Clinical experience of StarClose vascular closure device in patients with first and recurrent femoral punctures

J Interv Cardiol. 2008 Feb;21(1):67-73. doi: 10.1111/j.1540-8183.2007.00291.x.

Abstract

Objective: We present our clinical experience of StarClose in patients undergoing coronary interventions, including its use in patients after repeated puncture of the same femoral access site.

Background: The StarClose is a novel vascular closure device that deploys a small, flexible, circumferential nitinol clip onto the femoral artery surface.

Methods: In this study, 103 consecutive patients (24% with repeated punctures) who underwent percutaneous coronary intervention and received a StarClose were followed up prospectively. The patients were assessed for vascular complications prior to hospital discharge. Device success, based on time-to-hemostasis, was divided into (1) immediate success: hemostasis achieved immediately after StarClose deployment without the need for adjunctive manual compression, (2) partial success: occurrence of minor oozing after StarClose deployment and hemostasis achieved after <3 minutes of manual compression, and (3) device failure: need for adjunctive manual compression for >3 minutes.

Results: Immediate success, partial success, and device failure rates were 74% (n = 68), 16% (n = 15), and 10% (n = 9), respectively. There were no major complications attributable to the StarClose device. There were 10 (9.7%) cases of minor complications; all were recurrent wound bleeding requiring manual compression in the wards. Among these 10 cases of recurrent bleeding, 5 (50%) had initial device success (immediate success, n = 2, partial success, n = 3) in the catheterization laboratory. The risk for recurrent bleeding was 2.9% after immediate device success and 20.0% after partial device success.

Conclusion: Our study found no major complications but a 10% failure rate and a 9.7% rate of minor complications. Close surveillance is important as there is a risk for recurrent bleeding, especially in patients with partial device success as defined in this report.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary
  • Catheters, Indwelling*
  • Equipment Safety
  • Female
  • Femoral Artery*
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Punctures
  • Recurrence*
  • Risk Factors
  • Surgical Instruments*
  • Suture Techniques / instrumentation*
  • Time Factors