Annals of Vascular Surgery
Volume 21, Issue 6 , Pages 704-712, November 2007

Ischemic Complications of Percutaneous Femoral Artery Catheterization

  • Paul M. Schumacher

      Affiliations

    • Department of Vascular Surgery, Vanderbilt University Medical Center, Nashville, TN
    • ,
  • Charles B. Ross

      Affiliations

    • Department of Vascular Surgery, Vanderbilt University Medical Center, Nashville, TN
    • Corresponding Author InformationCorrespondence to: Charles B. Ross, 1161 22nd Avenue South, D-5237 Medical Center North, Nashville, TN 37232-2735, USA
    • ,
  • Yi-Chen Wu

      Affiliations

    • Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN
    • ,
  • Rafe M. Donahue

      Affiliations

    • Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN
    • ,
  • Timothy J. Ranval

      Affiliations

    • Department of Vascular Surgery, Vanderbilt University Medical Center, Nashville, TN
    • ,
  • Jeffery B. Dattilo

      Affiliations

    • Department of Vascular Surgery, Vanderbilt University Medical Center, Nashville, TN
    • ,
  • Raul J. Guzman

      Affiliations

    • Department of Vascular Surgery, Vanderbilt University Medical Center, Nashville, TN
    • ,
  • Thomas C. Naslund

      Affiliations

    • Department of Vascular Surgery, Vanderbilt University Medical Center, Nashville, TN

Article Outline

Ischemic injuries following percutaneous femoral artery catheterization are uncommon but have been associated with vascular closure devices (VCDs). The purpose of this study was to retrospectively compare ischemic and hemorrhagic complications of femoral artery catheterization and to identify factors associated with ischemic injuries. The operative registries of the attending vascular surgeons at one academic and two community hospitals were retrospectively reviewed to identify all complications of femoral artery catheterization requiring operative intervention. Demographic, clinical, procedural, operative, and outcome data were compared between patients who sustained ischemic and hemorrhagic complications. From January 2001 to December 2006, 95 patients required operative management of complications related to femoral artery catheterization including 40 patients who experienced ischemic (group 1) and 55 patients who experienced hemorrhagic (group 2) complications. Compared to those sustaining hemorrhagic complications, ischemic complications were more frequently associated with younger age, smoking, VCD deployment, and, when controlling for VCD use, female gender. Time to presentation was also significantly longer in patients experiencing ischemic complications. Ischemic complications are increasingly recognized following femoral artery catheterization. Vascular surgeons should anticipate a new pattern of injury following femoral artery catheterization, one that often requires complex arterial reconstruction.

 

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Introduction 

Access site complications occur in up to 14% of patients following femoral artery catheterization.1, 2 Though a spectrum of complications have been observed after percutaneous femoral artery access, hemorrhagic complications, including bleeding, hematoma, pseudoaneurysm, and arteriovenous fistula, have predominated.3, 4 Recently, the challenges of access site management have been emphasized by more intense anticoagulant therapy and the introduction of more aggressive cardiac and peripheral vascular interventions.

Following percutaneous intervention, manual compression has traditionally achieved effective arterial hemostasis at the femoral access site. However, manual compression is associated with a number of disadvantages, including prolonged immobilization, increased resource utilization, hampered interventional suite efficiency, and excessive patient discomfort.5, 6 In an attempt to simplify management of the arterial access site and to alleviate the disadvantages of manual closure, a variety of percutaneous vascular closure devices (VCDs) have been developed and subsequently adopted by cardiac and peripheral vascular interventionalists. Prospective and retrospective clinical studies of closure devices have documented their apparent safety and efficacy in decreasing hemorrhagic access site complications while increasing patient comfort and facilitating ambulation and discharge.7, 8

However, since the introduction and broad application of VCDs, we and others have observed a transition from relatively minor hemorrhagic to complex ischemic injuries presenting as disabling claudication, ischemic rest pain, and progression of previously stable, mildly symptomatic peripheral arterial disease. Further, several reports have identified a significant proportion of ischemic complications associated with delayed clinical presentation.9, 10, 11, 12, 13, 14, 15

The purpose of this study was to retrospectively describe a series of ischemic and hemorrhagic complications following percutaneous femoral artery catheterization that required operative management. Moreover, the study aimed to identify factors associated with ischemic injury after percutaneous arterial access with particular emphasis on the contribution of VCDs.

