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Rapid hemostasis of arterial puncture sites with Angio-Seal in patients undergoing percutaneous coronary intervention
1Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia-Dr. Cipto Mangunkusumo Hospital, Jakarta.
Insights
The Angio-Seal device significantly speeds up hemostasis after percutaneous coronary intervention (PCI), reducing patient immobilization time. This vascular closure device offers a safe and efficient alternative to manual compression for PCI access sites.
Area of Science:
- Cardiovascular Interventions
- Vascular Access Management
- Medical Device Technology
Background:
- Percutaneous coronary intervention (PCI) requires effective management of arterial access sites to ensure patient safety and facilitate recovery.
- Traditional manual compression for hemostasis can lead to prolonged immobilization and potential complications.
- The Angio-Seal device is designed to provide rapid and reliable hemostasis following vascular access procedures.
Purpose of the Study:
- To compare the efficacy and safety of the Angio-Seal device versus manual compression for achieving hemostasis after PCI.
- To evaluate the impact of the Angio-Seal device on key recovery metrics, including time to hemostasis and ambulation.
Main Methods:
- A comparative study involving 176 patients undergoing PCI (88 Angio-Seal, 88 manual compression) between December 2002 and November 2003.
- Key outcome measures included time to hemostasis, time to ambulation, and incidence of groin complications.
- Patient demographics and activated clotting times were recorded for comparative analysis.
Main Results:
- Angio-Seal significantly reduced time to hemostasis (1.5 vs. 38.1 minutes, p < 0.0001) compared to manual compression, even with higher activated clotting times.
- Patients treated with Angio-Seal experienced shorter leg immobilization (4-6 hours) and significantly earlier ambulation (5.2 hours) versus manual compression (10-14 hours, 13.0 hours).
- No significant difference in overall major complication rates was observed between the Angio-Seal and manual compression groups.
Conclusions:
- The Angio-Seal device facilitates rapid hemostasis at arterial puncture sites following PCI.
- Utilizing the Angio-Seal device leads to substantially shorter ambulation times compared to manual compression.
- The study supports the Angio-Seal device as a safe and effective option for vascular access closure post-PCI, without increasing groin complications.
Aim:
To evaluate the efficacy and safety of Angio-Seal device in achieving rapid hemostasis of the access site after percutaneous coronary intervention (PCI) compared with manual compression.
Methods:
From December 2002 to November 2003, the device was used in 88 nonconsecutive patients underwent PCI, their age was 58 +/- 9 years and 78% were male, and time to hemostasis, time to ambulation and in hospital groin complications were compared to 88 nonconsecutive patients (age 58 +/- 11 years and 77% were male), who had manual compression.
Results:
Time to hemostasis is significantly shorter in Angio-Seal group compared with manual compression (1.5 +/- 2.0 minutes vs 38.1 +/- 5.4 minutes, p < 0.0001) despite activated clotting time (319 +/- 37 seconds vs 131 +/- 18 seconds, p < 0.0001). Leg immobilization was 4-6 hours in 98% of patients using the Angio-Seal device. While in patients with manual compression the leg immobilization required 10-14 hours. Time to ambulation was significantly shorter in Angio-Seal group compared with manual compression (5.2 +/- 0.6 hours vs 13.0 +/- 0.7 hours. P < 0.05). There was no difference in overall major complication rate found between the two groups.
Conclusion:
This study showed that the Angio-Seal device rapid hemostasis could be obtained in the arterial puncture sites, so that time to ambulation became much shorter with Angio-Seal compared with manual compression, without any significant differences in groin complications.
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