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1. 2 Up to 21% of ICD Patients Receive Inappropriate Shocks 1-4 1 Kadish A, Dyer A, Daubert JP, et al, for the Defibrillators in Non-Ischemic Cardiomyopathy.

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Presentation on theme: "1. 2 Up to 21% of ICD Patients Receive Inappropriate Shocks 1-4 1 Kadish A, Dyer A, Daubert JP, et al, for the Defibrillators in Non-Ischemic Cardiomyopathy."— Presentation transcript:

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2 2 Up to 21% of ICD Patients Receive Inappropriate Shocks Kadish A, Dyer A, Daubert JP, et al, for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. May 20, 2004;350(21): Daubert JP, Zareba W, Cannom DS, et al, for the MADIT II Investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. April 8, 2008;51(14): Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359(10): Mitka M. New study supports lifesaving benefits of implantable defibrillation devices. JAMA. July 8, 2009;302(2):

3 3 To Reduce Pain and Anxiety and Increase Device Acceptance 1 To Reduce Healthcare Burden and Improve Patient Quality of Life 1 Why Avoiding Shocks Is Important Avoiding Shocks May Improve Survival/Heart Failure 2 1 Wathen MS, DeGroot PJ, Sweeney MO, et al, for the PainFREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. October 26, 2004;110(17): Sweeney MO, et al. Differences in effects of electrical therapy type on health care utilization in the MVP ICD Trial. HRS, 2010.

4 4 20 Years of Leadership in Shock Reduction It Is Time to Redefine the ICD 1 Wathen M. Implantable cardioverter defibrillator shock reduction using new antitachycardia pacing therapies. Am Heart J. April 2007;153(4 Suppl):44-52.

5 5 With Protecta ™ XT 98% of Patients are Free of Inappropriate Shocks at 1 Year 1 and 92% at 5 Years 1 1 Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125).

6 6 SmartShock ™ Technology Dramatically Reduces the Incidence of Inappropriate Shocks While Maintaining Sensitivity 1,2 1 Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125). 2 Protecta Clinical Study, Medtronic data on file. 3 Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359(10): t

7 7 SmartShock ™ Technology Includes 6 Exclusive Algorithms that Discriminate True Lethal Arrhythmias from Other Arrhythmic and Nonarrhythmic Events 1 1 Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125). 2 Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359(10): See Protecta XT CRT-D, DR, and VR Clinician Manuals for technical details

8 8 R/T VSVS VSVS VSVS VSVS VSVS VSVS VSVS Vtip-Vring EGM Sense EGM d/dt(Sense EGM) R T R T New approach to T-wave oversensing: – Frequency analysis versus manual sensitivity adjustment Fully automatic Does not require an initial shock for T-wave oversensing No compromise on VF detection sensitivity Sense EGM: In current devices, signal is filtered to isolate R-waves. May oversense T-waves. In Protecta ™, differentiation of sense EGM enlarges the ratio of R-to-T-wave amplitudes, enabling R-T pattern recognition. First and Only T-wave Discrimination Identify T-wave oversensing and provide ability to withhold therapy delivery without compromising VT/VF detection sensitivity

9 9 Lead Integrity Alert Provides advanced warning for lead fracture and extends the VF detection time Compares far-field cardiac activity to sensed event Lead Noise Discriminator + Alert Identifies oversensing due to noise artifacts and provides ability to withhold therapy delivery – No compromise of VT/VF detection sensitivity – Notifies clinician to potential lead noise Lead Integrity Suite Combines 2 algorithms that detect, alert, and withhold inappropriate therapy for lead failure,

10 10 Discrimination in the VF zone (nominal) SVT Limit = 260 ms VF High-Rate Timeout PR Logic Effectively discriminates Sinus Tach and most AF/A Flutter PR Logic ® + Wavelet Combines morphology and A-V pattern recognition to better discriminate against all types of SVTs – even the very fast ones + Wavelet Uses EGM morphology to improve SVT discrimination (i.e., conducted AF and sudden onset SVT)

