Annals of Vascular Surgery
Volume 24, Issue 3 , Pages 328-335, April 2010

Femoral Artery Complications after Cardiac Catheterization: A Study of Patient Profile

  • Mario Castillo-Sang

      Affiliations

    • The University of Toledo Health Science Campus, Toledo, OH
    • Corresponding Author InformationCorrespondence to: Mario Castillo-Sang, MD, Department of Surgery, The University of Toledo Health Science Campus, 3000 Arlington Avenue, Dowling Hall, Second Floor, Toledo, OH 43614, USA
    • ,
  • Albert W. Tsang

      Affiliations

    • The University of Toledo Health Science Campus, Toledo, OH
    • ,
  • Babatunde Almaroof

      Affiliations

    • The University of Toledo Health Science Campus, Toledo, OH
    • ,
  • James Cireddu

      Affiliations

    • The University of Toledo Health Science Campus, Toledo, OH
    • ,
  • Joseph Sferra

      Affiliations

    • The University of Toledo Health Science Campus, Toledo, OH
    • Saint Vincent Mercy Medical Center, Toledo, OH
    • ,
  • Gerald B. Zelenock

      Affiliations

    • The University of Toledo Health Science Campus, Toledo, OH
    • ,
  • Milo Engoren

      Affiliations

    • Saint Vincent Mercy Medical Center, Toledo, OH
    • ,
  • Gregory Kasper

      Affiliations

    • Saint Vincent Mercy Medical Center, Toledo, OH

published online 11 September 2009.

Article Outline

Background

Femoral artery complications after cardiac catheterization range from simple events to severe complications requiring invasive techniques or surgery with significant economic costs. This study evaluated early femoral arterial complications from percutaneous arterial access during diagnostic and interventional cardiac catheterizations in an era of widespread use of closure devices and intense anticoagulation.

Methods

Patients undergoing percutaneous cardiac catheterization via the femoral artery between August 2005 and December 2005 were identified using an ICD-9 patient database. Forty-six data points were extracted by retrospective chart review, including demographics, comorbidities, type of anticoagulation, procedural details, and postprocedural complications. Univariable analysis and binary logistic regression were used to determine factors associated with complications.

Results

Eighty-two of 579 patients (14%) suffered complications. The most common complications were hematomas (51 patients, 10%) and active bleeding (14 patients, 2.4%). Closure devices were used in 470 patients. After multivariable correction, use of preprocedural (odds ratio [OR]=5.65, 95% confidence interval [CI] 2.58-12.3, p<0.001) and intraprocedural (OR=4.88, 95% CI 1.95-12.3, p<0.001) antithrombotic agents (antiplatelet and/or anticoagulants), intraprocedural clopidogrel (OR=2.98, 95% CI 1.21-7.30, p=0.017), and postprocedural heparin (OR=29.4, 95% CI 3.56-250, p=0.002) were associated with increased risk. Coronary artery disease was associated with increased risk (OR=11.1, 95% CI 4.78-25.6, p<0.001), while use of a closure device (OR=0.263, 95% CI 0.125-0.553, p<0.001), male gender (OR=0.421, 95% CI 0.220-0.805, p=0.009), and prior catheterization (OR=0.033, 95% CI 0.012-0.095, p<0.001) were protective.

Conclusion

With increasing numbers of complex coronary endovascular procedures and widespread use of high-dose multidrug antithrombotic therapy, femoral artery injuries will continue to be a significant risk for patients. Postprocedural monitoring with a high level of suspicion and use of vascular closure devices in high-risk patients may decrease the incidence of femoral artery complications. The use of vascular closure devices after low-risk procedures in male patients or those with previous ipsilateral catheterization might not be warranted but needs further study.

 

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Introduction 

Femoral artery complications after cardiac catheterization range from simple events that require short, noninvasive interventions to severe complications that require invasive techniques or surgical intervention. These complications include simple hematomas, pseudoaneurysms, retroperitoneal hematomas, arteriovenous fistulas, external bleeding, groin abscess, mycotic aneurysms, femoral nerve palsy, and complications associated with closure devices (thrombosis, infection, and embolism).1, 2 In addition to causing significant morbidity, these complications lead to increased hospital costs of approximately $15,000 per patient.3 In the United States, it is estimated that by 2010 3 million cardiac catheterizations will be performed annually,4 most of which will be performed via the femoral approach. While the incidence of complications is low, ranging 0.6-9%,5, 6, 7, 8, 9, 10, 11, 12, 13 the large number of cardiac catheterizations makes femoral artery complication a common iatrogenic injury.

