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Patients with ischaemic stroke are at risk of recurrent stroke. In this study, we aimed to compare the effect of a structured ambulatory post-stroke care programme versus usual care on recurrent vascular events and death and control of cardiovascular risk factors. We did a prospective, open-label, cluster-randomised controlled trial (SANO) at stroke centres in regions of Germany. A cluster was defined as a region in which acute stroke care is provided by a participating stroke centre. Patients were eligible for participation if they were aged 18 years or older, had no severe disabilities before the index stroke (modified Rankin scale 0–1), had at least one modifiable cardiovascular risk factor, and presented within 14 days of symptom onset of their first ischaemic stroke. The participating regions were randomly assigned (1:1) to the intervention and control group (usual care) by the statistician using block randomisation (block sizes of six), stratified by rural and urban regions. In intervention regions, a cross-sectoral multidisciplinary network was established to provide a 1-year organisational and patient-centred intervention. Due to the type of intervention, masking of participants and study physicians was not possible. Endpoint adjudication was performed by an independent endpoint adjudication committee who were masked to cluster allocation. The primary endpoint was a composite of recurrent stroke, myocardial infarction, and all-cause death within 12 months after baseline assessment, assessed in the modified intention-to-treat (mITT) population, which included all patients who did not withdraw consent and completed the primary endpoint assessment at 12 months. This study was registered with the German Clinical Trials Register, DRKS00015322. Between Jan 1, 2019 and Dec 22, 2020, 36 clusters were assessed for eligibility, of which 30 were randomly assigned to the intervention group (n=15 clusters) or control group (n=15 clusters). No clusters dropped out of the study. 1203 (86%) of 1396 enrolled patients in the intervention group and 1283 (92%) of 1395 enrolled patients in the control group were included in the mITT population. The primary endpoint was confirmed in 64 (5·3%) of 1203 patients in the intervention group and 80 (6·2%) of 1283 patients in the control group (unadjusted odds ratio [OR] 0·80 [95% CI 0·49–1·30]; adjusted OR [aOR] 0·95 [95% CI 0·54–1·67]). All-cause deaths occurred in 31 (2·4%) of 1203 patients in the intervention group and 12 (1·0%) of 1283 patients in the control group. The incidence of serious adverse events was higher in the intervention group (266 [23·1%] of 1151) than the control group (106 [9·2%] of 1152). Falls (134 [11·4%] of 1203 patients in the intervention group; 39 [3·3%] of 1152 patients in the control group), hypertensive crisis (55 [4·7%]; 34 [2·8%]), and diagnosis of depression (51 [4·3%]; 13 [1·1%]) were the most frequent adverse events in both groups. No differences were identified in the rate of readmission to hospital between groups. No differences were identified between patients with ischaemic stroke in the intervention group and control group with regard to the incidence of vascular events 1 year after baseline assessment, despite positive effects with regard to the control of some cardiovascular risk factors. Longer-term effects and other potentially favourable effects on stroke-related sequelae and quality of life require further evaluation. Innovation Fund of the Federal Joint Committee. [ABSTRACT FROM AUTHOR]

Acute myocardial infarction (AMI) is the leading cause of death worldwide. Outcome has improved during the last decades due to secondary prevention and widespread coronary interventions, but recent studies still show sex differences and insufficient drug adherence. We aimed to determine differences in the treatment strategies and outcomes between women and men with ST-elevation myocardial infarction (STEMI) in Germany. From the Federal Association of the Local Health Insurance Funds (Allgemeine Ortskrankenkasse), 175,187 patients were identified who were hospitalized due to STEMI in Germany between January 1, 2010 and December 31, 2017. Compared to men, women were older (median 76 vs. 64 years) and had more often diabetes, hypertension, chronic heart failure, and chronic kidney disease (all p < 0.001). Women suffered from higher rates of in-hospital complications such as bleeding (9.3 vs. 6.6%), longer hospitalizations (12.2 vs. 11.7 days) and were less likely to undergo percutaneous coronary intervention (75.5 vs. 85.2%). After adjustment for patient's risk profile, female sex was associated with decreased overall survival (HR 1.02, 95% confidence interval (CI) 1.00–1.04; p= 0.036). Notably, more men received all four guideline-recommended drugs after STEMI (women 65.7% vs. men 69.8% after 90 days; p < 0.001). With increasing number of prescribed drugs, patients benefit even more. This concerned both sexes, but was more pronounced in men (with 4 prescribed drugs: women HR 0.52, 95%CI 0.50–0.55; men HR 0.48, 95% CI 0.47–0.50, p int = 0.014). In a contemporary nationwide analysis, women with STEMI were older, had more comorbidities, underwent revascularization less often and had an increased risk for major complications as well as overall survival. Guideline-recommended drug therapy was applied less frequently in women although associated with an improved overall-survival. [Display omitted] • Compared to men, women with STEMI were older and had more comorbidities. • Women had higher rates of inpatient complications, received percutaneous coronary intervention less often, and when adjusted for the risk profile, the female sex was associated with reduced overall survival. • After STEMI, women received all four guideline-recommended drugs less often, although the prognosis improved with the increase in these drugs. [ABSTRACT FROM AUTHOR]

