Management of thromboembolic risk in persons with haemophilia and atrial fibrillation: is left atrial appendage occlusion the answer for those at high risk?

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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Long-standing Persistent Atrial Fibrillation Ablation in a Patient With High Risk of Bleeding

Journal of Cardiac Arrhythmias ◽

10.24207/jca.v33i2.3409 ◽

2020 ◽

Vol 33 (2) ◽

pp. 115-121

Author(s):

Cristiano Pisani ◽

Muhieddine Chokr ◽

Carina Hardy ◽

Sissy Lara ◽

Mauricio Scanavacca

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Left Atrial ◽

Left Atrial Appendage ◽

Persistent Atrial Fibrillation ◽

Posterior Wall ◽

Atrial Appendage ◽

Risk Of Bleeding ◽

Left Atrial Appendage Occlusion ◽

Left Atrial Appendage Isolation

A 57 year-old patient with dilated cardiomyopathy, long-standing persistent atrial fibrillation, heart failure and episodes of gastrointestinal bleeding underwent AF ablation with pulmonary vein isolation, homogeneization of septal scar, posterior wall isolation and also left atrial appendage isolation. Additionally, because of the high risk of embolism, underwent left atrial appendage occlusion.

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Left atrial appendage occlusion in high-risk patients with non-valvular atrial fibrillation

Heart ◽

10.1136/heartjnl-2015-309150 ◽

2016 ◽

Vol 102 (24) ◽

pp. 1969-1973 ◽

Cited By ~ 21

Author(s):

Sergio Berti ◽

Luigi Emilio Pastormerlo ◽

Marco Rezzaghi ◽

Giuseppe Trianni ◽

Umberto Paradossi ◽

...

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

High Risk Patients ◽

Left Atrial Appendage Occlusion ◽

Risk Patients

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Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial

BMJ Open ◽

10.1136/bmjopen-2020-044695 ◽

2021 ◽

Vol 11 (3) ◽

pp. e044695

Author(s):

Mu Chen ◽

Qunshan Wang ◽

Jian Sun ◽

Peng-Pai Zhang ◽

Wei Li ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Ethics Committee ◽

Aspirin Therapy ◽

Atrial Appendage ◽

Control Group ◽

Coronary Syndrome ◽

Left Atrial Appendage Occlusion ◽

Increased Risk

IntroductionIt is the common clinical practice to prescribe indefinite aspirin for patients with non-valvular atrial fibrillation (NVAF) post left atrial appendage occlusion (LAAO). However, aspirin as a primary prevention strategy for cardiovascular diseases has recently been challenged due to increased risk of bleeding. Therefore, aspirin discontinuation after LAAO in atrial fibrillation (ASPIRIN LAAO) trial is designed to assess the uncertainty about the risks and benefits of discontinuing aspirin therapy at 6 months postimplantation with a Watchman LAAO device in NVAF patients.Methods and analysisThe ASPIRIN LAAO study is a prospective, multicentre, randomised, double-blinded, placebo-controlled non-inferiority trial. Patients implanted with a Watchman device within 6 months prior to enrollment and without pre-existing conditions requiring long-term aspirin therapy according to current guidelines are eligible for participating the trial. Subjects will be randomised in a 1:1 allocation ratio to either the Aspirin group (aspirin 100 mg/day) or the control group (placebo) at 6 months postimplantation. A total of 1120 subjects will be enrolled from 12 investigational sites in China. The primary composite endpoint is stroke, systemic embolism, cardiovascular/unexplained death, major bleeding, acute coronary syndrome and coronary or periphery artery disease requiring revascularisation at 24 months. Follow-up visits are scheduled at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment.Ethics and disseminationEthics approval was obtained from the Ethics Committee of Xinhua Hospital, Shanghai, China (reference number XHEC-C-2018-065-5). The protocol is also submitted and approved by the institutional Ethics Committee at each participating centre. Results are expected in 2024 and will be disseminated through peer-reviewed journals and presentations at national and international conferences.Trial registration numberNCT03821883.

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Comparison of Left Atrial Appendage Occlusion versus Non-Vitamin-K Antagonist Oral Anticoagulation in High-Risk Atrial Fibrillation: An Update

Journal of Cardiovascular Development and Disease ◽

10.3390/jcdd8060069 ◽

2021 ◽

Vol 8 (6) ◽

pp. 69

Author(s):

Shaojie Chen ◽

K. R. Julian Chun ◽

Zhiyu Ling ◽

Shaowen Liu ◽

Lin Zhu ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

High Risk ◽

Vitamin K ◽

Major Bleeding ◽

Left Atrial ◽

Left Atrial Appendage ◽

Vitamin K Antagonists ◽

Left Atrial Appendage Occlusion ◽

The Mean

Transcatheter left atrial appendage occlusion (LAAO) is non-inferior to vitamin K antagonists (VKAs) in preventing thromboembolic events in atrial fibrillation (AF). Non-vitamin K antagonists (NOACs) have an improved safety profile over VKAs; however, evidence regarding their effect on cardiovascular and neurological outcomes relative to LAAO is limited. Up-to-date randomized trials or propensity-score-matched data comparing LAAO vs. NOACs in high-risk patients with AF were pooled in our study. A total of 2849 AF patients (LAAO: 1368, NOACs: 1481, mean age: 75 ± 7.5 yrs, 63.5% male) were enrolled. The mean CHA2DS2-VASc score was 4.3 ± 1.7, and the mean HAS-BLED score was 3.4 ± 1.2. The baseline characteristics were comparable between the two groups. In the LAAO group, the success rate of device implantation was 98.8%. During a mean follow-up of 2 years, as compared with NOACs, LAAO was associated with a significant reduction of ISTH major bleeding (p = 0.0002). There were no significant differences in terms of ischemic stroke (p = 0.61), ischemic stroke/thromboembolism (p = 0.63), ISTH major and clinically relevant minor bleeding (p = 0.73), cardiovascular death (p = 0.63), and all-cause mortality (p = 0.71). There was a trend toward reduction of combined major cardiovascular and neurological endpoints in the LAAO group (OR: 0.84, 95% CI: 0.64–1.11, p = 0.12). In conclusion, for high-risk AF patients, LAAO is associated with a significant reduction of ISTH major bleeding without increased ischemic events, as compared to “contemporary NOACs”. The present data show the superior role of LAAO over NOACs among high-risk AF patients in terms of reduction of major bleeding; however, more randomized controlled trials are warranted.

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