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Antegrade Access to the Superficial Femoral Artery with Ultrasound Guidance: Feasibility and Safety
Antegrade Access to the Superficial Femoral Artery with Ultrasound Guidance: Feasibility and Safety Andreas Gutzeit, MD, Eric Schoch, MD, Thomas Sautter, MD, Regula Jenelten, MD, Nicole Graf, PhD, and Christoph A. Binkert, MD, MBA
PURPOSE: To evaluate the feasibility and safety of antegrade superficial femoral artery (SFA) access with the use of ultrasound (US) guidance. MATERIALS AND METHODS: One hundred consecutive patients (56% men) were prospectively enrolled, with a median age of 76 years. The SFA was punctured in antegrade fashion with a 19-gauge needle with US guidance, followed by sheath placement. The time from local anesthesia until successful blood aspiration from the sheath was measured. At the end of the case, hemostasis was achieved with a closure device or by manual compression. All cases were followed with US for access complications. RESULTS: Antegrade arterial access was successful in all cases. The arterial sheath was successfully placed into the SFA in 98 of 100 patients. In 95 of 98, the sheath was inserted with US guidance only; additional fluoroscopy was needed in three cases. In two of 100 patients, the common femoral artery (CFA) was accessed, accidentally in one case and deliberately in the other because the SFA was considered too small. Both patients were excluded from further analysis. The median time for arterial access was 3.5 minutes (interquartile range, 3.1– 6.2 min). All complications directly related to vascular access were minor (16; 15.68%): 10 pseudoaneurysms (10.2%; median diameter, 15 mm) and six hematomas (6.12%; median diameter, 31.5 mm). CONCLUSIONS: Antegrade puncture into the SFA with US guidance is feasible and fast. The rate of minor complications is similar to other reported series, but a direct comparison with other studies is difficult because study designs vary. J Vasc Interv Radiol 2010; 21:1495–1500 Abbreviations: femoral artery
BMI ⫽ body mass index, CFA ⫽ common femoral artery, IQR ⫽ interquartile range, PVD ⫽ peripheral vascular disease, SFA ⫽ superficial
PERIPHERAL vascular disease (PVD) is a common medical problem in the Western world, affecting as many as 8 million people in the United States alone (1,2). There are numerous therapeutic
From the Department of Radiology (A.G., E.S., T.S., C.A.B.) and Angiology (R.J.), Kantonsspital Winterthur, Brauerstrasse 15, 8401 Winterthur, Switzerland; and Clinical Trials Center/Center for Clinical Research (N.G.), University Hospital of Zurich, Zurich, Switzerland. Received July 6, 2009; final revision received November 22, 2009; accepted March 12, 2010. Address correspondence to C.A.B.; E-mail: [email protected] None of the authors have identified a conflict of interest. © SIR, 2010 DOI: 10.1016/j.jvir.2010.03.021
options, such as percutaneous transluminal angioplasty, stent insertion, local lysis, and rotational atherectomy, to treat patients with peripheral arterial disease of the lower extremity, which often prevent or delay the necessity of a bypass operation or amputation of the affected lower extremity concerned (3– 5). Access for endovascular treatment of the lower extremity is generally obtained by a retrograde contralateral approach or an antegrade ipsilateral approach. Traditionally, arterial access is made into the common femoral artery (CFA) by palpation. With the better availability of ultrasound (US) in angiography suites, the use of USguided arterial access is becoming more popular.
During the antegrade approach to the CFA, a common problem is the soft tissue layer over the artery, especially in obese patients. Other problems are steering the guide wire into the superficial femoral artery (SFA) or the accidental puncture of the deep femoral artery. These problems can be time-consuming and lead to repeated punctures, hematomas, and aneurysms in the groin (6). Antegrade access is especially difficult if a stenosis in the CFA is present. Direct antegrade puncture of the SFA was described in 1993 (7). In that relatively small study of 25 patients, only one minor complication, a small hematoma, was observed. In a more recent study (8), 30 antegrade punctures into the SFA were con-
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Table 1 Demographics and Clinical Data (N ⴝ 98) Characteristic
Value
Male sex Age (y) BMI (kg/m2) AFS diameter (mm) Cutis thickness (cm) Distance from arterial access (mm) To head of femur To femoral bifurcation INR Platelet count (⫻ 103 cells/L) Sheath size (F) 4 5 6 8 9 10
55 (56.1) 76.0 (68.0–81.0) 26.6 (22.8–29.9) 6.0 (5.0–6.2) 1.5 (1.1–1.9) 35.1 (21.5–44.9) 19.2 (13.3–29.3) 1.04 (0.98–1.11) 282.0 (226.0–329.3) 71 (72.4) 6 (6.1) 17 (17.3) 2 (2.0) 1 (1.0) 1 (1.0)
Note.—Individual values in parentheses are percentages. Ranges in parentheses are IQRs; values provided with IQRs are medians. INR ⫽ International Normalized Ratio.
ducted into a “hostile groin.” In these cases, access to the CFA was difficult or impossible because of scarring, obesity, or previous failed CFA puncture. The aim of the present study was to evaluate the feasibility and safety of an antegrade SFA puncture with US guidance in the general population with PVD.
