This presentation from 2008 discusses the most early recognized merits of remote patient monitoring as it pertained to implantable defibrillators. It was prsented at the European Cardiac Arrhythmia Society Annual Congress. These advantages of RPM can be extended to monitoring of other conditions today.

1. Clinical and Economic
Advantages of Implantable
Defibrillator Remote Patient
Monitoring
David Lee Scher, MD, FACC, FHRS
March, 2008

2. Aspects of Remote Patient
Management
Remote
Monitoring
• Device safety
alerts
• Arrhythmia
alerts
1
2
Remote Follow-
Up
• Patient
convenience
•Improves
efficiency
3
On Demand
Interrogation
• Determine
rhythm/device
function
• Reduce
office/ER visits

3. Advantages of Remote FU
 Safety alert notification
 Arrhythmia detection
 Integration with electronic health records
 Cost savings
 Secondary utilization of data

4. Follow-up of CRT-D: Need to Reprogram
Since Implant
Lunati M et al. PACE2008;31:38-46

5. TRUST Study
Varma N, et al. AHA 2008
• 105 centers
• 898 pts followed with convention visits
• 414 pts followed with remote follow-up
• Similar demographics, ICD indication, EF,
beta blockers, and amiodarone usage.

6. Patient Follow-Up Compliance
• Randomization gp 3mo 6mo 9mo 12mo
• Remote (%) 88 90 88 84
• Conventional F/U(%) 91 78 73 65

7. Mean # days between arrhythmia onset and
clinician evaluation of first arrhythmic
event
• Randomization group VF VT SVT AF
• Remote monitoring (d) 10.5 12.9 16.6 25.2
• Conventional F/U (d) 45 45.6 42.1 46.8

8. The Clinical Evaluation of Remote
NotificatioN to REduCe Time to Clinical
Decision (CONNECT) Trial:
The Value of Remote Monitoring
Crossley G, Boyle A, et al Am Heart J 2008:156;840-6

9. Time from Event to Decision by Alert Type
(median days)
Device Event No. of Events
(No. of Patients)
No. of Days from Event Onset To
Clinical Decision
Median (Interquartile Range)
Remote In-office Remote In-office
AT/AF burden at least 12 hrs 437 (107) 280 (105) 3 (1, 15) 24 (7, 57)
Fast V rate at least 120 bpm during at
41 (26) 47 (37) 4 (2, 13) 23 (5, 40)
least 6 hrs AT/AF
At least 2 shocks delivered in an
episode
44 (35) 32 (23) 0 (0, 1.5) 0 (0, 2)
Lead impedances out of range 26 (18) 12 (6) 0 (0, 9) 17 (5.5, 45)
All therapies in a zone exhausted for
16 (12) 11 (6) 0 (0, 1) 9 (0, 36)
an episode
VF detection/therapy off 10 (10) 8 (8) 0 (0, 0) 0 (0, 84)
Low battery 1 (1) 1 (1) 30 0
Total 575 (172) 391 (145) 3 (0, 13) 20 (4, 52)

10. Clinic Visits (Scheduled and Unscheduled)
1.68
2.24
3.92
4.33
1.94
6.27
7
6
5
4
3
2
1
0
Scheduled Visits Unscheduled Visits All Clinic Visits
Anualized Rate Per Patient Year
Remote Arm
In-office Arm

11. Health Care Utilization Visits
by Treatment Arm
* Includes Urgent Care Visits
0.50
0.24
2.24
0.47
0.21
1.95
3.00
2.50
2.00
1.50
1.00
0.50
0.00
CV Hospitalization Emergency Department Unscheduled Clinic Visit *
Annualized Rate Per Patient Year
Remote Arm
In-office Arm
p=0.52
p=0.33
p=0.10

12. Clinical Advantages: Interoperability With
Electronic Health Records
• Eliminates paper charts.
• Allows for synthesis of device and patient-specific
clinical data.
• Timely management of patient arrhythmia
problems detected with RM.

13. Electronic Record system Adoption and
Growth: USA and EU
KKeeyy PPooiinnttss::
• UUSS - HIGHTECH ACT
• CBO forecasts
penetration rate to
increase to 90%
by 20194
• EEUU – Avg. 40-50%
aaaaaadoption rate2,3
• Avg. CAGR of
~3.1% per year2
US
17%1,3
UK
58%2,3
Sweden
93%2,3
Germany
39%2,3
2015
France
6%2,3
Italy
23%2,3
France 7%2
Spain
25%2,3
2019
US 90%4
2015
UK 71%2
2015
Sweden 99%2
2015
Germany 45%2
2015
Italy 29%2
2015
Spain 31%2
CAGR (2009-2015)
UK 3.5%
Germany 3.1%
France 3.2%
Italy 4.0%
Spain 3.9%
Sweden 1.1%