Acute myocardial infarction (AMI) is the leading cause of death worldwide. Outcome has improved during the last decades due to secondary prevention and widespread coronary interventions, but recent studies still show sex differences and insufficient drug adherence. We aimed to determine differences in the treatment strategies and outcomes between women and men with ST-elevation myocardial infarction (STEMI) in Germany. From the Federal Association of the Local Health Insurance Funds (Allgemeine Ortskrankenkasse), 175,187 patients were identified who were hospitalized due to STEMI in Germany between January 1, 2010 and December 31, 2017. Compared to men, women were older (median 76 vs. 64 years) and had more often diabetes, hypertension, chronic heart failure, and chronic kidney disease (all p < 0.001). Women suffered from higher rates of in-hospital complications such as bleeding (9.3 vs. 6.6%), longer hospitalizations (12.2 vs. 11.7 days) and were less likely to undergo percutaneous coronary intervention (75.5 vs. 85.2%). After adjustment for patient's risk profile, female sex was associated with decreased overall survival (HR 1.02, 95% confidence interval (CI) 1.00–1.04; p= 0.036). Notably, more men received all four guideline-recommended drugs after STEMI (women 65.7% vs. men 69.8% after 90 days; p < 0.001). With increasing number of prescribed drugs, patients benefit even more. This concerned both sexes, but was more pronounced in men (with 4 prescribed drugs: women HR 0.52, 95%CI 0.50–0.55; men HR 0.48, 95% CI 0.47–0.50, p int = 0.014). In a contemporary nationwide analysis, women with STEMI were older, had more comorbidities, underwent revascularization less often and had an increased risk for major complications as well as overall survival. Guideline-recommended drug therapy was applied less frequently in women although associated with an improved overall-survival. [Display omitted] • Compared to men, women with STEMI were older and had more comorbidities. • Women had higher rates of inpatient complications, received percutaneous coronary intervention less often, and when adjusted for the risk profile, the female sex was associated with reduced overall survival. • After STEMI, women received all four guideline-recommended drugs less often, although the prognosis improved with the increase in these drugs. [ABSTRACT FROM AUTHOR]

Cardiac catheterization procedures require intra-arterial contrast agent administration. The amount of utilized contrast agent volume (CAV) is a risk factor for contrast-induced side-effects. In this study, we assess trends and associations of CAV utilization in diagnostic cardiac catheterization (DCC) and percutaneous coronary intervention (PCI). All cardiac catheterization procedures reported for quality assurance between 2008 and 2018 in Germany were included. Available site, patient, and procedural parameters were analyzed. CAV was reported by interventional cardiologists after the procedure. Multivariate linear regression analysis was used to identify associated factors with clinically relevant CAV change (defined >10 ml). We included 9,106,511 procedures (DCC: 5,401,525, PCI: 3,704,986). Median CAV of all DCCs was 80 (interquartile range, IQR 60–110) ml. CAV for DCC significantly lowered by 22% during the retrospective observational period (p < 0.001) and significantly varied according to the leading diagnosis (p < 0.001). We observed significant 2.5-fold variability of CAV between the catheterization laboratories (5th percentile: 40 ml, 95th percentile: 100 ml, p < 0.001). Median CAV for PCIs was 170 (IQR 120–223) ml. Independent associated factors for clinically relevant higher CAV use in PCI were male gender, coronary-artery-bypass-graft surgery, total coronary occlusion, ostial lesions, and multi-vessel coronary artery disease (all p < 0.001). The results of this large, multi-center study show significant lowering of CAV in clinical routine DCC, however, the large inter-site variability demonstrates the need for additional CAV reduction to further lower the risk of adverse side-effects. In PCI practice, CAV should be limited in the presence of the identified high contrast-dose scenarios. • Contrast agent volume utilization for diagnostic cardiac catheterization in clinical practice decreased by 22% during the last decade • Significant 2.5-fold variability of median contrast agent volume between clinical institutions demonstrates the need for further contrast agent reduction in diagnostic cardiac catheterization • Contrast agent volume used for percutaneous coronary intervention in clinical practice remained stable during the last decade • Significant factors for contrast agent increase in percutaneous coronary intervention are prior CABG surgery, PCI of total coronary occlusion, ostial lesions, and multi-vessel CAD disease [ABSTRACT FROM AUTHOR]

