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Background: Underuse of oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) results in thousands of preventable strokes in Germany each year. This study aimed to assess changes in antithrombotic therapy in AF patients after increased use of direct oral anticoagulants (DOACs) in Germany and to evaluate whether the adoption of DOAC therapy was associated with changes in AF-related stroke and bleeding over time., Methods: Analyses were carried out on a large claims-based dataset of 4 million health-insured Germans. The study population consisted of 601,261 prevalent AF patients between 2011 and 2016 who were assigned to one of the following four treatment groups: DOAC, VKA, antiplatelets or no antithrombotic treatment. Treatment patterns were descriptively analysed and represented by cohort and CHA 2 DS 2 -VASc score. Clinical outcomes before and after the adoption of DOAC therapy were assessed using Poisson regression models., Results: Use of OAC increased from 42 to 61% between 2011 and 2016, mainly due to more frequent prescription of DOACs. However, some underuse of OAC therapy remained even in high risk AF patients. In parallel with the increased prescription rate of OAC, there was an overall 24% incidence reduction in stroke between 2011 and 2016 which was mainly driven by reductions in ischemic strokes. Over the same time period the risk for major bleeding remained unchanged., Conclusion: Between 2011 and 2016, the use of guideline-conform antithrombotic therapy in Germany has significantly increased. This was associated with a significant decline in strokes without an increased incidence of bleeding complications.

Background: The use of quadripolar (QP) left ventricular leads for cardiac resynchronization therapy (CRT) is intended to improve outcomes compared with conventional bipolar leads (BP). Hence, the number of implanted quadripolar CRT systems is increasing despite limited long-term data., Purpose: The aim of this study is to evaluate clinical response and long-term outcomes of CRT recipients who were implanted with quadripolar versus bipolar left ventricular leads., Methods: Data from consecutive patients receiving a CRT defibrillator in one German and one Hungarian tertiary referral center were retrospectively collected. Long-term survival and response to CRT were analyzed., Results: A total of 536 patients with structural heart disease and a mean left ventricular ejection fraction (LVEF) of 25% received a CRT defibrillator (CRT-D) system for primary (79%) or secondary (21%) prevention of sudden death. Comorbidities did not differ significantly between patients receiving a QP (n = 123) or a BP lead (n = 413). Procedure (101 vs. 120 min) and fluoroscopy times (14 vs. 20 min) were shorter in patients implanted with QP compared with BP (both p < 0.001). At 6 months follow-up, QP patients were more likely to respond to CRT measured as improvement in the New York Heart Association (NYHA) functional class (77% vs. 63%; p < 0.001). Use of QP left ventricle/left ventricular (LV) leads was associated with greater reduction in QRS duration compared with patients implanted with BP LV leads (- 21 ± 30 vs. - 8 ± 35 ms, p = 0.004). Mortality was not significantly different between patients with QP and patients with BP LV leads at a mean follow-up of 39 ± 31 months., Conclusion: Implantation of quadripolar left ventricular leads was associated with better CRT response compared with bipolar left ventricular leads.

Geriatric characteristics such as high age, multi-morbidity, polypharmacy and frailty are common in patients with atrial fibrillation (AF). In a retrospective study using a German claims database, effectiveness (ischaemic stroke/systemic embolism) and safety (intracerebral, gastrointestinal and major extracranial bleeding) were compared in patients with non-valvular AF starting non-vitamin K oral antagonists (NOACs) (apixaban, dabigatran and rivaroxaban) and phenprocoumon. Cox proportional hazards models were used to calculate adjusted hazard ratios, and interaction terms of the treatment group and geriatric status (defined by age ≥75 years, frailty, ≥ 4 co-morbidities and polypharmacy) were entered into the model. A total of 42,562 and 27,939 patients initiated NOAC and phenprocoumon treatment (mean age 74 years ± 11, 51% male) with a follow-up time of 147,785 person-years. Note that 52.9% of patients were elderly, 50.8% were frail, 37.0% were co-morbid and 46.5% had polypharmacy. NOAC use was not associated with effectiveness and gastrointestinal bleeding, neither in geriatric nor in non-geriatric patients. The hazard of major extracranial and intracranial bleeding was significantly decreased for NOAC use, with similar risk reduction in geriatric and non-geriatric patients: major extracranial bleeding 0.70 (95% confidence interval [CI], 0.56-0.87) to 0.73 (95% CI, 0.60-0.89) for the geriatric groups and 0.71 (95% CI, 0.56-0.93) to 0.76 (0.59-0.98) for the non-geriatric groups ( p -values for interaction > 0.6); and intracranial bleeding 0.52 (95% CI, 0.39-0.69) to 0.59 (95% CI, 0.47-0.73) for the geriatric groups and 0.54 (95% CI, 0.37-0.79) to 0.65 (95% CI, 0.49-0.86) for the non-geriatric groups ( p -values for interaction > 0.2). Hence, NOACs showed similar effectiveness and superior safety in geriatric and non-geriatric patients., Competing Interests: Dr. Hohmann has served as a consultant for Pfizer and received non-financial support from Orion Pharma, Actelion Pharma, Bayer and MSD. Professor Hohnloser has served as a consultant for Bayer, BMS/Pfizer, Boehringer-Ingelheim, Daiichi Sankyo and Jansen. Professor Pfister received lecture fees from Bayer, BMS/Pfizer and Daiichi Sankyo. Other authors report no conflict of interest.The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Georg Thieme Verlag KG Stuttgart · New York.)