MATERIALS AND METHODS Patients This prospective single-center study was performed with the approval of the local institutional review board and informed consent from all patients. Between May 2008 and February 2009, a total of 100 consecutive patients (56 men) with a median age of 76 years (interquartile range [IQR], 68 – 81 y) were enrolled. A right-sided approach was performed in 51 patients, a left-sided approach in 49. All patients from a single institution referred for a peripheral arterial study older than the age of 18 years were included. In 97 patients, a therapeutic procedure (percutaneous transluminal angioplasty, stent placement, and/or thrombolysis) was performed; in the remaining three patients, only diagnostic angiography was performed. In all patients, the SFA was the attempted entry site. Besides age and
sex, the following parameters were recorded: body mass index (BMI) calculated from body height and weight, antiplatelet medication and anticoagulation, and laboratory findings such as platelet count and International Normalized Ratio. Demographics and clinical data are summarized in Table 1. There were no patients included who had had a previous surgical procedure or a bypass in the area of the access site. Technique All patients were placed supine, feet first, on the table. Standard preparation of the groin was performed. The proximal SFA was then scanned with B-mode US (Zonare Medical Systems, Mountain View, California) to determine the best access point. We used a 10/5-Mhz linear probe. The diameter of the SFA and the soft tissue layer above the SFA were measured (Fig 1). The time to gain access was defined as the time from the injection of local anesthesia until blood aspiration from the sheath placed into the SFA. For the purpose of the study, only US guidance was used. The use of additional fluoroscopy was recorded separately. The artery was punctured with a vascular access needle (SDN-19UT-7.0, 19 gauge, Cook, Bloomington, Indiana).
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With a J-tip guide wire, a sheath (Britetip, 4 –10-F; Cordis, Miami Lakes, Florida) was inserted into the SFA. An ipsilateral oblique view of the femoral artery was obtained in every patient, which allowed assessment of the exact entry site into the SFA. The distance between the entry point and the femoral artery bifurcation and the distance between the entry point and the lower margin of the femoral head were defined on angiography (Fig 2). At the end of the procedure, the sheath was removed and hemostasis was achieved with a closure device (Starclose; Abbott Vascular, Redwood City, California) or by manual compression at the discretion of the operator. The duration of manual compression was recorded. All patients received a compression bandage for 6 hours. Follow-up All patients had ordered bed rest for 6 hours. US follow-up of the access site was performed in all patients between 6 hours (outpatients) and 24 hours (inpatients) after the procedure, assessing the puncture site for hematoma, pseudoaneurysm, dissection, or stenosis of the SFA. If there was a hematoma or a pseudoaneurysm, exact measurements were obtained, with calculation of maximum size. Statistical Analysis Statistical analyses were performed with the SPSS statistical program (version 15.0.1; SPSS, Chicago, Illinois). Data were analyzed descriptively and described with the median and IQR for continuous data or the number of subjects and percentage of the total for categoric variables. Comparisons between groups were performed with a Mann-Whitney U test for quantitative data or Fisher exact test for binary variables. Potential risk factors for complications were further analyzed with a logistic regression analysis.
RESULTS Technical Success Antegrade arterial access was successfully obtained in all patients. The arterial sheath was placed into the SFA in 98 of 100 patients. In 95 of these
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Figure 1. (a) Documentation of the puncture site in the SFA with a 10/5-MHz transducer. In every patient, the distance from the skin to the anterior wall of the SFA, as well as the maximum diameter of the SFA, was measured in millimeters. This was followed by US-guided antegrade puncture of the SFA. (b) Corresponding B-mode US image and anatomic details from the right leg. We used a 10/5-MHz transducer, with the same view as in a.
Figure 2. (a) Based on the angiographic image, the exact entry site into the SFA was determined in relation to the femoral arterial bifurcation and the lower margin of the femoral head (in mm). (b) Corresponding angiographic image demonstrates the measurement between the arterial access and the lower margin of the femoral head and the femoral artery bifurcation, respectively (in mm).
98 cases, only US guidance was needed. In three cases, additional fluoroscopy was used to control safe guide wire advancement into the SFA.
In two patients, the CFA was punctured: accidentally in one while aiming for the SFA and deliberately in the other because the SFA was considered
too small and calcified for access. These two cases with access to the CFA were excluded from further analysis. Overall, a consistently short time
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Table 2 Efficacy and Safety Endpoints (N ⴝ 98) Endpoint Pseudoaneurysm Hematoma Dissection
Table 3 Clinical Data of Patients Treated with Closure Device and Manual Compression
No. of Pts. 10 (10.2) 6 (6.1) 0
Note.—Values in parentheses are percentages.
for arterial access was recorded: 3.5 minutes (IQR, 3.1– 6.2 min). Complications Fifteen of 98 patients encountered complications (Table 2). One patient had two complications—a pseudoaneurysm and a hematoma. Fourteen complications were minor but two were considered major. All complications directly related to the arterial access were minor; however, in two patients, there was a major complication after thrombin injection into a pseudoaneurysm. In both cases, thrombosis of the femoral artery was seen after thrombin injection. The sizes of these two pseudoaneurysms were 13 mm and 24 mm. Both patients were treated with thrombolysis and aspiration with an ipsilateral CFA approach without clinical sequelae. The remaining pseudoaneurysms were small, with a median diameter of 15 mm (IQR, 3–20 mm). Four of them thrombosed spontaneously within 1 week, as documented by US. Three of them were compressed with the use of US guidance, resulting in complete thrombosis. One was treated successfully with thrombin injection. Six hematomas were observed. The median diameter was 31.5 mm (IQR, 4 –90 mm). All hematomas resolved without the need of an additional intervention. The complication rates were compared between patients treated with manual compression and those treated with the use of a closure device (Table 3). The two groups differed in the following parameters: sheath size, clopidogrel after the intervention, and heparin during the intervention. Closure devices were mostly used in cases of sheath sizes of 6 F and larger compared with the smaller (mostly 4 F) accesses in the manual compression
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Characteristic BMI (kg/m2) Sheath size (F) 4 5 6 8 9 10 INR Platelet count (g/L) Cutis thickness (cm) Medication before intervention Aspirin Clopidogrel Phenprocoumon Heparin Medication after intervention Aspirin Clopidogrel Phenprocoumon Heparin Heparin dose during intervention (IU) Pseudoaneurysm Hematoma
Closure Device (n ⫽ 14)
Manual Compression (n ⫽ 84) P Value
27.2 (21.7–29.7)
26.6 (23.7–30.0)
0 1 (7.1) 10 (71.4) 2 (14.3) 1 (7.1) 0 1.02 (0.97–1.09) 281.0 (209.5–354.5) 1.40 (1.23–1.73)
71 (84.5) 5 (6.0) 7 (8.3) 0 0 1 (1.2) 1.04 (0.99–1.11) 283.0 (226.0–329.0) 1.50 (1.10–1.90)
11 (78.6) 2 (14.3) 0 3 (21.4)
64 (76.2) 10 (11.9) 4 (4.8) 18 (21.4)
12 (85.7) 10 (71.4) 1 (7.1) 2 (14.3) 5,000 (5,000–7,000) 1 (7.1) 2 (14.3)
68 (81.0) 23 (27.4) 11 (13.1) 28 (33.3) 5,000 (5,000–5,000) 9 (10.7) 4 (4.8)
.727 ⬍.001
.287 .863 .839 1.000 .680 1.000 1.000 1.000 .004 1.000 .215 .027 1.000 .203
Note.—Individual values in parentheses are percentages. Ranges in parentheses are IQRs; values provided with IQRs are medians. INR ⫽ International Normalized Ratio.
