Left Atrial Appendage Occlusion Research Articles

Patient Characteristics Associated With Using Transcatheter Left Atrial Appendage Occlusion Versus Oral Anticoagulants for Atrial Fibrillation.

Transcatheter left atrial appendage occlusion (LAAO) is an alternative to oral anticoagulants (OACs) for stroke prevention in patients with atrial fibrillation, but the predictors of LAAO use in routine care are unclear. We aimed to assess the utilization trends of LAAO and compare the change in characteristics of LAAO users versus OACs since its marketing. Using the US Medicare claims database (March 15, 2015, to December 31, 2020), we identified patients with atrial fibrillation, ≥65 years, and CHA2DS2-VASc score ≥2 (men) or ≥3 (women), with either first implantation of an LAAO device or initiation of OACs, including apixaban, dabigatran, rivaroxaban, edoxaban, or warfarin. Patient characteristics, measured 365 days before the first LAAO or OAC use date, were compared using logistic regression. There were 30 058 LAAO recipients (mean age, 77.74 years; female, 42.1%) and 792 600 OAC initiators (mean age, 78.48; female, 53.3%). In 2020, patients had higher odds of initiating LAAO use than in 2015 (0.52 versus 9.32%; adjusted odds ratio [aOR], 13.64 [95% CI, 12.56-14.81]). Old age (ie, >85 versus 65-75 years; aOR, 0.84 [95% CI, 0.80-0.88]), female sex (aOR, 0.74 [95% CI, 0.71-0.76]), Black race (aOR, 0.63 [95% CI, 0.58-0.68]) versus White race, and Medicaid eligibility (aOR, 0.61 [95% CI, 0.58-0.64]) were associated with lower odds of receiving LAAO. Among clinical characteristics, frailty, cancer, fractures, and venous thromboembolism were associated with lower odds of LAAO use, while history of intracranial and extracranial bleeding, coagulopathy, and falls were associated with higher odds of receiving LAAO. Among patients with atrial fibrillation receiving stroke-preventive therapy, LAAO use increased rapidly from 2015 to 2020 and was positively associated with the risk factors for OAC complications but negatively associated with old age, advanced frailty, and cancer. Black race and female sex were associated with a lower likelihood of receiving LAAO.

Minimally invasive left atrial appendage occlusion plus reduced dose direct oral anticoagulant to prevent stroke in patients with atrial fibrillation-the LAAO-PlusRE.

The onset of atrial fibrillation (AF) has a direct association with left atrial appendage (LAA) function, as demonstrated by recent studies demonstrating the link between left atrial (LA) wall fibrosis, impaired contractility, and the development of AF. Non-valvular AF (NVAF) affects almost 30 million people worldwide, with this number expected to increase in the next 20 years. It is the main cause of ischemic stroke, with significant subsequent economic and social impact. Currently, the mainstay of stroke prevention in patients with NVAF is oral anticoagulation (OAC), which reduces the incidence of ischemic events at the stake of increased hemorrhagic events. Despite the introduction and widespread use of direct oral anticoagulants (DOACs), which almost completely replaced vitamin K antagonists (VKAs), the adherence to OAC is still low, hindering the efficacy of stroke prevention. Percutaneous LAA occlusion (LAAO) is now indicated (class IIB) in patients with NVAF at increased ischemic risk who cannot undergo OAC. Recently published data demonstrated that a reduced dose of DOAC after percutaneous LAAO is superior to long-term dual antiplatelet therapy (DAPT) for stroke prevention in the mid-term. One of the possible pitfalls of percutaneous LAAO is postprocedural peri-device leaks (PDLs) that have been associated with increased thromboembolic events. According to LAAOS III results, surgical LAAO during cardiac surgery brings a 33% reduction in risk of stroke at five years, independently from the OAC regimen with a high rate of complete appendage occlusion. The combination of surgical LAAO and reduced dose DOAC might ensure adequate embolic prevention, lowering the hemorrhagic risk. The present manuscript aims to describe the rationale and design of the Minimally Invasive Left Atrial Appendage Occlusion Plus REduced Dose DOAC To Prevent Stroke In Patients With Atrial Fibrillation Randomized Clinical Trial (LAAO-PlusRE).

In-hospital safety outcomes of left atrial appendage occlusion in octogenarians and nonagenarians.