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Materials and Methods 

From January 2001 to December 2006, the operative registries of the attending vascular surgeons at Vanderbilt University Medical Center (Nashville, TN) (C. B. R., J. B. D., R. J. G., T. C. N.) and Lourdes Hospital (C. B. R., T. J. R.) and Western Baptist Hospital (C. B. R., T. J. R.) (Paducah, KY) were retrospectively reviewed to identify all complications of percutaneous femoral artery catheterization requiring operative intervention. Qualified procedures were included regardless of the subspecialty of the interventionalist. Complications of arterial line or aortic balloon pump placement were excluded. Femoral pseudoaneurysms amenable to and successfully treated by percutaneous thrombin injection were also excluded from analysis. Data were primarily gathered by electronic chart review. Institutional review board approval was obtained to conduct the study.

Individual demographic data were collected including age, gender, height, and weight, from which body mass index (BMI, weight [kg] ÷ height [m2]) was computed. Relevant clinical data, including medical comorbidities and atherosclerotic risk factors were tabulated, including a history of smoking, diabetes mellitus, hyperlipidemia, hypertension, coronary artery disease (CAD), peripheral arterial disease (PAD), and chronic kidney disease (CKD, Cr >1.3 mg/dL).

Details of the catheterization procedure, including the indication for catheterization, type of intervention (whether diagnostic or therapeutic), sheath size, procedural complications, and the use of completion femoral arteriography, were cataloged. The method used to achieve arterial hemostasis at the access site was categorized as either application of manual compression or a VCD. When a VCD was used, information on the type of device was collected including its principal mechanism of action, whether active or passive, and complications associated with its use.

Clinical presentation was categorized as ischemic or hemorrhagic. Ischemic presentations were defined as intermittent claudication or rest pain and further categorized as early (<48 hr of catheterization), delayed (≥48 hr but <21 days of catheterization), or late (≥21 days of catheterization) presentations. Hemorrhagic presentations were similarly defined and included access site bleeding, pseudoaneurysm, arteriovenous fistula, or expanding groin or retroperitoneal hematoma. The method of diagnosis and technique of vascular reconstruction, whether simple or complex, were determined, as was the anatomic site of injury. The time from femoral catheterization to presentation as well as the length of follow-up were calculated. Morbidity, including need for amputation, and mortality related to the corrective operation were determined.

On the basis of clinical presentation, patients were assigned to group 1 (ischemic complications) or group 2 (hemorrhagic complications). Each group was compared to delineate differences in demographic, clinical, procedural, operative, and outcome data. Subgroup analysis of those who sustained ischemic complications was also performed.

Statistical analysis was performed with R (A Language and Environment for statistical computing, version 2.5.0, vienna, Austria). Numerical data were recorded as median and interquartile range (IQR). Categorical data were analyzed with Pearson's chi-squared test or Fisher's exact test. Continuous data were analyzed with analysis of variance. p < 0.05 was used to define statistical significance.

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Results 

From January 2001 to December 2006, 95 patients required operative management of complications related to percutaneous femoral arterial catheterization. Table I summarizes the baseline characteristics of the study population. A substantial proportion of the group possessed risk factors for atherosclerosis. Of note, PAD was present in 47% of patients.

Table I. Baseline characteristics of the study population
n95
Median age (years)67 (range 31-88)
Male31 (33%)
Median BMI (kg/m2)27.7
HTN81 (85%)
DM36 (38%)
HLP64 (67%)
CAD68 (72%)
PAD45 (47%)
CKD20 (21%)
Smoking53 (56%)

HTN, hypertension; DM, diabetes mellitus; HLP, hyperlipidemia.

Fig. 1, Fig. 2 represent the distribution of ischemic complications over the study period and contrast them to the distribution of concurrent hemorrhagic complications. During the study period, a progressive increase in the ratio of ischemic to hemorrhagic injuries was noted. In the first half of the study (2001-2003), ischemic complications composed 9% of all injuries. In the second half of the study (2004-2006), 56% of injuries were ischemic.

