Impact of individual stroke risk on outcome after Amplatzer left atrial appendage closure in patients with atrial fibrillation

Author(s):  
Jonas D. Häner ◽  
Monika Fürholz ◽  
Caroline Kleinecke ◽  
Roberto Galea ◽  
Samuel R. Streit ◽  
...  
Author(s):  
Karen P Phillips ◽  
Aleksandr Romanov ◽  
Sergey Artemenko ◽  
Richard J Folkeringa ◽  
Tamas Szili-Torok ◽  
...  

Abstract Aims Clinical practice guidelines do not recommend discontinuation of long-term oral anticoagulation in patients with a high stroke risk after catheter ablation for atrial fibrillation (AF). Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the long-term outcomes of combining catheter ablation procedures for AF and LAAC from multicentre registries. Methods and results Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 142 subjects at 11 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful LAAC was achieved in 99.3% of patients. The 30-day device and/or procedure-related serious adverse event rate was 2.1%. After a mean follow-up time of 726 ± 91 days, 92% of patients remained off oral anticoagulation. The rates of the composite endpoint of ischaemic stroke/transient ischaemic attack/systemic thromboembolism were 1.09 per 100 patient-years (100-PY); and for non-procedural major bleeding were 1.09 per 100-PY. These represent relative reductions of 84% and 70% vs. expected rates per risk scores. Conclusion The long-term outcomes from these international, multicentre registries show efficacy for all-cause stroke prevention and a significant reduction in late bleeding events in a population of high stroke risk post-ablation patients who have been withdrawn from oral anticoagulation.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Shannon O Armstrong ◽  
Stacey L Amorosi ◽  
Susan S Garfield ◽  
Ken Stein

Introduction: Strokes associated with atrial fibrillation (AF) are estimated to cost Medicare $8 billion annually. Advancements in stroke prevention are aimed at improving clinical outcomes and reducing healthcare costs. This analysis quantifies the budget impact to Medicare and Medicare beneficiaries of left atrial appendage closure (LAAC) with the Watchman Device compared to warfarin, the standard of care, and rivaroxaban, the most commonly prescribed new oral anticoagulant in the US, for stroke risk reduction in non-valvular AF. Methods: A budget impact model was developed from a Medicare perspective using 2.3-year data from PROTECT AF and relative risks from ROCKET AF. The model captured all costs of treatment and associated complications. Costs for stroke included acute, direct costs as well as long-term disability costs. Cost data were from 2014 US DRGs. Medicare deductibles and co-insurance rates were used in the patient analysis. Results: In addition to better net clinical outcomes (table), LAAC is cost neutral to Medicare relative to warfarin and rivaroxaban by year 5, and one third less costly than both by year 10. Treatment-related complications comprised 33% of LAAC total costs compared to 65% for rivaroxaban and 87% for warfarin at year 5. Patient out-of-pocket costs for LAAC were lower than warfarin and rivaroxaban at 2 and 3 years, respectively. Conclusions: Upfront LAAC procedural costs are offset by ongoing therapy and complication costs associated with warfarin and rivaroxaban. LAAC with Watchman represents an opportunity for improved clinical outcomes and substantial savings to both Medicare and Medicare beneficiaries.


Heart Rhythm ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. S126
Author(s):  
Ciro Ascione ◽  
Marco Bergonti ◽  
Valentina Catto, Stefania I. Riva ◽  
Massimo Moltrasio ◽  
Fabrizio Tundo ◽  
...  

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