Key Clinical Trials and Mega Cohort Studies in the Area of ... · Key Clinical Trials and Mega Cohort Studies in the Area of Remote Monitoring ... Guideline Methodology Summit ReportA

September 2002 1

Key Clinical Trials and Mega

Cohort Studies in the Area of

Remote Monitoring

Suneet Mittal, MD

Director, Electrophysiology Laboratory

The Arrhythmia Institute at The Valley Hospital

Ridgewood, NJ; New York, NY

www.valleymedicalgroup.com; @drsuneet

August 9, 2016

Disclosures: Consultant to Boston Scientific, LivaNova, Medtronic, Philips Healthcare, and St. Jude Medical

Lifetime of Patient Care

There are 3 million existing cardiac device patients and 400,000 devices implanted annually.1

1 http://circ.ahajournals.org/content/123/11/e378.full

IMPLANT PATIENT CARE

Next Day Clinic

Opportunity for better quality of care


Home

Transtelephonic

Monitoring

circa, 1970s

Battery

Rhythm

Sensing/Capture

September 2002 2


Home

Transtelephonic

Monitoring

circa, 1970s

Battery

Rhythm

Sensing/Capture

Remote

Follow-Up

2002

Battery

Rhythm

Sensing/Capture

Diagnostics

TTM vs Remote Follow-Up

Crossley G et al. JACC 2009; 54: 2012–9

• 897 pacemaker patients

were randomized to remote

follow-up or in-office visits

and TTM to determine the

time to first diagnosis of a

clinically actionable events

• Clinically actionable

events were found, on

average, two months earlier

in the remote arm than in

the control armAT/AF episodes >48 h or longer were the 2nd most

frequent CAE reported (after NSVT)

Clinically Actionable Events (CAE) Per Year

2% 66%


Home

Transtelephonic

Monitoring

circa, 1970s

Battery

Rhythm

Sensing/Capture

Remote

Follow-Up

2002

Battery

Rhythm

Sensing/Capture

Diagnostics

Remote

Monitoring

2005

Battery

Rhythm

Sensing/Capture

Diagnostics

Heart Failure

September 2002 3


There are 3 million existing cardiac device patients and 400,000 devices implanted annually.1

1 http://circ.ahajournals.org/content/123/11/e378.full

IMPLANT PATIENT CARE

ERHospital

Nursing

Home

MRI

CenterSNF

HospiceSurgery

CenterNext Day HomeClinic

Opportunity for better quality of care

Device-related

• Elective replacement indicator (ERI) or end of life (EOL)

Lead-related

• Significant Δ in pacing

• Significant increase in pacing thresholds

• Significant increase in the % of RV pacing

• Significant decrease in the % of LV pacing

Arrhythmia-related

• New onset of AT/AF

• Rapid ventricular rates during ongoing AT/AF

• Non-sustained or sustained VT/VF, including information about

ATP and delivery of ICD shocks

Heart failure-related

The Promise of Remote Monitoring

TRUST Trial

Varma N et al. Circulation 2010; 122: 325-332

September 2002 4

The COMPAS Trial

Mabo P et al. EHJ 2011; doi:10.1093/eurheart/ehr419

Hospitalization

related to atrial

arrhythmias and

stroke observed:

• 6 active pts

• 18 control pts

(OR = 0.33;

95% CI: 0.14-0.87;

p = 0.02)

IN-TIME Study

Hindricks G et al. Lancet 2014; 384: 583-590

Mortality: 3.4% vs. 8.7%

HR 0.36 (95% CI: 0.17-0.74)

P=0.004

Impact on Survival

Saxon LA et al. Circulation 2010 122: 2359-2367

39 546

30 010

68 481

47 741

September 2002 5

Flow Chart of Patient Selection

SJM ICD/CRT-D

Implants

Implant Oct 2009

to Nov 2011

RM (none)

N = 142,391

54%

RM (high)

