Safety and Efficacy of Arterial Closure Devices Following Antegrade Femoral Access: A Case-Control Study.

PURPOSE: Vascular closure device (VCD) use following antegrade femoral access may present unique challenges relative to retrograde access. We retrospectively compared safety and efficacy of these devices between antegrade and retrograde patient cohorts undergoing percutaneous intervention. MATERIALS AND METHODS: Over a 5-year period, a consecutive series of 107 limbs in 84 patients underwent VCD arteriotomy closure following percutaneous revascularization using an antegrade approach (VCD-A). Device deployment success rates, time to ambulation, and complication rates were compared to a contemporaneous control group of 401 limbs in 305 patients who underwent closure following retrograde access (VCD-R) during revascularization or embolization procedures. RESULTS: Closure was attempted in VCD-A using 53 StarClose, 35 Perclose, and 19 Angio-Seal devices. Hemostasis (without supplemental manual compression) was achieved in 86/107 (80.4%) limbs. Closure was attempted in VCD-R using 215 StarClose, 119 Perclose, and 67 Angio-Seal devices with hemostasis in 357/401 (89.0%) limbs. Device deployment failure occurred in 7/107 (6.5%) of VCD-A and 20/401 (5.0%) of VCD-R (P = .52), independent of specific device type. Femoral pseudoaneurysm developed in 1/107 and 1/401 of VCD-A and VCD-R (P = .31), and minor hematoma developed in 3/107 and 8/401 of the VCD-A and VCD-R (P = .61). Mean time to ambulation was 204.1 minutes in VCD-A and 204.8 minutes in VCD-R (P = .97). CONCLUSION: Antegrade femoral closure was associated with high rates of technical success and low complications, similar to retrograde closure. Time to ambulation was the same in both groups despite higher heparin doses in the antegrade patients.

Nonfemoral Arterial Hemostasis Following Percutaneous Intervention Using a Focused Compression Device.

PURPOSE: Upper extremity and tibiopedal arterial access are increasingly used during endovascular therapies. Balloon compression hemostasis devices in these anatomic locations have been described, but most utilize a compression surface extending well beyond the puncture site. We report single-center experience with an arterial puncture-focused compression device following upper extremity and tibiopedal access. PATIENTS AND METHODS: A series of 249 focused compression hemostasis devices (VasoStat, Forge Medical, Bethlehem, Pennsylvania, USA) were used in 209 patients following lower extremity (n = 63) and upper extremity (n = 186; radial: 90%) arterial access procedures using 4-7 French sheaths. Demographic, operative, and follow-up data were collected. Logistic regression was used to evaluate potential association between patient/operative variables and time to hemostasis. RESULTS: Primary hemostasis was achieved in 97.2% (242/249) following sheath removal; in 7 cases (2.8%) puncture site oozing occurred after initial device removal and required reapplication. Secondary hemostasis was 100% (249/249). Seven complications (2.8%) were recorded: 5 minor hematomas (2%) and 2 transient access artery occlusions (0.8%). Mean time to hemostasis enabling device removal was 55 ± 28 min. Elevated body mass index (BMI) was not associated with increased time to hemostasis (p = 0.31). Accessed artery, sheath size, and heparin dose were also not associated with time to hemostasis (p = 0.64; p = 0.74; p = 0.75, respectively). CONCLUSIONS: The focused compression hemostasis device enabled rapid hemostasis with a low complication rate. Time to hemostasis was independent of BMI, access site, sheath size, or heparin dose.