Comparison of the Feasibility and Safety of First- versus Second-Generation AMPLATZER™ Occluders for Left Atrial Appendage Closure.

INTRODUCTION

Left atrial appendage closure (LAAC) is considered an alternative to oral anticoagulation therapy in patients with atrial fibrillation (AF). The aim of this study was to compare the safety and efficacy of the first- and second-generation AMPLATZER Devices for LAAC, AMPLATZER Cardiac Plug (ACP) versus AMPLATZER Amulet™.

METHODS

Procedural data, such as fluoroscopy time, radiation dose, and contrast-dye, as well as VARC criteria and major adverse events (MAEs) were assessed for both devices. The rate of peridevice leaks was analyzed at echocardiographic follow-up.

RESULTS

A total of 196 patients with AF underwent LAAC with the ACP ( = 99) or Amulet device ( = 97). The use of Amulet was associated with significantly lower fluoroscopy time (14.8 ± 7.4 min versus 10.6 ± 4.1 min; < 0.001), lower radiation dose (4833 ± 3360 cGy⁎cm versus 3206 ± 2169 cGy⁎cm; < 0.001), and reduced amount of contrast-dye (150.2 ± 83.9 ml versus 128.8 ± 46.0 ml; = 0.03). Furthermore, LAAC with Amulet devices resulted in lower device-resizing rates (3 versus 16 cases; = 0.001). Peridevice leaks were less frequent in the Amulet group (12 versus 4; = 0.03). MAE occurred in 6 ACP and 4 Amulet patients ( = 0.58).

CONCLUSIONS

The Amulet device is associated with shorter fluoroscopy times and radiation dosages, reduced use of contrast-dye, lower recapture rates, and less peridevice leaks as compared to the ACP.