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Published on: February 26, 2013
Midterm outcomes of LAA occlusion with the AMPLATZER Cardiac Plug and AMPLATZER Amulet devices in a high-risk cohort
Tobias Tichelbäcker1, L Scherner2, M Puls2
1Department of Cardiology, Heart Center Cologne, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany. Tobias.tichelbaecker@uk-koeln.de.
Insights
Left atrial appendage (LAA) occlusion effectively prevents stroke and bleeding in high-risk atrial fibrillation patients ineligible for anticoagulation. AMPLATZER devices show significant midterm effectiveness in real-world use.
Area of Science:
- Cardiology
- Medical Devices
- Thrombosis Prevention
Background:
- Left atrial appendage (LAA) occlusion is a key strategy for stroke prevention in atrial fibrillation (AF) patients unsuitable for oral anticoagulation.
- High-risk patient populations require proven, effective LAA closure devices for long-term safety.
Purpose of the Study:
- To evaluate the midterm effectiveness and safety of AMPLATZER Cardiac Plug (ACP) and AMPLATZER Amulet devices for LAA occlusion.
- To assess stroke and bleeding event rates in a high-risk AF cohort undergoing LAA closure.
Main Methods:
- Retrospective single-center cohort study of 212 AF patients treated with ACP or Amulet devices.
- Standardized midterm follow-up via phone calls, focusing on mortality, stroke, and bleeding events.
- Routine post-procedural management included dual antiplatelet therapy (DAPT) for 3 months.
Main Results:
- Follow-up was completed in 93% of patients (n=197) with a mean duration of 1244.2 days (674 patient-years).
- The study observed 25 events occurring after day 8 post-procedure.
- LAA closure demonstrated high effectiveness in preventing stroke and bleeding, with observed rates lower than predicted by CHA₂DS₂-VASc and HAS-BLED scores.
Conclusions:
- AMPLATZER Cardiac Plug and Amulet devices are highly effective for LAA occlusion in high-risk AF patients.
- LAA closure provides significant midterm protection against stroke and bleeding events in a real-world setting.
- Observed event rates suggest superior outcomes compared to risk stratification scores.
Abstract:
LAA occlusion has become a favourable option in patients with atrial fibrillation not eligible for oral anticoagulation therapy. Proof of effectiveness of LAA closure devices in a midterm follow-up period. This retrospective single-center cohort study analysed outcome in patients treated with AMPLATZER Cardiac Plug or AMPLATZER Amulet device. A standardized follow-up by phone call focusing on data of death, stroke and bleeding events was performed. Routine antiplatelet strategy was DAPT for 3 months post procedural. 212 patients (mean age 77 ± 6 years) were included. Follow up was performed in 197 (93%) patients. Patients were at high risk for thromboembolic or bleeding events (prior stroke/TIA 29%; prior bleeding 54%. Overall, there was a mean follow-up period of 1244.2 days (± 756.7) and a total of 674 patient years. We observed 25 events later than day 8 post procedure. We were able to demonstrate a high effectiveness of the AMPLATZER Cardiac Plug/AMPLATZER Amulet devices regarding the prevention of stroke and bleedings in a high-risk real-world cohort during a midterm follow-up period. Overall, we observed remarkably lower rates of stroke and bleedings as predicted with CHA2DS2-VASc and HASBLED scores.
