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Original article

Vol. 147 No. 4142 (2017)

The subcutaneous implantable cardioverter defibrillator in daily clinical practice

  • Tardu Özkartal
  • Alexander Breitenstein
  • Ardan M. Saguner
  • Devdas T. Inderbitzin
  • Markus J. Wilhelm
  • Stefano Benussi
  • Francesco Maisano
  • Thomas F. Lüscher
  • Frank Ruschitzka
  • Jan Steffel
DOI
https://doi.org/10.4414/smw.2017.14518
Cite this as:
Swiss Med Wkly. 2017;147:w14518
Published
22.10.2017

Summary

INTRODUCTION

In Switzerland, the first implantation of a subcutaneous implantable cardioverter-defibrillator (S-ICD) took place in November 2012. Up until the end of 2016, a total of 111 S-ICDs have been implanted. The aim of this study was to summarise the experience of a tertiary centre in Switzerland and to discuss the results in the context of international registries.

METHODS

All patients in whom an S-ICD was implanted between November 2012 and the end of December 2016 at the University Heart Centre Zurich were included in this study. The clinical records of all patients were reviewed for retrospective collection of baseline characteristics as well as implantation and follow-up data.

RESULTS

A total of 37 S-ICDs were implanted. The majority of patients (81%) were male, the mean age was 47 ± 15 years. The most common underlying cardiac condition was coronary artery disease (30%), followed by hypertrophic cardiomyopathy (24%), inherited channelopathies (19%) and nonischaemic cardiomyopathy (11%). The median left ventricular ejection fraction was 44% (interquartile range 28–61%). There were four peri-interventional complications, all of which were pocket site-related. There were no cases of systemic infection or perioperative death. During a median follow up of 3.7 months, there were three appropriate and successful ICD shocks (8.1%). Two patients (5.4%) experienced a total of three inappropriate shocks, all due to T-wave oversensing.

CONCLUSION

This first large Swiss experience demonstrates results consistent with available international data. The S-ICD may hence represent an attractive alternative to conventional transvenous ICDs for a variety of patients.

