INTRODUCTION: This prospective, multicenter, randomized trial evaluated the effects of atrial prevention and termination therapies on atrial tachyarrhythmia (ATA) burden in patients with a standard indication for an implantable cardioverter defibrillator (ICD). METHODS: A Jewel AF or GEM III AT ICD was implanted in 451 patients. At 1-month post-implant, patients were randomized to atrial prevention and termination therapies ON ( n = 199) or OFF ( n = 206) and followed for 6 additional months. Automatic atrial shocks were enabled in only 14% of the ON group. The follow-up time after randomization was 6.9 +/- 2.4 months ON versus 6.8 +/- 2.3 months OFF. RESULTS: There were 126/405 (31.1%) patients who had AT/AF episodes during follow-up. Only four patients received a shock to treat ATA's during follow-up. The median ATA burden was 0 hours/month in both the ON and OFF groups ( P = 0.40). The mean ATA burden was 4.3 +/- 20.0 hours/month ON versus 9.0 +/- 50.0 hours/month OFF ( P = 0.11). In a subgroup of 192 patients with a history of ATA's, the median burden was 0 hours/month in the both groups ( P = 0.23). However, the mean burden in this subgroup was 7.6 +/- 27.1 hours/month ON versus 19.2 +/- 73.7 hours/month OFF ( P = 0.056). CONCLUSIONS: In patients receiving an ICD for ventricular arrhythmias, no significant change in ATA burden was observed when atrial prevention and termination therapies were enabled. This may have been due to the low ATA burden in this population. In a subgroup of patients with history of ATA's, there was a trend towards a reduction in mean burden.
RCT Entities:
INTRODUCTION: This prospective, multicenter, randomized trial evaluated the effects of atrial prevention and termination therapies on atrial tachyarrhythmia (ATA) burden in patients with a standard indication for an implantable cardioverter defibrillator (ICD). METHODS: A Jewel AF or GEM III AT ICD was implanted in 451 patients. At 1-month post-implant, patients were randomized to atrial prevention and termination therapies ON ( n = 199) or OFF ( n = 206) and followed for 6 additional months. Automatic atrial shocks were enabled in only 14% of the ON group. The follow-up time after randomization was 6.9 +/- 2.4 months ON versus 6.8 +/- 2.3 months OFF. RESULTS: There were 126/405 (31.1%) patients who had AT/AF episodes during follow-up. Only four patients received a shock to treat ATA's during follow-up. The median ATA burden was 0 hours/month in both the ON and OFF groups ( P = 0.40). The mean ATA burden was 4.3 +/- 20.0 hours/month ON versus 9.0 +/- 50.0 hours/month OFF ( P = 0.11). In a subgroup of 192 patients with a history of ATA's, the median burden was 0 hours/month in the both groups ( P = 0.23). However, the mean burden in this subgroup was 7.6 +/- 27.1 hours/month ON versus 19.2 +/- 73.7 hours/month OFF ( P = 0.056). CONCLUSIONS: In patients receiving an ICD for ventricular arrhythmias, no significant change in ATA burden was observed when atrial prevention and termination therapies were enabled. This may have been due to the low ATA burden in this population. In a subgroup of patients with history of ATA's, there was a trend towards a reduction in mean burden.
Authors: V Fuster; L E Rydén; R W Asinger; D S Cannom; H J Crijns; R L Frye; J L Halperin; G N Kay; W W Klein; S Lévy; R L McNamara; E N Prystowsky; L S Wann; D G Wyse Journal: Eur Heart J Date: 2001-10 Impact factor: 29.983
Authors: Anne M Gillis; Christina Unterberg-Buchwald; Herwig Schmidinger; Santini Massimo; Kevin Wolfe; Deborah J Kavaney; Mary F Otterness; Stefan H Hohnloser Journal: J Am Coll Cardiol Date: 2002-11-06 Impact factor: 24.094
Authors: D G Wyse; J C Love; Q Yao; M D Carlson; P Cassidy; L H Greene; J B Martins; C Ocampo; M H Raitt; E Schron; N J Stamato; A Olarte Journal: J Interv Card Electrophysiol Date: 2001-09 Impact factor: 1.900