title: A pathologic study of explanted parachute devices from seven heart failure patients following percutaneous ventricular restoration.
abstract: OBJECTIVE
  We sought to evaluate the pathologic findings of the percutaneous Parachute device implanted in patients with severe heart failure (HF).
  
  
  BACKGROUND
  Currently, most treatments of HF rest on optimal medical therapy with adjunctive interventional or surgical palliative treatments. One such treatment is the Parachute device, which partitions the left ventricle excluding the scarred myocardium from functioning myocardium, and has shown promise in clinical studies.
  
  
  METHODS
  We have examined histopathologically seven cases [six males (age range 43–74 years; mean 56 years) and one female (55 years)] of Parachute device that were either retrieved at autopsy (n = 4) or during transplantation (n = 3); implant duration, 15-1,533 days.
  
  
  RESULTS
  Three patients died of cardiac causes and none died from complications. Histologic early changes (<30 days, n = 1) included adherent thrombus, with focal neutrophil infiltration and degenerating inflammatory cells. Over time (31–300 days, n = 4), there was organized thrombus and development of neoendocardial thickening especially at the free-edge of the device and its contact with the adjacent endocardium while the base of the device showed varying degrees of fibrin thrombus. The greatest organization of thrombus was observed in devices removed at >300 days (680 and 1533 days); both had fractures of the foot along with strut fracture and one had tearing of the expanded polytetrafluoroethylene.
  
  
  CONCLUSIONS
  The percutaneous Parachute device appears as a promising adjunctive treatment for patients suffering from severe HF. The pathologic changes are those of organizing thrombus with and without inflammation with minor complications of foot and strut fracture.
authors.forename: Elena
authors.initials: E
authors.lastname: Ladich
authors.forename: Fumiyuki
authors.initials: F
authors.lastname: Otsuka
authors.forename: Renu
authors.initials: R
authors.lastname: Virmani
mesh_terms: D000328:Adult; D000368:Aged; D000497:Alloys; D001344:Autopsy; D003324:Coronary Artery Disease / Q000150:complications; D020878:Device Removal; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000209:etiology / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009205:Myocarditis / Q000209:etiology*; D009206:Myocardium / Q000473:pathology*; D012720:Severity of Illness Index; D013927:Thrombosis / Q000209:etiology*; D013997:Time Factors; D014945:Wound Healing
chemical_list: D000497:Alloys; C013616:nitinol