The subcutaneous implantable cardioverter and defibrillator: advantages, limitations and future directions

References

• Smith TW, Cain ME. Sudden cardiac death: epidemiologic and financial worldwide perspective. J Interv Card Electrophysiol 2006;17(3):199-203
   PubMed Web of Science ®Google Scholar
• Lee TH, Goldman L. The coronary care unit turns 25: historical trends and future directions. Ann Intern Med 1988;108(6):887-94
   PubMed Web of Science ®Google Scholar
• Zoll PM, Linenthal AJ, Gibson W, et al. Termination of ventricular fibrillation in man by externally applied electric countershock. N Engl J Med 1956;254(16):727-32
   PubMed Web of Science ®Google Scholar
• Mirowski M, Mower MM, Staewen WS, et al. Standby automatic defibrillator. An approach to prevention of sudden coronary death. Arch Intern Med 1970;126(1):158-61
   PubMed Web of Science ®Google Scholar
• Schuder JC, Stoeckle H, Gold JH, et al. Experimental ventricular defibrillation with an automatic and completely implanted system. Trans Am Soc Artif Intern Organs 1970;16:207-12
   PubMedGoogle Scholar
• Lown B, Axelrod P. Implanted standby defibrillators. Circulation 1972;46(4):637-9
   PubMed Web of Science ®Google Scholar
• Mirowski M, Reid PR, Mower MM, et al. Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings. N Engl J Med 1980;303(6):322-4
   PubMed Web of Science ®Google Scholar
• Cannom DS, Prystowsky EN. The evolution of the implantable cardioverter defibrillator. Pacing Clin Electrophysiol 2004;27(3):419-31
   PubMed Web of Science ®Google Scholar
• Decision memo for implantable cardioverter defibrillators (ICDs) (CAG-00157N), FDA, Editor 2003
   Google Scholar
• Winkle RA, Mead RH, Ruder MA, et al. Long-term outcome with the automatic implantable cardioverter-defibrillator. J Am Coll Cardiol 1989;13(6):1353-61
   PubMed Web of Science ®Google Scholar
• Baum RS, Alvarez HIII, Cobb LA. Survival after resuscitation from out-of-hospital ventricular fibrillation. Circulation 1974;50(6):1231-5
   PubMed Web of Science ®Google Scholar
• Anderson JL, et al. Design and results of the antiarrhythmics vs implantable defibrillators (AVID) registry. The AVID Investigators. Circulation 1999;99(13):1692-9
   PubMed Web of Science ®Google Scholar
• Connolly SJ, Gent M, Roberts RS, et al. Canadian implantable defibrillator study (CIDS) : a randomized trial of the implantable cardioverter defibrillator against amiodarone. Circulation 2000;101(11):1297-302
   PubMed Web of Science ®Google Scholar
• Kuck KH, Cappato R, Siebels J, et al. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). Circulation 2000;102(7):748-54
   PubMed Web of Science ®Google Scholar
• Ezekowitz JA, Armstrong PW, McAlister FA. Implantable cardioverter defibrillators in primary and secondary prevention: a systematic review of randomized, controlled trials. Ann Intern Med 2003;138(6):445-52
   PubMed Web of Science ®Google Scholar
• Epstein AE, et al. ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities. Heart Rhythm 2008;5(6):e1-62
   PubMed Web of Science ®Google Scholar
• Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter automatic defibrillator implantation trial investigators. N Engl J Med 1996;335(26):1933-40
   PubMed Web of Science ®Google Scholar
• Buxton AE, Lee KL, Fisher JD, et al. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med 1999;341(25):1882-90
   PubMed Web of Science ®Google Scholar
• Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346(12):877-83
   PubMed Web of Science ®Google Scholar
• Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352(3):225-37
   PubMed Web of Science ®Google Scholar
• Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009–a World society of arrhythmia’s project. Pacing Clin Electrophysiol 2011;34(8):1013-27
   PubMed Web of Science ®Google Scholar
• Kleemann T, Becker T, Doenges K, et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation 2007;115(19):2474-80
   PubMed Web of Science ®Google Scholar
• Alter P, Waldhans S, Plachta E, et al. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol 2005;28(9):926-32
   PubMed Web of Science ®Google Scholar
• Epstein AE, Baker JH II, Beau SL, et al. Performance of the St. Jude Medical Riata leads. Heart Rhythm 2009;6(2):204-9
   PubMed Web of Science ®Google Scholar
• Grimm W, et al. Complications of third-generation implantable cardioverter defibrillator therapy. Pacing Clin Electrophysiol 1999;22(1 Pt 2):206-11
   PubMed Web of Science ®Google Scholar
• Khairy P, Landzberg MJ, Gatzoulis MA, et al. Transvenous pacing leads and systemic thromboemboli in patients with intracardiac shunts: a multicenter study. Circulation 2006;113(20):2391-7
