[ARENA-Project atrial fibrillation in the Rhein-Neckar region]. / ARENA ­ Projekt Vorhofflimmern in der Rhein-Neckar-Region.

Atrial fibrillation (AF) is the most common form of cardiac tachyarrhythmia. It is estimated that in the Rhein-Neckar region approximately 40,000-50,000 out of 2 million people are affected. Due to demographic changes in the near future there will be a significant increase in the prevalence of AF within the next decades. The ARENA project was initiated by the Foundation Institute for Cardiac Infarction Research (IHF) Ludwigshafen in cooperation with cardiological and neurological departments of neighboring hospitals, resident doctors and pharmacies to improve the awareness and care of patients with AF. The particular aim is the prevention of stroke as one of the most dreaded complications. The project focusses on the following three subtopics: interventions, medication, migration. The aim of the intervention project is to raise awareness of AF as a risk factor for stroke and to improve the diagnostic work-up and care for patients with diagnosed or unknown AF. The subproject medication focusses on the adherence of patients with AF to the prescribed antithrombotic medication. To evaluate differences concerning patients with and without a migration background the subproject migration was initiated.

The German CPU registry: Comparison of smokers and nonsmokers.

BACKGROUND: Chest pain is a major reason for admission to an internal emergency department, and smoking is a well-known risk factor for coronary artery disease (CAD) and acute coronary syndrome (ACS). The aim of this analysis is to illustrate the differences between smokers and nonsmokers presenting to German chest pain units (CPU) in regard to patient characteristics, CAD manifestation, treatment strategy, and prognosis. METHODS: From December 2008 to March 2014, 13,902 patients who had a complete 3­month follow-up were enrolled in the German CPU registry. The analysis comprised 5796 patients with ACS and documented smoking status. RESULTS: Of all the patients in the CPU registry, 35.2% were smokers. Compared with nonsmokers, they were 13.5 years younger (58.2 vs. 71.7 years, p < 0.001), predominantly men (77.1% vs. 65.2%, p < 0.001), and were more frequently diagnosed with single-vessel disease (32.1% vs. 25.2%) as well as ST-elevation myocardial infarction (STEMI; 23.8% vs. 15.5%, p < 0.001). Although the Global Registry of Acute Coronary Events (GRACE) Risk Score for hospital mortality was lower in the group of smokers (106.1 vs. 123.3, p < 0.001), we did not observe any differences in CPU death (0.4% vs. 0.4%, p = 0.69) and CPU major adverse cardiac event (MACE) rates (3.8% vs 2.9%, p = 0.073) between the groups. In the 3­month follow-up, we documented higher mortality rates in the nonsmoker group (1.9% vs. 2.9%, p = 0.035) in correlation with the GRACE Risk Score (80.3 vs. 105.2, p < 0.001). MACE rates were similar during the follow-up (3.1% vs. 4.1%, p = 0.065). CONCLUSION: Observations from the German CPU registry demonstrate that smoking is a strong predictor of acute CAD manifestation early in life, especially STEMI. In spite of a lower GRACE Risk Score and fewer comorbidities, smokers had a rate of hospital mortality similar to the older group of nonsmokers.

Long-term symptom improvement and patient satisfaction after AV-node ablation vs. pulmonary vein isolation for symptomatic atrial fibrillation: results from the German Ablation Registry.

