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Background: Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients., Methods and results: Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065)., Conclusions: This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.

In the countries like Japan where anticoagulation is not recommended in hemodialysis patients, the feasibility of percutaneous left atrial appendage closure (LAAC) in hemodialysis patients with non-valvular atrial fibrillation (NVAF) accompanying high risks of thromboembolic stroke and bleeding remains unknown. Peri-procedural and 45-day clinical outcomes following LAAC using WATCHMAN system, which were performed in our institute between Jun 2020 and April 2022 according to the Japanese Circulation Society guidelines, were retrospectively compared between those with and without hemodialysis. 118 patients (median 79 years, 81 men) consisting of 25 hemodialysis patients and 93 non-hemodialysis patients were included. CHADS score was 3 (2, 4) in the hemodialysis patients and 3 (2, 4) in the non-hemodialysis patients (p = 0.98). HAS-BREAD score was 4 (3, 5) in the hemodialysis patients and 3 (2, 3) in the non-hemodialysis patients (p < 0.001). All procedures were successful, except for a non-hemodialysis patient with a larger left atrial appendage. There were no major complications during index hospitalization and 45-day observational period, except for a hemodialysis patient with suspected bleeding and a non-hemodialysis patient who died due to cardiac amyloidosis. LAAC seems to be feasible in hemodialysis patients with high risks of thromboembolic events and bleedings., (© 2022. The Author(s).)

Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and its prevalence increases with age. AF causes palpitations, heart failure, and cardiogenic embolism. Of them, the most critical and fatal complication is a cardio-embolic event. Oral anticoagulation plays a central role in reducing stroke risk in AF patients. Recently, when oral anticoagulation is considered in patients with non-valvular AF who are eligible for direct oral coagulations, they are preferred to vitamin K antagonist based on accumulating evidence. Although many patients can tolerate oral anticoagulation, there is a subset of patients who cannot tolerate long-term oral anticoagulation. Such a subset has a higher bleeding risk as indicated by the HAS-BLED score under oral anticoagulation. This subset of patients requires effective and safe non-pharmacological alternative therapies for stroke prevention. One of the promising non-pharmacological therapies is left atrial appendage closure. Three randomized controlled trials demonstrated non-inferiority of percutaneous left atrial appendage closure using WATCHMAN family to oral anticoagulation (Boston Scientific, Marlborough, MA, USA). WATCHMAN FLX, which was innovated following WATCHMAN 2.5, was associated with fewer safety events and a higher success rate of effective appendage closure. Nevertheless, several unsolved issues remain, including device-related thrombosis, post-treatment antithrombotic therapy, and peri-device leakage. Left atrial appendage closure for patients with non-valvular AF may be an alternative therapy to avoid cardiac embolism for high bleeding risk patients with contraindications to long-term oral anticoagulation therapy., Competing Interests: Declaration of competing interest None., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Chronic obstructive pulmonary disease (COPD), a known risk factor for the development of congestive heart failure (CHF), was recently shown to predict the prevalence of atrial fibrillation (AF). Here, we explore the influence of AF on cardiac prognosis in COPD patients., Methods: A total of 339 consecutive patients who underwent spirometry from 2010 to 2013 for various reasons were retrospectively examined. Based on the diagnostic criteria, patients were stratified into COPD and non-COPD groups, which were both further divided into those with AF (chronic AF or paroxysmal AF) or sinus rhythm (SR) based on previous electrocardiography results. Significances of differences in cardiac events were assessed by the chi-square test. Multivariate logistic regression analyses and Cox proportional hazard models were applied to evaluate the influence of AF on cardiac events., Results: Of the 339 patients, 190 were diagnosed with COPD, with 42 of these were having AF. During the mean follow-up period of 7.4 ± 0.8 years, CHF developed more frequently in COPD patients with AF than in COPD patients without AF [50% vs 7%; odds ratio (OR) 12.4, 95% confidence interval (CI): 5.25-29.49, p < 0.05]. AF was an independent predictor of CHF development (OR 20.4, 95% CI: 6.55-79.80, p < 0.05) and cardiac mortality (OR 2.8, 95% CI: 1.79-4.72, p < 0.05). Moreover, positive correlations were found between the severity of pulmonary obstruction with AF and CHF development (R = 0.69, p < 0.05), as well as cardiac mortality (R = 0.78.p < 0.05)., Conclusions: These results suggest that AF may be strongly associated with cardiac mortality and CHF in COPD patients., (Copyright © 2018 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.)

