Key Points:
- Femoral access is used for 30% of all coronary procedures, and femoral access site complication can be catastrophic. Since the development of ultrasound-guided vascular access, many institutions have adopted ultrasound-guidance as the standard of care for femoral access. However, there is a paucity of randomized data to understand the role of ultrasound in improving the safety of coronary procedures via femoral access.
- In the UNIVERSAL study, patients randomized to ultrasound-guided femoral access did not experience a reduction in major bleeding or vascular complications at 30 days; however, ultrasound guidance did improve first attempt success and reduce the number of attempts and accidental venipuncture.
While femoral access for coronary artery catheterization was traditionally done via palpation, the advent of ultrasound has led to ultrasound-guided femoral access becoming the standard of care in many institutions. However, while ultrasound use may theoretically improve anatomic localization and reduce the risk of femoral access site bleeding, the safety of ultrasound-guided femoral access relative to palpation has not yet been established by randomized trial. In a breaking presentation at the 2022 TCT Conference today, Dr. Sanjit Jolly (McMaster University, Canada) and his team presented their study: “Routine ultrasound guidance for femoral vascular access for cardiac procedures: A randomized trial,” or the UNIVERSAL study.
The UNIVERSAL study (NCT03537118) was a single center randomized controlled trial conducted at McMaster University in Hamilton, Ontario which assessed the effect of ultrasound-guided femoral access on bleeding and vascular complications. The inclusion criteria comprised adults with planned femoral access for coronary procedures; relevant exclusions included STEMI and absence of palpable femoral pulse. A total of 621 patients were randomized to ultrasound-guided and no ultrasound-guided femoral access; fluoroscopy landmarking was used for both groups.
The primary outcome was the composite of major vascular complications (femoral artery pseudoaneurysm, arteriovenous fistula, retroperitoneal bleed, large hematoma of >5 cm, ischemic limb) or major bleeding (defined as BARC 2, 3, or 5) within 30 days. The primary outcome was not significantly different between the two groups (12.9% in the ultrasound group vs 16% in no ultrasound, p =0.25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% vs 10.7% (OR, 0.93[95%CI, 0.55-1.56]; P = .78). The rates of major vascular complications were 6.4% vs 9.4% (OR, 0.67 [95%CI, 0.37-1.20]; P = .18). In secondary analysis of procedural outcomes, patients who underwent ultrasound-guided access had improved first attempt access (86.6% vs 70%, p<0.001), reduced number of attempts (1.16 vs 1.43, p<0.001), and reduced accidental venipuncture (3.1% vs 11.7%, p<0.001). There was no significant difference in time to sheath insertion. On a pre specified subgroup analysis, patients in the ultrasound arm in whom a closure device was used experienced a reduction in bleeding and major vascular complications (OR 0.44, 95% CI (0.23, 0.82), p=0.004).
When discussing the clinical implications of the study at TCT, Dr. Jolly stated: “The use of ultrasound-guided femoral access improved first attempt success but did not reduce bleeding or vascular complications in UNIVERSAL. Ultrasound is particularly beneficial when you use a closure device, and ….an updated meta-analysis looking at the totality of more than 4000 patients randomized supports the benefit of routine ultrasound…I think we need to focus on training both the current and future generation of cardiologists [in ultrasound].”