BACKGROUND: We aimed to compare patient characteristics and outcome of patients who had either undergone pulmonary vein isolation (PVI) or AV-node ablation (AVN) to control AF-related symptoms. METHODS: From the German Ablation Registry, we analyzed data of 4444 patients (95%) who had undergone PVI and 234 patients (5%) with AVN. RESULTS: AVN patients were on average 10 years older than PVI patients (71 ± 10 vs. 61 ± 10 years, p < 0.001) with 33% aged > 75 years. AVN patients had significantly more cardiovascular comorbidities (diabetes 21% vs. 8%, renal insufficiency 24% vs. 3%, underlying heart disease 80% vs. 36%, severely reduced left ventricular function 28% vs. 1%, all p < 0.001). Significantly more PVI patients had paroxysmal AF (63% vs. 18%, p < 0.001), and more AVN patients had long-standing persistent AF (44% vs. 7%, p < 0.001). At 1-year follow-up, mortality in the AVN group was much higher (Kaplan-Meier estimates 9.8% vs. 0.5%). 20% of PVI patients had undergone another ablation vs. 3% AVN patients (p < 0.001). Symptomatic improvement was equally achieved in about 80%. Re-hospitalization for cardiovascular reasons occurred significantly more often in PVI vs. AVN patients (31% vs. 18%, p < 0.001). CONCLUSION: In the large German Ablation Registry, AVN ablation was performed much less frequently than PVI for symptomatic treatment of AF and typically in older patients with more comorbidity. Symptomatic improvement was similar in both groups. Hospitalizations for cardiovascular reasons were lower in AVN patients despite older age and more cardiovascular comorbidities. 20% of PVI patients had undergone at least one re-ablation.

Predictors of Atrial Fibrillation Recurrence after Catheter Ablation: Data from the German Ablation Registry.

Catheter ablation (CA) for atrial fibrillation (AF) has emerged as a widespread first or second line treatment option. However, up to 45% of patients (pts) show recurrence of AF within 12 month after CA. We present prospective multicenter registry data comparing characteristics of pts with and without recurrence of AF within the first year after CA. This study comprises all pts with complete follow-up one year after CA (1-y-FU; n = 3679). During 1y-FU in 1687 (45.9%) pts recurrence of AF occurred. The multivariate analysis revealed female sex and AF type prior to the procedure as predictors for AF recurrence. Furthermore, comorbidities such as valvular heart disease and renal failure as well as an early AF relapse were also predictors of AF recurrence during 1-y-FU. However, despite an AF recurrence rate of 45.9%, the majority of these pts (72.4%) reported a significant alleviation of clinical symptoms. In conclusion in pts with initially successful CA for AF female sex, AF type, in-hospital AF relapse and comorbidities such as renal failure and valvular heart disease are independent predictors for AF recurrence during 1-y-FU. However, the majority of pts deemed their interventions as successful with significant reduction of symptoms irrespective of AF.

Clinical effects of long-term cardiac contractility modulation (CCM) in subjects with heart failure caused by left ventricular systolic dysfunction.

INTRODUCTION: Heart failure is a major cause of morbidity and mortality throughout the world. Despite advances in therapy, nearly half of patients receiving guideline-directed medical therapy remain limited by symptoms. Cardiac contractility modulation (CCM) can improve symptoms in this population, but efficacy and safety in prospective studies has been limited to 12 months of follow-up. We report on the first 2 year multi-site evaluation of CCM in patients with heart failure. METHODS: One hundred and forty-three subjects with heart failure and reduced ejection fraction were followed via clinical registry for 24 months recording NYHA class, MLWHFQ score, 6 min walk distance, LVEF, and peak VO2 at baseline and 6 month intervals as clinically indicated. Serious adverse events, and all cause as well as cardiovascular mortality were recorded. Data are presented stratified by LVEF (all subjects, LVEF <35%, LVEF ≥35%). RESULTS: One hundred and six subjects from 24 sites completed the 24 month follow-up. Baseline parameters were similar among LVEF groups. NYHA and MLWHFQ improved in all 3 groups at each time point. LVEF in the entire cohort improved 2.5, 2.9, 5.0, and 4.9% at 6, 12, 18, and 24 months, respectively. Insufficient numbers of subjects had follow-up data for 6 min walk or peak VO2 assessment, precluding comparative analysis. Serious adverse events (n = 193) were observed in 91 subjects and similarly distributed between groups with LVEF <35% and LVEF ≥35%, and similar to other device trials for heart failure. Eighteen deaths (7 cardiovascularly related) over 2 years. Overall survival at 2 years was 86.4% (95% confidence intervals: 79.3, 91.2%). CONCLUSION: Cardiac contractility modulation provides safe and effective long-term symptomatic and functional improvement in heart failure. These benefits were independent of baseline LVEF and were associated with a safety profile similar to published device trials.

Safety and efficacy in ablation of premature ventricular contraction: data from the German ablation registry.

