| Autor: |
Bänsch, Dietmar, Bonnemeier, Hendrik, Brandt, Johan, Bode, Frank, Svendsen, Jesper Hastrup, Táborský, Miloš, Kuster, Stefan, Blomström-Lundqvist, Carina, Felk, Angelika, Hauser, Tino, Suling, Anna, Wegscheider, Karl |
| Zdroj: |
European Heart Journal; 10/1/2015, Vol. 36 Issue 37, p2500-2507, 8p, 2 Diagrams, 4 Charts |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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