Genetic risk scores for common diseases as myocardial infarction (MI) gain increasing attention for individual's risk prediction. One might wonder if assessing family history becomes redundant. It was the aim of this study to evaluate the amount of shared information between family history and genetic risk scores and to assess their independent and combined effects on prevalent and incident MI risk. A genome wide polygenic risk score (PGS) and one family risk score (FamRS) were calculated in a population-based study from Southern Germany (n = 3071) with up to 11 years of follow-up. Logistic and Cox Regression models were used adjusting for lifestyle and classical risk factors. A right shift in MI risk for increasing values of PGS was found, with. considerably increasing ORs along the top quantiles of PGS (OR = 3.03 for top 10%; OR = 5.55 for top 2.5%). The PGS was not associated with incident MI cases, though. The FamRS was significantly associated with both prevalent and incident MI cases with an OR of 2.9 for participants with a strong positive family history compared to average. ORs and HRs did hardly change in a combined model including both measures, indicating independent contribution to MI risk. The simultaneous addition of PGS and FamRS to a model including classical risk factors significantly enhanced prediction for prevalent cases and non-cases (p = 3.28 × 10−5). These findings emphasize that both genetic information and family history are relevant for the determination of MI risk and that neither of them can replace the other. [Display omitted] • A genome-wide polygenic risk score (PGS) was shown to be a strong risk predictor for especially "early" prevalent myocardial infarction (MI) cases. • A family risk score (FamRS) was a stronger predictor than simpler family history measures as "diseased parents". • The FamRS was highly informative for both prevalence and incidence. • Addition of PGS and FamRS to a model including classical risk factors enhanced prediction for prevalent cases and non-cases. [ABSTRACT FROM AUTHOR]

Introduction: The diagnosis or exclusion of obstructive stable coronary artery disease (SCAD) in clinical practice is challenging and therefore clinical guidelines provide recommendations on the use of non-invasive and invasive testing. For Germany, data obtained from the OECD and health insurances indicate a potential non-adherence to guideline-recommended diagnostic pathways. However, there is a lack of prospective and reliable evidence for appropriate use of invasive coronary angiography (CA) in Germany.Objective: To provide evidence on the nature and extent of guideline non-adherence in patients undergoing CA with presumed obstructive SCAD in Germany and, to evaluate the clinical and economic consequences of potential deviations in guideline adherence.Methods: ENLIGHT-KHK is a multicentre, prospective observational study recruiting 1500 patients being admitted for CA with presumed obstructive SCAD and exclusion of acute myocardial infarction (DRKS00015638). The primary outcome measure is the adherence to clinical guidelines in the decision-making process for use of CA. Therefore, the patients' diagnostic pathways and adherence to German and European guidelines will be assessed using clinical data, health-claims data, and a patient questionnaire. The primary safety outcome is a composite of myocardial infarction, stroke and all-cause death. Secondary outcome measures are periprocedural complications and costs. Using a decision-analytic model, the clinical and economic impact of observed guideline adherence in clinical practice will be assessed. Potential barriers and facilitators of guideline-adherent decision-making will be evaluated via semi-structured interviews.Conclusions: ENLIGHT-KHK will give insights into the appropriateness of invasive CA in Germany and enable the development of concepts to improve guideline-adherence in the German health-care setting. [ABSTRACT FROM AUTHOR]

