Prospective clinical study of a novel left atrial appendage occlusion device.
OBJECTIVE
This Food and Drug Administration-approved investigational device exempt trial assessed the safety and efficacy of a novel device for external left atrial appendage (LAA) exclusion.


METHODS
Delivery tool and implant consisting of connectors imbedded in a compliant, soft silicone applied to the base of the LAA flush with the external wall was assessed.


RESULTS
Patients in this prospective, multicenter trial were undergoing elective, nonendoscopic cardiac operations. A core laboratory independently assessed all intraprocedural and 90-day transesophageal echocardiograms. Sixty patients (37 men), aged 33 to 86 years, enrolled. The mean LAA application time was 27 seconds. Transesophageal echocardiograms at 90 days were available in 54 patients, and no leaks were detected. The residual LAA cavity exceeded 6 mm in 5 patients. One delivery device failed to close, and an adjunctive suture was required to complete LAA exclusion. One patient required adjunct sutures at a small tear site related to manual manipulation after fastener application.


CONCLUSIONS
The study demonstrated safety and efficacy of this LAA exclusion device, offering an alternative to manual suturing or staples with or without reinforcement.
Division of Thoracic and Cardiovascular Surgery, University of Louisville, Louisville, Kentucky 40202, USA.
A David
AD
Slater
Antone J
AJ
Tatooles
Arthur
A
Coffey
Patroklos S
PS
Pappas
Michael
M
Bresticker
Kevin
K
Greason
Mark S
MS
Slaughter
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000150:complications* / Q000000981:diagnostic imaging / Q000628:therapy*; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D057505:Embolic Protection Devices; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020766:Intracranial Embolism / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants; D013536:Suture Techniques / Q000295:instrumentation*