title: First in vivo evaluation of a flexible self-apposing left atrial appendage closure device in the canine model.
abstract: OBJECTIVE
  Aimed to evaluate the feasibility of deployment and healing response of a novel transcatheter left atrial appendage (LAA) occlusion device in the canine model
  
  
  BACKGROUND
  LAA occlusion is proposed to reduce the risk of stroke in atrial fibrillation patients
  
  
  METHODS
  Transseptal puncture and device deployment was guided under fluoroscopy and transesophageal echocardiography (TEE) in five dogs. First, a distal cylindrical bulb occluder was released and secured to the appendage wall with hooks. Subsequently, a proximal sail was unfolded, covering the LAA ostium. Rotational angiography, TEE, and histology outcomes were assessed 30 days following implantation
  
  
  RESULTS
  Pre-operative TEE revealed the mean diameter of the LAA ostium to be 17.2 ± 1.6 mm with a depth of 18.5 ± 1.7 mm. The landing zone for the distal bulb was measured to be 12.8 ± 1.3 mm. The mean bulb diameter at implant was 16.8 ± 1.8 mm. Post-operative TEE showed adequate positioning and successful LAA occlusion with all implanted devices. Pericardial effusion requiring pericardiocentesis was seen in one animal following device implantation. At 30 days, TEE revealed full occlusion of all LAA ostia with the exception of a minimal peri-device leak (<3 mm) observed in one animal. No pericardial effusion or device-related thrombus formation was found at termination. Histological analysis confirmed circumferential occlusion of all appendages and complete neointimal coverage on the luminal aspect of the occluder
  
  
  CONCLUSIONS
  The percutaneous delivery of a novel self-positioning LAA occlusion device is feasible and safe in a canine model. At 30 days, all devices displayed complete healing and occlusion of the LAA without any device related adverse events.
authors.affiliation: Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Yanping
authors.initials: Y
authors.lastname: Cheng
authors.affiliation: Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Gerard
authors.initials: G
authors.lastname: Conditt
authors.affiliation: Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Genghua
authors.initials: G
authors.lastname: Yi
authors.affiliation: Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Armando
authors.initials: A
authors.lastname: Tellez
authors.affiliation: Cardia Inc., Eagan, Minnesota.
authors.forename: Michael
authors.initials: M
authors.lastname: Corcoran
authors.affiliation: Alizée Pathology, LLC, Thurmont, Maryland.
authors.forename: Serge
authors.initials: S
authors.lastname: Rousselle
authors.affiliation: Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Greg L
authors.initials: GL
authors.lastname: Kaluza
authors.affiliation: Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Orangeburg, New York.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
mesh_terms: D000818:Animals; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D006328:Cardiac Catheterization; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D004195:Disease Models, Animal; D004285:Dogs; D017548:Echocardiography, Transesophageal; D005471:Fluoroscopy; D008026:Ligation / Q000295:instrumentation; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013537:Sutures
keywords: histopathology; left atrial appendage occlusion; transcatheter; transesophageal echocardiography