Rationale and design of a randomized clinical trial to compare two antithrombotic strategies after left atrial appendage occlusion: double antiplatelet therapy vs. apixaban (ADALA study)

Background and Purpose: Left atrial appendage occlusion (LAAO) is an accepted therapeutic option for stroke prevention; however, the ideal technique and device have not yet been identified. In this study we evaluate the potential role of a heart team approach for patients contraindicated for oral anticoagulants and indicated for left atrial appendage closure, to minimize risk and optimize benefit in a patient-centered decision-making process. Methods: Forty patients were evaluated by the heart team for appendage occlusion. Variables considered were CHA2DS2VASc, HASBLED, documented blood transfusions, comorbidities, event forcing anticoagulant interruption, past medical history, anatomy of the left atrial appendage, and patient quality of life. Twenty patients had their appendage occluded percutaneously (65% male, mean age 72.3 ± 7.5, mean CHA2DS2VASc 4.2 ± 1.5, mean HASBLED 3.5 ± 1.1). The other twenty underwent thoracoscopic occlusion (65% male, mean age of 74.9 ± 8, mean CHA2DS2VASc 6.0 ± 1.5, HASBLED mean 5.4 ± 1.4). Percutaneous patients were on dual antiplatelet therapy for the first three months and aspirin thereafter, whereas the others received no anticoagulant/antiplatelet therapy from the day of surgery. Follow up included TEE, CT scan, and periodical clinical evaluation. Results: Mean duration of procedures and hospital stay were comparable. All patients had complete exclusion of the appendage; at a mean follow up of 33.1 ± 14.1 months, no neurological or hemorrhagic events were reported. Conclusions: A heart team approach may improve the decision-making process for stroke and hemorrhage prevention, where LAAO is a therapeutic option. Percutaneous and thoracoscopic appendage occlusion seem to be comparably safe and effective. An epicardial LAAO could be advisable in patients for whom the risk of bleeding is estimated as being too high for post-procedural antiplatelet therapy.

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240 Left atrial appendage occlusion: safety, efficacy, and antiplatelet therapy in a single-centre experience

European Heart Journal Supplements ◽

10.1093/eurheartj/suab134.002 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Luigi Vignali ◽

Federico Barocelli ◽

Filippo Luca Gurgoglione ◽

Maria Alberta Cattabiani ◽

Arianna Maini ◽

...

Keyword(s):

Antiplatelet Therapy ◽

Major Bleeding ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Bleeding Events ◽

