BACKGROUND:Catheter-based closure of the left atrial appendage is an alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation. The effectiveness of this strategy, as compared with physician-directed best medical care, in patients at high risk for stroke and bleeding is unknown. METHODS:In this multicenter randomized trial conducted in Germany, we assigned patients with atrial fibrillation and a high risk of stroke and bleeding to undergo left atrial appendage closure or to receive physician-directed best medical care (including direct oral anticoagulants, if eligible). The primary end point, tested for noninferiority, was a composite of stroke (ischemic or hemorrhagic), systemic embolism, major bleeding, or cardiovascular or unexplained death, assessed in a time-to-event analysis. The noninferiority margin was a hazard ratio of 1.3. RESULTS:A total of 912 adult patients underwent randomization. The primary end-point analysis included 446 patients who were assigned to undergo left atrial appendage closure (device group) and 442 who were assigned to physician-directed best medical care (medical-therapy group). The mean (±SD) age was 77.9±7.1 years; 38.6% of the patients were women, the mean CHA2DS2-VASc score was 5.2±1.5 (range, 0 to 9, with higher scores indicating a greater risk of stroke), and the mean HAS-BLED score was 3.0±0.9 (range, 0 to 9, with higher scores indicating higher risk of bleeding). After a median follow-up of 3 years (interquartile range, 1.7 to 4.7), a first primary end-point event had occurred in 155 patients (incidence per 100 patient-years, 16.8) in the device group and in 127 patients (incidence per 100 patient-years, 13.3) in the medical-therapy group (difference in restricted mean survival time, -0.36 years; 95% confidence interval, -0.70 to -0.01; P = 0.44 for noninferiority). Serious adverse events occurred in 368 patients (82.5%) in the device group and 342 (77.4%) in the medical-therapy group. CONCLUSIONS:Among patients with atrial fibrillation at high risk for stroke and bleeding, left atrial appendage closure was not noninferior to physician-directed best medical care with regard to a composite end point of stroke, systemic embolism, major bleeding, or cardiovascular or unexplained death. (Funded by the German Center for Cardiovascular Research; CLOSURE-AF ClinicalTrials.gov number, NCT03463317.).
Skeletal fragility has long been overlooked by the nephrology community despite patients with chronic kidney disease (CKD) facing double the risk of hip fracture compared with the general population. Consequently, the term CKD-associated osteoporosis was recently coined to increase awareness. In this context, vertebral fractures are even less studied. Vertebral fractures predict increased fracture risk, and especially in advanced CKD, show a strong association with aortic and iliac vascular calcifications and cardiovascular events such as myocardial infarction. The scope of the present consensus paper is to comprehensively discuss the management of skeletal fragility in CKD patients, from diagnosis to treatment, with a particular focus on vertebral fractures in CKD G4-G5D.
Objective and Background: With the increasing use of catheter ablation for tachyarrhythmias, continuous evaluation of in-hospital complications is essential. This study aimed at analyzing complications associated with catheter ablation for atrial fibrillation (AF), atrial flutter (AFL), and ventricular tachycardia (VT) using nationwide administrative data. Methods: We conducted a retrospective multicentric data analysis from large German ablation centers between 2018 and 2023. Patients were identified using ICD and OPS codes for AF, AFL, and VT regarding predefined in-hospital complications: mortality, stroke, pericardial tamponade, pulmonary embolism, and vascular complications requiring intervention. Results: Among 19,258 ablation procedures from 11 centers, AF was most common (n = 12,241), followed by AFL (n = 5582) and VT (n = 1435). Major complications occurred in 2.2% (n = 433) of cases. VT ablations had the highest complication rate (9.8%), followed by AF (1.6%) and AFL (1.7%). Pericardial tamponade occurred in 0.9% patients, most commonly in VT ablations (4.0%). Vascular complications requiring intervention were reported in 1.1%, while stroke (0.3%) and pulmonary embolism (0.05%) were rare. In-hospital mortality was highest in VT patients (2.4%), compared to AF (0.08%) and AFL (0.13%). Higher AFL mortality as compared to AF was associated with older age and more comorbidities. Upon exploratory analysis, no statistical association between hospital volume and complication rates could be seen. Conclusions: In this multicenter analysis, catheter ablation was associated with a low overall complication rate. VT ablations carried the highest risk, highlighting the impact of structural heart disease and comorbidities.
AIMS:Atrial fibrillation (AF) ablation in heart failure reduces mortality and hospitalizations and improves ejection fraction. Arrhythmia-induced cardiomyopathy (AIC) is diagnosed after complete recovery of left ventricular systolic function after ablation. We aimed to identify the prevalence and pre-ablation predictors of AIC among patients with AF and left ventricular systolic dysfunction (LVSD). METHODS AND RESULTS:We utilized the DECAAF II database, where 815 patients with persistent AF underwent late gadolinium enhancement cardiac magnetic-resonance imaging (LGE-CMR) before and 3 months after AF ablation. We only included patients with available left ventricular ejection fraction (LVEF) and LVSD. AF burden was continuously monitored. AIC was defined as LVSD and coexisting AF in patients with ejection fraction improvement to ≥50% following ablation. We identified 119 patients with LVSD and AF with a mean LVEF of 39.1 ± 7.8% and mean baseline fibrosis of 20.0 ± 7.3%. Mean AF burden post-ablation was 16.8 ± 20.2%, and mean LVEF recovery was 13.9 percentage points. Seventy-two patients (60.5%) fulfilled the criteria for AIC, and 47 (39.5%) did not. AIC patients had a mean baseline LVEF of 39.1 ± 7.9% (vs. 39.2 ± 7.9% in non-AIC patients; p = 0.9), a significantly lower percentage of fibrosis in the left atrial septal wall (12.2 ± 10.0% vs. 20.7 ± 11.4% in non-AIC patients, p < 0.001). Additionally, LVEF improvement was correlated with lower AF burden post-ablation (r = -0.23, p = 0.02). CONCLUSIONS:In this post-hoc analysis of the DECAAF II trial, we found that the majority of patients with LVSD and persistent AF have AIC rather than primary cardiomyopathy. We identified LGE-CMR as a differentiator between AIC and other cardiomyopathies.
