Abstract Background. Vascular closure devices (VCDs) improve patient comfort and decrease time to ambulation. However, VCD studies have excluded patients with high-risk femoral artery anatomy; we examined the safety and efficacy of clip-based extravascular closure in this high-risk group. Methods. We performed a prospective registry enrolling 98 consecutive patients undergoing diagnostic coronary angiography. Inclusion criteria were femoral artery calcification, moderate femoral artery stenosis, or non-femoral arterial sheath insertion. All patients underwent immediate vessel closure with the Starclose device (Abbott Vascular). Patients with severe femoral arterial disease or femoral arterial diameter ≤ 4.0 mm were excluded. Hospital outcomes were assessed prospectively and femoral arterial stenosis was determined by quantitative angiography. Results. Inclusion was mainly related to at least one of 3 main high-risk characteristics: moderate femoral arterial stenosis (30%), femoral arterial calcification (24%) or nonfemoral sheath insertion (46%). The average femoral stenosis was 35.3 ± 5.1% among patients included for a significant femoral disease. There was a 100% procedural and 94% device success: one patient required manual compression for ≥ 30 minutes. The average time from sheath removal to hemostasis was 0.76 ± 1.3 minutes. Despite the higher-risk anatomy, there were no major vascular complications and only one minor vascular complication. The average time to ambulation was 78.1 ± 47.3 minutes. Conclusions. In this prospective registry, the Starclose VCD was safe and effective for early ambulation of patients despite the presence of high-risk femoral arterial anatomy. J INVASIVE CARDIOL 2008;20:328–332 Percutaneous femoral access is utilized for 7.5 million patients per year worldwide and vascular closure devices are used in approximately 2 million patients annually. All current vascular closure devices (VCDs) have been associated with adverse events, but VCDs appear to have a similar or somewhat reduced rate of overall complications compared to manual compression.1–4 The risks associated with the use of VCDs in high-risk patient subsets, such as those with non-ideal femoral anatomy, are unclear, as these patients have been excluded from the pivotal studies leading to FDA approval of these devices. Recently, a new extravascular clip-based closure device (Starclose™, Abbott Vascular, Abbott Park, Illinois) has become an option for vascular closure;5,6 unlike prior generations of VCDs, the extravascular nature of this device may allow expansion of their utilization to patients for whom intravascular closure devices might be associated with femoral arterial compromise. Thus, we performed a single-center, prospective registry to determine the safety and efficacy of clip-mediated extravascular closure among patients with high-risk femoral artery anatomy. Methods Study design and endpoints. We performed a single-center, multiple-operator, prospective registry enrolling 98 patients who met the inclusion criteria of non-ideal femoral anatomy or increased bleeding risk. The treatment cohort was obtained from 619 consecutive patients undergoing diagnostic coronary angiography via the femoral approach at the University of Vermont between November 2006 and November 2007. All patients provided written, informed consent to participate. The inclusion criteria were any of the following: • femoral artery is calcified (opacification of femoral artery without contrast dye); • femoral access is in the profunda femoris or superficial femoral artery; • femoral access is at the bifurcation of the profunda and superficial femoral arteries; • femoral artery stenosis of 30–70%; • femoral artery diameter 4–5 mm (as judged compared to a 6 Fr sheath with external diameter of 2.5 mm); • patients with access of the same femoral artery within the prior 8 weeks; • patient within 24 hours of fibrinolytic therapy; • patient with a platelet count Results A total of 98 patients were enrolled in this registry from 619 consecutive patients during the 12-month period. The average age was 64 years old and the majority were males (65%) undergoing outpatient procedures (86%). Approximately one-third of patients had more than one inclusion criteria, with sheath insertion at the bifurcation (37%), femoral stenosis (30%) or femoral calcification (24%) being the most common inclusion criteria (Table 1). These were followed in order of descending frequency by small femoral artery diameter 4–5 mm (9%), sheath below the bifurcation (9%), prior access in the ipsilateral femoral artery within 8 weeks (4%), platelet count 35.0) with a maximum BMI of 59.0 (weight 323 lbs). Angiographic characteristics. All patients had a 6 Fr arterial sheath. Figure 2 shows examples of high-risk femoral closure due to