Left atrial disc device thrombosis after atrial defect closure with the Gore® Cardioform septal occluder: A case series

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.

Right disc thrombosis of the new Gore Cardioform ASD Occluder

“…15,16 We think that the primary trigger of thrombus formation is blood stasis, thus, as supported by Kramer and colleagues case series with a similar design device, a double antiplatelet therapy is not enough to prevent this kind of complication. 13 According to our reported experience, the suggested steps to minimize the risk for right disc thrombosis might be as follows: (1) In borderline sizes according to the flowchart, the choice of a smaller device could prevent right disc oversizing. In fact, the mismatch with the interatrial septum determines the pathogenesis mechanism:…”

“…In this case, the higher incidence of thrombosis in the left chambers should lower the detection thresholds, since even small emboli could bring to disabling ictus cerebri, while pulmonary embolism is well tolerated with same dimensions clots. 13…”