Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: 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.

Safety and efficacy of a light antithrombotic regimen after left atrial appendage occlusion: Insights from the LOGIC (left atrial appendage occlusion in patients with gastrointestinal or IntraCranial bleeding) international multicenter registry.

Clinical Outcomes of Left Atrial Appendage Occlusion in Patients with Previous Intracranial or Gastrointestinal Bleeding: Insights from the Logic (Left Atrial Appendage Occlusion in Patients with Gastrointestinal or Intracranial Bleeding) International Multicenter Registry

Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Previous Major Gastrointestinal Bleeding (from the Amplatzer Cardiac Plug Multicenter Registry)

Left Atrial Appendage Occlusion in Patients With Prior Intracranial Hemorrhage.

Objective: To evaluate the safety and effectiveness of left atrial appendage occlusion (LAAO) in patients with atrial fibrillation and end-stage renal disease undergoing long-term hemodialysis. Methods: Six patients with AF and end-stage renal disease(ESRD)on long term hemodialysis who underwent LAAO from March 2017 to March 2021 in Beijing Anzhen Hospital were enrolled. Baseline characteristics such as age, sex, types of arrhythmia, stroke and bleeding score, and continuous dialysis time were collected. Four patients underwent LAAO, two patients underwent the combined procedure of catheter ablation and LAAO. Perioperative treatment and serious complications were recorded. Transesophageal echocardiography was repeated at 45 days and 60 days after the procedure. Telephone follow-up was conducted at 3, 6 and 12 months after the procedure, and every 6 months thereafter. Thromboembolism and major bleeding events and survival were evaluated. Results: The average age was (66.7±17.0) years old, and 5 were male (5/6). There were 4 patients with paroxysmal AF (4/6), and 2 patients with persistent AF (2/6). The mean CHA2DS2-VASc score was (4.8±1.5), and the HAS-BLED score was (3.5±1.4). The duration of hemodialysis was 2.6 (1.1, 8.3) years. Successfully Watchman implantation was achieved in all patients. There were no severe perioperative complications, and no device related thrombosis or leaks were observed by transesophageal echocardiography. During a mean of 22.0 (12.0, 32.0) months follow-up, there was no thromboembolism or major bleeding events. A total of 2 patients died, one from sudden cardiac death, and another one from heart failure. Conclusions: LAAO may be a safe and effective therapeutic option for prevention of thromboembolism in patients with atrial fibrillation and end-stage renal disease undergoing long-term hemodialysis, further studies with larger patient cohort are needed to confirm our results.

Background: The patient population undergoing left atrial appendage occlusion (LAAO) in the US is older and at a higher bleeding and thromboembolic risk than that enrolled in the initial trials that led to FDA approval. Real world outcomes in this population have implications for the use of LAAO. Goals: We sought to compare clinical outcomes of LAAO in patients with atrial fibrillation (AF) with prior major gastrointestinal (GI) bleeding to continued oral anticoagulation (OAC). Methods: Using data from a large US hospital system, patients with AF who underwent LAAO from 01/2016 to 11/2022 with a history of at least one major (requiring admission or transfusion) GI bleed event (LAAO group) were identified and compared to a control group with prior GI bleed with continued OAC. Controls were selected in a 1:2 fashion using propensity score matching based on 17 variables. Hospital admissions for major bleeding, ischemic stroke or transient ischemic attack (TIA) as well as survival were tracked during follow-up. Results: Patients in the LAAO group (n=642, age 76.5±8.2 years, 47.8% female) had higher CHA2D2-VASc (4.3±1.7 vs. 4.1±1.6, p=0.003) and lower HAS-BLED (3±0.9 vs. 3.3±0.9, p<0.001) scores than the control group (n=1273, age 76.3±10.1 years, 47.8% female) but were otherwise comparable. At baseline, a higher proportion of patients in the LAAO group was on a direct oral anticoagulant (59.7% vs. 44.9%, p<0.001), while fewer patients were on warfarin (15.9% vs. 53.3%, p<0.001). Over a median follow-up of 2.95 (1.53-4.89) years, patients in the LAAO group had lower rates of a major bleeding event (97.8 vs. 140 events per 1,000 person-years, p<0.001) as compared to the control group. Similarly, fewer patients in the LAAO group were admitted for ischemic stroke or TIA (15.4 vs. 26.1 events per 1,000 person-years, p=0.016) when compared to the control group. Finally, survival rates in the LAAO group were improved as compared with the control group (89.4 vs. 119.9 events per 1,000 person-years, p<0.001), Figure 1. Conclusions: In patients with prior major GI bleeding, LAAO is associated with superior clinical outcomes with lower bleeding and stroke rates when compared to OAC.

