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J Am Coll Cardiol, 2002; 39:1297-1304 © 2002 by the American College of Cardiology Foundation |
a Heart Lung Center, Utrecht, The Netherlands
b Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands
Manuscript received September 25, 2001; revised manuscript received January 16, 2002, accepted January 28, 2002.
* Reprint requests and correspondence: Dr. Karim Hamraoui, Department of Cardiology, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands.
khamraoui{at}freeler.nl
| Abstract |
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BACKGROUND: The FAP is an infrequent but troublesome complication after percutaneous transfemoral catheter procedures. If ultrasound-guided compression repair (UGCR) fails, vascular surgery is indicated. We have developed a less invasive method to close FAPs percutaneously by injecting collagen and, thus, inducing clotting within the aneurysm.
METHODS: Via a 9F needle or 11F sheath, a biodegradable adhesive bovine collagen is injected percutaneously into the FAP, guided by angiography from the contralateral site.
RESULTS: From 1993 to 2000, compression and UGCR had failed to obliterate 110 FAPs. These patients have been treated by collagen injection. Mean age of the patients was 65.6 ± 10.2 years (range: 32 to 85 years), and 50% were women. Immediate closure of the FAP was achieved in 107/110 patients (97.3%) without any complication or adverse effect. In one patient the collagen could not be applied due to unfavorable anatomy. One patient needed a second session of collagen injection. In one patient too much collagen was inserted, which resulted in external compression of the artery, and surgical intervention was required. The overall success rate was 108/110 (98%, 95% confidence interval: 93.5% to 99.8%). Among the patients with successful procedures, there were no recurrences during six months follow-up.
CONCLUSIONS: The percutaneous treatment of iatrogenic FAP, by injection with collagen, is an effective and safe strategy. This method provides an excellent therapeutic alternative to the traditional surgical management.
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Several recent attempts have shown that minimal invasive management may be a reasonable alternative to achieve pseudoaneurysm thrombosis.
In the 1980s, we introduced the treatment with collagen insertion. We have developed a nonsurgical, minimally invasive method to close the FAP percutaneously with collagen. It has been our approach to use biodegradable adhesive bovine collagen to facilitate clotting within the false aneurysm and, thus, achieve the closure. The aim of this study was to evaluate the efficacy and safety of this method in a large consecutive group of patients with a FAP.
| Methods |
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These patients underwent ultrasound examination with duplex scanning along with pulsed and color Doppler flow mapping (Sonos 2000, Hewlett Packard, Amsterdam, the Netherlands) employing 7.5 MHz linear array transducer. The persistence of the FAP was defined as the presence of a hypoechogenic cavity with blood flow from the artery into the FAP in systole and inversely in diastole, visible by Doppler color flow imaging and pulsed ultrasound. Also, the size of the FAP was measured (Fig. 1).
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After our initial experience with collagen plugs, a biodegradable adhesive bovine collagen paste (Collagen, Datascope Corp., Montvale, New Jersey) was used to promote hemostasis and accelerate the clotting process within the pseudoaneurysm.
Contraindications to this procedure included suspected underlying infection and known allergy to collagen or beef products.
Procedure. Initially, the collagen was applied guided by selective angiography using the contralateral access site with a 4F sheath. After puncture of the contralateral femoral artery, the 4F catheter is introduced through the sheath and positioned across the iliac bifurcation in the affected proximal common femoral artery over a guidewire. The injection of iodine-containing contrast medium allows one to locate the FAP exactly and correctly, together with its tract and connections.
After applying routine local anesthesia with 1% lignocaine, the pseudoaneurysm cavity is then directly punctured, leading to high-pressure backflow of blood ensuring correct access to the pseudoaneurysm. The initial application of the Vasoseal (collagen plugs) required a larger 11F sheath. After puncture of the pseudoaneurysm, a guidewire was introduced through the needle to the pseudoaneurysm. The needle is then removed, leaving the guidewire in place. A sheath-dilatator is passed over the guidewire into the pseudoaneurysm cavity, and the guidewire and the dilatator are removed, leaving only the sheath through which VasoSeal plug could be inserted (Fig. 2). The application of the collagen paste allows use of a thinner needle. The pseudoaneurysm cavity is directly punctured percutaneously using a 9F needle. Then the collagen paste is applied directly through this 9F needle into the center of the FAP. This produces a very rapid filling and thrombosis of the pseudoaneurysm. After 1 to 2 min, a repeat angiogram is performed through the 4F sheath of the opposite access, to confirm aneurysm occlusion (Fig. 3).
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Data analysis. The hospital records of these patients were reviewed for the following information: age, gender, type of procedure, the time interval (in days) between arterial puncture and collagen injection. The lesion type and the localization (common, superficial or profunda femoral artery) were noted.
Statistical analysis. Only descriptive statistics were used. The 95% confidence intervals (CIs) for rates were calculated with the exact binomial method.
| Results |
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One patient had partial obliteration of the pseudoaneurysm and needed a second successful session of collagen injection. Closure of the pseudoaneurysm was confirmed by the cardiac catheterization laboratory with a second angiogram via the contralateral artery.
There was one failure; too much collagen paste was injected, with protrusion to the vessel without peripheral migration, which required surgical intervention. Otherwise, we observed no major complications. In particular, no peripheral embolic events were documented. No patients have developed another iatrogenic injury at the contralateral puncture site. No other adverse effects or local groin complications were observed.
