Subcutaneous Implantable Cardioverter Defibrillators: An Overview of Implantation Techniques and Clinical Outcomes

Author(s): Bandar Al-Ghamdi* .

Journal Name: Current Cardiology Reviews

Volume 15 , Issue 1 , 2019

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Graphical Abstract:


Abstract:

Sudden Cardiac Death (SCD) is a significant health problem worldwide.

Multiple randomized controlled trials have shown that Implantable Cardioverter Defibrillators (ICDs) are effective life-saving management option for individuals at risk of SCD in both primary and secondary prevention. Although the conventional transvenous ICDs (TV-ICDs) are safe and effective, there are potential complications associated with its use, including localized pocket or wound infection or systematic infection, a vascular access related complication such as pneumothorax, and venous thrombosis, and lead related complications such as dislodgement, malfunction, and perforation.

Furthermore, transvenous leads placement may not be feasible in certain patients like those with venous anomaly or occlusion, or with the presence of intracardiac shunts. Transvenous leads extraction, when needed, is associated with considerable morbidity & mortality and requires significant skills and costs. Totally subcutaneous ICD (S-ICD) is designed to afford the same life-saving benefit of the conventional TV-ICDs while avoiding the shortcomings of the TV-leads and to simplify the implant techniques and hence expand the use of ICDs in clinical practice. It becomes commercially available after receiving CE mark in 2009, and its use increased significantly after its FDA approval in 2012. This review aims to give an overview of the S-ICD system components, implantation procedure, clinical indications, safety, efficacy, and future directions.

Keywords: Implantable cardioverter defibrillator, subcutaneous, side effects, efficacy, safety, FDA.

