DOI: 10.1148/radiol.2402050907
(Radiology 2006;240:597-602.)
© RSNA, 2006
Vascular and Interventional Radiology |
Prediction of Iatrogenic Pseudoaneurysm after Percutaneous Endovascular Procedures1
Wolfgang Mlekusch, MD,
Markus Haumer, MD,
Irene Mlekusch, PhD,
Petra Dick, MD,
Sabine Steiner-Boeker, MD,
Andrea Bartok, MD,
Schila Sabeti, MD,
Markus Exner, MD,
Oswald Wagner, MD,
Erich Minar, MD and
Martin Schillinger, MD
1 From the Departments of Internal Medicine II, Division of Angiology (W.M., M.H., I.M., P.D., S. Steiner-Boeker, A.B., S. Sabeti, E.M., M.S.) and Medical and Chemical Laboratory Diagnostics (M.E., O.W.), Vienna General Hospital, Medical University, Währinger Gürtel 18-20, A-1090 Vienna, Austria. Received June 1, 2005; revision requested July 29; revision received August 9; accepted September 7; final version accepted October 4.
Address correspondence to W.M. (e-mail: wolfgang.mlekusch{at}meduniwien.ac.at).
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ABSTRACT
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Purpose: To prospectively evaluate the accuracy of using physical examination to identify puncture-related groin pseudoaneurysms, as assessed by using duplex ultrasonography (US), after percutaneous transluminal procedures and to prospectively evaluate the association between preinterventional platelet count, antiplatelet medication, and the occurrence of pseudoaneurysms.
Materials and Methods: This study was approved by the local ethics committee, and informed consent was obtained from all patients. The study prospectively included 273 consecutive patients (161 men, 112 women; age range, 34–90 years) who were referred for duplex US evaluation of the inguinal arterial puncture site 1 day after endovascular procedures. Prior to duplex US, all patients underwent physical examination of the groin. In addition, clinical characteristics and preinterventional laboratory parameters were assessed. Statistical significance was determined by using 
2 tests, the Fischer exact test, and unpaired t tests.
Results: Twenty-three pseudoaneurysms were found in 273 patients by using duplex US. Pulsatile groin masses that were detected at physical examination were used to correctly identify all pseudoaneurysms (positive predictive value, 100%; negative predictive value, 100%). Painful pulse palpation had a slightly lower predictive power (positive predictive value, 92% [95% confidence interval: 81%, 100%]; negative predictive value, 100% [95% confidence interval: 100%, 100%]). Other clinical parameters, such as the presence of superficial hematomas, systolic bruits, or nonpulsatile groin masses, had no adequate predictive properties. Interobserver agreement was excellent between observers (97% agreement [95% confidence interval: 92%, 100%]). All patients with pseudoaneurysms had a preprocedural platelet count of less than 200 x 109/L. No subacute complications were observed at the access site in patients with a platelet count of more than 200 x 109/L.
Conclusion: Physical examination revealed sufficient predictive capability in facilitating the identification of iatrogenic pseudoaneurysms after percutaneous vascular procedures. A platelet count of less than 200 x 109/L was associated with high predictive capability, thereby warranting further assessment in a larger series of patient.
© RSNA, 2006
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INTRODUCTION
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Arterial puncture for angiography and interventional procedures involves considerable risk of access site complications (1,2). Local complications, such as dissection, arteriovenous fistula, hematoma, and pseudoaneurysm, have been reported to occur for 1%–6% of percutaneous vascular procedures (2–6). Due to the increasing number of percutaneous vascular interventions and the widespread use of aggressive antithrombotic regimens, the rates of hemorrhagic complications at the vascular access site have been reported to increase (7–9). In particular, pseudoaneurysms can rupture and cause massive bleeding, which may lead to considerable morbidity and costs if appropriate treatment is delayed (10).
The examination of the vascular access site after percutaneous vascular interventions before patient discharge and the identification of occult pseudoaneurysms is becoming increasingly recognized as a matter of utmost importance (6). For routine clinical practice, color-coded duplex ultrasonography (US) is suggested to be the reference standard for assessing the vascular access site after arterial puncture (6,11–13). Although noninvasive, US examinations can be time consuming and can add to the overall cost of the procedures. The prognostic value of physical examination in the diagnosis of iatrogenic pseudoaneurysms has not been unequivocally assessed because diagnostic accuracy was suggested only in a small series of patient (14–16).
