UNASSIGNED: We performed a pooled analysis of the FAUST (Femoral Arterial Access With Ultrasound Trial) and UNIVERSAL (Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures) trials, both multicenter randomized controlled trials of 1:1 ultrasound-guided versus non-ultrasound-guided TFA for coronary procedures. Outcomes included the composite of major bleeding or vascular complications and successful common femoral artery cannulation. Participants were stratified by the operators\' accrued case volume. We used adjusted repeated-measurement logistic regression, with random intercepts for operator clustering, for comparison against the non-ultrasound-guided TFA group and to model the learning curve.
UNASSIGNED: The FAUST and UNIVERSAL trials randomized a total of 1624 patients, of which 810 were randomized to non-ultrasound-guided TFA and 814 to ultrasound-guided TFA (cases 1-10, 391; 11-20, 183; and >20, 240). Participants who had operators who performed >20 ultrasound-guided TFAs had a decreased risk for the primary end point (5/240 [2.1%] versus 64/810 [7.9%]; adjusted odds ratio, 0.26 [95% CI, 0.09-0.61]) compared with non-ultrasound-guided TFA. Operators who performed >20 ultrasound-guided procedures had increased odds of successfully cannulating the common femoral artery (224/246 [91.1%] versus 327/382 [85.6%]; adjusted odds ratio, 1.76 [95% CI, 1.08-2.89]) compared with non-ultrasound-guided TFA. The learning curve plots demonstrated growing competence with increasing accrued cases.
UNASSIGNED: New operators should perform at least 20 ultrasound-guided TFA to decrease access site complications and increase proper cannulation compared with non-ultrasound-guided TFA. Additional accrued cases may lead to increased proficiency. Training programs should consider these findings in the transradial era.
我们对FAUST(股动脉接入超声试验)和UNIVERSAL(心脏手术血管接入常规超声引导)试验进行了汇总分析,1:1超声引导和非超声引导TFA用于冠状动脉手术的两项多中心随机对照试验。结果包括大出血或血管并发症的复合以及成功的股动脉插管。参与者按操作员的应计病例量进行分层。我们使用调整后的重复测量逻辑回归,使用随机截获的运算符聚类,用于与非超声引导的TFA组进行比较并对学习曲线进行建模。
■FAUST和UNIVERSAL试验将总共1624名患者随机分组,其中810个被随机分配到非超声引导的TFA和814个被随机分配到超声引导的TFA(病例1-10,391;11-20,183;和>20,240)。具有>20个超声引导下TFA的操作者的参与者的主要终点风险降低(5/240[2.1%]对64/810[7.9%];调整后的比值比,0.26[95%CI,0.09-0.61])与非超声引导的TFA相比。进行了>20例超声引导手术的操作者成功插管股动脉的几率增加(224/246[91.1%]对327/382[85.6%];调整后的比值比,1.76[95%CI,1.08-2.89])与非超声引导的TFA相比。学习曲线图显示,随着累积案例的增加,能力不断提高。
■与非超声引导的TFA相比,新操作员应进行至少20次超声引导的TFA,以减少进入部位并发症并增加适当的插管。额外的应计案例可能会导致熟练程度的提高。培训计划应考虑跨radial时代的这些发现。