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AIM: The 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Patients With Atrial Fibrillation provides recommendations to guide clinicians in the treatment of patients with atrial fibrillation. METHODS: A comprehensive literature search was conducted from May 12, 2022, to November 3, 2022, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline. Additional relevant studies, published through November 2022, during the guideline writing process, were also considered by the writing committee and added to the evidence tables, where appropriate. STRUCTURE: Atrial fibrillation is the most sustained common arrhythmia, and its incidence and prevalence are increasing in the United States and globally. Recommendations from the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation and the 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation have been updated with new evidence to guide clinicians. In addition, new recommendations addressing atrial fibrillation and thromboembolic risk assessment, anticoagulation, left atrial appendage occlusion, atrial fibrillation catheter or surgical ablation, and risk factor modification and atrial fibrillation prevention have been developed.

The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described. This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens. The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022. They grouped patients by mutually exclusive discharge antithrombotic strategies and compared the rates of adverse events at 45 days and 6 months using multivariable Cox proportional hazards regression. Among 53,878 patients undergoing successful LAAO with the second-generation LAA closure device, the most common antithrombotic discharge regimens were direct oral anticoagulant (DOAC) plus aspirin (48.3%), DOAC alone (22.6%), dual antiplatelet therapy (8.1%), warfarin plus aspirin (7.7%), and DOAC plus P2Y 12 inhibitor (4.9%). In multivariate analysis, DOAC alone had a lower rate of major adverse events and major bleeding at 45 days of follow-up compared with DOAC plus aspirin (major adverse events: HR: 0.78; 95% CI: 0.68-0.91; major bleeding: HR: 0.69; 95% CI: 0.60-0.80). These differences persisted at 6 months. Warfarin without aspirin also showed lower rates of major bleeding at both time points. No differences were seen in stroke/transient ischemic attack or device-related thrombus. In real-world U.S. practice, discharge on DOAC alone or warfarin alone was associated with a lower rate of adverse events compared with DOAC plus aspirin. [ABSTRACT FROM AUTHOR]

Patients treated with left atrial appendage occlusion (LAAO) are at high bleeding risk. Intensive antithrombotic treatment is recommended after the procedure to prevent device-related thrombosis. This study sought to evaluate the incidence, consequences, and predictors of early nonprocedural bleeding after LAAO. This was a multicenter study including 1,649 patients undergoing LAAO in 9 centers. Early nonprocedural bleeding was defined as bleeding unrelated to the procedure occurring within 3 months after device implantation. The severity of bleeding was defined by the Valve Academic Research Consortium-2 classification. A sensitivity analysis was performed at 45 days. A total of 121 (7.3%) patients experienced early nonprocedural bleeding events, and 69 (57.0%) were classified as major bleeding (4.2% of patients). Independent predictors of early nonprocedural bleeding were dual antiplatelet therapy (DAPT) at discharge (adjusted HR [aHR]: 1.61; 95% CI: 1.12-2.33; P = 0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P < 0.001), and multiple locations of prior bleeding (aHR: 2.33; 95% CI: 1.34-4.05; P < 0.001). DAPT at discharge was predictive of both all and major nonprocedural bleeding at 3 months and 45 days. After a median follow-up of 2.3 years (Q1-Q3: 1.1-4.1 years), early nonprocedural bleeding was independently associated with an increased risk of all-cause death (aHR: 1.53; 95% CI: 1.15-2.06; P < 0.001). This heightened mortality risk was similar at 45 days. Early nonprocedural bleeding after LAAO occurred in ∼7% of patients within 3 months, with more than one-half being classified as major bleeding. Regardless of severity, early nonprocedural bleeding was associated with increased mortality. DAPT at discharge determined an increased risk of early nonprocedural bleeding after LAAO. These results emphasize the importance of bleeding risk for determining antithrombotic strategies after LAAO. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: In the last few years, percutaneous LAA occlusion (LAAO) has become a plausible alternative in atrial fibrillation (AF) patients with contraindications to anticoagulation therapy. Nevertheless, the optimal antiplatelet strategy following percutaneous LAAO remains to be defined. Methods: Studies comparing single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following LAAO were systematically searched and screened. The outcomes of interest were ischemic stroke, device‐related thrombus (DRT) and major bleeding. A random‐effect meta‐analysis was performed comparing outcomes in both groups. The moderator effect of baseline characteristics on outcomes was evaluated by univariate meta‐regression analyses. Results: Sixteen observational studies with 3255 patients treated with antiplatelet therapy (SAPT, n = 1033; DAPT, n = 2222) after LAAO were included. Mean age was 74.5 ± 8.3 years, mean CHA2DS2‐VASc and HAS‐BLED scores were 4.3 ± 1.5 and 3.2 ± 1.0, respectively. At a weighted mean follow‐up of 12.7 months, the occurrence of stroke (RR 1.33; 95% CI 0.64–2.77; p =.44), DRT (RR 1.52; 95% CI 0.90–2.58; p =.12), and the composite of stroke and DRT (RR 1.26; 95% CI 0.67–2.37; p =.47) did not differ significantly between SAPT and DAPT groups. The rate of major bleedings was also not different between groups (RR 1.41; 95% CI 0.64–3.12; p =.39). Conclusions: Among AF patients at high bleeding risk undergoing percutaneous LAAO, a post‐procedural minimalistic antiplatelet strategy with SAPT did not significantly differ from DAPT regimens regarding the rate of stroke, DRT and major bleeding. [ABSTRACT FROM AUTHOR]

