Abstract
Purpose Retrograde contralateral common femoral access traditionally has comprised the majority of access sites for the endovascular treatement of infrainguinal arterial disease. As the volume and complexity of distal lower extremity arterial endovascular interventions have increased, nontraditional access sites have increased in use. Antegrade SFA access provides numerous advantages that include improved pushability of endovascular devices, decreased length requirements of devices used, and decreased angulation of the access sheath in obese patients. Antegrade SFA access in most patients requires the use of a closure device. The Angio-Seal device (St. Jude Medical, St. Paul, MN) is indicated for use in femoral artery puncture sites. Very little data exists regarding the safety and efficacy of the Angio-Seal device with antegrade SFA access sites. In this single-center retrospective study, we evaluate the safety and efficacy of the Angio-Seal closure device in SFA punctures in our patient population. Materials and Methods From August 2010 through August 2012, 50 limbs in a total of 30 patients with critical limb ischemia were treated in our practice with antegrade SFA access. Ultrasound was used for access in 100% of the cases. Analyzed patient data includes access site-specific complications, vessel size, sheath size, intraprocedural anticoagulation dose, and patient BMI. The mean value and range: vessel size 6.5mm (4mm-9mm); BMI 29.3 (15-43); sheath size 6Fr (5Fr-10Fr); heparin 5,400U (5000-14000U). Results In 50 antegrade punctures and closures, there were 5 access-related complications: 4 bleeding complications and 1 Angio-Seal migration resulting in additional stent placement. 75% (3/4) of the bleeding complications were classified as Minor class A hematomas with no clinical consequence. Overall, there was 1 (2%) Major Class D bleeding complication requiring >48 hour hospital stay with an increased level of care. Analysis of data revealed no statistically significant correlation between the tested variables with complications. Conclusion The Angio-Seal closure device is a safe and effective tool for use with antegrade SFA access.
Published Version
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