Dr Vanita Arora is a Senior Consultant Cardiac Electrophysiologist & Interventional Cardiologist, Cardiac Electrophysiology Lab and Arrhythmia Services, 3D Mapping Radio frequency Ablation of the Complex Arrtymias and Arrhythmia Cardiac Diagnosis in India.

1. NEWER DIAGNOSTIC TOOL
Vanita Arora
Incharge of Department of Cardiac Electrophysiology & Arrhythmia Services
Max Healthcare Superspeciality Hospital, Saket, New Delhi

2. Arrhythmia Diagnosis in India
• Problem area : arrhythmia diagnosis
• Current modalities for ambulatory cardiac
diagnosis
• Is ELR the solution..!!

3. Problem area: Arrhythmia Diagnosis
There is a large unmet need in India for diagnosis of cardiac
arrhythmia:
•177 Million over age 65 by 2025
» Declining function of the SA node with age is a major health issue
•Prevalence of arrhythmia in India: >20 million
• >50% of symptomatic patients with possible arrhythmia are
not correctly diagnosed
…all of these result in a significant opportunity to address an unmet
clinical need
Sources:
1)Krahn AD et al. “The utility of Holter monitoring compared to loop recorders in the evaluation of syncope
and pre-syncope.” ANE. 2000;5(3):284-289.
2)Singh H. “A 24 hour Holter study in asymptomatic early Indians.” JIACM. 2003;4(4):308-14.
3)CureResearch.com. “Statistics by country for arrhythmias.” October 26, 2011.

4. Arrhythmia Diagnostics: Technology
Options
Holter Monitor
Event Recorder
ELR / MCT
• ~7-14 days, eventbased monitoring
• Usually a wired
system
• Trans telephonic
• 7- 14-30 days,
wireless monitoring
• Real time reporting
Implantable Cardiac Monitor
Description:
• Well-known, globally
available
• 24-48 hr monitoring
• Up to 3 years of
continuous monitoring
• Report via
interrogation

5. Components of the patch
Piix : Wearable Patch
zLink : Wireless Data Transmitter
•
•
•
Reports generated every 7 days
In case of urgent episodes like sinus
pause, Vtach, etc, reports provided
within 2 hours
Key feature: Patient friendly reports,
easy to use, comfortable for the patient
* PiiX can collect approximately 500 ECGs and must
be replaced at 7.5 days or when the End of Life
indicator appears

6. Event reporting
ECG Collection
Conditions
(PiiX)
ECGs Included in
Clinical Reports
(Reportable Criteria)*
ECGs that ALSO
drive Notification
(Urgent Criteria)*
Ventricular
Automatic
Rate >= 130bpm
Rate <= 40bpm
Pause >= 3sec
Atrial Fibrillation
VTach/VFib
Ventricular Fibrillation
Ventricular Fibrillation
Sustained VTach
Sustained VTach
Non-Sustained VTach
Non-Sustained VTach >= 10 beats
ICD Shock
ICD Shock
PVCs >= 6/min
Not Urgent
Supraventricular
Sinus Tachycardia
Patient-Triggered
Driven by use of the
Patient Trigger Magnet
Not Urgent
Supraventricular Tachycardia
Not Urgent
Chronic AFib/AFlutter
Not Urgent
Paroxysmal AFib/AFlutter
Bradycardia & Conduction Defects
Sinus Bradycardia <= 30bpm
Sinus Bradycardia <= 30bpm
2nd Degree AV Block (Type I)
2nd Degree AV Block (Type I), HR <= 40bpm
2nd Degree AV Block (Type II)
2nd Degree AV Block (Type II)
High Degree Heart Block
High Degree Heart Block
Complete Heart Block
Complete Heart Block
Pause >= 2.0 sec
Pause >= 4.0 sec
* Summary only…details available on the Corventis Monitoring Center Reportable & Urgent Criteria Form.

