SCD 2014: Who Should Receive a Subcutaneous Defibrillator?

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Jason Koontz, MD, PhD

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SCD 2014: Who Should Receive a Subcutaneous Defibrillator?

  1. 1. Who Should Receive a Subcutaneous Defibrillator? Jason Koontz, MD, PhD Assistant Professor of Medicine Duke University Medical Center
  2. 2. Presenter  Disclosure  Informa2on   •  Biosense Webster (consulting < $10,000/yr) •  ChanRx (consulting < $10,000/yr)
  3. 3. Limitations of Transvenous ICDs •  •  •  •  •  •  •  Limited vascular access options Implantation risks Transvenous lead durability Hazards of lead extractions Risk of blood stream infections Inappropriate therapies Valve injury / tricuspid insufficiency
  4. 4. Requirements for an ICD System Effective Defibrillation Effective VT/VF Sensing •  Deliver adequate energy with an adequate safety margin to defibrillate •  Deliver this energy in a sufficiently short time to minimize syncope while still allowing the possibility of spontaneous termination •  Appropriate sensing of ventricular events at high rates while not oversensing non-ventricular/non-cardiac events •  Adequately distinguishing VT/VF events from supraventricular arrhythmias Safe ICD System Implantation
  5. 5. Effec&ve  Defibrilla&on   Configura&ons  tested  in  78  pt  –  Sept  2001  –  Feb  2004     G  Bardy,  et  al.  N  Engl  J  Med  (2010)  363:36-­‐44.    
  6. 6. Effec&ve  Defibrilla&on   TV-­‐ICD   s-­‐ICD   11.1  +  8.5   36.6  +  19.8   Compared  to  TV-­‐ICD  in  49  pt  –  April  2004  –  June  2005     G  Bardy,  et  al.  N  Engl  J  Med  (2010)  363:36-­‐44.    
  7. 7. Effec&ve  Defibrilla&on   M  Acha  and  D  Milan.  Circ  Arrhythm  Electrophysiol  (2013)  6:1246-­‐1251.     .  
  8. 8. Effec&ve  Defibrilla&on   •  US  IDE  Trial  –  IDE  trial  –  321  implants  with   808/809  successful  detec&ons  during   induc&ons  and  100%  conversion  of  successful   detec&ons   •  All  successfully  detected  induc&ons   successfully  converted   •  Chronic  cohort  –  71/74  DFT  success  at  6  mo  @   65J  
  9. 9. Effec&ve  Sensing   •  Primarily rate sensing (common to all ICDs) •  sICD Arrhythmia Discrimination Criteria –  Correlation between current beat and stored template – if < 50% favors VT –  Continuous beat-to-beat correlation – if polymorphic favors VT –  Continuous beat-to-beat QRS width – if wide QRS is noted during monomorhpic relationship, favors VT  
  10. 10. Effec&ve  Sensing   M.  Gold,  et  al.  J  Cardiovasc  Electrophysiol,  (2010)  23:  359-­‐366.  
  11. 11. Effec&ve  Sensing   M.  Gold,  et  al.  J  Cardiovasc  Electrophysiol,  (2010)  23:  359-­‐366.  
  12. 12. Effec&ve  Sensing   •  Sensitivity: 49/49 VT/VF events detected by sICD and •  Specificity: 50 SVT episodes –  sICD – 49 appropriately withheld –  TV-ICD (single v dual, SRD nominal v off) •  Medtronic 90-92% withheld •  Boston Scientific 70-82% withheld •  St Jude Medical 33-64% withheld M.  Gold,  et  al.  J  Cardiovasc  Electrophysiol,  (2010)  23:  359-­‐366.  
  13. 13. Effec&ve  Sensing   M.  Gold,  et  al.  J  Cardiovasc  Electrophysiol,  (2010)  23:  359-­‐366.  
  14. 14. Effec&ve  Sensing  
  15. 15. Effec&ve  Sensing   •  US  IDE  (321  pts)  –  38  with  inappropriate  shocks   –  15  pts     SVT  rate  >  condi&onal  zone   –  24  pts     oversensing  
  16. 16. Safety  of  Device   •  180  d  freedom  from  device  and  procedure   related  complica&ons  92.1%  (performance   goal  79%  for  approval)   •  18  suspected  infec&ons  –  4  resulted  in  device   removal  and  14  successfully  managed  as   superficial  infec&ons  
  17. 17. Current  sICD  Device   •  •  •  •  •  Parasternal  electrode  and  axillary  device   Output  of  80  J   Es&mated  bacery  longevity  ~  5  yr   Full  episode  storage  informa&on   Post-­‐shock  subcutaneous  pacing  available  
  18. 18. Current  sICD  Device   •  “Advantages”   –  No  transvenous  lead   –  Fluoroscopy  not  required  for  implant     –  Ultra  far  field  signals  for  arrhythmia  discrimina&on     •  “Disadvantages”     –  Post  shock  pacing  only  (No  Brady,  CRT,  ATP)     –  No  remote  monitoring     –  Larger  Pulse  generator    
  19. 19. Candidates for sICD Patients with risk of life threating arrhythmias without: •  Symptomatic bradycardia requiring pacing •  Cardiac resynchronization candidacy •  Recurrent VT responsive to ATP •  Incessant ventricular tachycardia
  20. 20. sICD “Prefenential” •  Individuals with increased risk for infection or vascular access difficulties for TV-ICD –  Prior TV-ICD blood stream infection –  End-stage renal disease on hemodialysis –  Prior vascular access issues/known occlusion –  Immunocompromise •  Consider for young patients with greater lifetime exposure to vascular access risk and risk of TV lead failure •  Consider for complex anatomy where lead delivery may be difficult/suboptimal
  21. 21. Thank  you      

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