Advertisement

Outcome differences and device performance of the subcutaneous ICD in patients with and without structural heart disease

  • Kevin Willy
  • Florian Reinke
  • Nils Bögeholz
  • Christian Ellermann
  • Benjamin Rath
  • Patrick Leitz
  • Julia Köbe
  • Lars Eckardt
  • Gerrit FrommeyerEmail author
Original Paper

Abstract

Background

The performance of the subcutaneous ICD (S-ICD™) has been described in different kinds of heart disease and has been proven to be an important advance in prevention of sudden cardiac death (SCD). While positive experiences with the S-ICD™ initially came from collectives of patients without structural heart diseases, positive results have also been collected from cohorts with structural heart disease.

Materials and methods

All S-ICD™ patients with either ischemic cardiomyopathy (ICM), dilated cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM) as the main indication for ICD implantation (n = 144 patients) or electrical heart disease/idiopathic ventricular fibrillation (n = 83 patients) in our large-scaled single-center S-ICD™ registry were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a mean follow-up of 18 ± 15 months.

Results

Baseline characteristics were significantly different between the two groups in most categories. In contrast, there was no difference concerning neither appropriate nor inappropriate shock delivery between the two groups. Also other outcome parameters such as need for surgical revisions and all-cause mortality did not differ. There was a significant difference between the first- and second-generation S-ICDs™ in inadequate shocks mainly driven by patients with HCM.

Conclusion

In our study, S-ICD™ performance was similar in patients with and without structural heart disease. Decision pro- or contra-S-ICD™ should be made rather on the basis of expected shock rate and probability of the need for future anti-tachycardia or anti-bradycardia pacing than in dependence of the underlying heart disease.

Highlights

  • The subcutaneous ICD system is safe and effective for prevention of sudden cardiac death.

  • A difference between first- and second-generation S-ICD in inadequate shocks was observed.

  • There was no difference concerning shock deliveries between the two groups.

