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Figure 1.  CONSORT Diagram for the UNIVERSAL Trial
CONSORT Diagram for the UNIVERSAL Trial
Figure 2.  Subgroup Analyses for the Primary Outcome
Subgroup Analyses for the Primary Outcome

BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared); CTO, chronic total occlusion; NSTE-ACS, non–ST-segment elevation acute coronary syndrome; PCI, percutaneous coronary intervention; US, ultrasonography.

Figure 3.  An Updated Meta-analysis in the Context of UNIVERSAL for the Composite of Major Vascular Complications or Major Bleeding and Major Vascular Complications Alone
An Updated Meta-analysis in the Context of UNIVERSAL for the Composite of Major Vascular Complications or Major Bleeding and Major Vascular Complications Alone

NA indicates not applicable; RCT, randomized clinical trial, RR, risk ratio.

Table 1.  Baseline and Procedural Characteristics for UNIVERSAL Trial Participants
Baseline and Procedural Characteristics for UNIVERSAL Trial Participants
Table 2.  Clinical Outcomes
Clinical Outcomes
1.
Jolly  SS, Yusuf  S, Cairns  J,  et al.  Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.   Lancet. 2011;377(9775):1409-1420. doi:10.1016/S0140-6736(11)60404-2PubMedGoogle ScholarCrossref
2.
Valgimigli  M, Gagnor  A, Calabró  P,  et al; MATRIX Investigators.  Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial.   Lancet. 2015;385(9986):2465-2476. doi:10.1016/S0140-6736(15)60292-6PubMedGoogle ScholarCrossref
3.
Seto  AH, Abu-Fadel  MS, Sparling  JM,  et al.  Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: FAUST (Femoral Arterial Access With Ultrasound Trial).   JACC Cardiovasc Interv. 2010;3(7):751-758. doi:10.1016/j.jcin.2010.04.015PubMedGoogle ScholarCrossref
4.
Katırcıbaşı  M, Güneş  H, Çağrı Aykan  A, Aksu  E, Özgül  S.  Comparison of ultrasound guidance and conventional method for common femoral artery cannulation: a prospective study of 939 patients.   Acta Cardiol Sin. 2018;34(5):394-398. doi:10.6515/acs.201809_34(5).20180524aPubMedGoogle Scholar
5.
Nguyen  P, Makris  A, Hennessy  A,  et al.  Standard versus ultrasound-guided radial and femoral access in coronary angiography and intervention (SURF): a randomised controlled trial.   EuroIntervention. 2019;15(6):e522-e530. doi:10.4244/EIJ-D-19-00336PubMedGoogle ScholarCrossref
6.
Stone  P, Campbell  J, Thompson  S, Walker  J.  A prospective, randomized study comparing ultrasound versus fluoroscopic guided femoral arterial access in noncardiac vascular patients.   J Vasc Surg. 2020;72(1):259-267. doi:10.1016/j.jvs.2019.09.051PubMedGoogle ScholarCrossref
7.
Marquis-Gravel  G, Tremblay-Gravel  M, Lévesque  J,  et al.  Ultrasound guidance versus anatomical landmark approach for femoral artery access in coronary angiography: a randomized controlled trial and a meta-analysis.   J Interv Cardiol. 2018;31(4):496-503. doi:10.1111/joic.12492PubMedGoogle ScholarCrossref
8.
Soverow  J, Oyama  J, Lee  MS.  Adoption of routine ultrasound guidance for femoral arterial access for cardiac catheterization.   J Invasive Cardiol. 2016;28(8):311-314.PubMedGoogle Scholar
9.
