-medical center that operates 24/7
Practice integration
Improve outcomes
Cost savings
40 4/17/2015
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HF Remote Monitoring NIH Research
41 February 13, 2015
PI Charles J. Bruce
Co-I
Paul Friedman, MD
Virend Somers, MD, PhD
Kevin Bennet, Engineer
Lyle Olson, MD
Kristin Vickers Douglas, PhD, LP
Rickey Carter, PhD
CoordinatorsNancy Lexvold, RN
Cindy Truex, RN
Remote LabRevelee Kaplan, CRAT
Doug Beinborn, RN; Peter Brady, MD
Industry Partner Preventice
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Patients With Established Cardiac Disease
Chronic kidney disease, Diabetes, Coronary artery disease, and Peripheral
vascular disease most important predictors of hyperkalemia
Hyperkalemia significant predictor of all-cause mortality
42 February 13, 2015
Jain et al: Am J Cardiol, 2012
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