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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 - PowerPoint PPT Presentation
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Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
Tanner BarnesBME 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
•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)
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
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
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
Design of S-ICD:
The S-ICD System is comprised of the following four devices: 1.SQ-RX Pulse Generator– 80-J biphasic shock– Charge time to 80-J ≤ 10 seconds– 5.1 year longevity– 30 seconds post-shock pacing
2.Q-TRAK Subcutaneous Electrode3.Q-GUIDE Electrode Insertion Tool (EIT)4.Q-TECH Programmer
Implantation of S-ICD:• All components implanted just below the skin• Only requires 3 small incisions• Can be an outpatient procedure
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
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
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
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
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
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
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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