Femoral artery catheterizations were more frequently diagnostic than therapeutic (55% vs. 45%, respectively). The most frequent indication for percutaneous femoral artery catheterization was diagnostic or therapeutic coronary intervention (69%), followed by percutaneous lower extremity revascularization (11%), diagnostic arteriography (6%), renovascular intervention (6%), and cerebrovascular intervention (5%). One patient sustained an ischemic complication after hepatic chemoembolization. The median sheath size was 6F and was used in 64% of patients (range 5-8F); in only 16% of patients was a sheath size greater than 6F utilized. Completion femoral arteriography was documented in a minority of patients (23%). During the index procedure, 21% of study patients experienced an access site complication that was immediately recognized, most frequently including hematoma (7%), leg ischemia (5%), and arterial dissection (3%).

VCDs were employed in 60% of cases and by mechanism included both deep active (72%, n = 41) and passive (28%, n = 16) devices. Representative VCDs included Angio-Seal (St. Jude Medical, St. Paul, MN), Vasoseal (Datascope, Montvale, NJ), Perclose (Abbott Vascular, Redwood City, CA), Starclose (Abbott Vascular), and Duett (Vascular Solutions, Minneapolis, MN). Manual compression was performed in 35% of patients.

The most frequent clinical presentations for the entire study population included pseudoaneurysm (27%), ischemic rest pain (22%), expanding groin hematoma (20%), and claudication (20%). Presentations such as arteriovenous fistula, bleeding, and retroperitoneal hematoma occurred substantially less frequently. The median time to presentation following femoral catheterization was 2 days (IQR 0-5.5 days). Early presentations (<48 hr of catheterization) were observed in 48% of patients; in 52%, presentation was delayed beyond 48 hr and frequently beyond hospital discharge. Notably, 15% of the study population presented at least 3 weeks from the index catheterization.

Diagnostic tests were primarily noninvasive and included duplex ultrasound (40%), computed tomography (CT) and CT arteriography (22%), and conventional arteriography (17%). Standard open repair was achieved in 87% of patients, while in 13% of patients a combined open and endovascular approach was required. Most patients (52%) required a simple operative intervention; however, 41% of patients required complex arterial reconstruction. The most common site of anatomic injury was the common femoral artery (74%).

Median follow-up was 96 days (IQR 7-609 days). Complications related to the corrective operation occurred in 16% of patients, the majority of which were related to the operative wound. Limb salvage was achieved in all patients. Eight mortalities occurred, none of which was related to the corrective operation.

Forty patients (42%) presented with ischemic complications and were assigned to group 1. In contrast, 55 patients (58%) presented with hemorrhagic complications and were assigned to group 2. Table II 2 summarizes and compares the baseline characteristics of both groups. Compared to those who sustained hemorrhagic complications, patients who experienced ischemic complications were significantly younger (median age 60 vs. 70 years, p < 0.001), more likely to have a history of smoking (72% vs. 44%, p = 0.005), and less likely to have hypertension (75% vs. 93%, p = 0.02). Female patients were more frequently represented in the group experiencing ischemic complications, though this association did not reach statistical significance (78% vs. 60%, p = 0.07).

Table II. Comparison of baseline characteristics by group
Baseline characteristicsGroup I (n = 40)Group II (n = 55)p
Median age (years)6070<0.001
Female78%60%0.07
BMI (m/kg2)27.628.10.48
HTN75%93%0.02
DM32%42%0.36
HLP72%64%0.36
CAD70%73%0.77
PAD48%47%0.98
CKD18%24%0.47
Smoking72%44%0.01

HTN, hypertension; DM, diabetes mellitus; HLP, hyperlipidemia.

Among those who sustained ischemic complications, presentation was nearly equally distributed between claudication (48%) and ischemic rest pain (52%). Among those who experienced hemorrhagic complications, pseudoaneurysm (47%) and expanding groin hematoma (35%) predominated. No significant differences existed between groups in indication for catheterization, purpose of catheterization, interventional procedure performed, sheath size, occurrence of intraprocedural complications, or performance of a completion femoral arteriogram.

VCDs were more commonly utilized in patients who sustained ischemic complications (78% vs. 50%, respectively; p = 0.002). Conversely, manual compression was more frequently performed in those who sustained hemorrhagic complications (50% vs. 18%, respectively; p = 0.002). When specific closure devices were analyzed after group stratification, the majority of ischemic injuries in group 1 was associated with active closure devices (84%), specifically Angio-Seal, while both active and passive devices accounted for hemorrhagic injuries in group 2 (58% vs. 43%, respectively). The distribution of the other representative devices was similar between the groups (Table III).

