open access

Vol 26, No 4 (2019)
Original articles — Clinical cardiology
Published online: 2018-03-26
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Initial experience with the subcutaneous implantable cardioverter-defibrillator with the real costs of hospitalization analysis in a single Polish center

Marcin Grabowski, Monika Gawałko, Marcin Michalak, Andrzej Cacko, Michał Kowara, Agnieszka Kołodzińska, Łukasz Januszkiewicz, Paweł Balsam, Laura Vitali Serdoz, Joachim Winter, Grzegorz Opolski
DOI: 10.5603/CJ.a2018.0024
·
Pubmed: 29611175
·
Cardiol J 2019;26(4):360-367.

open access

Vol 26, No 4 (2019)
Original articles — Clinical cardiology
Published online: 2018-03-26

Abstract

Background: The recent introduction of an entirely subcutaneous implantable cardioverter-defibril­lator (S-ICD) represents an important progress in the defibrillation technology towards a less invasive approach. This is a single-center observational study of S-ICD implantations in Poland.

Methods: The S-ICD was implanted in 11 patients with standard indications for an ICD. Patients in whom the device was implanted were evaluated for adverse events and device function at hospital discharge. All hospitalization costs were calculated and summed up for all patients. Costs were divided into following categories: medical materials, pharmaceuticals, operating theatre staff, cardiology depart­ment staff, laboratory tests, non-laboratory tests and additional non-medical costs.

Results: The mean age of patients was 51.6 ± 16.4 years, 9 were men and 2 were women. Four pa­tients had atrial fibrillation as the basal rhythm, 1 patient had atrial flutter and 6 patients had sinus rhythm. All patients had at least one condition that precluded the use of a traditional ICD system or the S-ICD was preferred due to other conditions, i.e. a history complicated transvenous ICD therapy (18%), anticipated higher risk of infection (27%), lack or difficult vascular access (18%), young age and anticipated high cumulated risk of lifetime device therapy (36%). The mean duration of the im­plantation procedure was 2 h. One patient developed a postoperative pocket hematoma. Mean total time of hospitalization was 28 (6–92) days. Average cost of hospitalization per patient was 21,014.29 EUR (minimal = 19,332.71 EUR and maximal = 24,824.14 EUR).

Conclusions: S-ICD implantation appears to provide a viable alternative to transvenous ICD, espe­cially for patients without pacing requirements.

Abstract

Background: The recent introduction of an entirely subcutaneous implantable cardioverter-defibril­lator (S-ICD) represents an important progress in the defibrillation technology towards a less invasive approach. This is a single-center observational study of S-ICD implantations in Poland.

Methods: The S-ICD was implanted in 11 patients with standard indications for an ICD. Patients in whom the device was implanted were evaluated for adverse events and device function at hospital discharge. All hospitalization costs were calculated and summed up for all patients. Costs were divided into following categories: medical materials, pharmaceuticals, operating theatre staff, cardiology depart­ment staff, laboratory tests, non-laboratory tests and additional non-medical costs.

Results: The mean age of patients was 51.6 ± 16.4 years, 9 were men and 2 were women. Four pa­tients had atrial fibrillation as the basal rhythm, 1 patient had atrial flutter and 6 patients had sinus rhythm. All patients had at least one condition that precluded the use of a traditional ICD system or the S-ICD was preferred due to other conditions, i.e. a history complicated transvenous ICD therapy (18%), anticipated higher risk of infection (27%), lack or difficult vascular access (18%), young age and anticipated high cumulated risk of lifetime device therapy (36%). The mean duration of the im­plantation procedure was 2 h. One patient developed a postoperative pocket hematoma. Mean total time of hospitalization was 28 (6–92) days. Average cost of hospitalization per patient was 21,014.29 EUR (minimal = 19,332.71 EUR and maximal = 24,824.14 EUR).

Conclusions: S-ICD implantation appears to provide a viable alternative to transvenous ICD, espe­cially for patients without pacing requirements.