BACKGROUND: Patients with frequent premature ventricular contractions (PVCs) are often highly symptomatic with significantly reduced quality-of-life. We evaluated the outcome and success of PVC ablation in patients in the German Ablation Registry. METHODS: The German Ablation Registry is a nationwide prospective multicenter database of patients who underwent an ablation procedure, initiated by the "Stiftung Institut für Herzinfarktforschung" (IHF), Ludwigshafen, Germany. Data were acquired from March 2007 to May 2011. Patients underwent PVC ablation in the enrolling ablation centers. RESULTS: A total of 408 patients (age 53.5 ± 15 years, 55 % female) undergoing ablation for PVCs were included. 32 % of patients showed a co-existing structural heart disease. Acute ablation success of the procedure was 82 % in the overall patient group. In patients without structural heart disease, acute success was significantly higher compared with patients with structural heart disease (86 vs. 74 %, p = 0.002). All patients were discharged alive after a median of 3 days. No patient suffered an acute myocardial infarction, stroke, or major bleeding. After 12 months' follow-up, 99 % of patients were still alive showing a significant different mortality between patients with structural heart disease compared with those without (2.3 vs. 0 %, p = 0.012). In addition, 76 % of patients showed significantly improved symptoms after 12 months of follow-up. CONCLUSION: Based on the data from this registry, ablation of PVCs is a safe and efficient procedure with an excellent outcome and improved symptoms after 12 months.

Admission heart rate in relation to presentation and prognosis in patients with acute myocardial infarction. Treatment regimens in German chest pain units.

BACKGROUND: Higher heart rates on admission have been associated with poor outcomes in patients with an acute coronary syndrome in previous cohorts. Whether such a linear relationship still exists in contemporary high-level care is unclear. METHODS: Prospectively collected data from patients presenting with myocardial infarction (MI) in centers participating in the Chest Pain Unit (CPU) Registry between December 2008 and July 2014 were analyzed. Patients were classified according to their initial heart rate (I: < 50; II: 50-69; III: 70-89; IV: ≥ 90 bpm). A total of 6,168 patients out of 30,339 patients presenting to 38 centers were included in the study. RESULTS: Patients in group IV had more comorbidities, while patients in group I more often had a history of MI. Patients in the lowest heart rate group presented significantly earlier to the hospital (4 h 31 min vs. 7 h 37 min; p < 0.05) and had the highest rate of interventions. The overall survival after 3 months was significantly worse in group IV after adjusting for baseline variables. In the subgroup analysis, heart rate was a prognostic factor in the non-ST-segment elevation MI group but not in the ST-segment elevation MI group. The correlation between heart rate and major adverse cardiac events followed a J-shaped curve with worst outcomes in the lowest and highest heart rate groups. CONCLUSION: Patients admitted to a dedicated CPU with the diagnosis of MI and a heart rate > 90 bpm experience reduced survival at 3 months despite optimal treatment. Patients with bradycardia also seem to be at increased risk for cardiovascular events despite much earlier presentation and treatment.

The impact of age on the benefits and risks of aliskiren treatment: analyses of the 3A registry.

We aimed to analyze benefits and risks of aliskiren treatment in older adults (⩾ 65 years) in clinical practice. Patients (n = 14,986) were assigned to either aliskiren (ALIS), an angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker (ACEi/ARB), or an agent not blocking the renin-angiotensin system (non-RAS). Older adults (n = 7396) had a longer history of hypertension (8.7 vs 4.7 years; P < 0.0001), lower mean diastolic blood pressure (DBP; 87.7 ± 11.0 vs 92.1 ± 11.0 mm Hg) and more renal (12.0 vs 5.6%; P < 0.0001) or cardiovascular disease (44.0 vs 18.9%; P < 0.0001); 4548 received aliskiren (68.8%), 1215 ACEi/ARBs (18.4%) and 850 non-RAS treatments (12.9%). Office BP at 1 year was reduced by 18.4 ± 21.5/7.2 ± 12.0 mm Hg. BP reductions were greater (19.5 ± 21.7/7.6 ± 12.1 mm Hg) in the aliskiren group than in the ACEi/ARB (15.6 ± 20.9/6.4 ± 11.9) and non-RAS groups (16.1 ± 20.7/6.5 ± 11.7 mm Hg), respectively (P<0.0001 for systolic BP (SBP) and <0.01 for DBP). After multivariable adjustment, differences in SBP reductions were clinically irrelevant and no differences were noted for DBP. Adverse effects were higher in older adults with no differences between treatment groups. In conclusion, the present analysis of a large, unselected cohort of patients in clinical practice from the 3A study, offers real-life evidence of the effectiveness and safety of aliskiren for the treatment of hypertension in older adults.

