EMBLEM S-ICD® System
Cardioversor Desfibrilador Implantável Subcutâneo
Abstract
O Sistema S-ICD EMBLEM da Boston Scientific foi desenvolvido com base no excelente desempenho clínico do primeiro sistema de CDI Subcutâneo do mundo. O Emblem deixa o coração e o sistema vascular intocados, fornecendo proteção para pacientes com risco de morte súbita, ao mesmo tempo que evita complicações associadas aos eletrodos endocárdicos (transvenosos). Assim como os CDIs transvenosos convencionais, o S-ICD Emblem utiliza um gerador de pulsos capaz de entregar uma terapia que salva vidas que, ao contrário deles, utiliza um eletrodo subcutâneo para analisar o ritmo cardíaco (ao invés de batimentos individuais) e, efetivamente, detectar, discriminar e reverter taquicardia e fibrilação ventriculares.
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References
1. Weiss, et al. The Safety and Efficacy of a Totally Subcutaneous Implantable-Defibrillator. Circulation 2013.
2. Lambiase, et al. A worldwide experience with a totally subcutaneous ICD; Preliminary results of the EFFORTLESS S-ICD Registry. European Heart Journal Mar2014.
3. Gold MR, et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc Electrophysiol. 2012.
4. SQ-RX PULSE GENERATOR USER’S MANUAL, PN 102098-211, Rev A 2012/12.
5. EMBLEM™ S-ICD PULSE GENERATOR USER’S MANUAL, 359278-002 EN US 2015-02.
6. Smith W, Hood M. HRS 2007 Abstract Presentation S-ICD System Comfort and Tolerability Study Heart Rhythm; 4(5) S210.
7. L.R.A. Olde Nordkamp et al. Implantable Cardioverter-Defibrillator Harm in Young Patients with Inherited Arrhythmia Syndromes: A Systematic Review and Meta-Analysis of Inappropriate Shocks and Complications. Heart Rhythm 2015.
8. Ranasinghe, et al. Long-Term Device-Related Adverse Events After Implantable Cardioverter-Defibrillator Therapy. AHA 2014 Abstract 20158.
9. Koneru J.N. et al. Risk factors associated with implantable cardiac defibrillator transvenous lead reintervention. HRS 2015. PO03-52
10. Bongiorni, et al. Current practice in transvenous lead extraction: a European Heart Rhythm Association EP Network Survey. Europace 2012;14:783-786.
11. Tarakji KG, et al. Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. Europace 2014;16:1490-5.
12. Poole, et al. Who Should Receive the Subcutaneous Implanted Defibrillator? The Subcutaneous Implantable Cardioverter Defibrillator (ICD) Should Be Considered in all ICD Patients Who Do Not Require Pacing. Circulation: Arrhythmia and Electrophysciology 2013;6: 1236-1245.
13. Bardy, G. H., W. M. Smith, et al. (2010). “An entirely subcutaneous implantable cardioverter-defibrillator.” N Engl J Med 363(1):36-44.
14. Heart Rhythm - May 2012; Vol 9:5(S1-33) AB07-2.
15. M.C. Burke et al. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-year Results from a Pooled Analysis of the IDE Study and EFFORTLESS Registry. JACC 2015.
16. Olde Nordkamp, L.R. et al. Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. Am. Heart. J. 2012 May;163(5):753-760.e2. doi: 10.1016/j.ahj.2012.02.012.
17. S-ICD® System Post Approval Study: https://clinicaltrials.gov/ct2/show/NCT01736618.
18. Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED): https://clinicaltrials.gov/ct2/show/NCT02433379.
19. PM Elliot 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy. Eur Heart J 2014 Page 1.
20. Rhythm Management Product Performance Report, Q2 2016 (Data as of June 2016).
21. Theuns, D, et al. Evaluation of a Novel Algorithm Designed to Reduce Oversensing in the S-ICD. HRS 2016; AB05-01. Cha YM et al. Heart Rhythm 2013;10:702-708.