Damluji  AA, Nelson  DW, Valgimigli  M,  et al.  Transfemoral approach for coronary angiography and intervention: a collaboration of international cardiovascular societies.   JACC Cardiovasc Interv. 2017;10(22):2269-2279. doi:10.1016/j.jcin.2017.08.035PubMedGoogle ScholarCrossref
10.
Alrashidi  S, d’Entremont  M-A, Alansari  O,  et al.  Design and rationale of routine UltrasouNd guidance for Vascular access foR cardiac procedureS: a randomized triaL (UNIVERSAL).   CJC Open. Published online August 29, 2022. doi:10.1016/j.cjco.2022.08.011Google ScholarCrossref
11.
Jayanti  S, Juergens  C, Makris  A, Hennessy  A, Nguyen  P.  The Learning Curves for Transradial and ultrasound-guided arterial access: an analysis of the SURF Trial.   Heart Lung Circ. 2021;30(9):1329-1336. doi:10.1016/j.hlc.2021.02.006PubMedGoogle ScholarCrossref
12.
Jolly  SS, Yusuf  S, Cairns  J,  et al; RIVAL trial group.  Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.   Lancet. 2011;377(9775):1409-1420. doi:10.1016/S0140-6736(11)60404-2PubMedGoogle ScholarCrossref
13.
Rashid  MK, Sahami  N, Singh  K, Winter  J, Sheth  T, Jolly  SS.  Ultrasound guidance in femoral artery catheterization: a systematic review and a meta-analysis of randomized controlled trials.   J Invasive Cardiol. 2019;31(7):E192-E198.PubMedGoogle Scholar
14.
Stanley  K.  Evaluation of randomized controlled trials.   Circulation. 2007;115(13):1819-1822. doi:10.1161/CIRCULATIONAHA.106.618603PubMedGoogle ScholarCrossref
15.
Sterne  JAC, Savović  J, Page  MJ,  et al.  RoB 2: a revised tool for assessing risk of bias in randomised trials.   BMJ. 2019;366:l4898. doi:10.1136/bmj.l4898PubMedGoogle ScholarCrossref
16.
Dudeck  O, Teichgraeber  U, Podrabsky  P, Lopez Haenninen  E, Soerensen  R, Ricke  J.  A randomized trial assessing the value of ultrasound-guided puncture of the femoral artery for interventional investigations.   Int J Cardiovasc Imaging. 2004;20(5):363-368. doi:10.1023/b:caim.0000041949.59255.3fGoogle ScholarCrossref
17.
Gedikoglu  M, Oguzkurt  L, Gur  S, Andic  C, Sariturk  C, Ozkan  U.  Comparison of ultrasound guidance with the traditional palpation and fluoroscopy method for the common femoral artery puncture.   Catheter Cardiovasc Interv. 2013;82(7):1187-1192. doi:10.1002/ccd.24955Google ScholarCrossref
18.
Slattery  MM, Goh  GS, Power  S, Given  MF, McGrath  FP, Lee  MJ.  Comparison of ultrasound-guided and fluoroscopy-assisted antegrade common femoral artery puncture techniques.   Cardiovasc Intervent Radiol. 2015;38(3):579-82. doi:10.1007/s00270-014-0998-7Google ScholarCrossref
19.
Vincent  F, Spillemaeker  H, Kyheng  M,  et al.  Ultrasound guidance to reduce vascular and bleeding complications of percutaneous transfemoral transcatheter aortic valve replacement: a propensity score-matched comparison.   J Am Heart Assoc. 2020;9(6):e014916. doi:10.1161/JAHA.119.014916PubMedGoogle ScholarCrossref
20.
Ambrose  JA, Lardizabal  J, Mouanoutoua  M,  et al.  Femoral micropuncture or routine introducer study (FEMORIS).   Cardiology. 2014;129(1):39-43. doi:10.1159/000362536PubMedGoogle ScholarCrossref
Original Investigation
September 18, 2022

