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Femoral artery hemostasis using an implantable device (Angio-Seal) after coronary angioplasty
W G Kussmaul1, M Buchbinder, P L Whitlow
1Pennsylvania Hospital, Philadelphia, USA.
Insights
Angio-Seal, an implantable device, provides quick and safe arterial hemostasis after coronary angioplasty. It successfully closed access sites in 93% of patients, minimizing complications in those receiving anticoagulation therapy.
Area of Science:
- Cardiology
- Vascular Surgery
Background:
- Coronary catheter interventional procedures carry a risk of access site complications.
- Femoral artery access is common in these procedures, often requiring anticoagulation.
Purpose of the Study:
- To evaluate the safety and efficacy of the Angio-Seal hemostasis device in achieving arterial hemostasis after coronary angioplasty.
- To assess complication rates and time to hemostasis in anticoagulated patients.
Main Methods:
- A prospective study of 68 patients undergoing coronary angioplasty with 8 French sheaths and heparin anticoagulation.
- The Angio-Seal device was deployed after sheath removal at a mean activated clotting time of 220 seconds.
- Hemostasis, time to hemostasis, and complications were recorded.
Main Results:
- Successful deployment and hemostasis were achieved in 93% of patients (63/68).
- Complete arterial hemostasis averaged 4.4 minutes, with 54% achieving immediate hemostasis.
- Complication rates included 13% significant bleeding, 3% hematomas, and one device embolization without sequelae.
Conclusions:
- The Angio-Seal device is a safe and effective option for achieving rapid arterial hemostasis in anticoagulated patients post-coronary intervention.
- The device demonstrated a low complication profile and was fully absorbed within two months.
Abstract:
Coronary catheter interventional procedures are associated with risk of access site complications. We report our experience with Angio-Seal, an implantable hemostasis device, when used in the femoral artery after coronary angioplasty procedures. Sixty-eight patients were studied. Their average age was 63 years; 84% of the patients were male. All had 8 French access sheaths and received bolus heparin (mean dose 12,690 U). The arterial sheaths were removed an average of 455 min after the conclusion of the procedure, when the activated clotting time was 220 +/- 94 sec (range 97-503 sec). The hemostasis device was successfully deployed in 63 patients (93%). The average time to achieve complete arterial hemostasis was 4.4 +/- 8.9 min (range 0-45). Immediate, total hemostasis without requiring any form of external pressure was obtained in 37 of these patients (54%). the incidence of complications was as follows: significant bleeding occurred in 9 patients (13%); there were 2 hematomas (3%); there were no vascular or infectious complications. One device embolization occurred when the connecting suture broke and the intravascular anchor was lost; no clinical sequelae resulted, and manual hemostasis was successful. In four other patients, the device did not deploy and was removed entirely, followed by uneventful manual hemostasis. Follow-up for 2 months revealed no late sequelae in any patient, and complete absorption of the device was documented by ultrasound study in all cases. We conclude that this implantable device can achieve arterial hemostasis quickly and safety when used in anticoagulated patients after coronary interventional procedures.