Background: Abnormalities in the left atrium (LA) detected on transesophageal echocardiography (TEE) are reliable predictors of thromboembolism in patients with atrial fibrillation (AF). Cardiac troponin I, a marker of subclinical myocardial damage, may also be a predictor of thromboembolic events in patients with AF. The relationship between cardiac troponin I and thromboembolic risk on TEE, however, remains unclear., Methods and results: TEE and laboratory data, including high sensitivity cardiac troponin I (hs-cTnI) and CHA 2 DS 2 -VASc score, were analyzed in 199 patients with non-valvular AF (NVAF). Patients were stratified into those with or without LA abnormality, defined as LA appendage flow velocity <20 cm/s or dense spontaneous echo contrast. On multiple logistic analysis of the clinical variables, hs-cTnI was associated with LA abnormality (95% CI: 1.0003-1.020, P=0.034). The area under the curve for LA abnormality increased on addition of hs-cTnI to CHA 2 DS 2 -VASc score. The incidence rate of ischemic stroke was higher in the high hs-cTnI group than in the low-hs-cTnI group (log-rank test, P<0.05)., Conclusions: Elevated hs-cTnI was independently associated with LA abnormality in NVAF patients. hs-cTnI level may be a useful biomarker for risk stratification of thromboembolism in NVAF patients.

Background: Percutaneous left atrial appendage closure (LAAC) reduces the incidence of stroke/bleeding events in patients with non-valvular atrial fibrillation, high risk of stroke, and contraindication in continuing anticoagulation therapy. Of them, patients with heart failure may remain at high risk of these events after LAAC. Method: Patients who underwent LAAC and were listed for the multi-center, prospectively collected OCEAN-LAAC registry, were eligible. Of them, individuals without baseline plasma B-type natriuretic peptide (BNP) levels and those dependent on hemodialysis were excluded. The prognostic impact of baseline plasma BNP levels on the incidence of death or stroke/bleeding events after LAAC was evaluated. Results: A total of 937 patients (median 78 years, 596 men) were included. The LAAC device was successfully implanted in 934 (98%) patients. Over the 366 (251, 436) days after the LAAC, 148 patients encountered a primary outcome. The common logarithm of baseline plasma BNP was independently associated with the primary outcome with an adjusted hazard ratio of 1.46 (95% confidence interval 1.06–2.18, p = 0.043). A calculated cutoff of 2.12 (equivalent to 133 pg/mL of plasma BNP level) significantly stratified the cumulative incidence of the primary outcome (29% vs. 21% for 2 years, p = 0.004). Conclusions: Using prospectively collected large-scale multi-center Japanese registry data, we demonstrated that a baseline higher plasma BNP level was independently associated with a higher incidence of stroke/bleeding events and mortality after LAAC. Further studies are warranted to understand the optimal therapeutic strategy for LAAC candidates with elevated baseline plasma BNP levels. [ABSTRACT FROM AUTHOR]

Background: Percutaneous left atrial appendage occlusion (LAAO) therapy using the WATCHMAN system has been introduced to prevent thrombosis and minimize the use of anticoagulants in patients with non-valvular atrial fibrillation. Given the high risk of bleeding and stroke in elderly patients, these patients would be good candidates for this therapy. However, the efficacy and feasibility of LAAO therapy in elderly patients remains uncertain. Methods: Consecutive patients who underwent LAAO therapy using the WATCHMAN system in a large academic center between June 2020 and March 2023 were included. The safety and efficacy of LAAO therapy during the 1-year observation period in patients aged ≥85 years old were compared with those in the younger cohort. Results: A total of 188 patients (78.4 ± 6.9 years old, 133 male patients) were included. 34 patients were ≥85 years old, 96 were between 75 and 84 years old, and 58 were <75 years old. The elderly group had a higher CHA2DS2-VASc score and were at greater risk of falling-related bleeding compared with the younger cohort. The device implantations were successful in all patients except for one. During the 1-year observation period, one patient had a peri-device leak >5 mm and there were 6 device-related cases of thrombosis, whose incidence was not significantly different between the groups (p = 0.98). The cumulative incidences of bleeding and thrombotic events in the elderly group were as low as in the younger cohort (p > 0.05 for both). Most anticoagulants were terminated regardless of age. Conclusion: The mid-term feasibility and efficacy of percutaneous LAAO therapy using the WATCHMAN system in elderly patients aged ≥85 years were as acceptable as in the younger cohort. [ABSTRACT FROM AUTHOR]