Data on safety outcomes of left atrial appendage occlusion (LAAO) in elderly patients are limited. This study aimed to compare the outcomes of LAAO between octogenarians (age 80-89) and nonagenarians (age ≥90) vs. younger patients (age ≤79). We conducted a retrospective cohort study using the National Inpatient Sample database to identify patients hospitalized for LAAO from 2016 to 2020 and to compare in-hospital safety outcomes in octogenarians and nonagenarians vs. younger patients. The primary outcome was a composite of in-hospital all-cause mortality or stroke. Secondary outcomes included procedural complications, length of stay (LOS), and total costs. Outcomes were determined using logistic regression models. Among 84 140 patients hospitalized for LAAO, 32.9% were octogenarians, 2.8% were nonagenarians, and 64.3% were ≤79 years of age. Over the study period, the volume of LAAO increased in all age groups (all Ptrend < 0.01). After adjustment for clinical and demographic factors, octogenarians and nonagenarians had similar odds of in-hospital all-cause mortality or stroke [adjusted odds ratio (aOR) 1.41, 95% confidence interval (CI) 0.93-2.13 for octogenarians; aOR 1.69, 95% CI 0.67-3.92 for nonagenarians], cardiac tamponade, acute kidney injury, major bleeding, and blood transfusion, in addition to similar LOS and total costs compared with younger patients (all P > 0.05). However, octogenarians and nonagenarians had higher odds of vascular complications compared with younger patients (aOR 1.47, 95% CI 1.08-1.99 for octogenarians; aOR 1.60, 95% CI 1.18-2.97 for nonagenarians). Octogenarians and nonagenarians undergoing LAAO have a similar safety profile compared with clinically similar younger patients except for higher odds of vascular complications.

Predicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion.

The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX. Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model. Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%-2.84%; interquartile range, 1.42%-1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65-0.70] and validation C-index, 0.66 [95% CI, 0.62-0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively. A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making.

The impact of contrast retention on thrombus formation risks in patients with atrial fibrillation: A numerical study

BackgroundContrast retention (CR) is an important predictor of left atrial appendage thrombus (LAAT) and stroke in patients with non-valvular atrial fibrillation (AF). We sought to explore the underlying mechanisms of CR using computational fluid dynamic (CFD) simulations. MethodsA total of 12 patients with AF who underwent both cardiac computed tomography angiography (CTA) and transesophageal echocardiography (TEE) before left atrial appendage occlusion (LAAO) were included in the study. The patients were allocated into the CR group or non-CR group based on left atrial appendage (LAA) angiography. Patient-specific models were reconstructed to evaluate time-averaged wall shear stress (TAWSS), oscillatory shear index (OSI), relative residence time (RRT), and endothelial cell activation potential (ECAP). Additionally, the incidence of thrombosis was predicted using residence time (RT) at different time-points. ResultsTAWSS was lower [median (Interquartile Range) 0.27 (0.19–0.47) vs 1.35 (0.92–1.79), p < 0.001] in LAA compared to left atrium. In contrast, RRT [1438 (409.70–13869) vs 2.23 (1.81–3.14), p < 0.001] and ECAP [122.70 (30.01–625.70) vs 0.19 (0.16–0.27), p < 0.001)] was higher in the LAA. The patients in the CR group had significantly higher RRT [(mean ± SD) 16274 ± 11797 vs 639.70 ± 595.20, p = 0.009] and ECAP [610.80 ± 365.30 vs 54.26 ± 54.38, p = 0.004] in the LAA compared to the non-CR group. Additionally, patients with CR had a wider range of thrombus-prone regions [0.44(0.27–0.66)% vs 0.05(0.03–0.27)%, p = 0.009] at the end of the 15th cardiac cycle. ConclusionsThese findings suggest that CR might be an indicator of high-risk thrombus formation in the LAA. And CT-based CFD simulation may be a feasible substitute for the evaluation of LAA thrombotic risk in patients with AF, especially in patients with CR.

