Key result
Tuned defibrillation waveforms using 3.5- and 4.5-ms membrane time constants significantly lowered defibrillation threshold voltage compared to a 2.5-ms waveform (P=0.004 and P=0.035, respectively).
Why the study?
Do tuned biphasic waveforms with 3.5- or 4.5-ms membrane time constants reduce defibrillation threshold voltage compared to 2.5-ms waveforms in ICD/CRT-D patients?
RCT (n=121)
Randomized to any two of three waveforms
Yes
Do tuned biphasic waveforms with 3.5- or 4.5-ms membrane time constants reduce defibrillation threshold voltage compared to 2.5-ms waveforms in ICD/CRT-D patients?
p-value: p=0.004 and 0.035
Programming ICDs with 3.5- or 4.5-ms membrane time constant-based waveforms significantly lowers defibrillation thresholds compared to 2.5-ms waveforms.
Supports 3.5- or 4.5-ms waveform programming in ICDs/CRT-Ds; extends RCT evidence on membrane time constant optimization.
BACKGROUND: The efficacy of tuned defibrillation waveforms versus the nominal fixed-tilt waveform has been previously studied. However, the optimal membrane time constant for tuning was not known. The POWER (Pulsewidth Optimized Waveform Evaluation tRial) trial was designed to determine the optimal membrane time constant for programming "tuned" biphasic waveforms. METHODS: This acute, multicenter study included 121 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator patients who were randomized at implant to any two of the three membrane time constant waveforms (2.5, 3.5, and 4.5 ms). Fixed pulse widths were programmed using the measured high voltage shock impedance. The defibrillation threshold (DFT) estimates were obtained using a hybrid protocol starting with an upper limit of vulnerability estimate followed by a step-up/step-down ventricular fibrillation induction process. RESULTS: DFT voltage was significantly lower using 3.5- and 4.5-ms waveforms as compared to the 2.5-ms waveform (P = 0.004 and 0.035, respectively). DFT voltage with both 3.5- and 4.5-ms waveforms was ≤ that obtained with the 2.5-ms waveform in 78.5% of the cases. The mean difference in DFT voltage using the 3.5-ms waveform and the 4.5-ms waveform was not significant (P = 0.4). However, the 3.5-ms waveform gave a lower DFT than the 4.5-ms waveform in 19 patients although the reverse was true in only nine (P = 0.02 not significant for multiple comparisons). CONCLUSIONS: The use of a 3.5- or 4.5-ms time constant-based waveforms had lower DFTs when compared to the 2.5-ms waveform. This study suggests that the first defibrillation attempt at implantation should be with 3.5- or 4.5-ms time constant-based waveforms. The 3.5-ms-based waveform trended toward the best choice.
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Doshi et al. (2012) conducted an RCT in Implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implantation (n=121). Tuned biphasic waveforms (3.5- and 4.5-ms membrane time constants) vs. 2.5-ms membrane time constant waveform was evaluated on Defibrillation threshold (DFT) voltage (p=0.004 and 0.035). Tuned defibrillation waveforms using 3.5- and 4.5-ms membrane time constants significantly lowered defibrillation threshold voltage compared to a 2.5-ms waveform (P=0.004 and P=0.035, respectively).
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