References

  1. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al.; 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(3):225–37. doi:.https://doi.org/10.1056/NEJMoa043399
  2. Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, et al.; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350(21):2151–8. doi:.https://doi.org/10.1056/NEJMoa033088
  3. Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, et al.; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012;367(24):2275–83. doi:.https://doi.org/10.1056/NEJMoa1211107
  4. Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, et al. 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. doi:.https://doi.org/10.1093/eurheartj/ehv316
  5. Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, et al.; 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(26):1933–40. doi:.https://doi.org/10.1056/NEJM199612263352601
  6. Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al.; 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(12):877–83. doi:.https://doi.org/10.1056/NEJMoa013474
  7. Mirowski M, Reid PR, Mower MM, Watkins L, Gott VL, Schauble JF, et al. Termination of malignant ventricular arrhythmias with an implanted automatic defibrillator in human beings. N Engl J Med. 1980;303(6):322–4. doi:.https://doi.org/10.1056/NEJM198008073030607
  8. Brady PA, Friedman PA, Trusty JM, Grice S, Hammill SC, Stanton MS. High failure rate for an epicardial implantable cardioverter-defibrillator lead: implications for long-term follow-up of patients with an implantable cardioverter-defibrillator. J Am Coll Cardiol. 1998;31(3):616–22. doi:.https://doi.org/10.1016/S0735-1097(97)00529-9
  9. van Welsenes GH, Borleffs CJ, van Rees JB, Atary JZ, Thijssen J, van der Wall EE, et al. Improvements in 25 Years of Implantable Cardioverter Defibrillator Therapy. Neth Heart J. 2011;19(1):24–30. doi:.https://doi.org/10.1007/s12471-010-0047-3
  10. Auricchio A, Schloss EJ, Kurita T, Meijer A, Gerritse B, Zweibel S, et al.; PainFree SST Investigators. Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results. Heart Rhythm. 2015;12(5):926–36. doi:.https://doi.org/10.1016/j.hrthm.2015.01.017
  11. Tung R, Zimetbaum P, Josephson ME. A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. J Am Coll Cardiol. 2008;52(14):1111–21. doi:.https://doi.org/10.1016/j.jacc.2008.05.058
  12. Borleffs CJ, van Erven L, van Bommel RJ, van der Velde ET, van der Wall EE, Bax JJ, et al. Risk of failure of transvenous implantable cardioverter-defibrillator leads. Circ Arrhythm Electrophysiol. 2009;2(4):411–6. doi:.https://doi.org/10.1161/CIRCEP.108.834093
  13. Alter P, Waldhans S, Plachta E, Moosdorf R, Grimm W. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol. 2005;28(9):926–32. doi:.https://doi.org/10.1111/j.1540-8159.2005.00195.x
  14. Kleemann T, Becker T, Doenges K, Vater M, Senges J, Schneider S, 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. doi:.https://doi.org/10.1161/CIRCULATIONAHA.106.663807
  15. Edelstein S, Yahalom M. Cardiac device-related endocarditis: Epidemiology, pathogenesis, diagnosis and treatment - a review. Int J Angiol. 2009;18(4):167–72. doi:.https://doi.org/10.1055/s-0031-1278347
  16. Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol. 2012;5(2):252–7. doi:.https://doi.org/10.1161/CIRCEP.111.965277
  17. Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010;363(1):36–44. doi:.https://doi.org/10.1056/NEJMoa0909545
  18. Rowley CP, Gold MR. Subcutaneous implantable cardioverter defibrillator. Circ Arrhythm Electrophysiol. 2012;5(3):587–93. doi:.https://doi.org/10.1161/CIRCEP.111.964676
  19. Brouwer TF, Yilmaz D, Lindeboom R, Buiten MS, Olde Nordkamp LR, Schalij MJ, et al. Long-Term Clinical Outcomes of Subcutaneous Versus Transvenous Implantable Defibrillator Therapy. J Am Coll Cardiol. 2016;68(19):2047–55. doi:.https://doi.org/10.1016/j.jacc.2016.08.044
  20. Brouwer TF, Miller MA, Quast AB, Palaniswamy C, Dukkipati SR, Reddy V, et al. Implantation of the Subcutaneous Implantable Cardioverter-Defibrillator: An Evaluation of 4 Implantation Techniques. Circ Arrhythm Electrophysiol. 2017;10(1):e004663. doi:.https://doi.org/10.1161/CIRCEP.116.004663
