VASCADE closure device use in severe common femoral artery disease

Over the years there has been a marked increase in the use of peripheral vascular interventions (PVIs) for PAD treatment. Conventionally, manual compression (MC) has been used for post‐ intervention hemostasis especially for extensive femoral artery access site disease. However, given the calcified nature of some of these access sites, a vascular closure device designed for PAD patients would be ideal. Many of the conventional closure devices require the use of intraluminal material which can increase the risk of complications in diseased arteries. TheVASCADE closure device has shown better efficacy than MC in hemostasis and non‐inferiority in access site complications in two small trials. It was associated with reduced time to hemostasis (TTH), analgesic requirement, time to ambulation (TTA), and length of stay postprocedure. The proposed benefit to VASCADE is that it involves only an extravascular collagen plug at the arteriotomy site; there is nothing intraluminal, making it an attractive option in PAD patients. However, in the RESPECT trial patients with extensive PAD or previous vascular grafts or surgery at the access site were excluded. Despite this, in real‐world experience, VASCADE has been used off‐label in patients with access site calcification for both retrograde and anterograde access PVI. In the current issue, Nagpal et al. report a single‐center, retrospective, propensity‐matched study involving 200 patients with moderate to severe CFA disease undergoing PVI. Overall, their results demonstrated non‐inferiority of safety outcomes with VASCADE compared to MC. The patient population was predominantly male, nonobese, and retrograde access was utilized. Access site calcification was subjectively assessed through fluoroscopy or angiography. Moderate to severe calcification was present in less than half (47.5%) of access sites. Patients with prior lower extremity bypass, history of endarterectomy; 7‐Fr sheath use and multiple access sites were more likely treated with MC. Interestingly, use of ultrasound in obtaining femoral access was not specified. Encouragingly, the VASCADE efficacy was similar to MC in setting of oral anticoagulant and antiplatelet use. Hemostasis was more readily achieved with VASCADE as reflected by lower utilization of external compression device than MC cohort. The dreaded complication of immediate device failure of VCD was noted in 2.9% of cases which was marginally higher than the earlier reported rate of 2%. VASCADE was associated with numerically lower incidence of bleeding and hematoma formation, while higher incidence of pseudoaneurysm than MC. Prior post‐marketing surveillance studies had raised the concern for thromboembolic distal vessel occlusion linked to VASCADE use which was not seen in this study. This was likely due to inappropriate intravascular collagen disc deployment rather than device failure, likely reflective of an early learning curve to the device. Few important safety measures highlighted in the study include deployment under fluoroscopy especially for instances where stents are present within the iliac vessels and severely disease vessel segments where premature deployment is a concern or retraction, and re‐deployment of device is needed. Moreover, the ACT cutoff before device deployment was <225 s. Despite being a retrospective, propensity‐matched study, inherent confounding, and selection biases may persist. For example, activated clotting time (ACT; 213 s vs. 198 s; p = 0.018) and closing systolic blood pressure (140.55 + 23.94mmHg vs. 147.74 + 24.64mmHg; p = 0.04) was higher in MC cohort which may have affected the outcomes in favor of VASCADE. Moreover, the MC cohort had higher prevalence of patients with lower extremity bypass (11.3% vs. 3.9%; p = 0.045) which might be reflective of comparatively severe PAD phenotype. The patient population was predominantly white, nonobese and had a low percentage of patients with advanced kidney disease which limits the generalizability of the results. However, the study adds to the body of literature regarding the expanding horizon of VASCADE utilization in patients with severe access site disease, which