Introduction: Four‐dimensional (4D) intracardiac echocardiography (ICE) is a novel cardiac imaging modality that has been applied to various workflows, including catheter ablation, tricuspid valve repair, and left atrial appendage occlusion (LAAO). The use of this type of advanced ICE imaging may ultimately allow for the replacement of transesophageal echocardiography (TEE) for LAAO, providing comparable imaging quality while eliminating the need for general anesthesia. Methods: Based on our initial clinical experience with 4D ICE in LAAO, we have developed an optimized workflow for the use of the NUVISION™ 4D ICE Catheter in conjunction with the GE E95 and S70N Ultrasound Systems in LAAO. In this manuscript, we provide a step‐by‐step guide to using 4D ICE in conjunction with compatible imaging consoles. We have also evaluated the performance of 4D ICE with the NUVISION Ultrasound Catheter versus TEE in one LAAO case and present those results here. Results: In our comparison of 4D ICE using our optimized workflow with TEE in an LAAO case, ICE LAA measurements were similar to those from TEE. The best image resolution was seen via ICE in 2‐dimensional and multislice modes (triplane and biplane). The FlexiSlice multiplanar reconstruction tool, which creates an en‐face image derived from a 4D volume set, also provided valuable information but yielded slightly lower image quality, as expected for these volume‐derived images. For this case, comparable images were obtained with TEE and ICE but with less need to reposition the ICE catheter. Conclusion: The use of optimized 4D ICE catheter workflow recommendations allows for efficient LAAO procedures, with higher resolution imaging, comparable to TEE. [ABSTRACT FROM AUTHOR]

To report the clinical outcomes of thoracoscopic left atrial appendage occlusion (LAAO) with the AtriClip PRO2 device (Atricure Inc, Mason, OH, USA). Stroke risk reduction with LAAO in patients with atrial fibrillation is now well-established. Many surgical and percutaneous techniques have been used, with varying rates of success. The percutaneous devices have had issues with procedural complications and peridevice flow. Thoracoscopic AtriClip offers an epicardial linear closure of the appendage at its ostium. This study sought to evaluate its safety and efficacy in achieving complete LAA closure. This is a prospective series of thoracoscopic AtriClip PRO2 as a standalone procedure or a thoracoscopic AtriClip deployed as an adjunct to minimal access cardiac and thoracic surgery. Study ethical approval was granted by the hospital Human Research Ethics Committee. In total, 144 thoracoscopic AtriClip procedures were conducted by a single surgeon from 2017 to 2022, 56 standalone and 88 concomitant. There was no mortality or major morbidities. A 100% success in complete LAA closure was observed, with 87% complete follow-up imaging. For patients that underwent standalone AtriClip after cessation of anticoagulation, no thromboembolic phenomena were seen in the 180 patient-years of follow-up. This study demonstrates that thoracoscopic placement of AtriClip is safe and effective in achieving consistent and complete LAAO. Future randomised trials will be useful to compare outcomes with percutaneous devices. [ABSTRACT FROM AUTHOR]

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Introduction: Endovascular left atrial appendage occlusion (LAAO) is associated with a high incidence of peri-procedure silent cerebral embolism (SCE), while the recommended activated clotting time (ACT) level by the expert consensus is lower than that in atrial fibrillation (AF) ablation. The aim of our study was to investigate whether raising the targeted ACT level during LAAO to the same level as AF ablation could decrease the incidence of SCE. Methods: It was a prospective observational cohort study. Consecutive AF patients receiving LAAO between January 2021 and December 2022 were included and categorized into two groups based on the time of enrollment. Patients enrolled in 2021 (group 250) maintained a target ACT level of ≥250 s during LAAO procedure, while patients enrolled in 2022 (group 300) maintained the peri-procedure ACT ≥300 s. All patients underwent cerebral magnetic resonance imaging before and after the procedure. Results: A total of 81 patients were included (38 in the group 250 and 43 in the group 300). After inverse probability of treatment weighting (IPTW), patients in the group 250 showed a significantly lower incidence of SCE than group 300 (IPTW p = 0.038). Only a stable high ACT pattern could decrease the risk of SCE. No significant differences were found between other ACT change patterns on the SCE incidence. Conclusion: Raising the peri-procedure ACT level to a stable 300 s could decrease the risk of the SCE without increasing the major bleeding events. [ABSTRACT FROM AUTHOR]

With the advances in percutaneous treatment technologies, the left atrial appendage occlusion (LAAO) and the transcatheter mitral valve repair using MitraClip (TMVR) are increasingly being performed today. The SAFARI 2™ guidewire is primarily used during transcatheter aortic valve implantation (TAVI), our group has also been using it during MitraClip and LAAO procedures. Our clinical study aimed to share our data on the safety and effectiveness for the use of the SAFARI 2™ guidewire during MitraClip or LAAO procedures. This study included a total of 1730 patients (948 patients of MitraClip and 782 of LAAO). It was designed as single arm, retrospective, and multicenter between July 2016 and August 2022. SAFARI 2™ guidewire was used exclusively during all the procedures. A total of 1730 patients (male 55.8 %) were included in the study. There was no guidewire-related complications, stroke/transient ischemic attack, bleeding (minor/major/life-threatening), need for cardiac surgery, pneumonia, and vascular dissection/rupture in patients undergoing LAAO. There were 2 device-related pericardial effusions without tamponade. No stroke/transient ischemic attack, bleeding (minor/major/life-threatening), mortality, need for cardiac surgery, pneumonia, guidewire-related complication, pericardial effusion, vascular dissection/rupture, or clip embolization was observed in patients undergoing MitraClip. By taking advantage of its pre-shaped structure, the SAFARI 2™ guidewire seems to offer a reliable and safe device delivery for both MitraClip and LAAO procedures as a regular work horse wire. Our results should be confirmed by larger randomized or prospective trials. • The LAAO and TMVR procedures are increasingly being performed. • Appropriate stiff wire selection in left sided structural heart interventions reduces the complication rate. • The use of SAFARI 2™ as a regular work horse guidewire during MitraClip or LAAO procedures is safe and effective. [ABSTRACT FROM AUTHOR]

The hemodynamic effects of transcatheter left atrial appendage occlusion (LAAO) remain unclear. We sought to assess the effect of LAAO on invasive hemodynamics and their correlation with clinical outcomes. We 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%). We 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. After 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. [ABSTRACT FROM AUTHOR]

Aims Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. Methods and results The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan–Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0–18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03–1.08, per year increase], heart failure (HR 1.73, CI: 1.24–2.41), vascular disease (HR 1.47, CI: 1.05–2.05), valvular disease (HR 1.63, CI: 1.15–2.33), abnormal liver function (HR 1.80, CI: 1.02–3.17), and abnormal renal function (HR 1.58, CI: 1.10–2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. Conclusion One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. Clinical trial registration The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282. [ABSTRACT FROM AUTHOR]