Clinical outcomes of patients referred for left atrial appendage exclusion who did and did not undergo the procedure

BackgroundLeft atrial appendage exclusion (LAAE) is an effective alternative to long-term anticoagulation in patients with atrial fibrillation. Not all patients considered for LAAE undergo the procedure because of ineligibility, anatomic or medical constraints, and preference of the patient. ObjectiveThe objective of this study was to report on the management strategies and long-term clinical outcomes of patients referred to a dedicated multidisciplinary LAAE clinic, including all who subsequently did and did not undergo LAAE. MethodsThis was a retrospective analysis of prospectively acquired data from all patients referred to the comprehensive multidisciplinary LAAE clinic at the University of Michigan between 2016 and 2022. A consecutive 301 patients (age, 75 ± 8 years; 106 women) with atrial fibrillation were evaluated. LAAE was performed in 168 patients (56%) with use of the Watchman device in 146 (49%) and surgically in 22 (7%). LAAE was not performed in 133 patients (44%, no-LAAE group) because of ineligibility in 62 (21%), anatomic constraints in 23 (7%), and preference of the patient in 48 (36%). The CHA2DS2-VASc score (4.7 ± 1.5 vs 4.1 ± 1.6; P = .002) and HAS-BLED score (3.4 ± 1.0 vs 2.8 ± 1.1; P < .001) were higher in the LAAE groups. ResultsAnticoagulant therapy was discontinued in 137 of 146 (94%) and 61 of 133 (61%) in the Watchman and no-LAAE groups, respectively (P < .001). During a median follow-up of 2.2 years (interquartile range, 1.2–4.0 years), in the LAAE (n = 168) and no-LAAE (n = 133) groups, respectively, 39 (23%) vs 29 (22%) deaths, 13 (8%) vs 5 (4%) thromboembolic events, and 24 (14%) vs 23 (17%) bleeding complications occurred. Continued long-term anticoagulation was not a predictor of clinical outcomes. ConclusionAfter a comprehensive evaluation in a multidisciplinary clinic, ∼50% of the patients referred for LAAE did not proceed with LAAE and resumed anticoagulation.

Left atrial appendage closure and advanced chronic kidney disease: Another string to the bow.

Key points Patients with severe chronic kidney disease (CKD) and nonvalvular atrial fibrillation are underrepresented in left atrial appendage occlusion (LAAO) studies, despite their higher fragility and greater intolerance to antithrombotic therapy. LAAO appears to be safe and effective in reducing thromboembolic and bleeding recurrences both in patients with and without advanced CKD. Despite favorable ischemic and bleeding outcomes, patients with severe CKD experienced higher mortality rate, compared to those without severe CKD

Association of transcatheter left atrial appendage occlusion with acute changes in left atrial pressure: An invasive hemodynamic study

BackgroundThe hemodynamic effects of transcatheter left atrial appendage occlusion (LAAO) remain unclear. ObjectiveWe sought to assess the effect of LAAO on invasive hemodynamics and their correlation with clinical outcomes. MethodsWe recorded mean left atrial pressure (mLAP) before and after device deployment. We assessed the prevalence and predictors of mLAP increase after deployment, the association between significant mLAP increase after deployment and 45-day peridevice leak (PDL), and the association between mLAP increase and heart failure (HF) hospitalization. A significant mLAP increase was defined as one equal to or greater than the mean percentage increase in mLAP after deployment (≥28%). ResultsWe included 302 patients (36.4% female; mean age, 75.8 ± 9.5 years). After deployment, mLAP increased in 48% of patients, 38% of whom experienced significant mLAP increase. Independent predictors of mLAP increase were baseline mLAP ≤14 mm Hg, nonparoxysmal atrial fibrillation, and age per 5 years (odds ratios: 3.66 [95% CI, 2.21–6.05], 1.81 [95% CI, 1.08–3.02], and 0.85 [95% CI, 0.73–0.99], respectively). Significant mLAP increase was an independent predictor of 45-day PDL (odds ratio, 2.55; 95% CI, 1.04–6.26). There was no association between mLAP increase and HF hospitalization. ConclusionAfter deployment, mLAP acutely rises in 48% of patients, although this is not associated with increased HF hospitalizations. PDL is more likely to develop at 45 days in patients with significant increase in mLAP after deployment, although most leaks were small (<5 mm). These findings suggest that mLAP increase after deployment is not associated with major safety concerns. Additional studies are warranted to explore the long-term hemodynamic effects of LAAO.

