Key result
Left atrial appendage closure using the Amplatzer cardiac plug resulted in an observed 1-year stroke rate of 2.14%/year, which was lower than the expected rate of 5.08%/year.
Why the study?
Does left atrial appendage closure using the Amplatzer cardiac plug prevent stroke and demonstrate procedural safety in high-risk patients with atrial fibrillation?
Observational (n=90)
Yes
Does left atrial appendage closure using the Amplatzer cardiac plug prevent stroke and demonstrate procedural safety in high-risk patients with atrial fibrillation?
Absolute Event Rate: 2.14% vs 5.08%
Left atrial appendage closure with the Amplatzer cardiac plug is feasible and safe, demonstrating a 1-year stroke rate lower than predicted by baseline risk scores in a high-risk real-world registry.
May support LAA closure in high-risk AF; leaves open stroke reduction versus anticoagulation in randomized trials.
AIMS: The aim of the present study was to evaluate the procedural feasibility, the safety and the 1-year outcome following left atrial appendage (LAA) closure using the Amplatzer cardiac plug (ACP) in Belgium. METHODS AND RESULTS: Data were prospectively collected among 90 consecutive patients, undergoing LAA closure with an ACP in 7 Belgian centres between June 2009 and September 2012. The patients (56 males, 74 +/- 8 years) were at high risk for stroke (CHA2DS2-VASc = 4.4 +/- 1.8) and bleeding (HAS-BLED = 3.3 +/- 1.3).Technical success was obtained in all but one patient and procedural success was 95%. Procedural major adverse events (MAE) were 3 tamponades resulting in death in one case. Minor complications were 3 insignificant pericardial effusions, 2 transient myocardial ischaemia due to air embolism and 1 femoral pseudoaneurysm. At 1-y follow-up, there were 4 deaths, 2 minor strokes, 1 tamponade and 1 myocardial infarction. Overall survival was 94% and freedom from MAE was 88%. In our population, the expected annual stroke risk according to the CHA2DS2-VASc score was 5.08%, while the observed stroke rate was 2.14%/year. CONCLUSIONS: The Belgian registry shows that LAA closure using the ACP device is feasible and safe. At 1-y follow-up, the observed stroke rate was 2.14%/year, less than predicted by the CHA2DS2-VASc score. Longer follow-up is needed to evaluate the long-term safety and its efficacy in reducing stroke.
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Kefer et al. (2013) conducted an observational in Atrial fibrillation (n=90). Left atrial appendage closure using the Amplatzer cardiac plug vs. Expected risk based on CHA2DS2-VASc score was evaluated on 1-year stroke rate. Left atrial appendage closure using the Amplatzer cardiac plug resulted in an observed 1-year stroke rate of 2.14%/year, which was lower than the expected rate of 5.08%/year.
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