Aims Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach. Methods and results We have launched a programme for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with a complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. We performed the combined procedure in 10 patients (50% males; median age 70 years) and excluded 2 patients (17%) because of a complex left atrial appendage anatomy. No death, stroke, or major bleeding events, including pericardial effusion, occurred. For single-procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. The total median procedure duration was 79 min (range 60–125) for the combined procedure, 71 min (25–241) for individual AF ablation (51 min without and 78 min with 3-dimensional electroanatomic mapping), and 47 min (15–162) for individual LAAO. The respective fluoroscopy times were 21 (15–26), 15 (5–44), and 10 (3–50) min. For the combined procedure, femoral vein access to last PFA application lasted 49 min (34–93) and LAAO added 20 min (15–37). Conclusion Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible and safe and can be executed within a short overall procedure duration. [ABSTRACT FROM AUTHOR]

Left atrial appendage occlusion affects systemic coagulation parameters, leading to additional patient-related benefits. The aim of this study was to investigate the differences in coagulation factor changes 6 months after epicardial left atrial appendage occlusion in patients with different LAA morphometries. This is the first study to analyze these relationships in detail. A prospective study of 22 consecutive patients was performed. Plasminogen, fibrinogen, tPA concentration, PAI-1, TAFI and computed tomography angiograms were performed. Patients were divided into subgroups based on left atrial appendage body and orifice diameter enlargement. The results of blood tests at baseline and six-month follow-up were compared. In a population with normal LAA body size and normal orifice diameter size, a significant decrease in analyzed clotting factors was observed between baseline and follow-up for all parameters except plasminogen. A significant decrease between baseline and follow-up was observed with enlarged LAA body size in all parameters except TAFI, in which it was insignificant and plasminogen, in which a significant increase was observed. Occlusion of the left atrial appendage is beneficial for systemic coagulation. Patients with a small LAA may benefit more from LAA closure in terms of stabilizing their coagulation factors associated with potential thromboembolic events in the future.

Objective To explore the influence of gender on the prognosis of patients with atrial fibrillation (AF) undergoing left atrial appendage occlusion (LAAO). Methods All non-valvular AF patients who were admitted in our hospital and underwent LAAO from August 2014 to August 2021 were enrolled and grouped according to gender. Their general information, including gender, age, comorbid underlying diseases, and results of transthoracic echocardiography and transesophageal echocardiography (TEE) were collected. The incidences of device-related thrombosis (DRT), pericardial tamponade, stroke, bleeding, hospitalization for heart failure, and cardiac death were recorded during follow-up. The influence of gender on the prognosis of these patients was analyzed. Results There were totally 673 patients with non-valvular AF were enrolled, including 366 males and 307 females, at a mean age of 68.2±9.4 years. When compared with the male patients, the female ones had a higher CHA2DS2-VASc score (P < 0.01), but smaller proportions of history of stroke, average compression ratio of occluders, and incidence of residual shunt (< 3 mm) after occlusion (P < 0.05). In 45~60 d after surgery, TEE revealed that there were 17 cases of DRT, including 8 males (2.2%) and 9 females (2.9%), though without statistical difference between the groups. Among the 17 DRT cases, 1 experienced stroke, and the incidence of stroke was 5.9% in those with DRT and 0.5% without. There were 4 cases of postoperative pericardial tamponade, including 1 in the male group and 3 in the female group (no significant difference), and all of them were improved after pericardial puncture and fluid extraction. During the follow-up period of 40.2±20.5 months, no obvious differences were observed between the 2 groups in terms of stroke, bleeding, hospitalization for heart failure, and cardiogenic death. Conclusion Gender shows no significant effect on the prognosis of patients with non-valvular AF after LAAO.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) has proved to be a safer alternative for long-term anticoagulation; however, patients with a history of intracranial bleeding were excluded from large randomized clinical trials. OBJECTIVE: The purpose of this study was to determine outcomes in atrial fibrillation (AF) patients with a history of intracranial bleeding undergoing percutaneous LAAO. METHODS: National Inpatient Sample and International Classification of Diseases, Tenth Revision, codes were used to identify patients with AF who underwent LAAO during the years 2016-2020. Patients were stratified based on a history of intracranial bleeding vs not. The outcomes assessed in our study included complications, in-hospital mortality, and resource utilization. RESULT: A total of 89,300 LAAO device implantations were studied. Approximately 565 implantations (0.6%) occurred in patients with a history of intracranial bleed. History of intracranial bleeding was associated with a higher prevalence of overall complications and in-patient mortality in crude analysis. In the multivariate model adjusted for potential confounders, intracranial bleeding was found to be independently associated with in-patient mortality (adjusted odds ratio [aOR] 4.27; 95% confidence interval [CI] 1.68-10.82); overall complications (aOR 1.74; 95% CI 1.36-2.24); prolonged length of stay (aOR 2.38; 95% CI 1.95-2.92); and increased cost of hospitalization (aOR 1.28; 95% CI 1.08-1.52) after percutaneous LAAO device implantation. CONCLUSION: A history of intracranial bleeding was associated with adverse outcomes after percutaneous LAAO. These data, if proven in a large randomized study, can have important clinical consequences in terms of patient selection for LAAO devices.

Abstract Transesophageal echocardiography (TEE) has been the preferred imaging modality to help guide left atrial appendage closure. Newer technologies such as the Nuvision 4D Intracardiac echocardiography (ICE) catheter allow for real-time 3D imaging of cardiac anatomy. There are no direct comparison studies for procedural imaging between TEE and 4D ICE. To evaluate the performance and safety of left atrial appendage (LAA) closure procedures with the Watchman FLX and Amulet, guided by the Nuvision 4D ICE Catheter. This retrospective observational analysis was conducted on institutional LAAO National Cardiovascular Data Registry from January 2022 to March 2023. Patients had undergone LAA closure procedures with the Watchman FLX or Amulet device guided by TEE or a 4D ICE Catheter. The primary outcome evaluated was successful LAAO device placement. A total of 121 patients underwent LAAO device placement with 46 (38.0%) patients guided by 4D ICE during LAAO implantation. The 4D ICE group had a shorter procedural time compared with TEE guidance. Post procedural 45-day TEE post implant was also comparable for both groups with no patients in either group having incomplete closure of the left atrial appendage and peri-device leak > 5 mm. No device related complications (device related access, stroke, or pericardial effusion) occurred in either group at follow-up. There was no significant difference in device implant success or post procedural outcomes at 45 days in either the TEE or 4D ICE group. However, there was a noticeable improvement in procedural time with the 4D ICE catheter.

