The future of real-life studies
(Source: European Journal of Heart Failure Supplements)
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Kakkar, L. A. Tags: Articles Source Type: research

Stroke prevention in atrial fibrillation: evidence from real-life studies
Atrial fibrillation (AF) is an increasing public health issue, especially owing to an accompanying five-fold increased risk of stroke. Anticoagulants are the cornerstone of therapy for stroke prevention in AF. The clinical benefits of vitamin K antagonists (VKAs; namely warfarin) shown in randomized controlled trials (RCTs) have been challenged when used in clinical practice by issues including the need for international normalized ratio (INR) monitoring, food and drug interactions, low time in the therapeutic range in substantial numbers of patients, and serious bleeding events. Combined, these have led to both an under-i...
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Akao, M., Beyer-Westendorf, J., Goto, S., Peterson, E. Tags: Articles Source Type: research

Venous thromboembolism prevention and treatment: expanding the rivaroxaban knowledge base with real-life data
This article will consider these uncertainties, along with data on rivaroxaban use from a number of key non-interventional studies and registries, namely XAMOS, ORTHO-TEP, the Dresden NOAC registry, RIETE, and PREFER in VTE. These data suggest that outcomes with NOACs such as rivaroxaban in RCTs are reproducible in real-life, making these agents a simple, effective treatment choice for a wide range of patients at risk of, or suffering from, VTE. (Source: European Journal of Heart Failure Supplements)
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Beyer-Westendorf, J., Cohen, A. T., Monreal, M. Tags: Articles Source Type: research

The GRACE registry: how real-life evidence contributes to acute coronary syndrome guidelines
(Source: European Journal of Heart Failure Supplements)
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Verheugt, F. W. Tags: Articles Source Type: research

Continued commitment to safety: building on the existing rivaroxaban knowledge base
Data from post-authorization studies and registries are valuable in establishing the safety and effectiveness of therapies in real-life settings, particularly as physicians may have concerns about the robustness of safety data from randomized controlled trials (RCTs). Furthermore, in routine clinical practice, there may be a potential for increased adverse event reporting with new therapies, and their true safety profile may be difficult to elucidate. The non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) rivaroxaban is a direct factor Xa inhibitor, first approved for the prevention of venous thromboembolism (VTE) fo...
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Beyer-Westendorf, J., Haas, S., Turpie, A. G. G. Tags: Articles Source Type: research

Achieving access: addressing the needs of payors and health technology assessment agencies
This article will discuss ways in which the healthcare industry, regulatory approval bodies, payors, and patients must collaborate to find adequate solutions for generating robust evidence for the use of new interventions. We will also consider the challenges and possible solutions that may allow the healthcare industry to ensure divergent needs of stakeholders are met, to achieve a balance of clinical effectiveness and value for all. (Source: European Journal of Heart Failure Supplements)
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Cox, J. L., de Pouvourville, G. Tags: Articles Source Type: research

Harnessing the power of real-life data
The total quantity of medical information available is expanding at an unprecedented pace, yet there remains a shortage of data to help clinicians and healthcare systems make choices among treatments and strategies. With rising healthcare costs, the need to optimize resource utilization is crucial. Comparative effectiveness research (CER) is emerging as a tool to facilitate head-to-head comparisons and provides evidence-based answers to important clinical questions. Many forms of CER exist, from randomized controlled trials and prospective clinical registries to retrospective studies and systematic reviews. Information fro...
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Cox, J. L., Pieper, K. Tags: Articles Source Type: research

Why do we need observational studies of everyday patients in the real-life setting?
Randomized controlled trials (RCTs) are performed with the primary goal of understanding the safety and efficacy of a new therapy in a selected group of patients. Even when evidence from these studies strongly favours a new therapy, its role in routine clinical practice may be unclear because of the considerable differences between its efficacy (in clinical trials) and its effectiveness (in the real-life setting). Real-life studies are observational studies that are essential to document benefits and harms of therapy in a wider population and to determine whether patients in routine practice are achieving expected outcomes...
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Cohen, A. T., Goto, S., Schreiber, K., Torp-Pedersen, C. Tags: Articles Source Type: research

Foreword: Getting research into practice
(Source: European Journal of Heart Failure Supplements)
Source: European Journal of Heart Failure Supplements - July 10, 2015 Category: Cardiology Authors: Kakkar, L. A. Tags: Articles Source Type: research

A simple method to localize transseptal puncture site during catheter ablation for atrial fibrillation
This study aims to describe a simple technique to safely localize appropriate TP site during atrial fibrillation (AF) ablation procedure. Inferior vena cava (IVC) angiography was performed at RAO 45°. The IVC, right atrium (RA), right-ventricular inflow tract, and right-ventricular outflow tract were sequentially visualized while the aorta was visualized as non-opacified filling defect. The appropriate TP site was in the middle of the RA, inferoposterior to the non-coronary aortic sinus (NCAS) and superoposterior to coronary sinus ostium. The spatial relationship of these structures was studied in 81 patients. The dist...
Source: European Journal of Heart Failure Supplements - June 25, 2015 Category: Cardiology Authors: Dong, J.-Z., Ning, M., Yu, R.-H., Long, D.-Y., Tang, R.-B., Sang, C.-H., Jiang, C.-X., Bai, R., Du, X., Nie, S.-P., Ma, C.-S. Tags: Articles Source Type: research