The Abiomed Impella 5.5 (Danvers, MA) is a newly developed axial flow transaortic cardiac support device mounted on a 9 Fr steering catheter with a 21 Fr pump cannula. Impella 5.5 is intended for longer use and was approved for 30 days in 2018. This study evaluated the first-in-man series at six high-volume mechanical circulatory support centers in Germany after CE approval. The first 46 consecutive patients worldwide underwent implantation in six German centers between March 2018 and September 2019 for post-CE approval evaluation. The primary end-point was 30 days and 90 days all-cause mortality. The mean age of patients was 59.0 ± 11.5 years , and 43 (93.4%) were men. Half of the patients had acute on chronic heart failure. The main indication for Impella 5.5 implantation was ischemic cardiomyopathy and acute myocardial infarction (47.8%). The mean support time was 15.5 ± 24.2 days (range 0-164, median 10 days (IQR = 7-19)) with a total of 712 patient-days on support. The 30 days and 90 days survival rates were 73.9% (95% CI: 63.3–88.9%) and 71.7% (95% CI: 60.7-87.1%), respectively. Additionally, 16 patients (34.8%) were weaned from the device for native heart recovery, and 19 (41.3%) were bridged to a durable device. Fifteen patients (32.6%) were mobilized to a chair, and 15 (32.6%) were ambulatory. We only noted one stroke and found no other thromboembolic complications. No aortic valve damage was observed in the study cohort. Finally, seven patients (15.2 %) had pump thrombosis, and nine (19.6 %) underwent device exchange. Sixteen patients (34.8 %) suffered from bleeding requiring transfusions during the whole treatment course. In ten patients (21.7%), the inflow cannula dislocated into the aortic root. The first version of the Impella 5.5 presents promising early outcomes for patients with acute heart failure and expands the spectrum of available devices. The adverse event profile is favorable for short-term devices. Dislocations have been addressed by design changes. With increasing experience with this device, our study suggests that the indications for use will expand to other cardiac shock etiologies and may improve myocardial recovery and survival in patients with cardiogenic shock. [ABSTRACT FROM AUTHOR]

Bioresorbable scaffolds (BRS) have been shown to be inferior to drug-eluting stents in randomized trials. Nevertheless, patients treated during daily routine differ from those treated within randomized trials and thus need further long-term evaluation. The present investigation aims to address this lack. Consecutive patients with coronary artery disease treated with implantation of everolimus-eluting BRS at 5 centers in Germany were included. Clinical follow-up was assessed up to 3 years. Analysis of clinical outcomes was performed by pooling of the individual patient data sets of each center. The major clinical endpoints of interest was target lesion failure (TLF) a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization. Furthermore occurrence of definite scaffold thrombosis was evaluated. A multivariable Cox regression analysis was applied to identify independent predictors of TLF. A total of 1614 patients treated with BRS were analyzed (mean age 64.0 ± 10.9 years, 75.8% male, 28.3% diabetics). A total 1817 lesions were treated with BRS and 56.0% were considered to be complex. At 3 years, the rate of TLF was 17.1% and definite scaffold thrombosis was noted in 2.6%. Independent predictors of TLF were a higher age, diabetes, bifurcation, complex lesions and the use of small BRS. In this large-scale analysis of patients undergoing BRS implantation in daily routine, event rates were high, but in line with randomized studies. Predictors of TLF were identified which may optimize patient and lesion selection for BRS. • The study addresses the lack of long-term data after unrestricted BRS implantation. • 3-year clinical outcomes of 1614 patients were analyzed. • Event rates were high, but consistent to randomized studies of selected patients. • Independent predictors of TLF included patient and lesion related factors. [ABSTRACT FROM AUTHOR]

After myocardial infarction, guidelines recommend pharmaceutical treatment with a combination of five different types of drugs for prevention in patients. However, studies from different countries have shown that this goal is not achieved in many patients. The aim of this study was to assess both healthcare and prescribed pharmaceutical treatment in the fourth quarter after index myocardial infarction. We conducted a claims data analysis with the data of patients who had had a myocardial infarction in the years 2013 or 2014, using information from the largest German health insurance fund ('AOK'). We analysed contact with physicians, hospital care and actual prescriptions for medication recommended in international guidelines, referring to beta-blockers, ACE inhibitors or angiotensin II receptor blockers, P2Y12-antiplatelet agents, acetylsalicylic acid and statins, one year after myocardial infarction. Analysis was stratified by age and sex, compared between patient groups and over time. We identified 2352 patients who had survived myocardial infarction. Some 96.9% of these participants had at least one contact with their general practitioner (GP) one year after myocardial infarction, 22.8% contacted a cardiologist and 19.7% were hospitalised. Prescription rates range from 37.8% for acetylsalicylic acid to 70.4% for ACE inhibitors. However, only 24.1% received statins, beta-blockers, ACE inhibitors and an antiplatelet drug simultaneously. Prescription of recommended drugs after myocardial infarction decreased steadily over time. Long-term medical prevention after myocardial infarction is improvable. GPs should take care of the pharmaceutical prevention after myocardial infarction as they are the physicians seen most intensively in this period. Health care utilisation and pharmaceutical treatment of patients in the fourth quarter after myocardial infarction. Unlabelled Image • Nearly all patients see their GP one year after myocardial infarction (MI). • Prescription of recommended drugs after MI decreases steadily over time. • 24% of patients receive drugs from every drug group one year after MI. • Elderly patients and women are most prone to under-provision. [ABSTRACT FROM AUTHOR]

