Device Diagnostics and Stroke Prevention: State of the Art
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1 Device Diagnostics and Stroke Prevention: State of the Art Ass. Prof. Dr. Carsten W. Israel Dept. of Cardiology Evangelical Hospital Bielefeld Germany
2 Disclosure of Relationships Conflicts of Interest Honoraria, travel expenses: Bayer Healthcare, Biotronik, BMS/Pfizer, Boehringer- Ingelheim, Boston-Scientific, Medtronic, Sanofi, Sorin, St. Jude Medical Advisory Board: Bayer Healthcare, Boehringer-Ingelheim, BMS/Pfizer, Medtronic, St. Jude Medical Participation in sponsored clinical trials: Boston-Scientific, Medtronic, Sanofi, Sorin, St. Jude Medical Patents, ownership, stocks: None Other financial support: None
3 Cumulative Hazard Rates Device Diagnostics and Stroke Prevention ASSERT: AT/AF >6 min >190 bpm ASSERT : Time to Adjudicated AHRE (>6 min >190 bpm) # at Risk Year month Visit Years of Follow-up
4 Undetectable Asymptomatic AF >48 h More than ⅓ of patients with AF episodes > 48 h a) asymptomatic plus b) always in sinus rhythm at time of follow-up 110 pts with AF treated by AADs + PM 50 pts with AF episodes >48 h 19 pts (38 %): no symptoms, FU Israel et al., JACC 2004;43:47-52
5 Atrial Arrhythmias in Pacemaker Memory Distinguish true from false AT/AF detection Program to get the true arrhythmia duration Study data: Clinical meaning of AT/AF detected solely by devices Summary: What to do?
6 Farfield Oversensing 10% 49% 41% correct AT detection FFRW others nominal PVAB 80 ms 80% of false positive AF detections in BEATS due to ventr. FF oversensing sufficiently long PVAB ( 100 ms) required Israel PACE 2006;29:582-8
7 Farfield Oversensing Duration Trigger ventricular FF oversensing can fill memory with trash and thus prevent AF detection
8 Far-Field Oversensing Cannot be Solved by Sensitivity Reprogramming Reduction of atrial sensitivity (e. g mv) may 25 mm/s - prevent detection of sinus rhythm - prevent detection continuous detection of atrial fibrillation - Not prevent farfield R wave oversensing
9 AF Undersensing AT onset criteria fulfilled high-degree AT undersensing Intermittent AF undersensing: Premature detection of AF termination (P wave 3.2 mv, atrial sensitivity 0.5 mv, bipolar)
10 AF Undersensing Duration Trigger reliable detection of AF duration requires high atrial sensitivity ( mv)
11 FFRW Oversensing Test AV delay 100 ms, atrial sensitivity 0.1 mv, PVAB 60 ms Use calipers: VP FFRW marker (paper speed 100 mm/s) PVAB ms longer Kolb et al., JCE 2006;17:992-7
12 Functional Atrial Undersensing PVARP PVAB 2:1 lock-in of alternate atrial flutter potentials within the blanking period Long atrial blanking times: Long AV delay + long PVAB Shorter blanking time, special algorithms, or AAI(R) Israel PACE 2002;25:380-93
13 Blanked Flutter Search and on top: maximum tracking rate 110 bpm
14 Far-Field Oversensing: Bipole Spacing De Voogt PACE 2005;28:782-8
15 Far-Field Oversensing: Bipole Spacing De Voogt PACE 2005;28:782-8
16 Optimized AT/AF Detection Max. Rate > Max. Duration No. of episodes No. of episodes 159 days of continuous AF detection without signal drop-out
17 AF Detection by Devices Problems for Sensitivity of AF Detection - atrial undersensing: a) true undersensing b) functional undersensing Problems for Specificity of AF Detection - atrial oversensing: a) farfield R wave oversensing b) myopotential oversensing c) P wave double counting d) EMI, lead failure - non-sustained AT - atrial pacing without capture (e. g. competitive AP)
18 Functional Non-Capture : RNRVAS RNRVAS: Repetitive Non-Reentrant Ventriculo- Atrial Synchrony Barold, J Interv Cardiac Electrophysiol 2001;5:45-58
19 Atrial Arrhythmias in Pacemaker Memory Distinguish true from false AT/AF detection Program to get the true arrhythmia duration Study data: Clinical meaning of AT/AF detected solely by devices Summary: What to do?
