Cardioversion Efficacy Using Pulsed Biphasic or Biphasic Truncated Exponential Waveforms: A Randomized Clinical Trial
Anders S Schmidt1,2,3, Kasper G Lauridsen1,2,3, Kasper Adelborg2,4,5
1Clinical Research Unit, Regional Hospital of Randers, Randers NE, Denmark.
Insights
Biphasic truncated exponential (BTE) waveform cardioversion proved more effective than pulsed biphasic (PB) waveform for atrial fibrillation and flutter. Both defibrillation methods demonstrated similar safety profiles regarding myocardial injury.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Devices
Background:
- Current defibrillators for cardiac arrhythmias vary.
- The efficacy of novel pulsed biphasic (PB) waveforms requires comparison with existing biphasic waveforms.
- Atrial fibrillation and flutter are common cardiac arrhythmias requiring cardioversion.
Purpose of the Study:
- To compare the efficacy and safety of pulsed biphasic (PB) shocks versus biphasic truncated exponential (BTE) shocks for cardioversion.
- To evaluate success rates and myocardial injury markers between PB and BTE waveforms.
Main Methods:
- Prospective, randomized study of patients undergoing elective direct current cardioversion.
- Patients randomized to receive either PB or BTE shocks with escalating energy levels.
- Successful cardioversion defined as achieving sinus rhythm 4 hours post-procedure; safety assessed by troponin I levels.
Main Results:
- Biphasic truncated exponential (BTE) waveform cardioversion achieved a significantly higher success rate (86%) compared to pulsed biphasic (PB) waveform (62%) (P=0.002).
- No significant difference in safety was observed between PB and BTE waveforms, as indicated by troponin I levels (P=0.15).
- The study was prematurely terminated due to an adverse event.
Conclusions:
- Biphasic truncated exponential (BTE) waveform is more effective for cardioversion of atrial fibrillation and flutter than pulsed biphasic (PB) waveform.
- Both PB and BTE waveforms exhibit comparable safety profiles concerning myocardial injury.
Background:
Several different defibrillators are currently used for cardioversion and defibrillation of cardiac arrhythmias. The efficacy of a novel pulsed biphasic (PB) waveform has not been compared to other biphasic waveforms. Accordingly, this study aims to compare the efficacy and safety of PB shocks with biphasic truncated exponential (BTE) shocks in patients undergoing cardioversion of atrial fibrillation or -flutter.
Methods And Results:
This prospective, randomized study included patients admitted for elective direct current cardioversion. Patients were randomized to receive cardioversion using either PB or BTE shocks. We used escalating shocks until sinus rhythm was obtained or to a maximum of 4 shocks. Patients randomized to PB shocks received 90, 120, 150, and 200 J and patients randomized to BTE shocks received 100, 150, 200, and 250 J, as recommended by the manufacturers. In total, 69 patients (51%) received PB shocks and 65 patients (49%) BTE shocks. Successful cardioversion, defined as sinus rhythm 4 hours after cardioversion, was achieved in 43 patients (62%) using PB shocks and in 56 patients (86%) using BTE shocks; ratio 1.4 (95% CI 1.1-1.7) (P=0.002). There was no difference in safety (ie, myocardial injury judged by changes in high-sensitive troponin I levels; ratio 1.1) (95% CI 1.0-1.3), P=0.15. The study was terminated prematurely because of an adverse event.
Conclusions:
Cardioversion using a BTE waveform was more effective when compared with a PB waveform. There was no difference in safety between the 2 waveforms, as judged by changes in troponin I levels.
Clinical Trial Registration:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02317029.
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