Abstract Background Surgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA2DS2-VASc score and preoperative atrial fibrillation or flutter (AF) status—the current trial attempts to provide such evidence. Methods The study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA2DS2-VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years. Discussion The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases. Trial registration Clinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318 . Protocol version https://doi.org/10.1016/j.ahj.2023.06.003 .

Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT. [Display omitted] [ABSTRACT FROM AUTHOR]

Percutaneous left atrial appendage occlusion (LAAO) has emerged as a non-pharmacologic alternative to oral anticoagulation in reducing stroke risk in AF patients. However, patients with mitral valve disease (MVD), who are expected to have a significantly greater risk of left atrium (LA) thrombus formation and embolic stroke were excluded from randomized trials examining percutaneous LAAO. To address this gap, we present a national registry analysis of the use of LAAO among patients with MVD. Using the National Readmissions Database, we performed a retrospective review of all hospitalizations for LAAO identified between September 2015 and November 2019. Of these, patients with ICD-10 codes for MVD were identified. Propensity matched (PSM) analysis was used to compare patients with MVD with a matched sample of patients undergoing LAAO with non-valvular AF. Outcomes examined included all-cause mortality, stroke, major bleeding, pericardial effusion (PE), and tamponade. 51,540 patients who underwent LAAO without a history of MVD and 3777 with a history of MVD were identified. Crude analysis demonstrated the odds of mortality, PE, and cardiac tamponade during index hospitalization to be higher in the MVD group. The length of stay and cost of index hospitalization were also slightly greater for the MVD group. A sample of 7649 patients (MVD: 3777 MVD and no MVD: 3872) were selected for PSM analysis with similar comorbidities across the two groups. In the PSM comparison, MVD was associated with higher risk of PE. The MVD group had a slightly higher rate of readmissions the association with PE remained at 30-day readmission (OR: 2.099 [1.360–3.238], p -value: <0.001). To our knowledge, this is the first study examining the use of LAAO among MVD patients. Our findings suggest that patients with MVD who underwent LAAO had a higher risk of post-procedural PE without an increase in mortality, stroke, or major bleeding. These results provide a rationale for considering LAAO as part of the stroke prevention strategy among patients with valvular AF. • No prior data for left atrial appendage occlusion (LAAO) in patients with atrial fibrillation (AF) and concomitant mitral valve disease (MVD) exists. • Following LAAO, MVD patients had higher odds of post-procedural PE without an increase in mortality, stroke, or major bleeding as compared with those without MVD. • MVD was also associated with higher odds of readmission at 30 days. • These results provide a rationale for LAAO as part of the stroke prevention strategy among patients with valvular AF. [ABSTRACT FROM AUTHOR]

Background: Amplatzer Amulet is a frequently used device for left atrial appendage occlusion (LAAO). The current sizing protocol is based on the maximum diameter of the left atrial appendage (LAA) landing zone. However, mean, perimeter-, or area-derived diameter might be more accurate measures for device sizing. Methods: Retrospective analysis of 150 consecutive patients undergoing LAAO is guided by pre-procedural cardiac CT. A total of 117 patients were included; 7 were excluded due to renal failure and 26 due to closure with the sandwich technique. The maximum, mean, area-, and perimeter-derived diameters of the landing zone were derived from pre-procedural cardiac CT scans, and their accuracy to predict the implanted device size was investigated. The predicted device size was determined based on the currently recommended sizing algorithm. Peri-device leak (PDL) was assessed (grade 1–3) along with the underlying mechanism. Results: Device-sizing accuracy was superior for mean, area-, and perimeter derived diameters compared with the maximal diameter, especially for eccentric landing zones. Mean difference between predicted and actually implanted device size was 0.08 mm (± 2.77), 0.30 mm (± 2.40), − 0.39 mm (± 2.43), and − 2.55 mm (± 2.57) across mean, area-derived, perimeter-derived, and maximal diameter, respectively. Grade 3 peri-device leak was seen in 8.5% of implants without a significant association to the eccentricity of the landing zone. The leading mechanism for PDL was device malalignment. Conclusion: Our results indicate mean, area-, and perimeter-derived diameters of the device landing zone to perform similar and superior in device-sizing accuracy compared with the maximum diameter. [ABSTRACT FROM AUTHOR]

