Continuous ECG telemonitoring with implantable devices: the expected clinical benefits
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1 Continuous ECG telemonitoring with implantable devices: the expected clinical benefits C. W. Israel, M.D. Dept. of Cardiology Evangelical Hospital Bielefeld Germany
2 Declaration of Interest 1. Advisory Board Medtronic Inc. 2. Speaker s Bureau Biotronik Boston-Scientific Medtronic Inc. Sorin St. Jude Medical 3. Participation in Sponsored Trials Biotronik Boston-Scientific Medtronic Inc. Sorin St. Jude Medical
3 Remote ECG Monitoring: VT/VF 1. Remote ECG Monitoring for Early VT/VF Detection 2. Remote ECG Monitoring for Early AF Detection 3. Remote ECG Monitoring for Detection of HF Deterioration 4. Remote ECG Monitoring for Detection of Lead Failure
4 Remote ECG Monitoring: VT/VF Events in Dual-Chamber ICDs Lazarus, PACE 2007:30:S2-12
5 Remote ECG Monitoring: VT/VF Event % of patients Number of events* per patient affected Median, IQR Days from FU to first subsequent event Median, IQR Registry Other Registry Other Registry Other Technical events (1-1) 1 (1-1) 8 (3-13) 14 (5-16) Ventricular fibrillation (1-4) 2 (1-4) 15 (2-42) 17 (3-49) Ventricular tachycardia (1-10) 3 (1-11) 24 (7-48) 18 (5-42) Supraventricular tachycardia (5-13) 28 (6-132) 33 (13-52) 11 (21-62) 30 J shock ineffective (2-7) 2 (1-5) 9 (2-32) 17 (13-40) 1249 ICD patients, follow-up 9 ± 5 months Piorkowski, Autumn Meeting of the Geman Society of Cardiology 2005
6 Remote ECG Monitoring for Prevention of Inappropriate Shocks reprogram VT/SVT discriminators as soon as possible
7 Reduce Inappropriate Shocks Prognostic Implications of ICD Therapy: MADIT II Moss et al., Circulation 2004;110:760-5
8 Reduce Inappropriate Shocks Prognostic Implications of ICD Therapy: SCD-HeFT Poole et al., N Engl J Med 2007;28:601-7
9 Prognostic Implications of ICD Shocks: COMPANION Saxon, Circulation 2006;114:
10 Remote ECG Monitoring of VT/VF early notification of VT/VF episodes: allows early work-up (drug compliance, K+, ischemia, HF deterioration, ) allows early reprogramming to avoid further shocks may be relevant in electrical storm, incessant VTs may help prevent inappropriate shocks for SVT may help prevent inappropriate shocks for oversensing
11 Incessant Slow VT Detected by RM β blocker reinitiated β blocker stopped all VTs (> 200 within 1 week) terminated by ATP unnoticed by the patient Siaplaouras, Europace 2006;8:512 4
12 Electrical Storm: Incessant VT immediate professional advice via RM requires special organization ATP Shock
13 Ineffective Shock at Maximum Energy Ineffective Last Shock
14 Remote ECG Monitoring of VT/VF MV Glc Further Param. RR Kunze, Telemedizinführer 2003;78-81
15 Remote ECG Monitoring: VT/VF 1. Remote ECG Monitoring for Early VT/VF (SVT) Detection 2. Remote ECG Monitoring for Early AF Detection 3. Remote ECG Monitoring for Detection of HF Deterioration 4. Remote ECG Monitoring for Detection of Lead Failure
16 Asymptomatic AF > 48 hrs 38 % of pts with device-detected AF episodes > 48 h had no symptoms and were always SR at time of follow-up visit! Israel et al., JACC 2004;43:47-52
17 ASSERT Patient Eligibility - New dual-chamber pacemaker or ICD - Age 65 years - History of hypertension - Excluded if any history of AF or on vitamin K antagonist Pre-specified primary analysis - month 0 3: AT >6 min + >190 bpm - follow-up for ischemic stroke or systemic embolism Adjudication of all available AHRE