Prolyl-4-hydroxylase-{alpha}1 improves the stability of advanced plaques but accelerates the atherosclerotic lesion formation of early plaques
To investigate the changes in Prolyl 4-hydroxylase (P4Hα1) expression during the pathological course of atherosclerotic plaque development and to test the effect of P4Hα1 overexpression on vulnerability of early and advanced plaque in apolipoprotein E-deficient (ApoE–/–) mice. In vivo, the changes in P4Hα1 level were assessed during the pathological course of spontaneously induced atherosclerotic plaque in the aortic root of ApoE–/– mice at 10, 12, 14, and 16 weeks of age and fed a high-fat diet. A lentivirus-mediated P4Hα1 construct was transfected in carotid plaque induced ...
Source: European Journal of Heart Failure Supplements - June 25, 2015 Category: Cardiology Authors: Huang, X. Z., Liu, X. X., Song, J. T., Wang, L., Liu, X. L., Qu, H. Y., Wang, S. x., Zhang, C., Zhang, Y., Zhang, M. Tags: Articles Source Type: research

Effects of Qili Qiangxin capsule on renal aquaporin-2 expression in rats with chronic heart failure
Qili Qiangxin is a traditional Chinese medical formulation, which can improve cardiac function, urine volume, and subjective symptoms in patients with chronic heart failure (CHF). We sought to investigate whether Qili Qiangxin could suppress renal aquaporin-2 (AQP2) expression in a rat model of CHF. High, medium, and low dosages of Qili Qiangxin (1.0, 0.5, and 0.25 g.kg–1.d–1, respectively) were administered intragastrically to rats with CHF. The continuous administration of Qili Qiangxin for 1 week increased urine volume while the indexes of cardiac function were unchanged after treatment for 1 week. Interesti...
Source: European Journal of Heart Failure Supplements - June 25, 2015 Category: Cardiology Authors: Zeng, Q.-C., Wu, Z.-L., Huang, Y.-L., Hua, J.-H., Ye, T.-C., Lai, W.-Y., Ren, H., Xu, D.-L. Tags: Articles Source Type: research

Novel risk scoring for pre-procedural prediction of contrast-induced nephropathy and poor long-term outcomes among patients with chronic total occlusion undergoing percutaneous coronary intervention
Contrast-induced nephropathy (CIN) is a known complication of percutaneous coronary intervention (PCI). We aimed to develop a simplified risk scoring system based upon pre-procedure characteristics for predicting CIN and poor long-term outcomes in patients with chronic total occlusion (CTO) undergoing PCI. We prospectively enrolled 629 consecutive patients with CTO who were scheduled to undergo PCI. The patients were randomized in a 3 : 2 ratio to create a training (n = 356) and a validation cohort (n = 273). The primary endpoint was CIN, which was defined as an absolute increase in serum creatinine (SCr) ≥0.5 mg/dL ove...
Source: European Journal of Heart Failure Supplements - June 25, 2015 Category: Cardiology Authors: Liu, Y., Liu, Y.-H., Tan, N., Chen, J.-Y., Zhou, Y.-L., Duan, C.-Y., Li, H.-L., Chen, P.-Y. Tags: Articles Source Type: research

A novel simplified thrombo-inflammatory prognostic score for predicting in-hospital complications and long-term mortality in patients with type A acute aortic dissection: a prospective cohort study
Inflammation and thrombosis are involved in the progression of acute aortic dissection (AD). A novel simplified thrombo-inflammatory prognostic score (sTIPS), based on white blood cell count (WBC) and mean platelet volume (MPV) to platelet count (PC) ratio (MPV/PC ratio), was assessed for its ability to predict adverse clinical outcomes in type A acute aortic dissection (AAD). One hundred and six patients with newly diagnosed AAD were included in the study. Simplified thrombo-inflammatory prognostic scores ranged from 0 to 2. Kaplan–Meier curves and multivariable Cox regression analyses were used to investigate the a...
Source: European Journal of Heart Failure Supplements - June 25, 2015 Category: Cardiology Authors: Li, D.-Z., Li, X.-M., Sun, H.-P., Yang, Y.-N., Ma, Y.-T., Qu, Y.-Y., Ma, X., Liu, F. Tags: Articles Source Type: research

Renal function-adjusted safe contrast volume to prevent contrast-induced nephropathy and poor long-term outcomes in patients with chronic total occlusions undergoing cardiac catheterization
We aimed to evaluate the value of the contrast volume to creatinine clearance (V/CrCl) ratio for predicting contrast-induced nephropathy (CIN) and to determine a safe V/CrCl cut-off value to avoid CIN in patients with chronic total occlusions (CTOs) undergoing cardiac catheterization. We prospectively enrolled 728 consecutive patients with CTOs undergoing cardiac catheterization. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for CIN was assessed using multivariate logistic regression. Twenty-one patients (2.88%) d...
Source: European Journal of Heart Failure Supplements - June 25, 2015 Category: Cardiology Authors: Liu, Y., Liu, Y.-h., Chen, J.-y., Tan, N., Li, H.-l., Luo, J.-f., Chen, Z.-j., Yu, D.-q., Li, G., Huang, W.-h., Xie, N.-j., He, P.-c., Yang, J.-q., Duan, C.-y., Chen, S.-q., Chen, P.-y. Tags: Articles Source Type: research