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Updated: Aug 26, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Incidence of thrombus formation on the CardioSEAL and the Amplatzer interatrial closure devices
Hitoshi Anzai1, John Child, Barbara Natterson
1University of California, Los Angeles, Center for Health Sciences, Los Angeles, California 90095, USA.
Insights
Transcatheter closure devices for atrial septal defects and patent foramen ovale can cause thrombus. The CardioSEAL device showed a higher incidence of thrombus formation compared to the Amplatzer device in this study.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Transcatheter closure is an alternative to surgery for atrial septal defects (ASD) and patent foramen ovale (PFO).
- Thrombus formation on implanted devices is a potential complication.
- Various closure devices are available, each with unique characteristics.
Purpose of the Study:
- To compare the incidence of thrombus formation between the Amplatzer and CardioSEAL devices after transcatheter closure of atrial communications.
- To evaluate the clinical outcomes and complications associated with these devices.
Main Methods:
- A cohort of 66 patients with ASD or PFO underwent transcatheter closure using either the Amplatzer or CardioSEAL device.
- Patients received antiplatelet and/or anticoagulant therapy post-procedure.
- Transesophageal echocardiography (TEE) was performed one month after implantation to assess for thrombus.
Main Results:
- No thromboembolic episodes occurred during follow-up.
- Thrombus formation was significantly more frequent on the CardioSEAL device (22%) compared to the Amplatzer device (0%) (p = 0.02).
- One patient required surgical explantation due to device thrombus despite anticoagulation.
Conclusions:
- The CardioSEAL device is associated with a higher likelihood of thrombus formation one month post-implantation compared to the Amplatzer device.
- Device selection may influence the risk of thrombus formation in transcatheter closure procedures.
- Further investigation into managing device-related thrombus is warranted.
Abstract:
Transcatheter closure for atrial septal defect (ASD) and patent foramen ovale (PFO) is a promising alternative to surgical closure or anticoagulant therapy. A potential complication is thrombus formation on the device after implantation. From February 2001 to June 2003, 66 patients with atrial communication were treated successfully with the Amplatzer device (16 septal and 20 PFO occluders) or the CardioSEAL device (30). Patients were discharged on antiplatelet medication (aspirin and clopidogrel) and/or anticoagulation. Fifty patients (76%) had transesophageal echocardiography (TEE) 1 month after device implantation (28 +/- 10 days). No patient experienced a thromboembolic episode during follow-up. TEE revealed that thrombus formation occurred more frequently on the CardioSEAL device (5 of 23 patients; 22%) than on the Amplatzer device (0 of 27 patients; 0%) (p = 0.02). Although thrombus disappeared or markedly diminished after additional anticoagulation therapy in 3 patients, 1 patient had surgical explantation of the device due to progressive increase in the size of thrombus with hypermobility despite intensive anticoagulation therapy. There was no variable associated with the presence of thrombus formation on the occluder other than the use of the CardioSEAL device. One month after insertion, the CardioSEAL device is more likely to have thrombus present than the Amplatzer device.
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