Left Atrial Appendage Occlusion In Patients Research Articles

Left atrial appendage occlusion in patients with non-valvular atrial fibrillation and cerebral amyloid angiopathy: insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) international multicenter registry.

Oral anticoagulation therapy (OAC) is often contraindicated in patients with atrial fibrillation (AF) and cerebral amyloid angiopathy (CAA) because of the high hemorrhagic risk. Left atrial appendage occlusion (LAAO) can prevent thromboembolic events while avoiding long-term anticoagulation. However, a short period of antithrombotic therapy (AT) is still recommended after LAAO, and, therefore, it is unclear whether patients with CAA can be candidates for LAAO. The aim of the study was to investigate the safety and efficacy of LAAO in patients with CAA and AF. In this sub-study of the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) registry, the authors considered only patients with previous intracranial (IC) bleeding, and patients with CAA were compared with patients who did not have CAA. Outcomes of interest were death from any causes and cardiovascular death, ischemic stroke, transient ischemic attack and systemic embolization, and any bleeding and major bleeding at 12 months. The analysis included 270 patients, 49 (18%) of whom had CAA. Patients with CAA were more frequently discharged without AT after LAAO compared with patients who did not have CAA (36.7% vs 6.8%, P less than .001), and this was confirmed at the 1-year follow-up (30.4% vs 14.1%, P = .001). There were no significant differences in all-cause or cardiovascular mortality, or ischemic or hemorrhagic endpoints at 1 and 12 months. LAAO seems to be safe and effective in reducing both ischemic and hemorrhagic risk in patients with AF and CAA. Although patients with CAA are more likely to be discharged without AT after LAAO, there are no significant differences in ischemic and hemorrhagic outcomes compared with patients with a history of IC bleeding from other causes.

Abstract 4137278: Efficacy and Safety of Left Atrial Appendage Closure Devices in Patients Aged Above 80 Years: A Systematic Review and Meta-Analysis

Background: Limited single-center and observational studies suggest that left atrial appendage occlusion (LAAO) may be a safe alternative in selected elderly patients with AFib. Hypothesis: We hypothesize that patients aged over 80 will have similar rates of complications and the same level of efficacy in stroke prevention as young patients. Aims: This review aims to establish the safety and efficacy of LAAO in octogenarians and nonagenarian patients with AFib. Methods: A systematic search of PubMed, Science Direct, and CENTRAL was performed for studies that reported outcomes comparing octogenarian and nonagenarian patients who underwent LAAo with their younger counterparts. The Review Manager 5.4 software was utilized to conduct a meta-analysis of the outcomes. Results: Seven observational studies consisting of 6,126 patients were included, of whom 1,879 (31%) were ≥80 years old and 4247 (69%) <80 years old. The mean age of the octogenarian and older cohort ranged from 82.3 to 84.5 years, while that of the younger cohort ranged from 68.2 to 75.9 years. The mean follow-up across the studies ranged from one month to five years post-LAAO. Our pooled analysis showed no significant difference in the odds of mortality (OR 1.30; 95% CI [0.49, 3.47]; p = 0.60), all causes of stroke (OR 1.22; 95% CI [0.61, 2.43]; p= 0.57), vascular complications (OR 1.70; 95% CI [0.61,4.73]; p=0.31), and pericardial complications (OR 1.45; 95% CI [0.69, 3.05]; p = 0.33) but a significant difference in the odds of major bleeding events (OR 1.88; 95% CI [1.51, 2.34]; p<0.00001)occurred in patients aged >80 compared to their younger counterparts. Conclusion: This meta-analysis suggests that LAAO in patients aged 80 years and above demonstrates comparable mortality rates, post-procedural complications, and efficacy to those seen in younger patients. The findings support the safety and effectiveness of LAAO as a viable alternative for stroke prevention in very elderly patients, with additional consideration needed for those with increased susceptibility to bleeding events.

