Introduction: In adults with congenital heart disease (ACHD), atrial arrhythmias (AA) confer an increased risk of thromboembolic events. Limited data exist on non-vitamin K oral anticoagulant (NOAC) treatment for ACHD. We aimed to assess the effectiveness and safety of apixaban in ACHD patients with AA. Methods: PROTECT-AR (NCT03854149) was a prospective, multicenter, observational study conducted from 2019 to 2023. ACHD patients with atrial fibrillation, atrial flutter, or intra-atrial re-entrant tachycardia, who were routinely treated with apixaban, were included. The primary efficacy endpoint was the composite of stroke or thromboembolism. The primary safety endpoint was major bleeding. Patients who were previously on vitamin K antagonists (VKAs) before transitioning to apixaban served as a historical control group. Results: In total, 218 patients with ACHD and AA on apixaban (previous VKA users 34.9%) were included (mean age 51±17 years; 45.9% male; predominantly moderate complexity). Over a mean follow-up of 2.4±1.3 years, the rate of stroke or thromboembolism was 0.57% [95% confidence interval (CI): 0.15-1.55] and the rate of major bleeding was 1.52% [95%CI: 0.71-2.88] per patient-year, respectively. In the subset of patients who were previously on VKA, the risk of the primary endpoints did not differ significantly between apixaban and VKA-treatment periods (Figure). Conclusion In ACHD patients with AA on routine apixaban treatment, the risk of major thromboembolic and bleeding events was low. Among prior VKA users, the risk of adverse events during the apixaban-treatment period was comparable to that during the VKA-treatment period. Prospective studies directly comparing NOAC and VKA-treated patients are needed.
Abstract Introduction/Background At present the impact of plasma biomarkers in predicting outcome of patients with isolated acute pericarditis (AP) has been poorly investigated. Purpose This study aimed to investigate the prognostic role of fibrin d-dimers (DD), an easily obtainable biomarker, in patients with AP. Methods This is a prospective clinical study enrolling 265 consecutive patients hospitalized between September 2010 and May 2019 with a first episode of AP. At baseline demographics, clinical features, laboratory, imaging findings and treatment were recorded. All patients were followed-up for a minimum period of 18 months. DD measurement at presentation was at the discretion of the examining physician since their measurement is not performed as per protocol in patients with suspected AP. End-points included cardiac tamponade, new-onset atrial fibrillation, pericardial drainage, recurrent/constrictive pericarditis and death. Results DD were measured in 165 out of 265 patients (62.3%, median levels 1456 ng/ml) at presentation. Among them 121 patients (73.3%) presented with elevated age-adjusted DD levels. Patients with elevated DD compared to those without depicted a higher rate of pleural (69.4%, vs 38.6%, p<0.001) and pericardial effusions (89.3% vs 72.7%, p=0.009). Concerning baseline laboratory values, patients with elevated DD presented with lower hematocrit and higher platelet counts, admission and peak C-reactive protein levels, as well as serum Glutamic pyruvic transaminase (SGPT) (Figure 1). In terms of outcome patients with elevated DD depicted a trend towards a greater prevalence of pericardial tamponade vs those without (14.9% vs 4.5% respectively, p=0.07). No significant difference was observed in the remainder of the endpoints during a median follow-up of 51 months. Notably, 43.8% of patients with elevated DD underwent computed tomography pulmonary angiography (CTPA), with all of the examinations being negative for pulmonary embolism. Conclusion Elevated DD plasma values in AP patients is a marker of high inflammatory burden. A trend of this plasma biomarker elevation and in-hospital cardiac tamponade was also observed. DD elevation in AP patients should be interpreted with caution and should not prompt unnecessary investigations (such as CTPA).
Objective: The Early Vascular Aging Ambulatory score (EVVAs) identify hypertensive patients with Early Vascular Aging using ambulatory blood pressure monitoring values and classic cardiovascular risk factors. Our aim was to validate the EVAAs externally in a new population-based cohort study. Design and method: This cohort study included all consecutive patients (N = 789, 45.87 ± 23.27, 45.4% men), who referred to the Hypertension-24hour Ambulatory Blood Pressure Monitoring Center of Excellence, at the 3rd Internal Medicine Department of Aristotle University for elevated BP and consented to participate to the study. Carotid-femoral pulse wave velocity (c-f PWV) was measured in all patients. EVA was defined as c-f PWV values higher than the expected for age average values according to European population data. We evaluated the predictive power of the original EVVAs. Results: The calculated sensitivity and specificity for EVAAS was 98% and 75% respectively. The EVVAs has a high positive predictive value (PPV) of 95%. The negative predictive value (NPV) was slightly lower at 92%. Receiver operating characteristic curve, including the area under the curve, was 0.951 which indicates a very high accuracy. Conclusions: The external validation of the EVVAs yields high sensitivity and PPV in an independent population. The EVAAs should now be evaluated for its predictive value regarding cardiovascular mortality and morbidity. Finally, the prediction of EVA, assessed by EVAAs, could be used to guide early lifestyle or pharmaceutical interventions in order to prevent future CV events.