Background: The goal of this study was to compare the procedural safety and long-term outcome associated with a combined catheter ablation and left atrial appendage occlusion (LAAO) procedure utilizing intracardiac echocardiography (ICE) guidance versus trans-esophageal echocardiography (TEE) guidance. The study focuses on implementing LAmbre and Watchman devices in patients diagnosed with nonvalvular atrial fibrillation (AF). Methods: A total of 363 patients diagnosed with nonvalvular AF and who underwent a combined procedure were prospectively enrolled between November 2017 and May 2022. Following 1:1 propensity score matching, the TEE group (n = 132) and ICE group (n = 132) were systematically compared in terms of the combined procedure, imaging parameters, events related to the procedure, and subsequent outcomes during follow-up, including mortality, stroke, bleeding, device-related thrombus (DRT), and peri-device leaks (PDLs). Results: The ICE group exhibited a significant reduction in total procedural duration (153.71 ± 31.71 vs. 174.74 ± 18.79 min), fluoroscopy radiation dosage (207.24 ± 108.39 vs. 268.61 ± 122.88 mGy), left atrial appendage occlusion procedure time (34.69 ± 10.91 vs. 51.46 ± 15.84 min), and contrast agent exposure (108.71 ± 37.59 vs. 158.41 ± 45.00 mL) compared to the TEE group. Angiography and ICE demonstrated a substantial correlation between the left atrial appendage (LAA) orifice and landing zone/LAA ostium (Pearson's correlation coefficient r = 0.808 and 0.536/0.697, two-tailed p < 0.001). No occurrences of device-related embolism, thromboembolism, significant bleeding, or unexpected fatalities were observed in either group. Comparable rates of all-cause death (0.76% vs. 0.76%), stroke or transient ischemic attack (2.27% vs. 1.52%), severe bleeding (1.52% vs. 0.76%), PDL (23.81% vs. 24.62%), and DRT (1.52% vs. 1.52%) were noted after an average follow-up of 18.46 ± 7.70 months in both groups, with no discernible differences. Multivariate logistic regression analysis identified a correlation between LAA velocity and the risk of PDL. Conclusions: The effectiveness and safety of ICE-guided combined treatment were demonstrated to be comparable to TEE guidance, accompanied by the additional advantages of decreased procedure time and fluoroscopy radiation exposure. Clinical Trial Registration: NCT04391504, https://register.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Transesophageal echocardiography (TEE) has been the preferred imaging modality to help guide left atrial appendage closure. Newer technologies such as the Nuvision 4D Intracardiac echocardiography (ICE) catheter allow for real-time 3D imaging of cardiac anatomy. There are no direct comparison studies for procedural imaging between TEE and 4D ICE. To evaluate the performance and safety of left atrial appendage (LAA) closure procedures with the Watchman FLX and Amulet, guided by the Nuvision 4D ICE Catheter. This retrospective observational analysis was conducted on institutional LAAO National Cardiovascular Data Registry from January 2022 to March 2023. Patients had undergone LAA closure procedures with the Watchman FLX or Amulet device guided by TEE or a 4D ICE Catheter. The primary outcome evaluated was successful LAAO device placement. A total of 121 patients underwent LAAO device placement with 46 (38.0%) patients guided by 4D ICE during LAAO implantation. The 4D ICE group had a shorter procedural time compared with TEE guidance. Post procedural 45-day TEE post implant was also comparable for both groups with no patients in either group having incomplete closure of the left atrial appendage and peri-device leak > 5 mm. No device related complications (device related access, stroke, or pericardial effusion) occurred in either group at follow-up. There was no significant difference in device implant success or post procedural outcomes at 45 days in either the TEE or 4D ICE group. However, there was a noticeable improvement in procedural time with the 4D ICE catheter. [ABSTRACT FROM AUTHOR]

Background: Frailty is associated with significant morbidity and mortality and may have clinical implications in an advanced age population with atrial fibrillation undergoing left atrial appendage occlusion (LAAO). We sought to develop a novel frailty scale to predict worse outcomes in patients undergoing LAAO. Methods: Patients in the NCDR LAAO Registry between 2016 and 2021 receiving percutaneous LAAO devices were categorized as non-frail (0 points), pre-frail (1–3 points), or frail (4–5 points) based on a 5-point scale representing multiple domains of frailty: hemoglobin <13.0 g/dL in male, <12.0 g/dL in female; creatinine ≥1.2 mg/dL; albumin <3.5 g/dL; body mass index <20 kg/m2; and increased risk of falls. Results: Of 57,728 patients, 44,360 (76.8%) were pre-frail and 7693 (13.3%) were frail. Compared to non-frail, pre-frail and frail patients were older, had a higher burden of co-morbidities, and more disability based on the Modified Rankin Scale. Compared to non-frail patients after adjustment, frail patients were at higher risk of in-hospital major complication (OR 1.29, 95% 1.02–1.62, p = 0.01), any complication (OR 1.29, 95% CI 1.09–1.52, p = 0.0005), and death (OR 5.79, 95% CI 1.75–19.17, p = 0.001), while no difference was observed in pre-frail patients. At 45-day follow-up, there was no difference in the risk of complications in frail patients as compared to non-frail, although mortality was significantly higher (OR 3.01, 95% CI 1.97–4.85, p < 0.0001). Conclusion: A simple and practical frailty scale accurately predicts adverse events in patients undergoing LAAO. The 13% of patients considered frail were at significantly higher risk of in-hospital adverse events and 45-day mortality. [ABSTRACT FROM AUTHOR]

Background Device-related thrombosis (DRT) is a known complication to left atrial appendage closure (LAAC). The surface of a LAAC device should ideally have antithrombotic properties. The novel WATCHMAN FLX Pro (WFP) incorporates a fluoropolymer-coated fabric membrane designed to increase thromboresistance and facilitate endothelialization. Such features could potentially allow for a minimal post-procedural antithrombotic regimen. Radiopaque platinum markers at the device shoulders and a large 40 mm device are other novel features of the WFP. Case summary A 75-year-old man with atrial fibrillation was referred for LAAC due to prior subdural haemorrhage during direct-acting anticoagulation treatment. He underwent the first-in-human WFP implantation as part of the WATCHMAN FLX Pro CT study (NCT05567172). Computed tomography (CT) was used for pre-planning, and the procedure was performed under local analgesia guided by intracardiac echocardiography from the left atrium (LA) without any complications. Post-procedural antithrombotic treatment consisted of acetylsalicylic acid 75 mg/day only, and 45-day CT, transoesophageal echocardiography (TEE), and magnetic resonance imaging demonstrated optimal device position with complete LAAC. Hypoattenuated thickening (6 mm) appeared on the device as a smooth surface in continuity with the left atrial wall on CT and TEE. A specific magnetic resonance T1-weighted scan, used for visualization of fresh thrombus, suggested this to represent tissue ingrowth rather than thrombus. Discussion The advanced follow-up imaging protocol suggested a good WFP implantation result with signs of tissue ingrowth at 45 days. The added radiopaque markers facilitated optimal deployment, evaluation of device stability during tug test, and assessment of device protrusion into the LA. [ABSTRACT FROM AUTHOR]

A significant proportion of patients who suffer from atrial fibrillation (AF) and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts, or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years, left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with AF. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular. [ABSTRACT FROM AUTHOR]