Combined left atrial appendage occlusion and catheter ablation for atrial fibrillation versus isolated left atrial appendage occlusion: A systematic review and meta-analysis.

Data on the effects of combined left atrial appendage occlusion (LAAO) and catheter ablation (CA) for atrial fibrillation (AF) remain limited. We aimed to perform a systematic review and meta-analysis comparing LAAO and CA versus isolated LAAO. We systematically searched PubMed, Embase, and Cochrane Library for studies comparing combined LAAO and CA versus isolated LAAO in patients with atrial fibrillation. Statistical analyses were performed using R software version 4.3.1. We pooled odds ratios (OR) with 95% confidence intervals (CI) for binary outcomes. We included eight studies comprising 51,802 patients, of whom 1375 (2.6%) underwent combined LAAO and CA. There were no significant differences between combined LAAO and CA versus isolated LAAO in terms of major bleeding (OR 0.55; 95% CI 0.09, 3.41; p=0.52; I2=0%), major adverse cardiovascular events (OR 0.88; 95% CI 0.40, 1.93; p=0.74; I2=0%), stroke (OR 1.03; 95% CI 0.35, 3.00; p=0.96; I2=0%), thromboembolism (OR 0.60; 95% CI 0.18, 1.98; p=0.40; I2=0%), minor bleeding (OR 1.32; 95% CI 0.63, 2.80; p=0.46; I2=0%), or pericardial effusion (OR 1.18; 95% CI 0.60, 2.33; p=0.63; I2=24%). In this meta-analysis of observational studies, combined LAAO and CA for AF was similar to isolated LAAO in terms of efficacy and safety. Further large randomized controlled trials are needed to explore the long-term effects of combining these procedures.

Concomitant left atrial appendage occlusion and transcatheter aortic valve replacement among patients with atrial fibrillation: an updated systematic review and meta-analysis

Abstract Background Atrial fibrillation (AF) is a prevalent arrhythmia in patients undergoing transcatheter aortic valve replacement (TAVR). Left atrial appendage occlusion (LAAO) has emerged as a viable strategy to prevent stroke in selected patients with AF. While both devices can be implanted simultaneously during a single procedure, the safety and efficacy of this approach remain uncertain. Purpose This study aims to evaluate the efficacy and safety of concomitant LAAO in patients with AF and aortic valve disease undergoing TAVR. Methods We conducted a systematic review and meta-analysis of randomized controlled trials and observational studies that compared concomitant TAVR and LAAO with isolated TAVR. The study's primary outcomes were all-cause mortality, stroke or transient ischemic attack (TIA), and major bleeding. We established a minimum follow-up time of six months. Results Three studies met our eligibility criteria, including one randomized controlled trial and two observational studies. The meta-analysis included 570 patients, 249 (44%) who underwent LAAO and TAVR, with a mean follow-up of 16.3 months. In the overall population, there was no significant difference between the groups in all-cause mortality (relative risk [RR] 0.95; 95% confidence interval [CI] 0.67-1.35; p = 0.78; figure 1A), major bleeding (RR 1.15; 95% CI 0.75-1.77; p = 0.51; 1B), and stroke or TIA (RR 0.70; 95% CI 0.33-1.45; p = 0.33; figure 1C). Conclusion In conclusion, concomitant LAAO and TAVR did not demonstrate discernible clinical differences compared to isolated TAVR in patients with AF and aortic valve disease. We recommend that this therapeutic approach be individualized until more robust data become available.

Stroke Prevention With Prophylactic Left Atrial Appendage Occlusion in Cardiac Surgery Patients Without Atrial Fibrillation: A Meta-Analysis of Randomized and Propensity-Score Studies.