22. Swerdlow CD et al. PACE 2007;30:675-700.
23. Kutyifa V, et al. J Cardiovasc Electrophysiol 2013;24:1246-52.
2. Lambiase, et al. A worldwide experience with a totally subcutaneous ICD; Preliminary results of the EFFORTLESS S-ICD Registry. European Heart Journal Mar2014.
3. Gold MR, et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc Electrophysiol. 2012.
4. SQ-RX PULSE GENERATOR USER’S MANUAL, PN 102098-211, Rev A 2012/12.
5. EMBLEM™ S-ICD PULSE GENERATOR USER’S MANUAL, 359278-002 EN US 2015-02.
6. Smith W, Hood M. HRS 2007 Abstract Presentation S-ICD System Comfort and Tolerability Study Heart Rhythm; 4(5) S210.
7. L.R.A. Olde Nordkamp et al. Implantable Cardioverter-Defibrillator Harm in Young Patients with Inherited Arrhythmia Syndromes: A Systematic Review and Meta-Analysis of Inappropriate Shocks and Complications. Heart Rhythm 2015.
8. Ranasinghe, et al. Long-Term Device-Related Adverse Events After Implantable Cardioverter-Defibrillator Therapy. AHA 2014 Abstract 20158.
9. Koneru J.N. et al. Risk factors associated with implantable cardiac defibrillator transvenous lead reintervention. HRS 2015. PO03-52
10. Bongiorni, et al. Current practice in transvenous lead extraction: a European Heart Rhythm Association EP Network Survey. Europace 2012;14:783-786.
11. Tarakji KG, et al. Risk factors for 1-year mortality among patients with cardiac implantable electronic device infection undergoing transvenous lead extraction: the impact of the infection type and the presence of vegetation on survival. Europace 2014;16:1490-5.
12. Poole, et al. Who Should Receive the Subcutaneous Implanted Defibrillator? The Subcutaneous Implantable Cardioverter Defibrillator (ICD) Should Be Considered in all ICD Patients Who Do Not Require Pacing. Circulation: Arrhythmia and Electrophysciology 2013;6: 1236-1245.
13. Bardy, G. H., W. M. Smith, et al. (2010). “An entirely subcutaneous implantable cardioverter-defibrillator.” N Engl J Med 363(1):36-44.
14. Heart Rhythm - May 2012; Vol 9:5(S1-33) AB07-2.
15. M.C. Burke et al. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-year Results from a Pooled Analysis of the IDE Study and EFFORTLESS Registry. JACC 2015.
16. Olde Nordkamp, L.R. et al. Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. Am. Heart. J. 2012 May;163(5):753-760.e2. doi: 10.1016/j.ahj.2012.02.012.
17. S-ICD® System Post Approval Study: https://clinicaltrials.gov/ct2/show/NCT01736618.
18. Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED): https://clinicaltrials.gov/ct2/show/NCT02433379.
19. PM Elliot 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy. Eur Heart J 2014 Page 1.
20. Rhythm Management Product Performance Report, Q2 2016 (Data as of June 2016).
21. Theuns, D, et al. Evaluation of a Novel Algorithm Designed to Reduce Oversensing in the S-ICD. HRS 2016; AB05-01. Cha YM et al. Heart Rhythm 2013;10:702-708.
22. Swerdlow CD et al. PACE 2007;30:675-700.
23. Kutyifa V, et al. J Cardiovasc Electrophysiol 2013;24:1246-52.
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Published
2018-01-08
How to Cite
Scientific, B. (2018). EMBLEM S-ICD® System: Cardioversor Desfibrilador Implantável Subcutâneo. JOURNAL OF CARDIAC ARRHYTHMIAS, 31(1), 31–33. Retrieved from https://jca.emnuvens.com.br/jca/article/view/55
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