title: Clinical, echocardiographic and histopathologic findings in nine patients with surgically explanted ASD/PFO devices: do we know enough about the healing process in humans?
abstract: BACKGROUND
  Atrial septal defects (ASD) and persistent foramen ovale (PFO) are managed in increasing numbers by catheter interventions as an attractive alternative to surgery. Early complications have been described in clinical series whereas late complications are rare. No series are reported with clinical, echocardiographic and histological data.
  
  
  RESULTS
  We collected clinical, echocardiographic, and histolological data of nine patients with surgically explanted devices. Occlusion devices were explanted after a mean interval of 3.4 ± 2.4 years (range 0.9-8.3). Indications were recurrent thromboembolic events in five, residual shunt/dislocation in three, and growing mass on echocardiography despite oral anticoagulation in one patient. Two patients suffered potentially live threatening events due to coronary embolism. One of them had to be resuscitated due to ventricular fibrillation. Histologically, residues of superficial thrombus formation could be demonstrated in two of the devices. In another patient, hyperplastic tissue formation was related to a local inflammatory process but not to a thrombus as suspected by echocardiography.
  
  
  CONCLUSIONS
  Late complications after device implantation may occur up to 8 years after device implantation and may be potentially live threatening. Echocardiographic controls should be prolonged beyond the first year after implantation and every explanted device should be histologically worked up in an experienced center. Up to now, the mechanisms of late thrombogenesis are not fully understood.
authors.affiliation: Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich, Technical University, Lazarettstr 36, D-80636 Munich, Germany. drvogt@dhm.mhn.de
authors.forename: Manfred Otto
authors.initials: MO
authors.lastname: Vogt
authors.forename: Andreas
authors.initials: A
authors.lastname: Kühn
authors.forename: Jürgen
authors.initials: J
authors.lastname: Hörer
authors.forename: Christian
authors.initials: C
authors.lastname: Schreiber
authors.forename: Heike
authors.initials: H
authors.lastname: Schneider
authors.forename: Rudi
authors.initials: R
authors.lastname: Foth
authors.forename: Andreas
authors.initials: A
authors.lastname: Eicken
authors.forename: John
authors.initials: J
authors.lastname: Hess
authors.forename: Matthias
authors.initials: M
authors.lastname: Sigler
mesh_terms: D000328:Adult; D020878:Device Removal / Q000379:methods / Q000592:standards; D017548:Echocardiography, Transesophageal; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D019919:Prosthesis Implantation / Q000009:adverse effects*; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology; D055815:Young Adult