Keywords

S-ICD Sudden cardiac death Structural heart disease Electrical heart disease 

References

  1. 1.
    Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M et al (2013) Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation 128(9):944–953.  https://doi.org/10.1161/CIRCULATIONAHA.113.003042 (PubMed PMID: 23979626) CrossRefPubMedGoogle Scholar
  2. 2.
    Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB et al (2014) Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J 35(25):1657–1665.  https://doi.org/10.1093/eurheartj/ehu112 (PubMed PMID: 24670710; PubMed Central PMCID: PMCPMC4076663) CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Burke MC, Gold MR, Knight BP, Barr CS, Theuns D, Boersma LVA 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(16):1605–1615.  https://doi.org/10.1016/j.jacc.2015.02.047 (PubMed PMID: 25908064) CrossRefPubMedGoogle Scholar
  4. 4.
    Priori SG, Blomstrom-Lundqvist C (2015) 2015 European Society of cardiology guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death summarized by co-chairs. Eur Heart J 36(41):2757–2759.  https://doi.org/10.1093/eurheartj/ehv445 (PubMed PMID: 26745817) CrossRefPubMedGoogle Scholar
  5. 5.
    Bogeholz N, Willy K, Niehues P, Rath B, Dechering DG, Frommeyer G et al (2019) Spotlight on S-ICD therapy: 10 years of clinical experience and innovation. Europace.  https://doi.org/10.1093/europace/euz029 (PubMed PMID: 30887039) CrossRefPubMedGoogle Scholar
  6. 6.
    Bettin M, Rath B, Ellermann C, Leitz P, Reinke F, Kobe J et al (2019) Follow-up of the first patients with a totally subcutaneous ICD in Germany from implantation till battery depletion. Clin Res Cardiol 108(1):16–21.  https://doi.org/10.1007/s00392-018-1296-1 (Epub 2018/06/28, PMID: 29948287) CrossRefPubMedGoogle Scholar
  7. 7.
    Willy K, Bettin M, Reinke F, Bogeholz N, Ellermann C, Rath B et al (2019) Feasibility of entirely subcutaneous ICD systems in patients with coronary artery disease. Clin Res Cardiol.  https://doi.org/10.1007/s00392-019-01455-5 (PubMed PMID: 30903274) CrossRefPubMedGoogle Scholar
  8. 8.
    Frommeyer G, Dechering DG, Zumhagen S, Loher A, Kobe J, Eckardt L et al (2016) Long-term follow-up of subcutaneous ICD systems in patients with hypertrophic cardiomyopathy: a single-center experience. Clin Res Cardiol 105(1):89–93.  https://doi.org/10.1007/s00392-015-0901-9 (PubMed PMID: 26233714) CrossRefPubMedGoogle Scholar
  9. 9.
    Frommeyer G, Reinke F, Andresen D, Kleemann T, Spitzer SG, Jehle J et al (2019) Implantable cardioverter defibrillators in patients with electrical heart disease and hypertrophic cardiomyopathy: data from the German device registry. Clin Res Cardiol.  https://doi.org/10.1007/s00392-019-01532-9 (Epub 2019/08/02, PubMed PMID: 31367999) CrossRefPubMedGoogle Scholar
  10. 10.
    Kooiman KM, Knops RE, Nordkamp LO, Wilde AA, de Groot JR (2014) Inappropriate subcutaneous implantable cardioverter-defibrillator shocks due to T-wave oversensing can be prevented: implications for management. Heart Rhythm 11(3):426–434.  https://doi.org/10.1016/j.hrthm.2013.12.007 (PubMed PMID: 24321235) CrossRefPubMedGoogle Scholar
  11. 11.
    Mulder BA, Maass AH, Blaauw Y (2018) Inappropriate shock caused by P wave oversensing in an entirely subcutaneous ICD. Neth Heart J 26(7–8):411–412.  https://doi.org/10.1007/s12471-018-1099-z (PubMed PMID: 29532365; PubMed Central PMCID: PMCPMC6046664) CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Lambiase PD, Gold MR, Hood M, Boersma L, Theuns D, Burke MC et al (2016) Evaluation of subcutaneous ICD early performance in hypertrophic cardiomyopathy from the pooled EFFORTLESS and IDE cohorts. Heart Rhythm 13(5):1066–1074.  https://doi.org/10.1016/j.hrthm.2016.01.001 (PubMed PMID: 26767422) CrossRefPubMedGoogle Scholar
  13. 13.
    Tachibana M, Nishii N, Banba K, Fujita S, Ikeda E, Okawa K et al (2019) SMART pass will prevent inappropriate operation of S-ICD. J Arrhythm 35(1):86–91.  https://doi.org/10.1002/joa3.12141 (PubMed PMID: 30805048; PubMed Central PMCID: PMC6373830) CrossRefPubMedGoogle Scholar
  14. 14.
    Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P et al (2017) Implant and midterm outcomes of the subcutaneous implantable cardioverter-defibrillator registry: the EFFORTLESS study. J Am Coll Cardiol 70(7):830–841.  https://doi.org/10.1016/j.jacc.2017.06.040 (PubMed PMID: 28797351) CrossRefPubMedGoogle Scholar
  15. 15.
    Knops RE, Brouwer TF, Barr CS, Theuns DA, Boersma L, Weiss R et al (2016) The learning curve associated with the introduction of the subcutaneous implantable defibrillator. Europace 18(7):1010–1015.  https://doi.org/10.1093/europace/euv299 (PubMed PMID: 26324840; PubMed Central PMCID: PMCPMC4927061) CrossRefPubMedGoogle Scholar
  16. 16.
    Quast ABE, Dijk VF (2018) Six-year follow-up of the initial Dutch subcutaneous implantable cardioverter-defibrillator cohort: Long-term complications, replacements, and battery longevity. J Cardiovasc Electrophysiol 29(7):1010–1016.  https://doi.org/10.1111/jce.13498 (PubMed PMID: 29626366) CrossRefPubMedGoogle Scholar
  17. 17.
    Brouwer TF, Knops RE, Kutyifa V, Barr C, Mondesert B, Boersma LVA et al (2018) Propensity score matched comparison of subcutaneous and transvenous implantable cardioverter-defibrillator therapy in the SIMPLE and EFFORTLESS studies. Europace 20(FI2):f240–f248.  https://doi.org/10.1093/europace/euy083 (PubMed PMID: 29771327) CrossRefPubMedGoogle Scholar
  18. 18.
    Nordkamp LRO, Brouwer TF, Barr C, Theuns DA, Boersma LV, Johansen JB et al (2015) Inappropriate shocks in the subcutaneous ICD: incidence, predictors and management. Int J Cardiol 195:126–133.  https://doi.org/10.1016/j.ijcard.2015.05.135 (PubMed PMID: 26026928) CrossRefGoogle Scholar
  19. 19.
    Nordkamp LRO, Knops RE, Bardy GH, Blaauw Y, Boersma LV, Bos JS et al (2012) Rationale and design of the PRAETORIAN trial: a prospective, randomized comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. Am Heart J 163(5):753–60 e2.  https://doi.org/10.1016/j.ahj.2012.02.012 (PubMed PMID: 22607851) CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Clinic for Cardiology II: ElectrophysiologyUniversity Hospital MünsterMünsterGermany

Personalised recommendations