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Close up view of the WATCHMAN implant on a gray background

Meta-analysis

Review of procedural and short-term follow-up outcomes of the WATCHMAN FLX™ Implant vs. the Amplatzer™ Amulet™ Occluder
 

About the analysis

The largest comparison of peri-procedural success and short-term outcomes of left atrial appendage closure (LAAC) devices, Amplatzer Amulet vs. WATCHMAN FLX, revealed superior procedural safety, higher procedural success, and better left atrial appendage (LAA) closure with the WATCHMAN FLX Implant.1

Safety endpoint

Safety endpoint was the occurrence of death, stroke, major bleeding, myocardial infarction, major vascular complications, device embolization, or pericardial effusion within seven days post-procedure.

Study design

  • Meta-analysis (published in Heart Rhythm) of 4,186 patients from 21 studies.
    • Note: A meta-analysis is a statistical technique used to systematically combine data from a number of independent studies to develop a single conclusion that is statistically stronger than the analysis of any single study
  • 3,187 Amulet implants
  • 999 WATCHMAN FLX implants
  • No difference in TE risk between groups
  • CHA2DSC2-VASc: 4.3±1.5 for Amulet
  • CHA2DSC2-VASc: 4.2±1.5 for WATCHMAN FLX
  • Data from a first imaging study performed within three-month were used to assess the incidence of peri-device leaks >5mm and device-related thrombosis (DRT)

The largest comparison of peri-procedural success and short-term outcomes of LAAC devices, Amplatzer Amulet vs. WATCHMAN FLX, revealed superior procedural safety, higher procedural success, and better LAA closure with WATCHMAN FLX. 

WATCHMAN FLX Device

Key results

Safety

The WATCHMAN FLX Implant showed a significantly lower incidence of peri-procedural complications (p<0.01)

Adverse Events graph

  • WATCHMAN FLX superior on primary safety endpoint (0.6% FLX vs 4.7% Amulet, p<0.01)

  • WATCHMAN FLX superior on overall pericardial effusion/tamponade (0.1% FLX vs 2.5% Amulet, p<0.01) 

  • WATCHMAN FLX superior on clinically relevant pericardial effusion/tamponade (0.01% FLX vs 0.7% Amulet, p=0.01) 

  • WATCHMAN FLX superior on peri-procedural major/intracranial bleeding (0.1% FLX vs 2.3% Amulet, p=0.01)  

  • 0 device embolizations occurred with WATCHMAN FLX vs. 15 with Amulet (0.1%; 95% CI: 0-0.3) 

  • WATCHMAN FLX demonstrated lower DRT than Amulet (1% vs 1.6%) 

  • No difference was observed for death or stroke between groups

Procedural performance

WATCHMAN FLX showed a trend towards higher procedural success (p=0.08). Procedural success was achieved in 99.9% of WATCHMAN FLX patients (99.4% for Amulet, p=0.08).

Seal

WATCHMAN FLX showed a trend towards more frequent appendage occlusion (leaks >5mm; p=0.06). WATCHMAN FLX demonstrated fewer peri-device leaks >5mm than Amulet (0.01% vs 0.34%, p=0.06).

Peri Device

Review the results of completed WATCHMAN clinical trials, and learn more about trials in progress

Next: Clinical trials

References 

1. Della Rocca, D., Magnocavallo, M., Gianni, C., Horton, R., Biase, L., Natale, A., Procedural and short-term follow-up outcomes of Amplatzer Amulet Occluder versus Watchman FLX Device: A Meta-Analysis, Heart Rhythm, February 2022, https://doi.org/10.1016/j.hrthm.2022.02.007.​