Table III. Comparison of VCDs by group
Vascular closureGroup I (n = 40)Group II (n = 55)p
Manual compression7 (18%)26 (50%)<0.01
VCD31 (78%)26 (50%)<0.01
Active
AngioSeal20 (65%)10 (39%)
Perclose5 (16%)4 (15%)
StarClose1 (3%)1 (4%)
Passive
VasoSeal4 (13%)10 (39%)
Duett1 (3%)1 (4%)

Time to presentation following femoral catheterization was significantly longer in those who suffered ischemic complications (median 4.5 days vs. 1 day, p = 0.006). When time to presentation was stratified by closure device, 70% of patients whose access site was closed with Angio-Seal and nearly half of patients closed with Perclose (44%) and Vasoseal (47%) presented at least 48 hr after catheterization. Similarly, 25% of patients in group 1 presented at least 30 days from catheterization, while 75% of patients in group 2 presented by postprocedural day 4 (Fig. 3).

Ischemic presentations more frequently required complex operative repair (100% vs. 2%, p < 0.001) and hybrid open and endovascular operations (30% vs. 0%, p < 0.001) (Table IV). Hybrid procedures employed adjunctive angioplasty and stenting to manage endarterectomy end points in the external iliac and superficial femoral arteries. The anatomic site of arterial injury, however, was similar between groups and most frequently involved the common femoral artery.

Table IV. Comparison of operative management by group
Operative managementGroup I (n = 40)Group II (n = 55)p
Method of repair <0.001
Open28 (70%)55 (100%)
Open/endovascular12 (30%)0
Complexity of repair <0.001
Simple
Lateral arteriorrhaphy049 (89%)
Arteriovenous fistula ligation05 (9%)
Complex
Embolectomy2 (5%)0
Thromboendarterectomy/patch angioplasty25 (63%)1 (2%)
Balloon angioplasty/stent implantation11 (28%)0
Interposition graft5 (13%)0

Complications of the corrective operation were similar between groups. Local wound complications represented the majority of complications and occurred in 13% of patients. No patient required amputation. No significant difference in mortality was observed between groups.

Group 1 was further analyzed to identify variables associated with ischemic injuries when a VCD was used for access site management. Patients in group 1 whose access site was managed with a VCD were more likely to be female (odds ratio = 1.96, p = 0.02) and to have delayed presentation (odds ratio = 1.74, p = 0.01) than those whose access site was managed with manual compression. Other examined variables were not significantly associated with VCD use and the presence of an ischemic complication (Table V).

Table V. Group 1 subanalysis: factors associated with ischemic injuries after closure device use
VariableVCDNo VCDp
Younger (than group median, 67 years)74%56%0.41
Female88%44%0.01
Overweight (BMI >27 kg/m2)48%33%0.48
HTN71%89%0.40
DM32%33%1.00
HLP81%44%0.08
CAD68%78%0.70
PAD45%56%0.71
CKD16%22%0.65
Smoking71%78%1.00
Sheath size (>6F)7%17%0.46
Interventional procedure41%14%0.39
Delayed presentation (≥2 days)74%22%0.01

HTN, hypertension; DM, diabetes mellitus; HLP, hyperlipidemia.

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Discussion 

Lower extremity ischemic complications following percutaneous femoral artery catheterization are increasingly recognized events. Our series suggests that ischemic complications may present in a delayed manner and that certain clinical factors may predict their occurrence. Moreover, our study has documented the emergence of complex ischemic injuries following catheterization that appear to parallel the introduction and broad utilization of VCDs.