moderate arterial stenosis or bifurcation sheath insertion site. The femoral arterial reference vessel diameter was 7.0 ± 2.0 mm in diameter, similar to the results of a prior large angiographic study of femoral anatomy.8 The minimum lumen diameter for the entire cohort was 6.1 ± 1.99 mm and reflects the inclusion of many high-risk patients due to nonstenotic indications (low sheath insertion, calcification). The minimum lumen diameter among patients included due to femoral arterial disease was 4.61 ± 1.56 mm consistent with mild-to-moderate femoral arterial disease. Patients with femoral arterial diameters Discussion The major concerns of femoral artery closure after cardiac catheterization are cost and complications.11 The risk of complications may be stratified by the presence of risk factors such as peripheral vascular disease12 as well as other clinical risk factors associated with bleeding complications.13 While the overall risk of vascular complications after diagnostic cardiac catheterization is 0.5–1.7%, it is significantly increased in patients with peripheral vascular disease.2,12,14,15 In this pilot registry, we demonstrated a very high rate of safety and efficacy with the use of an extravascular closure device after diagnostic catheterization despite the presence of multiple high-risk features. Comparison to prior studies. Prior studies of patients with peripheral vascular disease suggest an increased relative risk of vascular complications of 40–89%, with absolute rates of vascular complications of 2.6–8.9%.12,16–20 Patients with peripheral vascular disease have been excluded from the pivotal VCD trials, thus the role of VCD in patients with high risk is largely undefined. The presence of femoral artery calcification, bifurcation sheath insertion, smaller femoral arteries and mild-to-moderate femoral stenosis present a heightened concern for mechanical complications associated with VCDs. For example, the presence of an intra-arterial anchor or suture may be associated with plaque shift and femoral compromise requiring urgent surgery due to limb ischemia.21 On the other hand, there is a theoretical benefit to extravascular closure methods in such high-risk situations as a mechanism for avoiding plaque shift. To date, one extravascular closure device has been studied among patients with high-risk anatomy; in a single-center registry of 45 patients receiving the Angiolink staple-mediated closure device (Medtronic, Inc., Minneapolis, Minnesota), success and complications looked promising.17 Our results are consistent with this prior study and suggest that extravascular closure with a clip-based device may be especially promising among patients with high-risk features. Alternative strategies for management of high-risk femoral anatomy require further study. For example, it is possible that a low rate of complications and successful early ambulation could also be achieved with an alternative strategy utilizing smaller (4 or 5 Fr) catheters in conjunction with relatively brief manual compression.22 Caution is required in extrapolating the Starclose results to all extravascular closure devices; prior experience with an extravascular delayed closure device (Vasoseal, Datascope Corp., Mahwah, New Jersey) has been associated with an increased risk of vascular complications compared to manual compression.2 Furthermore, we note that our study required fluoroscopic identification of landmarks for access: the use of any vascular closure device is likely to be safest when access has been successfully attained in the common femoral artery. Thus, meticulous technique and attention to fluoroscopic markers of the ideal “landing zone” are required regardless of closure device utilization.8–10 VCD and early ambulation. Unlike the CLIP study (which left ambulation time to the discretion of the operators),5 all study patients were encouraged to ambulate 20 feet 1 hour after initial hemostasis. Patients in this high-risk registry had significantly shorter times to ambulation than patients in the randomized CLIP trial. This difference is due to our protocol-based goal of early ambulation (within 60 minutes) after successful closure. Despite high-risk features, extravascular closure with the Starclose device allowed greater than 90% of patients to ambulate Conclusions The results of this prospective registry study suggest that the Starclose VCD is safe and effective for arteriotomy closure after diagnostic catheterization in high-risk patient subsets with an increased risk of bleeding or non-ideal common femoral artery anatomy. Further multicenter study is warranted to definitively determine the broad applicability and safety of this extravascular closure device in patients at high risk for vascular complications.
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