BOSTON — Routine ultrasound guidance for accessing the femoral vein for percutaneous coronary procedures didn’t cut down on bleeding and vascular complications, the UNIVERSAL trial showed.
The primary combined endpoint of major bleeding and major vascular complications at 30 days showed no advantage to the imaging technique added to fluoroscopy, reported Sanjit S. Jolly, MD, MSc, of the Population Health Research Institute in Hamilton, Ontario, Canada, at the Transcatheter Cardiovascular Therapeutics (TCT) meeting hosted by the Cardiovascular Research Foundation. The results were simultaneously published in JAMA Cardiology.
Combined risk of BARC type 2, 3, or 5 bleeds along with femoral artery pseudoaneurysm, arteriovenous fistula, retroperitoneal bleed, a hematoma diameter over 5 cm, or ischemic limb requiring intervention or surgery was 12.9% in patients randomized to ultrasound guidance versus 16.1% without it (OR 0.77, P=0.25).
However, there were some secondary endpoints that favored routine ultrasound guidance (all significant at P<0.001):
- More success at access on the first pass: 86.6% vs 70.0% (odds ratio 2.76)
- Fewer arterial puncture attempts: mean 1.2 vs 1.4
- Less venipuncture: 3.1% vs 11.7% (OR 0.24)
As those benefits have been consistent across prior trials and ultrasonography doesn’t appear to carry any risks, the researchers concluded that “it seems logical that physicians with required expertise and ready access to ultrasonography will use it to aid access.”
In a JAMA Cardiology accompanying invited commentary, Alexander C. Fanaroff, MD, MHS, and Jay Giri, MD, MPH, both of the University of Pennsylvania in Philadelphia, agreed that the negative primary findings shouldn’t dissuade interventionalists. They advocated guidelines take a stance in favor of ultrasound guidance.
“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,” they wrote. “Guidelines should reflect this reality, and more importantly, so should the care we offer patients.”
A larger trial, and looking just at vascular outcomes without the “noise” of BARC 2 bleeding, likely would have made the trial positive, Jolly suggested at the TCT session.
Indeed, when his group analyzed their data together with those of nine other trials for a total of 4,410 patients, there ultrasound guidance did improve both the combined risk of major bleeding or major vascular complication (RR 0.58, 95% CI 0.43-0.76) and major vascular complications alone (RR 0.49, 95% CI 0.34-0.69).
The very best option is radial access, based on data showing 60% fewer complications and even reduced mortality in some studies compared with femoral access, Jolly noted. When radial isn’t an option, typically in more complex cases, ultrasound-guided femoral access is the next best alternative, he said. “It’s kind of like wearing the seat belt you already have in the car,” Jolly told MedPage Today.
However, some one-third of transcatheter coronary procedures in the U.S. are done via femoral access without ultrasound guidance.
That only applies to relatively small bore access, as ultrasound guidance is typically standard for structural interventions that require larger bore access, noted TCT press conference panelist Ajay J. Kirtane, MD, of NewYork-Presbyterian Hospital in New York City.
It makes no sense that seasoned operators would routinely advocate ultrasound for access with one kind of procedure and not the rest, Jolly countered.
“It’s the next generation that is changing practice,” he explained. “The fellows say, ‘I want to use ultrasound.’ It’s the old guy in the corner that says, ‘I’ve been doing this for 30 years, you don’t need it.’ This kind of iterative step takes us forward.”
That message was seconded by Matthew Tomey, MD, of the Icahn School of Medicine at Mount Sinai in New York City.
“I believe the totality of evidence indicates utility of ultrasound guidance as an adjunct to well-developed classical skills in femoral artery access,” he commented. “We should be teaching seasoned interventional cardiologists ultrasound skills and new trainees classical skills.”
UNIVERSAL randomized 621 patients getting femoral access percutaneous coronary intervention (42%) or coronary angiography at two centers in Canada to open-label use of routine ultrasound guidance or not along with fluoroscopy. Participants had a mean age of 71, and 25.4% were female. Half of the procedures in the trial were done by fellows; the other half by attending physicians.
At the participating academic medical centers, radial access is routine, so femoral access were for typically more complex cases.
The leading reason for femoral access was prior coronary artery bypass grafting, which was the indication for about half of patients. Other common reasons were chronic total occlusion PCI, at 16% to 17%, and lack of a radial pulse, in 11% to 15%.
The trial showed similar times to access between groups.
While prerandomization prespecified subgroups didn’t suggest any characteristics that impacted utility of ultrasound guidance, there was a significant interaction with closure device use. Fewer primary endpoint events occurred with ultrasonography than without it among the 52% of patients who got a closure device (11.8% vs 23.4%, OR 0.44, 95% CI 0.23-0.82), whereas no such association was seen with manual compression.
“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,” the researchers wrote. “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.”
Selection bias was also possible in that finding, the group acknowledged.
Limitations included that the trial was only powered to discover a 50% reduction in the primary outcome and that the biggest contributor to the primary endpoint was BARC 2 bleeding, which can be just hematomas requiring additional compression. “These outcomes are of less clinical importance than outcomes such as ischemic limbs requiring surgery or BARC 3 or 5 major bleeding, but a trial powered for these outcomes would need to be much larger, Jolly and colleagues noted.
UNIVERSAL was supported by the Hamilton Health Sciences Foundation and McMaster University.
Jolly disclosed relationships with Boston Scientific, Medtronic, and Penumbra.
Giri disclosed relationships with, and/or institutional support from Abiomed, Boston Scientific, Abbott Vascular, Inari Medical, and Recor Medical. Fanaroff disclosed relationships with industry.