Key result
Gore Cardioform septal occluders linked to 3 cases of LA device thrombosis and neurological impairment.
Why the study?
Device thromboses after PFO and ASD closure are rare but serious complications reported across various devices.
Case Report (n=3)
No
Late device thrombosis can occur after PFO/ASD closure with the Gore Cardioform septal occluder, suggesting a potential need for echocardiographic follow-up beyond 6 months.
Potential late thrombosis risk after Gore Cardioform closure warrants vigilance; hypothesis-generating for extended surveillance.
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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Krämer et al. (2023) conducted a case report in Patent foramen ovale (PFO) and atrial septal defect (ASD) (n=3). Gore Cardioform septal occluder was evaluated on Left atrial device thrombosis. Three cases of left atrial device thrombosis occurred after atrial defect closure with the Gore Cardioform septal occluder, presenting with neurological impairments up to 2 years post-implantation.
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