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Ultrasound Guidance in Femoral Artery Catheterization: A Systematic Review and a Meta-Analysis of Randomized Controlled Trials
Abstract: Background. During percutaneous cardiac procedures, the use of radial access is growing, but femoral access remains needed for large-bore, high-risk procedures. Methods are needed to make femoral access safer. In this systematic review and meta-analysis of randomized-controlled trials (RCTs), we assess whether ultrasound guidance is associated with a decreased risk of vascular complications during femoral artery catheterization. Methods. Medline, Embase, and Cochrane Central were searched from inception to April 2018. RCTs assessing the use of ultrasound among adult patients undergoing a femoral artery catheterization were included. The primary outcome was vascular-access related complications. Secondary outcomes included major and minor vascular access bleeding, success rate, venipuncture, number of attempts, and successful placement into the common femoral artery. Results. Five RCTs (n = 1553) met the inclusion criteria, with two trials using blinded outcome assessment. Ultrasound use was associated with a reduction in the rate of vascular-access related complications (1.9% vs 4.3%; odds ratio [OR], 0.44; 95% confidence interval [CI], 0.24-0.81; P<.01). This was primarily driven by a reduction in local hematomas; once hematomas were excluded, the association was no longer significant (0.6% vs 1.7%; OR, 0.39; 95% CI, 0.15-1.07; P=.07). There was no significant reduction in major bleeding (0.3% vs 1.3%; OR, 0.28; 95% CI, 0.07-0.1.16; P=.08) or minor bleeding (1.4% vs 2.8%; OR, 0.50; 95% CI, 0.24-1.05; P=.07). Conclusions. Ultrasound guidance during femoral artery catheterization is associated with a decreased risk of vascular complications, primarily driven by a reduction in local hematomas. Larger trials are needed to determine the effect of ultrasound on major bleeding and vascular complications (excluding hematomas).
J INVASIVE CARDIOL 2019;31(7):E192-E198.
Key words: arterial catheterization, femoral artery, ultrasound guidance
During percutaneous coronary procedures, the radial approach is associated with lower rates of vascular complications and bleeding.1-5 While the overall utilization rates of femoral access continue to drop, femoral access remains used even in radial centers for large-bore, high-risk procedures.6,7 The higher complication rates with the femoral approach are due, in part, to its use in very high-risk patients and potentially reduced operator expertise with the proliferation of radial access. Bleeding and vascular complications have been found to be independently associated with increased morbidity and mortality.8-13 Therefore, methods are needed to reduce bleeding and vascular complications associated with the femoral approach.14,15 The objective of this systematic review and meta-analysis is to assess whether ultrasound guidance is associated with a decreased risk of vascular-access related complications during femoral artery catheterization.
Methods
This systematic review and meta-analysis of randomized controlled trials (RCTs) is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines.16 No external funding was sought for this project. The authors assume full responsibility for study design, creation, and conduct, the statistical analyses, and the drafting and editing of the manuscript. Institutional ethics approval was not required for this study.
Data sources and search strategy. We performed a comprehensive and systematic literature search of Medline, Embase, and the Cochrane Central Register of Randomized Controlled Trials from inception to April 8, 2018. We reviewed references of included studies and prior systematic reviews to ensure inclusion of relevant studies. The following search terms were used: “femoral artery or femoral art*”; “ultrasound or ultrasonography or sonography or echography”; and “randomized controlled trial or random*”. The search was limited to humans. There was no time or language restriction applied.
Study selection. Two reviewers (MR and NS) independently screened all titles and abstracts to identify those studies meeting the inclusion criteria. Full texts of included studies were then reviewed by the same two reviewers for final selection. Disagreements were resolved by consensus. We selected RCTs assessing the use of ultrasound-guided femoral artery catheterization for any diagnostic or therapeutic procedure among adult patients.
Data extraction, study outcomes, and definitions. The following data were extracted for each study, if available: study characteristics (author, journal of publication, year, study population and sample size, number of participants, and study objective); patient characteristics (age, gender, weight, and baseline comorbidities); procedural results (number of attempts, access time, first-pass success rate, use of closure device, and rate of successful placement into the common femoral artery [CFA]); and clinical outcomes (vascular-access related complications, major bleeding, minor bleeding, and venipuncture). All outcomes were assessed at the longest available follow-up.
Primary outcome. The primary outcome was vascular-access related complications, defined as the composite of access-related major or minor bleeding, including local hematoma, arterial dissection, vessel thrombosis, arteriovenous fistula, or pseudoaneurysm formation. This definition is in accordance with definitions adopted in prior published studies.17,18
Secondary outcomes. Major bleeding was defined as any vascular-related bleeding resulting in hemoglobin drop >3 g/dL, transfusion, intervention, prolonged hospitalization, or death; this definition is in accordance with Bleeding Academic Research Consortium (BARC) types 2, 3, or 5.19 Minor bleeding was defined as any self-limited bleeding that did not result in hemoglobin drop >3 g/dL, transfusion, or require intervention, including local hematomas. Other secondary outcomes included venipuncture, first-pass success rate, number of attempts, access time, and successful placement into the CFA.