[Anticoagulation in high thromboembolic risk after catheter ablation for atrial fibrillation: results from the German Ablation Registry]. / Antikoagulationssituation bei hohem thromboembolischem Risiko nach Vorhofflimmerablation: Daten des Ablations-Qualitätsregisters.

BACKGROUND: Catheter ablation (CA) for atrial fibrillation (AF) is an effective therapeutic option for the treatment of symptomatic drug-refractory AF. According to current guidelines, the prevention of stroke and embolism is the most important therapeutic goal in AF and the recommendations for anticoagulation (OAC) after successful CA are based upon the CHA2DS2-VASc-Score 3. The aim of this study was to evaluate the use of OAC in patients with a high risk for thromboembolic events 1 year after CA and to identify predictor variables for discontinuation of OAC. METHODS: Between January 2007 and January 2010 13092 patients were enrolled in the study. A total of 52 German electrophysiological centers agreed to participate in this prospective multicenter registry. 41 centers included patients undergoing CA for AF. Analysis included patients who were discharged with OAC after CA and had a CHA2DS2-VASc-Score ≥ 2. A centralized 1 year follow-up (FU) was conducted via telephone. RESULTS: 1300 patients fulfilled the inclusion criteria. One year after CA 51.8 % of these patients were on OAC. Factors significantly associated with discontinuation of OAC included no AF recurrence in FU (adjusted odds ratio (OR): 2.14, [95 % confidence interval (CI): 1.73-2.66], P < 0.001) and paroxysmal AF (OR: 1.53 [95 % CI: 1.29-1.81], P < 0.001). Factors associated with continuation of OAK were patient age (OR per 10 years: 0.79 [95 % CI: 0.68-0.91], P = 0.002), valvular heart disease (OR: 0.67 [95 % CI: 0.48-0.92], P = 0.013), an implanted pacemaker, defibrillator or a cardiac resynchronization therapy system (OR: 0.55 [95 % CI: 0.41-0.74], P < 0.001) and neurological events in hospital or during FU (OR: 0.40 [95 % CI: 0.18-0.88], P < 0.022). CONCLUSION: Almost half of the patients with an indication for OAC are not adequately anticoagulated one year after CA for AF. Paroxysmal AF or freedom from AF is significantly associated with discontinuation of OAC.

Characteristics, management modalities and outcome in chronic systolic heart failure patients treated in tertiary care centers: results from the EVIdence based TreAtment in Heart Failure (EVITA-HF) registry.