Background:  This study assessed changes in anticoagulation therapy over time in patients with atrial fibrillation (AF)., Methods:  Analyses were performed on a claims-based dataset of 4 million health-insured individuals. The study population consisted of patients newly initiating a non-vitamin-K oral anticoagulants (NOACs) or vitamin K antagonist (VKA) for AF between 2013 and 2016. The study outcomes consisted of the proportion of patients who had (1) discontinued OAC treatment, (2) switched from VKA to NOAC, (3) switched from NOAC to VKA or (4) switched from one NOAC to another. Predictors of discontinuation or switching of OAC treatment were determined by Cox proportional hazards regression models with time-independent and time-dependent covariates., Results:  The study population comprised 51,606 AF patients initiating VKA ( n  = 21,468, 41.6%), apixaban ( n  = 8,832, 17.1%), dabigatran ( n  = 3,973, 7.7%) or rivaroxaban ( n  = 17,333, 33.6%). After 1 year, 29.9% of VKA and 29.5% of NOAC patients had discontinued OAC treatment without switching to another anticoagulant. A total of 10.7% of VKA patients switched to NOACs within 1 year, whereas 4.9% NOAC patients had switched to VKA. Of AF patients who were initiated on a NOAC, 5.2% switched to another NOAC. Treatment changes among NOAC starters were strongly associated with occurrence of stroke, myocardial infarction and gastrointestinal bleeding after treatment initiation. For VKA starters switching to a NOAC, stroke and bleeding events were associated with an increased likelihood of switching., Conclusion:  Overall discontinuation rates of VKA and NOACs are comparable over the first year of therapy, while switching from VKA to NOAC was more common than from NOAC to VKA. The majority of treatment changes were associated with clinical events., Competing Interests: Professor Hohnloser has served as a consultant for Bayer, BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo and Jansen. Professor Näbauer has received lecture fees from Bayer, BMS/Pfizer, Boehringer Ingelheim and Daiichi Sankyo. Dr. Basic is an employee of Pfizer Deutschland GmbH. The authors have indicated that they have no other conflicts of interest regarding the content of this article., (Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: The number of cardiac implantable electronic devices is growing worldwide because they play a relevant role in improving the survival rate in patients with specific heart diseases. Cardiac implantable electronic devices complications including infection, dysfunction or venous stenosis increase the need for the least traumatic way to explant leads. Our goal was to report the successes and procedural complication rates of transvenous lead extraction (TLE) in a consecutive series of patients., Methods: From 2010 to 2016, 108 patients underwent TLE of 227 leads due to endocarditis (n = 21; 19%), pocket infection (n = 58; 54%) or lead dysfunction (n = 29; 27%). In 98% (n = 106) of the patients, laser-assisted lead extraction was performed. In 2% (n = 2) of the patients, the application of a solitary locking stylet was sufficient. The patient mean age was 68 ± 14 years; 25% of the patients had previous cardiac surgery. TLE was performed a mean of 9 ± 6 years after the implantation of the existing device., Results: Complete procedural success (removal of all lead material from the vascular space) was achieved in 98.7% (n = 224), and clinical success (achievement of all clinical goals associated with the indication for lead removal and absence of major complications) was achieved in 98% (n = 106). In 2 patients the procedure failed due to a vascular tear requiring a thoracotomy. In 1 patient, complete lead extraction was not possible due to heavy calcification (coronary-sinus lead). The 30-day mortality rate was 3.7% (n = 4); the patients died of multiorgan failure (n = 1), cardiac failure (n = 1) and septicaemia (n = 2). The procedure-related major complication rate was 2% (n = 2)., Conclusions: Laser-assisted TLE seems to be a safe and effective procedure with an acceptable complication rate., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Introduction: Atrial fibrillation (AF) is associated not only with inflammation but also with structural remodelling and altered endothelial activation which may contribute to clot formation, embolization and mortality. We aimed to determine the predictive value of single-time biomarker analysis for prediction of outcome in patients with AF., Methods and Results: We conducted a prospective study to evaluate if biomarkers of structural, electrical or endothelial remodelling are predictive of cardiovascular events (composite primary endpoint of myocardial infarction, stroke, peripheral embolism or death). Secondary endpoint was all-cause mortality. Patients with any type of AF and without active inflammatory conditions were eligible. Plasma samples were collected for ELISA analysis of biomarkers (inflammation [hsCRP, sCD40L], structural [MMP-2] and endothelial remodelling [vWF, sVCAM-1]) at enrolment. Patients (n = 278) were followed for 28 ± 12 (median 32) months. Eighty-eight individuals (32%) experienced a primary outcome event, including 8 (2.9%) with myocardial infarction, 13 (4.8%) with stroke and 4 (1.5%) with peripheral embolism. Predictors of the primary endpoint were age >75 years, CHADS(2)-score >2, LVEF <35%, diabetes, presence of an ICD/pacemaker, elevated vWF, sVCAM-1 and MMP-2 levels. On multivariate regression analysis, only age >75 years, sVCAM-1 and MMP-2 levels remained independently associated with the endpoint. There were 75 deaths during follow-up. Age >75 years, reduced LVEF, elevated sVCAM-1 and MMP-2 levels were predictors of all-cause mortality., Conclusion: In this cohort of AF patients, old age, elevated sVCAM-1 and MMP-2 levels were associated with cardiovascular events. Our data indicate that single-time biomarker assessment may be a useful tool to improve risk stratification schemes.

