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Beygui F.,University of Caen Lower Normandy | Anguita M.,University of Cordoba, Spain | Tebbe U.,Abteilung Radiologie | Comin-Colet J.,IMIM Hospital del Mar Medical Research Institute | And 7 more authors.
Heart Failure Reviews

Heart failure (HF) is commonly described according to the severity of symptoms, using the New York Heart Association (NYHA) classification, and the assessment of ventricular function, by measuring the left ventricular ejection fraction (LVEF). It is important to acknowledge, however, that the severity of symptoms does not systematically correlate with the level of ventricular systolic dysfunction. Patients with no or only mild symptoms are still at high risk of HF-related morbidity and mortality. The objective of this review was to summarize the prevalence, characteristics, and treatment of patients with chronic HF and mild or no symptoms and to review epidemiological data from three recent registries conducted in Europe. From a clinical practice perspective, patients with a reduced ejection fraction who have only mild symptoms appear to represent a group of patients for whom the provision of adequate medical care is yet to be optimized. While prescription of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and beta-blockers appears to be consistently high, the use of mineralocorticoid receptor antagonists is more variable and does not appear to be in accordance with the latest clinical guidelines. As approximately half of patients with HF and a reduced LVEF have NYHA class II symptoms, significant reductions in morbidity and mortality could be achieved by more comprehensive treatment of this population. © 2015, Springer Science+Business Media New York. Source

Luik A.,Medizinische Klinik IV | Radzewitz A.,Medizinische Klinik IV | Kieser M.,University of Heidelberg | Walter M.,Medizinische Klinik IV | And 10 more authors.

Background - There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Methods and Results - In a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; P=0.933). For the intention-to-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, -0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, -0.097 to 0.116; P=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; P=0.002). Conclusion - This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation. © 2015 The Authors. © 2015 The Authors. Source

Hanefeld M.,Study Center Professor Hanefeld | Bramlage P.,Institute for Pharmacology and Preventive Medicine
Current Diabetes Reports

There has been a recent shift from a uniform treatment targeting HbA1c to a patient centered approach due to disappointing results of intensified glucose control in mega-trials such as VADT, ADVANCE, and ACCORD. In addition, morbidity and mortality has been substantially reduced since the UKPDS leading to an overestimation of the absolute risk for cardiovascular complications in randomized controlled trials. With substantial progress in prevention of cardiovascular complications, patients with type 2 diabetes now survive long enough to face diabetes-related complications and cancer risk. This requires rethinking of antidiabetic treatment strategies as exemplified by a recent consensus statement of the EASD and ADA, calling for a more patient centered treatment. Within this context the value of early insulin initiation was reinforced, the clinical utility of which has been demonstrated in the recent ORIGIN trial. ORIGIN demonstrated neutral results for the primary endpoint, but reduced microangiopathy in patients with an HbA1c value of ≥6.4 % with basal insulin glargine. After 5 years of follow-up 77 % of the patients in the glargine arm and 66 % with standard care remained at an HbA1c <7 %. An ongoing long-term follow-up (ORIGINALE) will clarify whether this also translates into a reduction of macrovascular events and mortality. © 2013 The Author(s). Source

Hanefeld M.,TU Dresden | Fleischmann H.,Sanofi S.A. | Schiffhorst G.,IGES Institute GmbH | Bramlage P.,Institute for Pharmacology and Preventive Medicine
Diabetes Technology and Therapeutics

Background: It was the aim of this study to assess baseline predictors for glycosylated hemoglobin (HbA1c) reduction, treatment-to-target, and insulin glargine dose in patients with an HbA1c level of ≥7.5% (58 mmol/mol) at baseline despite 3 months of maximum tolerated dose of metformin under daily conditions. Subjects and Methods: This was an open, multicenter, prospective observational study with a 6-month follow-up including 1,438 patients with type 2 diabetes. Baseline variables independently associated with HbA1c (overall reduction and achievement of target values) and insulin glargine dose used were determined using a stepwise multivariate linear regression analysis. Results: In a multivariate linear regression analysis (R2=0.545) baseline HbA1c (β=-0.722; P<0.001) and retinopathy (β=-0.064; P=0.007) were associated with a greater HbA1c reduction at 6 months, whereas duration of diabetes was associated with a lesser HbA1c reduction (β=0.084; P<0.001). In another multivariate linear regression analysis, weight (odds ratio [OR] 0.99; 95% confidence interval [CI] 0.98 to <1.00), duration of diabetes (OR 0.96; 95% CI 0.93-0.99), and baseline HbA1c (OR 0.65; 95% CI 0.56-0.76) were associated with a reduced likelihood of achieving an HbA1c level of <7% (53 mmol/mol); baseline HbA1c (OR 0.66; 95% CI 0.51-0.85) was the only variable associated with a reduced likelihood of achieving an HbA1c level of <6.5% (48 mmol/mol). In a further analysis (R2=0.135) the insulin dose needed was increased in those with a higher body weight (β=0.230; P<0.001), a longer duration of diabetes (β=0.134; P<0.001), a higher baseline HbA1c level (β=0.205; P<0.001), and the presence of microalbuminuria (β=0.096; P=0.003). Conclusions: Identified predictors of greater HbA1c reduction, target goal achievement, and insulin dose needed may help to optimize the balance of benefits and risks with the use of insulin glargine. © 2014, Mary Ann Liebert, Inc. Source

Schmieder R.E.,Friedrich - Alexander - University, Erlangen - Nuremberg | Ott C.,Friedrich - Alexander - University, Erlangen - Nuremberg | Bramlage P.,Institute for Pharmacology and Preventive Medicine
Current Hypertension Reports

In the last decade, intravenous renal denervation (RDN) has emerged as an alternative to pharmacological treatment in patients with resistant hypertension, but currently involves an invasive and technically challenging procedure. The Surround Sound™ system utilises externally delivered ultrasound to achieve RDN using a completely non-invasive, automated real-time tracking system coupled with a therapeutic delivery module thereby addressing these limitations. A brief history, technical overview and summary of preclinical and clinical studies of the KonaMedical Surround Sound™ system are presented. A literature search using the terms “renal denervation”, “resistant hypertension” and “external ultrasound” was performed using PubMed, and references retrieved were selected based on relevancy and year of publication (date range 1991–2015). The Surround Sound™ system appears to be a promising approach to RDN which eliminates several of the factors currently limiting the intravenous approach. So far, it has demonstrated efficacy for reducing blood pressure in resistant hypertension patients with minimal adverse effects. Several double-blind, sham-controlled clinical trials are currently underway to confirm the validity of these findings. © 2016, Springer Science+Business Media New York. Source

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