Left atrial appendage closure with the Amplatzer™ Cardiac Plug: impact of shape and device sizing on follow-up leaks

Background: The Amplatzer Cardiac Plug (ACP) is a relatively new system for left atrial appendage (LAA) closure. In general, the particular design of the device and the variability of the LAA anatomy make the sizing process challenging. The objective of our study was to analyze the impact of the shape and sizing of the device on the presence of follow-up leaks.

Methods: The shape was evaluated by angiography and classified as "strawberry-like", "square-like" and "tire-like". The presence of peri-device leaks was assessed by transesophageal echocardiography (TEE) and graded as: 1) severe, 2) major, 3) moderate, 4) minor and 5) absent.

Results: Twenty five patients were included. Overall, the device was oversized by 3.38 ± 2.26 mm and 1.58 ± 2.75 mm in relation to the largest angiographic and TEE diameter respectively. None of the patients presented any intra-procedural complication. After discharge, one patient was admitted for cardiac tamponade and another for stroke. In both, the device was optimally deployed. Follow-up TEE was done after a mean time of 7.9 ± 5.9 months. The presence of a leak was associated with a lower degree of device over-sizing by TEE (0.06 ± 3.31 mm if leak vs. 2.73 ± 1.85 mm if no leak; p=0.04) and a trend towards by angiography (2.39 ± 3.06 mm if leak vs. 3.98 ± 1.57 mm if no leak; p=0.16). The shape of the device was not associated with the presence of TEE leaks. Neither the shape nor the presence of leaks was associated with worse clinical outcomes.

Conclusions: Although the shape and sizing of the device were not linked to any particular clinical outcome, we found an association between a lower degree of over-sizing and the presence of follow-up leaks.