Percutaneous Femoral Arteriotomy Repair — <br />
Initial Experience with a Novel Staple Closure Device

Annually, approximately 7.5 million percutaneous catheter-based procedures are performed through the femoral artery worldwide.1–2 In order to increase patient comfort and the efficiency of patient care, several devices have been designed to expedite arteriotomy closure following removal of the femoral arterial introducing sheath. Such devices have been demonstrated to conserve resources and increase patient satisfaction. There is further evidence to suggest that these devices may be cost effective.5–7 Despite these advantages, several deficiencies associated with currently approved closure devices have contributed to slow market acceptance, such that these devices are currently utilized in only 15–20% of catheter-based femoral arterial procedures worldwide. These deficiencies include: 1) complex instructions for use associated with a significant learning curve; 2) requirements for bedrest following closure; 3) complication rates similar to manual closure; 4) increased incidence of certain types of complications compared to manual closure (arterial occlusion and infection); 5) impaired or delayed ability to re-access the femoral artery; and 6) additional procedure-related costs.5–28 Furthermore, most of the currently available devices mechanically incorporate the arterial lumen to effect closure, and are therefore not currently indicated for use in patients with significant peripheral vascular disease or smaller targeted vessels such as the superficial and profundal femoral arteries.38–41 Staple technology has been used extensively in the fields of vascular and cardiothoracic surgery over a period of many years with proven long-term safety in regard to acute and chronic biologic response.30–37 The Vascular Closure System (EVS™) closure device (Angiolink Company, Taunton, Massachusetts) utilizes a unique, proprietary, staple design to achieve extraluminal, percutaneous, mechanical closure of femoral arteriotomies. In this study, a prototype EVS™ design was tested to determine device safety, device efficacy and the potential for further development and design modification. Methods Following institutional approval of the protocol and appropriate patient informed consent, the EVS™ was used by three operators to close 89 consecutive percutaneous femoral arteriotomies in 5 consecutive series of unselected patients undergoing elective cardiac catheterization and/or percutaneous coronary revascularization between July and November 2001. The prototype devices were slightly modified between each patient series. Operators were given didactic operating instructions regarding the device following each modification. All patients treated with the device were included in the study, i.e., there was no “roll-in” phase. Successful arteriotomy closure was defined as total cessation of bleeding within 5 minutes of staple deployment without evidence of recurrent bleeding or other complications. Catheterization and arteriotomy closure procedures. Single wall arterial puncture was performed in standard sterile fashion using an 18 gauge needle. The introducing sheath was then inserted over a wire. Systemic heparin was administered to patients undergoing a revascularization procedure. In a subgroup of patients, contrast cineangiography of the femoral artery was performed through the side port of the introducing sheath prior to its removal. The EVS™ was deployed as described below. Any persistent low-grade bleeding from the skin puncture site (tissue tract bleeding “oozing”) was treated with non-occlusive manual pressure. Pressure was withdrawn at one-minute intervals to assess cessation of bleeding and was reapplied at each interval if necessary. The time at which bleeding completely ceased was observed and recorded. Following the determination of bleeding cessation, the groin area was observed for an additional five minutes. If the puncture site remained stable, a gauze dressing was applied and the patient was transferred to a stretcher. Twenty-four hours and 7 days following the procedure, patients were reassessed by interview and physical examination to assess for potential neurovascular complications. Vascular ultrasound. Two-dimensional and Doppler ultrasound examination of the femoral artery and its large distal branches was performed directly after EVS™ device arteriotomy closure using a 7.5 MHz transducer (Acuson, Seimens Company, Mountain View, California). Ultrasound studies were independently reviewed by a qualified physician to determine arterial patency, abnormal blood flow turbulence and extraluminal blood flow. Device description. There are three main components of the EVS™: 1. The introducer assembly, which contains several parts: i) the introducer; ii) the dilator with a blood marking lumen positioned 7 mm from the distal end of the introducer; and iii) two stabilization “arms” extending from the distal portion of the introducer. These stabilization “arms” incorporate small anchors, or “feet,” which are transiently deployed intraluminally. These anchors are undeployed and removed with the stabilization arms following staple deployment (Figure 1). The stabilizers act by securing the introducer to the arteriotomy and tissues surrounding the arteriotomy. Through gentle retraction of the stabilizers, the inside wall of the vessel is applied toward the distal end of the introducer, thereby optimizing control and centering the wound site during advancement of the stapler. 2. The biocompatible titanium staple (Figure 2). 3. The trigger activated staple deployment device (Figure 3). The staple and stapler have a unique design that allows initial expansion and advancement of the staple prior to its closure. The staple is currently adjusted to expand to a diameter of 15 French (Fr) prior to closure, allowing expansive tissue capture and closure of large size arteriotomies. Description of device use. Following removal of the arterial introducing sheath, the EVS™ dilator and introducer are advanced as a unit over a guidewire, through overlying tissues, until brisk blood response from the dilator arterial marking lumen is achieved. The guidewire is removed. The stabilization feet are then deployed intraluminally and retracted until there is tactile feedback against the anterior wall of the artery. At this point, the dilator is removed and the staple device is advanced through the introducer until resistance against the anterior wall of the artery is encountered. The staple is then trigger-activated. The stabilization feet are undeployed and the introducer is removed. Statistical analysis. Data are expressed as means ± standard deviation. Data were analyzed using standard Chi square, paired Student’s t-test, and proportion analysis as appropriate. All analyses were