[1]
Zipes DP, Wellens HJ. Sudden cardiac death. Circulation 1998; 98: 2334-51.
[2]
Writing Group Members. Benjamin EJ, Virani SS, Callaway CW, et al on behalf of On behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2018 update. A Report From the American Heart Association. Circulation 2018; 137: e1-e441.
[3]
Buxton AE, Lee KL, Fisher JD, et al. For the Multicenter Unsustained Tachycardia Trial Investigators. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med 1999; 341: 1882-90.
[4]
Moss AJ, Hall WJ, Cannom DS, et al. For the Multicenter Automatic Defibrillator Implantation Trial Investigators. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med 1996; 335: 1933-40.
[5]
Moss AJ, Zareba W, Hall WJ, et al. For the Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877-83.
[6]
Bardy GH, Lee KL, Mark DB, et al. For the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter– defibrillator for congestive heart failure. N Engl J Med 2005; 352: 225-37.
[7]
Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near fatal ventricular arrhythmias. N Engl J Med 1997; 337: 1576-84.
[8]
Connolly SJ, Hallstrom AP, Cappato R, et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg. Canadian Implantable Defibrillator Study. Eur Heart J 2000; 21(24): 2071-8.
[9]
Mirowski M, Reid PR, Mower MM. Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings. N Engl J Med 1980; 303: 322-4.
[10]
Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med 2010; 363: 36-44.
[12]
Gold MR, Aasbo JD, El-Chami MF, et al. Subcutaneous implantable cardioverter-defibrillator Post-Approval Study: Clinical characteristics and perioperative results. Heart Rhythm 2017; 14(10): 1456-63.
[13]
Chang SC, Patton KK, Robinson MR, Poole JE, Prutkin JM. Subcutaneous ICD screening with the Boston Scientific ZOOM programmer versus a 12-lead ECG machine. Pacing Clin Electrophysiol 2018; 41(5): 511-6.
[14]
Randles DA, Hawkins NM, Shaw M, Patwala AY, Pettit SJ, Wright DJ. How many patients fulfil the surface electrocardiogram criteria for subcutaneous implantable cardioverter-defibrillator implantation? Europace 2013; 16: 1015-21.
[15]
Olde Nordkamp LR, Warnaars JLF, 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: 494-9.
[16]
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: 1361-6.
[17]
Elliott PM, Anastasakis A, Borger MA, et al. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: The task force for the diagnosis and management of hypertrophic cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J 2014; 35: 2733-79.
[18]
Srinivasan NT, Patel KH, Qamar K, et al. Disease severity and exercise testing reduce subcutaneous implantable cardioverter-defibrillator left sternal ECG screening success in hypertrophic cardiomyopathy. Circ Arrhythm Electrophysiol 2017; 10(4): e004801.
[19]
Conte G, Kawabata M, de Asmundis C, et al. High rate of subcutaneous implantable cardioverter-defibrillator sensing screening failure in patients with Brugada syndrome: A comparison with other inherited primary arrhythmia syndromes. Europace 2018; 20(7): 1188-93.
[20]
Kamakura T, Wada M, Ishibashi K, et al. Impact of electrocardiogram screening during drug challenge test for the prediction of T-wave oversensing by a subcutaneous implantable cardioverter defibrillator in patients with Brugada syndrome. Heart Vessels 2017; 32(10): 1277-83.
[21]
Sarkozy A, Brugada P, Mont L, Brugada J. Optimizing the clinical use of implantable defibrillators in patients with Brugada syndrome. Eur Heart J 2007; 9: 174-80.
[22]
Zorzi A, ElMaghawry M, Rigato I, et al. Exercise-induced normalization of right precordial negative T waves in arrhythmogenic right ventricular cardiomyopathy. Am J Cardiol 2013; 112(3): 411-5.
[23]
Migliore F, Bertaglia E, Zorzi A, Corrado D. Cardioverter-defibrillator and arrhythmogenic right ventricular cardiomyopathy the importance of repeat ECG screening during exercise test. JACC Clin Electrophysiol 2017; 3(7): 785-6.
[24]
Zeb M, Curzen N, Veldtman G, et al. Potential eligibility of congenital heart disease patients for subcutaneous implantable cardioverter defibrillator based on surface electrocardiogram mapping. Europace 2015; 17(7): 1059-67.
[25]
Brouwer TF, Kooiman KM, Olde Nordkamp LR, van Halm VP, Knops RE. Algorithm-based screening may improve patient selection for the subcutaneous implantable defibrillator. JACC Clin Electrophysiol 2016; 2(5): 605-14.
[26]
Essandoh MK, Otey AJ, Abdel-Rasoul M, et al. Monitored anesthesia care for subcutaneous cardioverter-defibrillator implantation: A single-center experience. J Cardiothorac Vasc Anesth 2016; 30(5): 1228-33.
[27]
Brouwer TF, Miller MA, Quast AB, et al. Implantation of the subcutaneous implantable cardioverter-defibrillator: An evaluation of 4 implantation techniques. Circ Arrhythm Electrophysiol 2017; 10(1): e004663.
[28]
Ferrari P, Giofrè F, De Filippo P. Intermuscular pocket for subcutaneous implantable cardioverter defibrillator: Single-center experience. J Arrhythm 2016; 32: 223-6.
[29]
Knops RE, Olde Nordkamp LR, de Groot JR, Wilde AA. Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm 2013; 10: 1240-3.
[30]
Migliore F, Allocca G, Calzolari V, et al. Intermuscular two-incision technique for subcutaneous implantable cardioverter defibrillator implantation: Results from a multicenter registry. Pacing Clin Electrophysiol 2017; 40(3): 278-85.
[31]
Rattes MF, Jones DL, Sharma AD, Klein GJ. Defibrillation threshold: A simple and quantitative estimate of the ability to defibrillate. Pacing Clin Electrophysiol 1987; 10(1 Pt 1): 70-7.
[32]
Healey JS, Hohnloser SH, Glikson M, et al. Shockless IMPLant Evaluation [SIMPLE] Investigators. Cardioverter defibrillator implantation without induction of ventricular fibrillation: A single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet 2015; 385: 785-91.
[33]
Al-Ghamdi B, Shafquat A, Alruwaili N, Emmanual S, Shoukri M, Mallawi Y. Subcutaneous implantable cardioverter defibrillators implantation without defibrillation threshold testing: A single center experience. Cardiol Res 2017; 8(6): 319-26.
[34]
Lambiase PD, Barr C, Theuns DA, et al. EFFORTLESS Investigators Worldwide experience with a totally subcutaneous implantable defibrillator: Early results from the EFFORTLESS S-ICD Registry. Eur Heart J 2014; 35: 1657-65.
[35]
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: 359-66.