BACKGROUND: Limited data exist regarding baseline characteristics and management of heart failure with reduced ejection fraction (EF) in tertiary care facilities. METHODS: EVITA-HF comprises web-based case report data on demography, comorbidities, diagnostic and therapy measures, quality of life, adverse events and 1-year follow-up of patients hospitalized for chronic heart failure and an ejection fraction of less than 40%. RESULTS: Between February 2009 and June 2011, a total of 1,853 consecutive, hospitalized patients (pts) were included in 16 centers in Germany. Mean age was 70 years, 76% were male. Median EF was 30%, and 63% were in NYHA III/IV. Ischemic cardiomyopathy was present in 56%, history of hypertension in 76%, diabetes in 39%, impaired renal function in 33%, thyroid dysfunction in 12%, and malignoma in 7%. Sixty-eight percent of pts had a non-elective admission. Rhythm was sinus/atrial fibrillation or flutter/pacemaker in 64, 28 and 11%, respectively. Median heart rate amounted to 80 bpm, median blood pressure to 122/74 mmHg. LBBB was present in 26% of non-pacemaker pts. Eighteen percent had an ICD or CRT-D. Medication (admission vs. discharge) consisted of ACEI or ARB in 73 vs. 88%, ß-blocker in 71 vs. 89%, mineral corticosteroid receptor antagonist (MRA) in 32 vs. 57%, diuretics in 68 vs. 83% (p < 0.001 for each). Forty-two percent of pts received a specific treatment procedure beyond pharmacotherapy, of these 48% revascularization, 39% device therapy, 14% electrical cardioversion, 5% ablation procedures, 9 % valvular procedures, 6% iv inotropes, 1.8% IABP or LVAD implantation. At discharge, 33% of survivors had ICD- or CRT-D implants. One-year mortality amounted to 16.8%, and death or rehospitalization to 56%. NYHA class III/IV was found in 30% (p < 0.001 vs. index admission), general health status was improved in 45% and unchanged in 36% of patients. Eighty-five percent of pts took ACEI or ARB, 86% ß-blockers, 47% MRA, and 78% diuretics (p < 0.001 vs. index discharge for all). CONCLUSION: Patients with chronic heart failure and low ejection fraction represent an elderly and multimorbid population. While hospitalized, they experience a significant optimization of prognosis-relevant medication, revascularization and device therapy. After 1 year, mortality is moderate; drug adherence is high and NYHA status favourable. The EVITA-HF registry is able to reflect coherently the real-world management, efforts and follow-up in heart failure pts managed in tertiary care facilities.

Risk factors for clinical events at 1-year follow-up after drug-eluting stent implantation: results from the prospective multicenter German DES.DE registry.

BACKGROUND: Drug-eluting stents (DES) have substantially reduced target vessel revascularization (TVR) after percutaneous coronary interventions. Risk factors for clinical events need to be redefined with this treatment option. METHODS AND RESULTS: In the prospective DES.DE registry, baseline clinical and angiographic characteristics as well as in-hospital and follow-up events were recorded for all enrolled patients. Between October 2005 and May 2009, 21,774 patients receiving DES were enrolled at 98 DES.DE sites. The composite of death, myocardial infarction (MI) and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and TVR were predefined as primary endpoints. At 1-year follow-up rates for overall death, MI, stroke, MACCE, TVR and definite stent thrombosis were 2.7, 3.1, 1.4, 7.1, 11.5 and 0.6 %, respectively. Aside from well-known risk factors like age, diabetes mellitus and triple-vessel disease, stratification in patients with or without MACCE revealed atrial fibrillation, non-ST-segment elevation myocardial infarction, renal failure, impaired ejection fraction and peripheral vascular disease as strong predictors of MACCE at 1 year. CONCLUSION: Data collected in the DES.DE registry, reflecting the clinical practice in Germany, revealed favorable clinical outcomes after DES implantation in a real world setting but also identifying several high-risk populations.

[Treatment of ST-segment elevation acute myocardial infarction in hospitals with and without cardiac catheterization laboratory]. / Therapie des akuten ST-Streckenhebungs-Myokardinfarkts in Krankenhäusern mit und ohne Herzkatheterlabor.

BACKGROUND AND OBJECTIVE: The goal of treatment of patients with ST-segment elevation acute myocardial infarction (STEMI) is to restore perfusion as soon as possible, preferably by primary percutaneous coronary intervention (PCI). The aim of this study of the German Myocardial Infarction Registry (DHR) was to document acute care and in-hospital course of STEMI patients in Germany. METHODS: Over three months patients with STEMI were consecutively included and their basic data, treatments and in-hospital complications were centrally recorded using an internet-based standardized questionnaire. RESULTS: Included were 6,330 patients from 243 hospitals, in group 1 (primary admission in 136 hospitals with cath lab) 4,656 patients (74%) and in group 2 (primary admission in 107 hospitals without cath lab) 1,674 (26%). Reperfusion therapy was performed more frequently in patients of group 1 (91.1% PCI, 2.7% fibrinolysis) than in group 2 (80.7% PCI after transfer, 6.4% fibrinolysis). In-hospital mortality was 7.3% in all patients, 7.0% in group 1 and 8.3% in group 2. CONCLUSION: The DHR data show that about three quarters of patients with STEMI are primarily admitted to hospitals with cath labs. Primary PCI is the preferred treatment option both in hospitals with and without cath labs (in the latter after transfer); it is performed in about 85% of STEMI patients. In-hospital mortality is with over 7% higher in real-life than in randomized studies.

