Ist die Induktion von Kammerflimmern beim Einsetzen eines ICD noch erforderlich – die SIMPLE-Studie
08. März 2016 (online)
Defibrillation testing has been an integral part of implantable cardioverter defibrillator (ICD) placement for many years, however, data from randomised trials evaluating the need for it have not been available until recently. In the SIMPLE-study, 2,500 patients were randomised to either receive or not to receive defibrillation testing during de-novo ICD implantation and were followed for a mean of 3.1 years. The primary endpoint of arrhythmic death or ineffective adequate shock was reached in similar proportions in both groups satisfying the liberally set margins of non-inferiority in favour of a non-testing strategy. All cause mortality did not differ significantly between the groups. Similar results concerning first shock efficacy and mortality have been obtained from the NORDIC Study.
The SIMPLE study provides evidence that defibrillation testing during ICD implantation can be abandoned in patients receiving transvenous, left pectoral ICD for primary or secondary prevention of sudden cardiac death. This is notably true for patients with coronary artery disease or dilated cardiomyopathy as underlying cardiac diseases. Other entities are not well represented in the study and the continuation of defibrillation testing in these patients may be warranted. Patients with planned right sided ICD placement or supplied with an entirely subcutaneous ICD were not included in the SIMPLE-study and defibrillation testing should be upheld in these until data on the safety of a non-testing strategy becomes available.
The SIMPLE-study has significantly influenced the recently published HRS/EHRA/APHRS/SOLAECE consensus statement on optimal ICD programming and testing.
- 1 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: 2793-2867
- 2 Markewitz A. Jahresbericht 2013 des deutschen Herzschrittmacher- und Defibrillatorregisters. Teil 2: implantierbare Cardioverter-Defibrillatoren (ICD). Im Internet: http://www.pacemaker-register.de/pdf/zentralregister_herzschrittmacher_bericht13_teil2.pdf (Stand: 25. 1. 2016)
- 3 Healey JS, Dorian P, Mitchell LB et al. Canadian Registry of ICD implant testing procedures (CREDIT): current Practice, Risks and Costs of Intraoperative Defibrillation Testing. J Cardiovasc Electrophysiol 2010; 21: 177-182
- 4 Birnie D, Tung S, Simpson C et al. Complications associated with defibrillation threshold testing: the Canadian experience. Heart Rhythm 2008; 5: 387-390
- 5 Brignole M, Raciti G, Bongiorni MG et al. Defibrillation testing at the time of implantation of cardioverter defibrillation in the clinical practice: A nation-wide survey. Europace 2007; 9: 540-543
- 6 Kolb C, Zrenner B, Schmitt C. Near-fatal incident on routine induction of ventricular fibrillation at the replacement of an implantable cardioverter defibrillator. Int J Cardiol 2006; 112: e74-75
- 7 Semmler V, Biermann J, Haller B et al. ICD Shock, Not Ventricular Fibrillation, Causes Elevation of High Sensitive Troponin T after Defibrillation Threshold Testing – The Prospective, Randomized, Multicentre TropShock-Trial. PLoS One 2015; 10: e0131570
- 8 Poole JE, Johnson GW, Hellkamp AS et al. Prognostic importance of defibrillator shocks in the Sudden Cardiac Death in Heart Failure Trial. N Engl J Med 2008; 359: 1009-1017
- 9 Gula LJ, Massel D, Krahn AD et al. Is defibrillation testing still necessary? A decision analysis and Markov model. J Cardiovasc Electrophysiol 2008; 19: 400-405
- 10 Kolb C, Tzeis S, Zrenner B. Defibrillation threshold testing: tradition or necessity?. Pacing Clin Electrophysiol 2009; 32: 570-572
- 11 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: 2591-2596
- 12 Gasparini M, Proclemer A, Klersy C 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: 1903-1911
- 13 Moss AJ, Schuger C, Beck CA et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 2012; 367: 2275-2283
- 14 Healey JS, Hohnloser SH, Glikson M et al. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet 2015; 385: 785-791
- 15 Bänsch D, Bonnemeier H, Brandt J et al. Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial. Eur Heart J 2015; 36: 2500-2507
- 16 Wilkoff BL, Fauchier L, Stiles MK et al. HRS/EHRA/APHRS/SOLAECE Expert Consensus Statement on Optimal Implantable Cardioverter-Defibrillator Programming and Testing. Heart Rhythm 2016; 13: e50-e86
- 17 Mabo P, Defaye P, Mouton E et al. A randomized study of defibrillator lead implantations in the right ventricular mid-septum versus the apex: the SEPTAL study. J Cardiovasc Electrophysiol 2012; 23: 853-860
- 18 Kolb C, Solzbach U, Biermann J et al. Safety of mid-septal electrode placement in implantable cardioverter defibrillator recipients – results of the SPICE (Septal Positioning of ventricular ICD Electrodes) study. Int J Cardiol 2014; 174: 713-720