Control of local haemostasis with the AngioSeal® vascular closure device in peripheral endovascular interventions via 6-9 F femoral artery access

Background

Local complications at the site of vascular access such as large subcutaneous haematoma, pseudoaneurysm, arteriovenous fistula, ischaemia of the limb or local infection complicating percutaneous cardiovascular interventions significantly increase periprocedural morbidity, prolong the hospitalization period and may affect periprocedural mortality [1].

Current coronary interventions are frequently completed with the implantation of vascular closure device instead of using conventional hemostasis (removal of the sheath after 4-6 h followed by compression dressing for 6-8 h), which allows rapid cessation of bleeding from the arterial access and earlier patient mobilization. The AngioSeal® 6 F vascular closure device is frequently used to control local haemostasis (femoral artery) after coronary interventions (6 F). However, there are no systematic analyses regarding the application of this device for peripheral interventions. Moreover it should be noted that this peripheral procedure usually requires vascular access with the use of a larger (i.e. 8-9 F) cannula.

Aim

The aim of the study was to evaluate the efficacy of the 6 F and 8 F vascular closure device AngioSeal® in the reduction of local complications related to vascular access (femoral artery) and its influence on the timing of patient mobilization and hospital discharge after percutaneous interventions on carotid and peripheral arteries (femoral access with 6-9 F cannula).

Material and methods

Two hundred and one consecutive patients between 48 and 87 years of age (59.2% male, mean 66.9 ±8 years) undergoing percutaneous interventions on carotid, vertebral or peripheral arteries (internal carotid artery (n = 140), comon carotid artery (n = 3), vertebral artery (n = 32), iliac/femoral atery-contralateral access (n = 9), subclavian artery (n = 12), renal artery (n = 2), innominate artery (n = 2) or cervical-subclavian bypass) was randomized (1 : 1 ratio). Seven of the 98 patients (7%, 48-87 years of age, mean 66.85 ±8 years) randomized prior to the procedure to the AngioSeal® device had angiographic contraindications to the use of this device (arterial puncture at the site of common iliac artery bifurcation, diffused atherosclerosis of the punctured artery, vessel diameter < 5 mm) and thus required conventional haemostasis (Figures 1-2). Therefore the MC group (manual compression-removal of the vascular sheath from the femoral artery after 4-6 h followed by compression dressing for 6-8 h) included finally 110 patients and the AS group consisted of 91 patients. There was no difference between groups in terms of sex or age (AS – 58.2% male, 66.8 ±8 years of age, MC – 60.0% male, 66.7 ±9 years of age). Patient characteristics are presented in Table 1. The 6 F closure device was used after femoral artery cannulation with 6 F (n = 24) or 7 F (n = 1) sheaths and an 8 F device was applied after cannulations with 8 F (n = 65) or 9 F (n = 1) introducers. All patients (AS and MC) were on dual antiplatelet therapy (aspirin 75 mg + + clopidogrel 75 mg) and unfractionated heparin was used during the procedure to achieve activated coagulation time (ACT) > 250 s. Oral anticoagulant therapy was stopped before the procedure in all patients on chronic treatment with acenocoumarol/warfarin (n = 2 for AS – 2.2%, n = 1 for MC – 0.9%) to obtain INR < 1.4 allowing an elective percutaneous intervention. Subcutaneous injections of low molecular weight heparin were stopped for at least 12 h prior to the procedure and after the procedure in all patients on this type of therapy (n = 4 for the AS group; n = 1 for the MC group, 0.9%). Mean INR value in the AS group before the procedure was 1.07 ±0.16 vs. and in the MC group 1.06 ±0.13 (p = 0.79). Mean platelet count (PLT) was 212.48 ±57.05 in the AS group and 218.48 ±61.193 in the MC group (p = 0.532).

Local conditions at the site of vascular access were assessed (physical examination and dopler duplex was needed) directly after the implantation of the device, 1-3 h after the procedure, and at discharge from the hospital.



Statistical analysis



Qualitative variables are shown as percentages and number of cases in each group. Quantitative variables are presented as mean ± standard deviation and minimal and maximal values. Chi-square test or Fisher’s exact test was used to compare qualitative variables, where appropriate. Quantitative variables were compared using Student’s t-test or Mann-Whitney U test, when appropriate. Normality of distribution was assessed with the Shapiro-Wilk test, and Levene test was used to assess the equality of variances.

Analyses were performed with the R software (version 2.13.0) and with two-sided significance level of  = 0.05.

Results

The following complications occurred in the MC (n = 110) vs. the AS (n = 91) group: acute lower limb ischaemia requiring surgical intervention – 1 (0.9%) vs. 0 (0%) (p = 1.0); pseudoaneurysm – 5 (4.5%) vs. 0 (0%) (p = 0.065); arteriovenous fistula – 1 (0.9%) vs. 0 (0%) (p = 1.0); large subcutaneous haematoma – 13 (11.8%) vs. 6 (6.6%) (p = 0.235). Complications after the use of 6 F-9 F introducers in patients from the MC and the AS group are presented in Table 2 A.

