ARTICLE IN PRESS

doi:10.1510/icvts.2008.188623

Interactive CardioVascular and Thoracic Surgery 8 (2009) 353–358

www.icvts.org

ESCVS article - Vascular general

Femoral pseudoaneurysms post-cardiac catheterization
surgically treated: evolution and prognosis夞
Enrique M. San Norberto Garcı́a*, José-Antonio González-Fajardo, Vicente Gutiérrez,
Santiago Carrera, Carlos Vaquero

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Division of Vascular Surgery, Valladolid University Hospital, Valladolid, Spain

Received 29 July 2008; received in revised form 13 October 2008; accepted 14 October 2008

Abstract

Objectives: To analyze the postoperative complications of patients who have undergone surgical repair of femoral pseudoaneurysm after
cardiac catheterization. Design: Prospective study. Materials: Cardiovascular risk factors, related to surgery and cardiac catheterization
were collected prospectively in 79 patients from 2003 to 2006 in Valladolid University Hospital. The indications of surgery included necrosis
of adjacent soft tissue, rapid growth, infection, bleeding, hemodynamic instability or failure of the percutaneous treatment (US-guided
compression and US-guided percutaneous thrombin injection). Methods: Patient and management related predictors for 30-day outcome
were analyzed. Results: Fifty-six patients (56y79, 71%) experienced some type of postoperative complication, the most frequent being the
need for a transfusion. Infection (15y79, 19%) and dehiscence of the surgical wound (10y79, 12.7%) were the other two most common
complications. The mortality related to the intervention was 3.8% (3y79). The mean hospital stay was 32.5 days ("28.4 days). Significant
risk factors in logistic regression model were gender (Ps0.023, ORs9.66), 70 years old (Ps0.049, ORs0.15) and the concurrent use of
anticoagulation or antiplatelet therapy after the cardiac catheterization (Ps0.005, ORs0.03). Conclusion: Patients who undergo surgical
treatment of femoral pseudoaneurysm post-cardiac catheterization experience a high postoperative morbidity and hospital stay. Factors
such as female gender, age over 70 years and treatment with anticoagulants or antiplatelets increase the postoperative morbidity. A
seasonal influence was appreciated, with a higher frequency during the summer period.
䊚 2009 Published by European Association for Cardio-Thoracic Surgery. All rights reserved.

Keywords: Pseudoaneurysm; Cardiac catheterization; Surgical risk

1. Introduction The majority of studies about the surgical treatment of

this pathology w5–8x were performed in the early 1990s.
Vascular Interventional and Interventional Cardiology After more than ten years, these patients have not been
Laboratory have experienced remarkable advances in endo-
studied, in spite of the great advances which have taken
vascular techniques during the last few decades. The use
place, both in the technique of cardiac catheterization and
of an entry to the vascular tree constitutes an essential
part of the procedure. The commonly used arterial and in the treatment of critical patients. This article constitutes
venous approach is the femoral route. The most important an update on the evolution of patients submitted to a
group of technical complications is those related to the surgical repair of femoral pseudoaneurysms following
site of puncture, femoral pseudoaneurysms are the most cardiac catheterization.
frequent complication w1x.
The role of the surgery in the treatment of femoral
pseudoaneurysms has diminished since the development of 2. Materials and methods
less invasive therapeutic methods like echo-guided com-
pression, echo-guided thrombin injection or endovascular Between January 2003 and December 2006 we prospec-
repair w2–4x. This avoids the need for general or locore- tively recorded the data from every patient who experi-
gional anesthesia in a group of patients with a significant enced femoral pseudoaneurysm following cardiac
morbidity and who do not tolerate vascular reconstruction catheterization surgery in a database at the Angiology and
and bleeding. However, there still remain a subset of cases Vascular Surgery Division of the University Hospital of
in which open surgical repair is necessary. Valladolid. The diagnosis is usually straightforward and is
made on the combination of physical examination and
夞 Presented at the 57th International Congress of the European Society for duplex ultrasound findings. Ultrasound diagnostic criteria
Cardiovascular Surgery, Barcelona, Spain, April 24–27, 2008. were: an echolucent cavity on B-mode ultrasound exami-
*Corresponding author. CyRamón y Cajal n83, 47005, Valladolid, Spain.
Tel.: q34-686754618; fax: q34-983420000. nation, pulsatile expansion and contraction of the suspect-
E-mail address: [email protected] (E.M. San Norberto Garcı́a). ed echolucent area and bidirectional flow at the neck of
䊚 2009 Published by European Association for Cardio-Thoracic Surgery
 ARTICLE IN PRESS
354 E.M. San Norberto Garcı́a et al. / Interactive CardioVascular and Thoracic Surgery 8 (2009) 353–358