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Keywords

leadless; primary prevention; procedure cost; secondary prevention; subcutaneous implantable cardioverter-defibrillator; ventricular arrhythmias

About this article
Title

Initial experience with the subcutaneous implantable cardioverter-defibrillator with the real costs of hospitalization analysis in a single Polish center

Journal

Cardiology Journal

Issue

Vol 26, No 4 (2019)

Pages

360-367

Published online

2018-03-26

DOI

10.5603/CJ.a2018.0024

Pubmed

29611175

Bibliographic record

Cardiol J 2019;26(4):360-367.

Keywords

leadless
primary prevention
procedure cost
secondary prevention
subcutaneous implantable cardioverter-defibrillator
ventricular arrhythmias

Authors

Marcin Grabowski
Monika Gawałko
Marcin Michalak
Andrzej Cacko
Michał Kowara
Agnieszka Kołodzińska
Łukasz Januszkiewicz
Paweł Balsam
Laura Vitali Serdoz
Joachim Winter
Grzegorz Opolski

References (42)
  1. Pagidipati NJ, Gaziano TA. Estimating deaths from cardiovascular disease: a review of global methodologies of mortality measurement. Circulation. 2013; 127(6): 749–756.
  2. 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)Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015; 36(41): 2793–2867.
  3. Jacheć W, Tomasik A, Polewczyk A, et al. Impact of ICD lead on the system durability, predictors of long-term survival following ICD system extraction. Pacing Clin Electrophysiol. 2017; 40(10): 1139–1146.
  4. Aydin A, Hartel F, Schlüter 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): 913–919.
  5. 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(1): 29–36.
  6. Dabiri Abkenari L, Theuns DA, Valk SDA, et al. Clinical experience with a novel subcutaneous implantable defibrillator system in a single center. Clin Res Cardiol. 2011; 100(9): 737–744.
  7. Olde Nordkamp LRA, Dabiri Abkenari L, Boersma LVA, et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll Cardiol. 2012; 60(19): 1933–1939.
  8. Jarman JWE, 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(11): 1351–1359.
  9. Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013; 128(9): 944–953.
  10. Boveda S, Lenarczyk R, Haugaa K, et al. Implantation of subcutaneous implantable cardioverter defibrillators in Europe: results of the European Heart Rhythm Association survey. Europace. 2016; 18(9): 1434–1439.
  11. Ptaszyński P, Grabowski M, Kowalski O, et al. Opinia Sekcji Rytmu Serca Polskiego Towarzystwa Kardiologicznego dotycząca zastosowania podskórnego kardiowertera-defibrylatora w prewencji nagłego zgonu sercowego w warunkach polskich. Kardiol Pol. 2017; 75(10): 1057–1060.
  12. Bordachar P, Marquié C, Pospiech T, et al. Subcutaneous implantable cardioverter defibrillators in children, young adults and patients with congenital heart disease. Int J Cardiol. 2016; 203: 251–258.
  13. Akerström F, Arias MA, Pachón M, et al. The Entirely Subcutaneous Defibrillator (S-Icd): State of the Art and Selection of the Ideal Candidate. World J Cardiol. 2013; 5(9): 347–354.
  14. Grace A. The subcutaneous implantable cardioverter-defibrillator. Curr Opin Cardiol. 2010; 29(1): 10–19.
  15. de Bie MK, Thijssen J, van Rees JB, et al. Suitability for subcutaneous defibrillator implantation: results based on data from routine clinical practice. Heart. 2013; 99(14): 1018–1023.
  16. Al-Khatib S, Stevenson W, Ackerman M, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary. Heart Rhythm. 2017.
  17. Friedman DJ, Parzynski CS, Varosy PD, et al. Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States. JAMA Cardiol. 2016; 1(8): 900–911.
  18. Boveda S, Lenarczyk R, Fumagalli S, et al. Factors influencing the use of subcutaneous or transvenous implantable cardioverter-defibrillators: results of the European Heart Rhythm Association prospective survey. Europace. 2018 [Epub ahead of print].
  19. Korkeila P, Nyman K, Ylitalo A, et al. Venous obstruction after pacemaker implantation. Pacing Clin Electrophysiol. 2007; 30(2): 199–206.