AimsTo determine outcomes in atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion (LAAO) based on the underlying stroke risk (defined by the CHA2DS2-VASc score).Methods and resultsData were extracted from the National Inpatient Sample for calendar years 2016-20. Left atrial appendage occlusion implantations were identified on the basis of the International Classification of Diseases, 10th Revision, Clinical Modification code of 02L73DK. The study sample was stratified on the basis of the CHA2DS2-VASc score into three groups (scores of 3, 4, and ≥5). The outcomes assessed in our study included complications and resource utilization. A total of 73 795 LAAO device implantations were studied. Approximately 63% of LAAO device implantations occurred in patients with CHA2DS2-VASc scores of 4 and ≥5. The crude prevalence of pericardial effusion requiring intervention was higher with increased CHA2DS2-VASc score (1.4% in patients with a score of ≥5 vs. 1.1% in patients with a score of 4 vs. 0.8% in patients with a score of 3, P < 0.01). In the multivariable model adjusted for potential confounders, CHA2DS2-VASc scores of 4 and ≥5 were found to be independently associated with overall complications [adjusted odds ratio (aOR) 1.26, 95% confidence interval (CI) 1.18-1.35, and aOR 1.88, 95% CI 1.73-2.04, respectively] and prolonged length of stay (aOR 1.18, 95% CI 1.11-1.25, and aOR 1.54, 95% CI 1.44-1.66, respectively).ConclusionA higher CHA2DS2-VASc score was associated with an increased risk of peri-procedural complications and resource utilization after LAAO. These findings highlight the importance of patient selection for the LAAO procedure and need validation in future studies.

IntroductionRecent studies have shown gender differences in cardiovascular outcomes after left atrial appendage closure (LAAC), highlighting different complication rates and adverse events, particularly in short-term assessments. As a result, there remains a significant knowledge gap on how these differences directly impact the efficacy and safety of LAAC procedures. The aim of this retrospective study was to investigate the clinical outcomes of LAAC in women and men using the Watchman FLX device.MethodsThis retrospective, multicenter study analyzes gender-specific outcomes in 650 patients who underwent LAAC with the Watchman FLX device between March 2019 and May 2022, drawn from the ITALIAN-FLX registry.ResultsThe results show comparable rates of all-cause mortality, stroke, transient ischemic attack and major bleeding in men and women 12 months after the procedure. Notably, no significant gender differences were found for periprocedural complications.ConclusionIn conclusion, this study shows that LAAC with the Watchman FLX device has comparable clinical outcomes between genders at both short-term and long-term follow-up.

AimsThe safety and feasibility of combining percutaneous catheter ablation (CA) for atrial fibrillation with left atrial appendage occlusion (LAAO) as a single procedure in the USA have not been investigated. We analyzed the US National Readmission Database (NRD) to investigate the incidence of combined LAAO + CA and compare major adverse cardiovascular events (MACEs) with matched LAAO-only and CA-only patients.Methods and resultsIn this retrospective study from NRD data, we identified patients undergoing combined LAAO and CA procedures on the same day in the USA from 2016 to 2019. A 1:1 propensity score match was performed to identify patients undergoing LAAO-only and CA-only procedures. The number of LAAO + CA procedures increased from 28 (2016) to 119 (2019). LAAO + CA patients (n = 375, mean age 74 ± 9.2 years, 53.4% were males) had non-significant higher MACE (8.1%) when compared with LAAO-only (n = 407, 5.3%) or CA-only patients (n = 406, 7.4%), which was primarily driven by higher rate of pericardial effusion (4.3%). All-cause 30-day readmission rates among LAAO + CA patients (10.7%) were similar when compared with LAAO-only (12.7%) or CA-only (17.5%) patients. The most frequent primary reason for readmissions among LAAO + CA and LAAO-only cohorts was heart failure (24.6 and 31.5%, respectively), while among the CA-only cohort, it was paroxysmal atrial fibrillation (25.7%).ConclusionWe report an 63% annual growth (from 28 procedures) in combined LAAO and CA procedures in the USA. There were no significant difference in MACE and all-cause 30-day readmission rates among LAAO + CA patients compared with matched LAAO-only or CA-only patients.

BACKGROUND: Prevention of stroke by anticoagulation is essential in patients with Atrial fibrillation (AF); with direct oral anticoagulants (DOACs) being preferred over warfarin in most patients. The Long-term efficacy and safety of DOACs vs. Left Atrial Appendage Occlusion (LAAO) remain unknown. METHODS: Electronic databases (PubMed, Embase, Scopus) were searched from inception to February 10th, 2021. The primary endpoint was cardiovascular mortality. Secondary outcomes included incidence of ischemic stroke/transient ischemic attack (TIA) and systemicembolism. The safety endpoint was clinically relevant bleeding (a composite of major or minor clinically relevant bleeding). RESULTS: A total of three studies with 3039 participants (LAAO = 1465; DOACs = 1574) were included. Mean age was 74.2 and 75.3 years in the LAAO and DOAC group respectively. Average follow-up period was 2 years. There was no difference in terms of cardiac mortality (RR 0.90, 95% CI 0.40-2.03; p = 0.81), ischemic stroke/TIA (RR 1.15, 95% CI 0.80-1.65; p = 0.46; I 2 = 0) and clinically significant bleeding (RR 0.77, 95% CI 0.50-1.17; p = 0.22; I 2 = 69) between the groups. CONCLUSIONS: Among patients with AF, LAAO was comparable to DOACs with similar efficacy and safety profiles.

Objective: In patients with atrial fibrillation (AF) and end-stage renal disease (ESRD), oral anticoagulants are contraindicated, and left atrial appendage occlusion (LAAO) is an alternative treatment. However, the efficacy of thromboembolic prevention using LAAO in these patients has rarely been reported in Asian populations. To our knowledge, this is the first long-term LAAO study in patients with AF undergoing dialysis in Asia. Methods: In this study, 310 patients (179 men) with a mean age of 71.3 ± 9.6 years and mean CHA2DS2-VASc 4.2 ± 1.8 were consecutively enrolled at multiple centers in Taiwan. The outcomes of 29 patients with AF and ESRD undergoing dialysis who underwent LAAO were compared to those without ESRD. The primary composite outcomes were stroke, systemic embolization, or death. Results: No difference in mean CHADS-VASc score was noted between patients with versus without ESRD (4.1 ± 1.8 vs. 4.6 ± 1.9, p = 0.453). After a mean follow-up of 38 ± 16 months, the composite endpoint was significantly higher in patients with ESRD (hazard ratio, 5.12 [1.4–18.6]; p = 0.013) than in those without ESRD after LAAO therapy. Mortality was also higher in patients with ESRD (hazard ratio, 6.6 [1.1–39.7]; p = 0.038). The stroke rate was numerically higher in patients with versus without ESRD, but the difference was not statistically significant (hazard ratio, 3.2 [0.6–17.7]; p = 0.183). Additionally, ESRD was associated with device-related thrombosis (odds ratio, 6.15; p = 0.047). Conclusion: Long-term outcomes of LAAO therapy may be less favorable in patients with AF undergoing dialysis, possibly because of the poor condition of patients with ESRD.