the pseudoaneurysm in systole and diastole. Intraarterial cal risk factors and 30-day overall complications and death
angiography was reserved for patients who experienced rate was assessed by univariate analysis using the x2 and
associated lower extremity ischemia. the Fisher exact test. The variables that positively associ-
A total of 79 patients were included in this analysis, 5371 ated with postoperative outcome at P-0.05 were selected
cardiac catheterizations were performed during the same for a multivariate analysis using forward stepwise logistic
period (incidence 1.47%), 57 (1.06%) were treated success- regression. Odds ratios (OR) and 95% confidence interval
fully by ultrasound-guided compression and 21 (0.39%) by (CI) were calculated. A risk factor was considered statis-
thrombin injection. Their mean diameter was 3.2 cm cally significant when P-0.05.
(range 1.4–7.3 cm). The indications for surgical repair
were: rapidly expanding pseudoaneurysm, infected pseu- 3. Results
doaneurysm (this diagnosis was supported by fever, leuko-
cytosis or positive blood cultures), distal ischemia caused Of the 79 patients treated, 32 were women and 47 men.
by local pressure of the pseudoaneurysm on the femoral The mean age was 70 years (47–87). The diagnosis of
artery, neuropathy caused by local pressure on the femoral femoral pseudoaneurysm after cardiac catheterization was

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nerve, jeopardized viability of soft tissues and the superad- made by duplex ultrasound in 88.6% of the cases, requiring
jacent skin, failure of percutaneous treatment (US-guided arteriography study only in the remaining 11.4%. Arterio-
compression and US-guided percutaneous thrombin injec- venous fistula accompanied the pseudoaneurysm in 13.9%
tion), previous history of allergic reaction to thrombin or of the cases. Indications of surgical treatment collected
bovine products, bleeding or hemodynamic instability. were: necrosis of soft tissues and skin adjacent to the
Demographic data such as age and gender were gathered pseudoaneurysm 32.9%, rapid growth 25.3%, infection 22.8%
in the registry. The presence of accompanying cardiovas- or failure of the percutaneous treatment 10.1%, shock 6.3%
cular co-morbidity (chronic coronary artery disease, arte- and femoral neuropathy 2.5%. Baseline characteristics and
rial hypertension, diabetes mellitus, hyperlipidemia) or of catheterization details are summarized in Table 1.
another type (respiratory insufficiency, renal insufficiency, The postinterventional treatment included antiplatelet
auricular fibrillation, peripheral arterial disease) was also therapy in 37 patients (56.7%, 22.4% aspirin and 34.3%
obtained. Data related to the nature of cardiac catheteri- aspirin plus clopidogrel), anticoagulation and antiplatelet
zation (diagnostic vs. therapeutic) as well as post-cathe- therapy in 19.2% (15y79) of the subjects and double anti-
terization anticoagulation or antiplatelet therapy were also coagulant and antiplatelet therapy in six patients. In four
incorporated into our analysis. Postoperative surgical and patients (5.5%), the IIbyIIIa receptor antagonist was used.
medical 30-day complications were also recorded. The Seventy-nine patients underwent 98 surgical procedures.
sheath size of the devices used in the diagnostic interven- Fig. 1 shows the various surgical techniques that were
tions was 5F and in therapeutics 6F and 7F. Arterial closure utilized. The most frequently performed procedure was
devices (Prostar䊛, Perclose Peripheral Vascular Surgery, direct closure and resection of the sac 84 (79.7%), followed
Menlo Park, USA) were used in all the therapeutic by patch angioplasty 9 (11.4%), bypass grafting 5 (6.3%) or
procedures. vein angioplasty 2 (2.5%). The operation was performed on
The surgical approach to the femoral arteries for a pseu- the same day of the diagnosis in 40.6% (32y79) of the cases
doaneurysm was direct and gentle. A longitudinal groin
incision over the femoral pulse was elected. Instead of Table 1
entering the hematoma, the surgeon carried the dissection Baseline characteristics of patients and catheterization technique