Over the last two decades several advances in technology and new antithrombotic drugs have changed the practice of percutaneous catheterization. The first vascular closure device (VCD) was approved by the Food and Drug Administration in 1995. Since then, other models have been approved and second- and third-generation devices are now available. Glycoprotein IIb/IIIa inhibitors were introduced in 1997 to maintain coronary artery patency. In 2003, the first drug-eluting stents were introduced, which increased the use of thienopyridine drugs such as clopidogrel to prevent in-stent thrombosis.14 In the last two decades several studies on risk factors for vascular complications after catheterization have been published, but some of their findings may no longer apply as they preceded the changes in practice described above.10, 12, 13, 15, 16

Our objectives were to study, in an era of widespread use of VCDs and potent antithrombotic agents, (1) the incidence and types of early local complications from percutaneous femoral artery access during diagnostic and interventional cardiac catheterizations in contemporary practice and (2) the factors associated with these complications.

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Materials and Methods 

All patients at our institution who underwent percutaneous cardiac catheterization via the femoral artery between August 2005 and December 2005 were identified using an International Classification of Diseases, ninth edition (ICD-9), patient database search. The study was approved by the institutional review board, which waived informed consent. All Health Insurance Portability and Accountability Act (HIPAA) regulations were met. Resident physicians and trained medical students extracted data from hospital charts including surgical and catheterization records. The information was compiled in a computer database.

The study was powered to detect an increase in odds ratio (OR) of 1.65, with p=0.05, α=0.05 (80% power two-tailed), and β=0.20. This required 545 patients.17 All variables were initially compared with the t-test for normally distributed continuous variables and chi-squared or Fisher's exact test for categorical variables. Binary logistic regression using forward selection was performed for further analysis. All variables were entered initially. To control for collinearity between the medicines, we first evaluated the effects of the individual medicines, interactions, and grouping into pre-, intra-, and postprocedural time periods and used linear regression to determine their coefficient of determination and their variation.18 We accepted variables with variation <2.5 for further entry into the binary logistic regression models. p<0.05 was required for retention in the model. Final results are presented as ORs with 95% confidence intervals (CIs). SPSS 14.0 (SPSS, Inc., Chicago, IL) was used for statistical analysis. In order to control for the use of VCDs, which were inserted at the physician's discretion and might have been influenced by the physician's bias or perceptions about the likelihood of complications, propensity analysis was performed.19 Using propensity analysis, a nonparsimonious binary logistic regression was performed using all variables to predict the likelihood (ranging 0-1) or propensity that a patient received a closure device. The logistic regression models were then recomputed with the inclusion of the propensity scores. Because there were major differences in the anticoagulation practices between patients who received interventional procedures and those who received diagnostic procedures, we further analyzed separately these two populations. Univariable and multivariable analyses on the separate diagnostic and interventional groups were performed as described above.

The use of a VCD was left to the discretion of the attending physician, as was the use of glycoprotein IIB/IIIA inhibitors, bivalirudin, or enoxaparin. Patients undergoing percutaneous coronary interventions were given aspirin, clopidogrel, and heparin on a weight-based protocol. Activated clotting time testing was done in a minority of cases managed with therapeutic heparin who did not receive a VCD. No other measure of the medicine's effects was routinely obtained. Patients who did not have a VCD inserted were managed with manual compression by catheterization suite personnel for at least 20min. An external vascular compression device was not used routinely and was only indicated per unit protocol in enlarging hematomas or active external bleeding that failed to resolve after at least 20min of manual compression. The procedures were performed in both inpatient and outpatient settings, and patient follow-up was carried out only during the index hospitalization.

