BACKGROUND: Early defibrillation is the single most important factor for improving out-of-hospital ventricular fibrillation resuscitation rates. To achieve the earlier response times required for survival, typically < 6 minutes from time of collapse, it will be necessary to equip a far wider network of first responders (firefighters, police, and other individuals with responsibility for public safety) with small, lightweight, and inexpensive automatic external defibrillators (AEDs). An important step in reducing the size and cost of AEDs will be to improve defibrillation efficacy. Because biphasic waveform defibrillation has had a favorable impact on implantable cardioverter-defibrillators (ICDs), there are reasons to believe that biphasic waveforms would also improve transthoracic defibrillators. Our purpose, therefore, was to examine the efficacy of two different low-energy biphasic truncated waveforms referenced to a standard damped sine waveform for transthoracic defibrillation in humans. METHODS AND RESULTS: We prospectively and randomly compared the transthoracic defibrillation efficacy of two different truncated biphasic waveforms, 115 J (70 microF) and 130 J (105 microF), with that of a standard 200-J (36-microF, 28-mH) damped sine wave pulse using right anterior and left lateral thoracic pads (R2 Medical Systems) in 30 cardiac arrest survivors during transvenous ICD surgery. The right anterior patch electrode was used as the cathode and the left lateral thoracic pad as the anode. Transthoracic ventricular defibrillation rescue shocks were tested after a failed transvenous defibrillation shock delivered in the course of ICD testing. Each of the three different rescue shocks was tested in random order in each patient. All shocks were delivered at end expiration. The investigators responsible for determining transthoracic shock efficacy were blinded throughout the study to the transthoracic rescue waveform used. A total of 33 patients were considered for study, but three patients failed to satisfy all entry criteria or did not have a sufficient number of ventricular fibrillation inductions to allow for testing of all three waveforms. Percent efficacy for the three waveforms was then compared in the 30 patients who satisfied entry criteria and completed the protocol. The study population had a mean age of 61 +/- 11 years, with 22 (73%) being men. The mean left ventricular ejection fraction was 0.39 +/- 0.14. Coronary artery disease was present in 22 (73%). The 115-J (70-microF) biphasic pulse, the 130-J (105-microF) biphasic pulse, and the 200-J (36-microF, 28-mH) damped sine wave pulse were equally effective, resulting in a 97% first-shock ventricular defibrillation efficacy rate. Each waveform failed to defibrillate once, with each waveform failing in a different patient. CONCLUSIONS: The results of this study suggest that biphasic truncated transthoracic shocks of low energy (115 and 130 J) are as effective as 200-J damped sine wave shocks used in standard transthoracic defibrillators. This finding may contribute significantly to the miniaturization and cost reduction of transthoracic defibrillators, which could enable the development of a new generation of AEDs appropriate for an expanded group of out-of-hospital first responders and, eventually, layperson use.
RCT Entities:
BACKGROUND: Early defibrillation is the single most important factor for improving out-of-hospital ventricular fibrillation resuscitation rates. To achieve the earlier response times required for survival, typically < 6 minutes from time of collapse, it will be necessary to equip a far wider network of first responders (firefighters, police, and other individuals with responsibility for public safety) with small, lightweight, and inexpensive automatic external defibrillators (AEDs). An important step in reducing the size and cost of AEDs will be to improve defibrillation efficacy. Because biphasic waveform defibrillation has had a favorable impact on implantable cardioverter-defibrillators (ICDs), there are reasons to believe that biphasic waveforms would also improve transthoracic defibrillators. Our purpose, therefore, was to examine the efficacy of two different low-energy biphasic truncated waveforms referenced to a standard damped sine waveform for transthoracic defibrillation in humans. METHODS AND RESULTS: We prospectively and randomly compared the transthoracic defibrillation efficacy of two different truncated biphasic waveforms, 115 J (70 microF) and 130 J (105 microF), with that of a standard 200-J (36-microF, 28-mH) damped sine wave pulse using right anterior and left lateral thoracic pads (R2 Medical Systems) in 30 cardiac arrest survivors during transvenous ICD surgery. The right anterior patch electrode was used as the cathode and the left lateral thoracic pad as the anode. Transthoracic ventricular defibrillation rescue shocks were tested after a failed transvenous defibrillation shock delivered in the course of ICD testing. Each of the three different rescue shocks was tested in random order in each patient. All shocks were delivered at end expiration. The investigators responsible for determining transthoracic shock efficacy were blinded throughout the study to the transthoracic rescue waveform used. A total of 33 patients were considered for study, but three patients failed to satisfy all entry criteria or did not have a sufficient number of ventricular fibrillation inductions to allow for testing of all three waveforms. Percent efficacy for the three waveforms was then compared in the 30 patients who satisfied entry criteria and completed the protocol. The study population had a mean age of 61 +/- 11 years, with 22 (73%) being men. The mean left ventricular ejection fraction was 0.39 +/- 0.14. Coronary artery disease was present in 22 (73%). The 115-J (70-microF) biphasic pulse, the 130-J (105-microF) biphasic pulse, and the 200-J (36-microF, 28-mH) damped sine wave pulse were equally effective, resulting in a 97% first-shock ventricular defibrillation efficacy rate. Each waveform failed to defibrillate once, with each waveform failing in a different patient. CONCLUSIONS: The results of this study suggest that biphasic truncated transthoracic shocks of low energy (115 and 130 J) are as effective as 200-J damped sine wave shocks used in standard transthoracic defibrillators. This finding may contribute significantly to the miniaturization and cost reduction of transthoracic defibrillators, which could enable the development of a new generation of AEDs appropriate for an expanded group of out-of-hospital first responders and, eventually, layperson use.