Joëlle Kefer1, Paul Vermeersch2, Werner Budts3, Tom Depotter4, Adel Aminian5, Edouard Benit6, Francis Stammen7. 1. Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium. joelle.kefer@uclouvain.be 2. Middelheim ZNA, Antwerpen, Belgium. 3. UZ Leuven, Leuven, Belgium. 4. OLV Ziekenhuis Aalst, Belgium. 5. CHU Charleroi, Charleroi, Belgium. 6. Jessaziekenhuis, Hasselt, Belgium. 7. Heilig Hart Roeselare, Roeselare, Belgium.
Abstract
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.
RCT Entities:
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.
Authors: Apostolos Tzikas; David R Holmes; Sameer Gafoor; Carlos E Ruiz; Carina Blomström-Lundqvist; Hans-Christoph Diener; Riccardo Cappato; Saibal Kar; Randal J Lee; Robert A Byrne; Reda Ibrahim; Dhanunjaya Lakkireddy; Osama I Soliman; Michael Nabauer; Steffen Schneider; Johannes Brachmann; Jeffrey L Saver; Klaus Tiemann; Horst Sievert; A John Camm; Thorsten Lewalter Journal: Europace Date: 2016-08-18 Impact factor: 5.214
Authors: Cheuk-Man Yu; Ahmed A Khattab; Stefan C Bertog; Alex P W Lee; Joey S W Kwong; Horst Sievert; Bernhard Meier Journal: Nat Rev Cardiol Date: 2013-10-22 Impact factor: 32.419