Ultrasonography use to gain femoral access did not reduce bleeding or vascular complications, according to researchers, who also found the test did reduce venipuncture risk and number of attempts.
Presenting the findings during the Transcatheter Cardiovascular Therapeutics (TCT) 2022 conference in Boston, Sanjit Jolly, MD, MSc, said the study suggested larger trials were required to demonstrate additional potential benefits of ultrasonography-guided access. The findings were also reported in a manuscript simultaneously published online in JAMA Cardiology.
In Sunday’s TCT session, Jolly, from McMaster University, Hamilton, Ontario, explained that radial access can reduce bleeding and major vascular complications compared with femoral access.
However, femoral access is still needed for large-bore procedures or when the radial arteries are too small or occluded. The rate of femoral vascular complications remains high in this subgroup of patients.
“We still need femoral access, and we need to preserve that skill,” said Jolly, presenting on behalf of the UNIVERSAL investigative team.
“And so, perhaps, ultrasound guidance can do this. We know that ultrasound is only used in about a third of cases in surveys in the U.S., but we all have ultrasound machines in the catheter labs.”
The design details of the UNIVERSAL trial have been published previously. In brief, the trial used a multicenter randomized approach that compared an ultrasonography-guided approach vs. no ultrasonography for femoral access for cardiac procedures using fluoroscopic landmarking.
Using an open-label method with blinded assessment of outcomes, 621 patients were enrolled at two centers in Canada.
Mean (standard deviation [SD]) age was 71 [10.24] years and 158 subjects [25.4%] were female with a mean [SD] body mass index (BMI) of 30.3 [23.2].
Patients were eligible if referred for coronary angiography or percutaneous coronary intervention (PCI) with planned femoral access.
These patients were then randomly assigned in a 1:1 ratio of ultrasonography guidance with fluoroscopy or fluoroscopy alone.
The primary outcome of the trial was the composite of definitions agreed by the Bleeding Academic Research Consortium (BARC), specifically 2, 3, and 5 bleeding or major vascular complications within 30 days.
This included femoral artery pseudoaneurysm, arteriovenous fistula, retroperitoneal bleed, large hematoma of more than 5 cm in diameter or ischemic limb requiring intervention or surgery.
Set of results
The primary outcome occurred in 40 of 311 patients (12.9%) in the ultrasonography group vs. 50 of 310 patients (16.1%) without ultrasonography (odds ratio [OR], 0.77; 95% confidence interval [CI], 0.49-1.20; P = 0.25).
The rates of BARC 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (OR, 0.93; 95% CI, 0.55-1.56; P = 0.78).
The study also showed that the rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (OR, 0.67; 95% CI, 0.37-1.20; P = 0.18).
Ultrasonography improved first-pass success (277 of 311 [86.6%] vs. 222 of 310 [70.0%]; OR, 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).
The test also improved venipuncture success (10 of 311 [3.1%] vs. 37 of 310 [11.7%]; OR, 0.24; 95% CI, 0.12-0.50; P<0.001) with similar times to access (mean [SD], 114  vs 129  seconds; mean difference, −15.1; 95% CI, −45.9 to 15.8; P = 0.34).
“In patients receiving vascular closure devices, ultrasonography reduced the incidence of major bleeding and major vascular complications and improved safety,” Jolly and colleagues reported in their manuscript.
“The closure device findings are biologically plausible because ultrasonography reduces the potential for multiple punctures, which is likely important when using a vascular closure device that will only close one puncture.
“On the other hand, manual compression may compensate for multiple punctures by compressing them all, making it more difficult to see a difference in groups for less serious complications.”
Jolly and colleagues added that ultrasonography allowed operators to identify a puncture site free of calcium and disease making closure devices safer.
Jolly SS, AlRashidi S, d’Entremont MA, et al. Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures: The UNIVERSAL Randomized Clinical Trial. JAMA Cardio 2022 Sep 18 (Article in press).
Image Credit: Jason Wermers/CRTonline.org