directly to the inguinal ligament, where the femoral artery Number %

or distal external iliac artery can be exposed and con-
trolled. If femoral artery thrombosis had occurred or if Total 79
Sex
arterial repair with a graft or patch angioplasty was deemed Female 32 40.5
necessary, a low dose of intravenous heparin (2000–3000 U) Male 47 59.5
was administered. After the femoral artery was clamped Hypertension 47 59.5
at the inguinal ligament, the hematoma could be incised Diabetes 13 16.5
Hyperlipidemia 23 29.1
and evacuated. The puncture site could be identified and
Coronary artery disease 38 48.1
controlled with finger pressure. Usually a simple suture was Atrial fibrillation 38 48.1
sufficient. Large hematoma cavities were drained with a Renal failure 5 6.3
closed suction catheter. A separate suprainguinal external PAD 15 18.9
iliac approach was necessary for control in patients because Catheterization
Diagnostic 44 55.7
of proximal injury, massive pseudoaneurysm, morbid obe- Therapeutic 35 44.3
sity, or extensive groin scarring (ns11). Most pseudoaneu- Cardiac disease
ryms could be repaired by simple suture of the arterial Coronary 39 49.4
puncture. A patch angioplasty was necessary if it appears Valvulopathy 17 21.5
CorqVal 16 20.3
that closure of the defect in the arterial wall would Therapeutics
compromise the lumen. General anesthesia was used in 42 Valvuloplasty 39 49.4
cases (53.2%) and regional anesthesia in 37 (46.8%). Electrophysiologic intervention 24 30.4
Statistical analysis was carried out using the SPSS 14.0 for PTCAyStent 10 12.7
Windows program (SPSS Inc., Chicago, IL, USA). The cor- PAD, peripheral artery disease; PTCA, percutaneous transluminal coronary
relation between potential factors cardiovascular or surgi- angioplasty.
 ARTICLE IN PRESS
E.M. San Norberto Garcı́a et al. / Interactive CardioVascular and Thoracic Surgery 8 (2009) 353–358 355

Table 2
Postoperative complications

Complication Number %

Blood transfusion 42 53
Infection
Without dehiscence of surgical wound 16 20.3
With dehiscence of surgical wound 10 12.7
Cardiac insufficiency 5 6.3
Respiratory insufficiency 4 5.1
Acute myocardium infarction 3 3.8
Acute renal insufficiency 3 3.8
Atrial fibrillation 2 2.5
Pneumonia 2 2.5
Aortic insufficiency 2 2.5
Septic shock 2 2.5
Bronchospasm 2 2.5