Local hemostasis after arterial puncture is widely dependent on platelet-mediated actions. The role of platelet counts and antiplatelet medication in predicting puncture-related pseudoaneurysms in the groin has not been systematically evaluated in a larger patient series.
The purpose of our study was to prospectively evaluate the accuracy of using physical examination to identify puncture-related groin pseudoaneurysms, as assessed by using duplex US, after percutaneous transluminal procedures and to prospectively evaluate the association between preinterventional platelet count, antiplatelet medication, and the occurrence of pseudoaneurysms.
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MATERIALS AND METHODS
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We prospectively enrolled 273 consecutive patients (161 men, 112 women; median age, 68 years; age range, 34–90 years) in the study. Patients were referred to our US laboratory for evaluation of the arterial access site 24 hours after transfemoral intervention. A total of 199 consecutive patients were referred from the department of angiology after peripheral arterial interventions, and 74 patients were referred from the department of cardiology after percutaneous coronary interventions. The study was approved by the local ethics committee, and informed consent was obtained from all patients.
Patients
For all patients, assessment of the arterial access site with duplex US was routinely performed in the angiology department 1 day after percutaneous transluminal procedures. Assessments were made by one of three experienced sonographers (W.M., M.H., or S. Sabeti, with 6–13 years of experience) who were blinded to the results of physical examination. Cardiologists referred patients only in cases of difficult puncture or suspected complications. All 273 patients were willing to participate in the study and were included. Two independent investigators (P.D. and A.B., with 2 and 4 years of experience, respectively) worked in consensus and recorded each patient's medical history and current medications, with special attention to antiplatelet therapy and anticoagulant regimen. Puncture route (antegrade or retrograde), the size of the introducer sheath, heparin dose (5000 IU were usually used), platelet count, and the use of an arterial closure device were also recorded.
Study End Point
The study end point was the presence of a puncture-related pseudoaneurysm, as indicated at duplex US. A pseudoaneurysm was defined as a localized extravascular jet communicating with the artery through a fistula that exhibited the typical Doppler US "to-and-fro" flow pattern (11). Groin hematomas, which were defined as hypoechoic perivascular lesions at the access site that did not show signs of active blood flow at Doppler US, were not included in the study end point because there was no pending risk of rupture.
Access Site Management after Percutaneous Procedures
Routinely, arterial sheaths were removed after the patient returned to the inpatient ward from the interventional suite, and puncture sites were manually compressed until at least 5 minutes after bleeding had stopped, with an anticipated minimum compression time of 20 minutes (5). A compression bandage was then applied, and patients were advised to stay immobilized until the next morning after the procedure. In 72 patients, a vascular closure device was applied at the discretion of the interventionist. In these patients, bed rest for at least 4 hours after closure was recommended. Selection criteria for patients who were referred from the cardiology department were hematoma and patient-reported pain at the puncture site. No other selection criteria were systematically applied in these patients.
Groin Assessment
Every groin was assessed clinically by one of three experienced physicians (6–13 years of experience) prior to the duplex US examination. The presence of superficial hematomas, painful pulse palpation, pulsatile or nonpulsatile groin masses, systolic bruits, or diffuse induration were recorded and related to the results of color-coded duplex US. Three observers (W.M., M.H., S. Sabeti) performed all physical and US assessments. Interobserver agreement was excellent with respect to the detection of pseudoaneurysms at physical examination in an independent series of 10 patients who were verified as having pseudoaneurysms (97% agreement [95% confidence interval: 92%, 100%]).
Duplex US Examination
Color-coded duplex US was performed with a US system (XP128; Acuson, Mountain View, Calif) that was equipped with a 5-MHz linear array transducer. The arterial access site was visualized from the external iliac artery down to the midportion of the superficial femoral artery, with special attention to the femoral bifurcation. The maximum diameter of each pseudoaneurysm was determined and documented on transverse and longitudinal views.
