Lead Selection and Subcutaneous ICD Considerations. The Future of CIEDs
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1 Lead Selection and Subcutaneous ICD Considerations The Future of CIEDs February, 2013 Steven P. Kutalek, MD Director, Cardiac Electrophysiology Drexel University College of Medicine
2 New Technologies 2012 Pacing Miniaturization of components Leadless pacemaker Implantable Ultrasonic energy transmission Defibrillation Subcutaneous ICD
3 The Innovation S-curve in Implantable Bradycardia Therapy Physical limit of technology Performance First implantable, transvenous pacemaker Chardack- Greatbatch,1960 Full automaticity EnPulse Physiologic dual-sensor (activity/mv) Kappa Rate response Activitrax,1986 MVP + full automaticity Adapta First microprocessor-based, mode switching Thera MR Conditional Revo/Advisa MRI SureScan Dual-demand pulse generator Byrel Effort (funds) and/or Time Technological performance often follows an S-shaped curve Foster, Innovation: The Attackers Advantage, Summit Books, 1986
4
5 System proposed by Spickler in 1970
6
7 Unmet Needs in Cardiac Pacing Issues That May Require Extraction Acute complications related to subcutaneous pacing or ICD device and leads Pocket hematoma Lead dislodgement, perforation Chronic lead reliability issues: Crush, fracture, abrasion, insulation breach System connections Device pocket complications: Erosion through the skin Pain at incision/pocket Heart Rhythm 2009:
8 Unmet Needs in Cardiac Pacing Issues That May Require Extraction Infection Up to 1.2% within a year after procedure Replacement: rates ~3-5X higher Lead interactions with vasculature and heart structures: Tricuspid valve impairment Venous stenosis/thrombosis SVC syndrome Cosmesis Heart Rhythm 2009:
9 Potential Clinical Risks Leadless Pacemaker Fixation/dislodgement Large-bore catheters Access challenges Hemostasis Vascular complications Low, stable chronic thresholds Thromboembolic risk Extraction?
10 Other Potential Approaches Energy transfer Acoustic Induction Rechargeable? Epicardial?
11 Leadless Pacing Using Induction
12 ICD Lead Performance Circulation 2008;117:
13 The S-ICD System FDA approved device Implant technique Implant data Patient populations for application Lack of a transvenous lead system
14 The S-ICD System Totally subcutaneous system does not require electrodes in or on the heart System is placed strictly by anatomical landmarks without a need for fluoroscopy
15 The S-ICD System Implant Data 1900 systems implanted worldwide 500 implanted in the US 15 in patients < 18 years of age 22 in dialysis patients
16 The S-ICD System Implant Data Patients with concomitant implanted systems Total 11. LVAD 4 3 S-ICD first, 1 LVAD first VNS for HF 1 CCM 2 PM & ICD 4 Programmed off for tachy but retained for brady
17 S-ICD System Performance Implanted Systems S-ICD Systems Implanted (worldwide) Year End , Prior TV-ICD Devices Implanted IDE Study Launch JAN-2010 No 77% Yes 23% CHRONIC II CE Study Commercial Launch SEP-2009 May-08 Jun-08 Jul-08 Aug-08 Sep-08 Oct-08 Nov-08 Dec-08 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec
18 S-ICD System Performance Cumulative Implant Duration S-ICD System Cumulative Implant Duration n = 1061 patients, mean F/U ± std = 12.4 ± 8.5 months cumulative F/U = 13,123 patient months # of Devices Implant Months
19 The S-ICD System Implant Procedure
20 The S-ICD System S-ICD Therapy 80J (delivered) Biphasic shock Charge time is approximately 9 seconds to maximum output
21 S-ICD System Components SQ-Rx Pulse Generator Volume: Weight: Thickness: Energy: Waveform: 69 cc 145 grams 15.7 mm 80J (delivered) Biphasic
22 The S-ICD System Sensing the Subcutaneous Signal Three sense vectors Provides maximum sensing flexibility, especially in patients with extensive cardiac disease history ALTERNATE (A-B) A B CAN
23 S-ICD System Components Lead Distal Distal Sense A 9 FR Shock Coil Proximal Sense B
24
25 S-ICD System Performance New England Journal of Medicine, May 2010 N Engl J Med 2010; 363:36-44 July 1, 2010
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