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BIOTRONIK
Cardiac Rhythm Management
November 2011
Lumax 540 VR-T DX
Unique protection
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Agenda
Lumax 540 VR-T DX and Linoxsmart S DX
System description
Clinical Benefits
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The world’s only single-chamber ICD system with complete atrial diagnostics
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Lumax 540 VR-T DX
Additional atrial sensing channel optimized for use with floating sensing electrodes
3-channel IEGM incl. RA, RV and far-field
SMART Detection®
Complete AF and HF diagnostics
BIOTRONIK Home Monitoring®
9.4 years longevity*
Unique premium single-chamber ICD with atrial sensing
* RV 2.5 V/0.4 ms; 60 ppm; 700 Ω; RV 15 % pacing; 4 maximum energy shocks/year; Home Monitoring ON; diagnostics ON
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Linoxsmart S DX
Pentapolar 7.8 F single coil ICD lead with active fixation
Floating dipole for atrial sensing
Easy handling, no special implant technique
Based on proven Linoxsmart ICD Lead family
High performance lead with proven reliability
7.8 F
0.28 mm
Cross section Linoxsmart S DX
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Linoxsmart S DX Master Study Results
easy or very easy lead implantation
due to proven ICD lead technology
87%
Excellent Lead Handling
Lead Implantation Assessment
49%
38%
10%3%
very easy
easy
moderate difficult
difficult
very easy
easy
moderate difficult
difficult
n=116
* Linoxsmart S DX Master Study; data on file
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0
1
2
3
4
5
6
7
8
9
10
I mplant PHD 1-monthFU
3-monthFU
6-monthFU
P-w
av
e A
mp
lidu
te [
mV
]
Linoxsmart S DX Master Study Results
mean atrial sensing amplitudes
due to unique DX signal amplification
>5mV
Excellent Electrical Performance
Mean Atrial Sensing Amplitude
* Linoxsmart S DX Master Study; data on file
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50
60
70
80
90
100
PHD 1-month FU 3-month FU 6-month FU
App
ropr
iate
Atr
ial S
ensi
ng [%
]
Dorsal lying position Sitting, palms together Sitting, Jendrassik's m.
Linoxsmart S DX Master Study Results
Rate of appropriate atrial sensing (primary endpoint)
appropriate atrial sensing
due to specially adapted DX input stage
93.8%
Reliable Atrial Sensing
* Linoxsmart S DX Master Study; data on file
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Single-chamber ICD system with complete atrial
diagnostics
The extended Lumax 540 Portfolio
Lumax 540 VR-T DXLinoxsmart S DX
Single-chamber ICD
Lumax 540 VR-TDual-chamber ICD CRT-D
Lumax 540 DR-T Lumax 540 HF-T
Lumax 540 VR-T DX adds to the premium Lumax 540 Series
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Agenda
Lumax 540 VR-T DX and Linoxsmart S DX
System description
Clinical Benefits
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safe shock reduction
optimized AF management
enhanced arrhythmia diagnosis
Lumax 540 VR-T DX and Linoxsmart S DX
The world’s only single-chamber ICD system with complete atrial diagnostics!
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In many cases ventricular electrogram alone does not allow accurate diagnosis at high level of confidence
VT or
SVT ?
Conventional single-chamber ICD systems provide only ventricular rhythm information
ventricle
far-field
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The additional information on atrial rhythm give clear evidence about the origin of the tachycardia
enhancedUnique DX single-chamber ICD system provides atrial AND ventricular rhythm information
ventricle
far-field
atrium
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Availability of atrial electrograms in addition to ventricular electrograms significantly improves accuracy of arrhythmia diagnosis
Diagnostic accuracy with single versus dual chamber electrograms*
* Kim, MH. et al., Diagnostic value of single versus dual chamber electrograms recorded from an implantable defibrillator. J.Interv.Card Electrophysiol. 9 (1):49-53, 2003.
Additional atrial electrograms enable enhanced arrhythmia diagnosis
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Lumax 540 VR-T DXClinical example
73 year old male
Secondary prevention, no history of AF
CAD, hypertension, diabetes mellitus
EF 47%, NYHA II
Lumax 540 VR-T DX with Linoxsmart 65/17 S DX implanted on April 01, 2010
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Lumax 540 VR-T DXClinical example
Detection of sudden onset arrhythmia on July 7, 2010
Far-field
Atrium
Ventricle
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Lumax 540 VR-T DXClinical example
Far-field
Ventricle
Termination of arrhythmia by ATP -> classification as VT correct?
