scholarly journals Influence of Prior Major Bleeding on the Safety and Effectiveness of Left Atrial Appendage Closure in Non-Valvular Atrial Fibrillation Patients: A Single-Center Study

2021 ◽  
Author(s):  
Mingzhong Zhao ◽  
Cody R. Hou ◽  
Xiaolin Xiong ◽  
Felix Post ◽  
Nora Herold ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Survival Ratio ◽  
Left Atrial Appendage Closure ◽  
Procedural Complications ◽  
Implantation Success

Abstract Purpose: Left atrial appendage closure (LAAC) may present an alternative to anticoagulation in patients with non-valvular atrial fibrillation (NVAF). However, evidence regarding benefit of LAAC in patients with prior major bleeding is limited. We evaluate whether a previous bleeding factor influences the safety and effectiveness of LAAC. Methods: A total of 377 consecutive patients scheduled for LAAC were categorized into a bleeding group (n=137) and non-bleeding group (n=240). The implantation success and prevalence of severe peri-procedural complications, and efficacy/ safety endpoints during follow-up were investigated. Results: The bleeding group had more patients ≥75 years old (P=0.044), higher CHA2DS2-VASc (P=0.029) and HAS-BLED scores (P=0.001) than the non-bleeding group. Implantation success and severe peri-procedural complications were similar. During an average 2 years’ follow-up, major bleeding events (P=0.917), all-cause death (P=0.313), co-primary efficacy events (P=0.063), and the cumulative survival ratio (P=0.828) were comparable. However, the incidence of thromboembolism was lower in the bleeding group (P=0.031). The observed thromboembolism rate was reduced by 86.1% (P<0.005) and 43.9% (P<0.05) and the observed bleeding rate was decreased by 39.0% (P<0.05) and 34.8% (P<0.05) in the bleeding and non-bleeding groups, respectively. The extent of relative risk reduction in thromboembolism was significantly higher in the bleeding group (86.1% vs. 43.9%, P<0.01). Conclusion: LAAC may provide a safe and effective alternative to long-term antithrombotic therapy in NVAF patients with or without prior bleeding. The efficacy of LAAC in reducing thromboembolism instead of major bleeding seems to be higher in patients with versus without prior bleeding.

Evaluating long-term outcomes of left atrial appendage occlusion: the results of a prospective single-center registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Maarse ◽  
L Wintgens ◽  
E Aarnink ◽  
M Huijboom ◽  
B Abeln ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Left Atrial Appendage Occlusion ◽  
Long Term Follow Up

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 &gt;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

scholarly journals Left atrial appendage closure in atrial fibrillation patients with prior major bleeding or ineligible for oral anticoagulation

2019 ◽  
Vol 27 (12) ◽  
pp. 613-620 ◽  
Author(s):  
L. I. S. Wintgens ◽  
V. M. M. Vorselaars ◽  
M. N Klaver ◽  
M. J. Swaans ◽  
A. Alipour ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Oral Anticoagulation ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure

scholarly journals Experience of Combined Procedure During Percutaneous Left Atrial Appendage Closure.

2021 ◽  
Author(s):  
Guillaume Domain ◽  
Nicolas Dognin ◽  
Gilles O'Hara ◽  
Josep Rodes-Cabau ◽  
Jean-Michel Paradis ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Cardiovascular Death ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Combined Procedure ◽  
Safety Endpoint ◽  
Combined Strategy

Introduction: Percutaneous left atrial appendage closure (LAAC) is an alternative to oral anticoagulant (OAC) in patients with non-valvular atrial fibrillation (AF) and contraindication to long-term OAC. Combined strategy with percutaneous LAAC at the same time of other cardiac structural or electrophysiological procedure has emerged as an alternative to staged strategy. Aim: To describe our experience of combined LAAC procedures using Watchman™ devices. Method: All patients with combined LAAC procedure using Watchman™ (WN) devices performed from 2016-2021 were included. The primary safety endpoint was a composite of periprocedural complications and adverse events during follow-up. The primary efficacy endpoint included strokes, systemic embolisms, major bleeding, and cardiovascular death. Results: Since 2016, among the 157 patients who underwent LAAC using WN devices, 16 underwent a combined strategy: 6 TEMVR (37%), 6 typical atrial flutter ablation (37%), 2 LP implantation (13%) and 2 atrial fibrillation ablation (13%). The WN device was successfully implanted in 98% and 100% for single and combined LAAC respectively (p = 0.63). Median follow-up was 13 months (IQR 25/75 3/24) in the whole cohort. Device related complications occurred in 6 out of 141 patients (4%) who underwent single LAAC and in no (0/16) patient in the combined LAAC procedure (p=ns). The procedural related complications did not differ significantly between groups (5% vs 12%, respectively in the single and combined group, p=0.1). Conclusion: Combined procedure combining LAAC using the Watchman™ devices and one other structural or electrophysiological procedure is safe and effective. Larger series are needed to confirm these results.

scholarly journals Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience.