11 11 Confirmation + Better identifies that a tachycardia has been terminated with ATP or spontaneously during the charge and aborts the shock Avoids inappropriate shocks for single PVCs or single fast events at the end of the charge CONFIRMATION Confirmation + Modify determination of persisting arrhythmia based on intrinsic detected rate versus programmed lower therapy rate (sync interval) Confirmation now available after ATP During Charging™ sequence

12 12 1 Wathen MS, et al. PainFREE Rx II Study. Circulation. 2004;110: Ahmad M, et al. Patients’ attitudes toward ICD shocks. PACE. June 2000;23(6): Sears, Todaro, Saia, Sotile & Conti.Clinical Cardiology, 22, , Sears SE, et al. Clin Cardiol. 2003;26: The Antiarrhythmics Versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventriculr arrhythmias. N Engl J Med 1997; 337: For some patients, anxiety related to shocks may disrupt a normal active life 3,4 Some studies have demonstrated that experiencing a shock may cause temporary reductions in patients’ quality of life. 5 Reducing Shocks Has Been Shown to Improve ICD Patients’ QOL and Increase ICD Acceptance 1,2

13 13 OptiVol ® 2.0 Fluid Status Monitoring Maximise accuracy in predicting worsening heart failure. 1 OptiVol detects 3 times more future events than weight monitoring alone 1 OptiVol 2.0 reduces unexplained detections by > 40% – more accurate identification of higher risk patients 2 1 Abraham WT, Compton S, Haas G, et al. Superior performance of intrathoracic impedance-derived fluid index versus daily weight monitoring in heart failure patients: Results of the Fluid Accumulation Status Trial (FAST). J Card Fail. November 2009;15(9): Hettrick DA, Sarkar S, Koehler J, et al. Improved algorithm to detect fluid accumulation via intrathoracic impedance monitoring in patients with implantable devices. Poster. ACC

14 14 It’s the Office Visit Without the Office Visit Complete Capture Management ™ + Medtronic CareLink ® remote monitoring system = fast and easy remote device follow-up. 1 Battery check Unique threshold measurements and output adjustments (all chambers) Sensing adjustments beat-to-beat Impedance monitoring HF patient diagnostics and monitoring 1 Analysis from the German TEAM-Study, 2006 Medtronic Internal Data.

15 15 Protecta ™ XT Portfolio *Volume with connector holes unplugged. **Beginning of service. ***Recommended replacement time.

16 16 SmartShock Algorithms & Optivol 2.0 Technical Details, Case Studies, & Programming

17 17 TWave Discrimination

18 18 TWave Discrimination Operating Principles 1. Discrimination of R-waves and T-waves through differential filtering of the sensing signal Differential filtered R-wave Differential filtered T-wave 2. Determining the R-wave and T-wave discrimination threshold compute

19 19 3. Re-evaluation of R-waves and T-waves 4. Applying the discrimination criteria to R-waves and T-waves a. R-waves (filtered EGM) meets amplitude stability b. T-waves (filtered EGM) meets amplitude stability c. R-T pair meet a interval stability TWave Discrimination Algorithm

20 20 5.Applying the discrimination critera to R-waves and T-waves d. The R/T ratio from the filtered EGM must be less than the R/T ratio differential EGM. For example: R/T < 75%*R/T diff 3 < 0.75 x 8 = 3 < 6 e. The R-T pairs must meet a pattern criterion that would indicate alternating R- and T-waves. TWave Discrimination Algorithm

21 21 f. The “corrected” R-R interval is calculated. TWave Discrimination Algorithm

22 22 As long as 4 of the last 20 sets meet the T-wave criteria, oversensing is detected. This means that the determination can happen after evaluating four sets as long as all identify T-wave oversensing. TWave Discrimination Algorithm

