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Published on: May 26, 2023
Complications associated with the Angio-Seal arterial puncture closing device: intra-arterial deployment and
Einar Dregelid1, Guttorm Jensen, Alireza Daryapeyma
1Vascular Section, Department of Surgery, Haukeland University Hospital, Bergen, Norway. Einar.dregelid@haukeland.no
Insights
The Angio-Seal device can cause severe lower extremity ischemia due to intraluminal sponge deployment or plaque dissection. Avoid using it with superficial femoral artery punctures to prevent complications.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Complications
Background:
- The Angio-Seal device is commonly used for arterial closure after puncture.
- It aims to prevent bleeding and allow early patient mobilization.
Observation:
- Four female patients experienced severe lower extremity ischemia after Angio-Seal device use.
- Complications included intraluminal sponge deployment and plaque dissection beneath the device.
- Ischemia onset varied, with one case detected 20 days post-procedure due to microembolization.
Findings:
- Superficial femoral artery puncture was implicated in two to three cases.
- Intraluminal device components and related thrombus can cause delayed ischemia.
- Prompt investigation with duplex ultrasound is crucial for diagnosing device-related ischemia.
Implications:
- The Angio-Seal device should be avoided when the superficial femoral artery is punctured.
- Accurate procedural reporting of device use is essential for tracking long-term complications.
- Awareness of these risks can improve patient safety and clinical decision-making.
Abstract:
The Angio-Seal arterial closure device is widely used to prevent bleeding and facilitate early ambulation after arterial puncture. We had referred to us three female patients in whom this device had been used; its sponge had been unintentionally deployed in the arterial lumen. In a fourth female patient, a dissected plaque underneath the device occluded the femoral artery. Severe lower extremity ischemia occurred in each case. One intraluminal sponge was detected only after 20 days, when the patient had developed severe symptoms due to microembolization; in another patient, ischemia occurred 9 days after intraluminal deployment. In two, or possibly three, of the cases, the superficial femoral artery had been punctured. The device should not be used when the superficial femoral artery has been punctured, in which case complications are more likely to occur. Lower limb ischemia within several months after deployment of these devices should be investigated with duplex ultrasound scanning to examine the possibility that the ischemia may be caused by the device or by device-related thrombus. It is important to register the use of such devices in the procedural reports to make it possible to link their use to eventual later ischemic events.
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