Protocol clinical examination of the groin every hour was performed by trained nurses in the cardiovascular unit. The findings were documented in a standardized postprocedure assessment form, in which the presence of a hematoma, size, and presence or absence of pulses were documented. No routine postcatheterization surveillance arterial ultrasound was done. A hematoma was defined as significant swelling at the puncture site and was classified as small if <3cm in diameter, medium if 3-6cm in diameter, or large if >6cm in diameter. A pseudoaneurysm was defined as an extraluminal cavity connected to the adjacent artery with to-and-fro blood flow demonstrated by duplex color flow. Bleeding was defined as active extravasation of blood from the site of puncture requiring dressing changes or other more significant intervention, such as further compression or bed rest. An arteriovenous fistula was defined as a high-velocity jet of blood originating from the artery into the venous lumen on duplex ultrasound with a continuous flow on Doppler. Retroperitoneal hematoma was diagnosed by computerized tomography showing extravasation and/or stranding in the retroperitoneum on the side of the arterial cannulation.

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Results 

Five hundred and seventy-nine patients underwent cardiac catheterization (Table I). Eighty-two of 579 (14%) patients suffered 92 complications, with the vast majority being hematoma or bleeding (Table II). Seven patients received erythrocyte blood transfusions, and one received platelets. Transfusions were given for retroperitoneal hematoma, expanding pseudoaneurysm, large hematoma, and active bleeding. Two patients developed gastrointestinal bleeding after anticoagulation that required erythrocyte transfusion, and one patient with chronic renal failure required two units of single-donor platelets after unresolved bleeding at the cannulation site. Of the patients who developed pseudoaneurysms, five were managed with thrombin injection, one required groin exploration and repair of a ruptured common femoral artery pseudoaneurysm, and one required application of an external compression device. Three patients with active bleeding were operated on and underwent the following procedures: thromboendarterectomy of the right common femoral artery and Dacron patch angioplasty after removal of the closure device, primary repair of the superficial femoral artery, and suture repair of the right femoral artery.

Table I. Univariable predictors of complications
Complication (n=82) Uncomplicated (n=497)Total (n=579)
Factorn%pn%n%
Male gender3745%0.00830361%34059%
Diabetes mellitus1822%0.14915130%16929%
Insulin use56%1.00367%417%
Hypertension5770%0.02227756%33458%
Ever smoked2733%0.51514529%17230%
Current smoker2024%0.0056012%8014%
COPD1417%0.2856112%7513%
Coronary artery disease6073%<0.00124249%30252%
Stroke56%0.221173%224%
Peripheral vascular disease1113%0.088388%498%
Inguinal surgery11%1.00122%132%
Prior catheterization1215%0.06512124%13323%
Preprocedural aspirin4049%<0.0017615%11620%
Preprocedural clopidogrel2328%<0.001418%6411%
Preprocedural heparin1518%<0.001204%356%
Preprocedural enoxaparin1215%0.001214%336%
Preprocedural coumadin22%0.2034.8%61%
Preprocedural bivalirudin34%0.0222.4%50.8%
Preprocedural eptifibatide22%0.26051%71%
Any preprocedural antithrombotic5162%<0.0019319%14425%
Intraprocedural aspirin1113%<0.00161%173%
Intraprocedural clopidogrel4049%<0.0014810%8815%
Intraprocedural heparin3441%<0.001388%7212%
Intraprocedural enoxaparin45%0.0052.4%61%
Intraprocedural bivalirudin2530%<0.001439%6812%
Intraprocedural eptifibatide1134%<0.001153%264%
Any intraprocedural antithrombotic6076%<0.0018918%14926%
Postprocedural aspirin6174%<0.00112726%18832%
Postprocedural clopidogrel5567%<0.00110922%16428%
Postprocedural heparin67%<0.0012.4%81%
Postprocedural enoxaparin56%<0.0011.2%61%
Postprocedural coumadin45%0.02751%92%
Postprocedural bivalirudin34%0.00300%30.5%
Postprocedural eptifibatide34%0.09051%81%
Any postprocedural antithrombotic6681%<0.00113427%20035%
Procedure
Diagnostic cardiac2227%0.00724042%26245%
Interventional cardiac6073% 25752%31755%
Drug-eluting stents5365%<0.00121744%27047%
Closure device
Any4859%<0.00142285%47081%
Angioseala3879%0.72231975%35762%
Angioseal 6F2733% 27054%29751%
Angioseal 8F1113% 4910%6010%
Perclose 6F911% 10020%10919%
Starclose11% 3.6%40.7%
Right groin8199%0.04646293%54394%
Sheath size
4F710%0.474337%407%
6F6489% 41288%47682%
7F00% 1.2%10.2%
8F11% 235%244%
MeanSD MeanSDMeanSD
Age (years)63130.40862136213
Height (cm)168120.1331701117011
Weight (kg)90280.72591249125