  21. Burke MC, Gold MR, Knight BP, Barr CS, Theuns DA, Boersma LV, 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. doi:.https://doi.org/10.1016/j.jacc.2015.02.047
  22. Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, 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(25):1657–65. doi:.https://doi.org/10.1093/eurheartj/ehu112
  23. Gasparini M, Proclemer A, Klersy C, Kloppe A, Lunati M, Ferrer JB, 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(18):1903–11. doi:.https://doi.org/10.1001/jama.2013.4598
  24. Blatt JA, Poole JE, Johnson GW, Callans DJ, Raitt MH, Reddy RK, et al.; SCD-HeFT Investigators. No benefit from defibrillation threshold testing in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol. 2008;52(7):551–6. doi:.https://doi.org/10.1016/j.jacc.2008.04.051
  25. Kutyifa V, Huth Ruwald AC, Aktas MK, Jons C, McNitt S, Polonsky B, et al. Clinical impact, safety, and efficacy of single- versus dual-coil ICD leads in MADIT-CRT. J Cardiovasc Electrophysiol. 2013;24(11):1246–52. doi:.https://doi.org/10.1111/jce.12219
  26. Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013;128(9):944–53. doi:.https://doi.org/10.1161/CIRCULATIONAHA.113.003042
  27. van Rees JB, de Bie MK, Thijssen J, Borleffs CJ, Schalij MJ, van Erven L. 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(10):995–1000. doi:.https://doi.org/10.1016/j.jacc.2011.06.007
  28. Kirkfeldt RE, Johansen JB, Nohr EA, Moller M, Arnsbo P, Nielsen JC. Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 Danish patients. Heart Rhythm. 2011;8(10):1622–8. doi:.https://doi.org/10.1016/j.hrthm.2011.04.014
  29. Hammill SC, Kremers MS, Stevenson LW, Heidenreich PA, Lang CM, Curtis JP, et al. Review of the registry’s fourth year, incorporating lead data and pediatric ICD procedures, and use as a national performance measure. Heart Rhythm. 2010;7(9):1340–5. doi:.https://doi.org/10.1016/j.hrthm.2010.07.015
  30. Honarbakhsh S, Providencia R, Srinivasan N, Ahsan S, Lowe M, Rowland E, et al. A propensity matched case-control study comparing efficacy, safety and costs of the subcutaneous vs. transvenous implantable cardioverter defibrillator. Int J Cardiol. 2017;228:280–5. doi:.https://doi.org/10.1016/j.ijcard.2016.11.017
  31. Maytin M, Epstein LM. The challenges of transvenous lead extraction. Heart. 2011;97(5):425–34. doi:.https://doi.org/10.1136/hrt.2009.189910
  32. Lewis GF, Gold MR. Safety and Efficacy of the Subcutaneous Implantable Defibrillator. J Am Coll Cardiol. 2016;67(4):445–54. doi:.https://doi.org/10.1016/j.jacc.2015.11.026
  33. Sweeney MO, Ellenbogen KA, Tang AS, Whellan D, Mortensen PT, Giraldi F, et al.; Managed Ventricular Pacing Versus VVI 40 Pacing Trial Investigators. Atrial pacing or ventricular backup-only pacing in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010;7(11):1552–60. doi:.https://doi.org/10.1016/j.hrthm.2010.05.038
  34. Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, et al.; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002;288(24):3115–23. doi:.https://doi.org/10.1001/jama.288.24.3115
  35. Huang J, Patton KK, Prutkin JM. Concomitant Use of the Subcutaneous Implantable Cardioverter Defibrillator and a Permanent Pacemaker. Pacing Clin Electrophysiol. 2016;39(11):1240–5. doi:.https://doi.org/10.1111/pace.12955
  36. Erath JW, Sirat AS, Vamos M, Hohnloser SH. Implantation eines epikardialen CRT-P- und S-ICD bei einem jungen Patienten mit persistierender linker oberer Hohlvene [Epicardial CRT-P- and S-ICD Implantation in a Young Patient with Persistent Left Superior Vena Cava]. Herzschrittmacherther Elektrophysiol. 2016;27(4):396–8. Article in English. doi:.https://doi.org/10.1007/s00399-016-0451-5
  37. Tjong FV, Brouwer TF, Smeding L, Kooiman KM, de Groot JR, Ligon D, et al. Combined leadless pacemaker and subcutaneous implantable defibrillator therapy: feasibility, safety, and performance. Europace. 2016;18(11):1740–7. doi:.https://doi.org/10.1093/europace/euv457
