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Ultrasonography |
1 From the Departments of Radiology (E.K.P., D.H.S., M.A.K., R.C.N., L.B.E.), Surgery (M.W.S.), and Cardiology (M.H.S.), Duke University Medical Center, Box 3808, Erwin Rd, Durham, NC 27710. Received April 16, 1999; revision requested June 10; revision received July 8; accepted July 26. Address correspondence to E.K.P. (e-mail: pauls003@mc.duke.edu).
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Abstract |
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MATERIALS AND METHODS: Twenty-six patients with iatrogenic femoral arterial pseudoaneurysms were treated with direct thrombin injection. With US guidance, a 22-gauge needle was placed into the pseudoaneurysm flow lumen and thrombin (mean volume, 0.35 mL; range, 0.10–0.60 mL) was injected with continuous color Doppler US guidance. Demographics, clinical variables, pseudoaneurysm characteristics, and results in these patients were compared with those in 281 consecutive patients who underwent US-guided compression repair.
RESULTS: The success rate of thrombin injection was 96% (25 of 26 patients), which was significantly higher than that of compression, 74% (209 of 281 patients) (P = .013). Twenty of 26 (77%) patients required a single injection, and six (23%) required two injections. Mean thrombosis time for thrombin injection was 6 seconds, compared with 41.5 minutes for compression. For thrombin injection, there were no complications, foot pulses did not change and no patients required conscious sedation. Follow-up US at 24 hours showed no recurrent pseudoaneurysms.
CONCLUSION: For the treatment of iatrogenic femoral arterial pseudoaneurysms, thrombin injection with US guidance appears to be superior to compression repair.
Index terms: Aneurysm, femoral, 921.4124, 921.444, 922.4124, 922.444, 923.4124, 923.444 • Aneurysm, therapy, 921.1264, 921.12986, 922.1264, 922.12986, 923.1264, 923.12986 • Interventional procedures, comparative studies, 921.1264, 921.12986, 922.1264, 922.12986, 923.1264, 923.12986 • Interventional procedures, complications, 92.126, 92.444 • Ultrasound (US), guidance, 921.12986, 922.12986, 923.12986
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Introduction |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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While compression is relatively safe and effective, it has considerable limitations (5–14). Specifically, the duration of compression is often lengthy, which hinders patient throughput within the US laboratory. The procedures are painful and must be performed by using intravenous conscious sedation. In addition, the success rate of US-guided compression is only 75% and is even lower when patients undergo anticoagulation (5,6,8,9,14). Finally, some pseudoaneurysms are not amenable to compression, including those in which it is not possible to arrest flow in the pseudoaneurysm neck, those associated with exquisite groin tenderness, and those arising above the inguinal ligament.
An alternative to compression has been reported recently (15–17). In 21 consecutive patients with iatrogenic femoral arterial pseudoaneurysms, Kang et al (16) used US to percutaneously inject thrombin directly into the pseudoaneurysm flow lumen. Fifteen of the 21 patients' pseudoaneurysms achieved thrombosis less than 20 seconds after a single injection of thrombin. Five of the remaining six patients' pseudoaneurysms achieved partial thrombosis after one injection but achieved complete thrombosis after a second injection. The one patient in whom the procedure failed had two pseudoaneurysms combined with an arteriovenous fistula. There were no procedure-related complications. Kang et al concluded that thrombin injection with US guidance is safe and effective.
On the basis of the promising results of Kang et al (16), we recently altered our approach and initiated a trial of treating pseudoaneurysms with direct thrombin injection with US guidance. The purpose of our study was to evaluate this technique and to compare the results with our experience with US-guided compression, while emphasizing differences in success rates, procedure times, and complication rates.
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MATERIALS AND METHODS |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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For this study, the compression group consisted of the 281 consecutive patients who underwent US-guided compression from January 1992 to September 1998. The US-guided thrombin injection group consisted of 33 patients who were offered direct thrombin injection for pseudoaneurysm treatment. These patients were referred to our laboratory from September 1998 to February 1999.