group. In general, the interventions were more challenging in the closure device group, resulting in a higher incidence of clopidogrel administration after the procedure and a higher dose of heparin during the procedure. Despite these differences, there were statistically no more access-related complications in the closure device group. We further subanalyzed the patient group with manual compression. The platelet count was significantly lower in patients with hematomas compared with those without hematomas (P ⫽ .006; Fig 3a). There was a tendency for more complications with shorter compression times but it his was not significant (Fig 3b). There was no significant relationship between the complication rate and the distance from the access site to the femoral arterial bifurcation (Fig 3c) or to the lower portion of the femoral head (Fig 3d). Interestingly, there was also no statistical relationship between the complication rate and the BMI or soft tissue layer between the SFA and skin. The absence of any significant
relationship between complication rate and various potential risk factors is summarized in Table 4.
DISCUSSION Traditional access for endovascular treatment of the lower limb is performed by a retrograde contralateral or antegrade ipsilateral approach to the CFA. Marcus et al (8) previously reported a direct antegrade approach to the SFA with the use of US guidance. They used the SFA approach in cases in which CFA access was considered “hostile” secondarily to obesity, high CFA bifurcation, erythematous groin, excessive scar tissue, and severe atheromatous disease or aneurysm in the CFA. In the present study, the SFA was the general access point in 100 consecutive patients. In the vast majority (95%), SFA access was obtained with US guidance only. In three cases, additional fluoroscopy was needed for safe sheath placement. All our patients were followed up with US. We encountered an arterial pseudoaneurysm
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Figure 3. (a) Platelet counts versus incidence of hematoma in the manual compression group. The median platelet count was 286 cells/L in patients without hematoma (n ⫽ 80) compared with 191 cells/L in patients with hematoma (n ⫽ 4). This difference was statistically significant (P ⫽ .006). Box plots show the median; 10th, 25th, 75th, and 90th percentiles; and outliers. (b) Duration of manual compression versus complications. The duration of compression for patients with (n ⫽ 9) and without (n ⫽ 75) a pseudoaneurysm after intervention (white boxes) and for patients with (n ⫽ 4) and without (n ⫽ 80) hematoma after intervention (grey boxes). The median compression times were 16.0 min for patients with hematomas and 15.0 min for those with pseudoaneurysms, compared with 18.8 min in patients without hematomas and 19.0 min in patients without aneurysms. There was no significant relationship between duration of compression and pseudoaneurysm (P ⫽ .250) or hematoma (P ⫽ .196). Box plots show the median; 10th, 25th, 75th, and 90th percentiles; and outliers. (c) Distance from femoral bifurcation for patients with (n ⫽ 9) and without (n ⫽ 75) a pseudoaneurysm after intervention (white boxes) and for patients with (n ⫽ 4) and without (n ⫽ 80) hematoma after intervention (grey boxes). The median distances were 27.3 mm in patients with a hematoma and 28.0 mm in those with a pseudoaneurysm, compared with 19.4 mm in patients without hematomas and 19.4 mm in those without pseudoaneurysms. Patients who received a closure device (n ⫽ 14) were excluded from the analysis. There was no significant relationship between distance of femoral bifurcation and pseudoaneurysm (P ⫽ .173) or hematoma (P ⫽ .602). Box plots show the median; 10th, 25th, 75th, and 90th percentiles; and outliers. (d) Distance from lower portion of head of femur for patients with (n ⫽ 9) and without (n ⫽ 75) a pseudoaneurysm after intervention (white boxes) and for patients with (n ⫽ 4) and without (n ⫽ 80) hematoma after intervention (grey boxes). The median distances were 37.4 mm in patients with a hematoma and 41.0 mm in those with a pseudoaneurysm, compared with 34.6 mm in patients without hematomas and 32.8 mm in those without pseudoaneurysms. Patients treated with a closure device (n ⫽ 14) were excluded from analysis. There was no significant relationship between distance from head of femur and aneurysm (P ⫽ .244) or hematoma (P ⫽ .727). Box plots show the median; 10th, 25th, 75th, and 90th percentiles; and outliers. Table 4 Risk Factors for Complications in Cases with Manual Compression (n ⴝ 84) Odds Ratio Risk Factor
Crude
Adjusted
95% CI
P Value
BMI Cutis* Sheath size Duration of compression Distance from arterial access Femoral artery bifurcation Lower portion of femoral head
0.924 1.011 1.326 0.923
0.895 1.011 1.619 0.920
0.765–1.048 0.842–1.213 0.811–3.235 0.785–1.079
.169 .906 .172 .307
1.027 1.013
1.041 0.997
0.978–1.108 0.946–1.050
.205 .897
Note.—The reference category is 0. Among 84 cases with manual compression for hemostasis, there were 11 cases with complications and 73 cases without complications. Patients treated with a closure device (n ⫽ 14) were excluded from the analysis. * Distance between the skin surface and the front wall of the SFA (Fig 1a).