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Lumax 540 VR-T DXClinical example
Start of AV node reentry tachycardia (July 7, 2010)
Far-field
Atrium
Ventricle
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Lumax 540 VR-T DXClinical example
Detection as VT
Delivered ATP terminated ongoing arrhythmia
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safe shock reduction
optimized AF management
enhanced arrhythmia diagnosis
Lumax 540 VR-T DX and Linoxsmart S DX
The world’s only single-chamber ICD system with complete atrial diagnostics!
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safeAtrial arrhythmias increase the risk for ICD patients to receive inappropriate shocks
76% of inappropriate shocks are caused by AF and SVT (MADIT II)*
* Daubert, JP et al., Inappropriate implantable cardioverter-defibrillator shocks in MADIT II, JACC 2008, 51: 1357–65
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safe
Clinically proven dual-chamber SMART Detection® algorithm provides enhanced SVT discrimination based on atrial and ventricular rhythm information
Det
ectio
n S
VT
SMART Detection®
100% sensitivity
94% specificity
Available for VT1 and VT2 zone
Available for detection andredetection
Informative episode details
Traceable marker annotations
Unique DX single-chamber ICD allows enhanced SVT discrimination for safe shock reduction
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safeAtrial and ventricular sensing for enhanced SVT discrimination
SMART Detection® correctly identifies atrial arrhythmia and withholds inappropriate therapy
SMART episode details
Duration: 1 min 17 sec
Classification: SVT
Measured onset: 58%,
Measured stability: 2%
Delivered ATP: 0
Delivered shocks: 0
SMART details: Aflut
PP<RR,
RR stable,
N:1 multiplicity
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safeAtrial and ventricular sensing for enhanced SVT discrimination
IEGM-Online HD® transmission via BIOTRONIK Home Monitoring® allows timely remote evaluation of therapy appropriateness
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safe shock reduction
optimized AF management
enhanced arrhythmia diagnosis
uniqueprotection
Lumax 540 VR-T DX and Linoxsmart S DX
The world’s only single-chamber ICD system with complete atrial diagnostics!
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>13%of all ICD and
pacemaker patients have previously
unknown AF*
~25%is the lifetime risk of
developing AF in those who have reached the
age of 40**
Atrial fibrillation is most common arrhythmia with high incidence in cardiac device patients
Many cardiac device patients without history of atrial fibrillation show new or yet undiagnosed AF after implantation
* Ricci, RP. et al., Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace. 2009.
** Camm, AJ. et al., Guidelines for the management of AF: the Task Force for the Management of AF of the European Society of Cardiology (ESC). Europace. 2010
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optimized Early detection of atrial fibrillation allows reduction of associated risks
With AF monitoring zone and IEGM-Online HD® the unique Lumax DX enables early detection of silent AF in a single-chamber ICD system
Det
ectio
n A
Mon
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Lumax 540 VR-T DXClinical examples
47 years old female
Prophylactic indication
Hypertrophic obstructive cardiomyopathy
EF 60%, NYHA II, no history of AF
Lumax 540 VR-T DX with Linoxsmart S DX 65/17 implanted on June 4, 2010
R amplitude ~12mV, P amplitudes between 2-5 mV
Case 1: Early detection of AF
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Lumax 540 VR-T DXClinical examples
Start of atrial fibrillation on July 12, 2010, 22:44h
Detection in AF monitoring zone
Case 1: Early detection of AF
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Lumax 540 VR-T DXClinical examples
IEGM reveals fast conduction into ventricle (up to 180 bpm)
Spontaneous termination on July 13, 2011, 12:52h (>14h duration)
Case 1: Early detection of AF
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Lumax 540 VR-T DXClinical examples
AF statistics reveals both slow and fast conduction into ventricle (up to 20% pacing during night, mean ven. heart up to 130 bpm)
Case 1: Early detection of AF
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Anticoagulation necessary?
Risk for inappropriate therapy?
AF therapy effective?
Change of heart failure status?
In-office follow-up necessary?
optimized Lumax DX provide complete AF and HF diagnostics in a single-chamber ICD
Automatic transmission of relevant diagnostic data via BIOTRONIK Home Monitoring® allows immediate and remote assessment of clinical implications
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Monitor therapy successEvaluate AF
Change medication
Lumax DX and BIOTRONIK Home Monitoring® enable optimized AF management
Daily data transmission of complete AF diagnostics via BIOTRONIK Home Monitoring® allows remote monitoring of therapy success
Atrial Burden[% of day]
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safe shock reduction
optimized AF management
enhanced arrhythmia diagnosis
uniqueprotection
Lumax 540 VR-T DX and Linoxsmart S DX
The world’s only single-chamber ICD system with complete atrial diagnostics!