BackgroundAge-stratified analyses of atrial fibrillation (AF) patients undergoing percutaneous left atrial appendage occlusion (LAAO) are limited. The purpose of current study was to compare in-hospital outcomes in elderly AF patients (age > 80 years) to a relatively younger cohort (age £ 80 years) after LAAO.MethodsData were extracted from National Inpatient Sample for calendar years 2015-2018. LAAO device implantations were identified on the basis of International Classification of Diseases, 9th and 10th Revision, Clinical Modification codes of 37.90 and 02L73DK. The outcomes assessed in our study included complications, inpatient mortality, and resource utilization with LAAO.ResultsA total of 36,065 LAAO recipients were included in the final analysis, of which 34.6% (n=12,475) were performed on elderly AF patients. Elderly AF patients had a higher prevalence of major complications (6.7% vs. 5.7%, p < 0.01) and mortality (0.4% vs. 0.1%, p < 0.01) after LAAO device implantation in the crude analysis. After multivariate adjustment of potential confounders, age > 80 years was associated with increased risk of inpatient mortality (adjusted odds ratio [aOR] 4.439, 95% confidence interval [CI] 2.391-8.239) but not major complications (aOR 1.084, 95% CI 0.971-1.211), prolonged length of stay (aOR 0.943, 95% CI 0.88-1.101), or increased hospitalization costs (aOR 0.909, 95% CI 0.865-0.955).ConclusionOver 1 in 3 LAAO device implantations occurred in elderly AF patients. After adjusting for potential confounding variables, advanced age was associated with inpatient mortality, but not with other LAAO procedural-related outcomes including major complications, prolonged length of stay, or increased hospitalization costs.

Background and aim: Rivaroxaban is an emerging oral anticoagulant for postoperative anticoagulation after percutaneous left atrial appendage closure (LAAC). Because a once-daily dosing regimen of rivaroxaban causes fluctuations in the drug plasma concentration, we studied the feasibility and safety of twicedaily rivaroxaban as a postoperative anticoagulation regimen for patients with atrial fibrillation (AF) undergoing LAAC. Methods: This study involved patients with AF who underwent LAAC and took rivaroxaban postoperatively. A total of 326 patients who received a standard total dose (15 or 20 mg) of rivaroxaban based on their creatinine clearance rate were divided into the twice-daily (BID) rivaroxaban group (n = 208) and once-daily (QD) rivaroxaban group (n = 118) according to their anticoagulation strategy. Transesophageal echocardiography was recommended at 3-6 months postoperatively to check for device-related thrombosis (DRT). Clinical outcomes were evaluated during postoperative anticoagulation. Results: The median CHA2DS2-VASc score (4 [3, 5] vs. 4 [3, 5], p = 0.28) and HASBLED score (2 [2, 3] vs. 2 [2, 3], p = 0.48) were not significantly different between the groups. During the anticoagulation period (4.1 ± 0.7 vs. 4.1 ± 0.9 months, p = 0.58), 148 (71.2%) patients in the BID group and 75 (63.6%) in the QD group underwent follow-up transesophageal echocardiography. There were no statistically significant differences between the two groups in terms of DRT (1.4% vs. 2.7%, p = 0.60), minor bleeding (8.2% vs. 11.0%, p = 0.39), thromboembolic events (1.0% vs. 0.8%, p = 1.00), major bleeding (0.5% vs. 0.8%, p = 1.00), or death. Conclusion: A short course of twice-daily rivaroxaban following LAAC is a feasible alternative regimen with a low rate of major bleeding events, DRT, and thromboembolic events for patients with AF. [ABSTRACT FROM AUTHOR]

Introduction: This study was performed to explore the diagnostic value of cardiac computed tomography angiography (CCTA) for endothelial insufficiency (EIS) of a left atrial appendage (LAA) disc‐like occluder. Methods: Fifty‐nine patients with nonvalvular atrial fibrillation who underwent placement of an LAA disc‐like occluder (LAmbre; Lifetech Scientific) in our hospital were retrospectively analyzed. Patients who were found to have contrast agent entering the LAA at the 3‐month postoperative CCTA examination underwent Hounsfield unit (HU) measurement of the LAA and construction of a three‐dimensional (3D) model of the device for preliminary discernment between peri‐device leakage (PDL) and EIS. These patients were then further examined by transesophageal echocardiography (TEE) to check for concordance with the computed tomography (CT) findings. According to the CT and TEE results, all patients were divided into the PDL group, total endothelialization group, and EIS group. The endothelial conditions and other implantation‐related results were also tracked at the 6‐month follow‐up. Results: All 59 patients underwent successful implantation of the LAmbre LAA closure device with no severe adverse events during the procedure. Thirty‐five patients were found to have contrast agent entering the LAA at the 3‐month postoperative CCTA follow‐up. Based on the CT HU measurement and the 3D construction analysis results, these 35 patients were divided into the PDL group (19 patients) and the EIS group (16 patients). In the PDL group, the contrast agent infiltrated from the shoulder along the periphery of the occluder on two‐dimensional (2D) CT images, and the 3D model showed a gap between the LAA and the device cover. However, the CCTA images of the other 16 patients in the EIS group showed that the contrast agent in the occluder on the 2D CTA images and 3D construction model confirmed the absence of a gap between the LAA and the device cover. TEE confirmed all of the CT results. The 6‐month follow‐up results showed that 14 of 19 patients in the EIS group achieved total endothelialization, whereas this number in the PDL group was only five of 19 patients. Conclusion: CCTA can replace TEE for examination of the endothelialization status, and patients with EIS have a higher chance of endothelialization than patients with PDL. [ABSTRACT FROM AUTHOR]