rate of 10.2%. None of these relatively small pseudoaneurysms were clinically obvious. Our rate of pseudoaneurysms is comparable to those reported by others who used US for surveillance: Katzenschlager et al (9), who used a conventional antegrade access to the CFA, reported a 7.7% incidence of pseudoaneurysms. With
the use of antegrade or retrograde access to the femoral artery, Mlekusch et al (10) found a 7% incidence of pseudoaneurysms with conventional manual compression and a 9% incidence with a procoagulant wound dressing. Nice et al (6) investigated the difference between an ipsilateral ante-
grade and an ipsilateral retrograde approach without US guidance with an unusual technique. For the antegrade approach, the CFA was accessed and the guide wire advanced into the SFA. For the retrograde approach, a reverse-shaped catheter was used to redirect the guide wire from the iliac artery into the SFA. The mean procedure times for successful femoral sheath placement were 8.3 minutes for the retrograde approach and 8 minutes for the antegrade approach (6). By using US guidance, we were able to reduce to the mean procedure time for sheath placement to less than half the time reported by Nice et al (6), with a mean of 3.5 minutes. During clinical follow-up, Nice et al (6) found three hematomas among 47 cases in the retrograde access group (6.4%) and seven among the 45 cases in the antegrade access group (15.6%). In the present study, 6.1% of the cases had a postprocedural hematoma, which is similar to the incidence in the retrograde access group of Nice et al (6). They explained the increased hematoma rate for the
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antegrade access group by inadvertent punctures of the deep femoral artery (6). The use of US guidance helps to avoid these inadvertent punctures, thereby reducing the rate of hematomas for the antegrade approach. In the present study, we also looked at the complication rates of closure devices compared with manual compression, as well as the influence of platelet count, length of manual compression, obesity (based on BMI), and location of SFA access. Despite larger sheath sizes, the higher intraprocedural heparin dose, and the higher rate of postinterventional clopidogrel administration, the complication rate in the group of patients who received closure devices was not higher than in the manual compression group. Despite the relatively small number of cases (n ⫽ 14), it seems feasible to use closure devices in the SFA. Somewhat expected, among patients treated with manual compression, there was a higher hematoma rate with lower platelet counts and tendency for more complications with shorter compression times (Fig 3a, 3b). Surprisingly, there was no increased risk of an access site complication neither with a higher BMI, nor with a lower puncture site (Fig 3c, 3d). The latter finding contradicts the results found by Gabriel et al (11), who reported that a lower access site is related to a higher rate of pseudoaneurysms. They hypothesized that manual compression of a lower access site is more difficult because of the lack of a bony counter fort. These findings could not be confirmed in the present study. Unlike in some other institutions, we used regular 19-gauge needles for
arterial access. With the use of US guidance, the artery can be generally accessed with one attempt and therefore we believe that the additional costs for a micropuncture set were not justified. To our knowledge, no comparative study is available. There are some limitations to the present study. First, it is a single-arm study without a control group. Therefore, the rate of pseudoaneurysms for CFA puncture with US follow-up was not assessed for comparison. Second, there was no standardized compression time throughout the study. Some complications were probably a result of a short manual compression time. There was a tendency to encounter more complications with shorter manual compression, but without a statistically significant difference. In conclusion, antegrade puncture of the SFA with US guidance is feasible and fast. The rate of complications seems similar to the rates for arterial access into the CFA. Unfortunately, a direct comparison is difficult because of the lack of uniform follow-up among different studies. Acknowledgments: The authors thank Yvonne Fuchs and Martin Kliem, MD, for their support with patient care during the study, and Wolfgang Herzig for the illustrations. References 1. Rosamond W, Flegal K, Friday G, et al. Heart disease and stroke statistics— 2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2006; 115:69 –71. 2. McDermott MM, Tian L, Liu K, et al. Prognostic value of functional perfor-
3. 4.
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mance for mortality in patients with peripheral artery disease. J Am Coll Cardiol 2008; 15;1482–1489. Arain SA, White CJ. Endovascular therapy for critical limb ischemia. Vasc Med 2008; 13:267–279. Suding PN, McMaster W, Hansen E, Hatfield AW, Gordon IL, Wilson SE. Increased endovascular interventions decrease the rate of lower limb artery bypass operations without an increase in major amputation rate. Ann Vasc Surg 2008; 22:195–199. Rogers JH, Laird JR. Overview of new technologies for lower extremity revascularization. Circulation 2007; 116: 2072–2085. Nice C, Timmons G, Bartholemew P, Uberoi R. Retrograde vs. Antegrade puncture for infra-inguinal angioplasty. Cardiovasc Intervent Radiol 2003; 26:370 –374. Blais C. Antegrade puncture of the superficial femoral artery: a pilot project. Can Assoc Radiol J 1993; 44: 253–256. Marcus AJ, Lotzof K, Howard A. Access to the superficial femoral artery in the presence of a “hostile groin”: a prospective study. Cardiovasc Intervent Radiol 2007; 30:351–354. Katzenschlager R, Ugurluoglu A, Ahmadi A et al. Incidence of pseudoaneurysm after diagnostic and therapeutic angiography. Radiology 1995; 195: 463– 466. Mlekusch W, Minar E, Dick P, et al. Access site management after peripheral percutaneous transluminal procedures: Neptune pad compared with conventional manual compression. Radiology 2008; 249:1058 –1063. Gabriel M, Pawlaczyk K, Waliszewski K, Krasin´ski Z, Majewski W. Location of femoral artery puncture site and the risk of postcatheterization pseudoaneurysm formation. Int J Cardiol 2007; 120:167–171.