The role of left atrial appendage occlusion (LAAO) in patients without previous atrial fibrillation (AF) is not established. This meta-analysis was conducted on patients with normal sinus rhythm who underwent cardiac surgery, with and without concomitant LAAO, to evaluate its effect on the incidence of cerebrovascular accidents (CVAs). A systematic review was conducted from inception until December 2023 for randomized and propensity-score studies comparing CVA in patients without AF undergoing cardiac surgery with or without LAAO. Six studies met our inclusion criteria with a total of 4130 patients: 2146 in the LAAO group and 1984 in the no-LAAO group. The risk ratio of postoperative AF was 1.05 (95% CI, 0.86-1.28); P=0.628. The CVA rates at 5 years were 6.8±1.0% in the no-LAAO group and 4.3±0.8% in the LAAO group (log-rank P=0.021). The Cox regression analysis for CVA in patients undergoing LAAO reported a hazard ratio of 0.65 (95% CI, 0.45-0.94); P=0.022. Landmark analysis at 4 years highlighted a significant difference in overall survival between no-LAAO and LAAO groups, 86±12.2% versus 89.6±11.0%; P=0.041. In this meta-analysis of patients without previous AF undergoing cardiac surgery, LAAO was associated with a decreased risk of CVA, no difference in the incidence of postoperative atrial fibrillation, and a significant overall survival benefit at a 4-year landmark analysis. Although these findings support LAAO, the randomized LeAAPS trial (Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial), LAA-CLOSURE trial (A Randomized Prospective Multicenter Trial for Stroke Prevention by Prophylactic Surgical Closure of the Left Atrial Appendage in Patients Undergoing Bioprosthetic Aortic Valve Surgery), and LAACS-2 trial (Left Atrial Appendage Closure by Surgery-2) will help define the effectiveness of LAAO in patients undergoing cardiac surgery who have risk factors for AF and CVA. URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42024496366.

Thoracoscopic Left Atrial Appendage Occlusion with the AtriClip PRO2: An Experience of 144 Patients

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.

Left atrial appendage occlusion in patients suffering from advanced chronic kidney disease (stage 4 and 5). Long-term follow-up.

Advanced chronic kidney disease (A-CKD) combined with atrial fibrillation increases the risk of both thrombogenic and bleeding events. Left atrial appendage occlusion (LAAO) may be an alternative to oral anticoagulation to prevent thromboembolic events. We aimed to evaluate the outcomes of LAAO in patients with A-CKD. Comparison at long-term follow-up of patients diagnosed with and without A-CKD (eGFR<30 mL/min/1.73 m2 ) who underwent LAAO between 2009 and May 2022. Five hundred seventy-three patients were included. Eighty-one (14%) were diagnosed with A-CKD. There were no differences in sex, age, and cardiovascular risk factors, except for diabetes which was more frequent in patients with A-CKD. The control group had higher rates of stroke, both ischemic and hemorrhagic. There were no differences in the CHA2 DS2 -VASc score, although A-CKD patients had a higher bleeding risk according to the HASBLED scale. Global procedural success was 99.1%. At follow-up, there were no differences in stroke rate: at 1-year (HR: 1.22, IC-95%: 0.14-10.42, p = 0.861); at 5-years (HR: 0.60, IC-95%: 0.08-4.58, p = 0.594). Although bleeding events were higher in the A-CKD group, no differences were found in major bleeding (defined BARC ≥ 3) at 1-year (HR: 1.34, IC-95%: 0.63-2.88, p = 0.464) or at 5-years follow-up (HR: 1.30, IC-95%: 0.69-2.48, p = 0.434). Mortality rate at 5 years was higher in the A-CKD patients (HR: 1.84, IC-95%: 1.18-2.87, p = 0.012). LAAO is an effective and safe treatment in A-CKD patients to prevent ischemic events and bleeding. This strategy could be an alternative to oral anticoagulation in this high-risk group of patients.

