Original Contribution

Ultrasound-Guided Catheterization of the Femoral Artery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Maria Sobolev, MD1;  David P. Slovut, MD, PhD2;  Alfredo Lee Chang, MD3;  Ariel L. Shiloh, MD3;  Lewis A. Eisen, MD3

Maria Sobolev, MD1;  David P. Slovut, MD, PhD2;  Alfredo Lee Chang, MD3;  Ariel L. Shiloh, MD3;  Lewis A. Eisen, MD3

Abstract: Objectives. The goal of this meta-analysis was to determine the utility of real-time two-dimensional (2D) ultrasound guidance for femoral artery catheterization. Background. Despite the shift toward establishing vascular access via the radial artery rather than the femoral artery, femoral artery cannulation is still frequent in cardiac catheterization. Since vascular complications related to femoral artery cannulation can be quite devastating, preventing these complications is vital. Methods. A comprehensive literature search of Medline, Embase, Google Scholar, and the Cochrane Central Register of Controlled Trials was performed. Additionally, five years of conference abstracts from critical care, interventional radiology, vascular surgery, and cardiology were reviewed. Two independent reviewers identified prospective, randomized controlled trials comparing ultrasound guidance with traditional palpation techniques of femoral artery catheterization (with or without fluoroscopy). Data were extracted on study design, study size, operator and patient characteristics, complication rates, first-pass success, procedure time, and number of attempts. Results. Four trials with a total of 1422 subjects were included in the review, with 703 subjects in the palpation group and 719 subjects in the ultrasound-guided group. Compared with traditional methods, ultrasound guidance for femoral artery catheterization was associated with 49% reduction in overall complications, including hematoma and accidental venipuncture (relative risk, 0.51; 95% confidence interval, 0.28-0.91). It was also associated with 42% improvement in the likelihood of first-attempt success (relative risk, 1.42; 95% confidence interval, 1.01-2.00). Conclusions. The use of real-time 2D ultrasound guidance for femoral artery catheterization decreases life-threatening vascular complications and improves first-pass success rate. 

J INVASIVE CARDIOL 2015;27(7):318-323

Key words: cardiac imaging, ultrasound guidance, femoral artery cannulation

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Femoral artery catheterization is a common procedure in various specialties and especially in interventional cardiology.1 Despite the growing trend for radial artery access in cardiac catheterization, factors such as complex percutaneous coronary interventions (PCIs), operator and center expertise, procedural volume, longer access time, as well as operator radiation exposure, have swayed many interventionalists to continue to use the conventional femoral artery approach for cardiac catheterization.2-5 Clearly, whichever approach is utilized, it is important that vascular access be obtained in the safest way possible. Vascular complications such as retroperitoneal bleeding, loss of distal pulse requiring vascular surgery, and even seemingly minor complications like hematoma, pseudoaneurysm, and arteriovenous fistula can be devastating and contribute to periprocedure morbidity and mortality. Minimizing access-site complications has been associated with improved outcomes.6 

While femoral artery cardiac catheterization has been performed for several decades, there is no general agreement about the safest and most effective method for obtaining access. Many operators use palpation techniques with fluoroscopy or micropuncture with fluoroscopy. Ultrasound guidance, while seldom used in the past for femoral artery access, is growing in popularity among operators due to its accepted use in central venous catheterization (CVC) and radial artery catheterization.7,8 Given the lack of consensus to the optimal approach in femoral artery catheterization, we conducted a meta-analysis to systematically review the literature to determine the benefits of real-time ultrasound guidance.

Methods 

Medline, Excerpta Medica Database (EMBASE), and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from their inception through October 1, 2013 using broad Medical Subject Heading (MeSH) and Emtree terms for arterial catheterization and ultrasonography. Conference proceedings (from 2009 to 2013) of the American Thoracic Society, the Society of Critical Care Medicine, the European Society of Intensive Care Medicine, the American College of Chest Physicians, the American Heart Association, the American College of Cardiology, the Society of Vascular Surgery, the Society of Interventional Radiology, and the Cardiovascular and Interventional Radiological Society of Europe were searched for relevant abstracts. The reference lists of any identified titles were searched. There were no language restrictions. We followed PRISMA guidelines on the reporting of meta-analyses.9 The search strategy is listed in Table 1.