Complications including large subcutaneous haematoma (> 10 cm according to the American College of Cardiology/American Heart Association) [2], arteriovenous fistula, pseudoaneurysm, and acute lower limb ischaemia occurred in 13.8% of patients after MC vs. 4.0% after AS (p = 0.36) for cannulation with 6-7 F sheaths and in 19.7% after MC vs. 7.6% after AS (p = 0.035) for cannulation with 8-9 F sheaths (Table 2 B). In total, complications including acute limb ischaemia, pseudoaneurysm, large subcutaneous haematoma, and arteriovenous fistula occurred in 20 patients after MC (18.2%) vs. 6 patients after AS (6.6%) (p = 0.019) irrespective of the sheath size (Table 2 B). Pseudoaneurysms found after MC required blood transfusion in 1 case, thrombin injection in 1 case and ultrasound-guided mechanical compression in 4 cases. There were no cases of pulmonary embolism or infection of the access site observed in any of the groups.

Mean decrease of haematocrit (HCT) values after the procedure in the AS vs. the MC group was 3.93 ±1.95% vs. 4.19 ±2.53% (p = 0.4289). Mean decrease of haemoglobin (Hgb) level in the AS vs. the MC group was 1.37 ±0.62 vs. 1.49 ±0.89 (p = 0.288).

Patients with AS were mobilized after 1-12 h (mean 2.90 ±2.4 h) vs. 8.66-19.33 h (mean 14.18 ±2.28 h) for MC (p < 0.001) (Figure 3). Nine patients with AS (9.9%) required an additional compression dressing for 6-12 h due to prolonged bleeding from the access site despite the collagen plug use. This was associated with occurrence of a large subcutaneous haematoma in 6 cases (5 for the 8 F device and 1 for the 6 F device, 4.4%). Patients who received MC were discharged from the hospital after 24-240 h (mean: 68.1 ±34.08 h) vs. 24-72 h (mean: 33.6 ±14.16 h) for AS (p = 0.001) (Figure 4).

In one case, implantation of the 8 F AngioSeal® device was complicated by distal mobilisation of the device anchor with the blood flow. There were no symptoms of limb ischaemia and the access site was controlled with standard manual compression.

Discussion

Several prior studies demonstrated the efficacy and safety of the AngioSeal® vascular closure device for coronary interventions with a 6 F vascular access. In contrast, the present study systematically assessed the use of the 6 F and 8 F AngioSeal® vascular closure device for interventions on peripheral arteries via femoral access (6 F device after 6-7 F sheats and 8 F device after 8-9 F sheats). Most of the procedures involved an internal carotid artery (n = 140, 69%) which required an 8 F and 9 F cannula to allow the use of the neuroprotective systems.

According to the AS instruction for use and pior reports we have avoided the use of the vascular closure device in the case of severly diseased arteries, especially when the vessel diameter was below 5 mm, if significant atherosclerotic lesions were localized within the distance of 5 mm from the puncture site or when they caused a 40% reduction of the vascular lumen (less advanced changes were a relative contraindication) [3]. The AngioSeal® device was also not used in the case of a femoral artery bifurcation or a superficial/deep femoral artery puncture [3]. Importantly angiography of the femoral artery was performed in each case in our study prior to the AngioSeal® use. Femoral angiogram was assessed for the presence of significant lesions of the arterial wall at the site of the puncture. In the case of contraindications to the use of the device (7/98 patients randomized to AngioSeal® – 7.0%) a classic compression dressing was applied. Longer time of hospitalization of patients after manual compression was caused not only by the longer time of immobilization, but also by more frequent and more severe complications such as pseudoaneurysms and lower limb ischaemia. On the other hand successful haemostasis was not obtained in all of the patients who received the AngioSeal® device. Nine patients in the AngioSeal® group still required the use of a classic compression dressing due to prolonged bleeding and six of them developed a large subcutaneous haematoma. In 1 case implantation of the AngioSeal® device was complicated by a rupture of a Dexon suture with intra-arterial distal dislocation of the device anchor. In this patient manual compression was performed and subsequently a full dose of low molecular weight heparin (1 mg/kg s.c. every 12 h) was administrated for 3 days to prevent lower limb ischaemia (embolisation by the polymeric fragment – 1 mm × 2 mm × 10 mm). There were no symptoms of ischaemia during the hospitalization or during ambulatory visits which followed.

One patient from the MC group cannulated with an 8 F introducer who underwent successful angioplasty of the internal carotid artery presented symptoms of acute lower limb ischaemia 6 h after the procedure caused by thrombosis of the superficial and deep femoral artery. The patient had diffused atherosclerotic lesions in femoral and iliac arteries. She required two emergency surgical interventions: the first one consisted of trombi removal followed by angioplasty with implantation of an arterial patch; the second one wich took place after reccurence of thrombosis in the index location, was a hybrid procedure consisting of angioplasty of the common iliac artery, reopening of the superficial femoral artery with stent implantation and implantation of venous femoro-femoral bypass which led to the resolution of symptoms.

