BACKGROUND: The Amplatzer Amulet, a second-generation device for left atrial appendage occlusion (LAAO), has been designed to facilitate the implantation process, improve the closure performance, and reduce the risk of complications. The objective of this study was to compare the outcomes of the Amplatzer Cardiac Plug (ACP) with the Amplatzer Amulet for LAAO, with a special focus on the incidence of residual leaks. METHODS: This was a prospective, single-center review of consecutive patients undergoing percutaneous LAAO with either ACP or Amulet devices. The first transesophageal echocardiography (TEE) at follow-up (1-3 months) was utilized to assess the occurrence of residual leaks. RESULTS: Between November 2009 and August 2013, a total of 59 patients underwent LAAO with either the ACP device (n = 31) or Amulet device (n = 28). The device was successfully implanted in 58 patients (98.3%). There was no procedural device embolization, stroke, or cardiac tamponade. Follow-up TEE was available in 86% (50 patients; 25 ACP devices and 25 Amulet devices). At follow-up, there was no procedural device embolization, and only 1 patient who received an Amulet device presented with device thrombosis at follow-up. Amulet use was associated with a significant reduction of any leak (minor, moderate, or major) compared with ACP use (48% ACP vs 8% Amulet; P=.01). CONCLUSION: In this initial series, the Amulet showed similar procedural and short-term clinical outcomes compared with the ACP. The Amulet was, however, associated with a significant reduction of residual leaks at follow-up.
BACKGROUND: The Amplatzer Amulet, a second-generation device for left atrial appendage occlusion (LAAO), has been designed to facilitate the implantation process, improve the closure performance, and reduce the risk of complications. The objective of this study was to compare the outcomes of the Amplatzer Cardiac Plug (ACP) with the Amplatzer Amulet for LAAO, with a special focus on the incidence of residual leaks. METHODS: This was a prospective, single-center review of consecutive patients undergoing percutaneous LAAO with either ACP or Amulet devices. The first transesophageal echocardiography (TEE) at follow-up (1-3 months) was utilized to assess the occurrence of residual leaks. RESULTS: Between November 2009 and August 2013, a total of 59 patients underwent LAAO with either the ACP device (n = 31) or Amulet device (n = 28). The device was successfully implanted in 58 patients (98.3%). There was no procedural device embolization, stroke, or cardiac tamponade. Follow-up TEE was available in 86% (50 patients; 25 ACP devices and 25 Amulet devices). At follow-up, there was no procedural device embolization, and only 1 patient who received an Amulet device presented with device thrombosis at follow-up. Amulet use was associated with a significant reduction of any leak (minor, moderate, or major) compared with ACP use (48% ACP vs 8% Amulet; P=.01). CONCLUSION: In this initial series, the Amulet showed similar procedural and short-term clinical outcomes compared with the ACP. The Amulet was, however, associated with a significant reduction of residual leaks at follow-up.
Authors: Michael Gotzmann; Dinah S Choudhury; Maximilian Hogeweg; Florian Heringhaus; Andreas Mügge; Andreas Pflaumbaum Journal: Clin Cardiol Date: 2020-01-22 Impact factor: 2.882