Ultrasound-guided vs conventional venous puncture for atrial fibrillation ablation: the ULYSSES trial.

Whether ultrasound-guided femoral venous puncture reduces these vascular access complications remains uncertain.

超声引导下股静脉穿刺是否能减少这些血管通路并发症仍不确定。

Methods

In this investigator-initiated, multicentre, open-label, superiority trial, patients undergoing atrial fibrillation or left atrial tachycardia catheter ablation were randomized to an ultrasound-guided venous puncture strategy (intervention group) or to a conventional venous puncture group guided by palpation (control group).

在这项由研究者发起的、多中心的、开放标签的、优效性试验中，接受房颤或左心房心动过速导管消融术的患者被随机分配到超声引导下静脉穿刺策略（干预组）或通过触诊引导的传统静脉穿刺组（对照组）。

The composite primary outcome was the occurrence of venous access site complications until 30 days after the procedure, defined as arteriovenous fistula, false aneurysm, or access site bleeding requiring intervention or leading to prolonged hospitalization.

主要复合终点是在手术后30天内发生静脉通路部位并发症，定义为动静脉瘘、假性动脉瘤或需要干预的通路部位出血或导致住院时间延长。

Secondary endpoints included procedure duration, puncture duration, procedure-related stroke/transient ischaemic attack within 30 days, number of unintended arterial punctures, and number of failed venous access attempts, as well as hospital stay duration.

次要终点包括手术持续时间、穿刺持续时间、30天内的与手术相关的中风/短暂性脑缺血发作、意外动脉穿刺的次数以及静脉通路尝试失败的次数，以及住院时间。

Results

In six centres, 986 patients were randomized.

在六个中心，共有986名患者被随机分配。

A total of 496 patients were assigned to the ultrasound-guided puncture group, and 490 patients to the conventional puncture group.

共有496名患者被分配到超声引导穿刺组，490名患者被分配到传统穿刺组。

The trial was stopped for efficacy, following the first interim analysis after enrolment of half of the planned patients.

在招募了一半计划患者后的第一次中期分析后，由于效果显著，试验被停止。

The composite primary outcome occurred in 3 patients (0.6%) in the intervention group and 16 patients (3.3%) in the control group (risk ratio 0.19; 95% confidence interval0.05-0.63; P = .002).

复合主要结果在干预组的3名患者（0.6%）和对照组的16名患者（3.3%）中发生（风险比0.19；95%置信区间0.05-0.63；P = .002）。

Additionally, ultrasound-guided venous puncture significantly reduced the rate of an unintended arterial puncture (2% vs 16%, P < .0001) and the rate of unsuccessful venous access attempts requiring crossover to the other group (0.2% vs 8.2%, P < .0001).

此外，超声引导下的静脉穿刺显著降低了意外动脉穿刺的发生率（2%对比16%，P < .0001）以及需要交叉到另一组的静脉穿刺失败率（0.2%对比8.2%，P < .0001）。

Conclusions

Ultrasound-guided venous access for atrial fibrillation ablation procedures significantly reduced vascular access site complications.

超声引导下的静脉通路对于房颤消融手术显著减少了血管通路部位并发症。

ULYSSES CLINICALTRIALS.GOV NUMBER: NCT06403527.

ULYSSES CLINICALTRIALS.GOV编号：NCT06403527。