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    Ultrasound-Guided Transfemoral Access for Coronary Procedures: A Pooled Learning Curve Analysis From the FAUST and UNIVERSAL Trials
    (2024)
    Marc-André d’Entremont
    ;
    Arnold H. Seto
    ;
    Sulaiman Alrashidi
    ;
    Omar Alansari
    ;
    Bradley Brochu
    <jats:sec> <jats:title>BACKGROUND:</jats:title> <jats:p>The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS:</jats:title> <jats:p>We performed a pooled analysis of the FAUST (Femoral Arterial Access With Ultrasound Trial) and UNIVERSAL (Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures) trials, both multicenter randomized controlled trials of 1:1 ultrasound-guided versus non–ultrasound-guided TFA for coronary procedures. Outcomes included the composite of major bleeding or vascular complications and successful common femoral artery cannulation. Participants were stratified by the operators’ accrued case volume. We used adjusted repeated-measurement logistic regression, with random intercepts for operator clustering, for comparison against the non–ultrasound-guided TFA group and to model the learning curve.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS:</jats:title> <jats:p>The FAUST and UNIVERSAL trials randomized a total of 1624 patients, of which 810 were randomized to non–ultrasound-guided TFA and 814 to ultrasound-guided TFA (cases 1–10, 391; 11–20, 183; and &gt;20, 240). Participants who had operators who performed &gt;20 ultrasound-guided TFAs had a decreased risk for the primary end point (5/240 [2.1%] versus 64/810 [7.9%]; adjusted odds ratio, 0.26 [95% CI, 0.09–0.61]) compared with non–ultrasound-guided TFA. Operators who performed &gt;20 ultrasound-guided procedures had increased odds of successfully cannulating the common femoral artery (224/246 [91.1%] versus 327/382 [85.6%]; adjusted odds ratio, 1.76 [95% CI, 1.08–2.89]) compared with non–ultrasound-guided TFA. The learning curve plots demonstrated growing competence with increasing accrued cases.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS:</jats:title> <jats:p>New operators should perform at least 20 ultrasound-guided TFA to decrease access site complications and increase proper cannulation compared with non–ultrasound-guided TFA. Additional accrued cases may lead to increased proficiency. Training programs should consider these findings in the transradial era.</jats:p> </jats:sec>
      1Scopus© Citations 3
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    Ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of the randomised UNIVERSAL trial
    (2023)
    Marc-André d'Entremont
    ;
    Sulaiman Alrashidi
    ;
    Omar Alansari
    ;
    Bradley Brochu
    ;
    Laura Heenan
    Scopus© Citations 14  1
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    Scopus© Citations 72  14
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    Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures
    (2022)
    Sanjit S. Jolly
    ;
    Sulaiman AlRashidi
    ;
    Marc-André d’Entremont
    ;
    Omar Alansari
    ;
    Bradley Brochu
    <jats:sec><jats:title>Importance</jats:title><jats:p>A significant limitation of femoral artery access for cardiac interventions is the increased risk of vascular complications and bleeding compared with radial access. Strategies to make femoral access safer are needed.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>The Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial is a multicenter, prospective, open-label trial of ultrasonography-guided femoral access vs no ultrasonography for coronary angiography or intervention with planned femoral access. Patients were randomized from June 26, 2018, to April 26, 2022. Patients with ST-elevation myocardial infarction were not eligible.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>The primary composite outcome is the composite of major bleeding based on the Bleeding Academic Research Consortium 2, 3, or 5 criteria or major vascular complications within 30 days.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 621 patients were randomized at 2 centers in Canada (mean [SD] age, 71 [10.24] years; 158 [25.4%] female). 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, 0.77 [95% CI, 0.49-1.20]; <jats:italic>P</jats:italic> = .25). The rates of Bleeding Academic Research Consortium 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (odds ratio, 0.93 [95% CI, 0.55-1.56]; <jats:italic>P</jats:italic> = .78). The rates of major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (odds ratio, 0.67 [95% CI, 0.37-1.20]; <jats:italic>P</jats:italic> = .18). Ultrasonography improved first-pass success (277 of 311 [86.6%] vs 222 of 310 [70.0%]; odds ratio, 2.76 [95% CI, 1.85-4.12]; <jats:italic>P</jats:italic> &amp;amp;lt; .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]; <jats:italic>P</jats:italic> &amp;amp;lt; .001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; <jats:italic>P</jats:italic> &amp;amp;lt; .001) with similar times to access (mean [SD], 114 [185] vs 129 [206] seconds; mean difference, −15.1 [95% CI, −45.9 to 15.8]; <jats:italic>P</jats:italic> = .34). All prerandomization prespecified subgroups were consistent with the overall finding.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>In this randomized clinical trial, use of ultrasonography for femoral access did not reduce bleeding or vascular complications. However, ultrasonography did reduce the risk of venipuncture and number of attempts. Larger trials may be required to demonstrate additional potential benefits of ultrasonography-guided access.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT03537118">NCT03537118</jats:ext-link></jats:p></jats:sec>
      13Scopus© Citations 48
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    Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source
    (2020)
    Robert Mikulík
    ;
    Jens Eckstein
    ;
    Lesly A. Pearce
    ;
    Hardi Mundl
    ;
    Salvatore Rudilosso
    <jats:sec> <jats:title>Background and Purpose:</jats:title> <jats:p>Risks, sites, and predictors of major bleeding during antithrombotic therapies have not been well defined for patients with recent embolic stroke of undetermined source.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial) embolic stroke of undetermined source randomized trial comparing rivaroxaban 15 mg daily with aspirin 100 mg daily.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p> During a median follow-up of 11 months, 85 major bleeds occurred. The most frequent site was gastrointestinal (38%), followed by intracranial (29%). Assignment to rivaroxaban (hazard ratio [HR], 2.7 [95% CI, 1.7–4.3]), East Asia region (HR, 2.5 [95% CI, 1.6–3.9]), systolic blood pressure ≥160 mm Hg (HR, 2.2 [95% CI, 1.2–3.8]), and reduced estimated glomerular filtration rate (HR, 1.2 per 10 mL/min per 1.73 m <jats:sup>2</jats:sup> decrease, [95% CI, 1.0–1.3]) were independently associated with presence of major bleeds. Five (6%) were fatal. Among 15 patients with intracerebral hemorrhage, 2 (13%) were fatal. There was no evidence of an early high-risk period following initiation of rivaroxaban. The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2–18.0]). Distribution of bleeding sites was similar for rivaroxaban and aspirin. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>Among embolic stroke of undetermined source patients participating in an international randomized trial, independent predictors of major bleeding were assignment to rivaroxaban, East Asia region, increased systolic blood pressure, and impaired renal function. East Asia as a region was strongly associated with risk of intracerebral hemorrhage. Estimated glomerular filtration rate should be a consideration for stratifying bleeding risk.</jats:p> </jats:sec> <jats:sec> <jats:title>Registration:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT02313909. </jats:p> </jats:sec>
      1Scopus© Citations 6
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    Scopus© Citations 2  13  1