N = 65,489

25%

Mortality

Cohort

Time Period

RM Adherence

Outcomes

SJM PM/CRT-P

Implants

Implant Oct 2010

to Nov 2011

Follow-up to Nov 2012

RM (low)

N = 54,684

21%

N = 262,564

Varma N, Mittal S et al. JACC 2015; 65: 2601-2610

14

82,621

59,5477,704

112,692

PM

CRT-P CRT-D

ICD

43%

32%

23%3%

Study Cohort: Device Types

N = 262,564


15

Mortality Incidence Rates

N RM Any

Mortality Incidence Rates *Per 100,000 pt-year *

Deaths

RM Any RM None% per pt-yr

Pacemaker 115,07613,256

12%47% 3,016 5,365

CRT-P 7,9061,34517%

46% 4,502 8,612

ICD 85,01411,652

14%47% 3,020 5,817

CRT-D 61,47511,877

19%48% 4,698 8,593

Lower MIR across all device typesVarma N, Mittal S et al. JACC 2015; 65: 2601-2610

September 2002 6

0.70

0.75

0.80

0.85

0.90

0.95

1.00

0 1 2 3 4

Years from Implant

Pro

babili

ty o

f S

urv

iva

l

RM AdherenceHighLowNone

Survival, All Devices

142326 125892 67570 19681 1996 54679 50722 29559 10158 1081 65485 61457 31272 8321 567

− − − Number at Risk − − −

NoneLowHigh

RM High vs. Low HR: 1.53 [1.47−1.59], p<0.010RM Low vs. None HR: 1.56 [1.51−1.61], p<0.010RM High vs. None HR: 2.40 [2.32−2.49], p<0.010

−4

−2

0

2

4

6

8

16

Number at Risk

High 65,485 61,457 31,272 8,321 567

Low 54,679 50,722 29,559 10,158 1,081

None 142,326 125,892 67,570 19,681 1,996

RM High vs. None

HR: 2.10 [2.04−2.16] p<0.001

RM High vs. Low

HR: 1.58 [1.54−1.62]p<0.001

RM Low vs. None

HR: 1.32 [1.27−1.36] p<0.001

Survival, All Device Types


17

Number at Risk

High 18,605 17,597 10,345 4,305 361

Low 18,854 17,703 11,786 5,667 714

None 45,139 40,080 24,601 10,827 1,325

Number at Risk

High 14,217 13,342 7,454 2,744 206

Low 13,602 12,572 7,712 3,363 367

None 31,704 27,448 15,748 6,335 671

0.70

0.75

0.80

0.85

0.90

0.95

1.00

0 1 2 3 4

Years from Implant

Pro

babili

ty o

f S

urv

iva

l


Survival, ICD

45139 40080 24601 10827 1325 18854 17703 11786 5667 714 18605 17597 10345 4305 361