Patients with atrial fibrillation (AF) on oral anticoagulation (OAC) who have a history of intracranial hemorrhage (ICrH) or cerebral amyloid angiopathy (CAA) have an elevated risk of ICrH recurrence. Left atrial appendage occlusion (LAAO) has emerged as a potential alternative to OAC for stroke prevention in high-bleeding-risk AF patients. Small observational studies suggest that LAAO may be safe and feasible in patients with ICrH, when using single or dual antiplatelet therapy or short-term OAC post-procedure, though data remain limited. This systematic review and meta-analysis aims to consolidate evidence on the safety and efficacy of LAAO in patients with prior ICrH or CAA. We conducted a systematic review and meta-analysis examining the safety and efficacy of LAAO in patients with non-valvular AF and prior ICrH and/or CAA. PubMed/MEDLINE and EMBASE (via Scopus) databases were systematically searched from inception until 29 February 2024. Eligible studies included randomized control trials, observational studies, and case series (⩾10 participants) reporting stroke events in patients with AF and previous history of ICrH and/or CAA undergoing LAAO. Pooled incidence rates (IRs) with corresponding 95% confidence intervals (CIs) were calculated for primary outcomes (post-procedural ischemic stroke and recurrent ICrH) and secondary outcomes. Fourteen studies including 1235 patients met inclusion criteria. The pooled average follow-up period was 17.1 months. The pooled IRs for ischemic stroke, recurrent ICrH, and major hemorrhage were 2% (95% CI: 1-3%, I2 = 2%), 2% (95% CI: 0.4-3%, I2 = 45%) and 3% (95% CI: 1-5%, I2 = 54%), respectively. In prespecified subgroup analyses of studies focusing on patients with intraparenchymal hemorrhage and/or CAA, pooled IRs for ischemic stroke, recurrent ICrH, and major hemorrhage IR of 4% (95% CI: 1-8%), 4% (95% CI: 0.4-10%) and 6% (95% CI: 3-12%), respectively. LAAO may be a safe and effective treatment for selected AF patients with a history of ICrH and/or CAA, but the quality of evidence is poor. Future randomized controlled trials are essential to validate LAAO's efficacy and long-term safety.

Outcomes of Left Atrial Appendage Occlusion in Patients With Prior Gastrointestinal Bleeds.

Aim. To study the incidence, predictors, and clinical outcome of device-related thrombus (DRT) after left atrial appendage occlusion (LAAO) in patients with atrial fibrillation (AF).Methods. A prospective observational study included 120 patients with non-valvular AF who underwent LAAO with Watchman (n=92) and Amplatzer Amulet (n=28). The presence of device-related thrombus (DRT) was assessed at visits 45 days, 6 months, 1 year, 2 years, 3 years after implantation by transesophageal echocardiography.Results. A total of 11 (9.2%) patients had DRT during the follow-up period. The greatest number of thrombosis was observed after 45 days (n=4) and after 6 months (n=4). There was no significant difference in the incidence of DRT between device types. Independent predictors of thrombosis were: history of myocardial infarction (hazard ratio (HR) 12.88 [95% confidence interval (CI) 3.21-51.62]; p<0.001), chronic heart failure (HR 8.83 [95% CI 1.91-40.77]; p=0.005), residual leak size >5 mm in the early postoperative period (HR 6.13 [95% CI 2.53-14.86]; p<0.001) and the degree of spontaneous echo contrast during the initial examination (HR 9.09 [95% CI 1.36-60.58], p=0.023). There were no cases of thromboembolic complications associated with DRT. One patient developed a non-fatal stroke at 35 weeks of follow-up, while DRT was detected at the visit at the end of the 3rd year of follow-up.Conclusion. DRT after LAAO was observed in the early and long-term follow-up periods. This event was associated with the baseline patients’ characteristics and post-procedural aspects with no dependence on type of antithrombotic therapy.