Left appendage closure after intracranial hemorrhage: safety, efficacy and timing

Abstract Background Oral anticoagulation (OAC) use increases the risk of intracranial hemorrhage (ICH) in patients with atrial fibrillation (AF). Left atrial appendage occlusion (LAAO) is an alternative to OAC, however data about its use in patients with prior ICH is scare and the timing of its performance is controversial. Furthermore, the long-term outcomes in this group of patients have not been described. Objective To evaluate the safety and efficacy of LAAO in patients with non-valvular AF and prior ICH (CHA2SVASc &amp;gt;2) and to determine adequate timing of its performance. Methods The sample was obtained from a cohort of 397 patients with AF in which LAAO was performed between 2009 and 2020. In 115 of these patients, the indication for this procedure was ICH (29.8 %). Patients were divided into two groups: early occlusion (n=68; 59%), in which the procedure was performed before 90 days had elapsed after the bleeding, and late occlusion (n=47; 41%), after 90 days. Results Procedure success was 97% globally. Annual incidence of ischemic events was of 0,6%, with an absolute risk reduction of 5,9% and relative risk reduction of 90,3% compared to the predicted risk by CHA2DS2-VASC score. Regarding major hemorrhagic events, annual incidence was of 4%, with an absolute risk reduction of 3,4% and relative risk reduction of 45% compared to the predicted risk by HASBLED score. There were no significant differences between the procedures performed in patients with history of intracranial bleeding and other indications for the procedure. Early closure (first 90 days after the intracranial hemorrhage) was as safe as late closure, without an increase in in-hospital bleedings or complications. Furthermore, long-term follow-up demonstrated a significant reduction in all-cause mortality (11.76% versus 46.8%; HR 0.2, IC95% 0.07-0.55; p&amp;lt;0.001). compared with late occlusion. Conclusions Left atrial appendage occlusion is an effective and safe treatment option to reduce the risk of ischemic stroke in selected patients with AF patients and history of ICH over mean follow-up of 3 years. Early occlusion seems to be at least as safe and effective as late occlusion and therefore could potentially reduce the rate of complications after ICH in selected patients.Survival and closure timingIschemic and bleeding risk reduction

Abstract 12836: Safety and Efficacy of Left Atrial Appendage Occlusion in Patients With Chronic Kidney Disease: A Meta-Analysis

Introduction: Left atrial appendage occlusion (LAAO) has been recognized as an alternative to preventing thromboembolic stroke in selected patients with non-valvular atrial fibrillation (AF). However, limited evidence exists regarding the safety of LAAO in patients with chronic kidney disease (CKD). This meta-analysis aims to evaluate the safety and efficacy of LAAO in CKD patients. Methods: We conducted a comprehensive search across various electronic databases, including PubMed, Embase, and the Cochrane Library, to identify relevant studies comparing the outcomes of CKD and non-CKD patients undergoing LAAO. The outcomes of interest included procedural success, in-hospital mortality, major bleeding, stroke, transient ischemic attack (TIA), and pericardial effusion/tamponade. The outcomes were pooled using the Hartung-Knapp-Sidik-Jonkman random-effects model, and the results were expressed as odds ratios (OR) with their corresponding 95% confidence intervals (CI). Results: Seven studies involving 38,184 patients (5,742 CKD, 32,442 non-CKD) were included in the final analysis. The rate of procedural success (98.4% vs. 97.2%, OR 1.64, 95% CI: 0.78-3.45, p=0.19) was similar between both groups. Regarding procedural complications, there were no significant differences in terms of the risk of in-hospital mortality (OR 1.87, 95% CI: 0.60-5.82, p=0.28), stroke (OR 2.19, 95% CI: 0.76-6.29, p=0.15), TIA (OR 1.64, 95% CI: 0.78-3.45, p=0.19), major bleeding (OR 1.85, 95% CI: 0.78-4.42, p=0.16), or pericardial effusion/tamponade (OR 1.23, 95% CI: 0.76-2.00, p=0.39) between the two patient groups. Conclusions: Our study demonstrates comparable safety and efficacy of LAAO in patients with CKD compared to those without CKD. Further large prospective studies are warranted to confirm these findings.

