Abstract
Background
The subcutaneous ICD is a promising treatment option in patients at risk for sudden cardiac death. Approved in 2009, the first S-ICD® in Germany was implanted in June 2010. Although large prospective registry studies have shown safety and efficacy of the system, there is a lack of long-term data with regard to battery longevity of the S-ICD®. Therefore, we report follow-up of our first initial S-ICD® cases from implantation till battery depletion.
Materials and methods
All S-ICD® patients with device replacement for battery depletion in our large single-center S-ICD® registry were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a median follow-up of 75.9 ± 6.8 months.
Results
Twenty-eight patients with S-ICD® systems were included in this study. Of these patients, 21 were male and 7 were female, with an overall mean age of 41.9 ± 12.6 years. Primary prevention of sudden cardiac death was the indication in 19 patients (67.9%). Ventricular tachycardia was adequately terminated in two patients (7.1%). In 7 patients, non-sustained ventricular arrhythmias were not treated. A total of three inappropriate shocks occurred in three patients (10.7%). Mean time from implantation till battery depletion was 65.8 ± 8.1 months. Only one patient presented premature elective replacement criteria because of rapid battery depletion. No lead-related complication occurred during follow-up and no complications were seen regarding device replacement. In one patient (3.6%), the system was explanted without replacement due to patient’s preference.
Conclusion
The estimated battery longevity of S-ICD® of about 5 years was reached in all but one patient. Compared to larger S-ICD® registry studies, frequency of inappropriate shocks was relatively high in the initial S-ICD® cases. Both technological improvement as well as programming and operators’ experience have led to a reduction of complications. Replacement of the S-ICD® seems to be a safe and effective procedure.
Similar content being viewed by others
Abbreviations
- ATP:
-
Antitachycardia pacing
- ERI:
-
Elective replacement indicator
- ICD:
-
Implantable cardioverter defibrillator
- SCD:
-
Sudden cardiac death
- S-ICD® :
-
Subcutaneous implantable cardioverter defibrillator
- SVT:
-
Supraventricular tachycardia
- T-ICD:
-
Transvenous implantable cardioverter defibrillator
- VF:
-
Ventricular fibrillation
- VT:
-
Ventricular tachycardia
References
Lambiase PD, Barr C, Theuns DA et al (2014) Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J 3 5(25):1657–1665
Weiss R, Knight BP, Gold MR et al (2013) Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation 128:944–953
Brouwer TF, Yilmaz D, Lindeboom R et al (2016) Long-term clinical outcomes of subcutaneous versus transvenous implantable defibrillator therapy. J Am Coll Cardiol 68:2047–2055
Bardy GH, Smith WM, Hood MA et al (2010) An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med 363:36–44
Friedman DJ, Parzynski CS, Varosy PD et al (2016) Trends and in-hospital outcomes associated with adoption of the subcutaneous implantable cardioverter defibrillator in the United States. JAMA Cardiol 1:900–911
Priori SG, Blomström-Lundqvist C, Mazzanti A 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). Europace 2015,17(11):1601–1687
Frommeyer G, Zumhagen S, Dechering DG et al (2016) Intraoperative defibrillation testing of subcutaneous ICD systems—a simple issue? J Am Heart Assoc 4(3):e00318. https://doi.org/10.1161/JAHA.115.00318
Theuns DA, Crozier IG, Barr CS et al (2015) Longevity of the subcutaneous implantable defibrillator. Long-term follow-up of the European Regulatory Trial Cohort. Circ Arrhythm Electrophysiol 8:1159–1163
Köbe J, Hucklenbroich K, Geisendörfer N et al (2017) Posttraumatic stress and quality of life with the totally subcutaneous compared to conventional cardioverter-defibrillator systems. Clin Res Cardiol 106:317–321
Healey JS, Hohnloser SH, Glikson M et al (2015) Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet 385:785–791
Moss AJ, Schuger C, Beck CA et al (2012) Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 367:2275–2283
Frommeyer G, Dechering DG, Zumhagen S et al (2016) Long-term follow-up of subcutaneous ICD systems in patients with hypertrophic cardiomyopathy: a single-center experience. Clin Res Cardiol 105:89–93
Burke MC, Gold MR, Knight BP et al (2015) 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 65:1605–1615
Knops RE, Brouwer TF, Barr CS et al (2016) The learning curve associated with the introduction of the subcutaneous implantable defibrillator. Europace 18:1010–1015
Brisben AJ, Burke MC, Knight BP et al (2015) A new algorithm to reduce inappropriate therapy in the S-ICD system. J Cardiovasc Electrophysiol 26:417–423
Kooiman KM, Knops RE, Olde Nordkamp L et al (2014) Inappropriate subcutaneous implantable cardioverter-defibrillator shocks due to T-wave overesensing can be prevented: Implications for management. Heart Rhythm 11:426–434
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
FR, JK, LE, and GF received travel grants and lecture honoraria from Boston Scientific within the last 12 months.
Rights and permissions
About this article
Cite this article
Bettin, M., Rath, B., Ellermann, C. et al. Follow-up of the first patients with a totally subcutaneous ICD in Germany from implantation till battery depletion. Clin Res Cardiol 108, 16–21 (2019). https://doi.org/10.1007/s00392-018-1296-1
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00392-018-1296-1