Routine ultrasound improved femoral access; did not lower bleeding, vascular complications
BOSTON — Ultrasound-guided femoral access improved first attempt success in coronary procedures but did not reduce the occurrence of major bleeding and vascular complications vs. fluoroscopy alone, a speaker reported.
The results of the UNIVERSAL trial were presented at TCT 2022 and simultaneously published in JAMA Cardiology.
“We know that transradial [access prevents fluoroscopic dye leaks] compared to transfemoral and it reduces access-site bleeding by more than 60% and even reduces mortality in some studies,” Sanjit Jolly, MD, MSc, clinical trialist and interventional cardiologist at McMaster University in Hamilton, Ontario, Canada, said during a press conference. “However, we still need femoral access, and we need to preserve that skill. Perhaps ultrasound guidance can do this. We know that ultrasound is only used in about one-third of cases in surveys in the U.S., but we all have ultrasound machines in the cath labs.”
Jolly and colleagues designed the UNIVERSAL randomized trial to evaluate outcomes of ultrasound-guided with non-ultrasound-guided femoral access for coronary procedures. A total of 621 patients were randomly assigned and blinded to ultrasound or no ultrasound femoral access. The primary outcome was Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding and major vascular complications within 30 days.
Femoral access guided by ultrasound more often achieved access on the first try; required fewer attempts; and had less accidental venipuncture compared with non-ultrasound-guided procedures (P for all < .001), according to the researchers. The average time to sheath insertion was numerically less during ultrasound-guided femoral access, but the difference was not statistically significant.
Although numerically fewer in the ultrasound-guided femoral access group, occurrences of the primary outcome and any of its individual components did not significantly differ between ultrasound-guided and non-ultrasound guided femoral access:
- BARC 2, 3 or 5 bleeding or major vascular complications (ultrasound, 12.9%; controls, 16.1%; OR = 0.77; 95% CI, 0.49-1.2; P = .25);
- BARC 2, 3 or 5 bleeding (P = .78);
- major vascular complications (P = .18); and
- BARC 2 bleeding (P = .78).
The odds of an adverse fluoroscopy event following femoral access were lower in the ultrasound-guided group compared with the non-ultrasound-guided group when a closure device was used (OR = 0.44; 95% CI, 0.23-0.82; P for interaction with no closure device = .004).
Additionally, Jolly and colleagues completed a meta-analysis of nine studies — including UNIVERSAL — that described bleeding events and vascular complications following coronary procedures requiring femoral access, and reported that use of ultrasound guidance was associated with lower risk for bleeding and vascular events compared with non-ultrasound-guided access (RR = 0.58; 95% CI, 0.43-0.76).
“Ultrasound improved first attempt success but did not reduce major bleeding and vascular complications in the UNIVERSAL trial,” Jolly said during the press conference. “Ultrasound is particularly beneficial when you use a closure device and, as a clinician who does these procedures, that makes sense. Ultrasound allows me to do a single poke instead of two pokes. We know if poke the artery more than once, a closure device is not going to work very well. It allows you to see exactly where you put your closure device so it's not in calcium or disease.
“I'm not talking about a new TAVR valve that's $20,000 or $30,000,” he said. “We all have ultrasound machines in our labs. It has virtually no risks. It's widely available and I think we need to focus on training the current generation of interventional cardiologists as well as the next generation.”
In a related editorial published in JAMA Cardiology, Alexander Fanaroff, MD, MHS, interventional cardiologist and assistant professor of medicine in the division of cardiovascular medicine at the Perelman Center for Advanced Medicine, and Jay Giri, MD, MPH, associate director of the cardiovascular catheterization laboratories and assistant professor of medicine at the Hospital of the University of Pennsylvania, discussed the importance of ultrasound guidance during routine femoral artery access for coronary angiography.
“Interventional cardiologists should not use the primary null results of UNIVERSAL to argue against routine ultrasonography-guided femoral access for coronary angiography and PCI, and in favor of fluoroscopically guided access,” the authors wrote. “The anatomic rationale is too strong, and the combined weight of evidence from 9 clinical trials that ultrasonography guidance reduces vascular complications is too compelling to argue otherwise. Any interventional cardiologist undergoing femoral access would request ultrasonography guidance from an operator well versed in the technique, just as they would refuse to jump out of an airplane without a parachute. Guidelines should reflect this reality, and more importantly, so should the care we offer patients.”
References:
- Fanaroff AC, et al. JAMA Cardiol. 2022;doi:10.1001/jamacardio.2022.3413.
- Jolly SS, et al. JAMA Cardiol. 2022;doi:10.1001/jamacardio.2022.3399.
Perspective
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Many people are saying, "why do I have to use an ultrasound and go through all of that? I can just do a puncture." There are still centers that are using the femoral approach without ultrasound. [The UNIVERSAL investigators] were hoping to show a superiority and say, "who's doing this without ultrasound?" Almost mandating it. Unfortunately, they didn't show that because I think they were thinking the other way — as if to change the guidelines to say that if you're going to do femoral approach, you must use ultrasound. Unfortunately, that didn't happen because I think the study was small and the endpoint included all kinds of bleeding.
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Jolly SS, et al. Late-Breaking Clinical Science in Vascular Disease and Hypertension: Session III, in Collaboration With the Journal of the American Medical Association. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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