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Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD). Tanner Barnes BME 281. The Problem:. 300,000 people die each year in the United States due to sudden cardiac arrest (SCA ) 80-90% due to ventricular tachyarrhythmias

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Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

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  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-ICD’s 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 >30 kg • Possible for children <30 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. <http://www.bostonscientific.com/cardiac-rhythm-resources/cameron-health/sicd-system.html>. • "What Causes Sudden Cardiac Arrest?." National Heart, Lung, and Blood Institute. N.p., 1 1 2011. Web. 20 Oct 2013. <http://www.nhlbi.nih.gov/health/health-topics/topics/scda/causes.html>. • "Subcutaneous Implantable Defibrillator (S-ICD) System Advisory Panel Package Summary of Safety and Effectiveness Data." . FDA. Web. 20 Oct 2013. <http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM301237.pdf>. • <http://www.epdoc.net/professional/patientpages/Equipment-and-Device-Images.aspx> • Boston Scientific. “Fundamentals of ICD Therapy”. <http://www.columbia.edu/itc/hs/medical/hickey/docs/Evolution%20of%20ICD%20Therapy%20010907.pdf>

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