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

Author Affiliations
  • 1Population Health Research Institute, Hamilton, Ontario, Canada
  • 2McMaster University, Hamilton, Ontario, Canada
  • 3Hamilton Health Sciences, Hamilton, Ontario, Canada
  • 4Niagara Health, St Catherines, Ontario, Canada
  • 5Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec, Canada
  • 6CK Hui Heart Centre, Royal Alexandra Hospital Edmonton, Edmonton, Alberta, Canada
  • 7McGill University Faculty of Medicine and Health Sciences, Montreal, Quebec, Canada
  • 8Departamento de enfermedades cardiovasculares, Clínica Alemana De Santiago, Universidad del Desarrollo, Chile
JAMA Cardiol. 2022;7(11):1110-1118. doi:10.1001/jamacardio.2022.3399
Key Points

Question  Does routine ultrasonography guidance for femoral arterial access for cardiac procedures reduce bleeding or vascular complications?

Findings  In this randomized clinical trial that included 621 patients, ultrasonography did not reduce bleeding or vascular complications overall but did improve first-pass success and reduce venipuncture.

Meaning  Ultrasonography did not reduce bleeding or vascular complications for femoral access but did facilitate access.

Abstract

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

Introduction

Radial access has been shown to reduce bleeding and major vascular complications compared with femoral access.1,2 However, femoral access is still needed for large bore procedures or when the radial arteries are too small or occluded. The rate of femoral vascular complications remains high in this subgroup of patients. As a result, further strategies to make femoral access safer are needed.

The available trial data are mixed with some trials suggesting benefit and others showing no effect regarding the use of routine ultrasonography guidance for femoral access.3-7 Furthermore, surveys of interventional cardiologists demonstrated that only 13% to 27% of operators routinely used ultrasonography guidance for femoral access, despite 88% answering that ultrasonography was available in the catheterization laboratory.8,9

The Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures (UNIVERSAL) randomized clinical trial was designed to compare ultrasonography guidance vs no ultrasonography guidance for femoral arterial access on a background of fluoroscopic guidance for coronary angiography or intervention.

Methods
Study Design

The UNIVERSAL trial was a multicenter randomized clinical trial of ultrasonography-guided approach vs no ultrasonography for femoral access for cardiac procedures on background of fluoroscopic landmarking. The trial protocol and statistical analysis plan are available in Supplement 1. The details of the design of the UNIVERSAL trial have been published previously.10 The trial was an open-label trial with blinded assessment of outcomes. The study was approved by the ethics committee at each participating center. The academic steering committee designed the trial protocol. The Population Health Research Institute, a joint institute of McMaster University and Hamilton Health Sciences, conducted and coordinated the trial and also collected and held all trial data. This study followed Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Eligibility Criteria and Randomization

Patients were eligible if referred for coronary angiography or percutaneous coronary intervention (PCI) with planned femoral access. The only exclusion criteria were age 18 years or younger, ST-elevation myocardial infarction as initial presentation, and the absence of a palpable femoral pulse. All patients provided written informed consent prior to randomization. Patients were randomized from June 26, 2018, to April 26, 2022. Eligible patients were randomly assigned in a 1:1 ratio of ultrasonography guidance with fluoroscopy or fluoroscopy alone. Randomization was performed using permuted blocks with stratification according to study center with a 24-hour computerized central system located at the Population Health Research Institute. All patients and investigators were aware of study group assignments. Data on race or ethnicity were not collected due to oversight.

Ultrasonography Group

Operator expertise is important for ultrasonography-guided access.11 Operators were required to have completed at least 10 observed ultrasonography-guided femoral access and demonstrate proficiency including identifying the femoral bifurcation, femoral head, tracking the needle in real time, including tracking the needle tip on the anterior femoral wall with indentation and confirming the wire entry in orthogonal views on ultrasonography. Operators were required to use these steps in patients randomized to ultrasonography. Fluoroscopy to identify femoral head was recommended for both groups prior to puncture of the artery.

No Ultrasonography Group

Operators were required to use palpation and fluoroscopy to identify the femoral ahead prior to puncturing the femoral artery without the use of ultrasonography.

Study Outcomes

The primary outcome was the composite of Bleeding Academic Research Consortium (BARC) 2, 3, and 5 bleeding or major vascular complications (femoral artery pseudoaneurysm, arteriovenous fistula, retroperitoneal bleed, large hematoma of more than 5 cm in diameter, or ischemic limb requiring intervention or surgery) within 30 days. The key secondary outcome was BARC 2, 3, or 5 major bleeding. Other outcomes included components of the primary outcome including major vascular complications and the number of attempts for arterial puncture, successful common femoral artery cannulation, venipunctures, closure device failure, and the total time to obtain femoral access.

At discharge, a blinded investigator assessed the presence of a major vascular complication or major bleeding. A comprehensive medical record review and telephone follow-up within 30 days postprocedure to assess for complications was performed by individuals blinded to allocation.

Angiographic Core Laboratory Evaluation

Blinded research personnel analyzed peripheral angiograms in an angiographic core laboratory located at the Hamilton General Hospital, Hamilton, Canada. We reported the location of the femoral bifurcation, the presence of femoral artery calcification, the site of femoral artery cannulation, active bleeding, and femoral artery dissection. Successful cannulation of common femoral artery was defined as at or above femoral bifurcation and below inferior epigastric artery by core laboratory reviewers.

