scholarly journals TCT-114 Comparative Data on Left Atrial Appendage Occlusion Efficacy and Clinical Outcomes by Age Group in the Amplatzer Amulet Observational Study

2019 ◽  
Vol 74 (13) ◽  
pp. B114
Author(s):  
Xavier Freixa ◽  
Boris Schmidt ◽  
Patrizio Mazzone ◽  
Sergio Berti ◽  
Sven Fischer ◽  
...  
EP Europace ◽  
2020 ◽  
Author(s):  
Xavier Freixa ◽  
Boris Schmidt ◽  
Patrizio Mazzone ◽  
Sergio Berti ◽  
Sven Fischer ◽  
...  

Abstract Aims Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up. Methods and results We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA). Serious adverse events (SAEs) were reported from implant through a 2-year post-LAAO visit and adjudicated by an independent clinical events committee. Overall, 1088 subjects were prospectively enrolled. There were 265 subjects (24.4%) <70 years old, 491 subjects (45.1%) ≥70 and <80 years old, and 332 subjects (30.5%) ≥80 years old, with the majority (≥80%) being contraindicated to anticoagulation. As expected, CHA2DS2-VASc and HAS-BLED Scores increased with age. Implant success was high (≥98.5%) across all groups, and the proportion of subjects with a procedure- or device-related SAE was similar between groups. At follow-up, the observed ischaemic stroke rate was not significantly different between groups, and corresponding risk reductions were 62, 56, and 85% when compared with predicted rates for subjects <70, ≥70 and <80, and ≥80 years old, respectively. Major bleeding and mortality rates increased with age, while the incidence of device-related thrombus tended to increase with age. Conclusions Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.


2020 ◽  
Vol 319 ◽  
pp. 78-84
Author(s):  
Victor Agudelo ◽  
Xavier Millán ◽  
Chi-Hion Li ◽  
Lluís Asmarats ◽  
Estefania Fernández-Peregrina ◽  
...  

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e040455
Author(s):  
Kerstin Piayda ◽  
Katharina Hellhammer ◽  
Jens Erik Nielsen-Kudsk ◽  
Boris Schmidt ◽  
Patrizio Mazzone ◽  
...  

Objective To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS). Background Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO. Methods Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared. Results Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22 min vs CS: 27±19 min, p<0.001), total amount of contrast medium (GA: 105±81 mL vs CS: 86±66 mL, p<0.001) and fluoroscopic time (GA: 13±9 min vs CS: 12±13 min, p<0.001) were less in CS cases. Procedure-related or device-related serious adverse events during the first 7 days were numerically higher in the CS group (GA: 4.9% vs CS: 7.6%, p=0.114). Peridevice residual flow was absent or ≤5 mm 1–3 months after the procedure in 99.7% of the GA and in 100% of the CS group (p=1.000). Conclusions In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases. Trial registration number NCT02447081; Results.


PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0255721
Author(s):  
Kerstin Piayda ◽  
Shazia Afzal ◽  
Jens Erik Nielsen-Kudsk ◽  
Boris Schmidt ◽  
Patrizio Mazzone ◽  
...  

Aims To evaluate factors influencing the length of stay in patients undergoing percutaneous left atrial appendage occlusion (LAAO). Methods and results Patient characteristics, procedural data and the occurrence of serious adverse events were analyzed from the AmplatzerTM AmuletTM Occluder Observational Study. Patients were divided into three groups: same day (S, 0day, n = 60, 5.6%) early (E, 1day, n = 526, 48.9%), regular (R, 2-3days, n = 338, 31.4%) and late (L, ≥4days, n = 152, 14.1%) discharge and followed up for 60 days. Procedure and device related SAE during the in-hospital stay (S: 0.0% vs. E: 1.0% vs. R: 2.1% vs. L: 23%, p<0.0001) were a major trigger for a prolonged in-hospital stay. Of the 37 subjects in the late discharge group with an SAE prior to discharge, cardiac or bleeding complications were the most common underlying conditions, occurring in 26 subjects. Multinomial logistic analysis only identified HAS-BLED score as an independent influencing factor (p = 0.04) for a late discharge. After 60 days, mortality tended to be greatest in the late discharge group (S: 0.0% vs. E: 1.0% vs. R: 1.2% vs. L: 3.3%, p = 0.1066). Conclusion Over half of the subjects receiving an Amplatzer Amulet occluder were discharged within 1 day of the implant procedure. Serious adverse events were a major trigger for a late discharge after LAAO. Increased HAS-BLED score was associated with a prolonged in-hospital stay.


2021 ◽  
Vol 35 ◽  
pp. 100848
Author(s):  
Alberto Ranieri De Caterina ◽  
Jens Erik Nielsen-Kudsk ◽  
Boris Schmidt ◽  
Patrizio Mazzone ◽  
Sven Fischer ◽  
...  

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