Temporal Changes in Racial and Ethnic Disparities in the Utilization of Left Atrial Appendage Occlusion in the United States

Racial and ethnic disparities in the access to left atrial appendage occlusion (LAAO) have been previously described. However, it remains unclear if there have been any changes in these disparities over the years and if the disparities include other racial and ethnic groups not previously studied. We aimed to determine the temporal evolution of the racial and ethnic disparities in the utilization of LAAO from 2016 to 2019. We conducted a retrospective cohort study using the National Inpatient Sample from 2016 to 2019. International Classification of Diseases, 10th edition codes were used to identify all adult admissions with atrial fibrillation (AF) and those who underwent LAAO. The sample was divided into Asian American and Pacific Islander, Black, Hispanic, White, and other races/ethnicities. Our primary outcome was the utilization of LAAO in patients admitted with a diagnosis of AF. The Cochran-Armitage test was conducted to evaluate the yearly trend in LAAO utilization stratified by race/ethnicity. Multivariable regression analysis was conducted to assess the association of race/ethnicity with multiple end points. A total of 59,415 patients underwent LAAO. The highest yearly increase in LAAO utilization was seen in White patients (trend: 0.16%, p<0.001). Furthermore, compared with White patients, the yearly increase in LAAO utilization was lower in all other racial/ethnic groups. Black patients had the lowest odds of who underwent LAAO (odds ratio=0.45, 95% confidence interval 0.40 to 0.50, p<0.001). In conclusion, significant gaps exist in the utilization of LAAO between racial and ethnic groups, and they appear to continue worsening from 2016 to 2019.

PO-03-135 LEFT ATRIAL APPENDAGE OCCLUSION VERSUS STANDARD OF CARE IN PATIENTS WITH ATRIAL FIBRILLATION AND A PRIOR THROMBO-EMBOLIC EVENT DESPITE ORAL ANTICOAGULANT THERAPY: A PROPENSITY SCORE MATCHED COMPARISON

Patients with atrial fibrillation (AF) that suffer from ischemic stroke despite oral anticoagulant (OAC) therapy have a very high risk of recurrent stroke and better prevention strategies are needed. Left atrial appendage occlusion (LAAO) is a promising secondary prevention strategy that may provide mechanical protection. However, evidence showing effectiveness of LAAO in this population is scarce and the current international guidelines only consider LAAO in patients with a contra-indication for OAC. To compare percutaneous LAAO to standard-of-care including continuing/switching OAC therapy for secondary stroke prevention in patients with AF and a prior thrombo-embolic event and/or LAA thrombus under OAC therapy. The STR-OAC LAAO cohort is an international collaboration of multiple LAAO registries (21 participating centers). All patients that underwent percutaneous LAAO because of a thrombo-embolic event and/or LAA thrombus on OAC were included. Propensity score matching with a previously published multi-center dataset of patients continuing/switching OAC therapy after a thrombo-embolic event was performed to compare the occurence of ischemic stroke between groups.Time-to-event analysis was performed with Kaplan-Meier curves and Cox-proportional-hazard regression analyses. A total of 425 patients underwent LAAO between 2010-2021 and were included in the STR-OAC LAAO cohort. Mean age was 72±9 years; 45% was female and mean CHA2DS2-VASc and HAS-BLED score were 4.8±1.5 and 2.8±1.2, respectively. Oral anticoagulation was discontinued after LAAO at discharge or after confirmation of adequate LAA closure at 1-3 months follow-up in most patients, the remaining 30% of patients continued OAC after LAAO as an adjunctive strategy. All LAAO patients were propensity-score matched and included in the primary outcome analysis. During follow up including 1450 patient-years a total of 59 patients experienced ischemic stroke: 1.9% per patient-year in LAAO group versus 9.2% per patient-year in the control group. LAAO was associated with a significantly lower risk of ischemic stroke (HR 0.3, 95%CI [0.2-0.5], p<0.001) compared to standard-of-care. In this propensity-score matched study, LAAO was associated with a lower risk of ischemic stroke compared to standard-of-care in patients with a thrombo-embolic event and/or LAA thrombus despite OAC treatment. Randomized controlled trial data may further confirm the effectiveness of LAAO in this very high-risk population.

