- Design
- Investigator-initiated, multicentre, open-label, randomised superiority trial (ULYSSES), stopped early
- Population
- 986 adults undergoing AF or left atrial tachycardia catheter ablation
- Primary outcome
- Venous access-site complications within 30 days
- Effect
- 0.6% vs 3.3%, risk ratio 0.19 (95% CI 0.05–0.63), P=0.002
ULYSSES randomised 986 patients at six centres to ultrasound-guided or palpation-guided femoral venous puncture for atrial fibrillation or left atrial tachycardia ablation. Vascular access complications are the commonest procedure-related harm of ablation, so the question is a practical one.
Access-site complications within 30 days — arteriovenous fistula, false aneurysm, or bleeding needing intervention or prolonging admission — occurred in 0.6% with ultrasound versus 3.3% with palpation (risk ratio 0.19, 95% CI 0.05–0.63). Unintended arterial punctures fell to 2% from 16%, and failed venous access needing crossover to 0.2% from 8.2%. The trial was stopped early for efficacy at its first interim analysis.
Ultrasound for femoral venous access is low-cost, already present in most electrophysiology and many cath labs, and adds little procedure time. This is a straightforward technique change rather than new equipment.
- Use ultrasound rather than palpation to guide femoral venous puncture for ablation.
- Access complications fell to about 0.6% from 3.3%, roughly a fifth of the rate.
- Unintended arterial punctures dropped to 2% from 16%; failed access needing crossover to 0.2% from 8.2%.
- The technique needs an ultrasound probe already in most labs and adds little time.
Why it matters
It turns the commonest complication of ablation into a largely avoidable one with a technique most labs already own.
The statistics, in plain English
A risk ratio of 0.19 means roughly an 80% lower complication rate; the trial stopped early for efficacy, which can overstate the size of a benefit even when its direction is secure.
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