Innehållet i denna fil får endast användas för privat bruk. Kopiering eller annan användning kräver tillstånd från Nils Edvardsson

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1 Innehållet i denna fil får endast användas för privat bruk. Kopiering eller annan användning kräver tillstånd från Nils Edvardsson

2 Nytt koncept för långtidsmonitorering av hjärtrytm Nils Edvardsson Göteborg

3 Miniaturized Reveal LINQ ICM Device Breakthrough Technology 3-year monitoring remote management* 87% smaller and wireless transmissions * Under the following usage scenarios: Average of 1 auto-detected episode per day Average of 1 patient-activated episode per month Less than or equal to 6 months shelf life (between device manufacture and insertion) Note: Under maximum shelf storage time (12 months),longevity is reduced by approximately 3 months. 3

4 Reveal LINQ ICM System Medtronic CareLink 2090 Programmer CareLink Network Insertion Tools Nightly Wireless Summary Reveal LINQ ICM Manual Interrogation Reports Reveal Patient Assistant MyCareLink Patient Monitor All patient and clinical data are fictitious and for demonstration purposes only. 4

5 Reasons for Monitoring

6 Syncope

7 Classifications of syncope according to etiology and mechanism 60% 15% 15% Virtually any of the etiologies on the left can result in any of the arrhytyhmic outcomes indicated on the right. There remains a need to make an initial etiological assessment leading to risk stratification. For those not at high risk the mechanistic method must now be considered optimal. 10% undetermined Adapted from Brignole and Hamdan 2012 Sutton R, Progr Cardiovasc Dis 2013

8 ILRs in neurally mediated syncope ISSUE-3 = recurrence Findings consistent NMS not confirmed with NMS in 87% in 25 pts (13%) Tilt table test was unable to discriminate between presumed NMS and non-nms ILR findings showed other than NMS in a small, although non-negligible, number of patients older than 40 years Ungar et al., Heart 2013

9 Percent of subjects with an event ILRs in unexplained syncope Diagnostic yield over time the longer the better PICTURE 26% 36% Number at risk Days after implant Edvardsson et al., Europace 2010 Furukawa et al., JCE 2011 Reveal LINQ battery longevity 3 years (depending on programming)

10 Etiology of syncope after discharge and after work-up 600 pts discharged with a primary diagnosis of syncope, mean follow-up 2.5 years. Retrospective study Mean no of tests was 4.7. Diagnostic yield of tests was generally low (but TT 47%). ILRs were used in 38 pts (7%) with a diagnostic yield of 7 pts (18%). In the subset of pts with unknown etiology at discharge, the diagnostic yield was 50% (6 of 12 pts) Huth Ruwald et al., J Clin Med Res 2013

11 Reveal LINQ ICM Features Leveraging Reveal XT ICM New Features 1.2 cc 59 min ECG Storage Wireless one-way Telemetry Titanium nitride coated electrodes to improve sensing Reduces wandering baseline Designed to reduce loss of contact Enhanced atrial arrhythmia detection Nominal values customized by patient type Incision & insertion tools designed for a minimally invasive insertion Medtronic CareAlert Notifications Leveraging Reveal XT ICM Capabilities 3 year longevity* MR-Conditional Daily trended diagnostics via Cardiac Compass Reveal XT ICM Today Key Benefits Diagnose arrhythmias that occur infrequently Monitor patients ongoing responses to treatments Timely data access via CareLink Network. Patient Focus Syncope / Fainting Pre/Post AF ablation Secondary stroke prevention Primary stroke prevention Key Features Records AF, VT, FVT, Bradycardia, Asystole events MR-Conditional Three year longevity * Under the following usage scenarios: Average of 1 auto-detected episode per day Average of 1 patient-activated episode per month Less than or equal to 6 months shelf life (between device manufacture and insertion) Note: Under maximum shelf storage time (12 months),longevity is reduced by approximately 3 months. 11