  38. Mont L, Valentino M, Sambola A, Matas M, Aguinaga L, Brugada J. Arrhythmia recurrence in patients with a healed myocardial infarction who received an implantable defibrillator: analysis according to the clinical presentation. J Am Coll Cardiol. 1999;34(2):351–7. doi:.https://doi.org/10.1016/S0735-1097(99)00206-5
  39. Goldenberg I, Gillespie J, Moss AJ, Hall WJ, Klein H, McNitt S, et al.; Executive Committee of the Multicenter Automatic Defibrillator Implantation Trial II. Long-term benefit of primary prevention with an implantable cardioverter-defibrillator: an extended 8-year follow-up study of the Multicenter Automatic Defibrillator Implantation Trial II. Circulation. 2010;122(13):1265–71. doi:.https://doi.org/10.1161/CIRCULATIONAHA.110.940148
  40. Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008;359(10):1009–17. doi:.https://doi.org/10.1056/NEJMoa071098
  41. Humphreys NK, Lowe R, Rance J, Bennett PD. Living with an implantable cardioverter defibrillator: The patients’ experience. Heart Lung. 2016;45(1):34–40. doi:.https://doi.org/10.1016/j.hrtlng.2015.10.001
  42. Proietti R, Labos C, Davis M, Thanassoulis G, Santangeli P, Russo V, et al. A systematic review and meta-analysis of the association between implantable cardioverter-defibrillator shocks and long-term mortality. Can J Cardiol. 2015;31(3):270–7. doi:.https://doi.org/10.1016/j.cjca.2014.11.023
  43. Gold MR, Ahmad S, Browne K, Berg KC, Thackeray L, Berger RD. 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(3):370–7. doi:.https://doi.org/10.1016/j.hrthm.2011.10.004
  44. Wilkoff BL, Williamson BD, Stern RS, Moore SL, Lu F, Lee SW, 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(7):541–50. doi:.https://doi.org/10.1016/j.jacc.2008.05.011
  45. Gilliam FR, Hayes DL, Boehmer JP, Day J, Heidenreich PA, Seth M, et al. Real world evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: the ALTITUDE REDUCES study. J Cardiovasc Electrophysiol. 2011;22(9):1023–9. doi:.https://doi.org/10.1111/j.1540-8167.2011.02086.x
  46. van Rees JB, Borleffs CJ, de Bie MK, Stijnen T, van Erven L, Bax JJ, et al. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol. 2011;57(5):556–62. doi:.https://doi.org/10.1016/j.jacc.2010.06.059
  47. Daubert JP, Zareba W, Cannom DS, McNitt S, Rosero SZ, Wang P, et al.; MADIT II Investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. 2008;51(14):1357–65. doi:.https://doi.org/10.1016/j.jacc.2007.09.073
  48. Dabiri Abkenari L, Theuns DA, Valk SD, Van Belle Y, de Groot NM, Haitsma D, et al. Clinical experience with a novel subcutaneous implantable defibrillator system in a single center. Clin Res Cardiol. 2011;100(9):737–44. doi:.https://doi.org/10.1007/s00392-011-0303-6
  49. Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, Maass AH, de Groot JR, van Oostrom AJ, 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. doi:.https://doi.org/10.1016/j.jacc.2012.06.053
  50. Aydin A, Hartel F, Schlüter M, Butter C, Köbe J, Seifert M, et al. Shock efficacy of subcutaneous implantable cardioverter-defibrillator for prevention of sudden cardiac death: initial multicenter experience. Circ Arrhythm Electrophysiol. 2012;5(5):913–9. doi:.https://doi.org/10.1161/CIRCEP.112.973339
  51. Groh CA, Sharma S, Pelchovitz DJ, Bhave PD, Rhyner J, Verma N, et al. Use of an electrocardiographic screening tool to determine candidacy for a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. 2014;11(8):1361–6. doi:.https://doi.org/10.1016/j.hrthm.2014.04.025
  52. Conte G, Regoli F, Moccetti T, Auricchio A. Subcutaneous implantable cardioverter-defibrillator and drug-induced Brugada syndrome: the importance of repeat morphology analysis during ajmaline challenge. Eur Heart J. 2016;37(19):1498. doi:.https://doi.org/10.1093/eurheartj/ehv572
  53. Knops RE, Brouwer TF, Barr CS, Theuns DA, Boersma L, Weiss R, et al.; IDE and EFFORTLESS investigators. The learning curve associated with the introduction of the subcutaneous implantable defibrillator. Europace. 2016;18(7):1010–5. doi:.https://doi.org/10.1093/europace/euv299

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