Patient charts and catheterization reports were reviewed by one author (L.B.E.) to determine the type of catheterization performed (diagnostic, angioplasty, stent placement with or without angioplasty, or other), the use of arterial sheaths and sheath size, the use of heparin at the time of sheath removal, and the interval from sheath removal to attempted repair.
In addition, the US images obtained before, during, and after the repair were reviewed by one author (L.B.E.) to determine the side and site of involvement, the largest single pseudoaneurysm dimension, the artery of origin, the number of pseudoaneurysm lobes, the pseudoaneurysm neck length and width, and the use of anticoagulation.
For the US-guided compression procedures, the duration of compression was recorded. For the thrombin injections, the number of needle passes, the total injected dose, the number of injections, the time to pseudoaneurysm thrombosis, and the use of conscious sedation were recorded.
US-guided manual compression was performed by using the technique of Fellmeth et al (3). Prior to compression, a US examination of the puncture site was performed by using real-time equipment (model 128XP, Acuson, Mountain View, Calif; model HDI 3000, Advanced Technology Laboratories, Bothell, Wash; or a model Logiq 700, GE Medical Systems, Milwaukee, Wis), with a variety of transducers ranging from 3.5 to 7.0 MHz.
After written informed consent was obtained, the transducer was oriented to demonstrate the pseudoaneurysm neck to the best advantage. Manual compression was applied to the neck for 10–20-minute periods to completely arrest flow into the pseudoaneurysm. Compression was released as briefly as possible between cycles to assess pseudoaneurysm thrombosis, to reposition the transducer, or to switch operators. Compression was continued until the pseudoaneurysm achieved thrombosis or until patient or operator fatigue compelled termination, at the discretion of the attending radiologist.
After compression, patients were instructed to lie in bed with the affected leg straight for 4–6 hours, with frequent groin checks. Follow-up color Doppler US examinations at 24–48 hours were not routinely performed in cases of successful thrombosis unless there was a compelling clinical indication such as a persistent pulsatile mass or bruit. Conscious sedation was employed by using intravenous injections of 50 µg of fentanyl citrate (Sublimaze; Elkins Sinn, Cherry Hill, NJ) and 1–2 mg of intravenous midazolam hydrochloride (Versed; Roche Laboratories, Nutley, NJ).
US-guided thrombin injection was performed by using the technique described by Kang et al (16). By using a Logiq 700 US unit (GE Medical Systems) equipped with a 5.0–7.5-MHz linear-array or curved linear-array transducer, the puncture site was scanned to determine the anatomy of the pseudoaneurysm. In particular, the relationship of the flow lumen to the underlying pseudoaneurysm neck and artery was delineated. The soft tissues surrounding the pseudoaneurysm were searched for evidence of an arteriovenous fistula or of multiple interconnecting pseudoaneurysm lobes. The artery and vein were confirmed to be patent.
After written informed consent was obtained from the patient and alternative therapies were discussed, the overlying skin was prepared with povidone iodine (Betadine; Purdue Frederick, Norwalk, Conn) and was covered with a sterile drape. The transducer was covered with a sterile sleeve. By using an attachable biopsy guide (GE Medical Systems), a 22-gauge spinal needle (Becton Dickinson, Franklin Lakes, NJ) was advanced into the flow lumen (Fig 1). The needle was preloaded with bovine thrombin (1,000 U/mL Thrombin JMI; Johnson and Johnson, Middleton, Wis) and was attached to a 1-mL syringe, also loaded with thrombin.
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To maximize needle visualization during placement, it often was necessary to turn off the color Doppler US component of the duplex imager and use gray-scale imaging alone (Fig 2). Once the needle was positioned appropriately in the flow lumen, it was necessary to restore color Doppler US imaging to monitor the effect of the injected thrombin on flow. After confirmation of the needle position in the flow lumen, 0.1–0.3 mL (100–300 U) of thrombin was injected over 3–5 seconds. In many cases, the injected thrombin was seen as a color "jet" emanating from the needle tip.
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After the injection of thrombin, patients were instructed to lie in bed with the affected leg straight for 6 hours, with frequent groin and foot pulse checks. Follow-up color Doppler US was performed 1 day later. For both the compression and thrombin procedures, a success was considered to be complete thrombosis of the flow lumen.
