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A new vascular closure device for the transradial approach: the D Stat Radial system
Hubertus von Korn1, Marc A Ohlow, Jiangtao Yu
1Krankenhaus Hetzelstift, Clinic of Cardiology, Stiftstrasse 1067434, Neustadt an der Weinstrasse, Germany. h.vonkorn@new.marienhaus-gmbh.de
Insights
The D Stat Radial vascular closure system is effective for transradial procedures. However, bleeding occurred in 18.6% of patients, suggesting longer compression times are needed.
Area of Science:
- Cardiovascular Interventions
- Vascular Access Technologies
- Interventional Cardiology
Background:
- The transradial approach is favored for its low complication rates in vascular access.
- The D Stat Radial system aims to provide local hemostasis at the puncture site.
Purpose of the Study:
- To evaluate the efficacy and safety of the D Stat Radial vascular closure system in patients undergoing transradial procedures.
- To assess complication rates associated with the D Stat Radial system.
Main Methods:
- A prospective study included 113 patients undergoing diagnostic coronary procedures or percutaneous coronary intervention (PCI) using 4 Fr to 6 Fr sheaths.
- Heparin was administered, and compression was initially planned for 3 hours, with data collected via ultrasound.
- The D Stat Radial system was applied to all patients.
Main Results:
- The system was successfully applied in all 113 patients (mean age 65 years, 62% male).
- Bleeding occurred in 18.6% of cases, leading to prolonged compression in 17.7%.
- Hematoma formation (>5 cm) was observed in 4.4%, and radial artery occlusion in 6.2%.
Conclusions:
- The D Stat Radial vascular closure system demonstrates efficient application in transradial procedures.
- A significant rate of bleeding (18.6%) necessitates extending compression time to 6 hours for improved outcomes.
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.
