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CLINICAL RESEARCH: PERCUTANEOUS CLOSURE OF ASO

Cardiac perforation after device closure of atrial septal defects with the Amplatzer septal occluder

Abhay Divekar, MBBS^_*,_*, Tidimogo Gaamangwe, MSc, PEng, Nasir Shaikh, MBBS, Michael Raabe, MD and John Ducas, MD

^_* Section of Pediatric Cardiology, Health Sciences Center, Winnipeg, Manitoba, Canada
Section of Adult Cardiology, Health Sciences Center, Winnipeg, Manitoba, Canada
Section of Clinical Engineering, Health Sciences Center, Winnipeg, Manitoba, Canada
Section of Cardiovascular and Thoracic Surgery, Health Sciences Center, Winnipeg, Manitoba, Canada.

Manuscript received October 23, 2004; revised manuscript received December 18, 2004, accepted December 20, 2004.

^_* Reprint requests and correspondence: Dr. Abhay Divekar, FE-241, 685 William Avenue, Winnipeg, Manitoba R3E 0Z2, Canada. (Email: adivekar{at}exchange.hsc.mb.ca).

OBJECTIVES: Amplatzer septal occluder (ASO)-associated cardiac perforation (CP) at our institution prompted this retrospective review.

BACKGROUND: Cardiac perforation is a rare complication after transcatheter atrial septal defect (ASD) closure.

METHODS: To identify CP after transcatheter ASD closure with ASO, cardiac events (CE) describing definite CP, hemopericardium, pericardial effusion, cardiovascular collapse, or sudden death were analyzed. Cardiac events were identified from published literature (MEDLINE), medical device regulating agencies in North America and the European Commission, and AGA Medical Corporation (Golden Valley, Minnesota). Institutional cases were reviewed. Cardiac events were defined as early (pre-discharge) or late (post-discharge).

RESULTS: Twenty-nine CEs were identified. Five were excluded because findings were inconclusive for device-related CP. Ten patients were <18 years of age. Late CEs occurred in 66.6%; 25% presented weeks later (longest, three years). Three deaths were reported. Cardiac perforation occurred predominantly in the anterosuperior atrial walls and/or adjacent aorta.

CONCLUSIONS: Amplatzer septal occluder-associated CP uniquely involves the anterosuperior atrial walls and adjacent aorta. Pathophysiology remains poorly understood.

Abbreviations and Acronyms   ASD = atrial septal defect   ASO = Amplatzer septal occluder   CE = cardiac events   CP = cardiac perforation   FDA = Food and Drug Administration   MAUDE = Manufacturer And User facility Device Experience database   PFO = patent foramen ovale   SBD = stretched balloon diameter   TEE = transesophageal echocardiography

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