The patients who were treated with thrombin injection were compared with the patients treated with compression. Patient demographics, clinical variables, and pseudoaneurysm characteristics were compared by using the Pearson 
2 (categorical variables) or paired t (continuous variables) tests. The success rates of the thrombin injection and compression procedures were compared. Success rates were compared when the thrombin injection or compression was used either as the initial form of therapy or as the initial and final forms of therapy. Statistical test results were considered to indicate significance at P values of .05 or less.
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RESULTS |
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TOPAbstractIntroductionMATERIALS AND METHODSRESULTSDISCUSSIONReferences |
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Of the remaining 32 patients, 20 underwent thrombin injection as the initial and primary therapy for pseudoaneurysm treatment, and 12 patients were referred for compression instead of thrombin injection because the referring physicians were unfamiliar with the new technique. In these 12 patients, compression was successful in four. Of the eight patients in whom compression failed, six underwent subsequent successful thrombin injection, one underwent surgical repair, and one eventually had spontaneous thrombosis. Thus, to date, thrombin injection has been used to treat 26 patients with pseudoaneurysms.
The mean dose of thrombin was 0.35 mL (350 U) but ranged from as low as 0.05 mL (50 U) to as much as 0.60 mL (600 U). In six patients, complete thrombosis of the flow lumen was achieved with a dose of 0.10 mL (100 U) or less.
Twenty of the 26 (77%) patients required a single needle pass and a single thrombin injection. Six of the 26 (23%) patients had only partial thrombosis of the flow lumen after the first injection and required a second injection. For these patients, it usually was necessary to simply advance the needle several millimeters into the patent portion of the flow lumen. However, one patient required two separate skin punctures to appropriately position the needle into the flow lumen.
The injection of thrombin causes thrombosis to occur extremely quickly. In the 20 patients who had a single injection, the mean time for complete thrombosis was 6 seconds, with a range of 3–20 seconds. In the six patients who required more than one injection, partial thrombosis of the lumen occurred within seconds, although there continued to be residual flow. In these patients, the total time to complete thrombosis increased by 2–5 minutes, which reflected the time required to reposition the needle and inject the second dose.
Although the groin site was tender to palpation in most patients, the passage of the 22-gauge needle into the pseudoaneurysm was well tolerated by all, even though lidocaine hydrochloride (Lidocaine; Abbott Laboratories, North Chicago, Ill) was used to anesthetize the skin in only three patients. In all patients, the injection of the thrombin itself was painless.
In 25 of 26 patients, the injection of thrombin achieved complete thrombosis of the flow lumen. In one patient, there was a tiny amount of residual flow in the pseudoaneurysm lumen after two injections of 0.30 mL each. Because this residual flow was tiny and was close to the artery, a third needle injection was not attempted. At the 24-hour follow-up examination, there was a slight increase in the size of the persistent flow lumen. Repeat thrombin injection was performed, which resulted in the near-complete thrombosis of the residual flow lumen. US performed 1 day later showed complete thrombosis; no further intervention was required. This case was classified as a partial success.
In 23 of the remaining 25 patients, 24-hour follow-up groin US was performed. In these 23 patients, follow-up US showed complete thrombosis of the flow lumen.
In six of the 26 patients, there was residual flow in the pseudoaneurysm neck immediately after the injection of thrombin. In four of these patients, 24-hour follow-up US showed complete thrombosis of the pseudoaneurysm neck. In two of the six, there was a tiny amount of residual flow in the pseudoaneurysm neck at 24-hour follow-up US. No further intervention was performed in these two patients, and they were discharged.
There were no cases of a recurrent pseudoaneurysm at the 24-hour follow-up US examination. There were no complications as a result of the procedure. In all cases, US showed that the femoral artery and vein were patent immediately and 24 hours after the injection. In all cases, the strength of the foot pulses was unchanged after injection.
Tables 1 and 2 provide a comparison of the demographics, clinical variables, and pseudoaneurysm characteristics of patients treated before and after the thrombin technique was adopted. The two groups were similar in sex distribution, age, side of the body on which the pseudoaneurysm was located, and sheath size. The pseudoaneurysms were similar in chronicity, number of lobes, and neck length.