Statistical Considerations

The initial sample size was based on the Radial vs Femoral Access for Coronary Angiography and Intervention in Patients With Acute Coronary Syndromes (RIVAL) trial’s definition of major vascular complications and used a 3% expected event rate in the control arm and a 1% expected event rate in the experimental arm. These assumptions led to a sample size of 1538 patients to have 80% power with a 2-sided 5% type I error level.12

A limitation of our initial sample size calculation was that BARC 2 bleeding was not collected in RIVAL and therefore not an accurate assessment of event rates. As a result, we re-estimated our sample size based on blinded event rates after 450 patients. Our revised control event rate was estimated to be 14%. Subsequently, 600 patients were needed to have 80% power, a 2-sided 5% type I error level, and a 50% relative risk reduction for the primary outcome. The 50% relative risk reduction was chosen as consistent with prior meta-analyses.13 We amended the protocol on April 12, 2021. Power calculations were performed using PASS version 13 (NCSS Statistical Software). Recruitment took longer than expected because of the COVID-19 pandemic halting all non–COVID-19–related research during periods of 2020. Furthermore, our participating centers used primarily transradial access and so transfemoral access was generally reserved for high-risk patients/procedures.

For the primary analysis, an intention-to-treat analysis included all randomized patients.14 As such, patients were kept in the treatment group to which they were originally randomized. A secondary as-treated analysis was also prespecified. χ2 Tests or Fischer exact tests were performed on a per-patient basis, and statistical significance was claimed if the P value is less than .05. Of note, core-laboratory analyses were performed on a per-access basis. Odds ratios and 95% CIs were also be reported to quantify treatment effects.

Subgroup Analysis

We planned the following subgroup analyses to identify potential differing treatment effects in the following groups: age (≥75 years vs <75 years), sex (male vs female), body mass index (calculated as weight in kilograms divided by height in meters squared; ≥30 vs <30), peripheral vascular disease (presence vs absence), clinical presentation (non–ST-segment elevation acute coronary syndrome vs elective), coronary intervention (PCI vs angiography alone), type of procedure (chronic total occlusion procedure vs nonchronic total occlusion procedure), sheath size (≥7F vs <7F), and closure device use (used vs not used). The underlying hypothesis is that ultrasonography-guided access will be more beneficial to higher-risk groups and will facilitate use of closure devices and make them safer. We also examined a post hoc subgroup by attending physician vs interventional fellow performing procedure.

Meta-analysis

We registered the present meta-analysis in the PROSPERO international prospective register of systematic reviews (CRD42022341661) and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.

Search Strategy With Inclusion and Exclusion Criteria

We completed a systematic search of PubMed, Embase, and the Cochrane Central Register of Controlled Trials from inception to June 23, 2022. We restricted our search to the English language and randomized clinical trials. We included all randomized clinical trials comparing ultrasonography-guided access vs palpation with or without fluoroscopy for femoral arterial access. eTable 1 in Supplement 2 denotes our complete search strategy. Two independent authors (M.-A.D. and S.A.) performed the literature review with disputes resolved through consensus with the senior author (S.S.J.).

Outcomes

The primary outcome was the composite of major vascular complications (femoral artery pseudoaneurysm, arteriovenous fistula, retroperitoneal bleed, large hematoma of >5 cm, ischemic limb) or major bleeding (defined as BARC 2, 3, or 5). The secondary outcome was major vascular complications alone as defined above.

Data Extraction and Risk of Bias

Two investigators (M.-A.D. and S.A.) independently extracted the data, with consensus reached with the senior author as needed (S.S.J.). We assessed the studies for bias using Cochrane’s Collaboration risk-of-bias tool and verified for small study effects through visual inspection of funnel plots.15

Statistical Analysis

The meta-analysis was performed on an intention-to-treat basis using the fixed effect model. We calculated risk ratios with 95% CIs using the Mantel-Haenszel method for binary outcomes using aggregate study-level data. We used the I2 statistic to evaluate heterogeneity. Statistical significance was set at a threshold of P < .05. All analyses were performed using the Review Manager software (RevMan version 5.4; Cochrane Community).

Results

A total of 621 patients were randomized at 2 centers in Canada. The baseline characteristics were well balanced between the groups and are shown in Table 1. The patients had a mean (SD) age of 71 (10.24) years, 158 (25.4%) were female, and had a mean (SD) BMI of 30.3 (23.2). The trial population had a high rate of comorbidities: 319 (51%) had a prior myocardial infarction, 261 (42%) had diabetes, 278 (45%) had prior PCI, 353 (57%) had previous coronary bypass surgery, 115 (19%) had atrial fibrillation, and 110 (18%) had peripheral vascular disease (Table 1). Chronic total occlusion PCI was performed in 88 patients (14%). Clinical outcomes are available in Table 2.

