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1 All authors: Department of Diagnostic Imaging, Brown University School of Medicine and Rhode Island Hospital, 593 Eddy St., Providence, RI 02903.
Received August 25, 1999;
accepted after revision March 21, 2000.
Presented at the annual meeting of the American Roentgen Ray Society, New
Orleans, May 1999.
Abstract
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SUBJECTS AND METHODS. Twenty-three pseudoaneurysms ocurring after catheterization were treated percutaneously with an initial injection of 1.0 mL of thrombin solution via a 22-gauge spinal needle under continuous sonographic guidance. Four patients required the additional injection of 1.0-4.0 mL of thrombin for complete thrombosis. Repeated sonography was performed 24 hr after injection. Additionally, we compared our results with those of a control group by reviewing the imaging findings and medical records of 16 patients who underwent sonographically guided compression of iatrogenic pseudoaneurysms between January 1998 and July 1998.
RESULTS. Twenty-two of 23 pseudoaneurysms ocurring after catheterization were successfully treated with percutaneous thrombin injection. One recurrence was identified 24 hr after injection in a patient who experienced a significant complication. Procedure time was limited to 15 min with an overall success rate of 96%. Retrospectively, 18 iatrogenic pseudoaneurysms were identified in 16 patients. Six (60%) of 10 pseudoaneurysms were successfully compressed under sonographic guidance, with an average time to thrombosis of 32 min. Compression was unsuccessful for four pseudoaneurysms with an average compression time of 45 min. Compression could not be performed in seven patients (39%). The overall success rate of sonographically guided repair was 60%.
CONCLUSION. Preliminary evidence suggests that sonographically guided percutaneous thrombin injection is a safe and effective method of treatment for iatrogenic pseudoaneurysms and offers significant advantages over conventional sonographically guided compression.
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The percutaneous injection of thrombin has recently been advocated as an alternative to compression sonography in the treatment of pseudoaneurysms after catheterization [14,15,16]. Thrombin is a potent natural coagulant essential in the conversion of fibrinogen to the stable cross-linked fibrin clot and has been found useful in the cessation of bleeding from superficial skin wounds. In this study, we evaluated the efficacy of percutaneous thrombin injection as an initial treatment for patients presenting with iatrogenic pseudoaneurysms. Additionally, we describe our experience with sonographically guided compression repair in a retrospective review of consecutive patients identified between January and July of 1998.
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Diagnostic gray-scale, color, and spectral Doppler sonography were performed on either a High Definition Image 3000 (Advanced Technology Laboratories, Bothell, WA) or a Logiq 700 scanner (General Electric Medical Systems, Milwaukee, WI) with a 4- to 7-MHz linear transducer. All but two pseudoaneurysms arose from the common femoral artery; the others arose from the profunda femoris and the superficial femoral artery. We noted no evidence of associated arteriovenous fistulas. The size of the aneurysm in both the transverse and sagittal planes and the neck width were recorded. Pseudoaneurysm volume was calculated by multiplying the maximum length, width, and depth measured on transverse and sagittal images. Arterial and venous waveforms were recorded in the underlying femoral vessels. To detect possible embolic events, physical examination and assessment of distal pulses were performed before and after the procedure, with continuous-wave Doppler documentation of distal pulses if necessary. Continuous pulse oximetry from the first or second toe was recorded before and during the procedure. Successfully treated patients remained in bed for 4 hr; outpatients were not admitted. Specific parameters recorded at the time of treatment included procedure resulting in the pseudoaneurysm, number of days after catheterization, sheath size, and anticoagulation history.
The procedure was performed as described by Kang et al. [15]: a solution of bovine thrombin (1000 U) (Thrombin-JMI; Gentrac, Middleton, WI) was prepared by adding 5 mL of sterile saline (0.9% normal saline) to a 5000-U vial of powdered thrombin. The solution was loaded into a 5-mL syringe via a 22-gauge spinal needle. The skin overlying the pseudoaneurysm was prepared with Betadine (Purdue Frederick, Norwalk, CT). With the sonography transducer positioned over the pseudoaneurysm, the spinal needle was inserted into the center of the lumen with continuous sonographic visualization (Fig. 1). Then an initial 1000 U (1 mL) of thrombin was slowly injected. The injection rate was deemed appropriate if a clot was visible forming at the tip of the needle. If residual flow was visible, an additional 1000 U (or more) of thrombin was injected using the same technique (Fig. 2A,2B,2C). The needle was then withdrawn, and thrombosis was documented. Repeated color and spectral Doppler sonography of the underlying femoral vessels were performed. Patients were instructed to remain in bed for 4 hr. Repeated sonography was performed after 24 hr to detect recurrence. Using this technique, compression of the pseudoaneurym neck or lumen was not necessary. Sonography was used only for guidance.
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We retrospectively reviewed the imaging findings and medical records of 16 patients presenting to the sonography department with iatrogenic pseudoaneurysms between January 1998 and July 1998. Eighteen pseudoaneurysms were identified in this group of patients (two patients had bilateral pseudoaneurysms). We identified 10 women and six men; ten patients had undergone cardiac catheterization, four had lower extremity angiograms, and two had diagnostic cerebral angiograms. The mean age was 67 years (age range, 38-89 years). Patients had undergone catheterization a mean of 4.2 days (range, 1-9 days) before sonography. Characteristics of the pseudoaneurysms were recorded, and anticoagulation history was obtained (if available).
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Overall, 14 patients underwent a cardiac procedure, and eight of 14 patients underwent a cardiac interventional procedure (percutaneous transluminal coronary angioplasty alone or with stent placement) that required placement of an 8-French vascular sheath. Patients who underwent routine coronary angiography had placement of a 7-French vascular sheath (except for one who had a 6-French sheath). Patients who underwent diagnostic angiography (n = 5) had 6-French vascular sheaths (n = 3) or 5-French catheter access (n = 2). A 7-French long vascular sheath was used in the patient who underwent iliac intervention. All but three patients received heparin at the time of angiography.
At the time of thrombin injection, 12 patients were receiving some form of anticoagulation medication. All patients who underwent percutaneous transluminal coronary angioplasty with stent placement (n = 6) were receiving an antiplatelet regimen of aspirin (325 mg daily) and ticlopidine (250 mg twice daily); patients who underwent percutaneous transluminal coronary angioplasty alone (n = 2) received only aspirin. One patient who underwent diagnostic coronary angiography was receiving Coumadin (2.5 mg daily) (DuPont, Wilmington, DE), with a prothrombin time of 17.7 and an international normalized ration of 2.1. Two patients had heparin stopped 2 hr before thrombin injection; heparin was continued after thrombin treatment, and one patient received heparin at the time of treatment (partial thromboplastin time, 60; international normalized ratio, 1.1). Patients not receiving anticoagulation medication (n = 9) had normal coagulation parameters.
One significant complication occurred in one patient. One day after placement of bilateral iliac stents, a 62-year-old woman had a pulsatile left groin mass. Color and spectral Doppler sonography of the left groin confirmed the presence of two pseudoaneurysms arising from the common femoral artery. The first more proximal aneurysm measured 11.2 cm3; the second slightly distal aneurysm measured 2.8 cm3. Both aneurysms had well-defined necks measuring 3 and 2 mm, respectively. After discussion with the referring clinician, thrombin injection was performed. The presence of the dorsalis pedis pulse was confirmed with Doppler sonography. One thousand units of thrombin was injected into each aneurysm (total, 2000 U), resulting in complete thrombosis. After injection, the patient complained of paresthesias and pain in the left foot. Repeated Doppler sonography failed to reveal the presence of the dorsalis pedis. After 1 hr without additional intervention, the patient's symptoms resolved and the dorsalis pedis returned on Doppler sonography. However, follow-up examination performed 24 hr later revealed minimal residual flow in the neck and lumen of the distal pseudoaneurysm. After discussion with the vascular surgeon, no further attempt at percutaneous pseudoaneurysm repair was made. The patient subsequently underwent surgical repair. Incidentally, the patient suffered cardiac arrest during surgery.
In the remaining patients, no significant complications were encountered. None of the patients had major discomfort during the procedure nor did any require the use of analgesia or sedation. No recurrences were noted on repeated sonography performed 24 hr after injection. In patients in whom clinical follow-up was performed (n = 12; mean, 26 days after injection), no complications relating to the thrombin injection were identified.
Control Group
In the control group, 18 iatrogenic pseudoaneurysms were identified in 16
patients. Sonographically guided compression repair was attempted in 10 (56%)
of 18 pseudoaneurysms. A number of factors were specifically cited in eight
patients in whom this method was not attempted, including lack of
visualization of the pseudoaneurysm neck (n = 4), significant patient
discomfort during compression (n = 2), and continued anticoagulation
therapy (n = 1). In one patient, sonographically guided repair was
not attempted because of the small size (2.5 cm3) of the
pseudoaneurysm. Follow-up examination performed after the discontinuance of
heparin revealed spontaneous thrombosis. The average size of pseudoaneurysms
in the control group was 16.1 cm3 (range, 2.5-123.5
cm3). All patients but one received heparin at the time of
angiography. For patients who underwent percutaneous transluminal coronary
angioplasty alone (n = 1) or percutaneous transluminal coronary
angioplasty with stent placement (n = 6), a 7-French vascular sheath
was used. For patients who underwent routine coronary angiography (n
= 3), a 6-French vascular sheath was used. In two patients who underwent
diagnostic angiography, a 6-French sheath was used. In the remaining patients
(n = 4), vascular access was achieved with a 5-French catheter.
Overall, 13(81%) of 16 patients in the control group were receiving some form of anticoagulation therapy at the time of pseudoaneurysm diagnosis. Thirteen pseudoaneurysms were identified in these patients. Of the patients who underwent a cardiac procedure, six were receiving an antiplatelet regimen of aspirin (325 mg) and ticlopidine (250 mg); the remaining four patients were receiving a single aspirin per day. Of the patients who underwent diagnostic angiography, three were receiving therapeutic doses of heparin (mean partial thromboplastin time, 69 sec; range, 48-93 sec). Ten pseudoaneurysms were identified in eight patients who underwent sonographically guided compression repair; four (50%) of eight patients were receiving an antiplatelet regimen at the time of repair, and no patient receiving heparin underwent attempted sonographic compression. Overall, six of 10 pseudoaneurysms were successfully treated with sonographic compression. Compression times ranged from 10 to 90 min, with an average of 32 min in successful cases of sonographic compression repair; for patients in whom sonographic compression failed (n = 4), an average of 45 min of compression was applied (range, 10-90 min). Three pseudoaneurysms were successfully treated in four patients receiving anticoagulation medication, with a mean compression time of 45 min (range, 20-90 min); in the single patient who was receiving anticoagulation medication in whom this method failed, 90 min of compression was applied with residual flow revealed in the lumen on color and Doppler sonography. For patients not receiving anticoagulation medication at the time of compression repair (n = 4), the mean duration of compression was 26.6 min (range, 10-40 min) in successful cases (n = 3) and 40 min (range, 20-90 min) in unsuccessful cases (n = 3). There were no significant complications nor were there any recurrences on follow-up examination.
When comparing the patients who underwent thrombin injection with those who underwent compression repair, we found no significant variations in patient age (67 versus 70 years), type of interventional procedure (67% versus 63% cardiac), pseudoaneurysm size (18.5 versus 16.1 cm3), or neck width (3.2 versus 3.0 mm). The proportion of patients receiving some form of anticoagulation medication in the compression repair group was higher than that in the thrombin group (81% versus 57%); however, the number of pseudoaneurysms in patients who were receiving anticoagulation medication and were successfully treated in the thrombin group was significantly higher than that in the compression repair group. In the thrombin group, no specific determinants relating to aneurysm characteristics, type of vascular procedure, or ongoing anticoagulation medication were identified that precluded successful treatment. In our retrospective review of patients who underwent sonographically guided compression, 50% of patients with a documented pseudoaneurysm did not undergo attempted repair. Table 1 compares the results of percutaneous thrombin treatment and sonographically guided compression in all patients and in patients who were receiving anticoagulation medication at the time of treatment.
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In our retrospective review, only 56% of pseudoaneurysms were repaired with attempted compression. Reasons cited included failure to visualize the pseudoaneurysm neck and significant patient discomfort. We recognize that the number of patients in our study who underwent attempted compression sonography is small; we also recognize that these patients may not constitute an accurate comparison group. However, in a recent study by Brophy et al. [16], an indirect comparison group comprised patients with 15 iatrogenic pseudoaneurysms who underwent unsuccessful conventional compression. All were successfully treated with percutaneous injection of thrombin despite the presence of antiplatelet agents in 11 patients.
For percutaneous injection of thrombin, we report a 96% success rate. More important, 100% of pseudoaneurysms diagnosed were treated. Surgery is often performed in patients in whom manual compression fails or cannot be performed. In our retrospective review, we report a 75% success rate for manual compression for patients receiving anticoagulation medication with pseudoaneurysms compared with a 92% success rate for thrombin injection for the same type of patients. Compression times were longer for patients not receiving anticoagulation medication with successfully treated pseudoaneurysms than for patients receiving anticoagulation therapy. Additionally, in three patients in whom compression repair failed, anticoagulation therapy was not given.
Other limitations of our study include the significant patient discomfort and pain associated with prolonged compression [5, 9, 13, 21] and characteristics of the pseudoaneurysms that often preclude local compression, including lack of visualization of the pseudoaneurysm neck, pseudoaneurysm size, and inability to compress the pseudoaneurysm without occluding the underlying artery [5, 9, 16]. In our retrospective review, lack of visualization of the pseudoaneurysm neck was the most commonly cited reason for not attempting compression repair.
Percutaneous injection of thrombin for the treatment of pseudoaneurysms arising in the peripheral arteries was first described by Cope and Zeit [22] in 1986 and applied by Walker et al. [23] in the transluminal catheter treatment of a posttraumatic pseudoaneurysm arising from the profunda femoris artery. Despite these early reports, the method of inducing thrombosis with the injection of thrombin has not gained widespread acceptance. In 1997, Liau et al. [14] described the successful percutaneous treatment of five pseudoaneurysms arising from the femoral artery with the intravascular injection of thrombin via a catheter under continuous sonographic guidance [14]. This method was modified by Kang et al. [15] who described the successful treatment of 20 of 21 consecutive postcatheterization pseudoaneurysms with percutaneous injection of thrombin via a 22-gauge spinal needle with continuous sonographic visualization. In our series of 23 postcatheterization pseudoaneurysms initially treated with percutaneous injection of thrombin, we report an overall success rate of 96% and one failure. We could not identify any specific determinants relating to pseudoaneurysm characteristics (size, neck width, or location), type of vascular procedure, type of sheath used, or presence of systemic anticoagulation therapy that precluded successful treatment. Pseudoaneurysms that are larger may require more thrombin (as required in four of our patients). However, in the series of Brophy et al. [16], all pseudoaneurysms were treated with 500-1000 U of bovine thrombin regardless of size. In our series, several pseudoaneurysms larger than 20 cm3 were successfully treated with 1000 U of thrombin. Also, pseudoaneurysms requiring additional thrombin were some of the earliest treated in our series. It is likely that operator inexperience rather than pseudoaneurysm size accounts for the need of additional thrombin.
The greatest risk of thrombin injection is the egress of the coagulant into systemic (distal) circulation. Ideally, this should not occur because thrombosis is nearly instantaneous, and continuous sonographic guidance allows positioning of the needle away from the neck of the pseudoaneurysm. Liau et al. [14], Kang et al. [15], and Brophy et al. [16] reported no embolic events in 41 pseudoaneurysms treated with the percutaneous injection of thrombin. However, we present the first embolic complication of thrombin injection, to the best of our knowledge, in a patient with two common femoral pseudoaneurysms who developed paresthesias and loss of the dorsalis pulse in the left foot immediately after thrombin injection. We postulate that thrombin leaked into the distal circulation via a collateral branch of the profunda femoris artery and caused distal embolization of an already extensively diseased arterial system. The fact that the patient regained her distal pulse an hour later lends credence to the role that natural clot lysis plays in recovery. Indeed, several animal studies have reported that the IV infusion of 5 U/kg per minute of thrombin leads only to minor clinicopathologic effects [24,25,26,27]. Severe clinical symptoms such as disseminated intravascular coagulation are seen only with prolonged infusions, particularly in the presence of antifibrinolytic drugs [28]. Cope and Zeit [22] reported no evidence of ischemia or other symptoms in a young patient who underwent repair of a posttraumatic peroneal artery pseudoaneurysm despite the escape of thrombin into the foot. An intravariceal injection of 15,000 U of thrombin led to the development of a disseminated intravascular coagulation profile and hypotension that resolved after the procedure [29]. It is likely that a small amount of thrombin escapes into the systemic circulation with the percutaneous treatment of pseudoaneurysms; however, the natural anticoagulant mechanism prevents the development of clinically significant thrombosis. It may be that patients who have little vascular reserve, as in our case, are prone to develop symptoms after thrombin injection. No other complications relating to the injection of thrombin occurred in patients at the time of treatment or in patients in whom follow-up was obtained (n = 12).
Other side effects of thrombin injection include anaphylaxis to bovine products; in several studies, this side effect did not result in significant adverse reactions [14, 22, 23, 30, 31], a finding probably related to the nearly instantaneous thrombosis and immediate incorporation of the bovine protein that occurs in the stable clot. However, Dorion et al. [32] found that 10% of patients exposed to topical thrombin developed antibodies to the bovine protein and to a variety of coagulation factors. The clinical effects of thrombin exposure are rare, but there have been isolated reports of bleeding complications [33]. As a result, patients who have had previous exposure to thrombin or bovine proteins are not ideal candidates for percutaneous thrombin injection because of immunologic or bleeding complications.
Our preliminary evidence suggests that percutaneous thrombin injection is a safe and efficacious first-line method of treating postcatheterization pseudoaneurysms. It offers significant advantages over traditional sonographically guided compression in time-savings for the operator and avoidance of discomfort for the patient. Additionally, it appears that the anticoagulation status of the patient does not preclude successful treatment. On the basis of our findings, in addition to those recently described [14,15,16], percutaneous injection of thrombin has the potential to become the initial method of choice in the treatment of postcatheterization pseudoaneurysms. However, a larger prospective trial comparing the relative benefits of each treatment option is warranted.
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