PURPOSE: To evaluate the feasibility and safety of antegrade superficial femoral artery (SFA) access with the use of ultrasound (US) guidance. MATERIALS AND METHODS: One hundred consecutive patients (56% men) were prospectively enrolled, with a median age of 76 years. The SFA was punctured in antegrade fashion with a 19-gauge needle with US guidance, followed by sheath placement. The time from local anesthesia until successful blood aspiration from the sheath was measured. At the end of the case, hemostasis was achieved with a closure device or by manual compression. All cases were followed with US for access complications. RESULTS: Antegrade arterial access was successful in all cases. The arterial sheath was successfully placed into the SFA in 98 of 100 patients. In 95 of 98, the sheath was inserted with US guidance only; additional fluoroscopy was needed in three cases. In two of 100 patients, the common femoral artery (CFA) was accessed, accidentally in one case and deliberately in the other because the SFA was considered too small. Both patients were excluded from further analysis. The median time for arterial access was 3.5 minutes (interquartile range, 3.1– 6.2 min). All complications directly related to vascular access were minor (16; 15.68%): 10 pseudoaneurysms (10.2%; median diameter, 15 mm) and six hematomas (6.12%; median diameter, 31.5 mm). CONCLUSIONS: Antegrade puncture into the SFA with US guidance is feasible and fast. The rate of minor complications is similar to other reported series, but a direct comparison with other studies is difficult because study designs vary. J Vasc Interv Radiol 2010; 21:1495–1500 Abbreviations: femoral artery
BMI ⫽ body mass index, CFA ⫽ common femoral artery, IQR ⫽ interquartile range, PVD ⫽ peripheral vascular disease, SFA ⫽ superficial
PERIPHERAL vascular disease (PVD) is a common medical problem in the Western world, affecting as many as 8 million people in the United States alone (1,2). There are numerous therapeutic
From the Department of Radiology (A.G., E.S., T.S., C.A.B.) and Angiology (R.J.), Kantonsspital Winterthur, Brauerstrasse 15, 8401 Winterthur, Switzerland; and Clinical Trials Center/Center for Clinical Research (N.G.), University Hospital of Zurich, Zurich, Switzerland. Received July 6, 2009; final revision received November 22, 2009; accepted March 12, 2010. Address correspondence to C.A.B.; E-mail: [email protected] None of the authors have identified a conflict of interest. © SIR, 2010 DOI: 10.1016/j.jvir.2010.03.021
options, such as percutaneous transluminal angioplasty, stent insertion, local lysis, and rotational atherectomy, to treat patients with peripheral arterial disease of the lower extremity, which often prevent or delay the necessity of a bypass operation or amputation of the affected lower extremity concerned (3– 5). Access for endovascular treatment of the lower extremity is generally obtained by a retrograde contralateral approach or an antegrade ipsilateral approach. Traditionally, arterial access is made into the common femoral artery (CFA) by palpation. With the better availability of ultrasound (US) in angiography suites, the use of USguided arterial access is becoming more popular.
During the antegrade approach to the CFA, a common problem is the soft tissue layer over the artery, especially in obese patients. Other problems are steering the guide wire into the superficial femoral artery (SFA) or the accidental puncture of the deep femoral artery. These problems can be time-consuming and lead to repeated punctures, hematomas, and aneurysms in the groin (6). Antegrade access is especially difficult if a stenosis in the CFA is present. Direct antegrade puncture of the SFA was described in 1993 (7). In that relatively small study of 25 patients, only one minor complication, a small hematoma, was observed. In a more recent study (8), 30 antegrade punctures into the SFA were con-
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Table 1 Demographics and Clinical Data (N ⴝ 98) Characteristic
Value
Male sex Age (y) BMI (kg/m2) AFS diameter (mm) Cutis thickness (cm) Distance from arterial access (mm) To head of femur To femoral bifurcation INR Platelet count (⫻ 103 cells/L) Sheath size (F) 4 5 6 8 9 10
55 (56.1) 76.0 (68.0–81.0) 26.6 (22.8–29.9) 6.0 (5.0–6.2) 1.5 (1.1–1.9) 35.1 (21.5–44.9) 19.2 (13.3–29.3) 1.04 (0.98–1.11) 282.0 (226.0–329.3) 71 (72.4) 6 (6.1) 17 (17.3) 2 (2.0) 1 (1.0) 1 (1.0)
Note.—Individual values in parentheses are percentages. Ranges in parentheses are IQRs; values provided with IQRs are medians. INR ⫽ International Normalized Ratio.
ducted into a “hostile groin.” In these cases, access to the CFA was difficult or impossible because of scarring, obesity, or previous failed CFA puncture. The aim of the present study was to evaluate the feasibility and safety of an antegrade SFA puncture with US guidance in the general population with PVD.
