Interventional closure of patent foramen ovale with <scp>N</scp>it‐occlud® device in prevention of recurrent neurologic events—Long‐term results

Araszkiewicz, Aleksander; Sławek, Sylwia; Trojnarska, Olga; Lesiak, Maciej; Grygier, Marek

doi:10.1002/ccd.27386

Cited by 3 publications

(1 citation statement)

References 27 publications

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“…Device thrombosis is a rare but serious complication after interventional PFO or ASD closure which may result in recurrent thromboembolism and stroke. It has been observed in historic and contemporary devices of virtually all manufacturers including the CardioSEAL/STARFlex ® devices, 9,10 the Amplatzer™ occluder family, 11,12 the Nit-Occlud ® PFO occluder, 13 the Occlutech occluder family 14,15 as well as the Gore ® Helex septal occluder, 10 Cardioform septal occluder 6,7 and the recently introduced Cardioform ASD occluder. 16 To date, there is insufficient evidence on the best follow-up management and antithrombotic therapy regimen after PFO closure.…”

Section: Patientmentioning

confidence: 99%

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

Krämer

Opgen‐Rhein

Berger

et al. 2023

Cathet Cardio Intervent

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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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