Selection. Prospective, randomized controlled trials (RCTs) comparing femoral artery catheterization using real-time 2-dimensional (2D) ultrasound guidance techniques with traditional palpation techniques or a combination of palpation and fluoroscopy were included in the review. Trials evaluating the use of solely Doppler ultrasonography (without 2D ultrasound), marking techniques (without utilizing real-time guidance), or catheterization of other arteries were excluded. There were no age limitations. There were no language restrictions. Two reviewers independently evaluated the identified titles, confirmed eligibility, and extracted data. Discrepancies were resolved by consensus.

Validity appraisal. The methodological quality of selected trials was appraised by two independent reviewers using the Jadad criteria.10 The Jadad criteria include: (1) randomization of subjects; (2) the use of blinding; and (3) the completeness of subject follow-up. 

Statistical analysis. The primary outcome was overall complication rate. The overall complication rate was defined as a compilation of local hematoma, retroperitoneal hematoma, puncture of the femoral vein, puncture of the superficial femoral artery, pseudoaneurysm formation, arteriovenous fistula formation, and arterial dissection.     

Secondary outcomes were first-pass success rate, hematoma rate, venipuncture rate, number of attempts, and time of procedure. The secondary outcomes evaluated were not assessed or available for analysis in each trial. Analysis of the combined data was conducted using Review Manager (RevMan) version 5.2 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012). A random effects model was used to estimate the relative risk of dichotomous outcomes and associated 95% confidence intervals (CIs). Heterogeneity was assessed by visual assessment of the forest plot and formal statistical tests for heterogeneity. The c2 test was used to assess whether observed differences in results was compatible with chance alone. A P-value <.10 provided evidence of heterogeneity of intervention effects. In addition, the I2 statistic was employed to describe the percentage of the variability in effect estimates that is due to heterogeneity rather than chance. Heterogeneity was considered significant if the I2 statistic exceeded 50%.11

Results 

This study was conducted in accordance with the amended Declaration of Helsinki. As this was a meta-analysis of previously published trial data, this study was exempt from review by the Montefiore/Einstein Institutional Review Board. Participants provided informed consent to be included in the original trials. 

Selection. The flow diagram (Figure 1) summarizes the steps followed to identify the RCTs meeting the inclusion criteria. 

Included trial characteristics. Four trials were included in the review for the primary outcome, all of which compared real-time 2D ultrasound guidance techniques to traditional palpation techniques for femoral artery catheterization.12-15 A total of 1422 patients were randomized. The largest contribution, by Seto and colleagues, assessed over 1000 adults undergoing diagnostic or interventional coronary or peripheral vascular procedure. Gedikoglu et al evaluated 208 adults undergoing diagnostic or therapeutic transarterial procedures. Dudeck and colleagues studied 112 adults undergoing diagnostic or therapeutic transarterial procedures. Goh and colleagues studied 100 adults suited for arterial anterograde puncture (Table 2). 

Validity appraisal. All selected trials were randomized. Given the nature of the intervention, blinding was not possible. All subjects studied were reported in the final results of the trials. The individual Jadad scores can be found in Table 2. 

Main results. A total of 719 patients underwent arterial catheterization using an ultrasound-guided technique, of which 16 (2.2%) had complications, and 703 patients were catheterized using palpation or fluoroscopy techniques, of which 34 (4.8%) had complications (P=.02). The pooled relative risk for the use of ultrasound guidance was 0.51 (95% CI, 0.28-0.9). The Chi2 test and the I2 statistic for heterogeneity were non-significant (Chi2=1.98; I2=0%). The corresponding plot is seen in Figure 2. 