Background: Patients with chronic kidney disease (CKD) and atrial fibrillation have increased risks for stroke and bleeding under oral anticoagulation (OAC). We investigated an alternative therapy of percutaneous left atrial appendage occlusion (LAAO) in CKD patients in this study.Methods: Consecutive patients undergoing LAAO were included in a retrospective analysis and stratified for kidney function into CKD/Non-CKD groups (cutoff eGFR 60 ml/min). Procedural characteristics, in-hospital and follow-up events were analysed and compared between groups.Results: LAAO was performed in 146 patients (81 CKD; 65 Non-CKD), mean follow-up was 391 days. Groups differed in eGFR (40.1 (CKD) vs. 75.1 (Non-CKD) ml/min) and CHA2DS2VASc scores (4.65 ± 1.3 (CKD) vs. 4.06 ± 1.4 (Non-CKD)). Procedural success was 98.6%, contrast-induced acute kidney injury was significantly more frequent in CKD patients (11.1% vs. 0%; p = .004). Follow-up mortality was higher in CKD (10.5/100 PY vs. 4.2/100 PY; p = .156). Follow-up stroke rates were 2.3/100 (CKD) patient-years (PY) and 1.4/100 PY (Non-CKD) (p = 1.000), corresponding to a relative risk reduction (RRR) of 60% (all), 68% (CKD) and 71% (Non-CKD) compared to expected stroke rates. Follow-up major bleeding rates were 3.5/100 PY (CKD) and 4.2/100 PY (Non-CKD), corresponding to RRR of 57% (all), 61% (CKD) and 53% (Non-CKD) compared to OAC.Conclusions: Left atrial appendage occlusion shows comparable efficacy for stroke and bleeding prevention in CKD and Non-CKD patients. CKD patients experience more adverse events during follow-up and a significantly increased risk for periprocedural contrast-induced acute kidney injury.

Introduction: Patients with hypertrophic cardiomyopathy (HCM) and atrial fibrillation (AF) are at increased stroke risk in comparison to those without HCM. The role of left atrial appendage occlusion (LAAO) in these patients is unclear. Methods: In this retrospective cohort study, we identified patients with HCM and AF using the National Readmission Dataset from 2016-19. Patients were stratified based on LAAO status. The primary efficacy outcome was a composite of any stroke (ischemic and hemorrhagic), TIA, and all-cause mortality. The primary safety outcome was a composite of major bleeding and pericardial complications. Individual components of the primary outcomes were secondary outcomes. Patients were matched using inverse probability of treatment weighting. Cox-proportional hazard regression was applied to calculate hazard ratio (HR) with 95% confidence interval (CI) on matched cohorts. Results: We identified 71,980 patients with HCM and AF. Of these, 1,351 (1.9%) patients underwent LAAO. Those who underwent LAAO were significantly younger than those who did not (67.5±10.1 years vs. 70.0±13.1 years, p<0.001) and were more likely to be male (54.6% vs. 45.4%). LAAO was associated with a lower risk of the primary efficacy outcome (2.5% vs. 5.4%, HR: 0.38; 95% CI: 0.17-0.88; p=0.024) and the primary safety outcome (2.9% vs. 6.8%, HR: 0.39; 95% CI: 0.23-0.66, p=0.001). LAAO associated with reduced major bleeding (1.6% vs. 6.0%, HR 0.34, 95% CI 0.18-0.64, p=0.001), GI bleeding (0.2% vs. 1.3%, HR 0.22; 95% CI: 0.06-0.79, p=0.02), blood transfusions requiring admission (2.10% vs. 4.90%, HR 0.37, 95% CI 0.19-0.73, p=0.004), and admissions for bleeding (0.50% vs. 2.30%, HR 0.20, 95% CI 0.07-0.58, p=0.003). Pericardial complications were similar in both groups. Conclusion: LAAO was associated with a lower risk of stroke and major bleeding in patients with HCM and AF. Future prospective studies on the safety and efficacy of LAAO in concurrent AF and HCM are needed.

