Style-AF: Improved outcomes with vascular closure versus figure-of-eight suture

The Style-AF trial showed improved time to ambulation, time to haemostasis, time to discharge, and minor vascular complications without an increase in major vascular complications when using a vascular closure system compared with a figure-of-8 suture in patients with catheter ablation for atrial fibrillation.

Style-AF (NCT05563142) was a prospective, non-blinded, randomised trial in patients with catheter ablation for atrial fibrillation with 1 or 2 venous punctures performed at 3 high-volume centres in Germany [1]. Participants who underwent successful ultrasound-guided venous puncture of the groin were randomised to either a venous vascular closure system (n=63) or a figure-of-8 suture following manual compression (n=62). Prof. Roland Tilz (University Heart Center Lübeck, Germany) presented the primary efficacy endpoint, which was time to ambulation (defined as time from removal of the final closure device or removal of the final sheath to time when the patient can stand and walk 20 feet without evidence of venous rebleeding from the femoral access site), as well as the primary safety endpoint consisting of major periprocedural adverse events.

The time to ambulation in the vascular closure group was significantly shorter than in the figure-of-8 group (109 vs 269 minutes; P<0.001), with no difference in the rates of major periprocedural complications (0% vs 0%; P<0.001). The time to haemostasis (1 vs 5 minutes) and time to discharge eligibility (270 vs 340 minutes) was also significantly shorter in the vascular closure group (P<0.001 for both comparisons). Minor complications were reported in 20.6% of participants in the vascular closure group and 35.5% of participants in the figure-of-8 group (P=0.075), with significantly lower rates of groin haematoma <6 cm in the vascular closure group (9.5% vs 24.2%; P=0.033).

“Following atrial fibrillation ablation, the use of a vascular closure device results in a significantly shorter time to ambulation and time to discharge eligibility,” concluded Prof. Tilz, while “the use of manual compression and figure-of-8 suture showed a trend towards increasing incidence of minor bleeding complications.”

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   1. Tilz R, et al. Venous vascular closure system versus manual compression following single shot device AF ablation - The Style AF study. Late-Breaking Science: clinical. EHRA Congress 2024, 7–9 April, Berlin, Germany.

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Posted on 29 April, 202430 April, 2024