Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential...

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• Prospective studies comparing rectilinear biphasic waveform (RBW) and biphasic truncated exponential (BTE) shocks for atrial fibrillation cardioversion are lacking.
• Direct current cardioversion is a common procedure for treating atrial fibrillation.

Purpose of the Study:

• To compare the efficacy and safety of RBW versus BTE shocks for direct current cardioversion of atrial fibrillation.
• To evaluate the success rate of first shock cardioversion using a 200J RBW versus a 360J BTE synchronized shock.

Main Methods:

• An investigator-initiated, open-label, randomized controlled trial involving 546 adult patients with symptomatic atrial fibrillation.
• Patients were randomized to receive either a 200J RBW or a 360J BTE synchronized shock.
• Efficacy was defined as normal sinus rhythm on ECG ≥1 minute after shock delivery; safety events were also monitored.

Main Results:

• First shock cardioversion success rates were similar: 82.6% for RBW and 84.4% for BTE (P=0.565).
• No significant differences were observed in achieving normal sinus rhythm after multiple shocks or in safety events between the two waveform groups.
• The study utilized anterolateral skin pad placement for all participants.

Conclusions:

• Full-output RBW and BTE shocks demonstrate comparable safety and efficacy for atrial fibrillation cardioversion.
• The choice between RBW and BTE waveforms may not significantly impact cardioversion outcomes.