Clinical studies, including two meta-analyses and several large prospective randomized trials, have investigated the safety and efficacy of VCDs primarily following diagnostic and therapeutic coronary intervention. In the Suture to Ambulate and Discharge (STAND) I and II trials, Baim and colleagues8 conducted two prospective, randomized trials to evaluate the safety and efficacy of a suture-mediated closure device (Techstar and Prostar Plus, Abbott Vascular) for management of the femoral access site. The investigators determined that, when compared to manual compression, immediate hemostasis and reduced time to ambulation were successfully achieved with the closure device without significantly increasing the risk of local vascular complications. No patient specifically suffered an ischemic injury, though patients with significant PAD were excluded. The Perclose Accelerated Ambulation and Discharge (PARADISE) I and II trials achieved similar results.9, 10 Eggebrecht and colleagues11 described a prospective series of 1,317 consecutive patients in whom an Angio-Seal device was deployed for vascular closure. They reported immediate hemostasis in >90% of patients and a major complication rate of 0.53%, approximately half of whom sustained ischemic arterial injuries. Notably, patients with PAD were also excluded from the study. A myriad of other VCDs have been marketed and boast similar safety and efficacy profiles.10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Notwithstanding, a number of case series and retrospective reports have chronicled the emergence of complex ischemic injuries associated with VCDs. In 1999, Gonze and associates21 published one of the first studies reviewing complications associated with percutaneous femoral artery closure devices. In 408 patients in whom the devices were employed, 2.5% sustained complications, two of which were ischemic and associated with the Angio-Seal device. Similarly, Eidt and colleagues22 discovered a significantly increased rate of arterial occlusive complications compared to manual compression following access site closure with the Angio-Seal device. In a study comparing VCDs with manual compression, Boston and associates23 identified five episodes of limb ischemia associated with closure devices, a rate significantly greater than that observed with manual compression. A host of case series reflects similar clinical experiences.24, 25, 26, 27, 28 Our series has also documented a preponderance of ischemic complications paralleling an increase in closure device use. During the first half of our study, ischemic complications accounted for 9% of all access-related complications requiring operative repair. In the latter half of the study, however, limb ischemia represented 57% of access-related complications requiring operative attention, the majority of which were related to closure devices (Fig. 1, Fig. 2).

VCDs produce a recognizable injury pattern that often requires complex arterial reconstruction. Sprouse and associates29 commented on a retrospective review of peripheral vascular complications associated with percutaneous suture-mediated closure devices and found that, in patients whose access site was managed with a closure device, more extensive surgical treatment was required. Similarly, Nehler and associates30 concluded, after evaluating eight patients who sustained complications of percutaneous suturing devices, that vascular injuries produced by these devices often require complicated arterial repair and may possess a finite risk of actual limb loss. Our series has corroborated the findings of these investigators. Patients who experienced ischemic complications more often required a complex corrective operation and more frequently underwent a hybrid open and endovascular repair. Though postoperative complications and limb salvage were similar in both groups, the intangible morbidity and resource expenditures associated with ischemic injuries were not inconsequential.

Previous reports have attempted to identify populations at increased risk for adverse events following femoral artery catheterization, particularly with the application of a VCD. Factors that have been associated with adverse events following femoral artery catheterization include advanced age,31, 32, 33 female gender,22, 24, 34, 35, 36 sheath size,35 interventional procedure,37 arterial access location,32 PAD,33 and the use of a VCD, particularly those whose mechanism incorporates a collagen plug device.35, 38, 39 Warren and associates40 additionally suggest that a learning curve exists for VCD use and may predict local complications. To date, however, no data exist describing factors specifically associated with ischemic arterial injuries. Our study indicates that younger age, smoking, and the use of a VCD are factors more frequently associated with ischemic than hemorrhagic complications that require operative therapy. Similarly, our series suggests that female gender may be associated with ischemic injuries, particularly those in which a VCD is employed.

Discrepancies between the results of our series and the literature deserve discussion. First, our study fails to implicate sheath size or interventional procedure as variables more frequently associated with ischemic or hemorrhagic complications. Analysis of group 1 similarly identified no association between VCD deployment and sheath size or interventional procedure (Table V). This observation is likely related to a progressive reduction in device dimensions and, thus, sheath size for most cardiac and peripheral vascular interventions. That the median sheath size in our cohort was 6F further supports this conclusion. The association of younger age with ischemic complications is concerning and has not been previously reported. Younger females may be predisposed to ischemic injuries because of smaller arterial diameter. In our study, 52% of females, but only 30% of males, who experienced ischemic complications were younger than 60 years. This observation requires validation in a prospective study. We were unable to confirm an association between PAD and ischemic complications following catheterization. This discrepancy is likely related to the relatively high proportion of PAD in both study groups (48% vs. 47%) and thus limits our ability to discriminate group differences. As closure devices gain popularity and as new models enter the clinical arena, risk factors for adverse events, particularly ischemic events, may evolve.

