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1
Department of Radiology, Stanford University, 300 Pasteur Ave., Stanford, CA
94305.
2
Department of Radiology, Sinai Hospital, 2401 Belvedere Ave., Baltimore, MD
21215.
Received December 21, 2000;
accepted after revision March 8, 2001.
Address correspondence to D. M. Widlus.
Abstract
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MATERIALS AND METHODS. Twenty-three patients with 26 postcatheterization femoral pseudoaneurysms were administered thrombin injection with color-flow Doppler sonographic guidance. Pseudoaneurysm volume ranged from 1 to 41 cm3 with an average of 6.7 cm3 and a median of 4 cm3. Two patients received therapeutic doses of IV heparin for anticoagulation. When possible, the neck of the pseudoaneurysm was occluded during the injection to promote stagnation and prevent thrombin leakage. Sonographic follow-up was routinely performed after 24 hr.
RESULTS. An average dose of 192 U of thrombin was used (range, 50-450 U), and time to coagulation ranged from 10 to 60 sec. All 26 pseudoaneurysms were successfully thrombosed, although one required repeated treatment because of recanalization noted at 1-day follow-up. There were no complications.
CONCLUSION. Doses of thrombin at an average of fivefold lower than previously reported were effective in the treatment of 26 iatrogenic femoral pseudoaneurysms, even in the presence of anticoagulation. This experience shows that a much smaller dose of a potentially dangerous medication can achieve the same efficacy as previously used higher doses.
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Traditional treatment of pseudoaneurysms has been surgical repair [1,2,3], but several non-surgical techniques have been developed for their treatment. Sonographically guided compression repair has become the first-line treatment of pseudoaneurysms at many institutions [2, 4,5,6,7,8,9,10]. Because of the technical difficulties of the procedure, patient discomfort, and variable results, alternative forms of treatment have been advocated. These include mechanical compression with the FemoStop device (Bard, Billerica, MA) [11,12,13], coil insertion [14,] and injection of fibrin adhesive products with angiographic guidance [15].
The use of thrombin for treatment of pseudoaneurysms was introduced by Cope and Zeit [16] in 1986. Since then, several other groups have reported encouraging results (Table 1). Overall, 192 (97%) of 197 of reported patients were successfully treated, with an average dose of approximately 1100 U of thrombin (range, 100-5000 U) per patient. Three complications of distal limb ischemia resulting from injection of thrombin have been reported. Two occurred during brachial artery pseudoaneurysm repair [17,18,19], and one, more recently, after repair of an iatrogenic femoral artery pseudoaneurysm [20].
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The purpose of this study was to report our experience treating femoral artery pseudoaneurysms by injecting much smaller doses of thrombin than previously reported.
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Fifteen of the 23 patients were women and eight were men. The average age was 75 years (range, 49-85 years). At the time of thrombin injection, two patients were treated with IV heparin at therapeutic doses for anticoagulation. No patients were being treated with warfarin. Prothrombin times and activated partial thromboplastin times were within normal limits for all other patients. No patient had known prior exposure or contraindication to bovine thrombin.
Procedure
After informed consent was obtained, the site was cleaned and draped in a
sterile fashion. Pseudoaneurysms were identified and imaged with color-flow
Doppler sonography to identify the neck and visualize the hallmark swirling
blood in the pseudoaneurysm. Bovine thrombin (Thrombostat; Parke-Davis, Ann
Arbor, MI; Johnson & Johnson, New Brunswick, NJ), the only type of
thrombin available at our institution, was reconstituted at a concentration of
1000 U/mL and then diluted to a concentration of 100 U/mL with sterile saline.
With sonographic guidance (Elegra, Siemens, Munich, Germany; ATL 3000,
Phillips, Eindhoven, The Netherlands [5- to 7-MHz linear array]), a 22-to
25-gauge needle was introduced into the pseudoaneurysm. The needle tip was
visualized and positioned at a site distant from the neck of the
pseudoaneurysm (Fig. 1). Increments of 0.5-1.0 mL (50-100 U) of thrombin were slowly injected at a rate
of approximately 1 mL/10 sec. A period of 5-10 sec was allowed to elapse
before additional thrombin was injected. Results were monitored continuously
with color-flow Doppler sonography. Injection was stopped when no further flow
was identified in the pseudoaneurysm. When possible, the neck of the
pseudoaneurysm was occluded manually or with the sonographic probe during the
injection procedure. This option was not possible in approximately half of the
patients.
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Distal pulses and changes associated with limb ischemia (temperature, color, pain) were monitored before and after the treatment to detect potential thrombotic emboli. Follow-up sonography was performed immediately and after 24 hr to verify patency of the native arteries and thrombosis of the pseudoaneurysm. If flow was identified in the pseudoaneurysm at follow-up, the procedure was repeated. Patients were kept at bed rest for 24 hr after treatment.
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, where
A, B, and C are the diameters of the pseudoaneurysm
approximated as an ellipsoid. Volumes ranged from 1 to 41 cm3 with
an average of 6.7 cm3 and a median of 4 cm3. There was
no relationship between pseudoaneurysm volume and thrombin dose required
(r2 = 0.09, p < 0.001). Time to thrombosis of
the pseudoaneurysm ranged from 10 to 60 sec with a mean of 35 sec. No
complications were noted immediately or at the 24 hr follow-up visit. Distal
pulses were unchanged from preprocedure in all patients. We are not aware of
any late recurrences. Figure 2A,2B,2C contains an example of a pseudoaneurysm imaged with color flow Doppler sonography, before (Figs. 2A and 2B) and after (Fig. 2C) injection of thrombin. Before injection, swirling flow in the pseudoaneurysm and a flow jet were easily visualized. Complete cessation of flow occurred after thrombin injection. The neck of this pseudoaneurysm was 5 mm, and 300 U of thrombin were required to achieve thrombosis.
