Transcatheter occlusion of the left atrial appendage--experimental testing of a new Amplatzer device.
OBJECTIVE
This study assessed the feasibility and efficacy of implanting a new nitinol device in the left atrial appendage (LAA) in a canine model.


BACKGROUND
Left atrial thrombus occurs in the LAA in 90% of humans with nonvalvular atrial fibrillation (AF).


METHODS
The Amplatzer Left Atrial Appendage Occluder Device now known as the Amplatzer Cardiac Plug (Amplatzer Medical LLC, Plymouth MN) is a new transcatheter Nitinol device containing polyester fabric designed to seal the LAA. The device was implanted in 10 canines with immediate, approximately 30 and approximately 90-day follow-up by echocardiography, angiography, and final pathological examination.


RESULTS
The device was successfully implanted in all animals and found to be retrievable and repositionable. There was complete occlusion of the LAA in all cases without embolization. There was no thrombus formation on the device and no pericardial effusion or impingement on the circumflex coronary artery, mitral valve, or left pulmonary vein. A single instance of tiny left atrial mural thrombus at device end screw contact was attributed to the small canine left atrium.


CONCLUSIONS
The success of this animal study confirms safety and feasibility of the Amplatzer Cardiac Plug. Human trials are warranted.
Bass
John L
JL
Department of Pediatrics/Division Pediatric Cardiology, University of Minnesota Amplatz Children's Hospital, Minneapolis, MN 55455, USA. bassx001@umn.edu
D000497:Alloys; D000818:Animals; D020517:Atrial Appendage / Q000000981:diagnostic imaging / Q000473:pathology; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D004285:Dogs; D005240:Feasibility Studies; D008422:Materials Testing; D011091:Polyesters; D011474:Prosthesis Design; D011859:Radiography; D055989:Septal Occluder Device; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D014463:Ultrasonography
D000497:Alloys; D011091:Polyesters; C013616:nitinol