NoneLowHigh


−4

−2

0

2

4

6

8

0.70

0.75

0.80

0.85

0.90

0.95

1.00

0 1 2 3 4

Years from Implant

Pro

babili

ty o

f S

urv

iva

l


Survival, CRT−D

31704 27448 15748 6335 671 13602 12572 7712 3363 367 14217 13342 7454 2744 206


NoneLowHigh


−4

−2

0

2

4

6

8

RM High vs. None HR: 2.5 [2.3−2.7], p<0.001

RM High vs. Low HR: 1.4 [1.3−1.5], p<0.001

RM Low vs. None HR: 1.8 [1.7−1.9], p<0.001


RM High vs. Low HR: 1.5 [1.4−1.6], p<0.001

RM Low vs. None HR: 1.6 [1.5−1.7], p<0.001

Survival, Defibrillators

18

0.70

0.75

0.80

0.85

0.90

0.95

1.00

0 1 2 3 4

Years from Implant

Pro

babili

ty o

f S

urv

iva

l


Survival, Pacemaker

61173 54700 25805 2403 20763 19104 9496 1079 30733 28732 12784 1217


NoneLowHigh


−4

−2

0

2

4

6

8

0.70

0.75

0.80

0.85

0.90

0.95

1.00

0 1 2 3 4

Years from Implant

Pro

babili

ty o

f S

urv

iva

l


Survival, CRT−P

4310 3664 1416 116 1460 1343 565 49 1930 1786 689 55


NoneLowHigh


−4

−2

0

2

4

6

8

Number at Risk

High 30,733 28,732 12,784 1,217

Low 20,763 19,104 9,496 1,079

None 61,173 54,700 25,805 2,403

Number at Risk

High 1,930 1,786 689 55

Low 1,460 1,343 565 49

None 4,310 3,664 1,416 116


RM High vs. Low HR: 1.6 [1.3−1.5], p<0.001

RM Low vs. None HR: 1.4 [1.5−1.7], p<0.001


RM High vs. Low HR: 1.2 [0.9−1.5], p<0.111

RM Low vs. None HR: 1.7 [1.5−2.1], p<0.001

Survival, Pacemakers

September 2002 7

19

Piccini JP, Mittal S et al. (in review)

RM and Health Care Use

20

RM and Health Care Use:All-Cause Hospitalization


21

RM and Health Care Use: Hospitalization Costs


September 2002 8

RM and Health Care Use

• For every 100,000 patient-years of monitoring:

– 9,810 fewer hospitalizations

– 119,000 fewer days in the hospital

– >$370,000,000 less payments to the hospital

22


23

Mittal S et al. JICE 2016; 46: 129-136

Early Initiation of RM

HRS RM Consensus

Recommendations (Circa 2015)

Heart Rhythm 2015; 12 (7): e69-e100

September 2002 9

HRS RM Consensus

Recommendations

• All patents with CIEDs should be offered RM as part

of the standard follow-up management strategy

(Class I; LOE: A)

• A strategy of remote CIED monitoring and

interrogation, combined with at least annual in-

person evaluation, is recommended in preference to

a calendar-based schedule of in-person CIED

evaluation alone (Class I; LOE: A)

• It may be beneficial to initiate RM within 2 weeks

following CIED implant (Class IIA; LOE: C)

8/5/2016

1

www.HRSonline.org

2015 Consensus Statement:

Remote Interrogation & monitoring of

Cardiovascular Implantable Electronic

Devices

HRS / ACC / AHA / EHRA / APHRS / SOLAECE / PACES

David Slotwiner,MD, FHRS, FACC (Chair),

Niraj Varma,MD, PhD, FRCP (Co-chair)

Renato Pietro Ricci, MD

ACC/AHA Clinical Practice Guideline Methodology

Class (strength) of recommendation Level (quality) of evidence

Class I: StrongBenefits >>> Risks

Level A: High-qualityStrong

Class IIa: Moderate Benefits >> Risks

Level B-RRandomized

Class IIb: WeakBenefits ≥ Risks

Level B-NRNonrandomized

Class III: No Benefit – moderateBenefit = Risk

Level C-LDLimited Data

Class III: HarmRisk > Benefit

Level C-EOExpert Opinion

ACCF/AHA Clinical Practice Guideline Methodology Summit ReportA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: Journal of the American College of Cardiology, v. 61, p. 213-265

Consensus Statement

Recommendations

Device Monitoring Class of Recommendation

Level of Evidence

A strategy of remote CIED monitoring and interrogation, combined with at least annual IPE, is recommended over a calendar-based schedule of in-person CIED evaluation alone (when technically feasible)

I A

8/5/2016

2

Consensus Statement

Recommendations


Level of Evidence


I A

All patients with CIEDs should be offered RM as part of the standard follow-up management strategy

I A

Consensus Statement

Recommendations


Level of Evidence


I A


I A

Before implementing RM, it is recommended that each patient be educated about the nature of RM, their responsibilities and expectations, potential benefits, and limitations. The occurrence of this discussion should be documented in the medical record

I E

Consensus Statement

Recommendations


Level of Evidence


I A


I A


I E

It is recommended that all CIEDs be checked through direct patient contact 2–12 weeks post implantation

