Performance of the entirely subcutaneous ICD in borderline indications
The subcutaneous ICD (S-ICD™) is an important advance in device therapy for prevention of sudden cardiac death (SCD). In some patients, decision pro- or contra-ICD implantation is particularly challenging due to inconsistent data on risk of ventricular tachyarrhythmias or sudden cardiac death, rare entities, special medical or family history, or patients’ wishes. Whether decision-making in these borderline cases has been facilitated with the new option of a S-ICD™ is unknown.
Material and methods
All patients with an implanted S-ICD™ without a class I or IIa recommendation for primary prophylaxis of sudden cardiac death in the current guidelines (n = 30 patients) in our large-scaled single-centre S-ICD™ registry (n = 249 patients) were included in this study. Baseline characteristics, appropriate and inappropriate shocks, and complications were documented in a mean follow-up of 40 months.
In all patients S-ICD™ implantation was performed for primary prevention of SCD. Of all 30 patients with an overall mean age of 40.5 ± 15.6 years, 17 were male (57%). The mean left ventricular ejection fraction (LVEF) was 54.5 ± 9.9%. Indication were highly variable and ranged from structural heart disease, nsVT and LV-EF > 35% to patients with polymorphic non-sustained ventricular tachycardia (nsVT) and suspect syncope. During follow-up, six episodes of sustained ventricular tachyarrhythmias and four episodes of ventricular fibrillation (VF) were adequately terminated in three patients (10%). Two of these patients were implanted for polymorphic nsVT and previous syncope without structural heart disease. In three patients, T-wave-oversensing and in one patient also P-wave-oversensing resulted in an inappropriate shock (five in total), two additional episodes of oversensing ended before shock delivery. There were no S-ICD™ system-related infections. In five patients S-ICD™ replacement was performed due to battery depletion (four regular, one premature). In five patients, ablation procedures were performed after implantation (four because of frequent symptomatic ventricular extra beats, one because of atrial flutter). Change to a transvenous system was necessary in two patients due to need for antibradycardia pacing.
The use of the S-ICD™ was safe in patients with borderline or unclear indication for ICD implantation in our study. Of note, during a relatively short mean follow-up there were several appropriate therapies, especially for VF in these patients. On the other hand, oversensing also occurred in about 10% of patients, while lead problems were not problematic in this collective. S-ICD™ implantation may be considered as a possible alternative in cases of borderline indications and clinical uncertainty when decision pro-ICD implantation is made. Incidence of arrhythmias was quite high and mostly consisted of VF. Nevertheless, patient education seems even more important as there is a considerable risk for inappropriate therapies as well.
KeywordsSudden cardiac death S-ICD Borderline indications
Compliance with ethical standards
Conflict of interest
FR, NB, JK, LE and GF received travel grants and lecture honoraria from Boston Scientific.
- 1.Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M, Rashtian M, Kremers M, Crozier I, Lee KL, Smith W, Burke MC (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.Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kaab S, Murgatroyd F, Reeve HL, Carter N, Boersma L, E Investigators (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.Burke MC, Gold MR, Knight BP, Barr CS, Theuns D, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD (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.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.Willy K, Bettin M, Reinke F, Bogeholz N, Ellermann C, Rath B, Leitz P, Kobe J, Eckardt L, Frommeyer G (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
- 6.Bettin M, Rath B, Ellermann C, Leitz P, Reinke F, Kobe J, Eckardt L, Frommeyer G (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 (PubMed PMID: 29948287) CrossRefPubMedGoogle Scholar
- 7.Kooiman KM, Knops RE, Olde Nordkamp L, 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
- 9.van der Heijden AC, Borleffs CJ, Buiten MS, Thijssen J, van Rees JB, Cannegieter SC, Schalij MJ, van Erven L (2015) The clinical course of patients with implantable cardioverter-defibrillators: Extended experience on clinical outcome, device replacements, and device-related complications. Heart Rhythm 12(6):1169–1176. https://doi.org/10.1016/j.hrthm.2015.02.035 (PubMed PMID: 25749138) CrossRefPubMedGoogle Scholar
- 10.Kusumoto FM, Calkins H, Boehmer J, Buxton AE, Chung MK, Gold MR, Hohnloser SH, Indik J, Lee R, Mehra MR, Menon V, Page RL, Shen WK, Slotwiner DJ, Stevenson LW, Varosy PD, Welikovitch L, Heart Rhythm S, American College of C, American Heart A (2014) HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in clinical trials. J Am Coll Cardiol 64(11):1143–1177. https://doi.org/10.1016/j.jacc.2014.04.008 (PubMed PMID: 24820349) CrossRefPubMedGoogle Scholar