  20. 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 Arrhythm Electrophysiol. 2013; 6(6): 1236–44; discussion 1244.
  21. Berul CI, Van Hare GF, Kertesz NJ, et al. Results of a multicenter retrospective implantable cardioverter-defibrillator registry of pediatric and congenital heart disease patients. J Am Coll Cardiol. 2008; 51(17): 1685–1691.
  22. Janson CM, Patel AR, Bonney WJ, et al. Implantable cardioverter-defibrillator lead failure in children and young adults: a matter of lead diameter or lead design? J Am Coll Cardiol. 2014; 63(2): 133–140.
  23. Jarman JWE, Todd DM. United Kingdom national experience of entirely subcutaneous implantable cardioverter-defibrillator technology: important lessons to learn. Europace. 2013; 15(8): 1158–1165.
  24. 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. 2017 [Epub ahead of print].
  25. Ascoeta MS, Marijon E, Defaye P, et al. Impact of early complications on outcomes in patients with implantable cardioverter-defibrillator for primary prevention. Heart Rhythm. 2016; 13(5): 1045–1051.
  26. Olde Nordkamp LRA, Postema PG, Knops RE, et al. Implantable cardioverter-defibrillator harm in young patients with inherited arrhythmia syndromes: A systematic review and meta-analysis of inappropriate shocks and complications. Heart Rhythm. 2016; 13(2): 443–454.
  27. Kooiman KM, Knops RE, Olde Nordkamp L, et al. Inappropriate subcutaneous implantable cardioverter-defibrillator shocks due to T-wave oversensing can be prevented: implications for management. Heart Rhythm. 2014; 11(3): 426–434.
  28. Lewis GF, Gold MR. Safety and Efficacy of the Subcutaneous Implantable Defibrillator. J Am Coll Cardiol. 2016; 67(4): 445–454.
  29. 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(4): 417–423.
  30. Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008; 359(10): 1009–1017.
  31. Hanna R, Hellkamp A, Mark D, et al. Predictors of ventricular tachyarrhythmias treated with the ICD in the sudden cardiac death in heart failure trial. Poster, ESC Congress 2012. Munich, Germany. August; 26: 2012.
  32. Wathen MS, DeGroot PJ, Sweeney MO, et al. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. 2004; 110(17): 2591–2596.
  33. Saxon LA. The subcutaneous implantable defibrillator: a new technology that raises an existential question for the implantable cardioverter-defibrillator. Circulation. 2013; 128(9): 938–940.
  34. Sweeney MO, Wathen MS, Volosin K, et al. Appropriate and inappropriate ventricular therapies, quality of life, and mortality among primary and secondary prevention implantable cardioverter defibrillator patients: results from the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) trial. Circulation. 2005; 111(22): 2898–2905.
  35. Wathen MS, Sweeney MO, DeGroot PJ, et al. PainFREE Investigators. Shock reduction using antitachycardia pacing for spontaneous rapid ventricular tachycardia in patients with coronary artery disease. Circulation. 2001; 104(7): 796–801.
  36. Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003; 289(20): 2685–2694.
  37. Patel KH, Lambiase PD. The subcutaneous ICD - current evidence and challenges. Cardiovasc Diagn Ther. 2014; 4(6): 449–459.
  38. Chue CD, Kwok CS, Wong CW, et al. Efficacy and safety of the subcutaneous implantable cardioverter defibrillator: a systematic review. Heart. 2017; 103(17): 1315–1322.
  39. Kowara M, Michalak M, Cacko A, et al. First experience with a subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation - a case series study of single Cardiology Center. Heart Beat J. 2016; 1: 18–23.
  40. Honarbakhsh S, Providencia R, Srinivasan N, 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: 280–285.
  41. 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(25): 1657–1665.
  42. Pedersen SS, Lambiase P, Boersma LVA, et al. Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD: design and rationale of the EFFORTLESS S-ICD Registry. Pacing Clin Electrophysiol. 2012; 35(5): 574–579.

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