This meta-analysis was conducted to evaluate the efficacy and safety of transcatheter left atrial appendage (LAA) occlusion in patients with nonvalvular atrial fibrillation. The randomized controlled trials (RCT) or observational studies with any transcatheter LAA occlusion devices were searched in PubMed, Embase, and Cochrane library from inception to November 2015. The incidence rates from individual studies were combined to evaluate the procedural efficacy and safety, including all-cause death, cardiac/neurological death, stroke, transient ischemic attack (TIA), thrombosis, hemorrhagic complications, and pericardial effusion/tamponade. Thirty-eight studies involving 3585 patients and 6 different occlusion devices were eligible for our inclusion criteria. The procedural failure rate for LAA closure was 0.02 (95% CI: 0.02-0.03). The all-cause mortality was 0.03 (95% CI: 0.02-0.03) and cardiac/neurological mortality was 0 (95% CI: 0.00-0.01). The stroke/TIA rate was estimated only 0.01 (95% CI: 0.01-0.01). The incidence of thrombus on devices was 0.01 (95% CI: 0.01-0.02). The major hemorrhagic complication rate was estimated 0.01 (95% CI: 0.00-0.01). Pericardial effusion/tamponade was estimated 0.02 (95% CI: 0.02-0.03). No heterogeneity was observed for above pooled estimates (I = 0). In devices subgroups analysis, the all-cause mortality and cardiac/neurological mortality of PLAATO group were the highest (P = 0.01 and P < 0.01 respectively), whereas the incidence of thrombus on devices in the ACP group was the highest (P < 0.01). In follow-up period subgroups analysis, there were significant differences in all-cause death, stroke/TIA, major hemorrhage, and pericardial effusion/tamponade events between the shorter and longer follow-up period subgroups (P < 0.05). However, the differences among the subgroups were numerically small. the pooled data demonstrated that transcatheter LAA occlusion was effective and safe in the patients with nonvalvular atrial fibrillation who were not suitable for lifelong antithrombotic therapy.

Introduction: The optimal antiplatelet therapy following Left atrial appendage occlusion (LAAO) in atrial fibrillation patients who are not candidates for long-term oral anticoagulation therapy (OAC) is subject to debate. Hypothesis: Is single antiplatelet therapy (SAPT) safe and effective when compared to dual antiplatelet therapy (DAPT) in patients with high bleeding risk? Methods: We conducted a comprehensive search for all studies that compared the use of SAPT with DAPT following LAAO for patients in whom OAC is deemed highly risky or contraindicated. The outcomes of our study were device-related thrombosis (DRT), stroke and systemic embolization (SSE), and major bleeding (MB). The risk ratio (RR) with 95% confidence intervals (CIs) are presented as summary statistics and were calculated using a random-effects model. Results: A total of 15 observational studies with 3231 patients (SAPT, n=1036; DAPT, n=2195; 64.5% men; median follow-up duration 12 months; mean age 74.7±8.5 years; CHA2DS2-VASc score 4.3±1.6; HASBLED score 3.2±1.2) were included. For DRT, data were available from 10 studies (2910 patients); there was no difference between SAPT and DAPT groups (2.6% vs. 2.3%; RR: 1.41; 95%CI: 0.77-2.59; P=0.26; I 2 :0%). For SSE (8 studies, 959 patients); although numerically more events were observed in the SAPT group, there was no statistical difference between the two groups in the pooled analysis (2.9% vs. 1.5%; RR: 5.43; 95%CI: 0.74-39.81; P=0.1; I 2 :78%). Finally, for MB (8 studies, 1818 patients); although numerically more events were observed in the DAPT group, there was no statistical difference between the two arms (2.3% vs. 3.2%; RR: 1.90; 95%CI: 0.46-7.87; P=0.37; I 2 :72%). Conclusions: Our study showed comparable safety and efficacy profiles for SAPT and DAPT after LAAO. Adequately powered randomized studies determining the optimal antithrombotic therapy in the first weeks after LAAO are warranted in patients at high risk for bleeding.

Association between dementia and left atrial appendage occlusion in patients with atrial fibrillation: A TriNetX-based retrospective cohort study with target trial emulation