The use of the Angioseal device for femoral artery closure
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Published on: May 26, 2023
Alan Abando1, Douglas Hood, Fred Weaver
1Department of Surgery, Division of Vascular Surgery, University of Southern California Keck School of Medicine, Huntington Memorial Hospital, Pasadena, USA.
Insights
The Angioseal device offers a secure and satisfactory method for femoral artery closure in patients undergoing percutaneous procedures, including those with peripheral arterial disease, enabling early ambulation and discharge.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Percutaneous catheter-based procedures are increasing, necessitating familiarity with femoral artery closure methods.
- Limited data exist on closure device efficacy in patients with peripheral arterial disease (PAD).
Purpose of the Study:
- To evaluate the Angioseal device for achieving femoral artery puncture site hemostasis in patients with PAD.
Main Methods:
- Retrospective review of patients undergoing Angioseal closure by a single vascular surgeon.
- Data collected included procedure type, sheath size, time to mobilization/discharge, and complications (hemorrhage, pseudoaneurysm, infection, occlusion).
Main Results:
- 220 Angioseal plugs used in 188 patients; 92% of percutaneous procedures utilized the device.
- No major hematoma or infection occurred. Two complications: one spontaneous pseudoaneurysm, one vessel occlusion requiring surgery in a patient with severe PAD.
- Early mobilization and discharge were achieved, with times varying by procedure type and sheath size.
Conclusions:
- Angioseal provides secure femoral artery hemostasis, is easy to deploy, and improves patient satisfaction.
- Allows for early ambulation and hospital discharge, offering advantages over manual compression.
- Safe use is achievable in most PAD patients when adhering to simple guidelines.
Background:
As vascular surgeons perform increasing numbers of percutaneous catheter-based procedures, they will need to become familiar with varying methods of femoral artery closure. Few studies on closure devices have included significant numbers of patients with peripheral arterial disease. It is the purpose of this study to determine whether the Angioseal device (St. Jude Medical) is a satisfactory method of achieving femoral artery puncture site hemostasis in these patients.
Methods:
The records of all patients undergoing Angioseal closure of femoral artery puncture by a single vascular surgeon were reviewed. Indication, type of intervention, and size of the vascular sheath employed were recorded. Times to mobilization and discharge were determined. Patients were seen before discharge and 1, 4, and 12 weeks after the procedure, and at 3- month intervals thereafter. Complications including hemorrhage, pseudoaneurysm, infection, and vessel occlusion were noted.
Results:
Between February 1, 2002, and August 31, 2003, 220 Angioseal collagen plugs were deployed in 188 patients. Attempts were made to deploy Angioseal devices in 92% of patients undergoing percutaneous procedures during this time period. One hundred forty-four procedures were diagnostic and 74 procedures included 76 therapeutic interventions. One hundred forty-four 5F sheaths, 47 6F sheaths, and 29 7F sheaths were employed during the procedures. Time to mobilization and discharge was 58 +/- 19 minutes and 102 +/- 31 minutes in patients undergoing diagnostic studies, 68 +/- 22 minutes and 146 +/- 42 minutes following interventions using 6F sheaths, and 127 +/- 18 minutes and 219 +/- 37 minutes when interventions were performed using 7F sheaths. No patient developed a major hematoma or infection following the use of an Angioseal. There were 2 complications related to device deployment. One patient developed a 1.4-cm false aneurysm at the femoral artery puncture site that resolved spontaneously. A second patient required operation for vessel occlusion when an Angioseal was deployed in a markedly diseased femoral artery. These adverse events occurred early in our experience.
Conclusions:
The Angioseal provides a secure method of achieving hemostasis following femoral artery puncture. It is easy to deploy, has a high level of patient satisfaction, and allows for early ambulation and hospital discharge. When simple guidelines are observed, the device can be safely used in the great majority of patients with peripheral vascular disease. It offers considerable advantages over the traditional method of manual compression.