Delayed clinical presentation is characteristic of ischemic complications following femoral artery catheterization. Several interventionalists have reported presentations of intermittent claudication or ischemic rest pain occurring days to weeks after the index procedure.13, 14, 27, 41 Our series has particularly emphasized the delayed clinical presentation frequently associated with ischemic complications. In the present study, overall median time to presentation was 2 days and was significantly delayed in patients who sustained ischemic complications compared to hemorrhagic complications (4.5 days vs. 1.0 day). Several factors may account for this observed delay in presentation. Earlier ambulation and expedited hospital discharge, as well as delayed return to usual activity because of underlying cardiovascular disease, may hinder recognition of these injuries. Further, the arterial injury may initially remain asymptomatic, particularly in patients with PAD and collateral formation. Finally, the delay in presentation may relate to a progressive inflammatory response to thrombus or an intraluminal component of the closure device that with time may resolve or culminate in a symptomatic critical stenosis or occlusion. Thus, symptoms, and consequently recognition, of ischemic arterial injuries may not become apparent until late clinical encounters.

As discussed, the estimated rate of ischemic arterial injuries in a controlled interventional environment is consistently low (<1%). Investigative settings purposefully impose strict selection criteria and include experienced interventionalists to demonstrate the optimal benefit of the device under scrutiny. However, the incidence and detection of ischemic injuries in an uncontrolled, heterogeneous population likely differ substantially from those in a controlled clinical trial. Hence, the true incidence of ischemic arterial injuries in general practice may be underestimated. Factors responsible for underestimation may include asymptomatic or subtle presentations, institutional pressure to attain flawless procedural outcomes, misdiagnosis by physicians unfamiliar with ischemic complications of catheterization, exclusive management by the primary interventionalist, or failure to diagnose the complication because of lack of aggressive screening protocols or limited postinterventional clinical encounters. Heightened awareness and objective clinical assessment, including a thorough vascular examination, may confirm this hypothesis and allow early recognition of most ischemic injuries.

Interventionalists, especially those who use VCDs, must institute preventive measures against and vigilantly screen for access site complications. We advocate precise radiographic localization of the femoral head before arterial cannulation to increase the probability of an optimal puncture site. We believe that interventionalists should be familiar with closure device instructions for use and should recognize contraindications to device deployment, such as severe PAD, small arterial diameter (<5 mm), or suboptimal puncture site. In our practice, we routinely employ completion femoral arteriogram in the management of the arterial access site and selectively apply VCDs for hemostasis. Indeed, recent investigations question the use of VCDs following routine diagnostic catheterization.42, 43 We recommend that interventionalists perform and document a careful periprocedural pulse examination in every patient who undergoes percutaneous femoral artery catheterization. Optimally, the same practitioner should examine the patient to minimize interobserver variability. We propose that discrepancies in pulse examination or complaints of limb pain, particularly those suggestive of limb ischemia, undergo prompt and complete evaluation. Physicians engaged in postprocedural and follow-up encounters should specifically inquire about symptoms of new-onset claudication or ischemic rest pain. Similarly, progression of stable symptomatic PAD may signal an arterial injury and similarly demands investigation.

Several study limitations warrant discussion. First, our study is a retrospective, comparative series of ischemic and hemorrhagic complications that required operative intervention and is, thus, subject to selection and observational biases inherent to its design. For instance, several variables of the catheterization procedure were not documented in the medical record (e.g., technique of arterial puncture), precluding their inclusion in the analysis. Second, our data were compiled from a prospectively maintained operative registry and not from a catheterization databank. Thus, the total number of percutaneous femoral artery catheterizations during the study period is unknown, and we are unable to estimate the true incidence of and risk factors for ischemic injuries in our population, especially in regard to the application of vascular closure devices. Third, our study was likely influenced by referral bias, potentially contributing to an underestimation of ischemic injuries. Fourth, our relatively large experience with ischemic injuries may be attributable to practitioner variables unique to our study population, thus limiting the generalizability of our conclusions. The clinical judgment and manual skill, including learning curve, of the clinician, as well as preference for access site management, are potentially confounding factors.

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Conclusions 

Ischemic complications of percutaneous femoral artery catheterization are increasingly recognized events after cardiac and peripheral vascular intervention. The occurrence of ischemic complications requiring operative management is often delayed and may occur more commonly in females, smokers, younger populations, and those whose access site is managed with a VCD. We contend that interventionalists should selectively employ VCDs for access site management and should adhere to published instructions for use for each particular device. During immediate and delayed clinical encounters, interventionalists should specifically elicit complaints of new-onset limb ischemia or acceleration of stable symptomatic PAD. As the catheter-based armamentarium enlarges and management of the arterial access site evolves, vascular surgeons should anticipate a new pattern of injury following femoral artery catheterization, one that often requires complex arterial reconstruction.

