Application of femoral artery closure devices Starclose, Perclose and Boomerang in femoral hemostasis

BACKGROUND: Femoral artery closure devices have been widely employed in patients undergoing coronary angiography (CAG) and percutaneous coronary intervention (PCI). The objective evaluation and appropriate application of these closure devices need more attention. OBJECTIVE: To comparatively evaluate the safety and efficacy of manual compression and three closure devices for hemostasis at the femoral artery access site in patients undergoing CAG and PCI. DISIGN, TIME AND SETTING: A randomized, grouping design and comparative observation. The patients were selected from the Department of Cardiology, General Hospital of Air Force between March 2006 and July 2008. PARTICIPANTS AND MATERIALS: A total of 918 patients undergoing CAG (n=380) or PCI (n=538), including 562 males and 356 females aged 24-83 years, were selected. Starclose device and Perclose device were purchased from Abott, USA; Boomerang device from Cardiva, USA. METHODS: 918 patients were assigned into 4 groups according to different hemostasis methods: manual compression (MC, n=271): femoral artery access site was directly compressed immediately after CAG, while at the time of activated partial thromboplastin time (APTT) was below 65s after PCI. Boomerang (n=178) group: Boomerang device was put into sheath, unclosed its umbrella to fix it up, pulled out in 20 minutes after CAG and appropriate time by the dose of heparin after PCI, followed by artificial compression till hemostasis. Perclose (n=183): the femoral access site was sutured by Perclose joy stick to tie a knot after operation. Starclose (n=286): Starclose utilized a small flexible nitinol clip that gave circumferential extravascular closure of the femoral arteriotomy site after CAG or PCI. MAIN OUTCOME MEASURES: Hemostasis operation time, immobilization time, total incidence rate of vascular complications and device failure cases. RESULTS: All 918 cases were included in the final analysis. (1)Patients treated with Starclose or Perclose experienced shorter operation and immobilization time to hemostasis than Boomerang and manual compression groups (P < 0.01), while patients with Boomerang also experienced shorter time to than manual compression group (P < 0.01). (2)Compared with manual compression group, device hemostasis showed lower vascular complications incidence rate after PCI (P < 0.05). (3)Hemostasis failure occurred in 2/12 after CAG/PCI of manual compression patients, 1/5 of Boomerang patients, 1/10 of Perclose patients and 1/5 o