Amplatzer Amulet

Safety and Efficacy

Recent Prospective Studies

Global Study Reveals Excellent Performance in High-Risk Patients

The safety and performance of the Amplatzer Amulet device has been well documented and published.1 Trials continue to demonstrate its efficacy. 

Global AMPLATZER Amulet Observational Study2

This multicenter, prospective, real world registry included 1,088 patients:

  • Who were at high risk of stroke and bleeding
  • Who had paroxysmal, persistent, or longstanding nonvalvular atrial fibrillation

Because the vast majority of patients had a history of major bleeding, they were relatively or absolutely contraindicated for oral anticoagulation therapy. The observational study shows high implant success rates as well as few periprocedural complications. Outcomes are as shown.2
 

Global AMPLATZER Amulet Observational Study2

This multicenter, prospective, real world registry included 1,088 patients:

  • Who were at high risk of stroke and bleeding
  • Who had paroxysmal, persistent, or longstanding nonvalvular atrial fibrillation

Because the vast majority of patients had a history of major bleeding, they were relatively or absolutely contraindicated for oral anticoagulation therapy. The observational study shows high implant success rates as well as few periprocedural complications. Outcomes are as shown.2
 

These patients were followed for one year and patients experienced a reduction in ischemic events when compared to a predicted rate based on their stroke risk.3
 

Risk Reduction vs Predicted Stroke Risk Based on CHA2DS2-VASc Score


Patients in the Amulet Observational Study experienced:

  • A 57% risk reduction in ischemic stroke events compared to predicted events.
  • A 60% risk reduction in ischemic strokes, TIAs, and systemic embolisms compared to predicted events.
Risk Reduction vs Predicted Stroke Risk Based on CHA2DS2-VASc Score


Patients in the Amulet Observational Study experienced:

  • A 57% risk reduction in ischemic stroke events compared to predicted events.
  • A 60% risk reduction in ischemic strokes, TIAs, and systemic embolisms compared to predicted events.
  • Left Atrial Appendage Occlusion in patients with prior Intracerebral Hemorrhage

    Atrial fibrillation patients indicated for oral anticoagulation who had intracranial bleeding constitute a particularly difficult group with respect to their stroke risk management. In many cases these patients do not receive anticoagulation therapy due to concerns for recurrent intracranial bleeding or intracerebral hemorrhage (ICH).

    Nielsen-Kudsk conducted a propensity score matched trial that compared 147 patients with LAA occlusion (LAAO) and 147 standard care patients matched according to stroke and bleeding risks (CHA2DS2-VASc and HAS-BLED scores).4

    When comparing LAAO to standard care, LAAO showed a significant risk reduction of the following:

    • Combined endpoint of ischemic stroke, major bleeding, mortality: 81% relative risk reduction
    • Ischemic stroke: 65% relative risk reduction
    • Major bleeding: 61% relative risk reduction
    • Recurrent intracerebral hemorrhage: 71% relative risk reduction
    • All-cause mortality: 92% relative risk reduction
  • Investing in a Growing Body of Evidence

    Though the Amplatzer Amulet LAA Occluder has been successfully used for a number of years, Abbott is committed to investing in research to validate and further quantify the therapy’s potential benefits. Ongoing studies include the following.

    STUDYSAMPLE SIZELOCATION
    Amulet Investigational
    Device Exemption (IDE)
    1.878US, Canada, Europe, Australia
    Amulet Observational
    Study
    1,088Europe, Asia, Australia
    LAAO Post
    Approval Study
    1,000Canada, Latin America, Europe

AP2947041-WBO Rev. A

References
  1. Tzikas A. Left atrial appendage occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: a clinical trials update. J Atr Fibrillation. 2017;10(4):1651. doi: 10.4022/jafib.1651.
  2. Landmesser U, et al. Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study. EuroIntervention. 2017;13:867-876.
  3. Landmesser U, et al. Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study. EuroIntervention. 2017;13(7):867-876. doi: 10.4244/EIJ-D-17-00493.
  4. Nielsen-Kudsk J, et al. Left atrial appendage occlusion versus standard medical care in patients with atrial fibrillation and intracerebral hemorrhage: a propensity score matched follow-up study. EuroIntervention. 2017;13(3):371-378. doi:10.4244/EIJ-D-17-00201.
     

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