- 11.Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ, Task Force per il Trattamento dei Pazienti con Aritmie Ventricolari e la Prevenzione della Morte Cardiaca Improvvisa della Societa Europea di C (2016) 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. G Ital Cardiol 17(2):108–170. https://doi.org/10.1714/2174.23496 (PubMed PMID: 27029760) CrossRefGoogle Scholar
- 12.Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL (2018) 2017 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. Heart Rhythm 15(10):e190–e252. https://doi.org/10.1016/j.hrthm.2017.10.035 (PubMed PMID: 29097320) CrossRefPubMedGoogle Scholar
- 13.Al-Khatib SM, Arshad A, Balk EM, Das SR, Hsu JC, Joglar JA, Page RL (2016) Risk stratification for arrhythmic events in patients with asymptomatic pre-excitation: a systematic review for the 2015 ACC/AHA/HRS guideline for the management of adult patients with supraventricular tachycardia: 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 67(13):1624–1638. https://doi.org/10.1016/j.jacc.2015.09.018 (PubMed PMID: 26409260) CrossRefPubMedGoogle Scholar
- 14.Hertz CL, Christiansen SL, Ferrero-Miliani L, Dahl M, Weeke PE, Ottesen GL, Frank-Hansen R, Bundgaard H, Morling N (2016) Next-generation sequencing of 100 candidate genes in young victims of suspected sudden cardiac death with structural abnormalities of the heart. Int J Legal Med 130(1):91–102. https://doi.org/10.1007/s00414-015-1261-8 (PubMed PMID: 26383259) CrossRefPubMedGoogle Scholar
- 15.Milman A, Hochstadt A, Andorin A, Gourraud JB, Sacher F, Mabo P, Kim SH, Conte G, Arbelo E, Kamakura T, Aiba T, Napolitano C, Giustetto C, Denjoy I, Juang JJM, Maeda S, Takahashi Y, Leshem E, Michowitz Y, Rahkovich M, Jespersen CH, Wijeyeratne YD, Champagne J, Calo L, Huang Z, Mizusawa Y, Postema PG, Brugada R, Wilde AAM, Yan GX, Behr ER, Tfelt-Hansen J, Hirao K, Veltmann C, Leenhardt A, Corrado D, Gaita F, Priori SG, Kusano KF, Takagi M, Delise P, Brugada J, Brugada P, Nam GB, Probst V, Belhassen B (2018) Time-to-first appropriate shock in patients implanted prophylactically with an implantable cardioverter-defibrillator: data from the Survey on Arrhythmic Events in BRUgada Syndrome (SABRUS). Europace. https://doi.org/10.1093/europace/euy301 (PubMed PMID: 30590530) CrossRefGoogle Scholar
- 16.Milman A, Andorin A, Gourraud JB, Postema PG, Sacher F, Mabo P, Kim SH, Juang JJM, Maeda S, Takahashi Y, Kamakura T, Aiba T, Conte G, Sarquella-Brugada G, Leshem E, Rahkovich M, Hochstadt A, Mizusawa Y, Arbelo E, Huang Z, Denjoy I, Giustetto C, Wijeyeratne YD, Napolitano C, Michowitz Y, Brugada R, Casado-Arroyo R, Champagne J, Calo L, Tfelt-Hansen J, Priori SG, Takagi M, Veltmann C, Delise P, Corrado D, Behr ER, Gaita F, Yan GX, Brugada J, Leenhardt A, Wilde AAM, Brugada P, Kusano KF, Hirao K, Nam GB, Probst V, Belhassen B (2018) Profile of patients with Brugada syndrome presenting with their first documented arrhythmic event: data from the Survey on Arrhythmic Events in BRUgada Syndrome (SABRUS). Heart Rhythm 15(5):716–724. https://doi.org/10.1016/j.hrthm.2018.01.014 (PubMed PMID: 29325976) CrossRefPubMedGoogle Scholar
- 17.Takagi M, Sekiguchi Y, Yokoyama Y, Aihara N, Hiraoka M, Aonuma K (2014) Japan idiopathic ventricular fibrillation study I: long-term prognosis in patients with Brugada syndrome based on class II indication for implantable cardioverter-defibrillator in the HRS/EHRA/APHRS expert consensus statement: multicenter study in Japan. Heart rhythm 11(10):1716–1720. https://doi.org/10.1016/j.hrthm.2014.06.033 (PubMed PMID: 24981871) CrossRefPubMedGoogle Scholar
- 18.Kusumoto FM, Calkins H, Boehmer J, Buxton AE, Chung MK, Gold MR, Hohnloser SH, Indik J, Lee R, Mehra MR, Menon V, Page RL, Shen WK, Slotwiner DJ, Stevenson LW, Varosy PD, Welikovitch L (2014) HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in clinical trials. Circulation 130(1):94–125. https://doi.org/10.1161/CIR.0000000000000056 (PubMed PMID: 24815500) CrossRefPubMedGoogle Scholar
- 19.Knops RE, Brouwer TF, Barr CS, Theuns DA, Boersma L, Weiss R, Neuzil P, Scholten M, Lambiase PD, Leon AR, Hood M, Jones PW, Wold N, Grace AA, Olde-Nordkamp LR, Burke MC, Ide, investigators E (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
- 20.Frommeyer G, Dechering DG, Zumhagen S, Loher A, Kobe J, Eckardt L, Reinke F (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
- 21.Lambiase PD, Gold MR, Hood M, Boersma L, Theuns D, Burke MC, Weiss R, Russo AM, Kaab S, Knight BP (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
- 22.Quast ABE, van 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
- 23.Brouwer TF, Knops RE, Kutyifa V, Barr C, Mondesert B, Boersma LVA, Lambiase PD, Wold N, Jones PW, Healey JS (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