Percutaneous Transluminal Dilatation of Inadvertent Partial or Complete Occlusion of the Femoral Artery (FULL TITLE BELOW)

FULL TITLE: Percutaneous Transluminal Dilatation of Inadvertent Partial or Complete Occlusion of the Femoral Artery Caused by Angio-Seal™ Deployment for Puncture Site Closure After Cardiac Catheterization

ABSTRACT: Background. The use of access-site closure devices in interventional cardiology has expanded rapidly in the past several years. Initial reports indicated remarkable safety with these devices but there are a small number of major complications. This single-center, retrospective study was carried out to investigate the efficacy of percutaneous transluminal angioplasty (PTA) of inadvertent occlusion or severe stenosis of the femoral artery after deployment of the Angio-Seal™ closure device. From April 1995 to August 2009 a total of 8,587 Angio-Seal™ devices were deployed immediately after cardiac catheterization. Within 7 days after deployment, clinical signs of acute arterial occlusion or severe stenosis of the femoral artery were evident in 6 patients (0.07 %). They were immediately referred for diagnostic angiography and subsequent PTA. Angiography revealed occlusion of the femoral artery at the puncture site level in 4 patients and a severe stenosis in 2 patients. Using a cross-over access from the opposite groin, PTA of the closed or highly stenosed femoral artery was feasible in all cases. At routine follow up 12 months thereafter, there was no clinical evidence of symptomatic restenosis. Inadvertent occlusion or high-grade stenosis of the femoral artery after Angio-Seal™ closure device deployment is a rare but severe complication. PTA appears to be a safe and effective method of treatment, avoiding surgical removal of the plug.

J INVASIVE CARDIOL 2010;22:353–357

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Arterial puncture closure devices (APCDs) have become increasingly common in cardiac vascular interventions.^1–3 The potential major advantage of these devices is to allow immediate sheath removal and hemostasis, even in patients with a high level of anticoagulation. This is time-saving, reduces costs and may avoid the infrequent local complications related to leaving intraarterial sheaths in place for prolonged periods.^4,5 APCDs have high rates of success, and their efficacy and safety have already been evaluated.^6–9 However, with increased usage of APCDs, reports of complications have emerged. The reported overall vascular complication rates range from 0.5–17%,^6,10–17 and 20–40% of these patients require surgical repair.^15,17,18 Vascular complications include pseudoaneurysm, arteriovenous fistula, hematoma, thrombosis, infection at the percutaneous access site and puncture site-related vessel stenosis or occlusion. So far, cardiovascular surgery has been the treatment of choice in cases of APCD-associated vessel occlusion.¹⁹ We describe our experience of percutaneous catheter-guided treatment of inadvertent occlusion or severe stenosis of the femoral artery after deployment of the Angio-Seal™ device.

Methods

Between April 1995 and August 2009, the completely absorbable Angio-Seal closure device (St. Jude Medical, St. Paul, Minnesota), composed of a collagen plug, a T-shaped anchor (a copolymer of polylactic and polyglycolic acids) and a traction suture was deployed in 8,587 patients undergoing cardiac catheterization. The device was applied in the catheterization laboratory immediately upon completion of the procedure and inserted into the puncture site according to the standard method with direct femoral arterial hemostasis by the intra-arterial anchor and the collagen plug on the outside of the artery wall. Six French (Fr) Angio-Seal devices were deployed after the use of 5 Fr and 6 Fr sheaths, and 8 Fr Angio-Seal devices were used to seal puncture sites created by 7 Fr sheaths. Angiography of the ileofemoral arteries was not routinely performed before deployment of the Angio-Seal closure device. Therefore, the decision to deploy the Angio-Seal device was made based on clinical criteria. The known evidence of highly calcified plaques of the femoral artery access site at the time of vessel puncture was regarded as the main contraindication to Angio-Seal use. Patients were placed on bedrest for 2 hours after device deployment. If occlusion or high-grade stenosis after deployment of the Angio-Seal device occurred, percutaneous transluminal angioplasty (PTA) was performed as the first-choice revascularization procedure if written informed consent of the patient was obtained. To evaluate any symptoms concerning claudication or lower-extremity ischemia, all patients were surveyed at 12-month follow up including a color-coded duplex ultrasound (DUS) of the femoral arteries and measurement of the ankle-brachial index (ABI).