23 23 Uses both signal frequency content and pattern analysis to distinguish R- T pattern Once the device senses a signal, the frequency content is used to determine whether the VS is a T-wave or an R-wave. The pattern information assures the device does not withhold for VF. Note: This algorithm does not eliminate T-wave oversensing. It only attempts to withhold shocks for T-wave oversensing. RRRR TTT TWave Discrimination Review

24 24 User Programmability On, Off Nominally On T-wave oversensing Programming TWave Discrimination Programming

25 25 VOS episodes since last session Observations lists T-wave oversensing episodes TWave Discrimination Diagnostics – Quick Look II

26 26 1. Marker Channel shows each ventricular event is counted twice. 2. TW annotated upon initial detection of T-wave oversensing. 3. TW annotated to indicate T-wave oversensing on a per-event basis. TWave Discrimination Diagnostics – Episode Storage

27 27 How Does the Algorithm Work? T-wave oversensing Risk of shock if detection is not withheld for T-wave oversensing! The algorithm is withholding the therapy

28 28 Lead Integrity Suite RV Lead Noise Discrimination & RV Lead Integrity Alert

29 29 Lead Integrity Suite RV Lead Noise Discrimination & RV Lead Integrity Alert

30 30 Concept Lead noise oversensing is typically isolated to the near field sensing signal The far field EGM is analyzed to determine if the event sensed on the near field EGM is noise or a true ventricular event RV Lead Noise Discrimination

31 31 Algorithm 1. Amplitude is measured using far-field EGM a. Processing of the far-field EGM to determine peak-to peak amplitude 2. Evaluation of Amplitude (must meet two criteria) a. Average of the two smallest values is < 1mV b. Average of two smallest peak-to-peak amplitudes is <1/6 the maximum amplitude RV Lead Noise Discrimination

32 32 The algorithm uses a counter Each set of 12 peak-to-peak amplitudes are evaluated using a rolling window Once NID is reached, if 3 out of the last 12 sets are classified as noise, detection is withheld RV Lead Noise Discrimination Algorithm

33 33 Programming On, On+Timeout, or Off Nominal is On+Timeout for 0.75 min (45 seconds) Uses EGM2 (same as Wavelet) Nominal is Can-to-RVcoil RV Lead Noise Discrimination

34 34 Programming User programmable ON/OFF Interlocked with algorithm RV Lead Noise Discrimination Alert

35 35 Diagnostics: Quick Look II RV Lead Noise Discrimination Alert

36 36 Diagnostics: Episode Storage RV Lead Noise Discrimination Alert

37 37 How Does the Algorithm Work? Noise Risk of shock if detection is not withheld for Lead Noise! The algorithm is withholding detection and therapy

38 38 Lead Integrity Suite RV Lead Noise Discrimination & RV Lead Integrity Alert

39 39 Programming RV Lead Integrity Alert User Programmable On/Off

40 40 Diagnostics High Rate-NS episodes (New) With 1 High Rate-NS episode – the device automatically adjusts Pre- arrhythmia EGM parameter to ON – 1 month If Lead Impedance and SIC criteria are met, the device also changes the criteria for storing High Rate-NS episodes, allowing a High Rate-NS episode with EGM data to be recorded if a single ventricular interval < 220 occurs RV Lead Integrity Alert

41 41 Diagnostics Alerts and Observations for RV Lead Integrity warning RV Lead Integrity Alert

42 42 PR Logic & Wavelet

43 43 PR Logic ® + Wavelet Improved SVT Discrimination

44 44 Wavelet Auto Template Collection: Excludes templates where atrial pacing occurs before a ventricular sense to avoid template corruption Auto Template Collection shipped OFF in CRT-D Manual collection recommended Wavelet EGM: EGM 2 source shipped Can to RV-coil nominally (same far-field vector used in VR devices) When PR Logic ® is OFF and Wavelet is ON, Wavelet operates the same as in VR devices Wavelet in Dual and Triple Chamber Devices