[TRAMI (Transcatheter Mitral Valve Interventions) register. The German mitral register]. / TRAMI (Transcatheter Mitral Valve Interventions)-Register. Das Deutsche mitralklappen-register

The transcatheter mitral valve interventions (TRAMI) registry was established in 2010 in order to assess the safety and efficacy of percutaneous mitral valve therapy in Germany and to document baseline characteristics and decision-making in different subgroups of patients. The TRAMI registry is available to all German sites performing percutaneous mitral valve therapy. Follow-up is scheduled at 30 days, 1, 3, and 5 years. In addition, patients can be enrolled retrospectively without predefined times of follow-up. The vast majority of patients enrolled in TRAMI underwent MitraClip® therapy. As of March 2013, a total of 1,064 patients treated with MitraClip® have been enrolled at 21 different German sites. Preliminary results show that patients treated with MitraClip® in Germany were mainly elderly patients with significant comorbidities and high or inacceptable risk of surgery. The majority of patients had secondary mitral regurgitation and a large proportion of patients had reduced left ventricular ejection fraction (LV-EF). Nevertheless, MitraClip® was found to be safe and established risk factors for conventional cardiac mitral valve surgery, such as advanced age (≥76 years), female gender, severely reduced LV-EF (<30%) and high logistic EuroScore (≥20%) were not predictive for mortality or major complication rates. In contrast, severely reduced renal function was predictive for adverse outcome. The TRAMI registry is the largest real world cohort of patients treated with MitraClip®. As long as randomized studies in this high-risk cohort of patients are lacking, TRAMI provides important information on outcomes after MitraClip® therapy. The data are important for hypothesis generation for randomized trials and TRAMI is an important tool for quality assurance after percutaneous mitral valve therapy in Germany.

Outcome of percutaneous coronary intervention with drug-eluting stents in unprotected left main versus non-left main native coronary artery disease: results from the prospective multicenter German DES.DE registry.

BACKGROUND: Unprotected left main coronary artery (ULMCA) disease is considered an indication for surgical revascularization. However, refined percutaneous coronary intervention (PCI) technology and modern drug-eluting stents (DES) render the ULMCA a target for interventional treatment. METHODS AND RESULTS: Between October 2005 and September 2009, 374 patients receiving DES in ULMCA and 18,678 patients receiving DES in non-left main coronary arteries (nLMCA) with no previous coronary artery bypass graft surgery, were registered at 130 DES.DE sites. The composite of death, myocardial infarction (MI), and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) were defined as primary endpoints. Baseline clinical and descriptive morphology of coronary artery disease revealed more comorbidities and more complex anatomies in the ULMCA group. At 1-year follow-up, the ULMCA group suffered from higher rates of overall death (5.6 versus 2.3 %; p < 0.0001), stroke (2.0 versus 0.8 %; p < 0.05), MACCE (8.6 versus 4.9 %; p < 0.01); whereas rates for definite/probable stent thrombosis (2.4 versus 1.6 %; p = 0.29), TVR (14.2 versus 10.8 %; p = 0.06) and MI (1.3 versus 1.9 %; p = 0.44) were not statistically different. These results persisted even after adjustment for different baseline characteristics, except MACCE that was no longer statistically significant. CONCLUSION: Data collected in DES.DE revealed that ULMCA PCI with DES result in similar TVR rates as compared to PCI in nLMCA. Moreover, modern DES have not offset the higher comorbidity index and higher procedure-related complication rate with PCI of ULMCA lesions.

Ambulatory blood pressure monitoring: is it mandatory for blood pressure control in treated hypertensive patients?: prospective observational study.

