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After atrial fibrillation ablation, left atrial appendage closure was associated with a lower risk of bleeding than oral anticoagulation and was noninferior to oral anticoagulation with respect to clinical outcomes at 36 months.

Left atrial appendage closure (LAAC) has become a recommended addition to oral anticoagulation for patients with atrial fibrillation, who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic arterial embolism, potentially making oral anticoagulation (OAC) unnecessary or even harmful, when considering the associated increased risk of bleeding. This publication describes the rationale and design of a randomized trial, testing the hypothesis that stopping OAC is noninferior to continuing OAC after surgical LAAC in terms of the primary endpoint. The ATLAAC trial is a multicenter, randomized, controlled trial, aiming to enroll 1,220 patients with atrial fibrillation, who have undergone surgical LAAC and remain on OAC. A cardiac CT scan is performed to confirm success of the LAAC. Patients with successful closure are randomized to stop or continue OAC. The primary endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or major bleeding over an expected mean follow-up of 4 years. Secondary endpoints include all-cause mortality, cardiovascular mortality, any bleeding leading to hospitalization, blood transfusion, venous thromboembolism, myocardial infarction, and quality of life measures. Enrollment for the ATLAAC trial began in March 2024. As of January 18th, 2025, 554 patients have been enrolled in the study and 319 patients have been randomized. Recruitment is expected to continue for approximately 12 months. Follow-up will be stopped once 128 primary endpoints have occurred. The ATLAAC trial will evaluate the safety of stopping OAC after surgical LAAC. EU-CT: 2022-502986-92-00, clinicaltrials.gov ID: NCT06401616. [Display omitted]

Left atrial appendage exclusion (LAAE) has been shown in randomized trials to reduce ischemic stroke risk in patients undergoing cardiac surgery with known atrial fibrillation (AF). Many patients undergoing cardiac surgery without pre-existing AF are at risk of stroke and may benefit from LAAE. Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) is an international, prospective, randomized, multicenter, blinded trial evaluating the effectiveness of LAAE in preventing ischemic stroke or systemic embolism in patients undergoing cardiac surgery at increased risk of AF and ischemic stroke. The trial will enroll 6500 patients at increased risk of stroke in whom a cardiac surgery is planned at 250 sites worldwide. Eligible patients are ≥18 years old, have no pre-existing AF but are at increased risk for AF and stroke (based on age, CHA2DS2-VASc score, left atrium size or brain natriuretic peptide). Patients are randomized 1:1 to receive either LAAE with AtriClip or no LAAE during cardiac surgery. Healthcare providers outside of the operating room and the patient will be blinded to allocation. The primary effectiveness endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or surgical or endovascular LAA closure. The powered secondary effectiveness endpoint is ischemic stroke or systemic arterial embolism. The primary safety endpoint is the occurrence of one of the following events (through 30 days): pericardial effusion requiring percutaneous or surgical treatment, peri-operative major bleeding, deep sternal wound infection, or myocardial infarction. Other endpoints include mortality, rehospitalizations, clinically diagnosed AF, transient ischemic attack, and cognitive and quality of life assessments. Follow-up is every 6 months for a minimum of 5 years; primary analysis occurs when 469 patients have had an ischemic stroke or systemic embolism. The results of the LeAAPS trial will demonstrate whether LAAE with AtriClip at the time of other routine cardiac surgery reduces stroke or systemic arterial embolism during long-term follow-up in patients at high risk of stroke without pre-existing AF. ClinicalTrials.gov, Identifier: NCT05478304, https://clinicaltrials.gov/study/NCT05478304?term=%20NCT05478304&rank=1.

