Ultrasound-Guided Transfemoral Access for Coronary Procedures: A Pooled Learning Curve Analysis From the FAUST and UNIVERSAL Trials.

BACKGROUND: The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Ultrasound guidance for transfemoral access in coronary procedures: an individual participant-level data metaanalysis from the femoral ultrasound trialist collaboration.

BACKGROUND: Randomised controlled trials of ultrasound (US)-guided transfemoral access (TFA) for coronary procedures have shown mixed results. AIMS: We aimed to compare US-guided versus non-US-guided TFA from randomised data in an individual participant-level data (IPD) meta-analysis. METHODS: We completed a systematic review and an IPD meta-analysis of all randomised controlled trials comparing US-guided versus non-US-guided TFA for coronary procedures. We performed a one-stage mixed-model meta-analysis using the intention-to-treat population from included trials. The primary outcome was a composite of major vascular complications or major bleeding within 30 days. RESULTS: A total of 2,441 participants (1,208 US-guided, 1,233 non-US-guided) from 4 randomised clinical trials were included. The mean age was 65.5 years, 27.0% were female, and 34.5% underwent a percutaneous coronary intervention. The incidence of major vascular complications or major bleeding (34/1,208 [2.8%] vs 55/1,233 [4.5%]; odds ratio [OR] 0.61, 95% confidence interval [CI]: 0.39-0.94; p=0.026) was lower in the US-guided TFA group. In the prespecified subgroup of participants who received a vascular closure device, those randomised to US-guided TFA experienced a reduction in the primary outcome (2.1% vs 5.6%; OR 0.36, 95% CI: 0.19-0.69), while no benefit for US guidance was observed in the subgroup without vascular closure devices (4.1% vs 3.3%; OR 1.21, 95% CI: 0.65-2.26; interaction p=0.009). CONCLUSIONS: In participants undergoing coronary procedures by TFA, US guidance decreased the composite outcome of major vascular complications or bleeding and may be especially helpful when using vascular closure devices.

Changes in post-PCI physiology based on anatomical vessel location: a DEFINE PCI substudy.

BACKGROUND: Anatomical vessel location affects post-percutaneous coronary intervention (PCI) physiology. AIMS: We aimed to compare the post-PCI instantaneous wave-free ratio (iFR) in left anterior descending (LAD) versus non-LAD vessels and to identify the factors associated with a suboptimal post-PCI iFR. METHODS: DEFINE PCI was a multicentre, prospective, observational study in which a blinded post-PCI iFR pullback was used to assess residual ischaemia following angiographically successful PCI. RESULTS: Pre- and post-PCI iFR recordings of 311 LAD and 195 non-LAD vessels were compared. Though pre-PCI iFR in the LAD vessels (median 0.82 [0.63, 0.86]) were higher compared with those in non-LAD vessels (median 0.72 [0.49, 0.84]; p<0.0001), post-PCI iFR were lower in the LAD vessels (median 0.92 [0.88, 0.94] vs 0.98 [0.95, 1.00]; p<0.0001). The prevalence of a suboptimal post-PCI iFR of <0.95 was higher in the LAD vessels (77.8% vs 22.6%; p<0.0001). While the overall frequency of residual physiological diffuse disease (31.4% vs 38.6%; p=0.26) and residual focal disease in the non-stented segment (49.6% vs 50.0%; p=0.99) were similar in both groups, residual focal disease within the stented segment was more common in LAD versus non-LAD vessels (53.7% vs 27.3%; p=0.0009). Improvement in iFR from pre- to post-PCI was associated with angina relief regardless of vessel location. CONCLUSIONS: After angiographically successful PCI, post-PCI iFR is lower in the LAD compared with non-LAD vessels, resulting in a higher prevalence of suboptimal post-PCI iFR in LAD vessels. This difference is, in part, due to a greater frequency of a residual focal pressure gradient within the stented segment which may be amenable to more aggressive PCI.

Vascular Access in Percutaneous Coronary Intervention of Chronic Total Occlusions: A State-of-the-Art Review.

The outcomes of chronic total occlusion percutaneous coronary intervention have considerably improved during the last decade with continued emphasis on improving procedural safety. Vascular access site bleeding remains one of the most frequent complications. Several procedural strategies have been implemented to reduce the rate of vascular access site complications. This state-of-the-art review summarizes and describes the current evidence on optimal vascular access strategies for chronic total occlusion percutaneous coronary intervention.