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Coagulopathy 2 2.5
Ventricular fibrillation 1 1.3
Endocarditis 1 1.3
Fig. 1. Surgical techniques.
Cholestasis 1 1.3
Atrial-ventricular block 1 1.3
Digestive hemorrhage 1 1.3
Hemoptysis 1 1.3
and within the following day in 12.5% (10y79). One case
Embolism 1 1.3
required the substitution of the arterial suture material to Death 3 3.8
a vein angioplasty following the initial repair and it was
necessary to carry out 18 postoperative surgical resections
of devitalized skin limits (22.8%). No amputations were Table 3
Age and hospital stay of patients with complications and no complications
required.
Seventy-one percent of the subjects underwent some type No complication P Complication
of 30-day perioperative complication. Necessity for blood
transfusion was the most frequent non-lethal complication Age
M 63.64 0.03 73.20
42 (53%), with a maximum of 10 red blood cell concentrates S.D. 9.17 7.79
and an average of more than one red blood cell concentrate Hospital stay
per patient affected. Infection without 16 (20.3%) and with M 16 0.0983 40
dehiscence of the surgical wound 10 (12.7%) were the other S.D. 8.85 31.24
two most common complications (Table 2). The cultures M, mean; S.D., standard deviation.
taken from the infected wounds were primarily polymicro-
bial infections 18 (22.8%) in comparison with monomicro- anticoagulation or antiplatelet therapy after cardiac cath-
bial 8 (10.1%). The most frequently isolated microorganisms eterization (Ps0.005, ORs0.03).
were E. coli, S. epidermidis and S. aureus. Patients with A histogram of frequencies during the study period showed
infected wounds were treated with 10 days of intravenous a seasonal influence, around the summer months, focused
antibiotics. The infection rate was not correlated with the on May and August, correlates with a higher incidence of
employment of percutaneous closure devices (Ps0.836). femoral pseudoaneurysm at the same period, without a
Three postoperative intervention related deaths occurred higher overall catheterization techniques volume during
(mortality: 3.8%). Of the expired patients, the cause of this interval (Fig. 2).
death was attributed to cardiac failure in a 59-year-old
patient, and another two of 67 and 68-year-olds expired
4. Discussion
due to septic shock related infected pseudoaneurysms.
The mean hospital stay of this series was 32.5 days This is the first study to report a prospective review of
("28.4 days). patients submitted to surgical repair of femoral pseudo-
Statistically significant differences were found in relation aneurysm after cardiac catheterization. This study aims to
to the length of hospital stay (Ps0.027) and the age of contribute new knowledge to this literature.
the patients (Ps0.031) who underwent a perioperative Oweida et al. w5x in 1990, analyzed patients with any
complication and those who did not (Table 3). No other vascular complication after cardiac catheterization, includ-
demographic differences were found between patients with ing arterial thrombosis or embolization and even a case of
or without complications after surgical repair. Higher rates mesenteric ischemia. In our opinion, the patients examined
of adverse outcome were found in patients with hyperten- in this study constitute groups with very different pathol-
sion (5.7 vs. 2.9%, Ps0.072); however, the difference did ogies and prognoses. Hence an exclusive study of the
not reach statistical significance. Univariate and multivar- patients with pseudoaneurysm is required.
iate logistic regression models of risk factors predicting 30- Patients with vascular complications or pseudoaneurysms
day complication rates are shown in Table 4. Strong related to the use of an intraaortic balloon pump have also
independent predictors were female gender (Ps0.023, been excluded from this study in light of their severely
ORs9.66), age over 70 years (Ps0.049, ORs0.15) and depressed cardiac function and grim prognosis, making it
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356 E.M. San Norberto Garcı́a et al. / Interactive CardioVascular and Thoracic Surgery 8 (2009) 353–358

Table 4
Risk factors as independent factor for perioperative overall morbidity

Variable Univariate analysis Multivariate analysis

P OR (95% CI) P OR (95% CI)

Female 0.001 0.05 (0.06–0.42) 0.023 9.66 (1.37–68.23)

)70 years 0.010 6.33 (1.45–27.74) 0.049 0.15 (0.02–1.08)
AnticoagulantyAntiplatelet therapy 0.023 0.20 (0.46–0.85) 0.005 0.03 (0.00–0.34)
Anticoagulant therapy 0.654 0.74 (0.19–2.81)
DiagnosticyInterventional 0.885 1.01 (0.31–3.92)
Catheter size 0.231 0.05 (0.01–2.93)
Previous procedure through same femoral 0.351 1.34 (0.04–4.21)
Fibrinolytic therapy 0.771 2.34 (0.08–3.02)
Coronary artery disease 0.763 0.82 (0.23–2.96)
Hypertension 0.072 3.26 (0.87–12.11)
Diabetes mellitus 0.667 0.71 (0.14–3.47)

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Hyperlipidemia 0.975 1.02 (0.25–4.13)
Chronic renal insufficiency 0.228 0.03 (0.01–4.16)
Atrial fibrillation 0.321 2.32 (0.53–10.04)
Peripheral artery disease 0.428 0.48 (0.11–2.16)

OR, odds ratio; CI, confidence interval.