[36]
Burke MC, Gold MR, Knight BP, 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. J Am Coll Cardiol 2015; 65(16): 1605-15.
[37]
Jarman JW, Lascelles K, Wong T, et al. Clinical experience of entirely subcutaneous implantable cardioverter-defibrillators in children and adults: Cause for caution. Eur Heart J 2012; 33: 1351-9.
[38]
Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantablecardioverter defibrillator. Circulation 2013; 128: 944-53.
[39]
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: 1933-9.
[40]
Wilkoff BL. How to treat and identify device infections. Heart Rhythm 2007; 4: 1467-70.
[41]
Le KY, Sohail MR, Friedman PA, et al. for the Mayo Cardiovascular Infections Study Group Clinical predictors of cardiovascular implantable electronic device-related infective endocarditis. PACE 2011; 34: 450-9.
[42]
Köbe 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: 29-36.
[43]
Ezzat VA, Lee V, Ahsan S, et al. A systematic review of ICD complications in randomised controlled trials versus registries: Is our ‘real-world’ data an underestimation? Open Heart 2015; 2: e000198.
[44]
Freeman JV, Wang Y, Curtis JP, et al. Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation 2012; 125: 57-64.
[45]
van Rees JB, de Bie MK, Thijssen J, et al. Implantation-related complications of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices: A systematic review of randomized clinical trials. J Am Coll Cardiol 2011; 58: 995-1000.
[46]
Jarman JW, Todd DM. United Kingdom national experience of entirely subcutaneous implantable cardioverter-defibrillator technology: Important lessons to learn. Europace 2013; 15: 1158-65.
[47]
Lewis GF, Gold MR. Safety and efficacy of the subcutaneous implantable defibrillator. J Am Coll Cardiol 2016; 67(4): 445-54.
[48]
Theuns DA, Crozier IG, Barr CS, et al. Longevity of the subcutaneous implantable defibrillator: Long-term follow-up of the European Regulatory Trial Cohort. Circ Arrhythm Electrophysiol 2015; 8: 1159-63.
[49]
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: 2474-80.
[50]
Moss AJ, Schuger C, Beck CA, et al. MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 2012; 367: 2275-83.
[51]
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: 417-23.
[52]
Knops RE, Brouwer TF, Barr CS, et al. The learning curve associated with the introduction of the subcutaneous implantable defibrillator. Europace 2016; 18(7): 1010-5.
[53]
Rowley CP, Gold MR. Subcutaneous implantable cardioverter defibrillator. Circ Arrhythm Electrophysiol 2012; 5: 587-93.
[54]
Gold MR, Ahmad S, Browne K, et al. Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: Primary results of the Rhythm ID Going Head to Head Trial. Heart Rhythm 2012; 9: 370-7.
[55]
Gilliam FR, Hayes DL, Boehmer JP, et al. Realworld evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: The ALTITUDE REDUCES study. J Cardiovasc Electrophysiol 2011; 22: 1023-9.
[56]
Wilkoff BL, Williamson BD, Stern RS, et al. PREPARE Study Investigators. Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. J Am Coll Cardiol 2008; 52: 541-50.
[57]
Gasparini M, Proclemer A, Klersy C, et al. Effect of long-detection interval vs. standard detection interval for implantable cardioverter defibrillators on antitachycardia pacing and shock delivery: The ADVANCE III randomized clinical trial. JAMA 2013; 309: 1903-11.
[58]
Zipse MM, Sauer WH, Varosy PD, Aleong RG, Nguyen DT. Inappropriate shocks due to subcutaneous air in a patient with a subcutaneous cardiac defibrillator. Circ Arrhythm Electrophysiol 2014; 7(4): 768-70.
[59]
Crea P, Nicotera A, Crea B, Taormina A, Picciolo G. An anomalous case of S-ICD malfunctioning: A big trouble or a soap bubble? Cor et Vasa 2018; 60(5): e472-4.
[60]
Winter J, Kohlmeier A, Shin DI, O’Connor S. Subcutaneous implantable cardioverter-defibrillators and sternal wires: A cautionary tale. Circ Arrhythm Electrophysiol 2014; 7(5): 986-7.
[61]
Priori SG, Blomström-Lundqvist C, Mazzanti A, et al. ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J 2015; 36(41): 2793-867.
[62]
Bennett M, Parkash R, Nery P, et al. Canadian cardiovascular society/Canadian heart rhythm society 2016 implantable cardioverter-defibrillator guidelines. Can J Cardiol 2017; 33(2): 174-88.
[63]
Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2018; 72(14): 1677-749.
[64]
Varma N. Remote monitoring of ICDs and CRTs. J Arrhythm 2013; 29: 144-52.
[65]
Porterfield C, DiMarco JP, Mason PK. Effectiveness of implantation of a subcutaneous implantable cardioverter-defibrillator in a patient with complete heart block and a pacemaker. Am J Cardiol 2015; 115: 276-8.
[66]
Kuschyk J, Stach K, Tülümen E, et al. The subcutaneous implantable cardioverter-defibrillator – First single center experience with other cardiac implantable electronic devices. Heart Rhythm 2015; 12: 2230-8.
[67]
Röger S, Borggrefe M, Kuschyk J. Heart failure with reduced ejection fraction and a narrow QRS complex: Combination of a subcutaneous defibrillator with cardiac contractility modulation. J Atr Fibrillation 2015; 8: 74-8.
[68]
Al-Ghamdi B, Shafquat A, Mallawi Y. Cardiac contractility modulation device and subcutaneous implantable cardioverter defibrillator combination: A new hope for heart failure patients with low ejection fraction and narrow qrs complex. J Cardiovasc Med Cardiol 2016; 3(1): 018-22.
[69]
Poole JE, Gold MR. 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. Circ Arrhythmia Electrophysiol 2013; 6: 1236- 44. discussion 1244-5.
[70]
Tjong FVY, Brouwer TF, Koop B. Acute and 3-month performance of a communicating leadless antitachycardia pacemaker and subcutaneous implantable defibrillator. JACC Clin Electrophysiol 2017; 3(13): 1487-98.
[71]
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.
[72]
Available at. https://clinicaltrials.gov/ct2/show/NCT02881255 (Accessed on: March 10, 2018).
[73]
Kutyifa V, Beck C, Brown MW, et al. MADIT S-ICD Executive Committee. Multicenter Automatic Defibrillator Implantation Trial-Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol. Am Heart J 2017; 189: 158-66.


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Article Details

VOLUME: 15
ISSUE: 1
Year: 2019
Page: [38 - 48]
Pages: 11
DOI: 10.2174/1573403X14666180716164740
Price: $58

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