12 Reveal XT ICM vs. Reveal LINQ ICM Parameter Reveal XT ICM Reveal LINQ ICM Longevity 3 years *3 years Electrode Spacing 41 mm 38 mm Volume 9 cc 1.2 cc Mass 15 g 2.5 g Episode Storage 49.5 min 59 min Reveal Patient Assistant MR-Conditional Symptom and Query button 1.5 and 3.0 T; wait 6 weeks post implant; 30 minute limit over chest area Query button removed 6 week restriction removed Bi-Directional Telemetry Telemetry B Same * Under the following usage scenarios: Average of 1 auto-detected episode per day Average of 1 patient-activated episode per month Less than or equal to 6 months shelf life (between device manufacture and insertion) Note: Under maximum shelf storage time (12 months), longevity is reduced by approximately 3 months. 12

13 Assessment of AF

14 Assessing arrhythmia burden after AF ablation ABACUS 44 pts received ILRs and conventional monitoring (transtelephonic monitors (30 days at discharge, month 5 and 11 postablation). At 6 months randomization to arrhythmia management by ILR versus CM. Arrhythmia recurrence CM 7, ILR 18 p=0.002 Drug discontinuation rate control 39% vs. 60% p=0.02 Drug discontinuation AADs 44% vs. 71% p=0.04 Kapa et al., JCE 2013

15 ABACUS machine versus man in episode adjudication ILR + ILR - AF/OAT detection higher Bradyarrhythmia detection higher More patients taken off AADs Compliance with TTM declined after initial use false positive AF detection common (730 of 1421 episodes, 51%) could be improved by reprogramming Kapa et al., JCE 2013

16 Improved Arrhythmia Detection: P SENSE Performance Reveal XT ICM AF False Positive episode detected Reveal LINQ ICM P SENSE No AF False Positive episode detected All patient and clinical data are fictitious and for demonstration purposes only. 16

17 17

18 Algorithms to Reduce False Positives Improvements over time PAC Evidence Based on R-R regular coupling Ectopy Evidence R-R interval with irregular coupling Bigeminy and Trigeminy rhythms P -wave Evidence P-wave morphology Irregular coupling 18

19 XPECT detection and quantification of AF High sensitivity and negative predictive value, good specificity and positive predictive value 235 pts Hindricks et al., Circ Arrhythm Electrophysiol 2010

20 Detection / Termination Criteria Episode Type Detection Termination Pauses No R Waves for *3 sec 12 R Waves Tachy *16 beats > *Programmed rate FVT: non-programmable 30/40 beats > 231bpm(260ms) Eight consecutive sensed beats slower than the programmed VT detection interval (8 to terminate) Brady *4 beats < *30bpm(2000ms) Four consecutive sensed beats faster than the programmed Brady interval (i.e. 4 VS, TS or FS in a row) AT/AF Must be > recording threshold - Evaluate R-R intervals every 2min Evaluate R-R intervals every 2min Symptom Patient Activation (button press) 1min post activation * Programmable parameters 20

21 Overall Goal for AF Detection Enhancement in Reveal LINQ Insertable Cardiac Monitor (ICM) Preserve AF burden accuracy Preserve Sensitivity to AF detection Reduce episode review burden Algorithm enhancements in Reveal LINQ ICM Nominal programming based on patient type Enhanced episode storage scheme 21

22 Optimizing AF Detection Purpose: Reduce burden of episode review 22

23 Reveal XT ICM vs. Reveal LINQ ICM Parameter Reveal XT ICM Reveal LINQ ICM Accelerometer 1-axis 3-axis Activity Count Based (zero crossings) Energy Based (integrated) AF Detection Algorithm AF Episode Storage 2 minutes ECG Intervals on Lorenz Plot; Ectopy Rejection FIFO (First In First Out) Max (13) 2 min episodes Any 2 min segment identified as AF episode will create an AF log entry 2 minutes ECG Intervals on Lorenz Plot; Ectopy Rejection w/ P SENSE Detection FIFO Max (14) episodes - including preserving longest AF episode since last session Only AF episodes that meet the criteria for minimum duration setting will create an AF log entry. Will add to burden on Cardiac Compass New Longest AF Only storage option (default for syncope patients) 23