complications after surgical repair of femoral pseudoaneu-

rysm after a cardiac catheterization, were evaluated in our
study.
The morbidity experienced by patients in our study is
greater than in the morbidity reported in other
publications. In our study the need for transfusion has been
considered a perioperative complication which increases
our incidence of perioperative morbidity to 71%. The most
noteworthy postoperative complication of surgical repair is
its requirement of blood transfusion. If we excluded the
need for transfusion as a complication the percentage,
however, remains high, reaching 46%. The morbidities pub-
lished in prior studies range from 7.4 to 31.7% w5,10,13x.
This large disparity is explained by the lack of unanimity
in criteria for the registration of any complications. A
complication that has been commented on in these articles
has been the need for amputation of the affected member
in some cases. In the study by Messina et al. there were
up to three amputations. Unlike our study, the Messina
study analyzed all vascular complications after cardiac
catheterization, not only those with pseudoaneurysms, and
in these patients, although it is not detailed, the respon-
sible pathology is likely ischemia of the member in ques-
Fig. 2. Seasonal distribution of femoral pseudoaneurysm post-cardiac cath- tion. The mortality observed in our study reached 3.8% of
eterization surgically treated. the subjects. Mortalities of 7.9% have been reported in
prior studies amongst patients who have undergone thera-
peutic catheterizations w10x.
impossible to objectively and clearly differentiate surgical The only publication that established clear difference
morbidity from the patient’s underlying pathology w9x. among patient groups was that of Messina et al. w6x pub-
The published literature has identified several variables lished in 1991, in which 64 patients are considered inter-
that are responsible for a greater risk of peripheral vascular vened after a diagnostic catheterization and 37 after a
complications after cardiac catheterization. Such risks therapeutic procedure. In their analysis, morbidity differ-
include increasing age, female gender, fibrinolytic therapy, ences (27% as opposed to 19%) and mortality differences
postprocedural anticoagulation w5x or the procedure being (2.7 and 7.9%, respectively), were observed between both
diagnostic or interventional w6, 10–12x. Other variables groups. No statistical study between both groups was car-
have been studied with heretofore unjustified validity, ried out. Technical advances during the last years have
including hypertension, diabetes, catheter size, peripheral developed therapeutic sheaths with smaller diameters,
vascular arteriopathy, hemodialysis or a previous history of closer to the size of diagnostic devices.
another percutaneous procedure through the same vascular Results demonstrate that female patients, age over 70
entry w11x. All these risk factors, in the development of years and treatment with anticoagulants or antiplatelets
 ARTICLE IN PRESS
E.M. San Norberto Garcı́a et al. / Interactive CardioVascular and Thoracic Surgery 8 (2009) 353–358 357

are at higher risk for adverse outcomes following surgical w6x Kresowik TF, Khoury MD, Miller BV, Winniford MD, Shamma AR, Sharp
WJ, Blecha MB, Corson JD. A prospective study of the incidence and
repair of femoral pseudoaneurysm after cardiac catheter-
natural history of femoral vascular complications after percutaneous
ization. The explanation for the increased risk in most transluminal coronary angioplasty. J Vasc Surg 1991;13:328–333.
elderly patients may be related to age related changes in w7x Lumsden AB, Miller JM, Kosinski AS, Allen RC, Dodson TF, Salam AA,
the arterial wall associated, mediated by increasing calci- Smith RB 3rd. A prospective evaluation of surgically treated groin
fication and loss of elastin w14x. Careful monitoring of complications following percutaneous cardiac procedures. Am Surg
1994;60:132–137.
physical findings and ultrasound examination is recom- w8x Carere RG, Webb JG, Ahmed T, Dodek AA. Initial experience using
mended in these patients to offer early non-invasive treat- Prostar: a new device for percutaneous suture-mediated closure of
ment procedures as ultrasound-guided compression or arterial puncture sites. Cathet Cardiovasc Diagn 1996;37:367–372.
thrombin injection. The radial approach offers a safer w9x Franco CD, Goldsmith J, Veith FJ, Calligaro KD, Gupta SK, Wengerter
alternative to femoral access in selected patients. KR. Management of arterial injuries produced by percutaneous femoral
procedures. Surgery 1993;113:419–425.
Our study has several limitations. One limitation is the w10x Messina LM, Brothers TE, Wakefield TW, Zelenock GB, Lindenauer SM,
fact that this study is a post-hoc analysis on a prospectively Greenfield LJ, Jacobs LA, Fellows EP, Grube SV, Stanley JC. Clinical
compiled database. Another limitation is the use of differ- characteristics and surgical management of vascular complications in

