Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures - UNIVERSAL
Contribution To Literature:
The UNIVERSAL trial showed that, among patients undergoing coronary angiography or intervention, routine ultrasonography with fluoroscopy-guided femoral artery access did not reduce a composite of major bleeding and major vascular complications versus fluoroscopic guidance alone.
The goal of the trial was to compare ultrasonography guidance in addition to fluoroscopy versus fluoroscopic guidance alone among patients undergoing femoral arterial access for coronary angiography or intervention.
The UNIVERSAL trial was a multicenter, randomized, open-label trial of patients undergoing coronary angiography/intervention. Patients were randomized in a 1:1 fashion to ultrasonography guidance with fluoroscopy (n = 311) or fluoroscopy alone (n = 310). Fluoroscopy was utilized to identify the femoral head prior to puncture, and operators randomized to the ultrasonography arm were required to complete 10 observed ultrasonography-guided femoral access procedures and demonstrate proficiency.
- Total randomized participants: 621
- Mean patient age: 71 years
- Duration of follow-up: 30 days
- Percentage female: 25%
- Mean body mass index: 30 kg/m2
- Age ≥18 years
- Referral for coronary angiography or percutaneous coronary intervention with planned femoral access
- ST-segment elevation myocardial infarction as initial presentation
- Absence of a palpable femoral pulse
Other salient features/characteristics:
- 57% with prior coronary artery bypass grafting
- 18% with peripheral vascular disease
- 80% with 6 French introducer size; large bore access: 2%
- 52.1% with closure devices (45% total Angioseal)
- No patients with micro-puncture used in either arm
- Access by fellow: 50%
- Baseline use of oral anticoagulation: 16%
The primary outcome, a composite of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding or major vascular complication within 30 days, for ultrasonography and fluoroscopy guidance vs. fluoroscopy guidance alone, was: 12.9% vs. 16.1% (p = 0.25).
Primary outcome (as-treated analysis): 12.4% vs. 16.9% (p = 0.11)
Secondary outcome for ultrasonography and fluoroscopy vs. fluoroscopy alone:
- BARC 2, 3, or 5 criteria at 30 days: 10.0% vs. 10.7% (p = 0.78)
- Major vascular complications: 6.4% vs. 9.4% (p = 0.18)
- First attempt for arterial procedure: 86.6% vs. 70.0% (p < 0.001)
- Venipuncture: 3.1% vs. 11.7% (p < 0.001)
- Total time to obtain femoral artery access: 113.8 seconds vs. 128.9 seconds (p = 0.34)
The results of this trial show that, among patients undergoing coronary angiography or intervention, routine ultrasonography with fluoroscopy-guided femoral artery access did not reduce a composite of major bleeding and major vascular complications versus fluoroscopic guidance alone. The trial did show that the ultrasonography group had less accidental venipuncture and greater first-pass success without a significant difference in time to obtain femoral artery access. Meta-analyses of randomized controlled trials prior to the present study showed a reduction of major vascular access complications and bleeding with ultrasonography guidance, and the authors provide an updated meta-analysis in the present study showing similar findings. However, the findings of the UNIVERSAL trial alone were not statistically significant. Limitations of the trial include lack of use of a micro-puncture catheter, use of which may reduce vascular complications.
Taken into context, it appears that ultrasonography does not substantially add time to femoral access given the improvements in first-pass success and could be considered for use to guide femoral access given its widespread availability. However, the effect size of the reduction in vascular complications and bleeding is likely quite modest. Very few patients undergoing large bore access were included in this study. It is possible that a greater benefit may be observed in this setting with routine ultrasonography guidance.
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 Cardiol 2022;Sep 18:[Epub ahead of print].
Presented by Dr. Sanjit S. Jolly at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 18, 2022.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Aortic Surgery, Interventions and Imaging, Angiography, Echocardiography/Ultrasound, Nuclear Imaging
Keywords: Catheters, Coronary Angiography, Coronary Artery Bypass, Fluoroscopy, Hemorrhage, Percutaneous Coronary Intervention, Phlebotomy, TCT22, Transcatheter Cardiovascular Therapeutics, Ultrasonography, Vascular Diseases
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