45 45 How Does the Algorithm Work? SVT Risk of shock if the SVT is not detected! The algorithm is withholding detection and therapy

46 46 SVT Limit Nominal Change and VF High-Rate Timeout ItemConsulta ® /Secura ® DefinitionProtecta ™ Definition SVT Limit Nominal320 ms (VFDI 320 ms Nominal) 260 ms (VFDI 320 ms Nominal) High-Rate TimeoutApplies to VT and VF Zone with the same time limit Nominally OFF Unchanged VF High-Rate TimeoutNot AvailableApplies only to the VF Zone Nominally ON in VR (45 seconds) Nominally OFF in DR/CRT-D VF therapy changed from ATP Before Charging ® to ATP During Charging ™ after timeout

47 47 Programming SVT Limit change is within current programmable range VF High-Rate Timeout physician programmable High-Rate timeout that applies only to the VF zone Still have high-rate timeout that applies to all zones PR Logic + Wavelet

48 48 Confirmation +

49 49 Case Study: Operation in EnTrust Current Confirmation Interval = TDI + 60 ms 420 ms = 360 ms + 60 ms Reconfirm Sync Shock Confirmation +

50 50 Abort Confirmation Interval = Rhythm Cycle length + 60 ms 310 ms = 250 ms + 60 ms VT zone programmed ON at 360 ms (Old CI = 420 ms) Rhythm cycle length = 250 ms Shock would be aborted with Protecta Confirmation Interval = 250 ms + 60 = 310 ms Intervals after ATP During Charging used in confirmation Case Study: Operation in Protecta Confirmation +

51 51 Concept A stability calculation is used to classify regular and irregular: If the difference between the minimum and maximum of the intervals used for the Ventricular average is less than or equal to 50 ms, the rhythm is deemed regular. If the difference between the minimum and maximum of the intervals used for the Ventricular average is greater than 50 ms, the rhythm is deemed irregular. If Rhythm Based Confirmation Interval is in VF zone and rhythm is irregular: Confirmation interval = FDI + 60 ms Confirmation +

52 52 Concept These changes allow confirmation to apply to more scenarios: VF Rx1 can abort more than once per episode Confirmation and delivery algorithm are the same independent of ATP During Charging Confirmation +

53 53 Concept ItemCurrent DefinitionProtecta Definition Confirmation During Redetection Therapy during redetection is not confirmed. If the initial therapy aborts and the device redetects, Rx1 is confirmed during redetection Rx2-Rx6 are not confirmed during redetection Confirmation During Charging with ATP During the Charge Not Available Only intervals after charge end are considered. Available Uses intervals following the delivery of ATP During Charging to apply to the confirmation process. Confirmation +

54 54 Programming Programmable ON/OFF Nominally ON No new diagnostic data Confirmation +

55 55 How Does the Algorithm Work? ATP During Charging Aborted

56 56 Optivol 2.0

57 57 ChangeDescription of ChangeRationale/Benefit of Change 1. Reference Slope Adjustment Reference Impedance increases faster and decreases slower for first 100 days after initialization Enhanced ability to track impedance changes, thus improve sensitivity, after reference initialization 2. VariabilityAccumulate Fluid Index less in patients with higher day to day variability Reduce amount of accumulation in patients with high variability to reduce false detection 3. Finite MemoryAccumulate Fluid Index over a finite period of time (30 days) Accumulate over the recent past to make fluid index more representative of patient’s current condition No changes to daily impedance measurement OptiVol 2.0 Algorithm Changes

58 58 Reference Initialization Reference Impedance slopes up faster and slopes down slower for first 100 days after initialization OptiVol 1.0 OptiVol 2.0 Daily Impedance Fluid Index Daily Impedance Reference Impedance OptiVol 2.0 OptiVol 1.0 Days after initialization Reference changes faster after initialization OptiVol 2.0 Algorithm Changes: Slope

