A new vascular closure device for the transradial approach: the D Stat Radial system

J Interv Cardiol. 2008 Aug;21(4):337-41. doi: 10.1111/j.1540-8183.2008.00366.x. Epub 2008 Jun 28.

Abstract

Background: The transradial approach is associated with low complication rates. The D Stat Radial vascular closure system offers hemostatic pressure locally at the puncture site with residual venous flow.

Methods: We prospectively included 113 consecutive patients presenting between August 2006 and December 2006. Diagnostic coronary procedures were performed using 4 Fr or 5 Fr sheaths, while 6 Fr devices were used for PCI. In every case at least 5.000 IU heparin was given. Compression with the retention strap was planned for approximately 3 hours before the pad was fixed using a medical strip. All data were entered into a database after a two-dimensional ultrasound examination study of the puncture site.

Results: The mean age was 65 years (+/-SD 10.3), with 62% being male. Patients presenting with acute coronary syndrome amounted to 6.2%, where 5r F sheaths were usually used with these patients (64.6%). PCI was carried out in 21.2% of cases. The system was applied successfully in all patients. The mean duration of compression was 4.6 hours (+/-SD 1.4). Bleeding after removal of the system occurred in 18.6% of cases, which resulted in prolonged compression in 17.7%. A hematoma >5 cm was seen in 4.4% of the sample. Ultrasound examinations revealed closure of the radial artery in 6.2%.

Conclusions: We conclude that this new device operates efficiently, but bleeding occurred in 18.6%. Compression time should be extended to 6 hours.

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / methods*
  • Coronary Angiography
  • Female
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Male
  • Prospective Studies
  • Radial Artery / surgery*
  • Time Factors