title: Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device.
abstract: OBJECTIVE
  This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath.
  
  
  BACKGROUND
  Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure, rapid methods of obtaining hemostasis at the time of sheath removal.
  
  
  METHODS
  We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group I); 217 patients were assigned to the manual pressure control group (group II).
  
  
  RESULTS
  There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 +/- 15.2 vs. 15.3 +/- 11.7 min [mean +/- SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group.
  
  
  CONCLUSIONS
  This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.
authors.affiliation: Pennsylvania Hospital, Philadelphia, USA.
authors.forename: W G
authors.initials: WG
authors.lastname: Kussmaul
authors.forename: M
authors.initials: M
authors.lastname: Buchbinder
authors.forename: P L
authors.initials: PL
authors.lastname: Whitlow
authors.forename: U T
authors.initials: UT
authors.lastname: Aker
authors.forename: R R
authors.initials: RR
authors.lastname: Heuser
authors.forename: S B
authors.initials: SB
authors.lastname: King
authors.forename: K M
authors.initials: KM
authors.lastname: Kent
authors.forename: M B
authors.initials: MB
authors.lastname: Leon
authors.forename: D M
authors.initials: DM
authors.lastname: Kolansky
authors.forename: J G
authors.initials: JG
authors.lastname: Sandza
mesh_terms: D017541:Aneurysm, False / Q000000981:diagnostic imaging / Q000517:prevention & control; D015906:Angioplasty, Balloon, Coronary; D001672:Biocompatible Materials; D006328:Cardiac Catheterization; D003094:Collagen; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006406:Hematoma / Q000000981:diagnostic imaging / Q000517:prevention & control; D006470:Hemorrhage / Q000000981:diagnostic imaging / Q000517:prevention & control; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011312:Pressure; D012737:Sex Factors; D013997:Time Factors; D018616:Ultrasonography, Doppler, Duplex
chemical_list: D001672:Biocompatible Materials; D006493:Heparin; D003094:Collagen