The secondary outcome of first-pass success rate was significantly more common in the ultrasound group, of which 83% had first-attempt success, compared with 51% that were catheterized using palpation or fluoroscopy techniques (P=.04). The pooled relative risk for ultrasound-guided techniques was 1.42 (95% CI, 1.01-2.00). The Chi2 test and the I2 statistic for heterogeneity were significant (Chi2=29.9; I2=93%). However, a visual inspection of the data showed the results were generally in agreement (Figure 3).

Other secondary outcomes generally favored ultrasound use. The individual complication of venipuncture was significantly less in the ultrasound group (relative risk, 0.18; 95% CI, 0.09-0.39) (Figure 4). Hematoma was numerically less in the ultrasound group, although not statistically significant (relative risk, 0.51; 95% CI, 0.21-1.25; P=.14) (Figure 5). Time to access the artery was significantly less in the ultrasound group (Figure 6). The number of attempts was numerically less in the ultrasound group, although this was not statistically significant (P=.15) (Figure 7).

Discussion 

The use of ultrasound guidance for femoral artery catheterization decreased the overall complication rate by 49% when compared with traditional palpation methods (with or without fluoroscopy). With an absolute risk reduction for complications of 3%, the number needed to treat (NNT) to prevent 1 mechanical complication by using ultrasound for femoral artery catheterization is 33. Since complications from a femoral artery puncture attempt are serious and associated with increased mortality, preventing these complications is of utmost concern. Punctures above the inguinal ligament increase the chance of retroperitoneal hemorrhage.16 Punctures distal to the femoral head increase the likelihood of pseudoaneurysm formation.17 

Since most of the trials excluded patients in shock and those without palpable pulses, the true benefit of ultrasound guidance is likely higher.13,18 In these patients, visualization of the artery is important for a successful procedure. The trials on ultrasound-guided arterial catheterization involved relatively small patient populations. Our meta-analysis pooled these populations to allow for a robust sample size to demonstrate the effectiveness of using 2D ultrasound guidance for femoral artery catheterization. 

Patient-related and operator-dependent factors can play a role in vascular complications during a femoral cardiac catheterization. In addition to initial access technique, variables such as sheath size, patient body habitus, use of vascular closure devices, anticoagulation and antiplatelet therapy, and postprocedure manual compression play a role in vascular bleeding complications. Patient and procedural characteristics associated with vascular complications include age, female gender, extremes in weight, use of clopidogrel or glycoprotein IIb/IIIA inhibitors, renal failure and other comorbidities like diabetes, peripheral artery disease, hyperlipidemia, and New York Heart Association class III or IV heart failure.6 

Achieving successful femoral artery access is a result of multiple steps performed meticulously. These include identifying the appropriate puncture level, locating the artery, establishing access with the needle (micropuncture or larger bore), confirming proper level for arterial entry, and placing the sheath. The goal is for the sheath to enter the common femoral artery (CFA) in the “safe zone,” defined as the region from lowest border of inferior epigastric artery to inferior border of femoral head.16 While fluoroscopic guidance is often used in conjunction with palpation in order to identify the femoral head (safe zone), there is no proven benefit in fluoroscopy over palpation in reducing overall vascular complications.19-21 Ultrasound guidance has advantages over palpation and fluoroscopy, allowing the operator to directly visualize the CFA and its bifurcation, identify the needle puncture directly and to avoid posterior vessel wall puncture, inadvertent puncture of adjacent vein, and luminal atherosclerotic and calcified plaque.22 Its use is particularly advantageous in obese patients, for deep and/or small caliber vessels, and in patients who are anticoagulated, where first-pass success is particularly important.