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References 

  1. Muller DW, Sharmir KJ, Ellis SG, et al. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol. 1992;69:63–68
  2. Popma JJ, Satler LI, Pichard AD, et al. Vascular complications after balloon and new device angioplasty. Circulation. 1993;88:1569–1578
  3. Moscucci M, Mansour KA, Kent KC, et al. Peripheral vascular complications of directional coronary atherectomy and stenting: predictors, management, and outcome. Am J Cardiol. 1994;74:448–453
  4. Nasser TK, Mohler ER, Wilensky RL, et al. Peripheral vascular complications following coronary interventional procedures. Clin Cardiol. 1994;18:609–614
  5. Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001;13:354–362
  6. Bogart MA. Time to hemostasis: a comparison of manual versus mechanical compression of the femoral artery. Am J Crit Care. 1995;4:149–156
  7. Slaughter PM, Chetty R, Flintoft VF, et al. A single center randomized trial assessing use of a vascular hemostasis device vs. conventional manual compression following PTCA: what are the potential resource savings?. Cathet Cardiovasc Diagn. 1995;34:210–214
  8. Baim DS, Knopf WD, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: results of the Suture to Ambulate and Discharge (STAND I and STAND II) trials. Am J Cardiol. 2000;85:864–869
  9. Nasu K, Tsuchikane E, Sumitsuji S, et al. Clinical effectiveness of the Prostar XL suture-mediated percutaneous vascular closure device following PCI: results of the Perclose Accelerated Ambulation and Discharge (PARADISE) trial. J Invasive Cardiol. 2003;15:251–256
  10. Nasu K, Tsuchikane E, et al. The safety and efficacy of “pre-closure” utilizing the Closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the second Perclose Accelerated Ambulation and Discharge (PARADISE II) trial. J Invasive Cardiol. 2005;17:30–33
  11. Eggebrecht H, Haude M, Woertgen U, et al. Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients. Catheter Cardiovasc Interv. 2002;57:486–495
  12. Thalhammer C, Aschwanden M, Jeanneret C, et al. Symptomatic vascular complications after vascular closure device use following diagnostic and interventional catheterization. Vasa. 2004;33:78–81
  13. Kirchhof C, Schickel S, Schmidt-Lucke C, et al. Local vascular complications after use of the hemostatic puncture closure device Angio-Seal. Vasa. 2002;31:101–106
  14. Dregelid E, Jensen G, Daryapeyma A. Complications associated with the Angio-Seal arterial puncture closing device: intra-arterial deployment and occlusion by dissected plaque. J Vasc Surg. 2006;44:1357–1359
  15. Meyerson SL, Feldman T, Desai TR, et al. Angiographic access site complications in the era of arterial closure devices. Vasc Endovasc Surg. 2002;36:137–144
  16. The SEAL Trial Study Team. Assessment of the safety and efficacy of the DUETT vascular hemostasis device: final results of the Safe and Effective Vascular Hemostasis (SEAL) trial. Am Heart J. 2002;143:612–619
  17. Michalis LK, Rees MR, Patsouras D, et al. A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal, and Duett). Cardiovasc Intervent Radiol. 2002;25:423–429
  18. Hermiller JB, Simonton C, Hinohara T, et al. The StarClose vascular closure system: interventional results from the CLIP study. Catheter CardiovascInterv. 2006;68:677–683
  19. Abando A, Hood D, Weaver F, et al. The use of the Angio-Seal device for femoral artery closure. J Vasc Surg. 2004;40:287–290
  20. Mackrell PJ, Kalbaugh CA, Langan EM, et al. Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia?. J Vasc Surg. 2003;38:1305–1308
  21. Gonze MD, Sternbergh WC, Salartash K, et al. Complications associated with percutaneous closure devices. Am J Surg. 1999;178:209–211
  22. Eidt JF, Habibipour S, Saucedo JF, et al. Surgical complications from hemostatic puncture closure devices. Am J Surg. 1999;178:511–516
  23. Boston US, Panneton JM, Hofer JM, et al. Infectious and ischemic complications from percutaneous closure devices used after vascular access. Ann Vasc Surg. 2003;17:66–71
