title: Single center experience: Implantation failures, early, and late complications after implantation of a partially biodegradable ASD/PFO-device (BioStar®).
abstract: BACKGROUND
  In the search for a biodegradable device that leaves nothing but the tissue of the patient after complete endotheliazation and absorption, the BioSTAR® device was introduced in 2007 (CE Mark in European community and HPB in Canada) for ASD and PFO closure. It consists of a metal framework covered by a biodegradable membrane generated from a layer of porcine collagen that is broken down and absorbed over time. In a sheep model, the results were promising, showing complete closure of the defect with degradation of approximately 90% of the implanted membrane material after two years.
  
  
  METHODS
  We report a retrospective analysis of implantation failures, early and late complications in a series of 34 patients with 30 implanted BioStar® devices in a single center with a total follow-up of more than 75 patient years.
  
  
  RESULTS
  We report 12% of implantation failures, 9% of early and 12% of late complications. Implantation failures include one embolized device, which was interventionally retrieved. Early complications were exclusively rhythm disturbances, one patient needed electrical and pharmacological therapy. Four relevant late complications occurred. One device required explantation after 61 days because of recurrent severe fever episodes, severe headache, and malaise that subsequently subsided after device removal. One patient presented with Dressler's syndrome with pericardial effusion 5 month after implantation requiring pericardiocentesis and steroid treatment. One device showed a central residual shunt that was not clearly seen initially. Finally, one device was explanted after hemorrhagic pericardial effusion due to perforation of an arm of the frame through the right atrial roof into the pericardial fold after 19 months.
  
  
  CONCLUSIONS
  We conclude that implantation of the Biostar® device is difficult in patients with deficient aortic rims and early complications are similar to those seen in other devices. Of importance, the late complications seen with the Biostar® device might be attributable to specific material and immunological properties of the partially biodegradable device. Although a biodegradable device might theoretically be more favorable more efforts for optimization of these devices have to be taken.
authors.affiliation: Department for Congenital Heart Defects, Heart and Diabetes Centre North Rhine Westphalia, Ruhr University Bochum, Bad Oeynhausen, North Rhine Westphalia, Germany.
authors.forename: Christoph M
authors.initials: CM
authors.lastname: Happel
authors.forename: Kai Thorsten
authors.initials: KT
authors.lastname: Laser
authors.forename: Matthias
authors.initials: M
authors.lastname: Sigler
authors.forename: Deniz
authors.initials: D
authors.lastname: Kececioglu
authors.forename: Eugen
authors.initials: E
authors.lastname: Sandica
authors.forename: Nikolaus A
authors.initials: NA
authors.lastname: Haas
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D006328:Cardiac Catheterization; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D015150:Echocardiography, Doppler / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000628:therapy*; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000009:adverse effects* / Q000379:methods; D012189:Retrospective Studies; D018570:Risk Assessment; D055989:Septal Occluder Device; D017211:Treatment Failure; D055815:Young Adult
keywords: ASD/PFO closure; BioStar® occluder; biodegradable device; complications