MATERIALS AND METHODS Patients This prospective single-center study was performed with the approval of the local institutional review board and informed consent from all patients. Between May 2008 and February 2009, a total of 100 consecutive patients (56 men) with a median age of 76 years (interquartile range [IQR], 68 – 81 y) were enrolled. A right-sided approach was performed in 51 patients, a left-sided approach in 49. All patients from a single institution referred for a peripheral arterial study older than the age of 18 years were included. In 97 patients, a therapeutic procedure (percutaneous transluminal angioplasty, stent placement, and/or thrombolysis) was performed; in the remaining three patients, only diagnostic angiography was performed. In all patients, the SFA was the attempted entry site. Besides age and
sex, the following parameters were recorded: body mass index (BMI) calculated from body height and weight, antiplatelet medication and anticoagulation, and laboratory findings such as platelet count and International Normalized Ratio. Demographics and clinical data are summarized in Table 1. There were no patients included who had had a previous surgical procedure or a bypass in the area of the access site. Technique All patients were placed supine, feet first, on the table. Standard preparation of the groin was performed. The proximal SFA was then scanned with B-mode US (Zonare Medical Systems, Mountain View, California) to determine the best access point. We used a 10/5-Mhz linear probe. The diameter of the SFA and the soft tissue layer above the SFA were measured (Fig 1). The time to gain access was defined as the time from the injection of local anesthesia until blood aspiration from the sheath placed into the SFA. For the purpose of the study, only US guidance was used. The use of additional fluoroscopy was recorded separately. The artery was punctured with a vascular access needle (SDN-19UT-7.0, 19 gauge, Cook, Bloomington, Indiana).
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With a J-tip guide wire, a sheath (Britetip, 4 –10-F; Cordis, Miami Lakes, Florida) was inserted into the SFA. An ipsilateral oblique view of the femoral artery was obtained in every patient, which allowed assessment of the exact entry site into the SFA. The distance between the entry point and the femoral artery bifurcation and the distance between the entry point and the lower margin of the femoral head were defined on angiography (Fig 2). At the end of the procedure, the sheath was removed and hemostasis was achieved with a closure device (Starclose; Abbott Vascular, Redwood City, California) or by manual compression at the discretion of the operator. The duration of manual compression was recorded. All patients received a compression bandage for 6 hours. Follow-up All patients had ordered bed rest for 6 hours. US follow-up of the access site was performed in all patients between 6 hours (outpatients) and 24 hours (inpatients) after the procedure, assessing the puncture site for hematoma, pseudoaneurysm, dissection, or stenosis of the SFA. If there was a hematoma or a pseudoaneurysm, exact measurements were obtained, with calculation of maximum size. Statistical Analysis Statistical analyses were performed with the SPSS statistical program (version 15.0.1; SPSS, Chicago, Illinois). Data were analyzed descriptively and described with the median and IQR for continuous data or the number of subjects and percentage of the total for categoric variables. Comparisons between groups were performed with a Mann-Whitney U test for quantitative data or Fisher exact test for binary variables. Potential risk factors for complications were further analyzed with a logistic regression analysis.
RESULTS Technical Success Antegrade arterial access was successfully obtained in all patients. The arterial sheath was placed into the SFA in 98 of 100 patients. In 95 of these
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Figure 1. (a) Documentation of the puncture site in the SFA with a 10/5-MHz transducer. In every patient, the distance from the skin to the anterior wall of the SFA, as well as the maximum diameter of the SFA, was measured in millimeters. This was followed by US-guided antegrade puncture of the SFA. (b) Corresponding B-mode US image and anatomic details from the right leg. We used a 10/5-MHz transducer, with the same view as in a.
Figure 2. (a) Based on the angiographic image, the exact entry site into the SFA was determined in relation to the femoral arterial bifurcation and the lower margin of the femoral head (in mm). (b) Corresponding angiographic image demonstrates the measurement between the arterial access and the lower margin of the femoral head and the femoral artery bifurcation, respectively (in mm).
98 cases, only US guidance was needed. In three cases, additional fluoroscopy was used to control safe guide wire advancement into the SFA.
In two patients, the CFA was punctured: accidentally in one while aiming for the SFA and deliberately in the other because the SFA was considered
too small and calcified for access. These two cases with access to the CFA were excluded from further analysis. Overall, a consistently short time
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Table 2 Efficacy and Safety Endpoints (N ⴝ 98) Endpoint Pseudoaneurysm Hematoma Dissection
Table 3 Clinical Data of Patients Treated with Closure Device and Manual Compression
No. of Pts. 10 (10.2) 6 (6.1) 0
Note.—Values in parentheses are percentages.
for arterial access was recorded: 3.5 minutes (IQR, 3.1– 6.2 min). Complications Fifteen of 98 patients encountered complications (Table 2). One patient had two complications—a pseudoaneurysm and a hematoma. Fourteen complications were minor but two were considered major. All complications directly related to the arterial access were minor; however, in two patients, there was a major complication after thrombin injection into a pseudoaneurysm. In both cases, thrombosis of the femoral artery was seen after thrombin injection. The sizes of these two pseudoaneurysms were 13 mm and 24 mm. Both patients were treated with thrombolysis and aspiration with an ipsilateral CFA approach without clinical sequelae. The remaining pseudoaneurysms were small, with a median diameter of 15 mm (IQR, 3–20 mm). Four of them thrombosed spontaneously within 1 week, as documented by US. Three of them were compressed with the use of US guidance, resulting in complete thrombosis. One was treated successfully with thrombin injection. Six hematomas were observed. The median diameter was 31.5 mm (IQR, 4 –90 mm). All hematomas resolved without the need of an additional intervention. The complication rates were compared between patients treated with manual compression and those treated with the use of a closure device (Table 3). The two groups differed in the following parameters: sheath size, clopidogrel after the intervention, and heparin during the intervention. Closure devices were mostly used in cases of sheath sizes of 6 F and larger compared with the smaller (mostly 4 F) accesses in the manual compression
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Characteristic BMI (kg/m2) Sheath size (F) 4 5 6 8 9 10 INR Platelet count (g/L) Cutis thickness (cm) Medication before intervention Aspirin Clopidogrel Phenprocoumon Heparin Medication after intervention Aspirin Clopidogrel Phenprocoumon Heparin Heparin dose during intervention (IU) Pseudoaneurysm Hematoma
Closure Device (n ⫽ 14)
Manual Compression (n ⫽ 84) P Value
27.2 (21.7–29.7)
26.6 (23.7–30.0)
0 1 (7.1) 10 (71.4) 2 (14.3) 1 (7.1) 0 1.02 (0.97–1.09) 281.0 (209.5–354.5) 1.40 (1.23–1.73)
71 (84.5) 5 (6.0) 7 (8.3) 0 0 1 (1.2) 1.04 (0.99–1.11) 283.0 (226.0–329.0) 1.50 (1.10–1.90)
11 (78.6) 2 (14.3) 0 3 (21.4)
64 (76.2) 10 (11.9) 4 (4.8) 18 (21.4)
12 (85.7) 10 (71.4) 1 (7.1) 2 (14.3) 5,000 (5,000–7,000) 1 (7.1) 2 (14.3)
68 (81.0) 23 (27.4) 11 (13.1) 28 (33.3) 5,000 (5,000–5,000) 9 (10.7) 4 (4.8)
.727 ⬍.001
.287 .863 .839 1.000 .680 1.000 1.000 1.000 .004 1.000 .215 .027 1.000 .203
Note.—Individual values in parentheses are percentages. Ranges in parentheses are IQRs; values provided with IQRs are medians. INR ⫽ International Normalized Ratio.
