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Updated: Aug 12, 2025

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
23:33

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation

Published on: February 28, 2012

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Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial

Boris Schmidt1, Jens Erik Nielsen-Kudsk2, Christopher R Ellis3

  • 1Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.

JACC. Clinical Electrophysiology
|January 25, 2023
PubMed

Insights

Device-related thrombus (DRT) after left atrial appendage occlusion (LAAO) is uncommon. Early DRT is associated with dual-mechanism devices, while late DRT is linked to single-mechanism devices, with increased mortality risk for DRT patients.

Area of Science:

  • Cardiology
  • Medical Devices
  • Thrombosis

Background:

  • Device-related thrombus (DRT) is a complication of left atrial appendage occlusion (LAAO).
  • Limited data exist on DRT rates and outcomes from randomized trials following LAAO.

Purpose of the Study:

  • To investigate the incidence, predictors, and clinical outcomes of DRT after LAAO.
  • To compare DRT characteristics between dual and single occlusive mechanism devices.

Main Methods:

  • Analysis of the Amulet IDE trial data, comparing Amulet (dual occlusive mechanism) and Watchman (single occlusive mechanism) devices.
  • Follow-up of 903 patients with Amulet and 885 patients with Watchman devices for 18 months.
  • Assessment of DRT using transesophageal echocardiography.

Main Results:

  • Overall DRT incidence was 3.9% (3.4% dual, 4.8% single mechanism).
  • Early DRT (≤45 days) was more common with dual-mechanism devices; late DRT (>45 days) with single-mechanism devices.
  • Predictors of DRT included atrial fibrillation during procedure, female sex, and older age. Patients with DRT faced higher cardiovascular mortality risk.

Conclusions:

  • DRT incidence following LAAO is low, with distinct timing patterns for dual and single occlusive mechanism devices.
  • Further investigation into the increased cardiovascular mortality risk associated with DRT is warranted.
  • The study provides insights into DRT management and device selection in LAAO procedures.
Abstract

Keywords:
atrial fibrillationdevice-related thrombusleft atrial appendage occlusionstroke

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