Safety and Efficacy of the StarClose Vascular Closure Device in More Than 1000 Consecutive Peripheral Angioplasty Procedures

Purpose: To present a large single-center retrospective study investigating the safety and efficacy of the StarClose extravascular closure device in achieving hemostasis after antegrade or retrograde femoral artery catheterization during peripheral angioplasty procedures. Methods: Between January 2004 and October 2009, 1213 StarClose devices were implanted in 850 consecutive patients (598 men; mean age 65.8+/-12.2 years) who underwent peripheral endovascular procedures. Femoral artery punctures included 625 (51.5%) retrograde and 588 (48.5%) antegrade accesses. The primary endpoints were hemostasis success, device failure, and major and minor complication rates up to 30 days. Results: A 6-F vascular sheath was used in the majority of cases [39 (3.2%) 7-F and 9 (0.7%) 8-F]. The device was applied more than once in the same femoral artery of 124 (10.2%) limbs during different angioplasty sessions. Overall hemostasis success was achieved in 1139 (93.9%) cases. In 237 (20.8%) of those, additional manual compression for <5 minutes was necessary due to immediate vessel oozing. The remaining 74 (6.1%) cases required prolonged standard manual compression because of hemostasis failure, including 13 (1.1%) failures to deliver the clip. Overall major and minor complication rates were 0.3% (4/1213) and 5.3% (64/1213), respectively. Conclusion: The StarClose vascular closure device is safe and effective in achieving hemostasis during antegrade and retrograde peripheral angioplasty procedures. J Endovasc Ther. 2011;18:435-443