Quality assessment. The risk of bias was assessed using the Cochrane Collaboration’s tool for assessing risk of bias.20 Assessment was done by three independent reviewers (MR, NS, and KS). We assessed for risk of publication bias by visual inspection of the funnel plot for the primary outcome.
Statistical analysis. Data for continuous variables were collected as mean ± standard deviation, and as proportions for categorical variables. Using pooled data, odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using the Mantel-Haenszel method for binary outcomes. Mean differences, with 95% CIs, were calculated using the inverse variance method for continuous outcomes as estimates of the effect across included studies. We calculated I2 index (expressed as percentage) to estimate the degree of heterogeneity among the trials. The fixed-effect model was used for the primary analysis. Sensitivity analyses were performed to: (1) analyze outcomes using a random-effect model; and (2) assess vascular-access related complications after excluding local hematoma. Subgroup analysis was performed to include only studies that involved coronary procedures. Statistical significance was defined as a P-value of ≤.05. All statistical calculations were performed using Review Manager software (RevMan version 5.3; Cochrane Community).
Results
A total of 1152 citations were identified through the initial search (Figure 1). Of these, a total of 469 were duplicates. After screening titles and abstracts, five studies were identified and included in the final meta-analysis for a total of 1553 patients, of which 784 were randomized to ultrasound and 769 were randomized to the control arm.
Study descriptions. Details of the five selected studies21-25 are presented in Table 1. The studies were published between 2004 and 2018. Two studies22,25 included coronary procedures performed by interventional cardiologists, while three studies21,23,24 were performed by interventional radiologists. One study24 utilized antegrade access to the CFA. One study, FAUST22 (Femoral Arterial Access With Ultrasound Trial), contributed to 65% of the total patients in this meta-analysis. The majority of patients were male, with a mean age >60 years. A summary of the quality assessment of the included studies is found in Supplemental Figure S1. All studies were randomized, but none of the studies presented sufficient information to adequately assess for allocation concealment. Given the nature of the intervention, none of the studies involved blinding of participants and personnel. However, only two studies22,25 reported blinding of outcome assessments.
Clinical outcomes. As shown in Figure 2, vascular-access related complications occurred in 48 patients, representing a rate of 3.1%. The use of ultrasound was associated with a reduction in the rate of vascular-access related complications (15/784 [1.9%] vs 33/769 [4.3%] in the ultrasound vs control groups, respectively; OR, 0.44; 95% CI, 0.24-0.81; P<.01; I2=0%). There was no statistically significant difference in major bleeding (2/620 [0.3%] vs 8/613 [1.3%] in the ultrasound vs control groups, respectively; OR, 0.28; 95% CI, 0.07-1.16; P=.08; I2=0%) or minor bleeding (10/720 [1.4%] vs 20/704 [2.8%] in the ultrasound vs control groups, respectively; OR, 0.50; 95% CI, 0.24-1.05; P=.07; I2=42%). Procedural outcomes were largely heterogeneous, which is likely attributable to the variability in definitions across the studies (Figure 3). Venipuncture was less likely to occur with ultrasound guidance (23/622 [3.7%] vs 105/621 [16.9%] in the ultrasound vs control groups, respectively; OR, 0.18; 95% CI, 0.11-0.29; P<.001; I2=48%). The rate of first-pass success was higher with ultrasound guidance (586/730 [80.3%] vs 364/721 [50.5%] in the ultrasound vs control groups, respectively; relative risk [RR], 1.58; 95% CI, 1.46-1.71; P<.001; I2=90%). Ultrasound use was not associated with a higher success rate for placement into the CFA (491/567 [86.6%] vs 477/566 [84.3%] in the ultrasound vs control groups, respectively; RR, 1.03; 95% CI, 0.98-1.08; P=.27; I2=51%). The number of attempts (mean difference, -0.69; 95% CI, -0.84 to -0.54; P<.001; I2=97%) and access time (mean difference, -24.42 seconds; 95% CI, -36.93 to -11.91; P<.001; I2= 0%) were lower in the ultrasound group vs the control group.
Sensitivity and subgroup analyses. Sensitivity analyses were done using random-effect models, which were consistent with the primary analyses (Supplemental Figures S2 and S3). In a sensitivity analysis, the effect of ultrasound on vascular-access related complications, once local hematoma was excluded, was no longer significant (5/784 [0.6%] vs 13/769 [1.7%] in the ultrasound vs control groups, respectively; OR, 0.39; 95% CI, 0.15-1.07; P=.07; I2=0%) (Supplemental Figure S2). Subgroup analyses including only the two studies involving coronary procedures were also consistent with the primary analysis (Supplemental Figure S3).