Meta-Analysis Comparing Left Atrial Appendage Occlusion, Direct Oral Anticoagulants, and Warfarin for Nonvalvular Atrial Fibrillation

Randomized trials have shown that direct oral anticoagulants (DOACs) are superior to warfarin in patients with nonvalvular atrial fibrillation. However, long-term use of anticoagulation carries an inherent risk of bleeding and nonadherence. Although the use of percutaneous left atrial appendage occlusion (LAAO) has become readily available, its effectiveness relative to oral anticoagulants is still unclear. The present study aimed to compare the outcomes of warfarin, DOACs, and LAAO in patients with atrial fibrillation. Medline, Embase, CENTRAL, and Web of Science were systematically searched through December 2021 for randomized controlled trials comparing warfarin, DOACs, or LAAO, reporting on all-cause mortality, stroke, and clinically relevant bleeding. A random-effects model was used to assess the safety and efficacy outcomes of these 3 treatments relative to each other in a Bayesian network meta-analysis. A total of 40 trials with 95,469 patients (LAAO: 5 trials, 3,032 patients; DOAC: 36 trials, 54,327 patients; warfarin: 37 trials, 38,110 patients) were included. LAAO was associated with significantly lower mortality than warfarin (odds ratio [OR] 0.68; 95% credible interval [CrI] 0.50 to 0.90) and DOACs (OR 0.75, 95% CrI 0.55 to 0.99). LAAO was the best-ranked treatment with respect to mortality reduction (surface under the cumulative ranking curve [SUCRA] 98.77%) and bleeding avoidance (SUCRA 72.26%). Compared with warfarin, DOACs significantly reduced mortality (OR 0.91, 95% CrI 0.85 to 0.97), stroke (OR 0.80, 95% CrI 0.63 to 0.93), and bleeding (OR 0.78, 95% CrI 0.63 to 0.95) and were ranked as the best option at preventing stroke (SUCRA 82.63%). In conclusion, LAAO was associated with lower mortality compared with DOACs, and both LAAO and DOACs significantly reduce mortality compared with warfarin. Future trials are needed to rule out a significant inferiority of LAAO compared with DOACs in terms of stroke and bleeding risks.

Left atrial appendage occlusion versus standard of care in patients with atrial fibrillation and a prior thrombo-embolic event despite oral anticoagulant therapy: a propensity score matched comparison

