Background: Left Atrial Appendage Occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) pts. who are not eligible for long-term oral anticoagulation (OAC). We herewith present the rationale, design, occluder indication and procedural outcome of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE).
Materials and Methods: A total of 641 consecutive pts. were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Demographics, clinical characteristics, procedure indication, details of implantation were collected; patients were followed at 1 year post implant and then up to 5 years. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively.
Results: Patient demographics represent a critically-ill population with a mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively. Main indications for occluder implantation were bleeding events (79.4%), cerebral events (27.5%), contraindication to anticoagulation (19.0%), and patient’s choice (25.1%). Implanted devices were the Watchman occluder (43.5%), the Amplatzer Amulet (25.7%), Amplatzer Cardiac Plug (27.9%) and others (2.8%). Device success was achieved in 623 pts. (97.6%) with a rate of leaks <5mm in 32 pts. (5.2%) and a median procedure time of 59 min. The major in-hospital complication rate was 4.5% with a total complication rate of 12.6%. OAC dropped from 61.2% before the procedure to 12.7% at discharge, whereas antiplatelet treatment was increased from 34.4% to 96.1% with a dual antiplatelet therapy rate of 86.4%,
Conclusion: LAARGE, a prospective multicenter real world and all-comer registry, provides real world data. It is unique in its concept, as it is non-manufacturer sponsored and includes all commercially available devices. LAAO Implantation is mainly performed in patients with a history of bleeding, however in more than 20%, patient’s choice was a decision determinant. Severe periprocedural complications of 4.5% in the LAARGE high risk population (HAS-BLED 3.9) are within the previously reported range. The wide range of postprocedural treatment emphasizes the need of prospective trial data and standardisation.