Standard femoral artery catheterization relies on anatomic landmarks and the palpation of a pulse. While most studies show failure rates of the landmark technique of 1.5%-5% for elective femoral artery catheterizations, failure may be as high as 50% in patients in shock.23 Obesity, edema, and shock states may limit the ability to successfully palpate and catheterize a vessel.24 External landmarks can be unreliable in predicting the locations of underlying vessels, especially in cases of aberrant anatomy. The inguinal crease, a common puncture site for femoral artery catheterization, has been shown to be an inaccurate predictor of femoral vasculature.25 Additionally, in 20% of patients, the CFA bifurcation is above the inferior border of the femoral head, making it difficult to use the femoral head as a landmark.21,26 Ultrasound guidance can enable operators to visualize the CFA bifurcation in this scenario. In 65% of cases, a portion of the CFA overlaps the common femoral vein.27 Although not formally studied in trials, direct ultrasound use with visualization of the needle tip would likely prevent arteriovenous fistula formation in these cases. 

The technique used in the trials bears mention. The trial by Dudeck was the only trial to use a swivel arm to fix the ultrasound probe in a transverse position. This might have contributed to the low (53%) first-pass success rate compared with the other trials.12 All of the trials used an out-of-plane approach and could not ensure true needle tip visualization. An in-plane approach, as has been proposed for CVC, may decrease complication rates further.28,29 Techniques such as the use of a micropuncture needle or the use of echogenic needles could be considered, although they are not definitively beneficial in reducing complications. 

While there is a learning curve for ultrasound use and mastery of skill, operators who use ultrasound for CVC access will find it easy to begin using ultrasound for arterial catheterization. Requirements for the use of ultrasound for arterial and venous catheterization are similar. Costs include the purchase of the machine, sterile ultrasound sheaths, staff training and machine maintenance. The potential reductions in complications and numbers of catheter sets required, for both CVC and arterial catheterization may offset the fixed costs. As ultrasound-guided catheterization of arteries and veins are relatively similar, little additional cost or time would be required to train clinicians in ultrasound-guided arterial catheterization.18,30 Resnic et al estimated that the cost of treatment of a hematoma is $1399 per complication.31 The cost of a more serious complication to the patient, the practitioner, or the hospital could be considerable. This would seemingly make ultrasound guidance economically favorable. However, a formal cost-effectiveness analysis would have to be performed to prove cost savings.

Study limitations. There are several limitations to this study. First, there was a small number of patients and a small number of randomized controlled trials. However, the meta-analysis was able to find significant benefits from ultrasound use in primary and secondary outcomes. Another randomized trial comparing ultrasound to fluoroscopy for arterial access is ongoing (NCT01612026).32 Second, procedure time in the trials did not include the time required to set up the machine. Exactly how procedure time should be measured when ultrasound is used is debated. Third, there was no distinction between operator use of standard percutaneous needle or the micropuncture needle. It remains unclear whether micropuncture technique lowers complication rate.22,33 Fourth, trials have not studied all patient-centered outcomes such as perception of pain. It is highly likely that patient pain would be reduced when first-pass success is increased, although this remains speculative. 

Conclusion

In summary, our meta-analysis demonstrated a 49% decrease in likelihood of complications and a 42% increase in the likelihood of first-attempt success when using ultrasound guidance for femoral artery catheterization. The use of real-time 2D ultrasound guidance for femoral artery catheterization improves first-pass success rate and decreases complication rates.  

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From the 1Division of Cardiology, Department of Medicine, Montefiore Einstein Center for Heart and Vascular Care; 2Division of Cardiology, Department of Cardiothoracic and Vascular Surgery; and 3Division of Critical Care Medicine, Department of Medicine, The Jay B. Langner Critical Care Service; at the Montefiore Medical Center and the Albert Einstein College of Medicine, Bronx, New York. 

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Eisen reports receiving 12.5% salary support from CMS for a research grant “Project AWARE,” which is a study of a new computerized dashboard for presenting patient information. The authors report no conflicts of interest regarding the content herein.

Manuscript submitted August 7, 2014, provisional acceptance given September 3, 2014, final version accepted November 21, 2014.

Address for correspondence: Maria Sobolev, MD, Division of Cardiology, Montefiore Medical Center and the Albert Einstein College of Medicine, 111 East 210th Street, Bronx, NY 10467. Email: msobolev@gmail.com 

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