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BIOTRONIK Cardiac Rhythm Management November 2011 Lumax 540 VR-T DX Unique protection.

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Presentation on theme: "BIOTRONIK Cardiac Rhythm Management November 2011 Lumax 540 VR-T DX Unique protection."— Presentation transcript:

1 BIOTRONIK Cardiac Rhythm Management November 2011 Lumax 540 VR-T DX Unique protection

2 Agenda Lumax 540 VR-T DX and Linox smart S DX System description Clinical Benefits

3 3 The worlds only single-chamber ICD system with complete atrial diagnostics

4 4 Lumax VR-T DX works with the specially designed Linox smart S DX ICD lead. Atrial signals are sensed by the floating atrial dipole of the Linox smart S DX ICD lead A modified atrial input stage of the Lumax 540 VR-T DX device amplifies the atrial signals. The atrial information ensures accurate sensing and provides unique protection for single-chamber ICD patients. The Lumax 540 VR-T DX ICD and the Linox smart S DX lead can be implanted like a standard single-chamber ICD system without any additional effort.

5 5 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

6 6 Linox smart 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 Linox smart ICD Lead family High performance lead with proven reliability 7.8 F 0.28 mm Cross section Linox smart S DX

7 7 Linox smart 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 Linox smart ICD Lead family 150 / 170 mm 7.8 F 0.28 mm Cross section Linox smart S DX High performance lead with proven reliability

8 8 Linox smart S DX Master Study Results easy or very easy lead implantation due to proven ICD lead technology 87% Excellent Lead Handling Lead Implantation Assessment n=116 * Linox smart S DX Master Study; data on file

9 9 (n=119) (n=116) (n=104) (n=101) (n=85) (n=119) (n=113) (n=103) (n=101) (n=85) * Linox smart S DX Master Study; data on file Excellent Electrical Performance Linox smart S DX Master Study Results

10 10 (n=115) (n=120) (n=100) (n=100) (n=104) (n=116) (n=120) (n=100) (n=100) (n=104) * Linox smart S DX Master Study; data on file Excellent Electrical Performance Linox smart S DX Master Study Results

11 11 Linox smart S DX Master Study Results mean atrial sensing amplitudes due to unique DX signal amplification >5mV Excellent Electrical Performance Mean Atrial Sensing Amplitude * Linox smart S DX Master Study; data on file

12 12 Linox smart 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 * Linox smart S DX Master Study; data on file

13 13 Single-chamber ICD system with complete atrial diagnostics The extended Lumax 540 Portfolio Lumax 540 VR-T DX Linox smart S DX Single-chamber ICD Lumax 540 VR-T Dual-chamber ICDCRT-D Lumax 540 DR-TLumax 540 HF-T Lumax 540 VR-T DX adds to the premium Lumax 540 Series

14 Agenda Lumax 540 VR-T DX and Linox smart S DX System description Clinical Benefits

15 15 Lumax 540 VR-T DX and Linox smart S DX The worlds only single-chamber ICD system with complete atrial diagnostics! Compared to current standard single-chamber ICDs, Lumax DX enables unique patient protection by providing: enhanced arrhythmia diagnosis with full featured 3-channel IEGM including RA, RV and far-field safe shock reduction with clinically proven SMART Detection ® algorithm optimized AF management with complete atrial diagnostics and BIOTRONIK Home Monitoring ®

16 16 safe shock reduction optimized AF management enhanced arrhythmia diagnosis Lumax 540 VR-T DX and Linox smart S DX The worlds only single-chamber ICD system with complete atrial diagnostics!

17 17 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

18 18 The additional information on atrial rhythm give clear evidence about the origin of the tachycardia enhanced Unique DX single-chamber ICD system provides atrial AND ventricular rhythm information ventricle far-field atrium

19 19 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, Additional atrial electrograms enable enhanced arrhythmia diagnosis

20 20 Lumax 540 VR-T DX Clinical 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 Linox smart 65/17 S DX implanted on April 01, 2010

21 21 Lumax 540 VR-T DX Clinical example Detection of sudden onset arrhythmia on July 7, 2010 Far-field Atrium Ventricle

22 22 Lumax 540 VR-T DX Clinical example Far-field Ventricle Termination of arrhythmia by ATP -> classification as VT correct?

23 23 Lumax 540 VR-T DX Clinical example Start of AV node reentry tachycardia (July 7, 2010) Far-field Atrium Ventricle

24 24 Lumax 540 VR-T DX Clinical example Detection as VT Delivered ATP terminated ongoing arrhythmia

25 25 safe shock reduction optimized AF management enhanced arrhythmia diagnosis Lumax 540 VR-T DX and Linox smart S DX The worlds only single-chamber ICD system with complete atrial diagnostics!

26 26 safe Atrial 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

27 27 safe Clinically proven dual-chamber SMART Detection ® algorithm provides enhanced SVT discrimination based on atrial and ventricular rhythm information Detection SVT SMART Detection ® 100% sensitivity 94% specificity Available for VT1 and VT2 zone Available for detection and redetection Informative episode details Traceable marker annotations Unique DX single-chamber ICD allows enhanced SVT discrimination for safe shock reduction

28 28 safe Atrial 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

29 29 safe Atrial and ventricular sensing for enhanced SVT discrimination IEGM-Online HD ® transmission via BIOTRONIK Home Monitoring ® allows timely remote evaluation of therapy appropriateness

30 30 safe shock reduction optimized AF management enhanced arrhythmia diagnosis unique protection Lumax 540 VR-T DX and Linox smart S DX The worlds only single-chamber ICD system with complete atrial diagnostics!

31 31 >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 ** 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

32 32 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 Detection AMon

33 33 Lumax 540 VR-T DX Clinical examples 47 years old female Prophylactic indication Hypertrophic obstructive cardiomyopathy EF 60%, NYHA II, no history of AF Lumax 540 VR-T DX with Linox smart S DX 65/17 implanted on June 4, 2010 R amplitude ~12mV, P amplitudes between 2-5 mV Case 1: Early detection of AF

34 34 Lumax 540 VR-T DX Clinical examples Start of atrial fibrillation on July 12, 2010, 22:44h Detection in AF monitoring zone Case 1: Early detection of AF

35 35 Lumax 540 VR-T DX Clinical 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

36 36 Lumax 540 VR-T DX Clinical 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

37 37 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

38 38 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]

39 39 safe shock reduction optimized AF management enhanced arrhythmia diagnosis unique protection Lumax 540 VR-T DX and Linox smart S DX The worlds only single-chamber ICD system with complete atrial diagnostics!


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