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Postcatheterization Pseudoaneurysms and Arteriovenous Fistulas: Repair with Percutaneous Implantation of Endovascular Covered Stents¹

¹ From the Franz Volhard Clinic at the Max Delbrück Center for Molecular Medicine, Universitätsklinikum Charité, Medical Faculty of Humboldt University, Campus Berlin-Buch, Wiltberg Strasse 50, 13125 Berlin, Germany. Received May 1, 1998; revision requested July 6; final revision received April 26, 1999; accepted July 6. Address reprint requests to C.T. (e-mail: thalhammer@em.uni-frankfurt.de)

	Abstract

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
PURPOSE: To assess the effectiveness and safety of endovascular covered stents in the management of pseudoaneurysms and arteriovenous fistulas after cardiac and vascular catheterization.

MATERIALS AND METHODS: Twenty-six endovascular covered stents were used to repair 16 pseudoaneurysms, nine arteriovenous fistulas, and one combined lesion after femoral arterial puncture for diagnostic coronary angiography and/or angioplasty. Fistulas and aneurysms were in the superficial femoral artery in 16 cases, in the deep femoral artery in six cases, and in the common femoral artery in four cases. Implantation was performed from the opposite femoral artery in most cases. It was not possible to treat three additional cases transcutaneously for technical reasons (three of 29 cases).

RESULTS: Percutaneous closure of the lesions with an endovascular covered stent was successful in 26 of 29 cases. Initial follow-up showed good stent patency. Two major complications were observed after stent implantation. During follow-up (about 1 year in 23 of 26 patients [88%]), stent thromboses were detected in four of 23 patients (17%) with follow-up color duplex flow imaging.

CONCLUSION: Implantation of endovascular covered stents is an effective and safe method for the percutaneous closure of pseudoaneurysms and arteriovenous fistulas. Thus, endoluminal vascular repair with covered stents offers an alternative therapeutic approach to vascular surgery in selected patients.

Index terms: Arteries, femoral, 92.1268, 92.12983, 92.12986, 92.458 • Arteriovenous malformations, extremities, 92.12983, 92.12986, 92.458, 92.716 • Fistula, arteriovenous, 92.12983, 92.12986, 92.458, 92.7173 • Interventional procedures, complications, 92.126, 92.458 • Stents and prostheses, 92.1268

	Introduction

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
Local complications after femoral arterial catheterization, such as hematomas, pseudoaneurysms, arteriovenous fistulas, and arterial occlusions, are becoming more common with the growing numbers of complex invasive procedures required in increasingly older and sicker patients (1–3). The reported incidence of both femoral pseudoaneurysms and arteriovenous fistulas is 0.02%–9% (1,4–9). Risk factors include older age (10,11), low femoral arterial puncture (7,12), aggressive anticoagulation and fibrinolytic therapy (10,11), large arterial sheath size (10), and valvuloplasty (4).

Use of color Doppler flow ultrasonography (US) has facilitated the diagnosis of pseudoaneurysms and arteriovenous fistulas (9,13–15). The treatment of these lesions has generally been surgical (16–18); however, today most pseudoaneurysms and many arteriovenous fistulas can be repaired with US-guided compression (19–25). Watchful waiting for spontaneous occlusion of the aneurysm has also been advocated (8,26–28); however, the possibility of a fatal pseudoaneurysm rupture, the necessity of anticoagulation, and the presence of substantial pain make this option less attractive (29–31).

Covered stents have recently been introduced and appear safe and effective for the treatment of abdominal aortic aneurysms (32–34), iliac arterial aneurysms (35–37), and popliteal arterial aneurysms (38). However, to our knowledge, no data are yet available on the effectiveness of covered stents in the treatment of groin pseudoaneurysms or arteriovenous fistulas. A single observation of a percutaneous closed arteriovenous iliac fistula was reported recently (39).

We implanted covered stents in the treatment of iatrogenic, postcatheterization, vascular injuries. Our patients had fistulas and pseudoaneurysms that failed to close with watchful waiting and US-guided compression therapy. Our purpose was to assess the effectiveness and safety of endovascular covered stents in the management of pseudoaneurysms and arteriovenous fistulas after cardiac and vascular catheterization.

	MATERIALS AND METHODS

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
Twenty-nine patients with groin pseudoaneurysms or arteriovenous fistulas were included in the study. Twenty-six patients (15 men and 11 women) were treated percutaneously with implantation of a covered stent (Cragg EndoPro System, Mintec, Bahamas; since 1997 called Passager Stent Graft, Meadox/Boston Scientific) for repair of postcatheterization femoral arterial injury. We considered this treatment in three additional patients. We elected to have surgical treatment performed in two patients because of an aneurysm at the bifurcation of the femoral artery. Contraindications for stent implantation were extreme elongation and tortuosity of the iliac artery and location of the complication directly at the femoral arterial bifurcation. In one patient, we were unsuccessful because of technical difficulties with catheter passage.

