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Femoral artery closure for large sheath (≥14 FR) procedures has been traditionally performed using either manual compression or suture based devices. We present the first in man (FIM) experience with the velox LB closure device which utilizes an intra-arterial footplate connected to an epi-vascular plug by an intervening mandrel constructed from a uniform biodegradable, non-inflammatory magnesium alloy. The intra-arterial and extravascular components resorb within 36 hr and 3 weeks respectively.
Patients with a common femoral artery(CFA) vessel diameter of ≥ 6.0 mm were treated with ≥14 FR sheaths. Velox LB was inserted over a wire after removal of the procedural sheath. Examination of the arterial closure site, pedal pulses and vascular ultrasound were all performed pre & post-procedure and at 24 hr. Definitions: Procedure success = no access site bleeding ≤10 min after sheath removal without complication. Device success = implant deployment + no access site bleeding ≤ 10 min without complication.
Patient characteristics are displayed in table 1. Procedure success was (100%). Device success was achieved in 9 patients (90%). The device was not deployed in one patient due to operator error. Time to cessation of bleeding overall was 3.1 ± 3.1 min and fell to 2.4 ± 2.4 min with device success. Pedal pulses were unchanged following device deployment. Mean CFA diameter was unchanged at post procedure and 24 hr ultrasound. Patients with device success were out of bed 2.0 ± 0.3 hr post procedure. There significant findings on any access site exam or reported by patients.
|Age (yr)||57 ± 14|
|BSA||1.88 ± 0.17|
|CF vessel diameter (mm)||7.9 ± 1.5 mm|
|Sytolic BP (mmHg)||124 ± 30 mmHg|
|ACT (sec)||233 ± 32|
|Diabetes (n/%)||1 (10%)|
This study demonstrated rapid and effective large bore arteriotomy closure with the velox LB without a change in the CFA lumen size. The implant was well tolerated. This is the first human experience with a large bore VCD constructed with a magnesium alloy. Further investigation is warranted.
OTHER: Vascular Access