Abstract 17419: Gender Differences in Outcomes With Patients Undergoing Percutaneous Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Douglas J Darden ◽  
Thao Duong ◽  
Mohamad B Munir ◽  
Frederick Han ◽  
Ryan Reeves ◽  
...  

Introduction: Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation in select patients with atrial fibrillation (AF), however women are underrepresented in trial data and sex-specific sub analyses are limited. Hypothesis: Women will be more likely than men to experience adverse events following left atrial appendage occlusion (LAAO) procedure. Methods: Using the National Cardiovascular Data Registry LAAO Registry, patients undergoing Watchman implantation between January 2016 and December 2018 were included. Unadjusted and multivariable adjusted logistic regression analyses were performed to assess the association between gender and in-hospital outcomes, including any complication, major adverse events (pericardial effusion, major bleeding, stroke, and device embolization), hospital stay > 1 day, and mortality. Results: A total of 20,388 (41.3%) women and 28,969 (58.7%) men underwent Watchman implantation. Compared with male patients, women were older (76.5 vs 75.8 years, p<0.001) with a higher CHA2DS2-VASc score (1.5 vs 1.4, p<0.001), and higher prevalence of paroxysmal atrial fibrillation (59.0% vs 50.0%, p<0.001), prior stroke (27.5% vs 26.7%, p=0.003) and uncontrolled hypertension (29.3% vs 26.7%, p<0.001). Women had a lower prevalence of congestive heart failure (34.5% vs 39.7%, p<0.001), diabetes (34.8 vs 39.7%, p<0.001), and coronary artery disease (35% vs 55.7%, p<0.001). There were no differences with increased thromboembolic risk or history of major bleed, while women were more likely to have a high fall risk (39.8% vs 33.5%, p<0.001) and labile INR (9.1% vs 8.3%, p=0.003) as an indication for occlusion. After multivariable adjustment, women were more likely to have any complication (OR 1.62, 95% CI 1.62 - 1.77, p<0.001), major adverse event (OR 1.81, 95% CI 1.61 - 2.04, p<0.001), hospital stay >1 day (OR 1.46, 95% CI 1.38 - 1.54, p<0.001), and higher mortality (2.01, 95% CI 1.31 - 3.09, p=0.001). Conclusion: Women have a significantly higher risk than men of in-hospital adverse events and mortality following Watchman implantation. Further examination of the risk-benefit relationship of LAAO in women is warranted.

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.


BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044695
Author(s):  
Mu Chen ◽  
Qunshan Wang ◽  
Jian Sun ◽  
Peng-Pai Zhang ◽  
Wei Li ◽  
...  

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.


JAMA ◽  
2018 ◽  
Vol 319 (4) ◽  
pp. 365 ◽  
Author(s):  
Daniel J. Friedman ◽  
Jonathan P. Piccini ◽  
Tongrong Wang ◽  
Jiayin Zheng ◽  
S. Chris Malaisrie ◽  
...  

Author(s):  
Anders Dahl Kramer ◽  
Kasper Korsholm ◽  
Andreas Kristensen ◽  
Lone Hvitfeldt Poulsen ◽  
Jens Erik Nielsen-Kudsk

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Moghniuddin Mohammed ◽  
Nachiket Apte ◽  
Mohammed Ansari ◽  
Amit Noheria ◽  
Seth Sheldon ◽  
...  

Background: Pulmonary vein stenosis is a dreaded complication of endocardial atrial fibrillation (AF) ablation but rare after epicardial ablation and has not been reported after epicardial left atrial appendage occlusion (LAAO). Case: A 55-year-old male was referred to our tertiary hospital for management of left superior pulmonary vein (LSPV) stenosis causing dyspnea on exertion. About 2 years prior to presentation, he underwent quadruple coronary artery bypass grafting for non-ST elevation myocardial infarction along with modified Cox-Maze procedure with pulmonary vein and posterior wall isolation as well as epicardial LAAO with AtriClip for history of paroxysmal AF. At our institute, V/Q scan showed ventilation-perfusion mismatch and absent perfusion of the left upper lobe (Figure 1A). Cardiac CT showed persistent LSPV occlusion (Figure 1B). TEE showed atrial appendage occluded with a clip and no flow was observed from LSPV (Figure 1C). After multidisciplinary discussion between cardiology and cardiothoracic surgery teams, surgical approach to remove the AtriClip was deemed futile as it was placed 2 years ago and less likely to result in resolution of stenosis. Thus, an endovascular approach was attempted with left atrial and pulmonary vein angiography showing LSPV to be 100% occluded (Figure 1D). Pulmonary vein recanalization was attempted but was not successful. Conclusion: Our case highlights the importance of recognition of PVS as a possible complication after epicardial LAAO as early intervention can improve patient outcomes. PVS has been previously described with Maze procedure but that patient was successfully treated with catheter-balloon angioplasty. Given 100% occlusion and difficulty with recanalization makes epicardial ablation a less likely cause of occlusion in our case. More careful application of Atriclip protocols might be necessary to prevent this potential complication.


2019 ◽  
Vol 73 (20) ◽  
pp. 2638-2640 ◽  
Author(s):  
Laurent Fauchier ◽  
Alexandre Cinaud ◽  
François Brigadeau ◽  
Antoine Lepillier ◽  
Bertrand Pierre ◽  
...  

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