Results

Out of 8,587 patients undergoing diagnostic or therapeutic coronary angiography in which the puncture site was closed with an Angio-Seal closure device, 6 patients (0.07%) suffered from an arterial occlusion or a severe stenosis of the femoral artery. The mean age was 64.7 years (range 58–72), and 4 patients were female. All patients had undergone therapeutic procedures including angioplasty and stent placement. Sheath size was 6 Fr in 4 patients and 7 Fr in 2 patients. Three patients complained of intense pain directly after deployment of the Angio-Seal device and developed acute limb ischemia with paleness and reduced sensitivity. Physical examination revealed an absence of peripheral pulses. Two patients presented with rest pain, paleness and coldness 2–4 hours after deployment of the Angio-Seal closure device. One patient presented a week later with a new onset of claudication, which he had already noticed after the intervention. Clinical assessment of this patient at discharge had only revealed a small hematoma of the groin area without an audible bruit. DUS showed in 3 cases that the Angio-Seal sponge with the attached collagen plug was completely deployed intra-arterially, resulting in an occlusion or severe stenosis (Figure 1) of the common femoral artery (CFA). In 2 patients, the anchor of the Angio-Seal device was trapped under a plaque of the posterior wall and retracted against the collagen plug which was clearly found outside the vessel wall of the CFA. In 1 patient, the Angio-Seal anchor was placed in the superficial femoral artery (SFA), leading to a significant stenosis. Angiographic results. Immediately, all of those patients underwent peripheral angiography of the lower limb using the “cross-over technique” by puncturing the opposite CFA. Angiographic findings showed an occlusion of the CFA in 4 patients and a severe stenosis of the CFA and SFA in 2 patients. Figure 2 demonstrates an arterial occlusion at the former access site of the CFA due to deployment of the entire Angio-Seal device intraluminally. Calcifications or plaque formation in the CFA were found in all patients suffering from femoral artery occlusion (Table 1). Percutaneous transluminal angioplasty. Femoral recanalization was performed using the cross-over technique by puncturing the opposite femoral artery and a 7 Fr multipurpose-catheter to cross over to the other side. After recanalization of the femoral artery occlusion by balloon dilatation over a wire, sufficient blood flow in the femoral artery with a palpable popliteal pulse was achieved in all patients (Figure 3). Distal embolization of components of the previously deployed Angio-Seal was ruled out by angiography after PTA. No stents were implanted. Concerning the Angio-Seal device-associated stenosis of the SFA, stenting was avoided due to the intention to reduce the amount of foreign material inside the lumen of the femoral artery as low as possible. Furthermore, we were afraid of stent trauma or deformation by the unsuccessfully deployed Angio-Seal closure device due to a lack of experience in such cases. Because of the prior vascular complications associated with the use of APCDs, hemostasis of the puncture site was achieved by manual compression 4 hours after PTA followed by a bandage for an additional period of 6 hours. All patients experienced an uneventful postinterventional course and were discharged within 4 days after admission. Due to previous coronary intervention with implantation of drug-eluting stents, all patients were treated with aspirin 100 mg and clopidogrel 75 mg once daily for 12 months. None of the 8,587 patients receiving an Angio-Seal device required surgical repair due to device-related complications. Follow up. Follow up was complete with a mean of 12 months and none of the patients required reintervention thereafter. All patients were doing well at the time of their visit and had no symptoms of claudication. DUS showed triphasic flow and no significant stenosis of the femoral artery on the previous access site (Figure 4). The measurements of the DUS and the ABI are shown in Table 2. Due to claudication in the opposite lower limb, peripheral angiography was performed in 1 patient showing an asymptomatic mild stenosis at the former access site (Figure 5).