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Nine of 26 (35%) patients who underwent thrombin injection received heparin at the time of the injection. All nine (100%) underwent thrombosis successfully. In the patients who received heparin, the mean volume of injected thrombin was 0.26 mL. The mean time to thrombosis in the patients who underwent anticoagulation was 12 seconds. In comparison, 14 of 281 (5%) patients underwent anticoagulation at the time of compression. Of these 14 patients, five (36%) underwent thrombosis successfully with compression.
The success rates with the two techniques were compared in two ways. First, the success rates for the initial therapies performed, thrombin injection versus compression, were compared. Second, the success rates for the final therapies performed, thrombin injection versus compression, were compared. This latter comparison included all 26 thrombin injection cases, whether performed as the initial technique or after a failed compression attempt, and all the compressions, whether performed as the initial or final procedure. For both comparisons, the success rates with thrombin injection were significantly higher than the success rates with compression (Table 3).
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DISCUSSION |
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Thrombin is a potent enzyme that transforms fibrinogen to fibrin, the critical component of blood coagulation. Bovine thrombin has been used widely as a topical agent or as a spray after vascular or cardiac surgery and has been used to achieve thrombosis in esophageal varices (18). For these applications, it has proved to be both safe and effective.
While the percutaneous injection of thrombin directly into a flowing pseudoaneurysm with US guidance was described recently (16), others have used thrombin, fibrin adhesive, glue, or a detachable balloon for the treatment of pseudoaneurysms (19–23). Loose and Haslam (24) successfully treated 13 patients with peripheral pseudoaneurysms by injecting thrombin percutaneously with US guidance after advancing a vascular catheter with an occlusion balloon into the femoral artery to arrest flow to the pseudoaneurysm. While these techniques proved effective, the placement of a catheter selectively into a pseudoaneurysm neck or into the underlying artery from the contralateral groin can be risky, time-consuming, and technically difficult and likely requires more time than compression repair itself.
One could argue that a prudent approach for pseudoaneurysm thrombosis would be first to apply compression with a transducer to arrest flow into the neck and then to inject the thrombin into the lumen to promote thrombosis. A potential drawback of this approach, however, is that when compression is applied, the pseudoaneurysm anatomy is considerably distorted, which hinders accurate needle placement. In addition, the swirling flow of a pseudoaneurysm likely mixes and evenly distributes the thrombin in the lumen, which leads to complete thrombosis. It is our impression that when thrombin is injected, a relatively large clot forms quickly and is trapped within the lumen, since it exceeds the size of the pseudoaneurysm neck (16).
Our case-control study design allowed the direct comparison of the two techniques. While the patients were similar, the thrombin injection group had a higher percentage of patients who underwent angioplasty and a higher proportion of patients who underwent anticoagulation. Such patients are particularly difficult to treat successfully with compression, and therefore the composition of the thrombin injection cohort would be expected to bias results against thrombin injection therapy. Despite this potential bias, thrombin injection proved superior to compression, which underscores the effectiveness of the thrombin injection technique.
The results of our initial work indicate that there are several other distinct advantages of thrombin injection over compression. Thrombin injection may be performed in pseudoaneurysms located above the inguinal ligament, which are contraindicated for compression because of the theoretic risk of intraperitoneal or extraperitoneal rupture (4).
In addition, our results corroborate the observation of Kang et al (16) that thrombin injection appears to be effective in the face of systemic heparin administration, whereas the success of compression clearly is reduced in patients who undergo anticoagulation (5,6,8,9,14). Heparin inhibits thrombosis by deactivating activated factor X and by inhibiting the conversion of prothrombin to thrombin. Thus, systemic heparin administration likely has little effect on the formation of a thrombus.
Finally, some pseudoaneurysms are not amenable to compression because, even with extreme effort, it simply is not possible to arrest flow through the pseudoaneurysm neck. These cases would be amenable to thrombin injection.
Perhaps the most welcome advantage of the thrombin injection technique is that the procedure is considerably quicker than compression. To add a compression procedure to an already overtaxed US schedule is onerous because the procedure occupies an examination room for 1–2 hours and is physically exhausting for both patients and physicians.
