ArticleEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2023
Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval Study.
Article in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed.
- Outcomes of Different Device Sizing Strategies Using the Newer-Generation WATCHMAN Devices for Closure of Borderline-Sized Left Atrial Appendage.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Article
- Safety and efficacy of ultralow-dose fluoroscopy in left atrial appendage occlusion.Heart rhythm O2 · 2026Article
- Update on left atrial appendage closure for neurologists.European stroke journal · 2026Review
- Antithrombotic Therapy After Percutaneous Left Atrial Appendage Closure: Results From the TERMINATOR Registry.JACC. Asia · 2026Article
- Real-world outcomes of left atrial appendage closure in very elderly compared with younger patients.Heart rhythm O2 · 2025Article
- Imaging assessment after percutaneous left atrial appendage closure: from immediate to long-term follow-up.European heart journal. Cardiovascular Imaging · 2025Review
- The Search for an Ideal Left Atrial Appendage Occluder.JACC. Asia · 2025Article
- A Membrane Modification Technique for Left Atrial Appendage Occlusion: A Multicenter Randomized Controlled Trial.JACC. Asia · 2025Article
- Transesophageal echocardiography: Revolutionizing perioperative cardiac care.Biomolecules & biomedicine · 2025Review
- Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024Article
- Practical guide on left atrial appendage closure for the non-implanting physician: an international consensus paper.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024Article
- Percutaneous left atrial appendage closure with the Watchman device: a systematic review.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2024Review
- Left Atrial Appendage Occlusion and Post-procedural Antithrombotic Management.Journal of clinical medicine · 2024Review
- Three-dimensional intracardiac echocardiography for left atrial appendage sizing and percutaneous occlusion guidance.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023Article
- Prognostic value of chronic kidney disease in patients undergoing left atrial appendage occlusion.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023Article
- Long-term Clinical Outcomes in Contemporary Patients Undergoing Left Atrial Appendage Occlusion Procedures in Ontario, Canada.CJC open · 2023Article
- Mid-Term Feasibility of Percutaneous Left Atrial Appendage Occlusion in Elderly Patients with Non-Valvular Atrial Fibrillation.Journal of clinical medicine · 2023Article
- Diagnostic and therapeutic pathways for the malignant left atrial appendage: European Heart Rhythm Association physician survey.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023Article
- Leap or lag: left atrial appendage closure and guidelines.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023Article
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Authors and funding
11 authors.
Funding
Abstract
aimsThe FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting. METHODS AND
resultsPatients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centres in Europe, the mean age was 74.6 ± 8.0 years, mean CHA2DS2-VASc score was 4.3 ± 1.6, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients. The post-implant medication regimen was DAPT for 87.3% (262/300). At first follow-up, core-lab adjudicated complete seal was 88.2% (149/169), 9.5% (16/169) had leak <3 mm, 2.4 (4/169) had leak ≥3 mm to ≤5 mm, and 0% had >5 mm leak. At 1 year, 93.3% (280/300) had final follow-up; 60.5% of patients were on a single antiplatelet medication, 21.4% were on DAPT, 5.6% were on direct oral anticoagulation, and 12.1% were not taking any antiplatelet/anticoagulation medication. Adverse event rates through 1 year were: all-cause death 10.8% (32/295); CV/unexplained death 5.1% (15/295); disabling and non-disabling stroke each 1.0% (3/295, all non-fatal); pericardial effusion requiring surgery or pericardiocentesis 1.0% (3/295); and device-related thrombus 2.4% (7/295).
conclusionThe WATCHMAN FLX device had excellent procedural success rates, high LAA seal rates, and low rates of thromboembolic events in everyday clinical practice.
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