2021 ◽  
Author(s):  
Mohammed Saad ◽  
Osama Risha ◽  
Makoto Sano ◽  
Thomas Fink ◽  
Christian-Hendrik Heeger ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Pericardial Tamponade ◽  
Atrial Appendage ◽  
Bleeding Complications ◽  
Comparable Efficacy ◽  
Hospital Death ◽  
Left Atrial Appendage Closure

Abstract Objectives To compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry. Background Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. Methods Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during 2-year-follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death). Results After matching the patients for age (± 5 years), gender, CHA2DS2Vasc score (± 1) and HASBLED score (± 1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During 2-year follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively). Conclusion Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On 2-year follow-up, both devices showed comparable efficacy and safety.

scholarly journals Outcome and safety of intracardiac echocardiography guided left atrial appendage closure within zero-fluoroscopy atrial fibrillation ablation procedures

2021 ◽  
Author(s):  
yi he chen ◽  
Liangguo Wang ◽  
Xiaodong Zhou ◽  
ying fang ◽  
Lan Su ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Intracardiac Echocardiography ◽  
Atrial Appendage ◽  
Adverse Event Rate ◽  
Left Atrial Appendage Closure ◽  
Zero Fluoroscopy

Background: Simultaneous atrial fibrillation (AF) catheter ablation and left atrial appendage closure (LAAC) is sometimes recommended for both rhythm control and stroke prevention. However, the advantages of intracardiac echocardiography (ICE) guidance for this combined procedure have been scarcely reported. To evaluate the clinical outcomes and safety of ICE guided LAAC within a zero-fluoroscopy catheter ablation procedure. Methods and Results:From April 2019 to April 2020, 56 patients with symptomatic AF underwent concomitant catheter ablation and LAAC. ICE with a multi-angled imaging protocol mimicking the TEE echo windows was used to guide LAAC. Successful radiofrequency catheter ablation and LAAC was achieved in all patients. Procedure-related adverse event rate was 3.6%. During the 12-month follow-up, 77.8% of patients became free of arrhythmia recurrences and oral anticoagulants were discontinued in 96.4% of patients. No ischemic stroke occurred despite two cases of device-related thrombosis versus an expected stroke rate of 4.8% based on the CHA2DS2-VASc score. The overall major bleeding events rate was 1.8%, which represented a relative reduction of 68% versus an expected bleeding rate of 5.7% based on the HAS-BLED score of the patient cohort. The incidence of iatrogenic atrial septal defect secondary to a single transseptal access dropped from 57.9% at 2 months to 4.2% at 12 months TEE follow-up. Conclusion:The combination of catheter ablation and LAAC under ICE guidance was safe and effective in AF patients with high stroke risk. ICE with our novel protocol was technically feasible for comprehensive and systematic assessment of device implantation.

Clinical outcomes of Watchman vs. Amplatzer occluders for left atrial appendage closure (WATCH at LAAC)

EP Europace ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. 916-923
Author(s):  
Caroline Kleinecke ◽  
Jiangtao Yu ◽  
Philip Neef ◽  
Eric Buffle ◽  
Stefano de Marchi ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Comparable Efficacy ◽  
Left Atrial Appendage Closure ◽  
Bleeding Events ◽  
Safety Endpoint ◽  
Procedural Complications

Abstract Aims This study compares clinical outcomes of Watchman vs. Amplatzer devices for left atrial appendage closure (LAAC). Methods and results Of two real-world registries, the Watchman registry Lichtenfels, Germany, and the Amplatzer registry Bern-Zurich, Switzerland, 303 and 333 consecutive patients, respectively, were included. After a 1:1 propensity score matching, 266 vs. 266 patients were compared by use of the predefined primary efficacy endpoint of stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major peri-procedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. Mean age was 75.3 ± 7.8 (Watchman) vs. 75.1 ± 9.9 (Amplatzer) years, CHA2DS2-VASc score 4.5 ± 1.7 vs. 4.5 ± 1.5, and HAS-BLED score 3.2 ± 1.0 vs. 3.2 ± 1.0. At a mean follow-up of 2.4 ± 1.3 vs. 2.5 ± 1.5 years and 1.322 patient-years, the primary endpoints of efficacy [40/646, 6.2% [Watchman] vs. 43/676, 6.4% [Amplatzer]; hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.66–1.58; P = 0.92] and safety (33/646, 5.1% vs. 30/676, 4.4%; HR, 0.57; 95% CI, 0.29–1.11; P = 0.10), as well as the combined hazard endpoint (69/646, 10.7% vs. 66/676, 9.8%; HR, 0.80; 95% CI, 0.55–1.12; P = 0.26) were similar for both groups. Conclusion This study suggests comparable efficacy and safety of the Watchman and Amplatzer devices.

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