Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

1
Subcutaneous Implantable Cardioverter
Defibrillator (S-ICD)

• Tanner Barnes
• BME 281

2
The Problem

• 300,000 people die each year in the United States
  due to sudden cardiac arrest (SCA)
• 80-90 due to ventricular tachyarrhythmias
• People who have severe coronary heart disease are
  at a heightened risk for (SCA)
• Research shows that an implantable
  cardioverter-defibrillator (ICD) can reduce
  the chance of dying from (SCA)

3
A Solution

• Transvenous implantable cardioverter-defibrillator
  (T-ICD)
• First human implant in 1980
• Gained FDA approval in 1985
• First were shock only
• Now able to provide pacing and have advanced
  rhythm discrimination

4
Problems with T-ICD

• Infections in the venous system
• 2,201 patients required lead removals between
  2000-2011
• Complex and highly invasive operation
• T-ICDs often unsuccessful in children
• Requires x-ray imaging to ensure
  the lead is placed correctly

5
A New Alternative

• Cameron Health, recently purchased by Boston
  Scientific, pioneered the subcutaneous
  implantable cardioverter-defibrillator (S-ICD)
  and it was put into commercial use outside the
  U.S. in 2009
• The (S-ICD) was approved for observational study
  by FDA
• Awaiting FDA approval for commercial use

6
Design of S-ICD

• The S-ICD System is comprised of the following
  four devices
• SQ-RX Pulse Generator
• 80-J biphasic shock
• Charge time to 80-J 10 seconds
• 5.1 year longevity
• 30 seconds post-shock pacing
• Q-TRAK Subcutaneous Electrode
• Q-GUIDE Electrode Insertion Tool (EIT)
• Q-TECH Programmer

7
Implantation of S-ICD

• All components implanted just below the skin
• Only requires 3 small incisions
• Can be an outpatient procedure

8
Advantages

• Less invasive surgery
• Eliminates potential for infection and damage to
  venous system
• May be implanted using anatomical landmarks
• Potential for less inappropriate shocks in
  children

9
Disadvantages

• Size
• Twice that of current T-ICD
• Battery life
• 5 years as opposed to upwards of 10 with T-ICD
• Does not provide anti-tachycardia pacing (ATP) or
  bradycardia pacing

10
S-ICD in Children

• Study conducted in UK with two boys, aged 10 and
  12
• Early clinical trials suggest less inappropriate
  shocks than T-ICD
• Can be implanted in children gt30 kg
• Possible for children lt30 kg
• Adapts to growth better than
• T-ICD

11
Latest Observational Study

• 330 patients in 33 different centers
• 99 complication free after 180 days
• 100 success rate in converting induced VT/VF to
  sinus rhythm
• Only 1 out of 119 spontaneous VT/VF episodes
  required external defibrillation
• Storm episode
• 37 out of 38 discrete spontaneous VT/VF episodes
  were corrected with one or more 80-J shocks

12
Continued

• The one episode terminated spontaneously while
  device was charging for second shock
• Unintentional therapy occurred in 13.1 of
  patients over an 11-month follow-up
• Similar to inappropriate therapy with T-ICD
• The mean time to therapy for all inductions was
  14.6 seconds

13
Conclusion

• The S-ICD system represents a viable alternative
  to conventional T-ICD therapy in patients at risk
  of death from VT/VF
• Low rate of major complications thus far in
  European market and in clinical studies
• FDA decision on approval should be announced in
  the near future

14
References

• McLeod, Dr. Karen, and Dr. Andrew McLean.
  "Implantation of a Fully Subcutaneous ICD in
  Children." Authors. Journal compilation. 35.
  (2012) 20-23. Web. 19 Oct 2013.
• Hauser, Dr.Robert. "The Subcutaneous Implantable
  Cardioverter-Defibrillator." Journal of the
  American College of Cardiology. 61.1 (2013)
  20-22. Web. 19 Oct 2013.
• "Safety and Efficacy of a Totally Subcutaneous
  Implantable-Cardioverter Defibrillator."
  Circulation. 128. (2013) 944-953. Web. 20 Oct.
  2013.
• "Superior Vena Cava Defibrillator Coils Make
  Transvenous Lead Extraction More Challenging and
  Riskier." Journal of the American College of
  Cardiology. 61.9 (2013) 987-989. Web. 20 Oct.
  2013.
• Boston Scientific. Boston Scientific. Web. 20 Oct
  2013. lthttp//www.bostonscientific.com/cardiac-rhy
  thm-resources/cameron-health/sicd-system.htmlgt.
• "What Causes Sudden Cardiac Arrest?." National
  Heart, Lung, and Blood Institute. N.p., 1 1 2011.
  Web. 20 Oct 2013. lthttp//www.nhlbi.nih.gov/health
  /health-topics/topics/scda/causes.htmlgt.
• "Subcutaneous Implantable Defibrillator (S-ICD)
  System Advisory Panel Package Summary of Safety
  and Effectiveness Data." . FDA. Web. 20 Oct 2013.
  lthttp//www.fda.gov/downloads/AdvisoryCommittees/C
  ommitteesMeetingMaterials/MedicalDevices/MedicalDe
  vicesAdvisoryCommittee/CirculatorySystemDevicesPan
  el/UCM301237.pdfgt.
• lthttp//www.epdoc.net/professional/patientpages/Eq
  uipment-and-Device-Images.aspxgt
• Boston Scientific. Fundamentals of ICD Therapy.
  lthttp//www.columbia.edu/itc/hs/medical/hickey/doc
  s/Evolution20of20ICD20Therapy20010907.pdfgt