I E

8/5/2016

3

Consensus Statement

Recommendations


Level of Evidence


I A


I A


I E

It is recommended that all CIEDs be checked through direct patient contact 2–12 weeks post implantation

I E

It may be beneficial to initiate RM within the 2 weeks of CIED implantation

IIa C

Consensus Statement

Recommendations


Level of Evidence

All patients with an implantable loop recorder with wireless data transfer capability should beenrolled in an RM program, given the daily availability of diagnostic data

I E

Consensus Statement

Recommendations


Level of Evidence


I E

It is recommended that health care professionals responsible for interpreting RM transmissions and who are involved in subsequent patient management decisions have the same qualifications as those performing in-clinic assessments and should ideally possess ABIM CCE or IBHRE certification for device follow-up or equivalent experience

I E

8/5/2016

4

Consensus Statement

Recommendations


Level of Evidence


I E

It is recommended that health care professionals responsible for interpreting RM transmissions and who are involved in subsequent patient management decisions have the same qualifications as those performing in-clinic assessments and should ideally possess ABIM CCE or IBHRE certification for device follow-up or equivalent experience

I E

It is recommended that RM programs develop and document appropriate policies and procedures to govern program operations, the roles and responsibilities of those involved in the program, and the expected timelines for providing service

I E

Consensus Statement

Recommendations

Device & Disease Management Class of Recommendation

Level of Evidence

RM should be performed for surveillance of lead functionand battery conservation

I A

Consensus Statement

Recommendations


Level of Evidence

RM should be performed for surveillance of lead function and battery conservation

I A

Patients with a CIED component that has been recalled or is on advisory should be enrolled in RM to enable early detection of actionable events

I E

8/5/2016

5

Consensus Statement

Recommendations


Level of Evidence


I A


I E

RM is useful to reduce the incidence of inappropriate ICD shocks

I B-R

Consensus Statement

Recommendations


Level of Evidence


I A


I E


I B-R

RM is useful for the early detection and quantification of atrial fibrillation

I A

Consensus Statement

Recommendations


Level of Evidence


I A


I E


I B-R

RM is useful for the early detection and quantification of atrial fibrillation

I A

The effectiveness of RM for thoracic impedance alone or combined with other diagnostics to manage congestive heart failure is currently uncertain

IIb C

8/5/2016

6

www.HRSonline.org

Remote Monitoring is the

standard of care and should be

offered to all patients with CIEDs

7/29/2016

1

Remote Monitoring Workflow Challenges and Opportunities?

Colin Movsowitz, MBChB, FACCDirector of Electrophysiology

Einstein Medical Center Montgomery

My Disclosures

• Biotronik– Consultant and Speaker

• Saint Jude Medical– Consultant and Speaker

• Boston Scientific– Consultant

• Ambucor– Consultant

Challenges: Acceptance

• Patients and Physicians

• Remote Monitoring: Paradigm Shift in the Management of patients with CIEDs

– End of “Well Baby” in-person visits

– Alert Driven visits

Cardiol Clin 32 92014) 239-252

7/29/2016

2

Challenges: New Workflow

• “Virtual patient”

– Connectivity to the Internet– Compliance– Cost

• Copays• High deductables

– Streaming data• Scheduled• Unscheduled Alerts

– Litigation

Challenges: Infrastructure

• Appreciate the need for infrastructure– AHP alone cannot handle this workflow

• Hiring and retaining trained staff– AHP

– Technicians

AHP

Challenges: EMR and InteroperabilityData vs. Information

Implantable Devices

ILRs

Pacemakers

ICDS

EMR

Raw Data Information

http://medgadget.com/archives/2009/04/merlinnet_going_live_in_europe.html

7/29/2016

3

Solutions: Acceptance

• Education– Physicians [Internists, cardiologists, EPs]

• Guidelines – HRS Consensus Statement

• Journals

• VuMedi

– Patients• Pre-op in the office – in consultation

• At the bedside

• At wound check

• Two way communicator (future)