group. In general, the interventions were more challenging in the closure device group, resulting in a higher incidence of clopidogrel administration after the procedure and a higher dose of heparin during the procedure. Despite these differences, there were statistically no more access-related complications in the closure device group. We further subanalyzed the patient group with manual compression. The platelet count was significantly lower in patients with hematomas compared with those without hematomas (P ⫽ .006; Fig 3a). There was a tendency for more complications with shorter compression times but it his was not significant (Fig 3b). There was no significant relationship between the complication rate and the distance from the access site to the femoral arterial bifurcation (Fig 3c) or to the lower portion of the femoral head (Fig 3d). Interestingly, there was also no statistical relationship between the complication rate and the BMI or soft tissue layer between the SFA and skin. The absence of any significant
relationship between complication rate and various potential risk factors is summarized in Table 4.
DISCUSSION Traditional access for endovascular treatment of the lower limb is performed by a retrograde contralateral or antegrade ipsilateral approach to the CFA. Marcus et al (8) previously reported a direct antegrade approach to the SFA with the use of US guidance. They used the SFA approach in cases in which CFA access was considered “hostile” secondarily to obesity, high CFA bifurcation, erythematous groin, excessive scar tissue, and severe atheromatous disease or aneurysm in the CFA. In the present study, the SFA was the general access point in 100 consecutive patients. In the vast majority (95%), SFA access was obtained with US guidance only. In three cases, additional fluoroscopy was needed for safe sheath placement. All our patients were followed up with US. We encountered an arterial pseudoaneurysm
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Figure 3. (a) Platelet counts versus incidence of hematoma in the manual compression group. The median platelet count was 286 cells/L in patients without hematoma (n ⫽ 80) compared with 191 cells/L in patients with hematoma (n ⫽ 4). This difference was statistically significant (P ⫽ .006). Box plots show the median; 10th, 25th, 75th, and 90th percentiles; and outliers. (b) Duration of manual compression versus complications. The duration of compression for patients with (n ⫽ 9) and without (n ⫽ 75) a pseudoaneurysm after intervention (white boxes) and for patients with (n ⫽ 4) and without (n ⫽ 80) hematoma after intervention (grey boxes). The median compression times were 16.0 min for patients with hematomas and 15.0 min for those with pseudoaneurysms, compared with 18.8 min in patients without hematomas and 19.0 min in patients without aneurysms. There was no significant relationship between duration of compression and pseudoaneurysm (P ⫽ .250) or hematoma (P ⫽ .196). Box plots show the median; 10th, 25th, 75th, and 90th percentiles; and outliers. (c) Distance from femoral bifurcation for patients with (n ⫽ 9) and without (n ⫽ 75) a pseudoaneurysm after intervention (white boxes) and for patients with (n ⫽ 4) and without (n ⫽ 80) hematoma after intervention (grey boxes). The median distances were 27.3 mm in patients with a hematoma and 28.0 mm in those with a pseudoaneurysm, compared with 19.4 mm in patients without hematomas and 19.4 mm in those without pseudoaneurysms. Patients who received a closure device (n ⫽ 14) were excluded from the analysis. There was no significant relationship between distance of femoral bifurcation and pseudoaneurysm (P ⫽ .173) or hematoma (P ⫽ .602). Box plots show the median; 10th, 25th, 75th, and 90th percentiles; and outliers. (d) Distance from lower portion of head of femur for patients with (n ⫽ 9) and without (n ⫽ 75) a pseudoaneurysm after intervention (white boxes) and for patients with (n ⫽ 4) and without (n ⫽ 80) hematoma after intervention (grey boxes). The median distances were 37.4 mm in patients with a hematoma and 41.0 mm in those with a pseudoaneurysm, compared with 34.6 mm in patients without hematomas and 32.8 mm in those without pseudoaneurysms. Patients treated with a closure device (n ⫽ 14) were excluded from analysis. There was no significant relationship between distance from head of femur and aneurysm (P ⫽ .244) or hematoma (P ⫽ .727). Box plots show the median; 10th, 25th, 75th, and 90th percentiles; and outliers. Table 4 Risk Factors for Complications in Cases with Manual Compression (n ⴝ 84) Odds Ratio Risk Factor
Crude
Adjusted
95% CI
P Value
BMI Cutis* Sheath size Duration of compression Distance from arterial access Femoral artery bifurcation Lower portion of femoral head
0.924 1.011 1.326 0.923
0.895 1.011 1.619 0.920
0.765–1.048 0.842–1.213 0.811–3.235 0.785–1.079
.169 .906 .172 .307
1.027 1.013
1.041 0.997
0.978–1.108 0.946–1.050
.205 .897
Note.—The reference category is 0. Among 84 cases with manual compression for hemostasis, there were 11 cases with complications and 73 cases without complications. Patients treated with a closure device (n ⫽ 14) were excluded from the analysis. * Distance between the skin surface and the front wall of the SFA (Fig 1a).
