SAFETY OF LEFT ATRIAL APPENDAGE CLOSURE IN AN UNSELECTED HIGH RISK COHORT: RESULTS FROM THE BEAUMONT HOSPITAL LEFT ATRIAL APPENDAGE CLOSURE REGISTRY

Abstract Background Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation and may be especially attractive in patients with high risk or a history of bleeding. However, data of clinical benefit and incidence of post-procedural bleeding in patients with both high risk of bleeding and ischemic cerebral stroke after LAAC are lacking. Objectives This study sought to identify predictors and the prognostic impact of post-LAAC bleeding in patients at high risk and/or history of bleeding in the direct oral anticoagulant therapy (DOAC) era. Methods and results We retrospectively enrolled a total of 195 patients (75 ± 8.7 years, 38% female, 47% with previous major bleeding, mean CHA2DS2-VASc score 4.3 ± 1.6 and mean HAS-BLED score 2.7 ± 1.1) undergoing endocardial (91%) or epicardial (9%) LAAC during a mean follow-up of 339 ± 319 days. Twenty-three (11.9%) patients developed procedure-unrelated bleeding events after a median of 147 (43, 362) days after LAAC, in 12/23 (52%) patients under single antiplatelet therapy (SAPT), 6/23 (26%) dual antiplatelet therapy (DAPT), 1/23 (4%) DOAC, 1/23 (4%) VKA, 2/23 (9%) dual therapy (SAPT and DOAC/VKA) and 1/23 (4%) triple therapy (DAPT and DOAC/VKA). (Figure) Diabetes mellitus and previous major bleeding were identified as the independent predictors of post-LAAC bleeding (Odds ratio 2.65 [95% CI:1.04-6.73], p = 0.041, and 5.50 [95% confidence interval:1.72-17.5], p = 0.004). Post-LAAC bleeding was associated with all-cause death (9/23 [39%] vs 18/171 [11%], p = 0.001), but not ischemic stroke/TIA (1/23 [4%] vs 6/171 [4%], p = 0.593) nor device thrombus (2/23 [9%] vs 3/171 [2%], p = 0.108). Kaplan-Meier curve estimated that patients with post-LAAC bleeding had a worse mortality than those without post-LAAC bleeding (3-year mortality; 35.6% [95%CI; 11.6-61.0%] vs 68.7% [45.0-83.8], p = 0.029) Conclusions In AF patients with high bleeding risk or history of bleeding undergoing LAAC, bleeding events are common and may occur even after long-term duration after LAAC. Previous major bleeding history strongly predicts subsequent bleeding events following LAAC and is associated with unfavorable mortality. Further investigations are required to identify optimal post-procedural antithrombotic strategies for patients undergoing LAAC with previous major bleeding. Abstract Figure. The association between time to bleeding

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284Outcomes after left atrial appendage occlusion with AMPLATZER Amulet and WATCHMAN device: Results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

European Heart Journal ◽

10.1093/eurheartj/ehz747.0088 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

L Kretzler ◽

C Wunderlich ◽

M Christoph ◽

A Langbein ◽

S G Spitzer ◽

...

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Oral Anticoagulation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Minor Bleeding ◽

Left Atrial Appendage Closure ◽

Left Atrial Appendage Occlusion

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

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