key clinical trials and mega cohort studies in the area of ... · key clinical trials and mega...
TRANSCRIPT
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
Lifetime of Patient Care
Home
Transtelephonic
Monitoring
circa, 1970s
Battery
Rhythm
Sensing/Capture
September 2002 2
Lifetime of Patient Care
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%
Lifetime of Patient Care
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
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
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
Varma N, Mittal S et al. JACC 2015; 65: 2601-2610
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
Varma N, Mittal S et al. JACC 2015; 65: 2601-2610
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
RM AdherenceHighLowNone
Survival, ICD
45139 40080 24601 10827 1325 18854 17703 11786 5667 714 18605 17597 10345 4305 361
− − − Number at Risk − − −
NoneLowHigh
RM High vs. Low HR: 1.40 [1.30−1.52], p<0.010RM Low vs. None HR: 1.78 [1.68−1.88], p<0.010RM High vs. None HR: 2.50 [2.34−2.67], p<0.010
−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
RM AdherenceHighLowNone
Survival, CRT−D
31704 27448 15748 6335 671 13602 12572 7712 3363 367 14217 13342 7454 2744 206
− − − Number at Risk − − −
NoneLowHigh
RM High vs. Low HR: 1.47 [1.37−1.58], p<0.010RM Low vs. None HR: 1.63 [1.54−1.72], p<0.010RM High vs. None HR: 2.42 [2.27−2.57], p<0.010
−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. None HR: 2.4 [2.2−2.6], 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
RM AdherenceHighLowNone
Survival, Pacemaker
61173 54700 25805 2403 20763 19104 9496 1079 30733 28732 12784 1217
− − − Number at Risk − − −
NoneLowHigh
RM High vs. Low HR: 1.59 [1.47−1.71], p<0.010RM Low vs. None HR: 1.40 [1.33−1.49], p<0.010RM High vs. None HR: 2.25 [2.12−2.39], p<0.010
−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
RM AdherenceHighLowNone
Survival, CRT−P
4310 3664 1416 116 1460 1343 565 49 1930 1786 689 55
− − − Number at Risk − − −
NoneLowHigh
RM High vs. Low HR: 1.19 [0.94−1.52], p<0.111RM Low vs. None HR: 1.74 [1.45−2.10], p<0.010RM High vs. None HR: 2.10 [1.75−2.53], p<0.010
−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. None HR: 2.3 [2.1−2.4], p<0.001
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. None HR: 2.1 [1.8−2.5], 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
Piccini JP, Mittal S et al. (in review)
21
RM and Health Care Use: Hospitalization Costs
Piccini JP, Mittal S et al. (in review)
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
Piccini JP, Mittal S et al. (in review)
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
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
All patients with CIEDs should be offered RM as part of the standard follow-up management strategy
I A
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
All patients with CIEDs should be offered RM as part of the standard follow-up management strategy
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
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
All patients with CIEDs should be offered RM as part of the standard follow-up management strategy
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
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
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
All patients with CIEDs should be offered RM as part of the standard follow-up management strategy
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
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
Device Monitoring Class of Recommendation
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
Device Monitoring Class of Recommendation
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
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
Device Monitoring Class of Recommendation
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
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
Device & Disease Management Class of Recommendation
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
Device & Disease Management Class of Recommendation
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
RM is useful to reduce the incidence of inappropriate ICD shocks
I B-R
Consensus Statement
Recommendations
Device & Disease Management Class of Recommendation
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
RM is useful to reduce the incidence of inappropriate ICD shocks
I B-R
RM is useful for the early detection and quantification of atrial fibrillation
I A
Consensus Statement
Recommendations
Device & Disease Management Class of Recommendation
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
RM is useful to reduce the incidence of inappropriate ICD shocks
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
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.
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
Boca Raton Regional Hospital
CareLink Express Experience
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)
Remote Device Interrogators Usage
Tele 5th Floor
20% (369)
Tele 4th Floor
15% (260)
40% (706)
9th Fl.+ others 7% (128)
ER17% (310)
Tele 2nd Floor
Total transmissions n:1773 (8/2013-7/2016)
Transmissions Devices DistributionBoca Raton Regional Hospital (400 beds / 4 Interrogators)
Remote Device Interrogators Usage
Tachy Therapy
ICD+BIV
35% (628) 60% (1059)
5%(86)
ICM*
Brady Therapy
*ICM: Implantable Cardiac Monitor
Total transmissions n:1773 (8/2013-7/2016)
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
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