Abstract Introduction Patients with atrial fibrillation (AF) that suffer from ischemic stroke despite oral anticoagulant (OAC) therapy have a very high risk of recurrent stroke and better prevention strategies are needed. Left atrial appendage occlusion (LAAO) is a promising secondary prevention strategy that may provide mechanical protection in patients that suffer from thrombo-embolic events under OAC. However, evidence showing effectiveness of LAAO in this population is scarce and the current international guidelines only consider LAAO in patients with a contra-indication for OAC. Purpose To compare percutaneous LAAO to standard-of-care including continuing/switching anticoagulation therapy for secondary stroke prevention in patients with AF and a prior thrombo-embolic event and/or LAA thrombus under OAC therapy. Methods The STR-OAC LAAO cohort is an international collaboration combining a selection of patients from multiple LAAO registries (22 participating centers). Patients that underwent percutaneous LAAO because of a thrombo-embolic event and/or LAA thrombus on OAC were included. Propensity score matching (optimal matching method, 1:1 ratio) with a previously published multi-center dataset of patients continuing/switching anticoagulation treatment after a thrombo-embolic event was performed to adjust for imbalances in age, sex, hypertension, diabetes mellitus and CHA2DS2-VASc score. The primary outcome was ischemic stroke. Time-to-event analysis was performed with Kaplan-Meier curves and Cox-proportional-hazard regression analyses. Results A total of 404 patients underwent LAAO between 2010–2021 and were included in the STR-OAC LAAO cohort. Mean age was 72±9 years; 44% was female and mean CHA2DS2-VASc and HAS-BLED score were 4.8±1.7 and 2.5±1.4, respectively. Most patients received a Watchman or Amplatzer device (53% and 43%). Oral anticoagulation was discontinued after LAAO at discharge or after confirmation of adequate LAA closure at 1–3 months follow-up in 44% or 20%, respectively. The remaining 35% of patients continued OAC after LAAO as an adjunctive strategy. All LAAO patients were propensity-score matched and included in the primary outcome analysis. Baseline characteristics were well balanced after matching (Table 1). During follow up including 1406 patient-years (LAAO 1007; control 399) a total of 61 patients experienced an ischemic stroke: 2.2% per patient-year in LAAO group versus 9.8% per patient-year in the control group. LAAO was associated with a significantly lower risk of ischemic stroke (HR 0.33, 95% CI [0.19–0.59], p&amp;lt;0.001) compared to standard-of-care (Figure 1). Conclusion In this propensity-score matched study, LAAO was associated with a lower risk of ischemic stroke compared to standard-of-care in patients with a thrombo-embolic event and/or LAA thrombus despite OAC treatment. Randomized controlled trial data may further confirm the effectiveness of LAAO in this very high-risk population. Funding Acknowledgement Type of funding sources: None.

Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion.

Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF. The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort. At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days. A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%). Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Periprocedural Outcomes Associated With Use of a Left Atrial Appendage Occlusion Device in China

Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for patients with atrial fibrillation. However, the performance of LAAO among East Asian patients is unknown. To document the procedural success rate and configurations, major adverse event rates, and antithrombotic medication regimens during and after LAAO procedures among patients in China. In this cohort study, consecutive patients from 39 Chinese centers undergoing LAAO were prospectively enrolled between April 1, 2019, and October 31, 2020. Periprocedural and intraprocedural techniques and postprocedural medications were left to the surgeon's discretion. Data were analyzed from July 1 to November 1, 2021. LAAO for patients with atrial fibrillation. The main outcomes were procedural success and complication rates periprocedure and major adverse event rates of death, stroke, systemic embolism, and bleeding events at 30 days postprocedure; the composite end point of death, stroke, and systemic embolism was also analyzed. Unadjusted and multivariable-adjusted logistic regression analyses were performed to assess the associations of periprocedural techniques (types of anesthesia, intraprocedural imaging modalities, and combined ablation procedure) with 30-day adverse events. Among 3096 enrolled participants, 1782 participants (57.6%) were men, and the mean (SD) age was 69 (9) years. Participants had a high risk of stroke (mean [SD] cardiovascular risk score, 4.0 [1.8]) and a moderate-to-high risk of bleeding (mean [SD] bleeding risk score, 2.4 [1.2]). A total of 1287 procedures (41.6%) were performed under local anesthesia, while 493 procedures (15.9%) used only fluoroscopy guidance. In 1297 procedures (41.9%), LAAO implantation was combined with radiofrequency ablation or cryoablation for atrial fibrillation. Procedural success was achieved in 3032 patients (97.9%). At 30-day follow-up, the rate of the composite end point of death, stroke, or systemic embolism was 0.52% (95% CI, 0.32%-0.84%), and the rate of any life-threatening or major bleeding was 1.23% (95% CI, 0.90%-1.68%). No significant associations were observed between the procedural success or 30-day adverse events and the types of anesthesia (general or local), intraprocedural imaging (transesophageal echocardiography, fluoroscopy, or intracardiac echocardiography), or whether a combined ablation procedure was performed or not. In centers performing at least 40 procedures per year, compared with those performing fewer than 40 procedures per year, procedural success was significantly higher (adjusted odd ratio [aOR], 1.97; 95% CI, 1.01-3.53; P = .02) and risk of life-threatening or major bleeding was significantly lower (aOR, 0.42; 95% CI, 0.21-0.87; P = .02). These findings suggest that patients with a high risk of stroke and moderate to high risk of bleeding who underwent implantation of a LAAO device in Chinese centers had high rates of procedural success and low rates of short-term ischemic and bleeding events.

