Ultrasound-Guided Transfemoral Access for Coronary Procedures: A Pooled Learning Curve Analysis From the FAUST and UNIVERSAL Trials.

BACKGROUND: The learning curve for new operators performing ultrasound-guided transfemoral access (TFA) remains uncertain. METHODS: 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. RESULTS: 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 >20, 240). Participants who had operators who performed >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 >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. CONCLUSIONS: 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.

Ultrasound-guided femoral access in patients with vascular closure devices: a prespecified analysis of the randomised UNIVERSAL trial.

BACKGROUND: Whether ultrasound (US)-guided femoral access compared to femoral access without US guidance decreases access site complications in patients receiving a vascular closure device (VCD) is unclear. AIMS: We aimed to compare the safety of VCD in patients undergoing US-guided versus non-US-guided femoral arterial access for coronary procedures. METHODS: We performed a prespecified subgroup analysis of the UNIVERSAL trial, a multicentre randomised controlled trial of 1:1 US-guided femoral access versus non-US-guided femoral access, stratified for planned VCD use, for coronary procedures on a background of fluoroscopic landmarking. The primary endpoint was a composite of major Bleeding Academic Research Consortium 2, 3 or 5 bleeding and vascular complications at 30 days. RESULTS: Of 621 patients, 328 (52.8%) received a VCD (86% ANGIO-SEAL, 14% ProGlide). In patients who received a VCD, those randomised to US-guided femoral access compared to non-US-guided femoral access experienced a reduction in major bleeding or vascular complications (20/170 [11.8%] vs 37/158 [23.4%], odds ratio [OR] 0.44, 95% confidence interval [CI]: 0.23-0.82). In patients who did not receive a VCD, there was no difference between the US- and non-US-guided femoral access groups, respectively (20/141 [14.2%] vs 13/152 [8.6%], OR 1.76, 95% CI: 0.80-4.03; interaction p=0.004). CONCLUSIONS: In patients receiving a VCD after coronary procedures, US-guided femoral access was associated with fewer bleeding and vascular complications compared to femoral access without US guidance. US guidance for femoral access may be particularly beneficial when VCD are used.

Centralized Triage of Suspected Coronary Artery Disease Using Coronary Computed Tomographic Angiography to Optimize the Diagnostic Yield of Invasive Angiography.

Background: Coronary computed tomographic angiography (CCTA) is preferable to invasive coronary angiography (ICA) for coronary artery disease (CAD) diagnosis in elective patients without known CAD. Methods: We conducted a nonrandomized interventional study involving 2 tertiary care centres in Ontario. From July 2018 to February 2020, outpatients referred for elective ICA were identified through a centralized triage process and were recommended to undergo CCTA first instead of ICA. Patients with borderline or obstructive CAD on CCTA were recommended to undergo subsequent ICA. Intervention acceptability, fidelity, and effectiveness were assessed. Results: A total of 226 patients were screened, with 186 confirmed to be eligible, of whom 166 had patient and physician approval to proceed with CCTA (89% acceptability). Among consenting patients, 156 (94%) underwent CCTA first; 43 (28%) had borderline/obstructive CAD on CCTA, and only 1 with normal/nonobstructive CAD on CCTA was referred for subsequent ICA against protocol (99% fidelity). Overall, 119 of 156 CCTA-first patients did not have ICA within the following 90 days (i.e., 76% potentially avoided ICA, due to the intervention). Among the 36 who underwent ICA post-CCTA per protocol, 24 had obstructive CAD (66.7% diagnostic yield). If all patients who were referred for and underwent ICA at either centre between July 2016 and February 2020 (n = 694 pre-implementation; n = 333 post-implementation) had had CCTA first, an additional 42 patients per 100 would have had an obstructive CAD finding on their ICA (95% confidence interval = 26-59). Conclusion: A centralized triage process, in which elective outpatients referred for ICA are instead referred for CCTA first, appears to be acceptable and effective in diagnosing obstructive CAD and improving efficiencies in our healthcare system.

Contexte: La coronarographie par tomodensitométrie (coro-TDM) est préférable à la coronarographie invasive chez les patients sans coronaropathie connue chez qui le diagnostic d'une coronaropathie n'est pas urgent. Méthodologie: Nous avons réalisé une étude interventionnelle non randomisée dans deux centres de soins tertiaires en Ontario. Les patients ambulatoires pour qui une coronarographie invasive non urgente a été demandée entre juillet 2018 et février 2020 ont été recensés par un processus centralisé de triage et se sont fait recommander de subir d'abord une coro-TDM. Les patients qui présentaient une co-ronaropathie obstructive ou dont les résultats se trouvaient tout juste à la limite de ce diagnostic lors de la coro-TDM se faisaient recommander une coronarographie invasive subséquente. L'acceptabilité de l'intervention, sa fidélité et son efficacité ont été évaluées. Résultats: Au total, 226 patients ont été sélectionnés et 186 ont été jugés admissibles. Parmi ces derniers, 166 ont accepté de subir la coro-TDM recommandée par le médecin (acceptabilité de 89 %). Parmi les patients ayant donné leur consentement, 156 (94 %) se sont d'abord soumis à une coro-TDM, et 43 (28 %) présentaient une coronaropathie obstructive ou des résultats limites selon cet examen. Seulement un patient ne présentant pas de coronaropathie ou présentant une coronaropathie non obstructive à la coro-TDM a été orienté vers une coronarographie invasive subséquente, contrairement au protocole (fidélité de 99 %). En tout, 119 des 156 patients s'étant d'abord soumis à une coro-TDM n'ont pas eu à subir une coronarographie invasive dans les 90 jours suivants (76 % d'entre eux ont potentiellement évité une coronarographie invasive grâce à cette première intervention). Parmi les 36 patients qui ont subi une coronarographie invasive après la coro-TDM, comme le recommandait le protocole, 24 présentaient une coronaropathie obstructive (rendement diagnostique de 66,7 %). Si tous les patients qui ont été orientés vers une coronarographie invasive et qui se sont soumis à cet examen dans l'un ou l'autre des centres entre juillet 2016 et février 2020 (n = 694 avant l'instauration; n = 333 après l'instauration) avaient d'abord passé une coro-TDM, une coronaropathie obstructive aurait été décelée lors de la coronarographie invasive chez 42 patients de plus par tranche de 100 patients (intervalle de confiance à 95 % : 26 à 59). Conclusion: Le recours à un processus de triage centralisé permettant de faire d'abord passer une coro-TDM aux patients ambulatoires dans une situation non urgente qui doivent subir une coronarographie invasive semble être un moyen acceptable et efficace de diagnostiquer la coronaropathie obstructive et d'améliorer l'efficacité dans notre système de santé.

Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures: The UNIVERSAL Randomized Clinical Trial.

Importance: 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. Objective: To determine whether routinely using ultrasonography guidance for femoral arterial access for coronary angiography/intervention reduces bleeding or vascular complications. Design, Setting, and Participants: 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. Interventions: Ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic landmarking. Main Outcomes and Measures: 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. Results: 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]; P = .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]; P = .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]; P = .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]; P < .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 < .001) and venipuncture (10 of 311 [3.1%] vs 37 of 310 [11.7%]; odds ratio, 0.24 [95% CI, 0.12-0.50]; P < .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]; P = .34). All prerandomization prespecified subgroups were consistent with the overall finding. Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT03537118.