20 TRENDS n = 2.486, mean follow-up 1.4 years documented AT/AF before or after enrollment: n = Glotzer, Circulation AEP 2009;2:474-80
21 Stroke/Embolism Healey et al., N Engl J Med 2012;366:120-9
22 Which AF Duration Causes Stroke? ASSERT-Studie (data on file)
23 When after AF Detection Does a Stroke Occur? ASSERT-Studie (data on file)
24 TRENDS: Stroke without AF? 40 strokes in TRENDS (1.6% out of 2,486 pts) 20 pts without any stored AT/AF before stroke 9 pts with stored AT/AF >30 d before stroke 29/40 (73 %) pts with 0% AT/AF within 30 d before stroke Daoud, Heart Rhythm 2011;8:
25 ASSERT: Stroke without AF? 51 strokes in ASSERT only 18 pts with AF only 11 pts with AF before stroke only 4 pts with AF within 30 days before stroke Brambatti, Circulation 2014
26 Temporal Relationship AF & Stroke in IMPACT 69 thromboembolic events in both groups 9 (13%) preceded AT 40 (58%) occurred without AT detected during the monitoring period 20 (29%) followed AT (1-489 days) Martin, Eur Heart J 2015 (epub, doi: /eurhear tj/ehv115)
27 Atrial Arrhythmias in Pacemaker Memory Distinguish true from false AT/AF detection Program to get the true arrhythmia duration Study data: Clinical meaning of AT/AF detected solely by devices Summary: What to do?
28 ARTESIA Apixaban for the Reduction of Thrombo-Embolism in Patients With Device- Detected Sub-Clinical Atrial Fibrillation (ARTESiA) ClinicalTrials.gov Identifier: NCT Primary Outcome: Ischemic stroke/systemic embolism and major bleeding Inclusion Criteria: AF detection by pacemaker/icd/ilr, 1 episode of subclinical AF 6 min but no episode >24 hrs, CHA2DS2-VASc score of 4 Exclusion Criteria: AF documented by surface ECG 6 min, creatinine >2.5 mg/dl; creatinine clearance < 25 ml/min, Randomization: 81 mg aspirin versus apixaban 2.5/5 mg bid Mean follow-up: 3 years
29 Italian AT500 Registry P = % 5.0% P = Pts No AF 80 Pts No AF 24 Pts No AF 4 Pts No AF 0.6% 80 Pts No AF 24 Pts No AF 54 Pts 76 Pts 42 Pts 7 Pts 76 Pts 42 Pts AF AF AF AF AF AF >5min >5min >5min >5min >5min >5min 59 Pts AF >24h 113 Pts AF >24h 45 Pts AF >24h 6 Pts AF >24h 4.0% 113 Pts AF >24h 45 Pts AF >24h CHADS 2 score CHADS 2 score Botto, J Cardiovasc Electrophys 2009;20:241-8
30 Device Diagnostics for Stroke Prevention: State of the Art Program devices for optimum AF detection: Atrial sensitivity 0.2 mv PVAB 25 ms > VP-FFRW Check device memory each FU Confirm that it is really AT/AF > 5 min Check CHADS 2 score: CHADS 2 = 0 No OAC CHADS 2 = 1-2 OAC if AT/AF 24 h CHADS 2 3 OAC if AT/AF 5-6 min
31 Device-Detected AF and Remote Monitoring Shorter reaction time Empty the trash function
32 Thank you very much for your attention!
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