performed using the SAS-PC version 8.1 for Windows. Results Staple closure of 89 consecutive arteriotomies was performed. Baseline patient characteristics are presented in Table 1. Chronic aspirin therapy was administered before a majority of procedures (n = 70; 78.6%). Ticlopidine or plavix was administered prior to 22 procedures (24.7%). Heparin compounds were administered in 36 cases (40.4%). The mean dose of heparin was 5,193 ± 2,182 units. Of the 89 sheath arteriotomies, seventy-seven were 6 Fr (86.5%), one was 7 Fr (1.1%), ten were 8 Fr (11.2%) and one was 9 Fr (1.1%). Successful arterial closure was achieved in 82 cases (92.1%). Average time to total cessation of bleeding was 2.47 ± 1.42 minutes. Closure was achieved within 2 minutes for 48 patients (58.5%) and within 3 minutes for 61 patients (73.3%) (Figure 4). Successful closure was maintained in the remaining 28 patients at 5 minutes. No patients with successful device closure had rebleeding that required additional treatment. For the seven patients with unsuccessful device closure, hemostasis was achieved at 14 ± 8.42 minutes. In four unsuccessful closures, device failure was directly attributed to gross deviation by the operator from the prescribed instructions for use [premature staple deployment (n = 1), release of stabilizers prior to staple deployment (n = 1), and excessive advancement of introducing sheath (n = 2)]. Excluding these cases, device success rate was 96.4%. Subgroup comparisons of patients receiving heparin vs. no heparin, having prior ipsilateral arterial puncture vs. initial arterial puncture, and 6 Fr arteriotomies vs. > 6 Fr arteriotomies, revealed no significant differences in procedure success rate or time to cessation of bleeding. A subgroup of 65 patients had femoral arteriography performed via the introducing sheath prior to closure. Of these patients, arterial access was achieved in a branch of the common femoral artery in 23 (35.3%). Comparison of subgroups by common femoral access vs. branch femoral access demonstrated no significant difference between success rates [88.1% (n = 37) vs. 95.6% (n = 22; p = NS)] (Figure 5). Vascular ultrasound examination immediately following the procedure revealed a patent vessel lumen in all arteries. Follow-up examinations at 24 hours and 7 days revealed no incidence of repeat bleeding, pseudoaneurysm, arteriovenous fistula, infection or decreased distal perfusion. No patient required vascular surgical intervention or blood transfusion. The overall acute complication rate was 0%. Discussion Vascular procedures utilizing the percutaneous femoral artery approach are performed with increasing frequency. An estimated 7.5 million procedures were performed in the year 2000 worldwide.1,2 Manual compression has been the traditional method for closure of catheter-related femoral arteriotomies, but is associated with a complication rate of 1–5%, significant patient discomfort and immobility, and resource utilization.3,4 Devices for closure of catheter-based femoral arteriotomies have been demonstrated to be relatively safe and effective.5–29 Currently available devices utilize varied mechanisms of closure; however, they may be placed in two broad categories: 1) devices that modify or accelerate the normal biologic response to injury; or 2) devices that result in mechanical repair of the arteriotomy. The former group utilizes a biologic material (collagen or thrombin) carefully delivered to the site of injury to propagate/accelerate formation of a thrombotic “plug”. These devices necessitate a period of bedrest in order to effect closure.11–16 The latter group currently consists of suture-based devices which approximate the edges of the arteriotomy resulting in closure.17–21 These devices may be associated with shorter times to ambulation. Benefits in regard to patient comfort and cost have been shown with these devices. However, currently marketed devices have not been readily accepted and are used in only 10–15% of cases worldwide.1,2 Reasons for poor market acceptance are many, but principally include: 1) complex instructions for use and a significant learning curve; 2) multiple contraindications to use; 3) requirements for bedrest following closure; 4) complication rates similar to manual closure; 5) increased incidence of certain complications compared to manual closure (arterial occlusion and infection); 6) impaired or delayed ability to re-access the femoral artery; and 7) additional procedure costs. In order to address these issues, the Angiolink Vascular Closure System (EVS™) device has been developed. This device utilizes staple technology to effect mechanical closure. The purpose of this initial study was to determine the safety and efficacy of a prototype EVS™ device and the potential for future device development. Staple closure was effective in 92.1% of unselected, consecutive patients in this study. This success rate is similar to that observed with currently marketed devices. There was no “roll-in” phase of this study demonstrating the rapid learning curve associated with this device. Indeed, four unsuccessful closures may have been attributed to the operators’ unfamiliarity with the device. There were also no relative or absolute contraindications to device use in this patient series. Importantly, no complications were observed. Potential advantages of this staple device may include: 1) safe and effective use in patients with peripheral vascular disease and/or non-common femoral arteriotomy closure conferred by the extraluminal method of closure — evidence for this was demonstrated by the 100% closure success rate achieved for arteriotomies located in the large distal branches of the common femoral artery in this study; 2) a minimal biologic response — this is supported by the extensive data and experience accumulated over many years with staples and clips used for varied surgical procedures;30–37 3) the lack of a persistent communication between the external skin surface and the artery may help reduce the incidence of infection seen with some other devices; and 4) the simplicity of staple activation allowing for results in reduced operator error. The main limitation of this study was the relatively small number of patients examined. However, a high rate of success was achieved with no serious acute complications. Future studies with this device will be needed to examine the effects of early ambulation, long-term outcomes, co-administration of glycoprotein IIb/IIIa receptor inhibitors, and success rates for subgroups of patients with repeated arterial access, peripheral vascular disease and non-common femoral artery access. We conclude that the EVS™ staple closure device is a promising new technology and that future device development and investigation are indicated.

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