Statistical Analysis
Metric data are presented as the median and interquartile range (from 25th to 75th percentile), and discrete data are given as counts and percentages. Univariate comparisons between groups were made by using 2 tests, the Fischer exact test, and unpaired t tests, as appropriate. Sensitivity, specificity, positive predictive value, negative predictive value, and 95% confidence intervals were calculated according to the standard formulas. Calculations were performed by using two commercially available statistical software programs (Stata, release 8.0, Stata, College Station, Tex, and SPSS for Windows, version 12.0, SPSS, Chicago, Ill).
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RESULTS
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Iatrogenic pseudoaneurysms were detected in 23 (8%) of 273 patients by using duplex US; this group comprised nine (5%) of 199 unscreened patients who were referred from the angiology department and 14 (19%) of 74 patients who were referred from the cardiology department. The average size of the pseudoaneurysm was 17 mm in maximum diameter (interquartile range, 13–25 mm). No other local complications, such as arteriovenous fistulas or dissections, were found during duplex US in these patients. Characteristics of patients with pseudoaneurysms and those without pseudoaneurysms are given in the Table.
Clinical Assessment
The presence of a pulsatile groin mass at physical examination was used to identify all cases of pseudoaneurysms without false-positive findings (positive predictive value, 100%; negative predictive value, 100%). Painful pulse palpation had a slightly lower predictive power (positive predictive value, 92% [95% confidence interval: 81%, 100%]; negative predictive value, 100% [95% confidence interval: 100%, 100%]; Fig 1). The presence of superficial hematoma, diffuse induration, or nonpulsatile groin mass was not useful in predicting or excluding iatrogenic pseudoaneurysms. Similarly, the presence of systolic bruits was not appropriate for facilitating the detection of pseudoaneurysms (Fig 1). These associations with clinical findings were not affected by the application of an arterial closure device (Table), which was used in a total of 72 patients. Closure devices included 23 Perclose applications (Abbott Laboratories, Abbott Park, Ill), 46 Angio-Seal applications (St Jude Medical, St Paul, Minn), and three CloSur P.A.D. applications (Medtronic, Minneapolis, Minn).
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Figure 1: Sensitivity, specificity, positive predictive value, and negative predictive value are shown, with 95% confidence intervals in parentheses, for each of the tested clinical parameters and for low platelet count (less than 200 x 109/L). Palpable pulsatile groin mass and low platelet count were 100% predictive for pseudoaneurysms after inguinal arterial puncture.
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Platelet Count and Puncture-related Pseudoaneurysms
Each patient's preinterventional platelet count was strongly associated with the occurrence iatrogenic pseudoaneurysms (P < .001; Table; Figs 1 and 2). Surprisingly, all patients with pseudoaneurysms had a platelet count of less than 200 x 109/L, and no pseudoaneurysms were found in patients with a platelet count of more than 200 x 109/L. This finding was consistent for patients with and those without arterial closure devices. Patients with pseudoaneurysms more frequently received an aggressive antithrombotic regimen; intravenously administered abciximab had a significant effect on the development of pseudoaneurysms, and treatment with clopidogrel also was a potential risk factor (Table). In 15 patients with pseudoaneurysms, a percutaneous injection of thrombin was performed successfully. Seven pseudoaneurysms resolved after applying a compression bandage for another 24 hours. Surgical repair of the pseudoaneurysm was necessary in one patient.
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Figure 2: Box plot demonstrates a statistically significant association for platelet count between patients with (n = 23) and those without (n = 250) pseudoaneurysms. The bar indicates the median, the boxes represent the interquartile range, and the whiskers are the total range. Note that all patients with pseudoaneurysms had platelet counts of less than 200 x 109/L.
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DISCUSSION
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Our findings, which were obtained in a large cohort of consecutive patients after percutaneous vascular procedures, indicate that clinical assessment of the vascular access site is a reliable and reproducible means of identifying iatrogenic pseudoaneurysms. We found that pulsatile groin masses and painful pulse palpation are potent indicators of this puncture-related complication. Evident superficial hematomas, diffuse induration, or systolic bruits were not helpful in the detection of pseudoaneurysms. Surprisingly, there was a very clear cutoff point with regard to platelet count (200 x 109/L) between patients with pseudoaneurysms and those without pseudoaneurysms.