Immediate procedural success with complete closure of the pseudoaneurysm was achieved by collagen injection in 107 of 109 cases (97.3%, 95% CI: 92.2% to 99.4%). With one case of delayed success, the overall success rate was 98.2% (108 of 109 patients, 95% CI: 93.5% to 99.8%) (Table 3).
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| Discussion |
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In the last decade, UCGR has become the treatment of choice (Fellmeth et al. 1991) (7,8). The introduction of this method has significantly reduced the need for surgical repair of FAP. Nevertheless, several restrictions for application of this method, such as long procedure times, discomfort of patients, relatively high recurrence rate in patients receiving anticoagulant therapy should be taken into consideration (710,1216). Furthermore, UGCR requires the availability of an ultrasound device and the presence of skilled personnel during the procedure.
Since the first description of an attempt to close a FAP by percutaneous thrombin injection in the FAP by Cope and Zeit (17) and subsequently Walker et al. (18) in 1986 and 1987, several publications inspired by this simplified technique have followed (1923).
The first attempts to close a FAP with ultrasound-guided thrombin injections were not without complications. Two cases of distal migration of the thrombin have been described (24,25). These adverse events raise the question: were these complications due to the nature of the injected thrombin or was it caused by the way it is used? We believe that, because thrombin is used in liquid form, it can easily diffuse from the cavity through the neck of the FAP toward the lumen of the artery or leave the cavity through an arteriovenous fistula. It is also possible that if the thrombin is injected in a too diluted concentration, it does not remain in the cavity of the FAP long enough to form a clot.
Furthermore, it has been described that patients receiving thrombin are at risk for developing anti-factor V antibodies, which may expose them to an immunologic cross-reaction to human factor V (26,27).
One of the other treatments that have been described for closure of FAP is the placement of a covered stent in the femoral artery. This appears not to be an ideal solution for FAPs that are located near the femoral bifurcation or the femoral artery itself. This precludes subsequent access of the femoral artery by the Judkins technique, which is not a desired situation in patients with coronary artery disease who may need percutaneous interventions in the future. Besides that, in 12% to 17% of patients, stent occlusion occurs within one year (28,29).
Collagen injection. We started to use collagen for the treatment of FAP in 1993. The initial results proved to be encouraging because the treatment was safe, efficacious and without complications. Eventually, this method was developed in our department as an alternative choice for either primary treatment of this iatrogenic pathology or treatment in the majority of cases where UGCR was unsuccessful.
Only in 1 of 110 (0.9%) patients, in whom a collagen closure attempt was not undertaken, this method appeared to be not feasible due to an unfavorable anatomy of the FAP. This results in an overall feasibility of 99.1%. In contrast to the aforementioned materials that have been used for percutaneous treatment of FAP, none of the 109 patients treated with collagen showed a local or systemic adverse reaction. Obliteration of the FAP cavity was achieved in 107 of 109 patients with a single collagen injection; in 1 patient an additional injection was required; this results in an initial success rate of 97.3% and a final success rate of 98.2%. These results rank collagen injection among the most successful minimally invasive percutaneous FAP closure techniques.
Injection of collagen is easily accepted by the patients, and during the procedure there was no need for systemic analgesic medication. Complete obliteration was usually achieved within some 10 s, which is comparable to thrombin closure. Whether or not the patient is receiving anticoagulant therapy does not appear to impair the results.
One therapy failure was noted. In this case, the failure was caused by the excessive amount of collagen that was to be injected. Surgical exploration of the groin showed that the FAP cavity was well obliterated, but collagen that was present around the FAP caused a compression of the vessel, without migration of the collagen into the arterial lumen. No other complications were noted.
The advantages of collagen lie in its physical-chemical properties. The fact that it consists of long paste fibers allows the collagen to remain within the FAP cavity, which putatively reduces the risk of migration through the neck of the FAP or through a fistula.
Due to its procedural simplicity, ultrasound-guided injection of thrombin remains an appealing treatment. We have performed the injection of collagen under fluoroscopic guiding because this made better angiographic visualization possible, but as with thrombin injection, ultrasound-guided injection of collagen is certainly feasible. The first FAP closures in our hospital were realized with the aid of a collagen plug, which was initially developed for closure of arterial puncture sites. However, insertion of collagen plugs in FAPs requires the use of large introducer sheaths (11F). Subsequently, the development of a paste-like application form of collagen permitted us to use smaller introducer sheaths (9F). At present, our research efforts are directed at developing a sponge-like application form of collagen. Then, small quantities of sponge-like collagen would suffice to obliterate the FAP cavity, the percutaneous injection of which could be monitored by ultrasound.
During 24-h follow-up, clinical inspection of the groin and lower extremities and ultrasound imaging did not reveal any recurrences or complications.
Our encouraging preliminary results need further verification and confirmation by a prospective trial comparing collagen closure with other forms of minimally invasive percutaneous closure of FAP. This will help to establish success rates, clinical efficacy and cost-effectiveness of the respective procedures.
Limitations of collagen injection. Utilizing puncture of the contralateral femoral artery to establish vascular access as was done in this study appears to make the procedure more complex. The reason for this approach was to achieve optimal sterility. In fact, we thought it initially to be difficult to guarantee procedural sterility if collagen injection is performed under ultrasound guidance. In the latter case, the sterile work space is narrow because of the presence of an ultrasound transducer and gel. Another limitation may be because this study was performed in a single center.
Conclusions. In view of our experience with direct injection of collagen, we are convinced that this technique is safe and efficacious, and these results suggest that this method may be used not only after failure of traditional closure techniques, but also as primary treatment of FAP. Collagen injection is a fast, expeditious method permitting early mobilization and discharge.
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