The rate of crossover from no ultrasonography to ultrasonography was 7 of 310 patients (2.3%) and from ultrasonography to no ultrasonography was 1 of 311 patients (0.3%) (Figure 1). Two patients had a procedure cancelled after randomization because of medical decisions, and 4 patients had radial instead of femoral access after randomization because of physician decision.

Most procedures were 6 French (509 [80%]), and 262 (42%) were PCI procedures, with closure devices used 332 overall patients (52.1%) and no patients in either group had micro puncture used (Table 1).

Efficacy Outcomes

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 [OR], 0.77 [95% CI, 0.49-1.20]; P = .25). The rates of BARC 2, 3, or 5 bleeding were 10.0% (31 of 311) vs 10.7% (33 of 310) (OR, 0.93 [95% CI, 0.55-1.56]; P = .78) and major vascular complications were 6.4% (20 of 311) vs 9.4% (29 of 310) (OR, 0.67 [95% CI, 0.37-1.2]; P = .18; Table 2). The other components of the primary outcome were not different (Table 2). There were 2 cases of ischemic limb requiring intervention both in the no ultrasonography group and case descriptions are provided in eTable 2 in Supplement 2.

Subgroup Analyses

The prespecified prerandomization subgroup analyses showed consistent effect with no benefit of ultrasonography (Figure 2). For the postrandomization prespecified subgroup of those who received a closure device, there was a significant interaction with a benefit observed in patients who received a closure device; the primary outcome occurred in 20 of 170 patients (11.8%) in the ultrasonography group and 37 of 158 patients (23.4%) with no ultrasonography (OR, 0.44 [95% CI, 0.23-0.82]; interaction P = .004) with no benefit observed in those who received manual compression (OR, 1.76 [95% CI, 0.80-4.03]).

Procedural Outcomes

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; Table 2). Detailed data from the angiographic core laboratory are shown in eTable 3 in Supplement 2.

Meta-analysis

There were 9 randomized clinical trials included with a total of 4410 patients (eFigures 1 and 2 and eTables 4 and 5 in Supplement 2). Ultrasonography guidance was associated with reduced primary outcome of major bleeding or major vascular complications (risk ratio, 0.58 [95% CI, 0.43-0.76]; I2 = 49%; Figure 3A)3-7,16-18 and major vascular complications (risk ratio, 0.49 [95% CI, 0.34-0.69]; I2 = 20%; Figure 3B).

Discussion

Routine ultrasonography guidance for femoral access did not reduce the composite of major bleeding and major vascular complications. However, ultrasonography guidance did improve first-pass success, reduce the number of puncture attempts, and reduce the incidence of accidental venipuncture.

In patients receiving vascular closure devices, ultrasonography reduced the incidence of major bleeding and major vascular complications and improved safety. 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 1 puncture. 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. Furthermore, ultrasonography allows the operator to identify a puncture site free of calcium and disease making closure devices safer. Nonrandomized data suggest that ultrasonography has been associated with a reduction in vascular complications in patients receiving closure devices particularly for structural heart procedures, but randomized data are lacking.19 However, caution should be used when interpreting postrandomization subgroup outcomes because ultrasonography may bias the decision to use the closure device.

There have been a number of randomized clinical trials examining ultrasonography-guided femoral access. The 2 largest trials that were published earlier, the Femoral Arterial Access with Ultrasound Trial (FAUST; N = 1004)3 and the study by Katırcıbaşı et al (N = 939),4 showed benefits for vascular complications, but more recent trials did not show significant reductions in clinical outcomes.5-7,13 However, the trials consistently showed increased first-pass success rate and a reduction in the risk of venipuncture. An updated meta-analysis that we performed suggests significant ultrasonography guidance reduces major vascular access complications and bleeding but with significant heterogeneity. However, this may be related to bleeding definitions (ie, whether large hematoma was included) and when major vascular complications are examined there is a consistent benefit without heterogeneity. The UNIVERSAL trial put into context had generally consistent findings but with a more modest effect compared with some of the early trials, some of which did not have blinded outcome assessment but consistent with the large Standard vs Ultrasonography-Guided Radial and Femoral Access in Coronary Angiography and Intervention (SURF) trial (N = 1388),5 which showed no effect.