Discussion

Hemostasis has been successfully obtained in nearly 99% of patients in whom the Angio-Seal closure device was used.²⁰ Applegate et al showed that deployment of the Angio-Seal closure device was associated with similar or even lower vascular complications than manual compression, depending on the generation of Angio-Seal device analyzed. In a prospective registry of 9,823 consecutive patients receiving the Angio-Seal closure device or the Perclose system, the overall failure rate of APCDs was 2.7%.²¹ Hence, APCD failure is rare, but is associated with a significant increase in the risk of vascular complications.²¹ Complications of APCD such as infection, hemorrhage, local hematoma, pseudoaneurysm, arteriovenous fistula or vessel occlusion varies between 0.5% for diagnostic catheterization^10,11,14 and up to 17% among patients undergoing coronary stent implantation due to more complex interventions requiring larger sheaths and more aggressive anticoagulation.^12,22,23 In particular, the rising usage of the Angio-Seal device increases the risk of device-related severe complications such as laceration of the puncture site, embolization of various components,^24,25 infection^26,27 and arterial obstruction due to local injury, embolization or spasm.²⁸ Particular concern has been expressed about the most worrisome complication of femoral artery occlusion being found in 0.36–0.67% of cases,^19,23,29,30 but as shown in our study, this complication seems to be extremely rare in “high-volume users” with an occurrence of 6 cases out of 8,587 Angio-Seal applications (0.07%). Interestingly, an appreciable effect of a learning curve for the experienced interventionist using the Angio-Seal device could be assumed in our study because 5 of the 6 above-mentioned cases occurred during the first half of the study period. Hemostasis with the Angio-Seal device is achieved by compressing the arterial puncture site between the anchor and the collagen plug. In 2 patients of our series, the intra-arterial T-shaped anchor was entrapped under a posterior plaque, resulting in femoral occlusion by retracting the anchor against the plug located outside the arterial wall. A similar mechanism was found in 3 patients, with the difference being that the collagen plug was inserted through the vessel wall against the anchor which had been trapped under an atherosclerotic plaque, leading to total intra-arterial deployment of the device. The common cause of malfunction of the Angio-Seal device in these 5 patients was the presence of atherosclerotic plaques in the CFA. The coincidence of preexisting peripheral atherosclerosis and malfunction of APCD is supported by other reports, which have also found that atherosclerosis of the femoral vessels contributed to vessel occlusion.³¹ These findings claim for caution about the use of the Angio-Seal device in patients with severe atherosclerotic changes of the CFA. Other risk factors for occlusive complications seem to be obesity, in which the technical procedure is more difficult and an early reapplication of the Angio-Seal device via the same access site within 90 days which is required for resorption of the device components.³⁰ Furthermore, as shown in 1 patient in our series, deployment of the Angio-Seal device should be avoided if the puncture site is at or below the femoral bifurcation because the SFA appears to be too small for application of this device, making vessel occlusion more likely to occur. The most favorable location of a femoral puncture site is generally accepted to be over the femoral head, above the femoral bifurcation and below the inguinal ligament.³² Puncture in this ideal target zone seems to prevent vascular complications. In our series, 5 patients had their puncture within this safe zone. Consistently to a recent study by Ahmed et al³³ showing a 2.6 times higher risk of severe access complications in women than in men, 4 of our 6 patients with vascular occlusion/stenosis after failed APCD deployment were female, although just 36% of the 8,587 patients receiving an Angio-Seal closure device were women. This is thought to be related to smaller arterial diameters in women. As a consequence, and in accordance with Turi,³⁴ an ileo-femoral angiogram before APCD deployment should be performed via the arterial sheath both to confirm the correct arteriotomy site, appropriate vessel diameter > 5 mm and to exclude preexisting peripheral artery disease because its disadvantages — increased amount of contrast dye and higher radiation exposure, especially due to closer position of the interventional cardiologist to the X-ray source — are outweighed by its benefit. Since this study, an ileofemoral angiogram is mandatory before deployment of APCDs at our institution, reflecting the concerns that these severe complications might have been prevented by angiographic visualization of the puncture site. Alternatively, predeployment DUS can identify those patients at risk for ischemic complications after insertion of an Angio-Seal closure device. Usually, patients with APCD-related occlusions of the femoral artery are treated by surgical removal of the dislodged anchor with thrombectomy and endarterectomy followed by vessel closure with a dacron patch or direct suture. Gemmete et al³⁵ and Jang et al³⁶ showed that endovascular repair by means of balloon angioplasty is a rational option for treatment of femoral artery stenosis caused by suture-mediated APCDs like the Perclose closure device. As to collagen plug-mediated APCDs, our data demonstrate for the first time that a percutaneous approach for treatment of Angio-Seal device-induced occlusion of the femoral artery is feasible and effective in restoring blood flow with good short- and long-term results. The use of distal protection devices in this setting could be a rational option to prevent distal embolization. Despite avoiding stent implantation of the femoral artery due to fear of stent trauma and deformation caused by constant flexion at the inguinal ligament, there was no significant late arterial stenosis up to 12 months after Angio-Seal deployment in the reported cases. This is mainly due to the fact that the Angio-Seal is completely bioabsorbable within 60–90 days. In this context, we found no clinical events of peripheral embolization resulting from degradation of the resorbable components of the Angio-Seal device during follow up. Notwithstanding, due to the lack of a larger experience and studies, definite surgical repair with removal of the device should be the standard of treatment in cases of vessel occlusion from APCDs, but a percutaneous endovascular approach seems to be a feasible option in cases of increased risk of perioperative mortality. Study limitations. A couple of limitations of our study should be mentioned. First, it was a nonrandomized, retrospective, single-center study. Second, we did not record the frequency of other complications associated with the use of the Angio-Seal device such as retroperitoneal or groin hematoma, significant bleeding, pseudoaneurysm, arteriovenous fistula or infection. Third, we only used Angio-Seal and Star Close SE (Redwood City, California) as APCDs at our institution. Consequently, we could not assess the feasibility of PTA of closure device-related arterial occlusions or severe stenosis caused by other APCDs. It should be mentioned that Star Close SE-associated vessel occlusions have not occurred at our institution thus far. Finally, the study population was very small.

References

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Martin Brueck, MD*, Dirk Bandorski, MD*, Klaus Rauber, MD^§, Andreas Boening, MD^£ From the Departments of *Cardiology and §Diagnostic and Interventional Radiology, Clinic of Wetzlar, Germany, and the ^£Department of Cardiovascular Surgery, University of Giessen, Germany. The authors report no conflicts of interest or grant support concerning the content herein. Manuscript submitted March 30, 2010, provisional acceptance given April 12, 2010, final version accepted May 7, 2010. Address for correspondence: Martin Brueck, MD, Department of Cardiology, Clinic of Wetzlar, Forsthausstrasse 1, D-35578 Wetzlar, Germany. E-mail: Martin.Brueck@hkw.med.uni-giessen.de