7. India ELR Pilot
Patch system overview
Piix patch
•
•
•
•
•
•
zLink transmitter
FDA approved, CE mark received
7 day recording, extendable with multiple patches
Non-invasive, wireless, adhesive patch
High patient compliance and comfort
Monitoring center sends urgent & end of use report
Staffed with ECG trained technicians

8. ELR vs. Holter
ELRs have significant advantages over Holter
Holter
ELR
< 10%
Yield (symptom-rhythm
correlation)
40-50%
24-48 hours
Recording length
7-14 days
Wired
Patient Comfort
Wireless
Retrospective analysis
Continuous Remote
monitoring
24hours/day 7days/week
Low – 53% patients remove
(rash, showering, etc)
Patient compliance
High – showering
possible
Doctor involvement
Easy: 1 minute
installation, automatic
activation
Difficult: Apply many
patches, adjustment,
battery recharge
Sources:
•Ambulatory arrhythmia monitoring: choosing the right device. Zimetbaum, Peter and Goldman, Alena. Circulation, Vol. 122, pp.
1629-1636.
•Detection of asymptomatic arrhythmias in unexplained syncope. Krahn, A D, et al., et al. 2004, American Heart Journal, Vol. 148,
pp. 326-32.
•Syncope: Review of Monitoring Modalities. Subbiah, R, et al., et al. 2008, Current Cardiology Reviews, Vol. 4, pp. 41-48.

9. ELR: Proven results
Numerous publications about Nuvant ELR

10. ELR recommendations for use

11. Key points for use of ELR
European Society of Cardiology
Recommendations
• Clinical evaluation is enough to establish a likely mechanism of
syncope in the majority of patients
• Exclude high-risk patients, i.e. those with a clear indication for ICD,
pacemaker, or other treatments independent of a definite diagnosis
of the cause of syncope
• Be aware that the pre-test selection of the patients influences the
subsequent findings. Include patients with a high likelihood of
arrhythmic events
• Include patients with a high probability of recurrence of syncope in a
reasonable time period
• Due to the unpredictability of syncope recurrence, be prepared to
wait for a substantial time before obtaining such a correlation
• Your ideal goal should be to obtain a correlation between ECG
findings and syncopal relapse. Weaker end-points are non-syncopal
arrhythmias.
Source: EuroPace 2009.

12. End of Use Report

13. India ELR Pilot
Case Report
This patient received
an Adapta pacemaker

14. India ELR Pilot
Major results
Overview
• 125 patient pilot w/ Corventis
7day patch
• 5 metro cities (Delhi, Mumbai,
Bangalore, Calcutta, Pune)
• 6 month pilot
Customer value
• Less involvement, time saved – do other procedures
• No expensive capital equipment investments
• Differentiation from peers/competitors
Patient value
• Comfort, ease of use, high quality and reliable
Pilot Results
Diagnostic yield
36%
Patient compliance
98%
ICD or Pacemaker Implants as
a result of ELR monitoring
13

15. India ELR Pilot
Patient Classification and yield
(Stringent criteria)
Enrolled Patients
n = 125
Diagnosis Completed
n = 122
Error (No EOU)
n=1
Diagnostic patients
n = 117
AF Monitoring patients
n=5
Clinically significant
arrhythmia (A)
n = 42
ELR Diagnostic Yield =
Non adherent patents
n=2
Clinically insignificant
arrhythmia/Normal
rhythms (B)
n = 75
A
A+B
= 42/117 =
Takeaways:
• Yield for clinically
significant arrhythmias is
36%
• Use of tip card increases
yield.
36%

16. India ELR Pilot
Patient Classification and yield
(Liberal criteria)
Enrolled Patients
n = 125
Diagnosis Completed
n = 122
Error (No EOU)
n=1
Diagnostic patients
n = 117
AF Monitoring patients
n=5
Clinically significant
arrhythmia (A)
n = 42
Clinically insignificant
arrhythmia (B)
n = 53
Non adherent patents
n=2
Normal rhythms (C)
n = 22
Takeaways:
• Yield for any arrhythmia
is 81%
ELR Diagnostic Yield =
A+B
A+B+C
=
81%

17. Independent studies
High yield and efficacy of ELRs for a variety of arrhythmias
•
ROTHMAN, S. A., et al . (2007), The Diagnosis of Cardiac Arrhythmias: A Prospective Multi-Center Randomized
Study Comparing Mobile Cardiac Outpatient Telemetry Versus Standard Loop Event Monitoring. Journal of
Cardiovascular Electrophysiology.

18. Value of ELRs
Key benefits for you:
•Less involvement for you
– No data is analyzed or monitored, requiring less effort than a Holter
device
– Save time and effort
•Better value, more service to your patients
– Fulltime, long term and continuous monitoring for your patients
•Zero investment, turnkey
– No need to purchase an expensive Holter, no capital equipment
maintenance
•Differentiation from peers with cutting edge technology
– These ELRs represent the latest technology, far ahead and far more