Results from a multicentre randomised trial comparing ultrasound with fluoroscopic guidance versus fluoroscopic guidance alone during vascular femoral access for patients undergoing cardiac procedures did not reduce vascular complications or bleeding but it did lower the number of attempts and venipuncture. However, in patients receiving vascular closure devices, ultrasound did reduce vascular complications and bleeding.
These were findings of the UNIVERSAL trial, presented by Sanjit Jolly (McMaster University, Hamilton, Canada) during a late-breaking clinical science session at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA). The study results were also published in JAMA: Cardiology.
Although transradial access for cardiac procedures reduces bleeding at the access site by more than 60%, femoral access is still needed for large bore procedures and patients with small or occluded radial arteries, Jolly noted in his presentation. The rate of femoral vascular complications remains high in this subgroup of patients and previous randomised trials of ultrasound guidance have shown mixed results, he noted.
Between June 26, 2018, and April 26, 2022, 621 patients were randomised 1:1 at two centres in Canada. Patients with ST-elevation myocardial infarction (STEMI) were not eligible to participate. The trial population had a high rate of comorbidities including 51% of which had a prior myocardial infarction, 42% had diabetes, 45% had prior percutaneous coronary intervention (PCI), 57% had previous coronary bypass surgery, 19% had atrial fibrillation, and 18% had peripheral vascular disease. For the index procedure, 80% were 6 French, 42% underwent PCI, 14% underwent chronic total occlusion (CTO) PCI and closure devices were used in 52.1% of patients.
The primary outcome, defined as the composite of major vascular complications or major bleeding based on Bleeding Academic Research Consortium (BARC) 2, 3, or 5 criteria within 30 days, occurred in 40 of 311 patients (12.9%) in the ultrasonography group versus 50 of 310 patients (16.1%) without ultrasonography (odds ratio, 0.77 [95% CI, 0.49-1.20]; p=.25). The key secondary outcome of the rates of BARC 2, 3, or 5 bleeding were 10.0% (31 of 311) versus 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; p=.78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; p=0.18).
The study also found that ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; p<0.001) and reduced the number of arterial puncture attempts (mean [SD], 1.2 [0.5] vs 1.4 [0.8]; mean difference, −0.26 [95% CI, −0.37 to −0.16]; p<0.001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; p<0.001) with similar times to access.
In the pre-specified subgroup analysis, patients who had a closure device had a significant benefit for US (OR 0.44 95% CI 0.23-0.82, interaction p=0.004). This makes sense as US avoids multiple punctures and allows the operator to choose a site free of disease or calcium.
An updated meta-analysis of all the available trials including UNIVERSAL with more than 4,000 patients shows that US reduces major bleeding and vascular complications (RR 0.58; 95% CI 0.43–0.76).
“Although ultrasonography guidance for femoral access did not reduce the primary events of bleeding or vascular complications, some benefits were identified,” said Jolly. “Ultrasonography did improve first-pass success and reduced the number of attempts as well as the risk of venipuncture. Therefore, larger trials may be able to identify additional benefits for this technique.”
“We need to put this into perspective because ultrasonography has no risks and is low cost, and so we need to focus on training. Finally, transradial access remains the best way to prevent femoral access bleeding”.