OBJECTIVE: Twenty-four hour ambulatory blood pressure (ABP) is superior to office blood pressure (BP) in predicting cardiovascular events. However, its use to optimise BP control in treated hypertensive patients is less well examined. DESIGN AND METHOD: In this observational study conducted in 899 general practitioners' offices, 4078 hypertensive patients with uncontrolled office BP were included. Antihypertensive therapy was intensified and after 1 year office BP and 24-hour ABP were measured to categorise patients according to the ESC/ESH 2007 guidelines. RESULTS: In this cohort (mean office BP 156/90 mmHg, mean ABP 146/85 mmHg), 2059 out of 4078 patients (50.5%) had controlled office BP (<140/90 mmHg) at 1 year examination. Of these apparently controlled patients (N=2059), 1339 (65.8%) had 24-hour ABP ≥ 130/80 mmHg, indicating masked hypertension (32.9% of all treated patients). In the prespecified subgroups the prevalence of masked hypertension was the following: diabetes 28.2%, CVD 29.1%, and CKD 32.1%. White coat hypertension (24h-ABP<130/80 mmHg and office BP ≥ 140/90 mmHg) was found in 12.4% (N=233) of patients with elevated office BP (6.1% of all treated patients), and in 5.7% of the diabetic subgroup, 5.6% CVD and 7.1% CKD. Discrepancies in BP categorisation between office BP and 24-hour ABP were high; all subjects 52.8%, diabetes 50.0%, CVD 49.0% and CKD 50.4%. CONCLUSION: In hypertensive patients on therapy, 2 out of 3 with apparently controlled office BP had masked hypertension, suggesting a more aggressive therapy, and 1 out of 8 with elevated office BP had white coat hypertension potentially falsely forcing physicians to intensify therapy. The 3A Registry is listed under clinicaltrials.gov, NCT01454583.

Impact of coronary artery disease on in-hospital mortality in patients with aortic valve disease. Results from the German ALKK registry.

OBJECTIVE: Although aortic valve disease (AVD) is frequently associated with coronary artery disease (CAD), little is known about the impact of significant coronary artery disease on mortality after diagnostic cardiac catheterization in patients with AVD. METHODS: We analyzed data of the coronary angiography registry of the "Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte" (ALKK) in Germany. The primary endpoint was in-hospital mortality. RESULTS: A total of 1427 consecutive patients with AVD (438 patients with CAD versus 989 patients without CAD) underwent diagnostic catheterization in 2006 in 42 hospitals. All cause in-hospital mortality was more than threefold higher in patients with CAD (16/438; 3.7%) as compared to patients without CAD (12/989; 1.2%; p < 0.01; OR 3.09, 95% CI 1.45-6.58). Even after adjustment for age, sex, presence of diabetes mellitus and renal insufficiency, in-hospital all cause mortality remained statistically significant different between the two groups (OR 2.4; 95% CI 1.09-5.28; p < 0.01). Several factors, such as transient ischemic attack/stroke, volume of contrast agent, and left heart catheter-associated complications could not be identified as possible causes for the increase in mortality. CONCLUSION: This analysis in patients with the leading diagnosis of AVD shows a significantly higher in-hospital mortality after diagnostic cardiac catheterization in case of an accompanying CAD. However, further studies are necessary to identify the driving force for the increase in mortality.

Health economic evaluation of the use of drug-eluting stents : First results from the Drug-Eluting Stent Registry (DES.de).

OBJECTIVE: The purpose of the economic evaluation of the German Drug-Eluting Stent (DES) registry includes the investigation of the economic impact and cost-effectiveness of DES compared to bare-metal stents (BMS) and between paclitaxel-eluting (PES) and sirolimus-eluting stents (SES). Here, methodology and initial results are presented. METHODS: Patients were recruited in 2005 and 2006 in 87 centres across Germany. Selection of PES, SES, or BMS was made at the discretion of the cardiologists in charge. Clinical, economic, and quality of life (QoL) data were collected at baseline and up to 12 months. Group comparisons were conducted using Fisher's exact and t test. RESULTS: Overall, 3,930 patients were enrolled: 3,471 (75% male, 65 ± 11 years) received DES and 458 (74% male, 67 ± 11 years) BMS. Among the DES patients, 1,821 received PES (75% male, 65 ± 10 years) and 1,600 SES (76% male, 65 ± 11 years). There were baseline differences in clinical and procedural characteristics but not in QoL. During the hospital stay, major adverse cardiac and cerebrovascular events occurred in 1.6% of DES (PES 1.9%, SES 1.1%) and 2.2% of BMS patients (BMS vs. DES, PES, and SES p = 0.327, 0.706, and 0.098, respectively). Hospital treatment costs were 4,989 ± 1,284  and 3,609 ± 924 , respectively, in DES and BMS patients (p < 0.001) with no significant difference between PES and SES. CONCLUSION: The economic evaluation of the large DES registry demonstrates increased initial hospitalisation costs associated with DES compared to BMS. Further analysis of the economic impact and cost-effectiveness of DES will provide estimates on large "real world" patient populations for decision makers and aid in reimbursement decisions of DES within the German and other health care systems.

