Update on Device Innovation (S-ICD, Wearable, Leadless)
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1 Update on Device Innovation (S-ICD, Wearable, Leadless) C. W. Israel Dept. of Medicine - Cardiology Evangelical Hospital Bielefeld J. W. Goethe University Frankfurt Carsten.Israel@em.uni-frankfurt.de
2 Conflicts of Interest Honoraria (speakers bureau, etc.): Biotronik, Boston-Scientific, Medtronic, St. Jude Medical, Sorin, Zoll Advisory Board: Medtronic, St. Jude Medical, Zoll Participation in sponsored clinical trials: Biotronik, Boston-Scientific, Medtronic, Sorin, St. Jude Medical
3 Subcutaneous ICD (S-ICD)
4 Subcutaneous ICD: Size, Longevity new device thinner
5 S-ICD: EFFORTLESS Median FU 498 days Czech Republic, Denmark, Germany, Italy, Netherlands, New Zealand, UK Lambiase, Eur Heart J 2014;35:
6 S-ICD: EFFORTLESS 1 pt died: asystole followed by VF, 11 ineffective shocks (successful DFT at implant) Explants in 17 pts (3.7%): Infection (n=8), recurrent VT (n=2), inappropriate shocks (n=2), erosion, DFT failure at implant, failure to convert spontaneous VT/VF, inappropriate sensing, inappropriate shocks, pain (all n=1) 9 deaths Lambiase, Eur Heart J 2014;35:
7 S-ICD: EFFORTLESS Lambiase, Eur Heart J 2014;35:
8 S-ICD: Study/Registry Overiew McLeod, Eur Heart J 2015 (advance access, Oct 29 th, 2015)
9 Lead Selection to Prevent T Wave Oversensing McLeod, Eur Heart J 2015 (advance access, Oct 29 th, 2015)
10 S-ICD: Pooled Data Burke, J Am Coll Cardiol 2015;65:
11 Achilles Heel: Implanter, not Lead! 1. Ligaments compress the lead subclavian crush 2. Calcified ligaments crush the lead when sheath is retracted 3. Leads trapped in muscle are rubbed off by bone movements
12 ICD Leads: No Subclavian Puncture! 1. Ligaments compress the lead subclavian crush 2. Calcified ligaments crush the lead when sheath is retracted 3. Leads trapped in muscle are rubbed off by bone movements
13 Transvene : Subclavia vs. Cephalica 767 Medtronic Transvene ICD leads Lead fracture: 7/523 leads via subclavian vein 0/221 leads via cephalic vein All lead failures occurred in patients implanted via subclavian vein, no lead failure occurred in patients implanted via cephalic vein! Gallik, PACE 1996;19:
14 Sprint Fidelis: Subclavia vs. Cephalica Canadian Heart Rhythm Society Device Committee Birnie, Circulation 2012;125:
15 Riata : Subclavia vs. Cephalica Erkapic, J Carciovasc Electrophysiol 2011;22:
16 ESC Guidelines on SCD 2015 Priori, Eur Heart J 2015 (epub)
17 Subcutaneous ICD: Candidates patients with (recurrent) device infection, septicemia and TV ICD explantation patients with ICD lead fracture due to anatomic reasons (not only bad implanter ) patients with lack/obstruction of SVC patients on dialysis problem: risk of bradycardia patients with TV replacement
18 Subcutaneous ICD: No Candidates patients who require antibradycardia pacing patients who require CRT patients with VT (require antitachycardia pacing) patients who require AADs for VT or SVT ( patients with β blockers for CAD or HF) patients with HCM if T wave oversensing cannot be resolved thin patients young, sportive patients (device lifetime 5-6 years)
19 Wearable ICD
20 Wearable ICD: WEARIT II Registry Kutyifa, Circulation 2015;132:1613-9
21 WCD: Use in Hours per Day Kutyifa, Circulation 2015;132:1613-9
22 Wearable ICD: WEARIT II Registry Kutyifa, Circulation 2015;132:1613-9
23 Wearable ICD: WEARIT II Registry Kutyifa, Circulation 2015;132:1613-9
24 Wearable ICD: WEARIT II Registry Kutyifa, Circulation 2015;132:1613-9
25 Wearable ICD Post MI 1.4% of pts successfully treated for VT/VF in the first 3 months post MI Epstein, J Am Coll Cardiol 2013;62:2000-7
26 Wearable ICD Post MI Epstein, J Am Coll Cardiol 2013;62: % resuscitation survival rate
27 Wearable ICD: SCD Guidelines Prochnau, Successful use of a wearable cardioverter-defibrillator in myocarditis with normal ejection fraction. Clin Res Cardiol 2010;99: Chung MK. The role of the wearable cardioverter defibrillator in clinical practice. Cardiol Clin 2014;32: Priori et al., Eur Heart J 2015
28 Wearable ICD: SCD Guidelines 2015 Priori et al., Eur Heart J 2015
29 Wearable ICD: SCD Guidelines 2015 Priori et al., Eur Heart J 2015
30 Leadless Pacing
31 Nanostim (St. Jude Medical) Length 42 mm, maximum diameter 5.99 mm, 18F sheath nonretractable screw-in steroid-eluting helix (max. penetration 1.3 mm) Bipolar (tip: centre of the fixation helix, ring: titanium pacemaker case), electrode spacing >10 mm feature for docking delivery and retrieval catheters estimated battery life 8.4 years with 100% pacing (12.4 yrs with 50%) RV blood temperature-responsive VVIR Reddy, Circulation 2014;129:
32 Nanostim: Implantation Reddy, New Engl J Med 2015;129:
33 Innovationen Schrittmacher/ICD LEADLESS Trial Reddy, Circulation 2014;129:
34 Innovationen Schrittmacher/ICD Nanostim (St. Jude Medical) Reddy, Circulation 2014;129:
35 Nanostim: LEADLESS II successfully implantation in 504 of 526 patients (95.8%) Reddy, New Engl J Med 2015;129:
36 Nanostim: LEADLESS II Reddy, New Engl J Med 2015;129:
37 LEADLESS II: Complications Reddy, New Engl J Med 2015; 129:
38 Micra (Medtronic) Size 0.8 cm³, 2.0 g Length: 25.9 mm Outer diameter: 6.7 mm (27F sheath) Bipolar sensing/pacing Fixation mechanism: Nitinol tines Battery Lithium silver vanadium oxide/ Carbon monoflouride Longevity: 7.4/10.1 year (2.0/1.5V output, 60 bpm, 100% paced) Capabilities VVIR RV capture management Sensing assurance Diagnostics Deactivated to OOO at EoL
39 Micra: Implantation Reynolds, New Engl J Med 2015 (advance access)
40 MICRA Study successfully implantation in 719 of 725 patients (99.2%) Reynolds, New Engl J Med 2015 (advance access)
41 MICRA Study Reynolds, New Engl J Med 2015
42 What should be remembered? S-ICD: Alternative to TV-ICD for patients with (recurrent) lead problems (infection, fracture) or lack of venous access; performance compared to TV-ICD unclear (shock efficacy, VF undersensing, T wave oversensing, infection) WCD: Interesting for selected patients during waiting periods (compliance tool!), trials pending Leadless/transcatheter VVIR pacemakers: Promising performance, 4-6% complications (tamponade, vascular access, device dislodgement)
43 Thank you very much for your attention!
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