18 136 participating centres, 23 countries 2580 patients enrolled (2451 pacemaker patients, 129 ICD patients) Mean follow-up 2.8 years 36% of patients had at least one device-detected AT VKA use < 2% per year ASSERT
19 Cumulative Hazard Rates Time to 1 st AHRE ASSERT : Time to Adjudicated AHRE (>6 min >190 bpm) # at Risk Year month Visit Years of Follow-up
20 Cumulative Hazard Rates Stroke/Embolism in ASSERT # at Risk Year _ RR = % CI P = Device-Detected Atrial Tachyarrhythmia Detected month 0-3 No Asymptomatic Atrial Tachycardia Detected month T Years of Follow-up 0 at 3-month visit Healey et al., NEJM 2012
21 AFL Termination by Shock
22 Remote ECG Monitoring: VT/VF 1. Remote ECG Monitoring for Early VT/VF Detection 2. Remote ECG Monitoring for Early AF Detection 3. Remote ECG Monitoring for Detection of HF Deterioration 4. Remote ECG Monitoring for Detection of Lead Failure
23 Parameters for HF Monitoring Bui, JACC 2012;59:97 104
24 Parameters for HF Monitoring: Home-CARE 277 patients with a CRT-D system and daily remote monitoring Sack, Eur J Heart Fail 2011;13:
25 PARTNERS HF Whellan, J Am Coll Cardiol 2010;55:
26 Remote ECG Monitoring: VT/VF 1. Remote ECG Monitoring for Early VT/VF Detection 2. Remote ECG Monitoring for Early AF Detection 3. Remote ECG Monitoring for Detection of HF Deterioration 4. Remote ECG Monitoring for Detection of Lead Failure
27 ICD Lead Failure Up to 5% per year also in non-advisory ICD leads Kleemann, Circulation 2007;115:
28 Non-sustained Episodes of Non- Physiologically Fast Signals
29 Early Signs of Sprint Fidelis Failure Hauser, Heart Rhythm 2007;4:892-96
30 Electrical Abnormalities in Riata Ellenbogen, Heart Rhythm, Boston, May 2012
31 Prophylactic Replacement? 380 Medtronic Marquis devices, risk of malfunction 0.01% 1 out of 10,000 patients (0.038 of 380 patients) might develop an ICD problem 800fold general, 40fold death risk increase N = 45 (8.4%) Gould, JAMA 2006;295:
32 Automatic Alerts for Electrical Abnormalities Ellenbogen, Heart Rhythm, Boston, May 2012
33 ECG Monitoring and Automatic Alerts for Early Signs of Lead Failure non-physiologic short intervals nsvts representing oversensing ( noise ) VT with therapy representing oversensing ( noise ) sensing amplitude changes non-physiological signal morphology
34 Telemonitoring Spencker et al., Europace 2009;11:483-8
35 Interval between LIA Alert and Inappropriate Shock Delivery LIA: lead integrity alert, No CL: no CareLink, Non W-CL: nonwireless CareLink, W-CL: wireless CareLink Blanck, J Cardiovasc Electrophysiol 2011;22:
36 Detection of Riata Lead Failure by LIA RVtip-RVring Can-RVcoil Kneller, Europace 2012;22:
37 Sprint Fidelis Lead Failure Detection: ECOST 40 patients with Sprint fidelis leads 2 year remote monitoring remote monitoring with automatic alerts + in-hospital visit every 3 months alerts in 4 patients, lead failure confirmed in 3 patients 36 patients safe without any alert/intervention for 2 years Guédon-Moreau, Eur Heart J 2010;31:
38 Remote ECG Monitoring: Conclusion 1. Remote ECG Monitoring for Early VT/VF Detection 2. Remote ECG Monitoring for Early AF Detection 3. Remote ECG Monitoring for Detection of HF Deterioration 4. Remote ECG Monitoring for Detection of Lead Failure
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