The thrombin injection procedure seems safe. There were no episodes of downstream arterial embolization. On the basis of our experience with 26 patients who received injections, the calculated 95% CIs suggest that the complication rate could range from as low as 0% to as high as 13%. While studies with larger patient numbers will be required to define the complication rate, our rate is similar to that in the study by Kang et al (16).
To our knowledge, two complications of thrombin injection for the treatment of pseudoaneurysms have been reported (25,26). Both occurred in pseudoaneurysms that resulted from brachial arterial puncture, and both were due to the embolization of the downstream arterial system. One of these was due to inadvertent injection into the pseudoaneurysm neck. Compared with femoral arterial pseudoaneurysms, pseudoaneurysms arising from the brachial artery tend to be smaller and have a short neck, presumably because the depth of the soft tissues about the arm is less than that about the groin.
It has been reported that some patients who receive injections of bovine thrombin may develop antibodies to bovine factor V, which may cross-react with human factor V and cause coagulopathy (27,28). While we did not test specifically for factor V antibodies, none of our patients had clinical evidence of a coagulopathic or thrombotic complication after the injection of thrombin.
There are some technical aspects of the thrombin injection procedure that should be highlighted. Thrombin is an extremely potent promoter of thrombosis. In fact, in six of our patients there was complete thrombosis of the pseudoaneurysm after injection of as little as 0.10 mL (100 U) of thrombin. In addition, the thrombus forms extremely quickly, often within 2–5 seconds after the injection. The potency of thrombin underscores the need for careful monitoring of thrombus formation during the injection. We use a small, 1-mL syringe to better control delivery and to reduce the possibility of inadvertently injecting so much thrombin as to precipitate an embolic complication.
Lest one inadvertently inject thrombin into an artery or pseudoaneurysm neck, it is critical to delineate the pseudoaneurysm anatomy prior to injection and to be aware of interpretive pitfalls (29). Equally important is familiarity with US needle-guidance techniques. It is imperative that the needle tip be placed precisely within the flow lumen. Injecting thrombin into a rim of thrombus at the margin of the flow lumen or into the adjacent soft tissues will fail to result in thrombosis. One should also avoid injection into that portion of the flow lumen where the blood flow is directed toward the pseudoaneurysm neck. If there is any doubt as to the location of the needle tip, thrombin injection is ill advised.
While the thrombin injection technique has proved to be relatively easy to perform and appears to be suitable for most patients with iatrogenic femoral arterial pseudoaneurysms, there are some scenarios in which an alternative technique may be more appropriate. It seems intuitive that pseudoaneurysms with short and wide necks would be at higher risk of downstream embolization than ones with long and thin necks. However, our experience indicates that even patients with pseudoaneurysm necks as short as 5 mm may undergo this procedure. In addition, some tiny pseudoaneurysms, particularly if deeply located, may be too small to accurately puncture with a needle. In this scenario, an alternative treatment such as compression repair or waiting for spontaneous thrombosis seems most prudent (30).
There are limitations to this study that should be discussed. Thrombin injection was performed in a relatively small number of patients. Larger patient numbers will be required to refine the indications, limitations, and complications of this technique.
In addition, our case-control design was less rigorous than that of a double-blind, randomized trial, and it is conceivable that an unidentified selection bias could have been introduced into our analysis. This said, the patient composition of the two treatment groups would tend to bias results against the thrombin injection group, yet our results appear to convincingly demonstrate the superiority of thrombin injection.
In addition, while our data show that pseudoaneurysms treated with thrombin injection maintain thrombosis after 24 hours, we do not have results of long-term US follow-up. Yet, we know of no patient with a recurrence after thrombin injection.
Finally, recently released mechanical devices to occlude the sheath track may decrease the overall incidence of pseudoaneurysm formation.
In summary, we believe that thrombin injection is a superior technique to compression repair. The results of our preliminary work suggest that for most iatrogenic femoral arterial pseudoaneurysms, thrombin injection should replace compression repair as the first line of therapy.
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Acknowledgments |
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Footnotes |
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References |
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