Efficacy and safety of antegrade common femoral artery access closure using the Angio-Seal device: experience with 1889 interventions for critical limb ischemia in diabetic patients

Tommaso Lupattelli, Fadi Tannouri, Francesco Giuseppe Garaci, Giovanni Papa, Martina Pangos, Francesco Somalvico, Carlo Caravaggi, Ezio Faglia
Journal of Endovascular Therapy 2010, 17 (3): 366-75

PURPOSE: To report a retrospective evaluation of the 6-F Angio-Seal closure device in antegrade and retrograde common femoral artery (CFA) punctures during endovascular procedures in diabetic patients with critical limb ischemia (CLI).

METHODS: From January 2005 to March 2009, 2374 diabetic CLI patients underwent interventional procedures in the lower limbs at a single center under systemic anticoagulation (heparin 70 U/kg). In this population, 2016 patients (1184 men; mean age 69.6+/-9.1 years) had 2372 CFA punctures treated with either manual compression [205 punctures in 161 (8.0%) patients] or Angio-Seal deployment (2167 punctures in 1855 patients) and were eligible for this analysis. In the study cohort, there were 1889 antegrade CFA punctures closed with the device in 1626 (87.6%) patients compared to 278 retrograde punctures sealed in 229 (12.4%) patients. The complications from the antegrade CFA punctures were compared to those from retrograde closure and manual compression.

RESULTS: The success rate for achieving hemostasis after antegrade and retrograde Angio-Seal placement was 97.9% and 97.8%, respectively. Major complications following antegrade Angio-Seal deployment, retrograde Angio-Seal deployment, and manual compression occurred in 20/1889 (1.1%), 5/278 (1.8%), and 4/205 (2.0%) cases, respectively. All complications developed within 24 hours of the procedure. No further complications were recorded in the 18-month follow-up (range 1-36). The overall complication rates after antegrade puncture closure, retrograde puncture closure, and manual compression at 30 days was 2.5%, 4.0%, and 4.9%, respectively (p = NS).

CONCLUSION: This retrospective study shows that the 6-F Angio-Seal is a valuable and safe vascular closure device for percutaneous transfemoral antegrade access in diabetic patients undergoing interventional procedures for CLI.

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