Incidence of Acute Thrombosis After Surgical Left Atrial Appendage Occlusion for Atrial Fibrillation

BackgroundThe clinical implications of acute phase thrombosis after surgical left atrial appendage (LAA) closure remain unclear. This study sought to determine the frequency, prognosis, and factors involved in thrombogenesis after surgical LAA occlusion. MethodsIn this study, data from patients who underwent 2 types of standalone surgical LAA closure (either resection or clipping) between July 2014 and March 2020 at a single center were analyzed. ResultsA total of 239 consecutive patients with atrial fibrillation underwent minimally invasive standalone surgical LAA occlusion (184 resection cases and 55 clipping cases). On postoperative day 2, electrocardiogram synchronized contrast-enhanced computed tomography (CT) was performed in 223 cases (93.3%), and echocardiography follow-up was performed in 16 cases when CT was contraindicated. Acute postoperative thrombus on the closed stump was detected in 35 cases (14.7%), of which 29 cases (15.8%) belonged to the resection group and 6 cases (10.9%) belonged to the clipping group. No significant difference was detected between the groups, and no significant predictors of acute-phase thrombosis were found. Thromboembolism occurred in 4 patients before postoperative imaging follow-up, and there was no evidence of thrombi in these patients on postoperative day 2 CT. Three months after the first CT, thrombi were no longer detected in 34 of 35 patients (97.1%). ConclusionsThrombosis can occur after surgical LAA occlusion. Although the clinical significance is yet unclear, it may be reasonable to continue anticoagulation therapy until a lack of thrombosis is confirmed, unless there are contraindications.

Digital light 4D printing of bioresorbable shape memory elastomers for personalized biomedical implantation

Four-dimensional (4D) printing unlocks new potentials for personalized biomedical implantation, but still with hurdles of lacking suitable materials. Herein, we demonstrate a bioresorbable shape memory elastomer (SME) with high elasticity at both below and above its phase transition temperature (Ttrans). This SME can be digital light 3D printed by co-polymerizing glycerol dodecanoate acrylate prepolymer (pre-PGDA) with acrylic acid monomer to form crosslinked Poly(glycerol dodecanoate acrylate) (PGDA)-Polyacrylic acid (PAA), or PGDA-PAA network. The printed complex, free-standing 3D structures with high-resolution features exhibit shape programming properties at a physiological temperature. By tuning the pre-PGDA weight ratios between 55 wt% and 70 wt%, Ttrans varies between 39.2 and 47.2 ℃ while Young's moduli (E) range 40–170 MPa below Ttrans with fractural strain (εf) of 170 %-200 %. Above Ttrans, E drops to 1–1.82 MPa which is close to those of soft tissue. Strikingly, εf of 130–180 % is still maintained. In vitro biocompatibility test on the material shows > 90 % cell proliferation and great cell attachment. In vivo vascular grafting trials underline the geometrical and mechanical adaptability of these 4D printed constructs in regenerating the aorta tissue. Biodegradation of the implants shows the possibility of their full replacement by natural tissue over time. To highlight its potential for personalized medicine, a patient-specific left atrial appendage (LAA) occluder was printed and implanted endovascularly into an in vitro heart model. Statement of significance4D printed shape-memory elastomer (SME) implants particularly designed and manufactured for a patient are greatly sought-after in minimally invasive surgery (MIS). Traditional shape-memory polymers used in these implants often suffer from issues like unsuitable transition temperatures, poor biocompatibility, limited 3D design complexity, and low toughness, making them unsuitable for MIS. Our new SME, with an adjustable transition temperature and enhanced toughness, is both biocompatible and naturally degradable, particularly in cardiovascular contexts. This allows implants, like biomedical scaffolds, to be programmed at room temperature and then adapt to the body's physiological conditions post-implantation. Our studies, including in vivo vascular grafts and in vitro device implantation, highlight the SME's effectiveness in aortic tissue regeneration and its promising applications in MIS.

State-of-the-Art of Transcatheter Left Atrial Appendage Occlusion.

Left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with atrial fibrillation, especially in patients with absolute/relative contraindications to these therapies. This review will cover three main aspects of the procedure. In the fist part of the manuscript, we focus on patient selection. We describe three main categories of patients with primary indication to LAAO, namely patients with previous or at a high risk of intracerebral bleeding, patients with a history of major gastrointestinal bleeding and patients with end-stage renal disease and absolute contraindication to novel oral anticoagulants. Some other potential indications are also described. In the second part of the manuscript, we review available devices, trying to highlight different aspects and potential specific advantages. The last section overviews different ways for pre-, intra- and postprocedural imaging, in order to improve procedural safety and efficacy and ameliorate patient outcome. The characteristics of available contemporary devices and the role of imaging in procedural planning, intraprocedural guidance and follow-up are described.