Seasonal variation regarding the incidence and the short-term mortality of acute myocardial infarction (MI) was frequently reported, but data about sex-specific differences are sparse. We analysed the impact of seasons and temperature on incidence and in-hospital mortality of patients with acute MI in Germany between 2005 and 2015. The nationwide sample comprised 3,008,188 hospitalizations of MI patients (2005–2015). The incidence was 334.7/100,000 citizens/year. Incidence inclined from 316.3 to 341.6/100,000 citizens/year (β 0.17 [0.10 to 0.24], P < 0.001), while in-hospital mortality rate decreased from 14.1% to 11.3% (β −0.29 [−0.30 to −0.28], P < 0.001). Overall, 377,028 (12.5%) patients died in-hospital. Seasonal variation of both incidence and in-hospital mortality was of substantial magnitude. Seasonal incidence (86.1 vs. 79.0/100,000 citizens/year, P < 0.001) and in-hospital mortality (13.2% vs. 12.1%, P < 0.001) were higher in winter than in summer. Risk to die in winter was elevated (OR 1.080 (95% CI 1.069–1.091), P < 0.001) compared to summer season independently of sex, age and comorbidities. Reperfusion treatment with drug eluting stents and coronary artery bypass graft were more often used in summer. We observed sex-specific differences regarding the seasonal variation of in-hospital mortality: males showed lowest mortality in summer, while females during fall. Low temperature dependency of mortality seems more pronounced in males. Incidence of acute MI increased 2005–2015, while in-hospital mortality rate decreased. Seasonal variation of incidence and in-hospital mortality were of substantial magnitude with lowest incidence and lowest mortality in the summer season. Additionally, we observed sex-specific differences regarding the seasonal variation of the in-hospital mortality. • Incidence of myocardial infarction (MI) increased from 2005 to 2015 in Germany. • The in-hospital mortality rate decreased from 2005 to 2015. • Seasonal incidence and in-hospital mortality variation were of substantial magnitude. • Lowest incidence and lowest mortality were found in the summer season. • Sex-specific differences regarding the seasonal variation were detected. [ABSTRACT FROM AUTHOR]

Syncope is a common phenomenon in the general population. Although most of the causes are of benign origin, some comorbidities are accompanied by high mortality. We aimed to compare the in-hospital mortality of patients with syncope related to different comorbities and investigate the impact of syncope in patients with atrial fibrillation/flutter (AF). The nationwide inpatient sample of Germany of the years 2011–2014 was used for this analysis. Patients with syncope (ICD-code R55) were stratified by presence of selected comorbidities. Additionally, AF patients with and without syncope were compared. Incidence of syncope and in-hospital mortality were calculated. Syncope as a predictor of adverse outcome in AF patients was investigated. In total, 1,628,859 hospitalizations of patients with syncope were identified; incidence was 504.6/100,000 citizens/year with case-fatality rate of 1.6%. Patients with syncope revealed frequently comorbidities as AF, heart failure and pneumonia. In-hospital mortality was high in syncope patients with pulmonary embolism (PE, 13.0%), pneumonia (12.8%), myocardial infarction (MI, 9.7%) and stroke (8.5%). We analysed 1,106,019 hospitalizations (52.9% females, 54.9% aged > 70 years) of patients with AF (2011–2014). Among these, 23,694 (2.1%) were coded with syncope and 0.7% died. Syncope had no significant impact on in-hospital mortality (OR 1.04, 95%CI 0.92–1.17, P =.503) independently of age, sex and comorbidities, but was associated with PE (OR 1.83, 95%CI 1.42–2.36, P <.001), MI (OR 1.68, 95%CI 1.48–1.90, P <.001), stroke (OR 1.66, 95%CI 1.42–1.94, P <.001) and pneumonia (OR 1.26, 95%CI 1.16–1.37, P <.001). Syncope is a frequent cause for referrals in hospitals. While the overall in-hospital mortality rate is low (<2%), syncope in coprevalence with PE, pneumonia, MI and stroke showed a mortality rate > 8%. Syncope in AF patients had no independent impact on in-hospital mortality. • Syncope is a frequent cause for referrals in hospitals. • The overall in-hospital mortality was 1.6%. • Syncope in PE, pneumonia, MI and stroke showed an in-hospital mortality rate > 8%. • Syncope in AF patients was accompanied by higher in-hospital mortality. • Syncope did not influence the risk to die in-hospital independently in AF patients. [ABSTRACT FROM AUTHOR]

