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Left atrial appendage closure is a proven method for prevention against stroke in patients with non-valvular atrial fibrillation. This method is proven for having clinical utility as well as safety.
The need for coverage in this area is immense. Atrial fibrillation affects 1%–2% of the entire adult population.1 Of all ischaemic strokes, 15% are associated with atrial fibrillation. Both the CHADS2 and the CHA2DS2-VASc risk scores have been used for determining the level of anticoagulation in these patients. Multiple anticoagulants have been used for prevention of ischaemic stroke, including warfarin, dabigatran, rivaroxaban, apixaban and edoxaban. The main purpose of the ‘new’ oral anticoagulants is to provide anticoagulants without the additional need for monitoring.
The Amplatzer Cardiac Plug and the second-generation Amulet device have a large history of registry data since the device was first implanted in 2008. The paper by Lopez-Minguez et al2 reports results from 167 patients who were contraindicated for oral anticoagulation. Procedural success was high at 94.6% of patients, making the procedure very safe. Stroke was at 2.4% per year, which consisted of a 75% reduction compared with expected risk. For these patients, anticoagulation is not an option. This is in line with other large databases, including the ones mentioned in their table 4. The Canadian registry, which had a higher baseline stroke risk and a similar follow-up period, also showed a similar reduction as well as the ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology (ASAP) study. Of all the studies listed, the Iberian study had the highest annual risk of stroke. It is important here to mention the results from the international multicentre European Amplatzer Cardiac Plug (ACP) …
Contributors We wish to state that: this is an original manuscript; it is not under consideration elsewhere; none of its contents have been previously submitted or published; and all authors have read and approved the manuscript. SG, HS and PM were involved in conception and design, drafting of the manuscript and revision, and final approval of the manuscript submitted.
Competing interests The authors’ institution has ownership interest in or has received consulting fees, travel expenses or study honoraries from the following companies: Abbott, Access Closure, AGA, Angiomed, Arstasis, Atritech, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, Cardiac Dimensions, CardioKinetix, CardioMEMS, Coherex, Contego, CSI, EndoCross, EndoTex, Epitek, Evalve, ev3, FlowCardia, Gore, Guidant, Guided Delivery Systems, Inc., InSeal Medical, Lumen Biomedical, HLT, Kensey Nash, Kyoto Medical, Lifetech, Lutonix, Medinol, Medtronic, NDC, NMT, OAS, Occlutech, Osprey, Ovalis, Pathway, PendraCare, Percardia, pfm Medical, Rox Medical, Sadra, SJM, Sorin, Spectranetics, SquareOne, Trireme, Trivascular, Velocimed, Veryan.
Provenance and peer review Commissioned; internally peer reviewed.
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