  24. Siani A, Schioppa A, Flaishman I, et al. Management of acute lower limb ischemia following percutaneous arterial closure device application: our experience. G Chir. 2006;27:119–122
  25. Biancari F, Ylönen K, Mosorin M, et al. Lower limb ischemic complications after the use of arterial puncture closure devices. Eur J Vasc Endovasc Surg. 2006;32:504–505
  26. Castelli P, Caronno R, Piffaretti G, et al. Incidence of vascular injuries after use of the Angio-Seal closure device following endovascular procedures in a single center. World J Surg. 2006;30:280–284
  27. Wille J, Vos JA, Overtoom T, et al. Acute leg ischemia: the dark side of a percutaneous femoral artery closure device. Ann Vasc Surg. 2006;20:278–281
  28. Jang JJ, Kim M, Gray B, et al. Claudication secondary to Perclose use after percutaneous procedures. Catheter Cardiovasc Interv. 2006;67:687–695
  29. Sprouse LR, Botta DM, Hamilton IN. The management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices. J Vasc Surg. 2001;33:688–693
  30. Nehler MR, Lawrence WA, Whitehill TA, et al. Iatrogenic vascular injuries from percutaneous vascular suturing devices. J Vasc Surg. 2001;33:943–947
  31. Konstance R, Tcheng JE, Wightman MB, et al. Incidence and predictors of major vascular complications after percutaneous coronary intervention in the glycoprotein IIb/IIIa platelet inhibitor era. J Interv Cardiol. 2004;17:65–70
  32. Sherev DA, Shaw RE, Brent BN. Angiographic predictors of femoral access site complications: implication for planned percutaneous coronary intervention. Catheter Cardiovasc Interv. 2005;65:196–202
  33. Piper WD, Malenka DJ, Ryan TJ, et al. Predicting vascular complications in percutaneous coronary interventions. Am Heart J. 2003;145:1022–1029
  34. Eggebrecht H, von Birgelen C, Naber C, et al. Impact of gender on femoral access complications secondary to application of a collagen-based vascular closure device. J Invasive Cardiol. 2004;16:247–250
  35. Tavris DR, Gallauresi BA, Dey S, et al. Risk of local adverse events by gender following cardiac catheterization. Pharmacoepidemiol Drug Saf. 2007;16:125–131
  36. Ratnam LA, Raja J, Munneke GJ, et al. Prospective nonrandomized trial of manual compression and Angio-Seal and Starclose arterial closure devices in common femoral punctures. Cardiovasc Intervent Radiol. 2007;30:182–188
  37. Messina LM, Brothers TE, Wakefield TW, et al. Clinical characteristics and surgical management of vascular complications in patients undergoing cardiac catheterization: interventional versus diagnostic procedures. J Vasc Surg. 1991;13:593–600
  38. Nikolsky E, Mehran R, Halkin A, et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol. 2004;44:1200–1209
  39. Koreny M, Riedmüller E, Nikfardjam M, et al. Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 2004;291:350–357
  40. Warren BS, Warren SG, Miller SD. Predictors of complications and learning curve using the Angio-Seal closure device following interventional and diagnostic catheterization. Catheter Cardiovasc Interv. 1999;48:162–166
  41. Shaw JA, Gravereaux EC, Winters GL, et al. An unusual cause of claudication. Catheter Cardiovasc Interv. 2003;60:562–565
  42. Rosenstein G, Cafri C, Weinstein JM, et al. Simple clinical risk stratification and the safety of ambulation two hours after 6 French diagnostic heart catheterization. J Invasive Cardiol. 2004;16:126–128
  43. Doyle BJ, Konz BA, Lennon RJ, et al. Ambulation 1 hour after diagnostic cardiac catheterization: a prospective study of 1009 procedures. Mayo Clin Proc. 2006;81:1537–1540

 Presented at the Annual Winter Meeting of the Peripheral Vascular Surgery Society, Steamboat Springs, CO, January 26-28, 2007.

PII: S0890-5096(07)00256-7

doi:10.1016/j.avsg.2007.05.001

Annals of Vascular Surgery
Volume 21, Issue 6 , Pages 704-712, November 2007

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