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.