Although the UNIVERSAL trial did not meet its endpoint of reducing bleeding or vascular complications in femoral access, ultrasound guidance does reduce the risk of venipuncture and lowers the number of arterial puncture attempts.
The multicenter trial compared ultrasound with fluoroscopic guidance versus fluoroscopic guidance alone during vascular femoral access for patients undergoing cardiac procedures.
Findings of the UNIVERSAL trial, presented by Sanjit Jolly, MD, MSc, McMaster University, Hamilton, Canada, during a late-breaking clinical science session at the 2022 Transcatheter Cardiovascular Therapeutics meeting and published in JAMA: Cardiology.
Transradial access is the gold standard for most cardiac procedures, but in the event of radial artery occlusion or need for large-bore access, the femoral artery is the most common alternative and optimizing entry remains an important goal.
“We still need femoral access,” said Dr Jolly. “We need to preserve that skill and so perhaps ultrasound guidance can [help us] do this. We know that ultrasound is only used in about a third of cases in surveys in the US, but we all have ultrasound machines in the cath labs.”
Although the trial did not meet its primary endpoint, Jolly said the effect of ultrasound “was in the right direction,” especially in that it showed significant benefit for the primary endpoint in the subgroup of patients who received closure devices.
For the study, Jolly and colleagues randomized 621 patients (mean age 71 years; 25.4% female) from two Canadian centers who were undergoing coronary angiography or PCI to have their procedures with ultrasonography guidance (n = 311) or without (n = 310). There was an overall high burden of comorbidity with 51% having prior MI, 42% with diabetes, 45% with prior PCI, 57% with prior CABG, 19% with atrial fibrillation, and 18% with peripheral vascular disease. In total, 14% of patients underwent chronic total occlusion PCI.
The rate of crossover was 2.3% from no ultrasound to ultrasound and 0.3% from ultrasound to no ultrasound. About half of all procedures were performed by interventional cardiology fellows with the other half done by attendings. Each operator was approved for inclusion in the study after performing 10 cases. Closure devices were used in 52.1% of patients.
The primary composite endpoint of BARC 2, 3, or 5 bleeding or major vascular complications at 30 days did not differ between the study groups. However, procedures in the ultrasound group had better first-pass success and fewer arterial puncture attempts and accidental venipunctures. The time to access was similar for both the ultrasound and no ultrasound groups.
There were no differences in prespecified subgroup analyses with the exception of a significant benefit observed for the primary endpoint with ultrasound guidance for those who received closure devices (11.8% vs 23.4%; OR 0.44; 95% CI 0.23-0.82). There was also a nonsignificant trend of benefit for ultrasound in cases where the attending interventional cardiologist was the lead operator (10.2% vs 17.8%; OR 0.52; 95% CI 0.25-1.07).Back To Top
Ultrasound Doesn’t Reduce Complications in Femoral Access but Still Adds Value. Appl Radiol.