Several cases of acute and chronic limb ischaemia related to the AngioSeal® device implantation have been described previously. These occurred after implantation of the device in the atherosclerotically changed vessel or in the superficial femoral artery, after dissection of the atherosclerotic plaque or after thrombosis leading to occlusion of the artery [4-9]. In some cases a collagen plug was found intra-operatively in the lumen of the superficial femoral artery [4, 10]. These patients required percutaneous [11] or surgical [4-6] interventions due to limb ischaemia. All of the procedures succesful and no symptoms of ischaemia were observed during follow-up were reported. There is also a description of a patient in whom elements of the AngioSeal® device did not undergo biodegradation and who had a critical stenosis of the vessel caused by excessive proliferation of the connective tissue at the site of the intravasculary located anchor of the device [9]. An attempted percutaneous intervention led to distal embolization and occlusion of the trifurcating popliteal artery. The patient underwent a successful surgical procedure and did not present symptoms of ischaemia during subsequent observation [10]. Less severe symptoms of ischaemia including claudication of the lower limb after the AngioSeal® device implantation were also described [6]. In this case the patient remained under ambulatory follow-up because of the lack of symptoms of severe ischaemia. The symptoms were milder and eventually resolved with the end of biodegradation of the intravascular elements of the AngioSeal® device. The patient did not require interventional treatment [6]. Most of the studies report similar to ours frequency of local complications for the AngioSeal® device such as large subcutaneous haematoma, pseudoaneurysm, arteriovenous fistula, and limb ischaemia in comparison to the use of classic compression dressing [3, 12-18]. In one of the studies there was a tendency towards higher frequency of local complications in female patients, which was probably related to the lower diameter of the femoral artery in comparison to male patients [19]. Retrospective series by Assali et al. [20] and Dangas et al. [21] suggested a higher frequency of local complications after coronary interventions in patients who received vascular closure devices (including the AngioSeal® device) in comparison to patients who had a compression dressing, but the number of patients with the AngioSeal® device was approximately 4-fold [20] or even over 13-fold [21] lower than patients with conventional haemostasis. Also, implantation of the AngioSeal® device was not routinelly preceded in by angiography of the ipsilateral femoral artery. In a large group of patients, Carey et al. [22] reported that the use of the AngioSeal® device increased the risk of limb ischaemia in comparison to manual compression. However, in contrast to our strategy, angiography of the femoral artery was not performed routinely before implantation of the AngioSeal® device and therefore interpretation of the results of this study should be done with caution.

Other AS complications such as pseudoaneurysms resolved spontaneously [7] after manual compression or were successfully treated with surgery in some patients.

Koreny et al. [23] in 2004 and Biancari et al. [24] in 2009 performed a meta-analysis of approximately 30 prospective, randomized studies assessing the efficacy and safety of different types of vascular closure devices (including the AngioSeal®) in comparison to conventional haemostasis for the closure of femoral access, mainly after coronary interventions, and found a tendency towards higher frequency of local complications related to the use of these vascular devices (including the AngioSeal®). Interpretation of the results of these studies is limited by high heterogeneity of the compared groups, differences in end-point definitions (regarding for example the size of a large haematoma), the use of an older generation of closure devices in some of the studies, and exclusion of patients with high risk of local complications such as obese patients. Most of the studies included patients cannulated using a 6 F introducer, while patients in our study were mainly (73%) cannulated using an 8 F or 9 F introducer. In addition it should be noted that the use of AngioSeal® (like any other interventional device) involves a learning curve, and in the present study AngioSeal® was used by operators with a major prior experience.

It should be noted that resorpti on of the AngioSeal® device elements takes around 90 days, and during that period a vascular access in the proximity of the device should be avoided (according to the manufacturer’s recommendations). Some studies suggest that a 0.5-1.0 cm margin should be used [7, 25] if the index artery is used for vascular access within 90 days.

In the case of surgery, a vascular surgeon should pay special attention while operating in the proximity of the AngioSeal® device implanted into the femoral artery to avoid involuntary translocation of the device elements, which can lead to severe complications including limb ischaemia, as demonstrated in the case described by Ponton et al. [6].

Transradial access is currently considered as a safer approach leading to lower frequency of bleeding complications and it is used with increasing frequency for coronary interventions [26]. However, some endovascular interventions, mainly those on carotid arteries, require larger diameters of cannula to allow introduction of neuroprotective systems and therefore they currently require the femoral access.

Conclusions

We found that the 6 F and 8 F AngioSeal® device can be safely used to close the femoral access during peripheral interventions involving after cannulation with 6-7 F or 8-9 F introducers, respectively. We also showed that vascular closure device reduces the risk of peri-procedural local complications after femoral access and leads to shortening of the immobilization period and hospitalization time shortening.

Acknowledgments

The authors of the study do not have any conflict of interest (such as employment, counselling, possession of stock or honoraria) related to the producers or distributors of the AngioSeal® vascular closure device which might have caused a conflict of interest in the context of this study.

The use of vascular closure devices was financed by the John Paul II Hospital.

We thank Ms Justyna Stefaniak of data Management and Statistical Analysis (DMSA, Krakow) for data management and statistical analysis.

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