Aims: Implantable cardioverter defibrillator (ICD) technology has become more complex, particularly with respect to biventricular resynchronization devices. The incidence of hardware-related complications in single (SC)-, dual (DC)-, and triple (BiV)-chamber devices requiring surgical revision has not been investigated systematically., Methods and Results: We analysed data from consecutive ICD recipients implanted between January 2000 and December 2007 with respect to the need of surgical re-intervention for device- or lead-related complications. Generator exchanges due to normal battery depletion were not considered. From 816 patients (81% male, 69% ischaemic cardiomyopathy, 48% secondary prevention ICDs) followed for 31 +/- 24 months (2118 cumulative patient-years), 98 patients underwent 110 revisions (5.2% per patient-year). Complications included lead-related revision procedures in 81 cases and generator-related problems in 29 cases. The annual incidence of surgical revision due to complications was 11.8% in BiV compared with 4.9% in SC and 4.1% in DC patients (P = 0.002). This higher revision rate was mainly caused by lead-related complications. Implantation of a BiV system was an independent risk factor of the need for surgical revision (relative risk 2.37, 95% confidence interval 1.38-4.04)., Conclusion: Even with long-lasting operator experience, complications requiring surgical revision remain a clinically important problem of ICD therapy. The incidence of complications is significantly higher in BiV resynchronization devices than in SC and DC systems.

Atrial fibrillation (AF) is the most common arrhythmia requiring medical care, with a prevalence of almost 1% in the adult population. Particularly in the expanding elderly population, pharmacological therapy is and will continue to be the mainstay of AF therapy. Many currently used antiarrhythmic drugs have limited efficacy and cause cardiac and extracardiac toxicity. Thus, there is a continued need for development of new compounds with good efficacy and particularly with a favorable safety profile. Much emphasis is currently given to the development of so-called atrial-selective agents which target ion channels or proteins predominantly expressed in atrial myocardium. The rationale behind these compounds is to avoid unwanted effects on ionic currents on the ventricular site thus avoiding ventricular proarrhythmic effects. Alternatively, more conventional multichannel-blocking drugs are developed, for instance congeners of amiodarone. These molecules are designed to retain the electrophysiological efficacy of the mother compound while avoiding the extracardiac toxicity of this drug. The compounds which are far advanced in their clinical development are vernakalant ("atrial-selective") and dronedarone (multichannel-blocking). Preclinical and clinical findings of these substances are summarized.

Background: Noninvasive arrhythmia risk stratification in patients with nonischemic dilated cardiomyopathy (DCM) using autonomic markers have yielded disappointing results. Heart rate turbulence is a new method to assess cardiac autonomic function., Aim: The aim of the study was to compare the predictive value of heart rate turbulence with those of conventional autonomic risk markers for ventricular tachyarrhythmic events in patients with DCM., Methods: The predictive value of heart rate turbulence, baroreflex sensitivity (phenylephrine method), and heart rate variability was assessed in patients with symptomatic congestive heart failure due to DCM who were in sinus rhythm and had a 24-hour Holter recording. Patients were followed for a combined end point of ventricular tachyarrhythmic events., Results: A total of 114 patients (mean left ventricular ejection fraction, 28 +/- 11%), included in the Frankfurt DCM database between 1996 and 2000, fulfilled the criteria for inclusion in this study. Determinate test results were obtained for heart rate variability in 98%, for baroreflex sensitivity in 90%, and for heart rate turbulence in 75% of patients (P = .008). Correlation between the different autonomic markers were only modest (r values, 0.36-0.43). During a follow-up of 22 +/- 17 months, an end point event occurred in 15 patients. On univariate analysis, left ventricular ejection fraction and baroreflex sensitivity were significant predictors of arrhythmic events. On multivariate analysis, only baroreflex sensitivity remained an independent predictor (chi(2) = 3.17; P = .07)., Conclusion: Reliable analysis of heart rate turbulence is possible in approximately 75% of eligible patients with DCM. Whereas blunted baroreflex sensitivity is a predictor of arrhythmic events, heart rate variability and turbulence do not yield predictive power in these patients.