24 Reveal XT ICM vs. Reveal LINQ ICM Total Memory Reveal XT ICM 49.5 minutes - 27 minutes Auto Detected episodes minutes Patient Activated episodes Reveal LINQ ICM 59 minutes - 27 minutes Auto Detected episodes - 30 minutes Patient Activated episodes - 2 minutes reserved for longest AF episode Patient Activated Up to 22.5 minutes total - (3) 7.5 min - (2) 10 min - (1) 15 min 30 minutes total - (4) 7.5 min - (3) 10 min - (2) 15 min Max Episodes Recorded/Day FIFO Storage - Last 27 minutes of auto detected episodes saved in device with ECG - 3/2/1 Patient Activated episodes stored with ECG Max Daily Limit - 27 minutes of auto detected episodes saved in device with ECG - 4/3/2 Patient Activated episodes stored with ECG - Memory fills up each day and then freezes until midnight before allowing more episode ECG or details to be stored - Counters are always updated even when ECG storage is full 24

25 Cryptogenic stroke

26 Incidence of AF detected by ILR in cryptogenic stroke 51 pts, years, 22 with a patent foramen ovale. At least 24h of rhythm monitoring. AF identified in 13 pts (25%) Median time to AF 48 (0-154) days AF associated with Increasing age Interatrial conduction block Left atrial volume APBs in preceding external monitoring Cotter et al., Neurology 2013

27 ILR detection of AF in cryptogenic stroke Pts admitted to a German single-site stroke unit in year follow-up AF incidence 27% Etgen et al., Stroke 2013

28 AF in cryptogenic stroke 7-d Holter versus ILR 60 pts, median age 63 (48-72) years. AF detected by ILR in 10 pts (17%) vs. 1 (2%) with 2 x 7-d Holter (p=0.0077) Ritter et al., Stroke 2013

29 Survival distribution function year survival rates among patients with stroke & AF by CHADS 2 score 0.80 CHADS 2 score Months

30 Primary prevention risk factor analysis

31 Bloch Thomsen et al., Circulation 2010 CARISMA Incidence and prognostic significance of arrhythmias Recorded by ILR in pts with acute AMI Intermittent high-degree AV block was associated with A very high risk of cardiac death

32 REVEAL-AF - a prospective, single-arm, open-label, multicenter, clinical study Projected AF primary end point and secondary end point curves * Up to 450 patients enrolled * 5-10% expected to have AF detected during screening * 400 patients implanted * 70 pts with each of CHADS 2 scores 2, 3 and 4 * Follow-up 18 months * Visits every 6 months * CareLink Primary endpoint: time to first ILR recorded and adjudicated AF episode 6 minutes Secondary endpoint: Clinical actions taken by the physician after the detection of AF Reiffel et al., Am Heart J 2014

33 Required programming in REVEAL-AF.will use the components of the Medtronic Reveal ICM device (Reveal XT or newer approved compatible device) in accordance with the approved indications NB. Difference versus observational study/registry where no requirements are allowed! Reiffel et al., Am Heart J 2014

34 Daily Wireless Audit (One-way): When does it send? All patient and clinical data are fictitious and for demonstration purposes only. 34

35 Conclusions Reveal LINQ Much smaller than TX and still more potent Remote wireless audit continuous monitoring Insertable - but in sterile environment! More patient and physician friendly

36 Conclusions Reveal LINQ Programmable defaults per reason for monitoring Battery saving possible by programming Improved AF detection risk of false positives reduced Likely to be shown (in syncope): cost effectiveness