Surgical Ablation for Atrial Fibrillation in Mitral Valve Surgery: Improved Survival and Stroke Risk in US Veterans

Background: Surgical ablation for atrial fibrillation (AF) is strongly recommended in patients undergoing mitral valve (MV) surgery but is underutilized. Left atrial appendage occlusion (LAAO) in patients with AF undergoing cardiac surgery is a matter of debate, and it is not clear which patients derive long-term benefit. This issue has not been investigated in United States Veterans. Methods: We performed a retrospective review of 1289 patients with pre-operative AF who underwent MV surgery between 2010–2020. Patients were grouped based on whether their procedure included ablation and LAAO, LAAO without ablation, or neither. Cox proportional hazard models, adjusted for covariates, were used to calculate risk for stroke, myocardial infarction (MI), and death based on intervention. Results: Ablation was performed in 645/1289 (50.0%) of patients and LAAO without ablation was performed in 186/1289 (14.4%) patients. Mean follow-up was 4.1 ± 3.1 years. Patients who underwent ablation had a 62% lower long-term risk of stroke (0.38, 95% CI: 0.22–0.67, p &lt; 0.001) and 20% lower long-term mortality risk (adjusted hazard ratios (aHR) 0.80, 95% CI: 0.66–0.95, p = 0.012), but no difference in risk of MI (aHR 0.67, 95% CI: 0.38–1.16, p = 0.15). LAAO was not associated with differences in long-term risk of stroke, MI, or death. There were no differences in perioperative complications between groups. Conclusions: In veterans with AF undergoing MV surgery, ablation was inversely and independently associated with long-term stroke risk and long-term mortality, with no increased risk of perioperative complications. LAAO did not reduce long-term stroke risk.

Antithrombotic Therapy Following Structural Heart Disease Interventions: Current Status and Future Directions.

Interventions in structural heart disease cover many catheter-based procedures for congenital and acquired conditions including valvular diseases, septal defects, arterial or venous obstructions, and fistulas. Among the available procedures, the most common are aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure. Antithrombotic therapy for transcatheter structural heart disease interventions aims to prevent thromboembolic events and reduce the risk of short-term and long-term complications. The specific approach to antithrombotic therapy depends on the type of intervention and individual patient factors. In this review, we synopsize contemporary evidence on antithrombotic therapies for structural heart disease interventions and highlight the importance of a personalized approach. These recommendations may evolve over time as new evidence emerges and clinical guidelines are updated. Therefore, it's crucial for healthcare professionals to stay updated on the most recent guidelines and individualize therapy based on patient-specific factors and procedural considerations.

Left Atrial Appendage Occlusion versus Direct Oral Anticoagulants in the Prevention of Ischaemic Stroke in Patients with Atrial Fibrillation

Introduction: Existing randomised controlled trials assessing the safety and efficacy of left atrial appendage occlusion (LAAO) in atrial fibrillation (AF) were of relatively small sample size or included patients who could receive oral anticoagulant treatment after device implantation. We compared the outcomes of patients with newly diagnosed AF who received percutaneous LAAO or direct oral anticoagulant (DOAC) treatment, in a large population from a global federated health network (TriNetX). Methods: Patients with AF treated with percutaneous LAAO were matched with those treated with DOAC between December 1, 2010, and October 1, 2018. Outcomes were all-cause mortality, ischaemic stroke, and intracranial haemorrhage (ICH) at 5 years. Results: We included 200 patients with AF, who received either LAAO or DOAC. The risk of all-cause mortality, ischaemic stroke, and ICH at 5 years was not significantly different between the two groups (risk ratio [RR] for all-cause mortality: 1.52, 95% confidence interval (CI): 0.97–2.38, RR for ischaemic stroke: 1.09, 95% CI: 0.51–2.36, and RR for ICH: 1.0, 95% CI: 0.44–2.30). Conclusion: Patients newly diagnosed with AF, eligible for DOAC, showed similar 5-year risk of death, ischaemic stroke, and ICH when comparing those who underwent percutaneous LAAO to those receiving DOAC. Future randomised controlled trials are needed to confirm the findings and advise changes in guidelines.