COPD, chronic obstructive pulmonary disease; SD, standard deviation.

aCompares Angioseal vs. combined Perclose and Starclose.

Table II. Complications of arterial access for catheterization
Complicationsn%
Active bleeding1415%
Arteriovenous fistula11%
VCD bleeding910%
VCD failure67%
VCD embolism11%
Pseudoaneurysm78%
Retroperitoneal hematoma11%
Small hematoma (<3cm)3033%
Medium hematoma (3-6cm)1415%
Large hematoma (>6cm)78%
Closure device thrombosis22%

More than half of the patients (n=317, 55%) underwent interventional catheterization, with nearly half (n=270, 47%) receiving drug-eluting stents. A total of 470 VCDs were used (81% of all catheterizations). The use of any VCD was associated with a decreased risk of complications (p<0.001, Table I). However, there was no difference in complications between the three brands used (p=0.722, Table I).

Univariable analysis results are shown in Table I. After multivariable correction, use of anticoagulation and/or antiplatelet agents and coronary artery disease remained associated with an increased risk of complications, while use of a closure device and prior catheterization on the ipsilateral groin were protective (Table III). Including the propensity scores in the analysis caused no change in the variables associated with complications and only minimal change in the ORs.

Table III. Binary logistic regression showing factors associated with complications for all patients
FactorOR95% CIp
Coronary artery disease11.14.78-25.6<0.001
Prior catheterization0.0330.012-0.095<0.001
Intraprocedural clopidogrela2.981.21-7.300.017
Postprocedural heparin29.43.56-2500.002
Any closure device0.2630.125-0.553<0.001
Male gender0.4210.220-0.8050.009
Any preprocedural antithromboticb5.652.58-12.3<0.001
Any intraprocedural antithromboticc4.881.95-12.3<0.001

aAt doses of 300-600mg.

bClopidogrel, heparin, enoxaparin, coumadin, bivalirudin, integrillin, aspirin.

cBivalirudin, heparin, clopidogrel, enoxaparin, aspirin, eptifibatide.

When we further analyzed our population by splitting them into diagnostic and interventional catheterization groups, we found that use of antithrombotics was still associated with increased incidence of complications. Specifically, use of any preprocedural antithrombotic agent was associated with 10-fold increased OR of complications in patients undergoing diagnostic catheterization (Table IV) and both pre- and intraprocedural antithrombotic use was associated with twofold and a 24-fold, respectively, increased ORs of complications in the interventional group (Table V). In both groups, prior catheterizations and use of a VCD were protective (Table IV, Table V).

Table IV. Binary logistic regression showing factors associated with complications for diagnostic catheterization patients only
FactorOR95% CIp
Any preprocedural antithrombotica10.63.69-30.3<0.001
Prior catheterization0.0840.016-0.4560.004
Closure device0.3190.111-0.9130.033

aClopidogrel, heparin, enoxaparin, coumadin, bivalirudin, integrillin, aspirin.

Table V. Binary logistic regression showing factors associated with complications for interventional catheterization patients only
FactorOR95% CIp
Any preprocedural antithrombotica2.411.02-5.680.044
Any intraprocedural antithromboticb24.48.06-71.4<0.001
Prior catheterization0.1500.061-0.370<0.001
Closure device0.1380.036-0.5300.004

aClopidogrel, heparin, enoxaparin, coumadin, bivalirudin, integrillin, aspirin.

bBivalirudin, heparin, clopidogrel, enoxaparin, aspirin, eptifibatide.