59 59 Attenuates accumulation of the Fluid Index based on day to day variation in daily impedance, from day 5 through 90 of the fluid index event Behaves same as OptiVol 1.0 if the Fluid Index Event lasts longer than 90 days days Impedance Fluid Index Threshold Variability Fraction Accumulation Duration OptiVol 2.0 Fluid Index is accumulatio n of shaded portion Reference Accumulate Fluid Index less aggressively in patients with higher day to day variability OptiVol 2.0 Algorithm Changes: Variability

60 60 Accumulate only over last 30 days Impedance Reference Fluid Index Impedance Reference Fluid Index Optivol 1.0Optivol 2.0 Threshold OptiVol 2.0 Algorithm Changes: Finite Memory

61 61 OptiVol 2.0 Case Study

62 62 Differences in Behavior to the User OptiVol ® 1.0/1.1OptiVol 2.0 Fluid IndexCan increase or reset to 0Can increase, remain the same, decrease, or reset to 0 ThresholdReprogramming threshold to a value higher than the fluid index terminates the OptiVol event Reprogramming threshold during an OptiVol event has no effect on current event Adjust Reference Impedance Cannot reset the Reference impedance Available to reset the Reference impedance

63 63 References: 1 Kadish A, Dyer A, Daubert JP, et al, for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. May 20, 2004;350(21): Daubert JP, Zareba W, Cannom DS, et al, for the MADIT II Investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. April 8, 2008;51(14): Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. September 4, 2008;359(10): Mitka M. New study supports lifesaving benefits of implantable defibrillation devices. JAMA. July 8, 2009;302(2): Wathen MS, DeGroot PJ, Sweeney MO, et al, for the PainFREE Rx II Investigators. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. October 26, 2004;110(17): Sweeney MO, Sherfesee L, DeGroot PJ, Wathen MS, Wilkoff BL. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverterdefibrillator patients. Heart Rhythm. March 2010;7(3): Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125). 8 Protecta Clinical Study, Medtronic data on file. 9 Sweeney MO, et al. Differences in effects of electrical therapy type on health care utilization in the MVP ICD Trial. HRS, 2010.

64 64 Brief Statement: Protecta XT CRT-D, DR, VR ICDs Indications: The Protecta XT CRT-D system is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- threatening ventricular arrhythmias and for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. The Protecta DR and VR system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional class II/III heart failure. The Protecta DR is also is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. Additional Protecta XT DR System Notes: ● The ICD features of the device function the same as other approved Medtronic market-released ICDs. ● Due to the addition of the OptiVol diagnostic feature, the device indications are limited to the NYHA functional class II/III heart failure patients who are indicated for an ICD. ● The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure. ● The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. ● The effectiveness of high- frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied. ● The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to 18.2% in the AF-only patient population studied. Additional Protecta XT VR System Notes: ● The ICD features of the device function the same as other approved Medtronic market-released ICDs. ● Due to the addition of the OptiVol diagnostic feature, the device indications are limited to the NYHA functional class II/III heart failure patients who are indicated for an ICD. ● The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure. Contraindications: The Protecta XT CRT-D, DR and VR system is contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis. The device is contraindicated for patients who have a unipolar pacemaker implanted. The device is contraindicated for patients with incessant VT or VF. Contraindications specific to Protecta XT CRT-D and DR: The device is contraindicated for patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. Contraindications specific to Protecta XT VR: The device is contraindicated for patients whose primary disorder is atrial tachyarrhythmia. Warnings and Precautions: Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device. Additionally, for CRT-ICDs, certain programming and device operations may not provide cardiac resynchronization. Potential Complications: Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult Medtronic’s website at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

65 65 World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN USA Tel: (763) Fax: (763) Medtronic USA, Inc. Toll-free: 1 (800) (24-hour technical support for physicians and medical professionals) UC EN © Medtronic Minneapolis, MN. All Rights Reserved. Printed in USA.


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