   PubMed Web of Science ®Google Scholar
• van Rooden CJ, Molhoek SG, Rosendaal FR, et al. Incidence and risk factors of early venous thrombosis associated with permanent pacemaker leads. J Cardiovasc Electrophysiol 2004;15(11):1258-62
   PubMed Web of Science ®Google Scholar
• Gold MR, Peters RW, Johnson JW, et al. Complications associated with pectoral implantation of cardioverter defibrillators. World-Wide Jewel Investigators. Pacing Clin Electrophysiol 1997;20(1 Pt 2):208-11
   PubMed Web of Science ®Google Scholar
• Kron J, Herre J, Renfroe EG, et al. Lead- and device-related complications in the antiarrhythmics versus implantable defibrillators trial. Am Heart J 2001;141(1):92-8
   PubMed Web of Science ®Google Scholar
• FDA. Medtronic, Inc., Sprint Fidelis Defibrillator Leads: Class I Recall. FDA recalls, 2007
   Google Scholar
• FDA. St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class I Recall. FDA recalls, 2011
   Google Scholar
• Aziz S, Leon AR, El-Chami MF. The subcutaneous defibrillator: a review of the literature. J Am Coll Cardiol 2014;63(15):1473-9
   PubMed Web of Science ®Google Scholar
• Buiten MS, van der Heijden AC, Schalij MJ, et al. How adequate are the current methods of lead extraction? A review of the efficiency and safety of transvenous lead extraction methods. Europace 2015;17(5):689-700
   PubMed Web of Science ®Google Scholar
• Alexander ME, Cecchin F, Walsh EP, et al. Implications of implantable cardioverter defibrillator therapy in congenital heart disease and pediatrics. J Cardiovasc Electrophysiol 2004;15(1):72-6
   PubMed Web of Science ®Google Scholar
• Madan N, Gaynor JW, Tanel R, et al. Single-finger subcutaneous defibrillation lead and “active can”: a novel minimally invasive defibrillation configuration for implantable cardioverter-defibrillator implantation in a young child. J Thorac Cardiovasc Surg 2003;126(5):1657-9
   PubMed Web of Science ®Google Scholar
• Luedemann M, Hund K, Stertmann W, et al. Implantable cardioverter defibrillator in a child using a single subcutaneous array lead and an abdominal active can. Pacing Clin Electrophysiol 2004;27(1):117-19
   PubMed Web of Science ®Google Scholar
• Rowley CP, Gold MR. Subcutaneous implantable cardioverter defibrillator. Circ Arrhythm Electrophysiol 2012;5(3):587-93
   PubMed Web of Science ®Google Scholar
• Grace AA, Smith W, Hood M, et al. A prospective, randomised comparison in humans of defibrillation efficacy of a standard transvenous ICD system with a totally subcutaneous implantable defibrillatory system (S-ICD). European Society of Cardiology Meeting. Stockholm, September 7, 2005
   Google Scholar
• Burke MC, Coman JA, Cates AW, et al. Defibrillation energy requirements using a left anterior chest cutaneous to subcutaneous shocking vector: implications for a total subcutaneous implantable defibrillator. Heart Rhythm 2005;2(12):1332-8
   PubMed Web of Science ®Google Scholar
• Lieberman R, Havel WJ, Rashba E, et al. Acute defibrillation performance of a novel, non-transvenous shock pathway in adult ICD indicated patients. Heart Rhythm 2008;5(1):28-34
   PubMed Web of Science ®Google Scholar
• Gold MR, Theuns DA, Knight BP, 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;23(4):359-66
   PubMed Web of Science ®Google Scholar
• Lupo PP, Pelissero G, Ali H, et al. Development of an entirely subcutaneous implantable cardioverter-defibrillator. Prog Cardiovasc Dis 2012;54(6):493-7
   PubMed Web of Science ®Google Scholar
• Knops RE, et al. Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm 2013;10(8):1240-3
   PubMed Web of Science ®Google Scholar
• Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med 2010;363(1):36-44
   PubMed Web of Science ®Google Scholar
• Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll Cardiol 2012;60(19):1933-9
   PubMed Web of Science ®Google Scholar
• Jarman JW, Todd DM. UK national experience of entirely subcutaneous implantable cardioverter-defibrillator technology: important lessons to learn. Europace 2013;15(8):1158-65
   PubMed Web of Science ®Google Scholar
• Kobe J, Reinke F, Meyer C, et al. Implantation and follow-up of totally subcutaneous versus conventional implantable cardioverter-defibrillators: a multicenter case-control study. Heart Rhythm 2013;10(1):29-36
   PubMed Web of Science ®Google Scholar
• Weiss R, Knight BP, Gold MR, et al. Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator. Circulation 2013;128(9):944-53
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.Gov. S-ICD System Post Approval Study. NCT01736618. 2012. Available from: https://clinicaltrials.gov/ct2/show/NCT01736618
   Google Scholar