Efficacy and Safety of Left Atrial Appendage Occlusion in Mild Mitral Stenosis Patients with High Bleeding Risk.

Atrial fibrillation (AF) is highly prevalent in patients with mitral stenosis (MS), but the efficacy of left atrial appendage occlusion (LAAO) in these patients remains unclear.The aim of this study was to evaluate the efficacy and safety of LAAO in patients with MS complicated by AF at high risk of bleeding.We recruited patients from September 2015 to September 2018. We compared the 3-year outcomes of LAAO in 21 patients with AF complicated by MS and 42 sex- and age-matched patients with AF without MS.The MS group had more cases of peripheral arterial embolism (28.6% versus 2.4%, P = 0.004), more spontaneous echo contrast (47.6% versus 9.5%, P = 0.001), a larger LAA orifice diameter (P < 0.01), and a slower LAA flow (P < 0.05) than the Non-MS group. The mean size of the selected occluder device was bigger for patients with MS than for patients with Non-MS (29.2 ± 3.7 versus 26.9 ± 3.1 mm, P = 0.014). In the first 45 follow-up days, 2 (9.5%) patients with MS had device-related thrombi (DRT); one of them had transient ischemic attack 24 hours postoperatively. From 45 days to 6 months, one patient in each group had DRT. After 6 months, two patients in the Non-MS group still had residual leaks; one of them had a stroke, with a small DRT. The proportion of dual antiplatelet therapy was higher in the Non-MS group than in the MS group (33.3% versus 4.8%, P = 0.012), but this population had an increased bleeding risk.LAAO is relatively effective and safe for preventing embolic events in patients with MS complicated by AF, at high risk of bleeding.

Anatomy of the left atrial appendage for the interventional cardiologist.

Exact knowledge of the anatomy of the left atrial appendage (LAA) is crucial for LAA isolation by catheter ablation and for interventional LAA occlusion in patients with atrial fibrillation. This review outlines the current anatomical understanding of LAA morphology from ostium to distal lobes, myocardial fiber orientation and wall structure, and adjacent structures such as the left upper pulmonary vein with the Coumadin ridge, the circumflex artery with its side branches, the aortic root, pulmonary artery, and the pericardial space. Insight into these details will facilitate these interventions and reduce the risk of complications.

PO-685-06 LIVER CIRRHOSIS IS ASSOCIATED WITH AN INCREASE IN BLEEDING AND MORTALITY IN PATIENTS UNDERGOING LEFT ATRIAL APPENDAGE OCCLUSION: INSIGHTS FROM A NATIONWIDE COHORT ANALYSIS

Patients with liver cirrhosis are at an increased risk of bleeding secondary to diminished clotting factor synthesis. In patients with both atrial fibrillation (AF) and cirrhosis, there is an additional risk of cardioembolic stroke. Thus, left atrial appendage occlusion (LAAO) is an attractive therapeutic option. There is limited data available that examine the safety and outcomes of LAAO in patients with cirrhosis.

PO-668-05 LEFT ATRIAL APPENDAGE OCCLUSION IN PATIENTS WITH CIRRHOSIS: A NATIONWIDE ANALYSIS

Left atrial appendage occlusion (LAAO) is an effective alternative to anticoagulation in patients with atrial fibrillation (AF) and is often considered in patients with increased bleeding risk. The prevalence of AF is higher in cirrhosis patients than in the general population, but anticoagulation strategy can be challenging due to anemia and risk of bleeding. While there are studies on anticoagulation in patients with cirrhosis, there is no study to date that investigated LAAO in patients with cirrhosis.