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Updated: Jul 26, 2025
Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure
Published on: February 8, 2022
Left atrial disc device thrombosis after atrial defect closure with the Gore® Cardioform septal occluder: A case
Peter Kramer1,2, Bernd Opgen-Rhein1,2, Felix Berger1,2,3
1Department of Congenital Heart Disease - Pediatric Cardiology, Deutsches Herzzentrum der Charité, Berlin, Germany.
Insights
Late device thrombosis can occur after atrial defect closure, even with antiplatelet therapy. Regular echocardiography may be advisable for Gore® Cardioform septal occluder devices to detect these rare but serious complications.
Area of Science:
- Cardiology
- Medical Devices
- Thrombosis
Background:
- Device closure is a common treatment for patent foramen ovale (PFO) and atrial septal defects (ASD).
- While generally safe, rare complications like device thrombosis can occur, impacting patient outcomes.
Observation:
- Three cases of left atrial device thrombosis were observed following Gore® Cardioform septal occluder (GSO) implantation.
- Patients presented with neurological impairments and cerebral thromboembolism, despite antiplatelet therapy in two cases.
- Thrombosis occurred late (around 2 years post-implantation) in two patients.
Findings:
- One GSO device required surgical explantation.
- Anticoagulation led to complete thrombus resolution in two patients, with favorable neurological recovery.
- These findings highlight the potential for late-onset thrombosis with specific PFO/ASD closure devices.
Implications:
- Regular echocardiographic follow-up beyond 6 months may be beneficial for GSO device recipients to monitor for late thrombosis.
- Further long-term data on device safety and complications are needed to guide antithrombotic therapy and follow-up strategies for PFO/ASD closure.
- This study underscores the importance of vigilance for rare but serious device-related complications.
Abstract:
Device thromboses after patent foramen ovale (PFO) and atrial septal defect (ASD) closure are rare but serious complications. They have been reported in different devices of virtually all manufacturers. Here, we report three cases of left atrial device thrombosis after atrial defect closure with the Gore® Cardioform septal occluder (GSO) in our recent institutional experience. All patients were symptomatic with new-onset neurological impairments and evidence of cerebral thromboembolism. Device thromboses have occurred despite antiplatelet therapy in two patients and moreover were observed late, at approximately 2 years after implantation, in two patients. One device was surgically explanted while in two cases, thrombi completely resolved with initiated anticoagulation. All patients had a favorable neurological recovery. Our observations suggest that regular follow-up echocardiography beyond 6 months after device implantation might be advisable in patients with GSO devices to rule out late device thromboses. More long-term follow-up data considering safety and late complications of contemporary PFO and ASD devices is required to establish confident evidence-based recommendations on long-term follow-up management and antithrombotic therapy regimen after PFO and ASD closure.
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