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ent surgical techniques in this study. Additionally, our study patients undergoing cardiac catheterization: interventional versus diag-
has a relatively low prevalence of diabetes (13%) and nostic procedures. J Vasc Surg 1991;13:593–600.
w11x Morgan R, Belli AM. Current treatment methods for postcatheterization
follow-up time is low (30 days). Furthermore, the popula- pseudoaneurysms. J Vasc Interv Radiol 2003;14:697–710.
tion constitutes a selective group of patients who could not w12x Khoury M, Rebecca A, Greene K, Rama K, Colaiuta E, Flynn L, Berg R.
undergo percutaneous repair of the pseudoaneurysms and Duplex scanning-guided thrombin injection for the treatment of iatro-
were therefore relegated to surgery. In spite of these genic pseudoaneurysms. J Vasc Surg 2002;35:517–521.
w13x Ricci MA, Trevisani GT, Pilcher DB. Vascular complications of cardiac
limitations, our findings, which were obtained in a large
catheterization. Am J Surg 1994;167:375–378.
number of consecutive, unselected patients, provide suffi- w14x Wixon CL. Hemodynamics. In: Hallett JW Jr, Mills JL, Earnshaw JJ,
cient support for our conclusions. Reekers JA. Comprehensive vascular and endovascular surgery. Edin-
The technical procedure of cardiac catheterization by burgh: Mosby, 2004;9–15.
femoral route takes time, in accordance with a learning w15x Wyman RM, Safian RD, Portway V, Skillman JJ, McKay RG, Baim DS.
curve to attain a pre-defined level of proficiency w15, 16x. Current complications of diagnostic and therapeutic cardiac catheteri-
zation. J Am Coll Cardiol 1988;12:1400–1406.
The finding of a maximum incidence of pseudoaneurysms w16x Schaub F, Theiss W, Busch R, Heinz M, Paschalidis M, Schömig A.
postcatheterization in the summer vacation period, urges Management of 219 consecutive cases of postcatheterization pseudo-
thoughtful search of possible justifications. A possible rea- aneurysm. J Am Coll Cardiol 1997;30:670–675.
son for this finding is the fact that it is a specialized
multidisciplinary technique. Previous to the puncture, eComment: Follow-up for femoral pseudoaneurysms
norms of asepsis and antisepsis are required to maintain to
Author: Narcis Hudorovic, Department for Cardiovascular Surgery, Uni-
prevent infection; especially when devices for percutane-
versity Hospital Sestre Milosrdnice, Zagreb, Croatia
ous suture are implanted. Post-procedurally, an adequate doi:10.1510/icvts.2008.188623A
compression as well as of the patient are important factors. I really appreciate the fascinating article by San Noberto Garcia and co-
In our opinion, these multiple factors that affect the workers w1x.
integrity of the femoral vessels after a catheterization The authors stated that there is a maximum incidence of femoral pseudo-
aneurysms post cardiac catheterization in the summer vacation period, and
exist, making this procedure a multidisciplinary technique
that this finding urges thoughtful search of possible justifications.
with a steep learning curve. Periodic review of these When we started to investigate satisfaction between cardiovascular surg-
complications may help identify additional factors that can eons and co-operating cardiologists in order to define the most frequent
be modified to reduce them. postcatheterization complications needing surgical repair in the aim to
In conclusion, female gender, increasing age and antico- implement a quality management system according to EN ISO 9001:2000 w2x
at the University Clinic Cardiovascular Department (UCCD) in 2004 w3x, 1410
agulant or antiplatelet therapy, have an adverse influence follow-up consultations of postcatheterization patients took place over a
on the 30-day morbidity and complications of patients one-year period. Our findings revealed that middle grade cardiologists dealt
submitted to surgical repair of femoral pseudoaneurysms with 58% of the catheterizations while young specialists performed 33% of
after cardiac catheterization. Additional studies will be the catheterizations. When we analyzed the workload split (young specialist
– middle grade professor), it was evident that the postcatheterization
needed to expand the existing literature and thus improve
femoral pseudo-aneurysms predominantly persisted after the procedure had
the perioperative management of the affected population. been performed by young specialists.
It was notable that 96% of the catheterization procedures during the
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