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Discussion 

In our study, 82 of 579 (14%) patients suffered 92 complications after femoral arterial access for catheterization for percutaneous coronary intervention and diagnostic catheterization. The vast majority were hematomas or active bleeding. Our incidence rate was higher than that reported in other series (14% vs. ≤9% respectively)5, 6, 7, 8, 9, 10, 11, 12, 13 but lower than that (29-31%) reported by Rao et al.,20 likely because their and our definitions of complications included either Thrombolysis in Myocardial Infarction (TIMI) minimal or Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) mild bleeding or small hematomas (<3cm diameter) without major index hospitalization clinical sequelae. This category comprised 33% of the complications found in our study. Other studies required hematomas to be at least 5cm1 or even 10cm21, 22 in diameter. After excluding patients with small hematomas, we found 62 (11%) complications, still a higher incidence than that reported in previous studies.5, 6, 7, 8, 9, 10, 11, 12, 13 This may have been related to the high proportion of interventional procedures and the concomitant antithrombotic therapy, which are known to increase risk for complications.10

Bleeding complications after cardiac catheterization have been associated with increased risk of mortality. In a study by Yatskar et al.23 hematomas requiring transfusion after cardiac catheterization were associated with increased in-hospital and 1-year mortality. Ndrepepa et al.24 found the 1-year mortality among patients in whom bleeding, not just major bleeding but even minor or any bleeding, occurred within 30 days after percutaneous coronary intervention to be statistically significantly higher than in those who did not develop a bleeding complication. When the authors compared bleeding within 30 days of percutaneous coronary intervention to other variables, they found the former to have the highest hazard ratio, even when compared to myocardial infarction within 30 days and urgent revascularization within 30 days. Similarly, Rao et al.20 found that even TIMI minimal or GUSTO mild bleeding, which occurred in 13% and 19% of subjects, respectively, was associated with an increased risk of 30-day and 6-month myocardial infarction or death.

While previous studies have found several other factors to be associated with complications, such as failed closure device,21 renal failure,21, 25 peripheral vascular disease burden,2, 21 diabetes mellitus,16, 26 larger sheath size,2, 21, 26 duration of procedure,25 larger body mass index,26 and increased age,16, 21, 25 we did not find these factors to be significant. This may be related to different patient populations, operator skill, or the overwhelming effect of antiplatelet and anticoagulation medications on complication risk that dwarves other potential risk factors. We found, in agreement with other studies,16, 21 that being male was protective against complications, which could be explained by larger arteries and the inherent ease of finding and cannulating them. This suggests that the use of ultrasound to locate the artery and facilitate arterial cannulation should be evaluated for its ability to decrease complications.

After multivariable correction, antiplatelet or anticoagulation agents remained associated with an increased risk of complications in our study. Therapeutic use of clopidogrel, heparin, enoxaparin, integrillin, and bivalirudin immediately prior to or during the procedure was associated with higher risk of complications; postprocedural use of heparin was also associated with increased risk of complications. This agrees with studies that found therapeutic doses of heparin2, 13, 16 and IIb/IIIa inhibitor21, 27 to be associated with increased risk of complications.

Measuring the impact of antithrombotic (anticoagulation and antiplatelet) agents on the incidence of complications is difficult. The differences in types and dosing of antithrombotic agents across time periods make the comparison cumbersome. Studies performed before 199512, 13, 15, 16 do not reflect the widespread use of VCDs and glycoprotein IIb/IIIa inhibitors, thienopyridine drugs, low-molecular weight heparin, or bivalirudin.13, 16 With the introduction of drug-eluting stents in 2003 along with concomitant use of high-dose antithrombotic agents to prevent stent closure, older studies of complications based on the lesser anticoagulation associated with bare metal stents may no longer be applicable.12, 13 We collected data from a period of peak use of drug-eluting stents, and in that sense this better reflects the vascular complications associated with their current use. A recent study suggests that even higher loading doses of antiplatelet medicines than used in this study, particularly when administered before percutaneous coronary intervention to improve stent patency, may lead to an increase in catheterization site complications.28 Further studies will be needed to evaluate this possibility.