We initially treated only those patients in whom surgical intervention was considered particularly risky by our consulting vascular surgeons and anesthesiologists. As success was demonstrated, the indications for our procedure were extended to patients who could safely undergo vascular surgery.

All patients were explained the nature of their treatment and the alternatives, namely, general anesthesia and surgical intervention. All patients signed an informed consent statement. Our institutional review board chairman was fully informed of our work and deemed it unnecessary to undergo institutional review board approval. Intraarterial stent placement into coronary and peripheral vessels is viewed as a standard therapy in our hospital.

The patients' mean age was 67 years ± 11 (SD), and ages ranged from 50 to 86 years. The patients all had coronary and peripheral vascular disease. They were older, and all had smoked. Thus, most were high-risk candidates for general anesthesia and vascular surgery.

Color duplex flow US (Sonos 2000; Hewlett-Packard, Andover, Mass) showed a pseudoaneurysm in 16 patients (62%), an arteriovenous fistula in nine patients (35%), and a combined pseudoaneurysm and arteriovenous fistula in one patient (4%). Locations of the lesions were the superficial femoral artery in 16 patients (62%), the deep femoral artery in six patients (23%), and the common femoral artery in four patients (15%). The false aneurysms were invariably greater than 2 cm in diameter, were partially thrombosed and multiloculated, and were highly irregular in structure.

US-guided compression for 20–40 minutes combined with local compression was attempted in all patients to no avail. The lesions were identified at physical examination of the puncture site within 24 hours of the intervention. Compression of the lesions was generally attempted for several sessions until they were deemed intractable by the US operator.

Our patients had undergone coronary angiography, usually with coronary stent placement, prior to development of their complications. Many had congestive heart failure, and some had ventricular aneurysms. Thus, all underwent anticoagulation with 3,000 IU of low-molecular-weight heparin (Certoparine or Monoembolex; Sandoz, Nuremberg, Germany) while those receiving coronary stents also were routinely treated with ticlopidine hydrochloride (2 x 250 mg, Tiklyd; Sanofi Winthrop, Munich, Germany). All had recently received 100 mg of acetylsalicylic acid (Aspirin 100; Bayer, Leuerkusen, Germany). We cannot state for certain to what degree anticoagulation interfered with compression in terms of closing the lesions. However, we were not in a position to discontinue anticoagulation in our patients because of other possible clinical consequences.

Fifteen patients had undergone diagnostic cardiac catheterization, two patients had undergone catheterization because of electrophysiologic study findings, eight patients had undergone percutaneous transluminal coronary angioplasty, and one patient had undergone embolization of a septal branch for treatment of hypertrophic cardiomyopathy.

Three patients were considered for this treatment but could not be treated transcutaneously. In two patients, an aneurysm had developed at the femoral arterial bifurcation, which we elected not to treat. In one patient, we were unable to traverse an extremely tortuous iliac artery from the opposite side. All three patients were treated successfully surgically.

We employed a standard stent implantation technique. After local anesthetic (prilocaine hydrochloride [Xylonest 1%]; Astra, Wedel, Germany) was administered subcutaneously, a 5-F introducer sheath (Terumo, Tokyo, Japan) was inserted into the common femoral artery. All patients received a 10,000-IU heparin natrium (Liquemin N; Hoffmann-La Roche, Grenzach-Wyhlen, Germany) bolus intraarterially prior to selective angiography. Selective intraarterial angiography (iopromide [Ultravist-370; Schering, Berlin, Germany]) of the femoral artery was performed to image the vascular lesion.

By using a crossover technique in most patients, a stable 8-F introducer sheath 45 cm in length (Arrow International, Reading, Pa) was inserted via the aortic bifurcation. In the first six patients, we did not use a crossover approach but instead relied on an antegrade puncture technique. After crossing the lesion with a flexible hydrophilic guide wire (Compass; Mallinckrodt Medical, St Louis, Mo), a self-expandable nitinol stent covered with polyester fabric (diameter, 6–8 mm; length, 30 or 40 mm) was transported from the cartridge of the implantation system over the introducer sheath and was finally set free with a pusher. The covered stents did not cross the common femoral arterial bifurcation, and the origins of the deep and superficial femoral arteries were not compromised.

After the stents were deployed and the delivery system was withdrawn, balloon dilation up to 16-bar (1,680-Pa) pressure was performed inside the covered stent. The final result was angiographically confirmed.