Aliskiren for the treatment of essential hypertension under real-life practice conditions: design and baseline data of the prospective 3A registry.

BACKGROUND: The renin-angiotensin system (RAS) is a key target for blood pressure control and for cardiovascular and renal protection. Aliskiren is the first-in-class direct oral inhibitor of renin that controls the rate-limiting step in the RAS cascade. So far little is known about the use and efficacy of aliskiren in the treatment of essential hypertension under clinical practice conditions. METHODS: The 3A registry was an open, prospective cohort study (observational registry) of 14,988 patients in 899 offices throughout Germany. Consecutive patients were eligible for inclusion if their physician had decided to modify their antihypertensive therapy. This included treatment with aliskiren or an angiotensin converting enzyme inhibitor (ACE-I)/angiotensin receptor blocker (ARB) or agents not blocking the RAS, alone or on top of an existing drug regimen. RESULTS: Mean age of patients was 65 years, their mean body mass index was 28.2 kg/m(2) 53.5% were men, 36% working, 90% in statutory health insurance and 26% in any disease management programme. Patients in the aliskiren and the RAS groups compared with the non-RAS group were older, more often men, had a longer history of hypertension, and had a higher prevalence of comorbidities (diabetes, chronic heart failure, ischaemic heart disease, renal disease). Mean systolic, but not diastolic blood pressure was substantially higher in the aliskiren group (158/91 mmHg vs. 154/89 mmHg in ACE-I/ARB vs. 152/89 mmHg in non-RAS). Mean number of antihypertensive drugs was higher in the aliskiren group compared with the other groups (3.0 drugs vs. 2.5 in ACE-I/ARB vs. 1.6 in non-RAS; p < 0.0001). CONCLUSIONS: In this large cohort of outpatients with hypertension, aliskiren was used mainly in patients with more severe stages of hypertension and those with concomitant diseases such as diabetes mellitus and impaired renal function. The 3A registry will provide important information about the use and efficacy of aliskiren in a real-life setting.

[Registries of myocardial infarction in Germany. Consequences for drug therapy of patients with acute ST elevation myocardial infarction]. / Herzinfarktregister in Deutschland. Konsequenzen für die Arzneimitteltherapie bei Patienten mit akutem ST-Strecken-Hebungsinfarkt.

Current national and international guidelines for patients with ST elevation myocardial infarction (STEMI) are mainly based on the results of randomised clinical trials. However, it is well perceived that patients in such trials often represent a low risk population. Therefore the results of randomised clinical trials are not necessarily applicable to patients in clinical practice. This gap can be filled by prospective registries. Since the early nineties a number of prospective large registries in patients with STEMI have been performed in Germany. It could be shown that guideline adherent acute therapies and secondary prevention therapies were associated with an improvement in inhospital and mid-term outcomes. The benefit of guideline adherent therapy observed was especially high in patients with higher baseline risk. Registries are not able to replace randomised clinical trials, but can help to test if the results of these trials are comprehensible in clinical practice. Therefore prospective STEMI registries are an important part of clinical research to optimize therapies and improve outcome in patients with STEMI.

[ICD therapy for primary prevention. The patient in the early post-infarct phase]. / ICD-Therapie zur Primärprävention. Der Patient in der frühen Postinfarktphase.

There is high mortality during the first few weeks after an acute myocardial infarction. However, according to the guidelines, the prophylactic implantation of an ICD, given the corresponding risk constellation, is recommended not earlier than 1 month after acute myocardial infarction. This article analyzes available data and highlights that the recently published IRIS study supports current clinical practise.