Abstract Background: Valvular heart disease (VHD) in non-valvular atrial fibrillation (AF) is a puzzling clinical entity. The aim of this study was to evaluate the prognostic effect of significant VHD (sVHD) among patients with non-valvular AF. Methods: This is a post-hoc analysis of the MISOAC-AF trial (NCT02941978). Consecutive inpatients with non-valvular AF who underwent echocardiography were included. sVHD was defined as the presence of at least moderate aortic stenosis (AS) or aortic/mitral/tricuspid regurgitation (AR/MR/TR). Cox regression analyses with covariate adjustments were used for outcome prediction. Results: In total, 983 patients with non-valvular AF (median age 76 years) were analyzed over a median follow-up period of 32 months. sVHD was diagnosed in 575 (58.5%) AF patients. sVHD was associated with all-cause mortality (21.6%/yr vs. 1.6%/yr; adjusted HR [aHR] 1.55, 95% confidence interval [CI] 1.17-2.06; p = 0.02), cardiovascular mortality (16%/yr vs. 4%/yr; aHR1.70, 95% CI 1.09-2.66; p = 0.02) and heart failure-hospitalization (5.8%/yr vs. 1.8%/yr; aHR 2.53, 95% CI 1.35-4.63; p = 0.02). The prognostic effect of sVHD was particularly evident in patients aged <80 years and in those without history of heart failure (p for interaction < 0.05, in both subgroups). After multivariable adjustment, moderate/severe AS and TR were associated with mortality, while AS and MR with heart failure-hospitalization. Conclusion: Among patients with non-valvular AF, sVHD was highly prevalent and beared high prognostic value across a wide spectrum of clinical outcomes, especially in patients aged <80 years or in the absence of heart failure. Predominantly AS, as well as MR and TR, were associated with worse prognosis.
Introduction The risk for stroke in adults with congenital heart disease (ACHD) is increased, especially in the setting of commonly ensuing atrial arrhythmias (AA), namely atrial fibrillation, atrial flutter or intra-atrial re-entrant tachycardia. Data are limited regarding treatment with non-vitamin K oral anticoagulants in long-term studies involving patients with ACHD and AA. Methods and analysis PReventiOn of ThromboEmbolism in Adults with Congenital HearΤ disease and Atrial aRrhythmias is a prospective, multicenter, single-arm, non-interventional cohort study designed to investigate the safety and efficacy of apixaban for the prevention of thromboembolism in ACHD with AA in a ‘real-world’ setting. Eligible patients will be evaluated by the means of available registries and clinical counter. The study aims to accumulate approximately 500 patient-years of exposure to apixaban as part of routine care. Enrolment will take place at four ACHD centres in Greece. The first patient was enrolled in July 2019. The primary efficacy endpoint is a composite of stroke, systemic or pulmonary embolism and intracardiac thrombosis. The primary safety endpoint is major bleeding, according to the International Society on Thrombosis and Haemostasis bleeding criteria. Ethics and dissemination The study protocol has been approved by the institutional review board/independent ethics committee at each site prior to study commencement. All patients will provide written informed consent. Results will be disseminated at scientific meetings and published in peer-reviewed journals. Trial registration number NCT03854149 ; Pre-results.
Dilated cardiomyopathy (DCM) is a heart disorder of diverse etiologies that affects millions of people worldwide, associated with increased mortality rate and high risk of sudden cardiac death. Patients with DCM are characterized by a wide range of clinical and pre-clinical phenotypes which are related with different outcomes. Dominant studies have failed to demonstrate the value of the left ventricular ejection fraction as the only indicator for patients’ assessment and arrhythmic events prediction, thus making sudden cardiac death (SCD) risk stratification strategy improvement, more crucial than ever. The multifactorial two-step approach, examining non-invasive and invasive risk factors, represents an alternative process that enhances the accurate diagnosis and the individualization of patients’ management. The role of genetic testing, regarding diagnosis and decision making, is of great importance, as pathogenic variants have been detected in several patients either they had a disease relative family history or not. At the same time there are specific genes mutations that have been associated with the prognosis of the disease. The aim of this review is to summarize the latest data regarding the genetic substrate of DCM and the value of genetic testing in patients’ assessment and arrhythmic risk evaluation. Undoubtedly, the appropriate application of genetic testing and the thoughtful analysis of the results will contribute to the identification of patients who will receive major benefit from an implantable defibrillator as preventive treatment of SCD.