Open in new tab Download slide OBJECTIVES The aim of this study was to evaluate in-hospital outcomes and long-term survival of patients undergoing cardiac surgery with preoperative atrial fibrillation (AF). We compared different strategies, including no-AF treatment, left atrial appendage occlusion (LAAO) alone, concomitant surgical ablation (SA) alone or both. METHODS A retrospective analysis using the KROK registry included all patients with preoperative diagnosis of AF who underwent cardiac surgery in Poland between between January 2012 and December 2022. Risk adjustment was performed using regression analysis with inverse probability weighting of propensity scores. We assessed 6-year survival with Cox proportional hazards models. Sensitivity analysis was performed based on index cardiac procedure. RESULTS Initially, 42 510 patients with preoperative AF were identified, and, after exclusion, 33 949 included in the final analysis. A total of 1107 (3.26%) received both SA and LAAO, 1484 (4.37%) received LAAO alone, 3921 (11.55%) SA alone and the remaining 27 437 (80.82%) had no AF-directed treatment. As compared to no treatment, all strategies were associated with survival benefit over 6-year follow-up. A gradient of treatment was observed with the highest benefit associated with SA + LAAO followed by SA alone and LAAO alone (log-rank P  < 0.001). Mortality benefits were reflected when stratified by surgery type with the exception of aortic valve surgery where LAAO alone fare worse than no treatment. CONCLUSIONS Among patients with preoperative AF undergoing cardiac surgery, surgical management of AF, particularly SA + LAAO, was associated with lower 6-year mortality. These findings support the benefits of incorporating SA and LAAO in the management of AF during cardiac surgery. [ABSTRACT FROM AUTHOR]

Objective: The present study evaluated the differences between left atrial appendage occlusion (LAAO) and left atrial appendage resection (LAAR) in terms of the safety and efficacy. Materials and methods: From January 2018 to August 2022, 94 patients underwent a stand-alone LAAO, and 90 patients underwent stand-alone LAAR in our institution. All of these patients were included in this study. LAAO was performed via left mini-thoracotomy, and LAAR was performed via a left thoracoscopic approach. The patients' characteristics and perioperative and postoperative data were obtained by retrospectively reviewing their medical records. Results: The mean age of the patients was 72.4 ± 10.2 (LAAO) and 66.2 ± 9.4 (LAAR) years old (P < 0.05). There were no marked differences in the mean duration of atrial fibrillation (AF) or the ratio of AF type between both groups. The average CHA2DS2-Vasc scores were 4.4 ± 1.6 (LAAO) and 2.7 ± 1.8 (LAAR) (P < 0.05), and the average HAS-BLED scores were 2.9 ± 1.0 (LAAO) and 2.2 ± 1.2 (LAAR) (P < 0.05). The mean operation time was 49 ± 20 min (LAAO) and 34 ± 15 min (LAAR) (P < 0.05). No substantial gaps were detected in preoperative echo-graphic findings between the groups. No significant differences were observed in the amount of intraoperative or postoperative bleeding or the rate of intraoperative massive bleeding events between the groups. Successful LAA closure was achieved in all cases in both groups. Approximately 50% of patients underwent concomitant left pulmonary vein isolation (LPVI) during surgery, indicating no significant differences between the groups (P = 0.872). The early mortality rate was 1.04% in the LAAO group and 0% in the LAAR group (P = 0.132). There was no significant difference in the rate of postoperative LAA stump thrombus between the groups (8.5% in the LAAO group and 6.7% in the LAAR group; P = 0.320). The mean follow-up period was 851 ± 500 (6–1618) days in the LAAO group and 1208 ± 357 (49–1694) days in the LAAR group. Postoperative stroke events were detected in 1 patient in each group (P = 0.432). There was no significant difference in the sinus rhythm recovery rate after LPVI between these groups (31.1% in the LAAO group and 28.6% in the LAAR group; P = 0.763). Conclusion: There were no significant differences between LAAO and LAAR in terms of the feasibility and the effectiveness as a method for stroke prophylaxis only to selected patients for both procedures, although further studies including the comparison between groups with the same backgrounds to confirm the authentic differences in the clinical results between these procedures. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Left atrial appendage occlusion (LAAO) is an established alternative to oral anticoagulation for stroke prevention in atrial fibrillation. Antithrombotic therapy is used in the post-procedural period to prevent device-related thrombosis (DRT). The risk of DRT is considered highest in the first 45–90 days after device implantation, based on animal studies of the device healing process. Clinically applied antithrombotic regimens vary greatly across studies, continents, and centers. This article gives an overview of the evidence behind current antithrombotic regimens, ongoing randomized trials, and future post-procedural management. [ABSTRACT FROM AUTHOR]

Background The absence of the left atrial appendage is an exceedingly rare structural variant that could have important implications for anticoagulation regimens in patients with atrial fibrillation. Case summary We report the case of a 63-year-old Puerto Rican female with a history of hypertension, cerebral artery aneurysms, and type 2 diabetes mellitus who suffered multiple haemorrhagic strokes. The patient had never received anticoagulation therapy. During the indicated stroke work-up, the patient was found to have paroxysmal atrial fibrillation. Given the patients high risk for thromboembolism and contraindications to anticoagulation therapy, the patient was referred for left atrial appendage occlusion. Pre-procedural transoesophageal echocardiography failed to identify the left atrial appendage. Evaluation by way of cardiac computed tomography confirmed absence of the left atrial appendage. Left atrial appendage occlusion could not be carried out. The patient had been deemed being at high risk of bleeding, was not anticoagulated, and was instead closely followed. The patient has not had thrombo-embolic events nor has she experienced a haemorrhagic stroke recurrence at follow-up appointments. Discussion To our knowledge, this is the first such case report that reports left atrial appendage absence in the setting of multiple haemorrhagic strokes. Given the rarity of the condition and lack of available guidelines, the most viable way to currently manage this patient population is on a case-to-case basis. However, we propose that absence of the left atrial appendage could confer a decreased risk of thrombo-embolic phenomena in patients with atrial fibrillation. [ABSTRACT FROM AUTHOR]