TWOSOME trial: Randomized comparison of single-shot vs single-tip pulsed field ablation for pulmonary vein isolation.
Stefan Hartl, Nico Reinsch, Anna Füting et al.
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In 30 seconds
The TWOSOME randomized trial compared two pulsed field ablation (PFA) systems for initial pulmonary vein isolation in patients with paroxysmal atrial fibrillation. One hundred patients were assigned to single-shot pentaspline or single-tip contact force-sensing ablation. Acute isolation was achieved in all patients. At 12 months, arrhythmia-free survival was 76% with single-shot and 82% with single-tip PFA (P = .46). Single-shot ablation shortened total procedure time but involved longer fluoroscopy; single-tip ablation permitted adjunctive treatment of new-onset arrhythmias.
Key findings
- Acute pulmonary vein isolation was achieved in 100% of patients.
- At 12 months, arrhythmia-free survival was 76% with single-shot versus 82% with single-tip PFA (P = .46).
- Total procedure time was 44 ± 11 minutes vs 119 ± 30 minutes, while fluoroscopy time was 14 ± 5 minutes vs 4 ± 2 minutes, respectively (both P < .001).
- Major complications included one non-PFA-related stroke and one pericardial tamponade; neither resulted in permanent sequelae.
Why it matters
The trial provides a direct comparison of two PFA approaches, showing that both achieved acute isolation and similar observed 12-month arrhythmia-free survival. Their procedural trade-offs differed: single-shot ablation was faster overall, whereas single-tip ablation used less fluoroscopy and allowed additional ablation when new arrhythmias arose. These findings help frame system choice around procedural characteristics as well as clinical outcomes.
What to keep in mind
The trial included 100 patients with paroxysmal atrial fibrillation, limiting the scope of the comparison to this population.