Our institution is a tertiary care center in a health care system that clearly separates in-hospital patient care from ambulatory patient care. Patients can be examined in our institution only after referral from their personal physician. We offered to follow up the patients at regular intervals with color duplex flow imaging of the stents.

A clinical duplex US evaluation of the stents was carried out in 23 patients (88%), with a mean follow-up of 301 days ± 280 (range, 1–1,050 days). No clinical follow-up was possible in three patients (12%) who failed to keep their appointments.

	RESULTS

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
Twenty-six patients were treated percutaneously with implantation of a covered stent for repair of postcatheterization femoral arterial injury. In all patients, earlier treatment attempts with repeated US-guided compression had showed no success. Stent placement was technically possible and was successfully carried out in 26 of 29 patients. All the pseudoaneurysms and arteriovenous fistulas were totally closed in 26 patients. Patients were ambulatory the next day.

Representative examples from our patients are shown in the accompanying figures. Figure 1 shows a large pseudoaneurysm of the proximal superficial femoral artery before and after implantation of a covered stent. Figure 2 shows an arteriovenous fistula of the deep femoral artery before and after implantation of a covered stent. Figure 3 demonstrates color duplex flow imaging of a covered stent 2 years after implantation. The arteriovenous fistula of the superficial femoral artery was totally occluded, and the covered stent showed good patency, with laminar flow and only slight intimal hyperplasia.

View larger version (116K): [in this window] [in a new window] [Download PPT slide]   Figure 1a. Anteroposterior angiograms show pseudoaneurysm (arrow in a) of the superficial femoral artery (a) before and (b) after implantation of a covered stent. The clips (arrows in b) are radiopaque markers at the ends of the stent. Several branch vessels, now missing, were covered by the stent and had to be sacrificed.

View larger version (118K): [in this window] [in a new window] [Download PPT slide]   Figure 1b. Anteroposterior angiograms show pseudoaneurysm (arrow in a) of the superficial femoral artery (a) before and (b) after implantation of a covered stent. The clips (arrows in b) are radiopaque markers at the ends of the stent. Several branch vessels, now missing, were covered by the stent and had to be sacrificed.

View larger version (98K): [in this window] [in a new window] [Download PPT slide]   Figure 2a. Anteroposterior angiograms show arteriovenous fistula (arrows in a) of the deep femoral artery (a) before and (b) after implantation of a covered stent.

View larger version (107K): [in this window] [in a new window] [Download PPT slide]   Figure 2b. Anteroposterior angiograms show arteriovenous fistula (arrows in a) of the deep femoral artery (a) before and (b) after implantation of a covered stent.

View larger version (30K): [in this window] [in a new window] [Download PPT slide]   Figure 3a. Color duplex flow images (longitudinal view) of a covered stent 2 years after implantation to treat an arteriovenous fistula between the superficial femoral artery and vein. (a) B-mode US image shows the covered stent (arrows) in the superficial femoral artery. (b) Color duplex flow image shows that the arteriovenous fistula of the superficial femoral artery is totally occluded and that the covered stent shows good patency with laminar flow and only slight intimal hyperplasia (arrows), as demonstrated by a region with little echogenicity that lies between the column of flowing blood and the margins of the stent.

View larger version (48K): [in this window] [in a new window] [Download PPT slide]   Figure 3b. Color duplex flow images (longitudinal view) of a covered stent 2 years after implantation to treat an arteriovenous fistula between the superficial femoral artery and vein. (a) B-mode US image shows the covered stent (arrows) in the superficial femoral artery. (b) Color duplex flow image shows that the arteriovenous fistula of the superficial femoral artery is totally occluded and that the covered stent shows good patency with laminar flow and only slight intimal hyperplasia (arrows), as demonstrated by a region with little echogenicity that lies between the column of flowing blood and the margins of the stent.

In the 26 patients in whom stents were placed, we observed no kinking. As shown in Figure 1, stent placement can result in the loss of branch vessels. Fortunately, in no patient were we able to detect any clinical consequences from occluded vessels; therefore, we saw no need to check for occlusion. However, this possibility is not excluded and must be kept in mind by the operator.

In 19 of 23 patients (83%) who kept their follow-up appointments, color duplex flow imaging showed good stent patency without significant stenoses or clinically important intimal hyperplasia (Fig 3). Low-grade intimal hyperplasia was observed in a single patient. In the observation time, we observed four patients with stent occlusions (17%). Superficial femoral arterial occlusion at the site of the stent was seen in three patients and in the deep femoral artery in one patient. Surgical repair was required only in the patient with the deep femoral arterial stent occlusion. The stent was removed, and thromboendarterectomy was performed. No patch was placed and no femoral-popliteal arterial bypass proved to be necessary. The other three patients had only minimal flow impairment without symptoms in spite of their lesions because of good collateralization from the deep femoral artery. These patients required no further treatment.

