UNIVERSAL Evaluates Use of Ultrasound Guidance for Femoral Vascular Access in Cardiac Procedures

September 18, 2022—The large, multicenter, UNIVERSAL randomized clinical trial demonstrated that 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 did lower the number of attempts and venipuncture. In patients receiving vascular closure devices, the use of ultrasound did reduce vascular complications and bleeding.

Findings from the UNIVERSAL trial were reported at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts. The study was simultaneously published online by Sanjit S. Jolly, MD, et al in JAMA: Cardiology.

The TCT press release noted that although transradial access for cardiac procedures reduces bleeding at the access site by > 60%, femoral access is still needed for large-bore procedures and patients with small or occluded radial arteries. The rate of femoral vascular complications remains high in this subgroup of patients, and previous randomized trials of ultrasound guidance have shown mixed results.

The UNIVERSAL investigators enrolled 621 patients who were randomized 1:1 at two centers in Canada between June 26, 2018, and April 26, 2022. Patients with ST-segment elevation myocardial infarction were not eligible to participate.

The investigators reported that the trial population had a high rate of comorbidities, including previous myocardial infarctions (51%), diabetes (42%), previous percutaneous coronary intervention (PCI; 45%), previous coronary bypass surgery (57%), atrial fibrillation (19%), and peripheral vascular disease (18%).

For the index procedure, 80% were 6 F, 42% underwent PCI, 14% underwent chronic total occlusion PCI, and 52.1% were treated with closure devices.

The primary outcome was 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.

As summarized in the TCT press release, the primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group versus 50 of 310 patients (16.1%) without ultrasonography (odds ratio [OR], 0.77; 95% CI, 0.49-1.20; P = .25).

The key secondary outcome of the rates of BARC 2, 3, or 5 bleeding occurred in 10.0% versus 10.7% (OR, 0.93; 95% CI, 0.55-1.56; P = .78). The rates of major vascular complications were 6.4% versus 9.4% (OR, 0.67; 95% CI, 0.37-1.20; P = .18).

The study also found that ultrasonography improved first-pass success in 86.6% versus 70.0% (OR, 2.76; 95% CI, 1.85-4.12; P < .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 < .001) and venipuncture (3.1% vs 11.7%; OR, 0.24; 95% CI, 0.12-0.50; P < .001) with similar times to access.

In the prespecified subgroup analysis, patients who had a closure device had a significant benefit with ultrasound (OR, 0.44; 95% CI, 0.23-0.82; interaction P = .004). This makes sense as ultrasound avoids multiple punctures and allows the operator to choose a site free of disease or calcium, noted the investigators.

Finally, the investigators reported that an updated meta-analysis of all the available trials, including UNIVERSAL, with > 4,000 patients shows that ultrasound reduces major bleeding and vascular complications (risk ratio, 0.58; 95% CI, 0.43-0.76).

Dr. Jolly, who is an interventional cardiologist with Hamilton Health Sciences and Professor of Medicine at McMaster University in Hamilton, Canada, commented in the TCT press release, “Although ultrasonography guidance for femoral access did not reduce the primary events of bleeding or vascular complications, some benefits were identified. 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.”

Dr. Jolly concluded, “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.”