TY - JOUR
T1 - Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators
T2 - the NORDIC ICD randomized clinical trial
AU - Bänsch, Dietmar
AU - Bonnemeier, Hendrik
AU - Brandt, Johan
AU - Bode, Frank
AU - Svendsen, Jesper Hastrup
AU - Táborský, Miloš
AU - Kuster, Stefan
AU - Blomström-Lundqvist, Carina
AU - Felk, Angelika
AU - Hauser, Tino
AU - Suling, Anna
AU - Wegscheider, Karl
AU - NORDIC ICD Trial Investigators
A2 - Tfelt-Hansen, Jacob
N1 - © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2015/10/1
Y1 - 2015/10/1
N2 - AIMS: This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation.METHODS AND RESULTS: Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of -10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095).CONCLUSION: Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.
AB - AIMS: This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation.METHODS AND RESULTS: Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of -10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095).CONCLUSION: Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.
U2 - 10.1093/eurheartj/ehv292
DO - 10.1093/eurheartj/ehv292
M3 - Journal article
C2 - 26112885
SN - 1522-9645
VL - 36
SP - 2500
EP - 2507
JO - European Heart Journal (Online)
JF - European Heart Journal (Online)
IS - 37
ER -