Clinical and Economic Advantages of Implantable Defibrillator Remote Patient

Monitoring

David Lee Scher, MD, FACC, FHRSMarch, 2008

Aspects of Remote Patient Management

Remote Monitoring

• Device safety alerts

• Arrhythmia alerts

1

Remote Follow-Up

• Patient convenience

•Improves efficiency

2

On Demand Interrogation

• Determine rhythm/device function

• Reduce office/ER visits

3

Advantages of Remote F\U

Safety alert notification Arrhythmia detection Integration with electronic health records Cost savings Secondary utilization of data

Follow-up of CRT-D: Need to Reprogram Since Implant

Lunati M et al. PACE2008;31:38-46

TRUST StudyVarma 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.

Patient Follow-Up Compliance

• Randomization gp 3mo 6mo 9mo 12mo• Remote (%) 88 90 88 84• Conventional F/U(%) 91 78 73 65

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

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

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 least 6 hrs AT/AF

41 (26) 47 (37) 4 (2, 13) 23 (5, 40)

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 an episode

16 (12) 11 (6) 0 (0, 1) 9 (0, 36)

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)

1.68

2.24

3.92

4.33

1.94

6.27

0

1

2

3

4

5

6

7

Scheduled Visits Unscheduled Visits All Clinic Visits

Annualized Rate Per Patient Year

Remote Arm

In-office Arm

Clinic Visits (Scheduled and Unscheduled)

Health Care Utilization Visits by Treatment Arm

* Includes Urgent Care Visits

0.50

0.24

2.24

0.47

0.21

1.95

0.00

0.50

1.00

1.50

2.00

2.50

3.00

CV Hospitalization Emergency Department Unscheduled Clinic Visit *

Ann

ualiz

ed R

ate

Per

Pati

ent

Year

Remote Arm

In-office Arm

p=0.52

p=0.33

p=0.10

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.

Electronic Record system Adoption and Growth: USA and EU

Key Points:Key Points:

• USUS - HIGHTECH ACT• CBO forecasts penetration rate to increase to 90% by 20194

• EU EU – Avg. 40-50% aaaaaadoption rate2,3

• Avg. CAGR of ~3.1% per year2

US17%1,3

UK

58%2,3

Sweden93%2,3

Germany39%2,3

France6%2,3

Italy23%2,3

Spain25%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

2015

France 7%2

CAGR (2009-2015)UK 3.5%Germany 3.1%France 3.2%Italy 4.0%Spain 3.9%Sweden 1.1%

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 SystemAnalysis 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

Point-to-point transactions using varied and incompatible medium

Health Information Exchange

Health Information Exchange – The Regional Model?

Standards-based communication; regionally and beyond

Health Information Exchange – The National Model?

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.

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.

Development Issues

• No ‘seamless’ integration without Paceart intermediary.

• Cost to companies (no return on investment)

• Incompatible with cellular phones with most companies.

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.

Secondary Use of Data

“The Most Valuable Commodity that I know of is Information”.

-Gordon Gekko

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

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

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

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

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

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.

Office Visits

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

Transportation Costs

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

Physician Time

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

Clinic Costs

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

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

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

Economic Advantages of Remote Monitoring

Fauchier L et al. PACE 2005;28:S255-9

Economic Advantages of Remote Monitoring

Fauchier L et al. PACE 2005;28:S255-9

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.