The benefits of ultrasonography on secondary outcomes need to be put into context: ultrasonography does not appear to have any risks, facilitates access, and is widely available. Therefore, it seems logical that physicians with required expertise and ready access to ultrasonography will use it to aid access.

Finally, the SURF trial5 was a randomized 2 × 2 factorial trial that found that transradial reduced complications compared with transfemoral, but ultrasonography did not reduce complications even in the femoral subgroup. As a result, based on the evidence, radial should be the first approach with ultrasonography-guided femoral access an alternative when femoral access is needed when radial is not possible.1,2

Limitations

First, the trial was powered for a 50% reduction and thus was not powered for more modest 20% to 25% reductions in the primary outcome and so may not have had sufficient power. If the closure device rate had been higher, this may have made it more likely that the trial was positive given the subgroup findings. Expertise with ultrasonography is important. About half the procedures were done by interventional fellows who, despite the training, were most likely still on their learning curve. A post hoc subgroup analysis by staff vs fellows is shown in Figure 2, and while the point estimates suggest a greater effect with staff physicians, this was not statistically significant. It should be noted that femoral access without ultrasonography also has a learning curve. An additional limitation of the trial is that micropuncture was not used in the trial. However, micropuncture did not show a difference in reducing complications in the only randomized clinical trial to test the intervention.20 Finally, the trial outcome was driven primarily by BARC 2 bleeding, which may include 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.

Conclusions

Routine use of ultrasonography for femoral access did not reduce the primary events of 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.

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Article Information

Accepted for Publication: August 19, 2022.

Published Online: September 18, 2022. doi:10.1001/jamacardio.2022.3399

Corresponding Author: Sanjit S. Jolly, MD, MSc, Population Health Research Institute, Hamilton General Hospital, 237 Barton St E, Hamilton, ON L8L 2X2, Canada (sanjit.jolly@phri.ca).

Author Contributions: Dr Jolly and Ms Heenan had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Jolly, AlRashidi, d’Entremont, Alansari, Raco, Tsang, Sheth, Akl, Tawadros, Winter.

Acquisition, analysis, or interpretation of data: AlRashidi, d’Entremont, Alansari, Brochu, Heenan, Skuriat, Tyrwhitt, Raco, Tsang, Valettas, Velianou, Sheth, Sibbald, Mehta, Pinilla-Echeverri, Schwalm, Natarajan, Kelly, Akl, Tawadros, Camargo, Faidi, Bauer, Moxham, Nkurunziza, Dutra, Winter.

Drafting of the manuscript: Jolly, AlRashidi, d’Entremont, Alansari, Heenan, Pinilla-Echeverri, Nkurunziza.

Critical revision of the manuscript for important intellectual content: AlRashidi, d’Entremont, Brochu, Skuriat, Tyrwhitt, Raco, Tsang, Valettas, Velianou, Sheth, Sibbald, Mehta, Pinilla-Echeverri, Schwalm, Natarajan, Kelly, Akl, Tawadros, Camargo, Faidi, Bauer, Moxham, Dutra, Winter.

Statistical analysis: AlRashidi, d’Entremont, Alansari, Heenan.

Obtained funding: Jolly, Winter.

Administrative, technical, or material support: Jolly, AlRashidi, d’Entremont, Alansari, Brochu, Skuriat, Tyrwhitt, Raco, Tsang, Valettas, Velianou, Sheth, Pinilla-Echeverri, Natarajan, Kelly, Akl, Tawadros, Camargo, Faidi, Bauer, Moxham, Nkurunziza, Dutra.

Supervision: Jolly, AlRashidi, Tyrwhitt, Raco, Valettas, Sibbald, Pinilla-Echeverri, Natarajan, Kelly, Akl, Tawadros.

Conflict of Interest Disclosures: Dr Pinilla-Echeverri reports personal fees from Abbott Vascular, Philips, Novartis, and Amgen outside the submitted work. No other disclosures were reported.

Funding/Support: Funding was provided by grants from the Hamilton Health Sciences Foundation and McMaster University, Division of Cardiology.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Meeting Presentation: This paper was presented at TCT 2022; September 18, 2022; Boston, Massachusetts.

Data Sharing Statement: See Supplement 3.

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