We were unable to reexamine three patients, who did not keep their follow-up appointments. Since asymptomatic occlusion or referral to another institution was possible, we cannot conclude that these three patients have patent, well-functioning stents.

	DISCUSSION

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
We have presented the results of use of covered stents for femoral arterial injuries that could not be repaired with US-guided compression therapy. Our 29-patient study is the first comprehensive series to our knowledge in which this approach was used to treat iatrogenic pseudoaneurysms and arteriovenous fistulas. Stent placement was possible and successful in 26 of 29 patients, and the pseudoaneurysms and arteriovenous fistulas were totally closed. Three other patients were considered for this therapy. We elected to not treat two patients with aneurysms at the common femoral arterial bifurcation. In one patient, we misjudged how difficult traversing a tortuous iliac artery would be.

Many pseudoaneurysms and arteriovenous fistulas will respond to US-guided compression therapy (31). The natural history of stable pseudoaneurysms and arteriovenous fistulas is relatively benign because of frequent spontaneous resolution (8). In fact, in an earlier report (28), only 14% of patients required surgical repair of pseudoaneurysms or fistulas, while 89% of pseudoaneurysms and 81% of fistulas closed spontaneously. During our study, most of our patients with such complications were successfully treated conservatively, with watchful waiting. However, if this approach is not successful, these lesions are not benign.

Arteriovenous shunts of any degree are poorly tolerated in this patient population with heart disease. An arteriovenous fistula in a patient who undergoes hemodialysis generally steals about 1 L/min. The pseudoaneurysms are subject to the Laplace law and are likely to increase in size and cause further problems.

In some patients, US-guided compression therapy had not been attempted under ideal conditions because of concurrent administration of anticoagulants. In these patients, there is a need for an alternative percutaneous treatment. According to our results, stent placement in the femoral artery may be a safe and effective way to treat these patients, many of whom would be high-risk candidates for surgical repair. Our patients all had coronary disease in addition to peripheral vascular disease and presented a high surgical risk. However, we would have referred these patients for surgical intervention had we not been able to treat them with stent placement. We advocate placement of a stent, even in patients who otherwise can tolerate surgery.

We observed two major complications after stent placement. However, these incidents were not directly related to the intervention itself. In our opinion, the major contraindication for stent implantation is the presence of lesions near the femoral arterial bifurcation because of the danger of occlusion of the deep or superficial femoral artery after stent placement. Our patients were older, had other vascular complications, and were viewed as high-risk surgical candidates.

The covered stent could provide disadvantages for younger patients with a long life expectancy, since the long-term consequences of implanting covered stents are not known for certain. Conceivably, implantation of a stent limits the accessibility to the cardiovascular system for subsequent catheterizations. Persons with coronary disease are likely to require multiple catheterizations because of disease recurrence in their native vessels or grafts. Our patients now have unilateral stents and can undergo subsequent catheterization on the opposite side.

Moreover, most of the stents lie in the superficial femoral artery and do not extend to the common femoral artery, which is the site of catheterization. To our knowledge, no information is available on the safety of puncturing a stent. Because of these considerations, the conditions of young patients who are good surgical candidates may warrant surgery rather than stent implantation.

Another advantage of stent implantation compared with surgical repair is the patients' rapid return to ambulatory activity. The patients were generally out of bed the next morning, were ambulatory, and could leave the hospital the day after getting out of bed.

Cost considerations also are important. The cost of the stent itself (approximately U.S. $1,500 in Germany), of the expenses incurred by the catheterization laboratory and its personnel, and of the shorter hospitalization time compare favorably with the costs of surgical intervention.

We conclude that implantation of covered stents is an effective and safe method for the percutaneous closure of pseudoaneurysms and arteriovenous fistulas. The approach is particularly helpful in high-risk patients and provides a good alternative to surgical repair. A prospective randomized trial would more carefully delineate the role of this procedure.

	Acknowledgments

 
We thank Friedrich C. Luft, MD, for helping us with the text.

	Footnotes

 
Author contributions: Guarantor of integrity of entire study, C.T.; study concepts and design, C.T.; definition of intellectual content, C.T.; literature research, C.T., A.S.K.; clinical studies, C.T., A.S.K.; data acquisition, F.U., J.W.; data analysis, C.T., A.S.K.; manuscript preparation and review, C.M.G.; manuscript editing, J.W.

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TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 

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