Abstract
LAA occlusion has become a favourable option in patients with atrial fibrillation not eligible for oral anticoagulation therapy. Proof of effectiveness of LAA closure devices in a midterm follow-up period. This retrospective single-center cohort study analysed outcome in patients treated with AMPLATZER Cardiac Plug or AMPLATZER Amulet device. A standardized follow-up by phone call focusing on data of death, stroke and bleeding events was performed. Routine antiplatelet strategy was DAPT for 3 months post procedural. 212 patients (mean age 77 ± 6 years) were included. Follow up was performed in 197 (93%) patients. Patients were at high risk for thromboembolic or bleeding events (prior stroke/TIA 29%; prior bleeding 54%. Overall, there was a mean follow-up period of 1244.2 days (± 756.7) and a total of 674 patient years. We observed 25 events later than day 8 post procedure. We were able to demonstrate a high effectiveness of the AMPLATZER Cardiac Plug/AMPLATZER Amulet devices regarding the prevention of stroke and bleedings in a high-risk real-world cohort during a midterm follow-up period. Overall, we observed remarkably lower rates of stroke and bleedings as predicted with CHA2DS2–VASc and HASBLED scores.
Highlights
LAA occlusion with percutaneous catheter-delivered devices has become an alternative in the prevention of stroke in patients with atrial fibrillation and high bleeding risk (ESC Guidelines 2016: IIb/B recommendation)[1]
Several devices of different manufacturers are available in the US and European market but only one device was tested in a randomized controlled trial (RCT) with a long-term follow-up period of 5 years and favourable results[6]
Between 08/2009 and 04/2016, a total of 212 patients were treated with the AMPLATZER Cardiac Plug (ACP) (n = 102) and the AMPLATZER Amulet device (n = 110)
Summary
LAA occlusion with percutaneous catheter-delivered devices has become an alternative in the prevention of stroke in patients with atrial fibrillation and high bleeding risk (ESC Guidelines 2016: IIb/B recommendation)[1]. Beyond the seminal RCTs of Apixaban2, Rivaroxaban[3] and Dabigatran[4], real world data of British patients showed a high proportion of discontinuation of DOACs, indicating the clinical need and relevance for alternative options in stroke prevention in many patients[5]. Validation of success of prophylactic interventions differ from therapeutical interventions especially in stroke prevention because no “instant” effect is expectable postprocedural. CHA2DS2–VASc 4 = 8.5% annual stroke rate)[8] and possible procedure related complications, success of stroke prevention with percutaneous devices has to be proven after a longer time period than 1 or 2 years (classic follow-up period of therapeutical interventions)
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