14. Wireless Substitution: Implications for Remote
Follow-up of ICDs and pacemakers
USA 2009 2010 2011 2012 2013 2014
% population w/o POTS 21.50 24.80 28.10 31.40 34.70 38.00
% >55 yrs w/o POTS 6.54 7.72 8.90 10.08 11.26 12.44
International 2009 2010 2011 2012 2013 2014
% population w/o POTS 39 44 48 53 58 63
% >55 yrs w/o POTS 12 14 15 17 19 21
POTS = Plain Old Telephone System
Analysis based on Wireless Substitution: Early Release of Estimates From the National Health Interview Survey,
January 2005-June 2008 by Stephen J. Blumberg, Ph.D., and Julian V. Luke Division of Health Interview Statistics,
National Center for Health Statistics

15. Point-to-point transactions using
varied and incompatible medium
Health Information Exchange

16. Health Information Exchange – The Regional Model?
Standards-based communication;
regionally and beyond

17. Health Information Exchange – The National Model?

18. Flow of Information
• Transmitter to CRM Company servers.
• Servers then transmit to the office Medtronic Paceart®
CRM system which then relays information to EMR.
There is bidirectional communication between the
Paceart System and the EMR.
• Bidirectionality allows for confirmation of patient identifier
on multiple levels and for alteration of the report.
• Results in paperless transfer of information which is
uniform for all the devices, regardless of manufacturer.

19. Development Issues
• Standardization of display features of different
companies’ device parameters and data
collection. Need for clinical input for definition,
organization, and display of data.
• Interface software development by both the
EMR company and device companies.

20. Development Issues
• No ‘seamless’ integration without Paceart
intermediary.
• Cost to companies (no return on investment)
• Incompatible with cellular phones with most
companies.

21. Ideal Integration With EHR
• All information regarding leads, device data,
programmed parameters, function, arrhythmia
events.
• Side by side with patient diagnoses and medications
for easy clinical assimilation of data and
adjustments if necessary.
• EMR deposition of the information allows for
potential physician electronic signature of the review
process.

25. Secondary Use of Data
“The Most Valuable
Commodity that I know of
is Information”.
-Gordon Gekko

26. Secondary Use of Data
Challenges
• Volume and complexity of data
• Integrating massive volumes of disparate data
• Requires sophisticated analytics
• Growing collaboration across ecosystem
• Privacy and security issues

27. Advantages of Remote Monitoring:
Secondary Use of Data
• Post-market surveillance of leads and devices
– Early detection of trends towards failure or
technical problem
– Utilization of types of devices and leads
• Arrhythmia management
– Device therapy
– Pharmacologic therapy

28. Advantages of Remote Monitoring: Secondary
Use of Data
• Public sector utilization
– Surveillance of product performance
– Disease/outcomes management
• Private sector utilization
– Identify market trends
– Third party data management business
– Marketing data for Pharma, consumer products,
healthcare stakeholders
– Clinical research

29. Economic Advantages of Remote
Monitoring
• Reduce patient visits
– Travel costs
– Office utilization costs
– Eliminates of patient loss of work costs
• Reduces device company costs
– Personnel for office follow-ups and troubleshooting

30. Randomized Multicenter Comparison of Home
Monitoring vs Regular F/U in MADIT II Pts
Elsner CH et al. Proceedings Computers Cardiology 2006;33:241-244
• 115 pts, 110 single chamber, 5 dual chamber ICDS
• Randomized after 3 months to 1 office f/u with HM
or Q 3 month office f/u with HM
• Endpoints:
– primary-number of unplanned visits
– Secondary- total costs, QOL, total mortality

31. Randomized Multicenter Comparison of Home
Monitoring vs Regular F/U in MADIT II Pts:
Results
• Mean F/U time 117 days (23-513)
• No significant difference in hospitalization or
mortality rates.

32. Office Visits
Elsner CH et al. Proceedings Computers Cardiology 2006;33:241-244

33. Transportation Costs
Elsner CH et al. Proceedings Computers Cardiology 2006;33:241-244

34. Physician Time
Elsner CH et al. Proceedings Computers Cardiology 2006;33:241-244

35. Clinic Costs
Elsner CH et al. Proceedings Computers Cardiology 2006;33:241-244

36. Raatikainen, MJP et al. Europace 2008;10:1145-51

37. Raatikainen, MJP et al. Europace 2008;10:1145-51

38. Economic Advantages of Remote Monitoring
Fauchier L et al. PACE 2005;28:S255-9

39. Economic Advantages of Remote Monitoring
Fauchier L et al. PACE 2005;28:S255-9

40. SUMMARY
• Remote monitoring offers patient safety benefits.
• Better clinic and emergency department efficiency.
• Better management of atrial and ventricular
arrhythmias.
• Integration with electronic health records.
• Improvement in overall ICD patient management
costs.
• Facilitate secondary use of data for clinical and
economic purposes.