Background Intracardiac echocardiography (ICE) appears to be a potential alternative for percutaneous left atrial appendage occlusion (LAAO) to transesophageal echocardiography (TEE). Thus, a meta-analysis was performed comparing ICE vs. TEE for LAAO guidance. Methods A comprehensive literature search was performed using MEDLINE, Scopus and Web of Science electronic databases from their inception to November 2023. Results 18 studies (124,230 patients) were included. Technical success was higher in ICE- compared to TEE-guidance (OR: 1.36, 95% CI 1.14 to 1.63, p  = 0.006) and fewer devices employed (SMD: -0.22, 95% CI -0.43 to -0.01, p  = 0.04, I2 = 62%). ICE guidance related with more pericardial effusion/tamponade and iatrogenic residual shunts (logRR: 0.62, 95% CI 0.36 to 0.89, p  < 0.001 and RR: 1.53, 95% CI 1.12 to 2.09, p  = 0.02, I2 = 1%, respectively). More vascular complications were noted in ICE group (logRR: 0.45, 95% CI 0.11 to 0.78, p  = 0.009). Conclusion ICE-guided imaging is an effective alternative to TEE in LAAO, as it shows better efficacy than TEE, considering technical success. However, the higher rates of adverse events should be carefully considered.

In a randomized trial, 4811 patients with atrial fibrillation were assigned to undergo or not undergo left atrial appendage occlusion during cardiac surgery for another indication. At 3 years, 77% of the patients continued to receive oral anticoagulation. At 3.8 years, the risk of ischemic stroke or systemic embolism was significantly lower with occlusion than without it.

Percutaneous left atrial appendage (LAA) closure is a viable alternative to chronic oral anticoagulation for reducing thromboembolic risk in non-valvular atrial fibrillation (AF) patients. To date, no clinical data have been published on the novel nonpacifier LAA closure device evaluated herein. We therefore conducted a prospective, non-randomized, multi-center registry across 6 Chinese hospitals to provide the first clinical evidence of its safety and effectiveness among AF patients with an increased risk of stroke, using performance goals to assess 6-month effective LAA closure and 12-month ischemic stroke incidence. Among 187 enrolled patients (mean age 67.7 ± 7.5 years; mean CHA 2 DS 2 -VASc 4.0 ± 1.6; mean HAS-BLED 2.5 ± 1.1), device implantation succeeded in 184 (98.4%), with 4 (2.1%) major peri-procedural complications. Effective LAA closure was achieved in all (100%) patients at 6 months with a 1-sided 95% lower confidence interval (CI) of 98.0%. During the 12-month follow-up period, 1 of 176 patients (0.6%, 1-sided 95% upper CI 2.9%) experienced ischemic stroke, thus meeting both prespecified performance goals. The cumulative incidence of major clinical events was 11 of 176 patients (6.5%, 95% CI 2.9–10.1%). This novel LAA closure device is effective for stroke prevention in non-valvular AF, with high procedural success and low adverse events.

Percutaneous catheter‐based left atrial appendage (LAA) closure is a potential alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation (AF). The effectiveness and safety of LAA closure in patients with AF at high risk of stroke (CHA2DS2‐VASc Score ≥2) and high risk of bleeding compared to best medical care including a nonvitamin K antagonist oral anticoagulant [NOAC] when considered eligible is not known. The prospective, multicenter, randomized clinical Left atrial appendage CLOSURE in patients with Atrial Fibrillation at high risk of stroke and bleeding compared to medical therapy (CLOSURE-AF) trial compared catheter-based LAA closure to best medical care (including NOAC therapy if considered eligible) in patients with AF at high risk of stroke and with either a history of bleeding or a high estimated bleeding risk (HASBLED ≥ 3). The primary endpoint is time to a composite of first stroke (ischemic or hemorrhagic), systemic embolism, cardiovascular or unexplained death or major bleeding (Bleeding Academic Research Consortium 3-5). Secondary outcomes include components of the primary outcome and total mortality. The primary efficacy analysis will be performed in the intention‐to‐treat population using Cox regression models for noninferiority with an option to test for superiority once noninferiority has been proven. The first patient in the CLOSURE-AF trial was enrolled in March 2018. By April 2025 the complete study cohort of n = 912 patients had been enrolled in 42 sites. CLOSURE-AF will contribute evidence on the effectiveness and safety of LAA occlusion compared to optimal medical therapy in patients with AF at high risk of stroke and bleeding. The trial results will help to define the clinical use of catheter-based LAA closure in the future. clinicaltrials.gov Identifier: NCT03463317