rate of 10.2%. None of these relatively small pseudoaneurysms were clinically obvious. Our rate of pseudoaneurysms is comparable to those reported by others who used US for surveillance: Katzenschlager et al (9), who used a conventional antegrade access to the CFA, reported a 7.7% incidence of pseudoaneurysms. With
the use of antegrade or retrograde access to the femoral artery, Mlekusch et al (10) found a 7% incidence of pseudoaneurysms with conventional manual compression and a 9% incidence with a procoagulant wound dressing. Nice et al (6) investigated the difference between an ipsilateral ante-
grade and an ipsilateral retrograde approach without US guidance with an unusual technique. For the antegrade approach, the CFA was accessed and the guide wire advanced into the SFA. For the retrograde approach, a reverse-shaped catheter was used to redirect the guide wire from the iliac artery into the SFA. The mean procedure times for successful femoral sheath placement were 8.3 minutes for the retrograde approach and 8 minutes for the antegrade approach (6). By using US guidance, we were able to reduce to the mean procedure time for sheath placement to less than half the time reported by Nice et al (6), with a mean of 3.5 minutes. During clinical follow-up, Nice et al (6) found three hematomas among 47 cases in the retrograde access group (6.4%) and seven among the 45 cases in the antegrade access group (15.6%). In the present study, 6.1% of the cases had a postprocedural hematoma, which is similar to the incidence in the retrograde access group of Nice et al (6). They explained the increased hematoma rate for the
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antegrade access group by inadvertent punctures of the deep femoral artery (6). The use of US guidance helps to avoid these inadvertent punctures, thereby reducing the rate of hematomas for the antegrade approach. In the present study, we also looked at the complication rates of closure devices compared with manual compression, as well as the influence of platelet count, length of manual compression, obesity (based on BMI), and location of SFA access. Despite larger sheath sizes, the higher intraprocedural heparin dose, and the higher rate of postinterventional clopidogrel administration, the complication rate in the group of patients who received closure devices was not higher than in the manual compression group. Despite the relatively small number of cases (n ⫽ 14), it seems feasible to use closure devices in the SFA. Somewhat expected, among patients treated with manual compression, there was a higher hematoma rate with lower platelet counts and tendency for more complications with shorter compression times (Fig 3a, 3b). Surprisingly, there was no increased risk of an access site complication neither with a higher BMI, nor with a lower puncture site (Fig 3c, 3d). The latter finding contradicts the results found by Gabriel et al (11), who reported that a lower access site is related to a higher rate of pseudoaneurysms. They hypothesized that manual compression of a lower access site is more difficult because of the lack of a bony counter fort. These findings could not be confirmed in the present study. Unlike in some other institutions, we used regular 19-gauge needles for
arterial access. With the use of US guidance, the artery can be generally accessed with one attempt and therefore we believe that the additional costs for a micropuncture set were not justified. To our knowledge, no comparative study is available. There are some limitations to the present study. First, it is a single-arm study without a control group. Therefore, the rate of pseudoaneurysms for CFA puncture with US follow-up was not assessed for comparison. Second, there was no standardized compression time throughout the study. Some complications were probably a result of a short manual compression time. There was a tendency to encounter more complications with shorter manual compression, but without a statistically significant difference. In conclusion, antegrade puncture of the SFA with US guidance is feasible and fast. The rate of complications seems similar to the rates for arterial access into the CFA. Unfortunately, a direct comparison is difficult because of the lack of uniform follow-up among different studies. Acknowledgments: The authors thank Yvonne Fuchs and Martin Kliem, MD, for their support with patient care during the study, and Wolfgang Herzig for the illustrations. References 1. Rosamond W, Flegal K, Friday G, et al. Heart disease and stroke statistics— 2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2006; 115:69 –71. 2. McDermott MM, Tian L, Liu K, et al. Prognostic value of functional perfor-
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mance for mortality in patients with peripheral artery disease. J Am Coll Cardiol 2008; 15;1482–1489. Arain SA, White CJ. Endovascular therapy for critical limb ischemia. Vasc Med 2008; 13:267–279. Suding PN, McMaster W, Hansen E, Hatfield AW, Gordon IL, Wilson SE. Increased endovascular interventions decrease the rate of lower limb artery bypass operations without an increase in major amputation rate. Ann Vasc Surg 2008; 22:195–199. Rogers JH, Laird JR. Overview of new technologies for lower extremity revascularization. Circulation 2007; 116: 2072–2085. Nice C, Timmons G, Bartholemew P, Uberoi R. Retrograde vs. Antegrade puncture for infra-inguinal angioplasty. Cardiovasc Intervent Radiol 2003; 26:370 –374. Blais C. Antegrade puncture of the superficial femoral artery: a pilot project. Can Assoc Radiol J 1993; 44: 253–256. Marcus AJ, Lotzof K, Howard A. Access to the superficial femoral artery in the presence of a “hostile groin”: a prospective study. Cardiovasc Intervent Radiol 2007; 30:351–354. Katzenschlager R, Ugurluoglu A, Ahmadi A et al. Incidence of pseudoaneurysm after diagnostic and therapeutic angiography. Radiology 1995; 195: 463– 466. Mlekusch W, Minar E, Dick P, et al. Access site management after peripheral percutaneous transluminal procedures: Neptune pad compared with conventional manual compression. Radiology 2008; 249:1058 –1063. Gabriel M, Pawlaczyk K, Waliszewski K, Krasin´ski Z, Majewski W. Location of femoral artery puncture site and the risk of postcatheterization pseudoaneurysm formation. Int J Cardiol 2007; 120:167–171.