Background: Percutaneous left atrial appendage closure using the WATCHMAN system, to prevent thrombosis and minimize anti-coagulant use in patients with non-valvular atrial fibrillation, has recently been introduced. The safety and efficacy of new-generation WATCHMAN FLX, as compared to conventional WATCHMAN 2.5, remain unknown. Methods: Consecutive patients who received percutaneous left atrial appendage closure using the WATCHMAN system in our institute, between June 2020 and December 2021, were retrospectively analyzed. Safety and efficacy during the 45-day observational period were compared between the two devices. Results: A total of 93 patients (73.0 ± 7.3 years old, 63 men) who received WATCHMAN FLX (n = 44) or WATCHMAN 2.5 (n = 49) were included. The device implant success rate was 100% in the FLX device group and 98% in the 2.5 device group. There were no procedure-related complications in the FLX group, and one non-relevant pericardial effusion in the 2.5 device group. During the 45-day observational period, there were no procedure-related adverse events. No patients in the FLX group had a peri-device leak >3 mm, whereas two patients in the 2.5 device group had a peri-device leak >3 mm. Anti-coagulants could be terminated in most of the patients (85% versus 88%; p = 0.68). Conclusions: Percutaneous left atrial appendage closure using new-generation WATCHMAN FLX seemed to be as safe and effective as conventional WATCHMAN 2.5 during the short-term observational period. [ABSTRACT FROM AUTHOR]

The use of leadless trans-catheter pacemakers is increasing particularly in the elderly population. However, its indication for those with anatomical anomaly remains unknown. We had a 75-year-old woman with atrial standstill and ventricular escape. Micra leadless pacemaker (Medtronic, Inc, Minneapolis, MN, USA) failed to be deployed due to too enlarged right atrium accompanied by atrial septal deficiency, followed by successful implantation of transvenous pacemaker lead by using SelectSecure lead (Medtronic) with a C315 delivery catheter that enhanced back-up force toward the ventricular septum against significant tricuspid regurgitation. The Micra is a promising system, but we should understand its limitations as well as alternative systems particularly for such an anatomical anatomy. < Learning objective: A Micra leadless trans-catheter pacemaker is a promising system with less invasiveness, particularly for elderly patients, but we should understand its technical limitation and consider alternative systems if necessary, particularly for those with enlarged right heart.> [ABSTRACT FROM AUTHOR]

ABSTRACT Background Objectives Methods Results Conclusion Research on the impact of angiographically detected residual trabeculation after left atrial appendage closure (LAAC) is limited.To investigate the incidence, characteristics, and clinical implications of angiographically detected residual trabeculation after LAAC using the WATCHMAN device.We analyzed 1350 consecutive patients with atrial fibrillation undergoing LAAC using the WATCHMAN device from the OCEAN‐LAAC registry, which is a prospective ongoing, multicenter Japanese registry. The inclusion criteria comprised patients who successfully underwent LAAC and whose presence or absence of residual trabeculation can be confirmed using a contrast medium. The clinical outcomes were compared between patients with and without angiographically detected residual trabeculation.Residual trabeculation was angiographically detected in 5.6% (75/1350 patients). At the procedure, the proportion of peri‐device leak (PDL) was significantly higher in the residual trabeculation group than in the non‐residual trabeculation group (20% vs. 5.1%, p < 0.001). However, the PDL and device‐related thrombosis at 45 days and 1 year were comparable between the two groups (37% vs. 23%, p = 0.24; 28% vs. 31%, p = 0.84; 2.1% vs. 1.4%, p = 0.50; 6.9% vs. 6.0%, p = 0.69, respectively). The 3‐year cumulative incidence of ischemic stroke, all cardiovascular death, and all‐cause death were comparable between the two groups (5.7% vs. 5.5%, log‐rank p = 0.96; 7.7% vs. 8.9%, log‐rank p = 0.34, 31.4% vs. 22.3%, log‐rank p = 0.71, respectively).The angiographically detected residual trabeculation rate was 5.6%, and this population had a significantly higher prevalence of PDL at the procedure. However, the presence of residual trabeculation did not contribute to PDL or device‐related thrombosis at follow‐up or affect the clinical outcomes. [ABSTRACT FROM AUTHOR]