Population Health Research Institute, Hamilton, ON, Canada (M.-A.d., L.H., E.S., J.T., T.S., S.R.M., J.-D.S., M.K.N., S.S.J.).
Hamilton Health Sciences, ON, Canada (M.-A.d., S.A., O.A., M.R., M.B.T., N.V., J.V., T.S., M.S., S.R.M., N.P.-E., J.-D.S., M.K.N., A.K., S.T., W.F., J.B., R.M., J.N., G.D., S.S.J.).
Circ Cardiovasc Interv. 2024 Aug;17(8):e013817. doi: 10.1161/CIRCINTERVENTIONS.123.013817. Epub 2024 Jun 18.
The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain.
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.
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.
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.
新操作员在进行超声引导经股动脉入路（TFA）时的学习曲线仍不确定。
我们对 FAUST（经股动脉入路的超声试验）和 UNIVERSAL（心脏手术血管入路的常规超声引导）试验进行了汇总分析，这两项试验均为多中心随机对照试验，比较了 1:1 的超声引导与非超声引导 TFA 用于冠状动脉介入治疗。主要结果包括大出血或血管并发症的复合终点以及股总动脉成功穿刺。参与者根据操作员累计的病例量进行分层。我们使用调整后的重复测量逻辑回归，考虑了操作员聚类的随机截距，与非超声引导 TFA 组进行比较，并对学习曲线进行建模。
FAUST 和 UNIVERSAL 试验共纳入 1624 例患者，其中 810 例随机分为非超声引导 TFA 组，814 例随机分为超声引导 TFA 组（病例 1-10，391 例；11-20，183 例；>20，240 例）。与非超声引导 TFA 相比，有≥20 例超声引导 TFA 操作经验的操作员的主要终点风险降低（240 例中的 5 例[2.1%]与 810 例中的 64 例[7.9%]；调整后的优势比，0.26 [95%CI，0.09-0.61]）。进行≥20 例超声引导操作的操作员成功穿刺股总动脉的可能性更高（246 例中的 224 例[91.1%]与 382 例中的 327 例[85.6%]；调整后的优势比，1.76 [95%CI，1.08-2.89]）。学习曲线图显示，随着累计病例数的增加，操作员的能力不断提高。
与非超声引导 TFA 相比，新操作员应至少进行 20 例超声引导 TFA，以降低入路部位并发症并提高正确穿刺率。额外的累计病例数可能会提高熟练度。培训计划应考虑到这些发现，以适应经桡动脉时代。