The sensitivity and specificity of using physical examination to detect groin complications compared well with data published in smaller patient series (14–16). To our knowledge, however, ours was the first adequately powered study to assess the predictive value of various parameters of physical examination with acceptably small confidence intervals. Compared with color-coded duplex US results, pulsatile groin masses were 100% predictive of pseudoaneurysms without false-positive findings. US is currently considered the reference standard for evaluation of the arterial access site; however, US may also have its limitations under certain conditions (6,11–13). Nevertheless, for routine purposes it seems acceptable to rely on physical examination for the postinterventional evaluation of the puncture site and to perform confirmatory US only in patients with pulsatile groin masses (rather than performing mandatory US in every patient after percutaneous transluminal interventions).
Systolic bruits were not helpful in identifying iatrogenic pseudoaneurysms. We still believe, however, in the diagnostic value of the presence of bruits as a means of detecting other puncture-related complications, such as arteriovenous fistulas or dissection of the arterial wall, which were not found in our patient series.
Remarkably, all patients with pseudoaneurysms had a preprocedural platelet count of less than 200 x 109/L. Mechanical constriction, which is caused by the elastic properties of the arterial wall at the puncture hole after the removal of the sheath, and platelet aggregation are the key mechanisms of local hemostasis at the arterial access site (5,17). Low platelet counts are known to predict bleeding complications after vascular surgery (18). In this context, a strong association between low preprocedural platelet counts and the occurrence of pseudoaneurysms after arterial puncture seems clinically plausible.
Surprisingly, however, there was a very clear cutoff point at a platelet count of 200 x 109/L, which resulted in a predictive power of 100% for iatrogenic pseudoaneurysms. This potentially clinically useful predictor of complications has not been described previously and certainly needs validation in a larger independent cohort. If confirmed, it seems worth considering preventive measures for access site management, such as the use of dedicated closure devices in patients with low platelet counts. Unfortunately, the number of patients in the current study in whom a closure device was applied may have been too small to detect a relevant effect on complications in patients with low platelet counts. In previous studies, however, researchers have demonstrated no convincing beneficial effect of closure devices in unselected patients (19).
Considering the importance of platelet aggregation for local hemostasis, the association between antiplatelet medication and iatrogenic pseudoaneurysms was not unexpected. Combined platelet inhibition with acetylsalicylic acid and clopidogrel has been recognized as a risk factor for local hemorrhagic complications (20–22). Low platelet counts seem to be associated with pseudoaneurysms, regardless of exposure to antiplatelet agents.
We are aware of some limitations of our study. Only 72 patients were treated with an arterial closure device, which was not randomly applied. Stratification of patients according to the application of a closure device revealed virtually identical results, but a type II statistical error cannot be excluded. The inclusion of two patient groups is also a potential limitation of the study. Pulsatile masses and low platelet counts, however, showed a predictive accuracy of 100% in selected patients (cardiology department) and unselected patients (angiology department), thereby indicating the potential robustness of these parameters in clinical practice.
In conclusion, physical examination revealed sufficient predictive capability in facilitating identification of iatrogenic pseudoaneurysms after percutaneous vascular procedures. A platelet count of less than 200 x 109/L was 100% predictive of pseudoaneurysms, thereby warranting further assessment in a larger patient series. The latter observation in particular seems new and needs confirmation in an independent patient population.
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ADVANCES IN KNOWLEDGE
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- The presence of a palpable groin mass is 100% predictive of puncture-related pseudoaneurysms.
- A platelet count of less than 200 x 109/L is strongly associated with puncture-related pseudoaneurysms.
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FOOTNOTES
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Authors stated no financial relationship to disclose.
Author contributions: Guarantors of integrity of entire study, all authors; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, W.M.; clinical studies, all authors; statistical analysis, W.M., I.M., M.S.; and manuscript editing, W.M., M.H., I.M., E.M., M.S.
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ABSTRACT
INTRODUCTION