Left Atrial Appendage Occlusion ◽

Clinical Events

Abstract Aims Oral anticoagulation (OAC) is the cornerstone therapy for stroke prevention in patients with atrial fibrillation (AF). However, a not negligible proportion of AF patients experiences major bleeding events or is affected by concomitant disorders that represent a contraindication for OAC. Left atrial appendage occlusion (LAAO) has emerged as an effective strategy to minimize the risk of thromboembolism in AF patients (without moderate/severe mitral stenosis or mechanical prosthetic heart valves) that are poor candidates for OAC. After the procedure variable regimens of antithrombotic therapy are prescribed, in order to provide protection and prevent device-related thrombus (DRT). The optimal post-procedural antithrombotic strategy remains to be assessed. Therefore, we aim to evaluate the safety and efficacy of LAAO procedure and the relationship between antiplatelet therapy and outcomes at long-term follow-up. Methods and results We conducted a retrospective observational study including consecutive AF patients who underwent LAAO at Azienda Ospedaliero-Universitaria of Parma from October 2010 to June 2021. The incidence of major ischaemic events [DRT, ischaemic stroke, transient ischaemic attack (TIA) and systemic embolism], Bleeding Academic Research Consortium major bleeding events and net adverse clinical events (major ischaemic + bleeding events) were assessed at follow-up. We enrolled 130 patients [median age 77 years (73; 81)] characterized by both high ischaemic (mean CHA2DS2-VASc 4.48) and bleeding risk (mean HAS-BLED 3.24). Technical procedure success was achieved in 123 (94.6%). Thirty-nine (31.7%) patients were discharged on short (≤1 month)-dual antiplatelet therapy (DAPT); 35 (28.5%) on long-DAPT (1–12 months) and 49 (39.8%) on single antiplatelet therapy (SAPT). Antiplatelet therapy was chosen after multidisciplinary discussion on the basis on the hemorrhagic risk [mean HAS-BLED 3.55; 3.11; 2.97 (P = 0.038) in SAPT, short-DAPT and long-DAPT groups respectively], while no differences were observed in ischaemic risk between the three groups. Clinical follow-up was completed in 119 (98.2%) of successfully implanted patients. After a median follow-up of 31 ± 16 months, 24 (20.2%) patients had a major adverse event: 11 (9.2%) ischaemic events [8 (6.7%) strokes and 3 (2.5%) TIA] and 13 (10.9%) major bleedings. Patients on short-DAPT had a significantly lower occurrence of major bleedings [0 vs. 4 (11.4%) on long-DAPT vs. 9 (18.4%) on SAPT; P = 0.033] and net adverse clinical events [3 (7.7%) vs. 7 (20.0%) on long-DAPT vs. 14 (28.6%) on SAPT; P = 0.005] compared to the other two groups, while no difference was observed in the incidence of major ischaemic events [3 (7.7%) on short-DAPT vs. 3 (8.6%) on long-DAPT vs. 5 (10.2%) on SAPT; P = 0.340]. Conclusions In our cohort of AF patients with a contraindication for OAC therapy, LAAO showed high procedural success; however, long-term major ischaemic and bleeding events were not negligible. Short-DAPT therapy turned out to be the best antiplatelet regimen regarding net ischaemic-hemorrhagic balance. Evidence from well-designed randomized trials would be desirable to guide a tailored approach in the selection of post-procedural antithrombotic regimens.

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Meta-analysis of postoperative antithrombotic therapy after left atrial appendage occlusion

Journal of International Medical Research ◽

10.1177/0300060520966478 ◽

2020 ◽

Vol 48 (11) ◽

pp. 030006052096647

Author(s):

Shu-yue Li ◽

Juan Wang ◽

Xiang Hui ◽

Huai-jun Zhu ◽

Bao-yan Wang ◽

...

Keyword(s):

Adverse Events ◽

Antiplatelet Therapy ◽

Anticoagulant Therapy ◽

Cardiovascular Mortality ◽

Left Atrial ◽

Left Atrial Appendage ◽

Meta Analysis ◽

Atrial Appendage ◽

Left Atrial Appendage Occlusion ◽

All Cause Mortality

Objective This meta-analysis explored the safety and effectiveness of different anticoagulant regimens after left atrial appendage occlusion (LAAO). Methods Databases, such as PubMed, MEDLINE, EMBASE, Web of Science, and Cochrane Library, were searched to identify eligible studies according to the inclusion criteria. The incidences of events, including device-related thrombus (DRT) formation, stroke, systemic thromboembolism, bleeding, cardiovascular mortality, and all-cause mortality, were analyzed using R version 3.2.3. Results The screening retrieved 32 studies, including 36 study groups and 4,474 patients. The incidence of outcomes after LAAO was calculated via meta-analysis. In the subgroup analysis, the rates of DRT formation, cardiovascular mortality, and all-cause mortality were significantly different among different antithrombotic methods. Single antiplatelet therapy was associated with the highest rate of adverse events, followed by dual antiplatelet therapy (DAPT). Vitamin K antagonists (VKAs) and new oral anticoagulants (NOACs) carried lower rates of adverse events. Conclusions Anticoagulant therapy had better safety and efficacy than antiplatelet therapy. Thus, for patients with nonabsolute anticoagulant contraindications, anticoagulant therapy rather than DAPT should be actively selected. NOACs displayed potential for further development, and these treatments might represent alternatives to VKAs in the future.

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