Solutions: New Workflow

• Connectivity

• Compliance• Daily data transmission

• Proactive compliance management

• Contract

• Two way communicator (future)

7/29/2016

4

Solutions: Infrastructure

• In-house coordinated team– Technician [triage]

– AHP [clinical oversight/consent]

– Scheduler [compliance]

– Biller [understands coding RM]

– IT technical staff [bridging Internet and EMR with

common language]

– Physician

Solutions: InfrastructureOutsource: Shared labor force

Scottcare/Ambucor

J Interv Card Electrophysiol. 2011;31(1):81-90.

Work Flow

8/9/2016

1

E. Martin Kloosterman, MD, FACC, FHRS

Boca Raton Regional Hospital

Director of the Lynn Heart and Vascular Institute

Assistant Professor, Florida Atlantic University

The Use of Remote Device Interrogators

The Patient with an Implantable Cardiac Device:

Improving Outcomes Through the

Use of Remote Monitoring

Dr. Kloosterman receives modest honoraria as a

consultant, proctor, and speaker from the following

companies:

Boston Scientific

Medtronic

St. Jude Medical

Disclaimer

PREMISE:If we can control a robot in Mars.

We can certainly control a pacemaker in Boca.

http://desktopwallpaper-s.com/r?12

8/9/2016

2

2.3 min.

69min

41 consecutive patients/devices were successfully evaluated: 29 were ICDs

and 12 were pacemakers (DDD ICD: 17; VVI ICD: 5; DDD BIV ICD: 5, VVI

BIV ICD: 2; DDD PM; 11 DDD BIV PM: 1). Thirty-three devices were evaluated in the ER and eight in the OR.

LimitationsRegulatory (information security, HIPPA, etc.)

Real time service model

Scale, Technical and Communication protocols

Of those brave ones, how many of you would

be willing to be available 24/7 for remote real

time cardiac device management?

I mean… real remote, real mobile, real time, device management.

How many of you would feel comfortable

managing a cardiac device remotely real time?

Conventional

Bedside Programmer Expert user required at bedside

Limited availability

One on one care

Allows multiple users (different level of expertise)

Concept of response time

Concept of consistency

Concept of scale

CareLink Express 8/2012

Latitude Consult 4/2014

ANY patient can use the transmitter.

ONE Hospital account assigned.

Remote Device Interrogators

Exponential growth of devices.

Limited / inefficient man power.

Time constrains for clinic / office and hospital checks.

Device check automation (self-check).

Growing diagnostic data (Device activity, Arrhythmia, Heart Failure, etc.)

Advances in communications and electronic medical data.

Contributing Factors to Service Model Evolution

Latitude 2005

Home Remote Monitoring

Merlin 2008 Biotronik 2012

DEVICE COMPANY

SERVICE

CareLink 2002

ONE patient per transmitter

ONE clinic assigned for f/u.

Remote Interrogation

24/7 availability

Concept of scale

8/9/2016

3

REMOTE DEVICE INTERROGATORS

LOCATIONS to CONSIDER

LATITUDE Consult

Technical Services

Technical Review

Simple to Use

Focused Device Report

Hospital

SatelliteFacility

Emergency Room

Pre / PostOp

LATITUDE Consult Communicator

Radiology

Remote

Technical Support

at the Point-of-Care

Emergency Room

•ED Arrival to ED Departure

•Admitted Patients (Benchmark = 175 min)

• Admit Decision to ED Departure•Admitted Patients (Benchmark = 42 min)

• ED Arrival to ED Departure (Discharged from ED)

• ED Patients Only (Benchmark = 93 min)

• ED Arrival to Diagnostic Evaluation

• ED Patients Only (Benchmark = 14 min)

• ED Arrival to Pain Medication Administration • ED Patients Only (For Long Bone Fractures)

(Benchmark = 36 min)

Five Metrics 2014

ED Arrival to ED Departure

Admitted Patients

• Time from ED presentation to discharge

or transfer to an inpatient unit.