First-in-Human Percutaneous Removal of Left Atrial Appendage Occlusion Devices With a Novel Retrieval System

First-in-Human Percutaneous Removal of Left Atrial Appendage Occlusion Devices With a Novel Retrieval System

Postoperative atrial fibrillation (POAF) after cardiac surgery: clinical practice review.

Postoperative atrial fibrillation (POAF) after cardiac surgery is associated with elevated morbidity and mortality. Although current prediction models have limited efficacy, several perioperative interventions can reduce patients' risk of POAF. These begin with preoperative medications, including beta-blockers and amiodarone. Moreover, patients should be screened for preexisting atrial fibrillation (AF) so that concomitant surgical ablation and left atrial appendage occlusion can be performed in appropriate candidates. Intraoperative interventions such as posterior pericardiectomy can reduce mediastinal fluid accumulation, which is a trigger for POAF. Furthermore, many preventive strategies for POAF are implemented in the immediate postoperative period. Initiating beta-blockers, amiodarone, or both is reasonable for most patients. Overdrive atrial pacing, colchicine, and steroids have been used by some, although the evidence base is less robust. For patients with POAF, rate-control and rhythm-control strategies have comparable outcomes. Decision-making regarding anticoagulation should recognize that the stroke risk associated with POAF appears to be lower than that for general nonvalvular AF. The evidence that oral anticoagulation reduces stroke risk is less clear for POAF patients than for patients with general nonvalvular AF. Given that POAF tends to be shorter-lived and is associated with greater bleeding risks in the perioperative period, decisions regarding anticoagulation should be individualized. Finally, wearable technology and machine learning algorithms for better predicting and managing POAF appear to be coming soon. These technologies and a comprehensive clinical program could meaningfully reduce the incidence of this common complication.

Left atrial appendage occlusion for patients with valvular diseases without atrial fibrillation (the OPINION Study): study protocol for a multicentre, randomised controlled trial

IntroductionAtrial fibrillation (AF) is a significant cause of perioperative stroke in aortic and mitral valve surgeries. Although several large studies have evaluated surgical left atrial appendage occlusion (SLAAO) during cardiac...

The use of percutaneous left atrial appendage occluder device in a patient with prior surgical ligation with incomplete exclusion: a case report

Abstract Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and the most common cause of cardioembolic stroke. The left atrial appendage (LAA) is the main source of thrombus formation in patients with AF. Therapies include use of percutaneous LAA closure devices, or surgical LAA occlusion (LAAO). Despite these options, complete closure of the LAA is not always achieved, and residual communication between the LAA and atrium may result in increased thrombus formation. Although studies have analysed the use of percutaneous measures such as coils, plugs, or second occluder device deployment in LAA with peri-device leak (PDL), use of percutaneous occlude devices in surgically occluded LAA is far less studied. Case summary We present a case of a 79-year-old female patient who underwent LAAO device deployment within a surgically occluded LAA with PDL. She underwent 27 mm LAAO device (WATCHMANTM) deployment and all the P.A.S.S. (Position, Anchor, Size, and Seal) criteria were satisfied. Only 1.4 mm PDL was present. She was continued on apixaban and aspirin post-operatively. Post-operative transoesophageal echocardiogram at 6 weeks demonstrated trivial PDL measuring 1.49 mm. Patient was continued on aspirin and clopidogrel, with discontinuation of apixaban. Discussion Percutaneous LAAO device deployment in previously surgically ligated LAA with incomplete exclusion is a potential therapeutic option for patients with AF and a high bleeding risk seeking a minimally invasive strategy, in an attempt to de-escalate anticoagulation therapy.

First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study.

The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7days or hospital discharge (whichever is later). Major adverse events through 45days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-left atrial appendage occlusion and 87.1% at 45days. A safety composite endpoint event occurred in 0.76% patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs high operator experience 1.8% vs 1.1%; P = 0.006) and at 45days (2.3% vs 1.5%; P = 0.012). The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of theAmulet occluder in the real-world setting. More experienced operators had improved implant success and fewerPEs,suggesting a learning curve effect implanting this dual occlusive mechanism device.

LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry

BackgroundInterventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group.AimThis sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke.MethodsLAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events.ResultsA total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan–Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS).ConclusionsPatients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients.ClinicalTrials.gov identifierNCT02230748.Graphical LAA occlusion in patients with and without prior stroke – results from the multicentre German LAARGE registry