Cardiology Research and Practice / 2011 / Article / Tab 3 / Review Article
Left Atrial Appendage Closure in Atrial Fibrillation: A World without Anticoagulation? Table 3 Studies evaluating percutaneous left atrial appendage closure devices.
No. Study Study design Year Device Comparison Subjects (n ) Population Followup (mean) Results Adverse events (1) Meier et al. [36 ] Prospective 2003 Amplatzer Septal Occluder None 16 AF-continuous/paroxysmal; c/i to coumadin 4 months 0% stroke/TIA Device embolization (1) (2) Sievert et al. [37 ] Prospective 2002 PLAATO None 15 Chronic, nonrheumatic AF; c/i to coumadin 1 month 0% stroke/TIA Hemopericardium (1), device exchange (4) (3) Ostermayer et al. [38 ] Prospective 2005 PLAATO None 111 Chronic nonrheumatic AF patients at risk for stroke; c/i to coumadin 10 months Stroke/TIA 2.2% (versus estimated 6.3%) Implant failure (3), Hemopericardium (5) (4) Block et al. [39 ] Prospective 2009 PLAATO None 64 C/P AF; CHADS2 ≥ 2; c/i to coumadin 5 years Stroke 3.8% (versus estimated 6.6%) Cardiac tamponade (1), (%) (5) Sick et al. [40 ] Prospective 2007 WATCHMAN None 75 C/P AF; CHADS2 ≥ 1; eligible for coumadin 2 years 0% stroke/TIA Implant failure (2), device failure, embolization, or pericardial effusion (6), TIA’s (2) (6) PROTECT AF [45 ] Randomized Controlled Trial 2009 WATCHMAN Warfarin 707 C/P AF; CHADS2 ≥ 1; eligible for coumadin 18 months >99% probability of noninferiority for stroke/TIA prevention Adverse events higher among controls
AF: atrial fibrillation, c/i: contraindication, C/P: Chronic/Paroxysmal, TIA: transient ischemic attack, PLAATO: percutaneous left atrial appendage transcatheter occlusion, and PROTECT AF: WATCHMAN left atrial appendage system for embolic protection in patients with atrial fibrillation.