scholarly journals TCT-97 Long term follow up of 134 patients with non valvular atrial fibrillation and contraindications to oral anticoagulation therapy, treated with the Ampatzer Cardiac Plug Device for left atrial appendage occlusion

2013 ◽  
Vol 62 (18) ◽  
pp. B32
Author(s):  
Miroslava Stolcova ◽  
Marco Rezzaghi ◽  
Francesco Meucci ◽  
Cataldo Palmieri ◽  
Umberto Paradossi ◽  
...  
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


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Kretzler ◽  
C Wunderlich ◽  
M Christoph ◽  
A Langbein ◽  
S G Spitzer ◽  
...  

Abstract Aims Left atrial appendage occlusion (LAAO) is a therapeutic option for patients with non-valvular atrial fibrillation (NVAF) and high risk of bleeding. This study reports outcomes of patients enrolled in the prospective multicentre, investigator initiated real life registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure). Methods and results Data of all consecutive 521 patients (64.7% adult males, 35.3% adult females, mean age: 75.1 (SD 7.9) years with non-valvular atrial fibrillation undergoing interventional left atrial appendage occlusion procedure in the ORIGINAL prospective registry were analysed. The CHA2DS2-VASc and HAS-BLED scores were 4.3 (SD 1.5) and 3.7 (SD 1.1), respectively. 78.9% of the patients had a history of bleeding. 89.3% of the patients were considered as non-eligible for long term oral anticoagulation. A left atrial appendage occlusion device was successfully implanted in 97.5% of cases. A mean follow-up of 463 days could be reached in 386 patients. Among these, the distribution of the follow-up length reached was as follows: 1 year 205, 2 years 118, 3 years 65 and 4 years 17 patients. In the follow-up the annual frequency of stroke was very low (0.4%), which resulted in the 4.98% absolute risk reduction in the amount of thromboembolic strokes, which would have been expected according to the calculated CHA2DS2-VASc score in the hypothetic group not receiving any anticoagulant therapy. The occurrence of major and minor bleeding in the follow-up was 1.55% and 3.37% respectively. Conclusions In this prospective multicentre study we included the patients who are at high risk of stroke and bleeding. The annual ischemic stroke rate was 0.4%, the LAA could be sealed in 97.5%. Six months after the LAA closure only 3.63% of all patients were further on treated using oral anticoagulation. Considering the stroke reduction rates, the implantation of an LAAO device proves to be effective and safe in the clinical routine in the studied population. Acknowledgement/Funding None


2019 ◽  
Vol 3 (3) ◽  
Author(s):  
Ümit Güray ◽  
Ahmet Korkmaz ◽  
Havva Tuğba Gürsoy ◽  
Özgül Uçar Elalmış

Abstract Background  Atrial fibrillation (AF) is the most common cardiac arrhythmia and is a major cause of embolic stroke. In patients with hereditary bleeding disorders such as haemophilia, management of AF particularly anticoagulation can be quite challenging. Left atrial appendage (LAA) closure is an emerging option in AF patients who are not eligible for oral anticoagulation therapy because of contraindications or high bleeding risk. Case summary  A 67-year-old man with permanent AF and haemophilia was referred for further evaluation of our cardiology clinic by his primary haematologist. The CHA2DS2-VASc score was estimated to be 3 and the HAS-BLED score was 3. Due to high risk of bleeding, we decided to perform percutaneous LAA closure instead of oral anticoagulation. Pre-procedural cardiac computerized tomography angiography and transoesophageal echocardiography were performed for measurements of LAA dimensions and exclude LAA thrombus. Percutaneous LAA occlusion was performed using a 28-mm AmplatzerTM AmuletTM device. The final result was excellent without significant residual leak, pericardial effusion, and embolic complication. Clopidogrel 75 mg/day and aspirin 81 mg/day for 1 month with adequate FVIII prophylaxis and then only aspirin 81 mg/day for 2 months were recommended. No antiplatelet was given after 3 months. The patient did not report any thrombotic or haemorrhagic adverse events and there were no complications related to implanted device after 1 year of follow-up. Discussion  In patients with hereditary bleeding disorders such as haemophilia, management of AF particularly anticoagulation can be quite challenging. In this report, we present a case of percutaneous LAA occlusion using AmplatzerTM AmuletTM device in a patient who has haemophilia and permanent AF. LAA closure has the potential to be more cost effective as compared to oral anticoagulation therapy due to lesser necessity of clotting factor infusion.


2020 ◽  
Vol 13 (11) ◽  
Author(s):  
Jorge Romero ◽  
Luigi Di Biase ◽  
Sanghamitra Mohanty ◽  
Chintan Trivedi ◽  
Kavisha Patel ◽  
...  

Background: Left atrial appendage electrical isolation (LAAEI) has been proposed for the treatment of nonparoxysmal atrial fibrillation (AF). The long-term clinical outcomes of this approach remain unclear. The objective of our study was to investigate the incremental benefit and safety of LAAEI in patients undergoing catheter ablation for nonparoxysmal AF. Methods: Propensity score-matched analysis was performed using a prospective registry database from 2010 to 2014. All patients in the LAAEI group were matched based on baseline characteristics, echocardiographic parameters, and procedural ablation techniques. Results: We identified 1842 patients who underwent catheter ablation for nonparoxysmal AF. Propensity score matching yielded 1092 patients, 546 patients with LAAEI, and 546 patients without LAAEI. At 5-year follow-up, overall freedom from all-atrial arrhythmia recurrence, off-antiarrhythmic drugs, in patients who underwent LAAEI was 68.9% versus 50.2% in those who underwent standard ablation alone ( P <0.001). Acute complication rates were similar between groups (LAAEI 1.3% versus non-LAAEI 0.73%, P =0.36). At 5-year follow-up, 382 (70%) patients in the LAAEI group remained on oral anticoagulation versus 217 (39.7%) in the non-LAAEI group. At 5-year follow-up, thromboembolic events occurred in 15/546 (2.75%) in the LAAEI group and 4/546 (0.73%) in the non-LAAEI group ( P =0.01). No thromboembolic events occurred in either group on-oral anticoagulation. In patients who were off-oral anticoagulation, at 5-year follow-up, thromboembolic events occurred in 15/164 (9.1%) in the LAAEI group and 4/329 (1.2%) in the non-LAAEI group ( P <0.001). Conclusions: At 5-year follow-up, LAAEI was associated with significantly higher freedom from all-atrial arrhythmia recurrence in patients with persistent and long-standing persistent AF without increasing acute procedural complication rate. In patients off-oral anticoagulation, there appears to be a higher risk of thromboembolic events in the LAAEI group.


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