• Lambiase PD, Barr C, Theuns DA, et al. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J 2014;35(25):1657-65
   PubMed Web of Science ®Google Scholar
• Olde Nordkamp LR, Knops RE, Bardy GH, 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;163(5):753-60 e2
   PubMed Web of Science ®Google Scholar
• Keller J, Neužil P, Vymazal J, et al. Magnetic resonance imaging in patients with a subcutaneous implantable cardioverter-defibrillator. Europace 2015;17(5):761-6
   PubMed Web of Science ®Google Scholar
• Lerman BB, Deale OC. Relation between transcardiac and transthoracic current during defibrillation in humans. Circ Res 1990;67(6):1420-6
   PubMed Web of Science ®Google Scholar
• Crozier I. The subcutaneous defibrillator will replace the transvenous defibrillator. J Interv Card Electrophysiol 2011;32(1):73-7
   PubMed Web of Science ®Google Scholar
• Walcott GP, Killingsworth CR, Ideker RE. Do clinically relevant transthoracic defibrillation energies cause myocardial damage and dysfunction? Resuscitation 2003;59(1):59-70
   PubMed Web of Science ®Google Scholar
• Killingsworth CR, Melnick SB, Litovsky SH, et al. Evaluation of acute cardiac and chest wall damage after shocks with a subcutaneous implantable cardioverter defibrillator in Swine. Pacing Clin Electrophysiol 2013;36(10):1265-72
   PubMed Web of Science ®Google Scholar
• Daubert JP, Zareba W, Cannom DS, et al. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol 2008;51(14):1357-65
   PubMed Web of Science ®Google Scholar
• Dorian P, Hohnloser SH, Thorpe KE, et al. Mechanisms underlying the lack of effect of implantable cardioverter-defibrillator therapy on mortality in high-risk patients with recent myocardial infarction: insights from the Defibrillation in Acute Myocardial Infarction Trial (DINAMIT). Circulation 2010;122(25):2645-52
   PubMed Web of Science ®Google Scholar
• van Rees JB, Borleffs CJ, de Bie MK, et al. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol 2011;57(5):556-62
   PubMed Web of Science ®Google Scholar
• Poole J.E, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med 2008;359(10):1009-17
   PubMed Web of Science ®Google Scholar
• Groh CA, Sharma S, Pelchovitz DJ, et al. Use of an electrocardiographic screening tool to determine candidacy for a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm 2014;11(8):1361-6
   PubMed Web of Science ®Google Scholar
• Olde Nordkamp LR, Warnaars JL, Kooiman KM, et al. Which patients are not suitable for a subcutaneous ICD: incidence and predictors of failed QRS-T-wave morphology screening. J Cardiovasc Electrophysiol 2014;25(5):494-9
   PubMed Web of Science ®Google Scholar
• Moss AJ, Schuger C, Beck CA, et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 2012;367(24):2275-83
   PubMed Web of Science ®Google Scholar
• Kooiman KM, Knops RE, Olde Nordkamp L, et al. Inappropriate subcutaneous implantable cardioverter-defibrillator shocks due to T-wave oversensing can be prevented: implications for management. Heart Rhythm 2014;11(3):426-34
   PubMed Web of Science ®Google Scholar
• Korkeila P, Nyman K, Ylitalo A, et al. Venous obstruction after pacemaker implantation. Pacing Clin Electrophysiol 2007;30(2):199-206
   PubMed Web of Science ®Google Scholar
• De Maria E, Cappelli S, Cappato R. Shock efficacy of the entirely subcutaneous defibrillator for termination of spontaneous ventricular fibrillation in Brugada syndrome. Heart Rhythm 2013;10(12):1807-9
   PubMed Web of Science ®Google Scholar
• De Maria E, Olaru A, Cappeli S. The subcutaneous defibrillator: who stands to benefit. J Cardiol Pract 2014;12(17
   Google Scholar
• Bloch Thomsen PE, Jons C, Raatikainen MJ, et al. Long-term recording of cardiac arrhythmias with an implantable cardiac monitor in patients with reduced ejection fraction after acute myocardial infarction: the Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) study. Circulation 2010;122(13):1258-64
   PubMed Web of Science ®Google Scholar
• Gillespie S. Incidence of pacemaker implantation in SCD-HeFT: Are single-chamber ICDs enough in heart failure? in HRS. Heart Rhythm Society Meeting. San Francisco, May 7, 2014
   Google Scholar
• Brisben AJ, Burke MC, Knight BP, et al. A new algorithm to reduce inappropriate therapy in the S-ICD System. J Cardiovasc Electrophysiol 2015;26(4):417-23
   PubMed Web of Science ®Google Scholar
• Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation 2014;129(14):1466-71
   PubMed Web of Science ®Google Scholar
• Ritter P, Duray GZ, Steinwender C, et al. Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study. Eur Heart J 2015. [Epub ahead of print]
   Web of Science ®Google Scholar