scholarly journals Long term outcomes after left atrial appendage closure with the LARIAT device—Stroke risk reduction over five years follow-up

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0208710 ◽  
Author(s):  
Radoslaw Litwinowicz ◽  
Magdalena Bartus ◽  
Marian Burysz ◽  
Maciej Brzeziński ◽  
Piotr Suwalski ◽  
...  
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significant reduction in late bleeding events in a population of high stroke risk post-ablation patients who have been withdrawn from oral anticoagulation.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
S Kany ◽  
J Brachmann ◽  
T Lewalter ◽  
I Akin ◽  
H Sievert ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Stiftung für Herzinfarkforschung Background  Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death compared with paroxysmal AF (PAF). This study investigates the procedural safety and long-term outcomes of left atrial appendage closure (LAAC) in patients with different forms of AF. Methods  Comparison of procedural details and long-term outcomes in patients (pts) with PAF against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC in Germany (LAARGE).  Results  A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. NPAF consisted of 31.6% patients with persistent AF and 68.4% with longstanding persistent AF or permanent AF. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The PAF group had significantly less history of heart failure (19.0% vs 33.0%, p < 0.001) while the current median LVEF was similar (60% vs 60%, p = 0.26). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), but no difference in the HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was observed. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77) in both groups. In the three-month echo follow-up, device-related thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak >5 mm (0.0% vs 7.1%, p= 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95%-CI: 1.02-2.72). Conclusion  Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE of patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality and combined outcome of death, stroke and systemic embolism.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Maarse ◽  
L Wintgens ◽  
E Aarnink ◽  
M Huijboom ◽  
B Abeln ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted grant from Boston Scientific. Boston Scientific was not involved in the design/conduct of the study, data collection/analysis and interpretation of the data and preparation of the manuscript. Background Percutaneous left atrial appendage occlusion is an emerging alternative to anticoagulation in the prevention for stroke in patients with atrial fibrillation, especially in patients with a contra-indication for oral anticoagulation therapy. Long-term results on the efficacy and safety of this treatment remain scarce. Methods In this single-center prospective registry, data of all consecutive patients that underwent percutaneous left atrial appendage closure between 2009 and 2019 were collected. Patients with successful left atrial appendage closure (peri-device leakage ≤5mm) and at least one year of follow-up data were analyzed. The occurrence of thrombo-embolic events (ischemic stroke, TIA and systemic embolism), major bleeding events (BARC >2) and anticoagulation use during long-term follow-up were evaluated. Results A total of 192 patients after left atrial appendage occlusion were included (61 % male, age 69.0 ± 8.4 years, CHA2DS2-VASc 4.0[3.0-5.0], HAS-BLED 3.0[2.0-3.25]) with a mean follow-up duration of 5.7 ± 2.8 years (in total 1087 patient-years). During follow-up 36 patients (19%) died. 49 thrombo-embolic complications were observed in 38 patients. The ischemic stroke rate was 1.9 events per 100 patient-years, accounting for a 70% reduction compared to CHA2DS2-VASc predicted rate. Device-related thrombus (DRT) occurred in 5 patients (2.6%), 3 were observed during routine follow-up and were not associated with thrombo-embolic complications. The other 2 DRT were observed in patients presenting with ischemic stroke more than 3 years after device implantation. Furthermore, 38 non-procedural major bleeding complications occurred in 19 patients, resulting in 3.5 events per 100-patients years, accounting for a reduction of 43% compared to estimated bleeding rates under OAC use. At the end of the study 71% of all patients were on single antiplatelet or no antiplatelet/anticoagulation treatment at all. Conclusions During long-term follow-up thrombo-embolic event rates and non-procedural major bleeding rates were consistently low (ischemic stroke rate reduction 70% and non-procedural major bleeding rate reduction 40% compared to predicted rates). These results confirm the efficacy of left atrial appendage occlusion. Abstract Figure. Ischemic stroke rates


2016 ◽  
Vol 68 (18) ◽  
pp. B11 ◽  
Author(s):  
Vivek Reddy ◽  
Matthew Price ◽  
Miguel valderrabano ◽  
Jose Sanchez ◽  
Shephal Doshi ◽  
...  

EP Europace ◽  
2020 ◽  
Author(s):  
Jorge Romero ◽  
Mohamed Gabr ◽  
Kavisha Patel ◽  
David Briceno ◽  
Juan Carlos Diaz ◽  
...  

Abstract Aims Left atrial appendage electrical isolation (LAAEI) has been shown to improve freedom from all-atrial arrhythmia recurrence in patients with non-paroxysmal atrial fibrillation (AF). The aim of this study is to investigate the long-term efficacy and safety outcomes of LAAEI in patients with non-paroxysmal AF undergoing catheter ablation. Methods and results A systematic review of Medline, Cochrane, and Embase was performed for clinical studies evaluating the benefit of LAAEI in non-paroxysmal AF. Nine studies with a total of 2336 patients were included (mean age: 65 ± 9 years, 63% male). All studies included patients with persistent AF, long-standing persistent AF, or both. At a mean follow-up of 40.5 months, patients who underwent LAAEI had significantly higher freedom from all-atrial arrhythmia recurrence than patients who underwent standard ablation alone [69.3% vs. 46.4%; risk ratio (RR) 0.54; 95% confidence interval (CI) 0.42–0.69; P < 0.0001]. A 46% relative risk reduction and 22.9% absolute risk reduction in atrial-arrhythmia recurrence was noted with LAAEI. Rates of cerebral thromboembolism were not significantly different between the two groups (LAAEI 3% vs. standard ablation 1.6%, respectively; RR 1.76; 95% CI 0.61–5.04; P = 0.29). Furthermore, there was no significant difference in the acute procedural complication rates between the two groups (LAAEI 4% vs. standard ablation 3%, respectively; RR 1.29; 95% CI 0.83–2.02; P = 0.26). Conclusion At long-term follow-up, LAAEI led to a significantly higher improvement in freedom from all-atrial arrhythmia recurrence in patients with non-paroxysmal AF, when compared to standard ablation alone. Importantly, this benefit was achieved without an increased risk of acute procedural complications or cerebral thromboembolic events.


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