Discussion
In this meta-analysis of RCTs involving 1553 patients, we found that the use of ultrasound guidance during femoral artery catheterization reduced the risk of vascular-access related complications, which was driven primarily by a reduction in local hematomas. Ultrasound guidance was not associated with a reduction in major or minor bleeding.
Major bleeding and vascular access-site complications during percutaneous coronary interventions have been shown to be associated with increased morbidity and mortality.26-28 However, large hematomas alone have not been consistently associated with mortality.29 The finding of no effect on access-related vascular complications when local hematoma was excluded suggests further data are needed. In our study, the safety outcomes of major and minor bleeding did not reach statistical significance; however, there was a trend toward a reduction in bleeding with an ultrasound-guided approach. Other strategies that have been studied in relation to vascular-access related bleeding reduction include the adoption of radial access, vascular closure device, periprocedural bivalirudin, and the use of micropuncture needles.14,30,31
The use of ultrasound may lead to a greater proportion of higher sheath placements in cases of high femoral bifurcation, which could lead to a paradoxical increase in the rate of retroperitoneal hematoma while reducing pseudoaneurysms and local hematomas.22 Furthermore, the FAUST trial demonstrated a learning curve such that ultrasound may not be beneficial early on in the learning curve, but is once sufficient expertise and experience are obtained.22 Both the RIVAL (Radial Versus Femoral Access for Coronary Angiography and Intervention in Patients With Acute Coronary Syndromes) and MATRIX (Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: A Randomised Multicentre Trial) studies demonstrated a greater benefit for radial access in centers with greater experience and expertise.1,3
Current use of ultrasound for femoral access during cardiac procedures remains low, with reported rates of 13%-27%.32,33 Possible explanations for this include the fact that clinical benefit is driven by a reduction in small hematomas, increased costs associated with greater availability of ultrasound machines, and concerns regarding increased procedural times with ultrasound use. The lack of expertise with the use of this technology could also be a barrier for a wider use of ultrasound for vascular access in practices with lower success rates in their initial experiences.
The conclusions from this meta-analysis are consistent with a prior review by Sobolev et al.17 Our study did the following: (1) identified a recent RCT; (2) assessed bleeding outcomes as defined by standard definitions and categorized into major and minor bleeding; and (3) assessed the primary outcome of vascular-access related complications with and without local hematoma.
Study limitations. First, this systematic review identified only a small number of relevant RCTs. Moreover, most of the studies had a small sample size, with 65% of the pooled population coming from a single study.22 Second, reporting of outcomes and definitions varied among the studies and only two studies had blinded outcome assessments.22,25 Third, only two trials22,25 assessed patients undergoing coronary procedures, which affects the generalizability of the findings to the cardiac world. Among those two trials, FAUST22 was not powered to assess vascular complications as a primary outcome, while the primary outcome in the study by Marquis-Gravel et al25 combined access-site outcomes with immediate procedural outcomes (access failure, ≥1 puncture, transfixing arterial puncture, venipuncture, and catheter insertion outside the CFA). Therefore, the effect of ultrasound utilization on clinically relevant vascular-access related complications (with and without local hematoma) during femoral artery catheterization for coronary procedures remains unclear. In this study, the observed benefit of ultrasound on vascular-access related complications was largely driven by a reduction in local hematomas, which are often inconsequential, and thus not likely to be sufficient to alter practice.
To address these limitations and add to the limited body of knowledge, we are undertaking an RCT entitled “Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: A Randomized Trial” (UNIVERSAL; ClinicalTrials.gov Identifier NCT03537118). The trial is planning to enroll 1538 patients to assess whether ultrasound-guided femoral artery access, compared with fluoroscopy, reduces the rate of major vascular complications among patients referred for coronary angiography or percutaneous coronary intervention. This question is of particular importance because the SAFARI (Safety and Efficacy of Femoral Access vs Radial Access in STEMI) trial, which was recently presented at the American College of Cardiology 68th Scientific Session, failed to demonstrate a superiority of the radial approach compared with the femoral approach in patients undergoing primary percutaneous coronary intervention.
Conclusion
In this study, we found that ultrasound-guided femoral artery catheterization was associated with a decreased risk of vascular-access related complications; however, this appeared to be driven by a reduction in local hematomas. Ongoing trials will determine the effect of ultrasound guidance for femoral procedures. Given the available evidence, ultrasound guidance by operators with sufficient expertise is a reasonable approach to reduce femoral vascular complications.
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From the 1Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada; and 2the Department of Cardiology, Gold Coast University Hospital, Griffith University, Gold Coast, Australia.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript submitted March 18, 2019, provisional acceptance given March 27, 2019, final version accepted April 8, 2019.
Address for correspondence: Sanjit Jolly, MD, MSc, FRCP, Cardiology Division, Hamilton Health Sciences, Hamilton General Hospital Site, Population Health Research Institute (PHRI), McMaster University, 237 Barton Street East, Hamilton, Ontario, Canada L8L 2X2. Email: sanjit.jolly@phri.ca