• Benchmark: 93-175 minutes

8/9/2016

4

Example of Remote Interrogator Service Layout

PATIENT

COMPANY REP.

For back up

NURSE

Physician

ER

OR

Floor

EP

Cardiologist

CareLink Express®

Consistent Predictable Quality Service

POST-CARELINK EXPRESS SERVICEPredictable time-to-diagnostic report2

PRE-CARELINK EXPRESS® SERVICESample of Hospital device check variability1

Consistent Predictable Quality Service

CareLink Express Service helps reduce variability in device check response time.

ConsistentPredictableQuality Service

Improve efficiencies with predictable, quality service.

1Pre-CareLink Express pilot data collected in 5 Medtronic districts for 4 consecutive weeks. Results may vary.²Medtronic CareLink Express Pilot Summary (June 1, 2012 - December 31, 2012).

84 min


CareLink Express Experience

http://www.google.com/url?sa=i&source=images&cd=&cad=rja&docid=p2jSGOVRy9ta-M&tbnid=SbUAdPWMPBeBWM:&ved=0CAgQjRw4wAE&url=http://www.psdgraphics.com/psd-icons/psd-global-communications-icon/&ei=bOqjUtWaMorokAfLwoHoBg&psig=AFQjCNEk94CNSt3gl_U_pgBH1Bn4A99clw&ust=1386560492905943

http://www.google.com/url?sa=i&source=images&cd=&cad=rja&docid=pwgivW_NgMRrvM&tbnid=QpMGNvE6c6fHOM:&ved=0CAgQjRw&url=http://www.answercarolina.com/physicians&ei=2e2jUsClArHisAT8vIDwCw&psig=AFQjCNEFgbyi_FQftvbxklU543yQPt8Npg&ust=1386561369199249

8/9/2016

5

Patient:

Presents with atrial arrhythmia on current EGM, Cardiac Compass/Arrhythmia

summary suggest chronic arrhythmia. Ventricular paced 23.5%

2 Supraventricular tachycardia detections noted, therapy withheld. EGM’s

provided for physician review to assess possible Ventricular tachycardia.

Battery good.

No atrial capture management data due to atrial arrhythmia.

Ventricular capture management data within safety margin.

Sensing/impedances within safety margin.

Optivol fluid index slightly elevated, Heart Failure Management report included

for review.

Feel free to contact me if you need any additional information.

86 y/o WM

h/o ICMP, s/p CABG, EF 30%,

Atrial Fibrillation, s/p ICD;

presents to the EMR with

c/o near syncope.

No CP, no SOB, no palpitations.

CareLink Express ER case.

10:50

Conclusion: Our data demonstrate the feasibility of a new diagnosis-only, remote

interrogation device and remote evaluation process for the interrogation of CIEDs in an in-

hospital environment.

Clinicians had access to full technical consultation in ≤15 min in 89 % of instances.

130 (26%) CIED further evaluation or reprogramming was needed.

509 transmissions (median duration of facility interrogator availability was 4 month)

Communicators (n = 53) installed in 42 hospital facilities. (May 2014 – March 2015)

Most common location: Emergency Dpt. (n= 32/ 60 %); PACU (n =145/ 28 %).

Only 53 (10 %) of the 509 transmissions were classified as urgent.

Cardiac Devices Remote Interrogation Initial Experience at Boca Raton Regional Hospital

#1 US Transmission Volume (400 beds – 4 Units)

Number of US CareLink Express active sites = 327

Boca Raton’s # of CLE transmissions to date = 998

#2 Global Transmission Volume(#1=2114 transmissions; 900 beds – 22 Units)

Number of OUS CareLink Express active sites = 105

Global number of CLE transmissions to date, 432 sites = 27,838

#1 Globally in Utilization Rate(#1=2114 transmissions; 900 beds – 22 Units vs. BRRH: 998 transm. 400 beds – 4 Units )