BACKGROUNDGenomic and experimental studies suggest a role for PITX2 in atrial fibrillation (AF). To assess if this association is relevant for recurrent AF in patients, we tested whether left atrial PITX2 affects recurrent AF after AF ablation.METHODSmRNA concentrations of PITX2 and its cardiac isoform, PITX2c, were quantified in left atrial appendages (LAAs) from patients undergoing thoracoscopic AF ablation, either in whole LAA tissue (n = 83) or in LAA cardiomyocytes (n = 52), and combined with clinical parameters to predict AF recurrence. Literature suggests that BMP10 is a PITX2-repressed, atrial-specific, secreted protein. BMP10 plasma concentrations were combined with 11 cardiovascular biomarkers and clinical parameters to predict recurrent AF after catheter ablation in 359 patients.RESULTSReduced concentrations of cardiomyocyte PITX2, but not whole LAA tissue PITX2, were associated with AF recurrence after thoracoscopic AF ablation (16% decreased recurrence per 2-(ΔΔCt) increase in PITX2). RNA sequencing, quantitative PCR, and Western blotting confirmed that BMP10 is one of the most PITX2-repressed atrial genes. Left atrial size (HR per mm increase [95% CI], 1.055 [1.028, 1.082]); nonparoxysmal AF (HR 1.672 [1.206, 2.318]), and elevated BMP10 (HR 1.339 [CI 1.159, 1.546] per quartile increase) were predictive of recurrent AF. BMP10 outperformed 11 other cardiovascular biomarkers in predicting recurrent AF.CONCLUSIONSReduced left atrial cardiomyocyte PITX2 and elevated plasma concentrations of the PITX2-repressed, secreted atrial protein BMP10 identify patients at risk of recurrent AF after ablation.TRIAL REGISTRATIONClinicalTrials.gov NCT01091389, NL50069.018.14, Dutch National Registry of Clinical Research Projects EK494-16.FUNDINGBritish Heart Foundation, European Union (H2020), Leducq Foundation.

The optimal approach for prevention of cardiovascular events and reduction of bleeding in patients with acute coronary syndrome (ACS) and atrial fibrillation (AF) is still controversial. The aim of our study is to asses our single-center experience with concomitant left atrial appendage occlusion (LAAO) and percutaneous coronary intervention (PCI). 50 patients with ACS without ST elevation and history of AF were randomized after successful PCI to LAAO or conventional medical therapy. The primary endpoints were safety and length of hospitalization. The follow-up period was 30 days. The mean procedural times were 113 ± 23 min PCI + LAAO implantation and 39 ± 19 min of PCI only ( p  < 0.001), while mean fluoroscopy times were 18 ± 8 min and 12 ± 8 min ( p  < 0.001), respectively. No procedure-related complications were observed . There was no difference observed for length of hospitalization between two groups. LAAO in patients with ACS and AF undergoing PCI appears safe. Graphical abstract

Background Approximately 90% of intracardial thrombi originate from the left atrial appendage in non-valvular atrial fibrillation patients. Even with anticoagulant therapy, left atrial appendage thrombus (LAAT) still occurs in 8% of patients. While left atrial appendage closure (LAAC) could be a promising alternative, the current consensus considers LAAT a contraindication to LAAC. However, the feasibility and safety of LAAC in patients with LAAT have yet to be determined. Methods This systematic review synthesizes published data to explore the feasibility and safety of LAAC for patients with LAAT. Results This study included a total of 136 patients with LAATs who underwent successful LAAC. The Amulet Amplatzer device was the most frequently utilized device (48.5%). Among these patients, 77 (56.6%) had absolute contraindications to anticoagulation therapy. Cerebral protection devices were utilized by 47 patients (34.6%). Transesophageal echocardiography (TEE) is the primary imaging technique used during the procedure. Warfarin and novel oral anticoagulants were the main anticoagulant medications used prior to the procedure, while dual antiplatelet therapy was primarily used post-procedure. During a mean follow-up period of 13.2 ± 11.5 months, there was 1 case of fatality, 1 case of stroke, 3 major bleeding events, 3 instances of device-related thrombus, and 8 cases of peri-device leakage. Conclusions This review highlights the preliminary effectiveness and safety of the LAAC procedure in patients with persistent LAAT. Future large-scale RCTs with varied LAAT characteristics and LAAC device types are essential for evidence-based decision-making in clinical practice.