Patients with a diagnosis of coronary artery disease were more likely to have complications. This persisted after correction for other factors, including use of antithrombotics. This higher rate of complications previously described by other authors may be explained by the need for more complex coronary procedures in those with a diagnosis of coronary artery disease with repeated manipulation of the cannulation site.22, 26

We also found, as Applegate et al.21 did, that a history of catheterization at the same site was protective against complications. The scar tissue created around the site may be protective against significant extravasation after percutaneous interventions. It is also possible that knowledge of a patient having previous cannulations might make the operator more meticulous in technique. Further research is needed to clarify this point as it suggests that use of a VCD in patients at low risk for complications and prior previous ipsilateral catheterizations may not be warranted.

VCD use is a variable that had not been studied before 1995.13, 15, 16 We found the use of a VCD to be associated with a lower incidence of complications even after controlling for other risk factors. Nonetheless, 20% of the complications were related to VCDs, including arterial thrombosis, embolism, and failure of deployment. Our results differ from two studies that found an overall increased incidence of complications associated with VCD.29, 30 These studies were done shortly after VCDs entered the market. The learning curve for deployment and the earlier versions of such devices may lessen the applicability of these studies. In contrast, our finding of protection agrees with more recent studies21, 22, 25, 31 as device improvements and user familiarity and skills have developed over time.

There are no universally accepted indications for use of VCDs, and not every patient will benefit from them. Some studies allowed the operator to decide on VCD use and select the brand,1, 21, 27, 31, 32 introducing investigator bias, while another study25 describes routine use of VCDs in all percutaneous coronary interventions at their institution. We attempted to control for operator bias by using propensity analysis, which found that the use of VCD, and not recorded factors related to their use, was predictive of a lower rate of complications. Further studies will be needed to assess if VCDs should be used only in higher-risk patients and avoided in lower-risk patients, such as minimally anticoagulated patients with previous catheterization.

The limitations of our study include its retrospective nature, which introduces the possibility of incomplete data entry. However, puncture sites were routinely inspected by experienced registered nurses, who used a written protocol to document their findings in a standardized format within a dedicated cardiovascular unit. Additionally, data collection was done in a strict fashion by trained medical students and resident physicians. We also lacked hemoglobin levels. Some studies have suggested that drops in hemoglobin levels may be a significant complication.20, 24 However, these data were not uniformly available to us, but their inclusion would increase the number of complications in our study. Rao et al.20 found that bleeding, even when minimal or mild by clinical criteria, was associated with increased risk of 30-day and 6-month myocardial infarction and death. Another limitation is the fact that the catheterizations were conducted at one center by fellowship-trained, experienced cardiologists. Catheterizations performed by residents, fellows, or noncardiologists may have a different incidence of complications; and the findings of our study may not apply to other centers and operators. However, our study may be more applicable to the majority of centers that have no training program, where catheterizations are performed by cardiology attendings. Because patient follow-up was limited to the index hospitalization, complications that occurred once the patient was discharged and that were treated at outside hospitals were potentially missed. Finally, a standardized imaging study was not performed to screen for or to assess every complication. Hence, small complications felt to be clinically insignificant by the interventional cardiologist may have been missed, and the incidence of complications may be higher than recorded.

The major strength of our study is that it included a variety of VCDs and antiplatelet and anticoagulant drugs that may better reflect the current practice of most cardiologists.

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Conclusion 

With increasing numbers of complex coronary endovascular procedures and widespread use of high-dose multidrug antithrombotic therapy, femoral artery injuries will continue to be a risk to patients. Coronary artery disease, preprocedural and postprocedural use of high-dose antiplatelet and anticoagulation agents, and high-dose intraprocedural clopidogrel are all associated with an increased risk of femoral artery complications. Vigilant postprocedural monitoring and VCD use in high-risk patients may decrease the incidence of complications. The use of VCDs in male patients or those with previous ipsilateral catheterization might not be warranted after low-risk procedures.

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We thank the following persons for their assistance on this project: Paul Clark, MD; Varun Gupta, MD; David Allison, MD; and Natalie Singer, MD.

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PII: S0890-5096(09)00155-1

doi:10.1016/j.avsg.2009.06.025

Annals of Vascular Surgery
Volume 24, Issue 3 , Pages 328-335, April 2010

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