A Novel, Simple, and Secure, Mechanical Closure Device for Left Atrial Appendage Amputation or Atrial Incision

BACKROUND: Complete resection of the LAA is critical for the efficacy of surgical amputation. Due to the thin, fragile, delicate LAA postoperative bleeding after suture closure remains problematic. Current mechanical devices for LAA for use in open or minimally invasive surgery, although effective, are not always able to achieve complete appendage resection.

The Amsel Device, a novel mechanical, transfixion-like suture, is delivered through an 18G needle that easily and securely allows closure along any shaped resection line necessary to achieve complete LAA resection.

The objective of this study was to evaluate, in a porcine model, the performance of the Amsel™ Device for closure after LAA resection and atrial incision in the porcine model.

Methods: The AD was used to close the excision site after LAA amputation or simple atrial incision in the isolated heart ex-vivo, and in the in-vivo porcine model.

Results: Measurement of atrial thickness at excision site (~6mm) and length of wound (~4-5cms) and number of occluders (~n=5-7) were obtained ex vivo. Two pigs (60Kg) underwent closure with the AD following open LAA resection and RA incision. Secure closure of the suture lines was achieved with complete hemostasis.

Conclusions: This study confirms that the AD can be effectively and safely delivered during open cardiac surgery to provide a permanent, secure, mechanical closure after amputation of the LAA or atrial incision. The small foot-plate (an 18G needle) allows flexibility in following any suture line. Modification of this prototype delivery device and the occluding elements is simple. The AD may provide a cost effective and simple alternative closure method after atrial procedures and may be used as an adjunct with current LAA resections technologies eliminating any residual appendage remnant.