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Iatrogenic Femoral Pseudoaneurysms: Thrombin Injection after Failed US-guided Compression¹

¹ From the Departments of Radiology (D.P.B., R.G.S., P.A.) and Vascular Surgery (C.M.A.), Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215. Received March 10, 1999; revision requested April 27; revision received May 26; accepted July 12. Address reprint requests to D.P.B. (e-mail: dbrophy@caregroup.harvard.edu).

	Abstract

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Fifteen iatrogenic femoral pseudoaneurysms failed ultrasonography (US)-guided compression treatments. Despite concomitant antiplatelet or anticoagulation treatment, the 15 pseudoaneurysms were successfully and definitively treated without complication with US-guided thrombin injection. Results in this preliminary study suggest US-guided thrombin injection is a safe, expeditious, low-cost, and comfortable definitive treatment for femoral pseudoaneurysms that has advantages over both US-guided compression and open surgical repair.

Index terms: Aneurysm, femoral, 921.73 • Angiography, complications, 921.73 • Ultrasound (US), guidance, 921.12986, 921.73

	Introduction

TOP Abstract Introduction Materials and Methods Results Discussion References

 
The number of coronary and peripheral endovascular revascularization procedures performed with a percutaneous femoral approach is increasing (1). Unlike routine diagnostic studies, revascularization procedures usually necessitate use of larger sheaths and postprocedural anticoagulation or antiplatelet therapy, and they are associated with an increased incidence of pseudoaneurysm formation (2). Rates as high as 7.7% have been reported (3). At our tertiary care institution, a pseudoaneurysm has been diagnosed in an increasing number of patients who have undergone a revascularization procedure and are receiving antiplatelet medications with or without concomitant anticoagulant medications.

Ultrasonography (US)-guided compression is currently the first line of treatment for pseudoaneurysm, with success rates of more than 90% in patients who are not receiving anticoagulation medications at the time of compression. Patients receiving anticoagulant therapy, however, can often expect an extended duration of compression and success rates of only 62%–73% (4–6). Hence, performance of US-guided compression as a first-line treatment in this scenario can impose considerable strain on resources and can have a high failure rate. With increasing performance of peripheral revascularization procedures and use of postprocedural antiplatelet or anticoagulation therapy, the incidence of pseudoaneurysms unresponsive to US-guided compression is likely to rise. Clearly, there will be an increasing need for an alternative, minimally invasive treatment for such pseudoaneurysms. In this study, we evaluated the use of thrombin injection as a second line of therapy after failed US-guided compression.

	Materials and Methods

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Between June 1997 and June 1998, 42 iatrogenic femoral pseudoaneurysms were diagnosed in the noninvasive laboratory at our institution. These aneurysms were initially considered candidates for US-guided compression, which was considered the first line of treatment for iatrogenic femoral pseudoaneurysm at our institution. None of these pseudoaneurysms had undergone any form of attempted treatment previously. Pseudoaneurysm volume was calculated by multiplying the pseudoaneurysm width, depth, and length as measured on transverse and longitudinal US images.

For 13 pseudoaneurysms with a maximum diameter of less than 2 cm and a volume less than 6 cm³, treatment was initially observation alone (7,8). Color and power Doppler US at 7–10-day follow-up showed spontaneous total thrombosis in 11 of these 13 pseudoaneurysms. In the remaining two cases, persistent pseudoaneurysm indicated the need for treatment with US-guided compression. Twenty-nine pseudoaneurysms measuring larger than 2 cm in maximum diameter and larger than 6 cm³ in volume were considered suitable for US-guided compression at the time of diagnosis.

Therefore, a total of 31 pseudoaneurysms were treated by means of US-guided compression with the protocol described by Fellmeth et al (4). Briefly, the US transducer was positioned so that the pseudoaneurysm neck was centered in the color flow image, and pressure was directed downward until the flow through the neck was eliminated. In cases in which the pseudoaneurysm neck was very short or not apparent, direct compression of the pseudoaneurysm was attempted to obliterate flow. Contraindications for US-guided compression included skin ischemia or infection at the anticipated site of compression. In the presence of uncontrollable hemorrhage or limb-threatening ischemia resulting from a pseudoaneurysm, immediate surgical repair was mandatory.

