Combining left atrial appendage closure and catheter ablation for atrial fibrillation: 2-year outcomes from a multinational registry

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significant reduction in late bleeding events in a population of high stroke risk post-ablation patients who have been withdrawn from oral anticoagulation.

Combined Therapy of Catheter Ablation and Left Atrial Appendage Closure for Patients with Atrial Fibrillation: A Case-Control Study

“…By comparing the single procedures, the combined therapy (i) does not introduce additional periprocedural complications; (ii) has comparable rate of AF recurrence and successful LAA occlusion, and (iii) provides satisfactory outcomes of stroke prevention and bleeding events during a mean of 2 years of follow-up. The results support and supplement the safety and efficacy of the combined procedure of AF ablation and LAAC, which were previously published in noncontrol studies [ 8 – 12 ].…”

“…The combination of LAAC with CA is an effective way to ameliorate the symptoms of AF, while at the same time, reducing the risk of stroke, which was first reported by Swaans et al in a small observational study of 30 patients [ 6 ]. Since then, a number of studies, from single-center experiences to multicenter registry results, support and strengthen that the combined therapy can be feasible, safe, and successful [ 7 – 12 ]. However, all these observational studies lack control groups.…”

“…Recently, combined procedures of CA for AF and LAAC for stroke prevention have raised increasing attention in selected patients with high risk of stroke and bleeding. Observational studies without controls have reported the feasibility and safety of performing combined procedures [ 6 – 12 ]. However, clinical outcomes on procedural safety, AF recurrence, and adverse events of the combined procedure compared with those of the single procedures have not been reported.…”

Prevention of Recurrent Stroke: Response to the Letter by Arugaslan et al

“…Also, it has high rates of discontinuation. 4,5 We observed similar rates of side effects and discontinuation. There were no additional patients who discontinued their treatment.…”

One‐stop hybrid procedure combining catheter ablation and left atrial appendage closure increases long‐term risk for adverse events in patients with atrial fibrillation

“…However, the impact of CA on the long‐term outcomes of LAAC in patients who undergo such hybrid procedures remains largely unknown. Although some studies provided strong evidence that the combined procedure can effectively achieve long‐term stroke prevention as well as a reduction in the risk of major bleeding by allowing high‐risk patients to safely discontinue OAC therapy after ablation, 18–20 one of the major limitations of these studies was the lack of a control group consisting of patients who underwent LAAC only. Moreover, we believe that systematic TEE follow‐up is crucial in evaluating the degree of this impact; unfortunately, the aforementioned studies lacked such reliable data.…”