What question did this study set out to answer?

This analysis aimed to compare the clinical outcomes of two left atrial appendage closure devices in practice.

December 1, 2020EuroIntervention

WATCHMAN versus ACP or Amulet devices for left atrial appendage occlusion: a sub-analysis of the multicentre LAARGE registry

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Why the study?

Due to device design differences, results of specific left atrial appendage occluders cannot simply be generalised to all devices, prompting assessment of two contemporary devices in clinical practice.

Does the WATCHMAN device compared to the ACP or Amulet occluder provide similar procedural success, safety, and clinical outcomes in patients undergoing left atrial appendage occlusion?

Key Points

This analysis aimed to compare the clinical outcomes of two left atrial appendage closure devices in practice.
Non-randomised sub-analysis of the multicentre LAARGE registry.
641 patients enrolled from 38 centres, with 278 receiving WATCHMAN and 340 receiving ACP/Amulet.
Evaluation of technical success, procedural safety, and one-year composite outcomes.
High technical success was achieved: 96% for WATCHMAN vs 99% for ACP/Amulet; p=0.007.
Procedural safety rates were comparable: 98% for WATCHMAN vs 97% for ACP/Amulet; p=0.55.
One-year composite event rates of death or stroke were 12.0% for WATCHMAN and 12.9% for ACP/Amulet; p=0.79.

Structured PICO

Does the WATCHMAN device compared to the ACP or Amulet occluder provide similar procedural success, safety, and clinical outcomes in patients undergoing left atrial appendage occlusion?

Population

641 patients undergoing left atrial appendage occlusion enrolled in the prospective, multicentre LAARGE registry in Germany.

Intervention

WATCHMAN left atrial appendage closure device (n=278)

Comparator

AMPLATZER Cardiac Plug (ACP) or Amulet occluder (n=340)

Outcome

Technical success, procedural safety, and one-year composite of death or strokecomposite

Both WATCHMAN and ACP/Amulet devices provide excellent procedural safety and comparable one-year clinical outcomes for left atrial appendage occlusion, though ACP/Amulet had slightly higher technical success.

Limitations

non-randomised design

Implication

Comparable real-world outcomes with both devices; leaves open optimal selection pending randomized trials.

Abstract

AIMS: Several left atrial appendage (LAA) closure systems are available. Due to differences in device design, the results of specific occluders derived from trials cannot simply be generalised to all devices. The present analysis sought to assess two contemporary LAA closure devices in clinical practice. METHODS AND RESULTS: The work represents a non-randomised sub-analysis of the prospective, multicentre, Left-Atrium-Appendage Occluder Register - GErmany (LAARGE) registry. The WATCHMAN (group 1) and the AMPLATZER Cardiac Plug (ACP) or Amulet occluder (group 2) were assessed. A total of 641 patients at 38 centres were enrolled. Of these, 278 (43%) and 340 (53%) patients received the WATCHMAN and ACP/Amulet occluder, respectively. High technical success was achieved with a slight difference between the groups (96% in group 1 vs 99% in group 2; p=0.007). Procedural safety did not differ (98% in group 1 vs 97% in group 2; p=0.55). The Kaplan-Meier estimated one-year composite of death or stroke was 12.0% and 12.9%, respectively (p=0.79). CONCLUSIONS: Both the WATCHMAN and the ACP/Amulet occluder provide excellent procedural results with comparable implantation success and no differences with respect to procedural safety and long-term effectiveness.