US-guided compression was considered failed in cases of persistent pseudoaneurysm after the allotted period of compression, inability of the patient to tolerate US-guided compression despite intravenous analgesia, inability of the operator to compress a pseudoaneurysm without occluding the femoral artery, or recurrent pseudoaneurysm after US-guided compression.

US-guided compression failed for the aneurysm in 15 of these 31 patients (nine women and six men; mean age, 64 years; age range, 59–75 years). These 15 patients form the basis of this study, and they underwent US-guided thrombin injection. Parameters measured in all patients included pseudoaneurysm diameter, volume, neck length, and site; the procedure that caused the pseudoaneurysm; the size of catheter or sheath used; the time interval from catheterization to pseudoaneurysm treatment; antiplatelet or anticoagulation medication; and prothrombin and partial thromboplastin times.

Our institutional review board approved US-guided thrombin injection for the treatment of iatrogenic femoral pseudoaneurysm after failed US-guided compression. Written informed consent was obtained from all patients. Contraindications to thrombin injection included local infection at the potential site of needle placement for injection and previous exposure to thrombin. No patients were excluded on this basis. Hence, all 15 patients underwent US-guided thrombin injection as a second line of therapy for femoral pseudoaneurysm.

A 22-gauge spinal needle was inserted with direct US guidance by using a linear 7.5-MHz transducer and a freehand technique, taking care to place the needle at the apex of the pseudoaneurysm as far away as possible from the communication with the femoral artery (Fig 1). Topical thrombin (Thrombin-JMI; Jones Medical Industries, St Louis, Mo) was formed by means of dilution with sterile normal saline solution to 500–1,000 U/mL. Thrombin was injected during a 3–12-second period with real-time US monitoring, at a rate sufficient to cause thrombus formation (represented by echoes forming and aggregating at the tip of the needle). We found gray-scale US optimal for visualizing thrombus formation and color and power Doppler at maximum sensitivity settings optimal for evaluating residual flow within the pseudoaneurysm. The injection was stopped when color and power Doppler US showed total thrombosis of the pseudoaneurysm (Fig 2). During the thrombin injection, no attempt was made to manually compress the ipsilateral femoral artery to diminish flow within a pseudoaneurysm.

View larger version (59K): [in this window] [in a new window] [Download PPT slide]   Figure 1. Schematic transverse diagram through the left hip region shows the left common femoral vein (V), artery (A), and pseudoaneurysm (PA). Before thrombin injection, US guidance facilitates placement of the needle as far away as possible from the connection of the pseudoaneurysm to the femoral artery.

View larger version (99K): [in this window] [in a new window] [Download PPT slide]   Figure 2a. (a) Color Doppler US scan of left femoral pseudoaneurysm before treatment shows typical flow within the pseudoaneurysm. (b) Gray-scale US scan was obtained at the commencement of thrombin injection after placement of the needle just inside the pseudoaneurysm wall away from the pseudoaneurysm neck. Echoes representing thrombus (solid arrow) can be seen forming at the needle tip (open arrow). (c) Color Doppler US scan was obtained after injection of 1,000 U of thrombin. Cessation of flow is depicted, which indicates pseudoaneurysm thrombosis.

View larger version (165K): [in this window] [in a new window] [Download PPT slide]   Figure 2b. (a) Color Doppler US scan of left femoral pseudoaneurysm before treatment shows typical flow within the pseudoaneurysm. (b) Gray-scale US scan was obtained at the commencement of thrombin injection after placement of the needle just inside the pseudoaneurysm wall away from the pseudoaneurysm neck. Echoes representing thrombus (solid arrow) can be seen forming at the needle tip (open arrow). (c) Color Doppler US scan was obtained after injection of 1,000 U of thrombin. Cessation of flow is depicted, which indicates pseudoaneurysm thrombosis.

View larger version (111K): [in this window] [in a new window] [Download PPT slide]   Figure 2c. (a) Color Doppler US scan of left femoral pseudoaneurysm before treatment shows typical flow within the pseudoaneurysm. (b) Gray-scale US scan was obtained at the commencement of thrombin injection after placement of the needle just inside the pseudoaneurysm wall away from the pseudoaneurysm neck. Echoes representing thrombus (solid arrow) can be seen forming at the needle tip (open arrow). (c) Color Doppler US scan was obtained after injection of 1,000 U of thrombin. Cessation of flow is depicted, which indicates pseudoaneurysm thrombosis.

Follow-up US was performed 7–10 days after thrombin injection. This included color and power Doppler assessment of the pseudoaneurysm, Doppler evaluation of the underlying vasculature, and physical assessment of the patient's groin. Thrombin injection was considered successful only if complete pseudoaneurysm obliteration persisted with patency of the underlying vasculature and resolution of a patient's groin mass. Clinical follow-up included a history of allergy to thrombin or hemorrhagic complications and a coagulation profile with assays of prothrombin and partial thromboplastin times.

Results in the study groups were compared with the Student t test for parametric data and the ² test for nonparametric data. Differences were considered to be statistically significant if the P value was less than .05.

	Results

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Fifteen of 31 (48%) pseudoaneurysms failed US-guided compression. Reasons for failure were persistent pseudoaneurysm after 30 minutes of compression (n = 9), recurrent pseudoaneurysm after US-guided compression (n = 1), excessive patient discomfort despite intravenous analgesia (n = 4), and US-guided compression causing femoral artery occlusion (n = 1). Five of the 15 pseudoaneurysms failed US-guided compression before 30 minutes of compression had been completed; therefore, these five patients were excluded from comparison. Findings in the remaining 10 of 15 pseudoaneurysms that failed US-guided compression were compared with those in the 16 aneurysms that were successfully treated with US-guided compression. The only parameter that predicted failure was concomitant administration of aspirin and ticlopidine hydrochloride (Table 1).

Table 2 shows the profile of each patient who received US-guided thrombin injection. All but one patient received heparin during the catheterization procedure. At the time of thrombin injection, pseudoaneurysm mean maximum diameter was 3.1 cm (range, 1.7–5.0 cm) and mean volume was 17.9 cm³ (range, 4.8–55.1 cm³). The pseudoaneurysm originated from the common femoral artery (n = 7), superficial femoral artery (n = 7), or deep femoral artery (n = 1). Aneurysm neck length ranged between 0 and 11 mm (mean, 3.7 mm). All pseudoaneurysms treated with US-guided thrombin injection were uniloculated, and none were associated with an arteriovenous fistula. Thrombin injection was performed a mean 8.06 days after catheterization (range, 4–25 days). Fourteen of 15 patients were receiving either aspirin (81–325 mg daily) alone (n = 4) or aspirin (81–325 mg daily) and ticlopidine hydrochloride (250 mg twice daily) in combination (n = 10) at the time of thrombin injection. No patients received warfarin at the time of thrombin injection, but three patients received therapeutic doses of heparin until 3 hours before US-guided thrombin injection. One patient continued treatment with heparin after the thrombin injection.

	Discussion

TOP Abstract Introduction Materials and Methods Results Discussion References

 
Since being described in 1991, US-guided compression has replaced surgery as the first line of treatment for pseudoaneurysms unsuitable for conservative management. However, US-guided compression is time-consuming, often uncomfortable for the patient despite analgesia and conscious sedation, and an endurance test for the operator performing the compression. In addition, the procedure can ultimately fail to achieve thrombosis of the pseudoaneurysm, especially in patients receiving anticoagulation or antiplatelet therapy. Failure rates with US-guided compression can be lower than 10% for patients not receiving anticoagulation or antiplatelet medications, but higher failure rates of 27%–38% can be expected in patients receiving such therapy (4–6). To achieve these rates, extended periods of compression as long as 300 minutes can be expected. In our study, the relatively high failure rate of 48% included cases in which US-guided compression could not be completed for technical reasons or excessive patient discomfort. Hence, our true failure rate for patients completing our US-guided compression protocol was 10 of 26 (38%), which may also be considered high. This can be explained by the extent of concomitant aspirin or ticlopidine hydrochloride use, which was significantly higher in these patients than in those with successful US-guided compression. We do not believe our compression duration of 30 minutes led to an increase in failure rate. The literature reports an association between administration of anticoagulants and failure of US-guided compression. Although our patient numbers are small, we have shown that the combined antithrombotic effect of aspirin and ticlopidine hydrochloride is likely to result in failed US-guided compression of pseudoaneurysms with mean diameter of 2.9 cm (mean volume, 15.9 cm³). However, such pseudoaneurysms respond favorably to thrombin injection.

Even when US-guided compression is initially successful, pseudoaneurysm recurrence rates are reported as 20% in patients receiving anticoagulants compared with 6% in patients not receiving anticoagulation or antiplatelet therapy at the time of or after US-guided compression. Recurrence is most common within 72 hours of US-guided compression (4). In our study, there was a single recurrence after US-guided compression (one of 17, 6%), which was successfully treated with US-guided thrombin injection. There were no recurrences or complications after US-guided thrombin injection as indicated at follow-up US at 7 days and clinical follow-up at a mean 186 days.

Kang et al (9) and Liau et al (10) described US-guided thrombin injection as a first-line treatment that was successful in 25 of 26 femoral pseudoaneurysms. In our series of 15 patients, we found that US-guided thrombin injection can be used safely to repair a pseudoaneurysm after failed US-guided compression. US-guided thrombin injection was successful as the definitive treatment in all cases, also without recurrence. This success was despite treatment of 11 of the 15 patients with ticlopidine hydrochloride and aspirin both during and after US-guided thrombin injection. One patient also received heparin after US-guided thrombin injection without evidence of recurrence.

US-guided thrombin injection offers considerable advantages over US-guided compression, particularly for patients receiving anticoagulation or antiplatelet medications as seen in our study group. US-guided thrombin injection offers an effective, inexpensive (less than $5 per 1,000-U vial of thrombin), quick, and well-tolerated means of definitively treating iatrogenic femoral pseudoaneurysm without the need for conscious sedation or analgesia and its associated nursing support. If US-guided thrombin injection had been used as a first-line treatment in the 15 patients in our study with an aneurysm that failed US-guided compression, more than 7 hours of direct patient care could have been otherwise directed. Furthermore, patients would not have had to endure the discomfort of prolonged painful compression or the risks of sedation and analgesia associated with US-guided compression. Sedation or analgesia is not needed for US-guided thrombin injection. With its rapid effectiveness and low cost, US-guided thrombin injection offers an attractive first-line treatment for iatrogenic femoral pseudoaneurysm in these times of health cost constraints.

Complications of intravascular thrombin injection include embolization. Cope and Zeit (11) reported thrombin injection with fluoroscopic rather than US guidance for treatment of femoral pseudoaneurysm. Their report described injection of a large volume of 10 mL of saline solution containing 1,000 U of thrombin, after which angiography documented embolism to the profunda femoris artery. Liau et al (10) reported no embolic events on the basis of distal pulse examination in five patients with femoral pseudoaneurysm treated with US-guided thrombin injection. Kang et al (9) also reported no embolic events on the basis of distal pulse examination and Doppler-derived ankle-brachial indexes after US-guided thrombin injection of 21 pseudoaneurysms in 20 patients. In our study of 15 patients receiving US-guided thrombin injection after failed US-guided compression, clinical pulse examination, Doppler-derived ankle-brachial indexes, segmental pressures, and Doppler US failed to document any embolic events either during or after thrombin injection despite pseudoaneurysm neck length ranging between 0 and 11 mm.

Limitation or suspension of flow into the pseudoaneurysm before injection of thrombotic material could both promote clot formation and prevent embolization complications. Loose and Haslam (12) achieved this by inflating an angioplasty balloon in the native vessel across the neck of the pseudoaneurysm. For thrombus to form during thrombin injection, the equilibrium between fibrinolytic and coagulation pathways must be tipped in favor of clot formation (13). Although limitation of flow can facilitate this, our experience indicates that this is not necessary when US-guided thrombin injection is used to treat femoral pseudoaneurysm. We did not compress the femoral artery during the thrombin injection. During injection of thrombin with US guidance, it is clear that the rate of injection influences the rate of thrombus formation (represented by echoes forming and aggregating at the tip of the needle at gray-scale real-time US). US guidance allows placement of the injection needle away from the pseudoaneurysm neck. With increased concentrations of thrombin, more exuberant thrombus formation can be expected that could result in embolization. With real-time US guidance of the thrombin injection, the rate of injection can be increased to a rate at which thrombus formation is visualized at gray-scale US. The goal is direct US depiction of a constant rate of thrombus formation at the needle tip. Injection above this rate could theoretically result in embolization complications. With use of hand injection technique with the needle away from the pseudoaneurysm neck and gray-scale US guidance to determine injection rate, embolization complications can be avoided.

Immunologic response to thrombin administration may prove to be of more concern than the embolization complications. Topical bovine thrombin has been extensively used to accelerate vascular stasis in cardiovascular, neurosurgical, otolaryngologic, and radiologic procedures in humans for more than 20 years (14–18). Only recently has the risk and clinical importance of development of antibodies induced by thrombin preparations been documented (16,19,20). Dorion et al (20) found that 10% (12 of 120) of patients exposed to topical thrombin developed antibodies directed against bovine thrombin and other coagulation factors and that patients with repeated exposure were eight times more likely to develop antibodies to coagulation factors. Carroll et al (19) documented the pattern of immunoglobulin (Ig) M and IgG antibody reaction to topical thrombin: Peak levels of IgG and IgM occur at 68 weeks, with IgG levels at 8 months 20-fold lower than the mean maximal level and IgM levels returning to normal range. Clinical effects of this immune response after topical thrombin appear to be rare, but bleeding complications have been reported that necessitate plasmapheresis for treatment (21,22). Although no study of use of thrombin to treat pseudoaneurysm has documented hemorrhagic complications, to our knowledge, this risk remains. Consequently, we avoid thrombin injection in patients with previous thrombin exposure.

Our preliminary investigations suggest that US-guided thrombin injection is an efficient, safe, and definitive treatment for pseudoaneurysms that have failed US-guided compression, even for patients receiving anticoagulation or antiplatelet therapy. On the basis of our findings combined with those of Kang et al (9) and given the drawbacks of US-guided compression, it is reasonable to contemplate replacement of US-guided compression with US-guided thrombin injection as the first-line treatment for pseudoaneurysm. Clearly, comparison of US-guided thrombin injection with US-guided compression in a prospective randomized trial is warranted. Because of potential bleeding complications, however, US-guided thrombin injection should be avoided in patients previously exposed to either topical or intravascular thrombin.

	Footnotes

 
Abbreviation: Ig = immunoglobulin

Author contributions: Guarantor of integrity of entire study, D.P.B.; study concepts and design, D.P.B., R.G.S., C.M.A.; definition of intellectual content, D.P.B., R.G.S.; literature research, D.P.B.; clinical studies, D.P.B., R.G.S., C.M.A.; data acquisition, all authors; data analysis, D.P.B., R.G.S., P.A.; statistical analysis, D.P.B., R.G.S.; manuscript preparation, D.P.B., P.A.; manuscript editing, D.P.B., R.G.S.; manuscript review, D.P.B., R.G.S., C.M.A.

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