Data through: 1/1/2014 ---3/30/2015

8/9/2016

6

Regular Business Hours 8 am – 5 PM

After hours and Weekends

39%(685)

61%(1087)

Transmissions Working HoursBoca Raton Regional Hospital (400 beds / 4 Interrogators)

Remote Device Interrogators Usage

Total transmissions n:1773 (8/2013-7/2016)

Transmissions Location DistributionBoca Raton Regional Hospital (400 beds / 4 Interrogators)


Tele 5th Floor

20% (369)

Tele 4th Floor

15% (260)

40% (706)

9th Fl.+ others 7% (128)

ER17% (310)

Tele 2nd Floor


Transmissions Devices DistributionBoca Raton Regional Hospital (400 beds / 4 Interrogators)


Tachy Therapy

ICD+BIV

35% (628) 60% (1059)

5%(86)

ICM*

Brady Therapy

*ICM: Implantable Cardiac Monitor


8/9/2016

7

Company Service System

MerlinOnDemand Pending FDA approval

Interrogation without programmer at:

Emergency Department, Pre-op/PACU,

Satellite Clinic etc.Fax Report

Email Report

Transmission to

Company Remote

Monitoring Site

Report contains: Contact info of site and

device clinic

Summary Report

Freeze capture

Episodes summary

Most recent VT/VF

episode + SEGM

Diagnostics summary

Parameters summary

Reports emailed to

device

professional(s) for

remote consultation

Transmission also sent

to Company Remote

Monitoring Site if

patient is enrolled.

Alerts delivered via

mobile notificationMobile Alerts

Notification

Shortens time to follow up for the immediate care team, provides convenient access to device information.

How and Who Gets the Interrogation Reports?

Future uses of Remote Device Interrogators

cc

7’

3’

The Journal of Innovations in Cardiac Rhythm Management, 7 (2016), 2249–2256

REMOTE CARDIAC DEVICE MANAGEMENT STUDY

WORK FLOW

#100 pts.

#30 pts.

11 minutes

7 minutes

8/9/2016

8

MONDAY 1

TUESDAY 2

WEDNESDAY3

THURSDAY 4

FRIDAY 5

SATURDAY

SUNDAY

MONDAY 6

TUESDAY 7

WEDNESDAY8

THURSDAY 9

FRIDAY 10

SATURDAY

SUNDAY

CARDIAC DEVICE MANAGEMENT in the CARDIOLOGIST OFFICE

SERVICE MODEL – SCHEDULING EXAMPLE

123456789101112131415

= 15

Unscheduled check may take ~1hour

Closed scheduled =

Conventional

Company’s

Technician

Supported Model

4

3

3

3

2

15=

= Open

scheduled

Remote On-line and

Real-time

Interrogation Guided

Reprogramming

Understand, Cost Paradigm Change → “Spend to Save” (overall minimal cost)

Keys to Establish a Successful

Remote Device Interrogator Program

Understand, Not one size fits all.

It helps to identify a physician to champion the program in your institution.

Discuss with the device company team your institution’s professional

characteristics to establish a strategy and layout that better suits your needs.

Keep in mind “Critical Mass”.

The sporadic ER check may fall short of what the system can bring.

Consider expanding to involved cardiac areas OR, ICU’s and telemetry.

Floating teams, i.e. ECG technicians, can cover the whole hospital needs.

How and Who?

The system allows for many individuals to order a device check.

Not all of them will have the same level of understanding of a report;

communications lines with the specialists and the local device company team

should be clearly established.

E. Martin Kloosterman, MD, FACC, FHRS


Director of the Lynn Heart and Vascular Institute

Assistant Professor, Florida Atlantic University

The Use of Remote Device Interrogators

The Patient with an Implantable Cardiac Device:

Improving Outcomes Through the

Use of Remote Monitoring

Documents

Key Clinical Trials and Mega Cohort Studies in the Area of ... · Key Clinical Trials and Mega Cohort Studies in the Area of Remote Monitoring ... Guideline Methodology Summit ReportA