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Surgical treatment requires an incision over the pseudoaneurysm to gain direct access for digital compression and enucleation of thrombi. The artery is then directly repaired. Exposure can be impeded by large overlying hematomas, which make it necessary to access and clamp the iliac artery through an abdominal incision.
In 1991, Fellmeth et al. [4] described a non-operative method of treating pseudoaneurysms by compressing the neck of the pseudoaneurysm with a sonographic probe to allow the cavity to be thrombosed. Effective in approximately 74% of patients, this technique rapidly gained favor over surgery [2, 5,6,7,8,9,10]. However, the procedure often requires compression times of 1-2 hr and is uncomfortable for both the patient and the operator. Additionally, anti-coagulation lengthens compression time and decreases success rates. Other nonoperative methods of treating pseudoaneurysms, such as use of the FemoStop device [11,12,13], coil insertion [14], and fibrin adhesive injection [15] have not become popular.
Thrombin (factor IIa) is a 34 kd polypeptide derived in vivo from prothrombin (factor II) by the action of factor Xa, factor Va, phospholipid, and calcium. It is the activated form of prothrombin, a circulating zymogen that cleaves fibrinogen to fibrin, which in turn participates directly in the formation of a blood clot [23]. IV injection of exogenous bovine-derived thrombin causes rapid cleaving of endogenous fibrinogen and subsequent thrombus formation, even in the presence of anticoagulation with warfarin or heparin.
Cope and Zeit [16] introduced the use of thrombin to treat pseudoaneurysms in 1986, although it took another 11 years for the technique to gain popularity [24]. The literature contains several reports documenting the efficacy and safety of high-dose thrombin injection for pseudoaneurysm treatment (17-20, 24-30], although Pezzullo et al. [20] recently reported distal limb ischemia after the repair of a femoral artery pseudoaneurysm. The average dose of thrombin reported in the literature was approximately 1100 U, with a range of 100-5000 U (Table 1).
Our study shows that injection of far less thrombin, one fifth of the average dose reported in the literature, can successfully treat pseudoaneurysms, even in anticoagulated patients. We achieved successful thrombosis of each pseudoaneurysm on the first attempt, and the only recurrence was noted on the required 24 hr follow-up sonogram and could be retreated immediately. All pulses were maintained at postprocedure and at follow-up, and no complications occurred. An average dose of only 192 units of thrombin was required.
One difference in our procedure was the use of more dilute thrombin. We diluted the thrombin tenfold, down to 100 U/mL. Improved control over injection volume or the larger volume of fluid per unit of thrombin injected may have accounted for the reduction of thrombin dose necessary to achieve successful pseudoaneurysm thrombosis. When possible, we would also occlude the neck of the pseudoaneurysm during the procedure. Because this occlusion was performed less than half of the time and because all procedures were successful and without complication (the only recurrence being in a patient whose pseudoaneurysm neck was occluded), we cannot claim that this made the procedure safer or more effective.
No correlation was found between pseudoaneurysm volume and thrombin dose. This finding may relate to the small size of our study. Pezzullo et al. [20] recently found a correlation between pseudoaneurysm volume and required thrombin dose with only 22 patients. The relationship between thrombin dose and pseudoaneurysm-neck diameter may also prove of interest. Unfortunately, this measurement was not always available for our retrospective study.
Compared with sonographically guided compression repair, treatment of pseudoaneurysms with thrombin injection offers many advantages. The success rate of thrombin injection reported in the literature has been consistently high, at an average of 97%, even with patients treated with therapeutic levels of anticoagulants (Table 1). In addition, the rate of distal limb ischemia has been low, with only one reported complication from femoral pseudoaneurysm treatment. The procedure is nearly painless, requiring, at most, local anesthetic. Treatment can be completed in a few minutes, freeing the sonography machine and technologist to perform other studies.
Theoretically, using a lower dose of a potentially dangerous medication should decrease the risks associated with its use. Thus far, to our knowledge, few complications of thrombin use for this indication have been reported [17,18,19,20], but there are few articles dealing with this subject. As more reports are published, more complications will come to light. In addition to distal limb ischemia caused by in situ thrombosis from thrombin leakage, there is a hypothetical risk of type I IgE-mediated allergic reaction to bovine thrombin. Topical bovine thrombin has been used extensively for hemostasis for more than 20 years. Recent descriptions of antibody responses [31,32,33] show high titers against endogenous coagulation factors, with resulting bleeding complications [34, 35]. Prior exposure to bovine thrombin is considered a contraindication to treatment of pseudoaneurysms with thrombin by some investigators [30].
In conclusion, this study supports the postulate that treatment of iatrogenic pseudoaneurysms by thrombin injection is definitive, safe, and efficacious. Furthermore, it shows that substantially lower thrombin doses than previously reported are equally effective. Dose-related complications could be reduced with no loss of efficiency.
Acknowledgments
We thank Heidi Beilis, David J. Spinak, and Kimberly A. Smyth for their
assistance.
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