Subcutaneous ICD Emerging Role of Sudden Cardiac Death Prevention

Transcription

1 Subcutaneous ICD Emerging Role of Sudden Cardiac Death Prevention Dr Ngai-Yin Chan, MBBS, FRCP(Lond), FRCP(Edin), FRCP(Glasg), FACC, FHRS, Consultant Physician, Department of Medicine & Geriatrics, Princess Margaret Hospital, Clinical Associate Professor (Hon), Department of Medicine & Therapeutics, The Chinese University of Hong Kong Heart Rhythm Refresher Course 2015 Module 2, November 29, 2015

2 Problems With Transvenous ICD Lead Placement

3 Configurations of SICD Mean DFT 32.5J Mean DFT 40.4J Mean DFT 40.1J Mean DFT 34.3J Bardy GH, et al. An entirely subcutaneous implantable cardioverterdefibrillator. NEJM 2010;363:36-44.

4 Sensing of SICD Secondary vector Alternate vector Primary vector

5 Pre-operative ECG Screening

6 Eligibility for SICD Supine and Erect 48% 37.2% 3.6% 11.2% Randles DA et al. How many patients fulfil the surface ECG criteria for SICD implantation. Europace 2014;16:

7 Right Parasternal Electrode Configuration Chan NY et al. Right parasternal electrode configuration converts a failed electrocardiographic screening to a pass for SICD implantation. Heart, Lung and Circulation 2015;24:e203-5.

8 Right Parasternal Electrode Configuration Chan NY et al. Right parasternal electrode configuration converts a failed electrocardiographic screening to a pass for SICD implantation. Heart, Lung and Circulation 2015;24:e203-5.

9 Defibrillation of SICD

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11 VF Induction by 50Hz, 200mA Pulse VF Termination by 65J SICD Shock

12 CXR Post-SICD Implantation

13 One Week Post-SICD Implantation

14 One Month Post-SICD Implantation

15 Indications Priori SG et al ESC guidelines for the management of patients with ventricular arrhythmias and prevention of sudden cardiac death. EHJ 2015;36:

16 Pooled Analysis EFFORTLESS and IDE Study N=882 patients who had standard indications for ICD but without class I indications for permanent pacing, pace-terminable VT and functional unipolar pacing system Burke MC et al. Safety and efficacy of the totally subcutaneous implantable defibrillators. 2-year results for a pooled analysis of the IDE study and EFFORTLESS registry. JACC 2015;65(16):

17 Pooled Analysis EFFORTLESS and IDE Study Device-related complications 11.1% at 3 years No electrode failure, no SICD-related endocarditis or bacteraemia Burke MC et al. Safety and efficacy of the totally subcutaneous implantable defibrillators. 2-year results for a pooled analysis of the IDE study and EFFORTLESS registry. JACC 2015;65(16):

18 Infection and Erosion Calvagna GM et al. Pocket infection as a complication of a SICD. IJC 2014;177: Santarpia G et al. First case of SICD extrusion. IJC 2015;192:19-20.

19 FU 651±345 days Efficacy of SICD Spontaneous VT/VF totalled 111 episodes in 59 patients 100 (90.1%) terminated with 1 shock, 109 (98.2%) terminated with 5 available shocks; 1 spontaneously terminated after the 5 th shock; another one with undersensing after 2 shocks, a new episode immediately reinitiated and terminated with one additional shock Burke MC et al. Safety and efficacy of the totally subcutaneous implantable defibrillators. 2-year results for a pooled analysis of the IDE study and EFFORTLESS registry. JACC 2015;65(16):

20 Inappropriate Shocks 3-year inappropriate shock rate 13.1% Burke MC et al. Safety and efficacy of the totally subcutaneous implantable defibrillators. 2-year results for a pooled analysis of the IDE study and EFFORTLESS registry. JACC 2015;65(16):

21 Dual-zone Programming

22 Requirement for Pacing Only 3 (0.3%) devices replaced for RV pacing Burke MC et al. Safety and efficacy of the totally subcutaneous implantable defibrillators. 2-year results for a pooled analysis of the IDE study and EFFORTLESS registry. JACC 2015;65(16):

23 TV-ICD Programming to Reduce Inappropriate Shocks Conventional therapy: Therapy delivery at HR 170/min (11.6% inappropriate shocks) High-rate therapy: Therapy delivery at HR 200/min (2.4% inappropriate shocks) Delayed therapy: Therapy delivery with 60s delay at HR /min; 12s delay at HR /min and 2.5s delay at HR 250/min (2.4% inappropriate shocks) Moss AJ et al. Reduction in inappropriate therapy and mortality through ICD programming. NEJM 2012;367:

24 SICD Algorithm to Prevent Oversensing Certification Phase Waveform Appraisal Detection Certification CWADD WCDD AIDD Rate Certification T-wave double detection 2 Wide Complex double detection 2 LONGER INTERVAL SHORTER 1 1

25 SICD Algorithm to Differentiate Supraventricular from Ventricular Arrhythmias SHOCK ZONE Heart rate within Shock Zone? YES T (Tachy) NO INSIGHT DISCRIMINATION Heart rate within Conditional Shock Zone? NO S (Sensed) YES STATIC MORPHOLOGY Compare morphology & width to NSR Template GOOD MATCH S (Sensed) POOR MATCH DYNAMIC MORPHOLOGY Compare beat-to-beat morphology POLYMORPHIC T (Tachy) MONOMORPHIC QRS WIDTH Compare QRS Width with NSR Template WIDE QRS T (Tachy) NARROW QRS S (Sensed)

26 Management of Inappropriate Shocks in SICD N=581 from the EFFORTLESS Registry 48 patients experienced 101 inappropriate shocks over a mean FU 21±13 months Cardiac signal oversensing (73%), mainly due to TW oversensing 18 shocks (18%) due to SVT, 15 in shock-only zone Nordkamp LRAO et al. Inappropriate shock in the SICD. Incidence; predictors and management. IJC 2015;195:126-33

27 Management of Inappropriate Shocks in SICD Nordkamp LRAO et al. Inappropriate shock in the SICD. Incidence; predictors and management. IJC 2015;195:126-33

28 N=700 Noninferiority study 1 composite EP: IAS+ICD-related CX 2 EP: Shock efficacy Mortality PRAETORIAN Trial Expected median FU Olde Nordkamp L et al. A prospective randomized comparison of subcutaneous and transvenous ICD therapy. AHJ 2012;163: