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1 Both authors: Department of Radiology, Beth Israel Deaconess Medical Center and Harvard Medical School, 330 Brookline Ave., Boston, MA 02215.
Received March 17, 2003;
accepted after revision May 14, 2003.
Address correspondence to R. G. Sheiman.
Abstract
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SUBJECTS AND METHODS. Under sonographic guidance, we injected thrombin into 54 consecutive iatrogenic pseudoaneurysms of the common femoral artery. We statistically compared the volume, maximum dimension, and neck diameter of the pseudoaneurysms and thrombin doses injected into the successfully treated (persistent thrombosis on a follow-up duplex sonogram obtained 7–10 days after thrombin injection) and unresponsive (sonographically documented recurrence within 24 hr) pseudoaneuryms to determine whether any of these factors could help to predict a failure to respond to thrombin. For all patients in whom treatment failed, findings at surgical repair were noted and sonograms were reviewed to confirm the dimensions and appearance of the pseudoaneurysm and the absence of an associated arteriovenous fistula.
RESULTS. Complete and persistent thrombosis was achieved in 49 (91%) of the 54 common femoral artery pseudoaneurysms. In comparing the 49 successfully treated patients and the five patients in whom treatment failed, we identified no significant differences in the volume, maximum dimension, or neck diameter of the pseudoaneurysm (two-sample t test) or in the thrombin dose (Wilcoxon's rank sum test). In all five patients with failed treatment, an arteriotomy site laceration measuring at least 8.0 mm (n = 4) or infection (n = 1) was identified at surgical repair, none of which were identifiable even in retrospect on duplex and color Doppler sonography.
CONCLUSION. Failure of an iatrogenic pseudoaneurysm of the common femoral artery to respond to thrombin may indicate an occult vascular injury. In these patients, surgical repair, rather than reinjection of thrombin, should be considered.
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Therefore, thrombin injection was performed in 54 patients (24 men, 30 women; mean age, 74.5 years; range 24–93 years). Sonographic diagnosis was made using one of two scanners with duplex and color Doppler capabilities (HDI-5000 or 3000, ATL, Bothell, WA), using a 7.4-MHz linear transducer. At the time of diagnosis, the maximum dimension and volume of the pseudoaneurysm were determined and entered into a database, as is routine in our vascular laboratory. Volumes were calculated assuming an elliptical shape (length x width x height x 0.52). All measurements made of the patent pseudoaneurysm lumen in cases in which an element of thrombus was noted. Neck size (maximum diameter) of the pseudoaneurysm and sheath size used for arterial access were also noted for each patient. In all patients, hemostasis at the puncture site was carried out using manual compression without the use of any percutaneous closure device. All 54 pseudoaneurysms were categorized as simple using criteria that have been previously described [12]: a single well-delineated compartment with a single neck communicating with the native common femoral artery, with or without an element of thrombosis.
The distal extremity pulses in each patient were examined by both palpation and Doppler sonography. The overlying skin was then cleansed and draped to provide a sterile field. Bovine thrombin (thrombin-JMI, Jones Medical, St. Louis, MO) was reconstituted with normal saline in a concentration of 1,000 U per 3 mL. Under sonographic guidance, we inserted a 20-gauge spinal needle into the pseudoaneurysm at the most distal possible point from its neck. Injections were performed by one of three attending interventional radiologists, all of whom had performed at least 10 prior pseudoaneurysm obliterations with thrombin before this study began. We determined the rate of injection using real-time sonography of clot formation and continued injecting thrombin until the thrombus filled the entire pseudoaneurysm lumen. Duplex and color Doppler sonography was repeated 10 min after pseudoaneurysm treatment to ensure continued obliteration.
The thrombin dose injected for each patient was recorded. Although some patients were on heparin or antiplatelet medication at the time of thrombin injection, we did not record this data because in prior studies [12, 15], neither medication has been shown to affect the success rate of pseudoaneurysm repair using thrombin.
After the procedure, all patients were placed on 3 hr of strict bed rest and instructed to avoid strenuous activity for 24 hr. A follow-up duplex and color Doppler sonogram was obtained 7–10 days after treatment to assess for persistent pseudoaneurysm obliteration; sonography was performed sooner in patients whose clinical findings suggested possible recurrence of the pseudoaneurysm (expanding hematoma, persistent pain, or recurrent bruit). We defined persistent obliteration on the follow-up sonogram as evidence of a successful treatment; we defined recurrence, documented on the standard follow-up sonogram (7–10 days after treatment) or a sonogram obtained earlier because of clinical indications, as evidence of a failed treatment. For patients in whom thrombin injection was repeated after failure of the initial treatment, the outcome was noted but not included in the data analysis.
The volume, maximum dimension, and neck size of the pseudoaneurysm and the sheath size of the successful and unsuccessful treatment groups were compared using a two-sample t test. The Wilcoxon's rank sum test was used to identify any difference in thrombin dosage. In all patients in whom treatment failed, the sonogram obtained at the initial diagnosis and at the time of treatment was retrospectively reviewed to ensure that the pseudoaneurysms were simple, had originated from the common femoral artery, and were not associated with an arteriovenous fistula. We also reviewed the catheterization procedure report of patients with failed treatment to determine whether access to the common femoral artery was technically complicated (i.e., whether multiple attempts had been required or whether passage of a wire to the aorta had been difficult).
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The mean (± SD) maximum dimension and volume of the five pseudoaneurysms that failed to respond to injection were 3.6 (± 1.5) cm and 25.38 (± 15.10) cm3, respectively. These measurements did not significantly differ from the mean maximum dimension and volume of the 49 pseudoaneurysms that were successfully treated, which had a mean maximum dimension of 3.0 (± 1.5) cm and a mean volume of 23.57 (± 35.34) cm3. The amount of thrombin used in the five patients in whom the initial treatment failed (mean, 1510 ± 1035 U) was not significantly different than the amount used in the 49 patients in whom treatment was successful (mean, 703 ± 516 U) but showed a trend toward statistical significance (p = 0.059). In all five patients with failed treatment, the size of the vascular access was 5-French, and in all patients with successful treatment, the size of the vascular access ranged from 5- to 7-French; thus, access size was smaller overall in the patients in whom treatment failed but not significantly different from access size in the successful cases. Size of the pseudoaneurysm neck also did not differ between the unsuccessfully and successfully treated patient groups with a mean of 2.1 (± 0.5) mm and 2.1 (± 0.4) mm, respectively.
Four patients underwent surgical repair within 24 hr of referral and were found to have a common femoral artery laceration at the arteriotomy site that measured at least 0.8 cm (24-French) and was the cause of the pseudoaneurysm. One patient underwent surgical repair 72 hr after the failed thrombin treatment and was found to have an infected common femoral artery site that required a bypass of the infected region. Staphylococcus aureus was isolated from the resected common femoral artery wall.
We reviewed the diagnostic and treatment duplex and color Doppler sonograms obtained in the five patients with failed treatment and reconfirmed that the pseudoaneurysms were simple, arose from the central femoral artery, and were not associated with an arteriovenous fistula. No gray-scale or color Doppler sonographic findings suggested a vessel laceration, even on retrospective review. Additionally, the catheterization procedure notes for these patients indicated that common femoral artery access was uncomplicated.
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On the basis of our results, although the number of failed cases is small, it appears that if sonographically guided thrombin injection of a simple pseudoaneurysm fails, an underlying sonographically occult vascular injury may be present and surgical exploration may be required. In all patients in whom treatment failed (9% of our patients during the study period), the failures were due to a vessel laceration that required surgical repair or a vessel infection that required bypass. Maximum dimension, overall volume, and neck size of the pseudoaneurysms in all patients with unsuccessful thrombin treatment were similar to those found in patients who were successfully treated. In the single patient with a common femoral artery infection, no focal pain or excessive skin changes during sonographic evaluation were noted. Most important, in patients with failed thrombin treatments, Doppler sonography revealed no finding either at diagnosis or treatment that would have allowed prospective identification of a refractory pseudoaneurysm. Even upon retrospective review, gray-scale and color Doppler sonography failed to reveal evidence of a vessel laceration at the arteriotomy site (Fig. 1A, 1B, 1C).
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We should point out that some of our 49 successfully treated patients may possibly also have had a vascular laceration and responded to thrombin despite the laceration; hence, we cannot exclude the possibility that a vessel with a large arteriotomy site or laceration may respond to thrombin. Our results only show that either a lack of response to continued injection of thrombin or a repeated recurrence of the pseudoaneurysm after complete obliteration suggests that there may be an underlying vascular abnormality requiring surgical attention.
Although the thrombin dose did not significantly differ between our successfully and unsuccessfully treated patients, there was a tendency to use higher doses in those patients in whom treatment failed. Pfister et al. [16] evaluated the tolerance of the common femoral artery in a swine model to direct intraarterial administration of thrombin and found that thrombin-mediated thrombosis was directly related to thrombin dose and was inversely related to baseline blood flow in the common femoral artery. The volumetric flow within a common femoral artery pseudoaneurysm most likely depends on many anatomic factors (e.g., the neck diameter and volume of the pseudoaneurysm and the patient's blood pressure and cardiac output) and is also a function of time (declining to zero at the time of flow reversal). Although we did not attempt to quantify pseudoaneurysm volumetric flow by correlating, for example, mean velocities within the neck of the pseudoaneurysm with neck diameter, it follows intuitively that the larger the arteriotomy site is, the larger the mean volumetric flow is, all else being constant. Thus, the need for a large dose of thrombin to achieve a partially or an initially complete thrombosis may in part be an indicator of the volumetric flow of a pseudoaneurysm and thus an indirect indicator of the size of the arteriotomy site defect. This reasoning is speculative and requires confirmation through additional studies; however, we now perform closer clinical follow-up of patients who have required more than 1,000 U of thrombin to achieve thrombosis of a common femoral artery pseudoaneurysm. This thrombin value was chosen on the basis of the results of our study as well as those of several other investigators [7, 17].
In conclusion, although the inherently high success rate of this procedure resulted in a small number of patients with failed treatment, an iatrogenic pseudoaneurysm of the common femoral artery that is unresponsive to thrombin may be the result of a vascular injury, such as a laceration or infection. Such pseudoaneurysms can be sonographically occult and not prospectively identifiable. Early pseudoaneurysm recurrence (within 24 hr after treatment) should be viewed with suspicion and considered a potential selection criterion for surgical repair rather than reinjection.
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