Abstract Background The goal of this study was to analyze the impact of dronedarone on the risk of myocardial infarction and stroke in atrial fibrillation (AF) patients followed in general practices in Germany. Methods This study included patients who had received a first prescription of dronedarone, amiodarone, flecainide, propafenone, or sotalol in 1258 general and 62 cardiology practices between January 2010 and March 2017 (index date). The main outcomes of this study were the percentages of patients with myocardial infarction and stroke in the dronedarone group and in the group of individuals who had received other antiarrhythmic drugs within six years of the index date. Cox proportional regression models were used to estimate the relationship between dronedarone and myocardial infarction and stroke. Results This study included 3498 individuals who had received dronedarone and 17,724 individuals who had received other antiarrhythmic drugs. After six years of follow-up, 3.9% of patients who had received dronedarone and 5.2% of patients who had received other antiarrhythmic drugs had been diagnosed with myocardial infarction (log-rank p -value = 0.002). At the end of the follow-up period, 7.4% of individuals with dronedarone prescriptions and 8.3% of those who had been prescribed other antiarrhythmic drugs had been diagnosed with a stroke (log-rank p -value = 0.003). Dronedarone was associated with a significant decrease in the risk of developing myocardial infarction (HR = 0.78) and suffering a stroke (HR = 0.84) compared to other antiarrhythmics. Conclusions In our study, dronedarone was associated with a lower risk of myocardial infarction and stroke in patients with AF compared to other antiarrhythmics. Highlights • This study included 21,222 patients receiving antiarrhythmic drugs. • Dronedarone was associated with a lower myocardial infarction risk compared to other antiarrhythmics. • Dronedarone was associated with a lower stroke risk compared to other antiarrhythmics. [ABSTRACT FROM AUTHOR]

Objective: In patients with ST-segment elevation myocardial infarction (STEMI), disturbed cardiac repolarization before percutaneous coronary intervention (PCI) is a risk factor for malignant ventricular arrhythmia. We tested the hypothesis that sleep-disordered breathing (SDB) in patients with STEMI is associated with disturbed cardiac repolarization.Methods: Thirty-three patients with STEMI who underwent PCI were prospectively enrolled. To assess cardiac repolarization, the heart-rate corrected interval from the peak of the T wave to the end of the T wave (TpTec) and QTc intervals were assessed with 12-lead electrocardiography before PCI, within 24 h after PCI, and 12 weeks after PCI. SDB defined as an apnea-hypopnea index (AHI) ≥15 per hour was diagnosed by polysomnography.Results: Before PCI, patients with SDB had a significantly prolonged TpTec interval compared to patients without SDB (133 vs 104 ms, p = 0.035). Within 24 h after PCI, the TpTec interval was 107 vs 92 ms (p = 0.178). QTc intervals showed a similar pattern (pre-PCI: 443 vs 423 ms, p = 0.199; post-PCI: 458 vs 432 ms, p = 0.115). In multiple linear regression analyses, AHI was significantly associated with prolonged TpTec intervals (pre-PCI: B-coefficient = 1.11, 95% confidence interval (CI) 0.48-1.74, p = 0.001; post-PCI: B = 0.97, 95% CI 0.29-1.65, p = 0.007), prolonged QTc intervals (pre-PCI: B = 1.05, 95% CI 0.20-1.91, p = 0.018; post-PCI: B = 1.37, 95% CI 0.51-2.24, p = 0.003), and higher TpTe/QT-ratios (pre-PCI: B = 0.16, 95% CI 0.05-0.27, p = 0.007; post-PCI: B = 0.13, 95% CI < 0.01-0.25, p = 0.036), independent of known risk factors for cardiac arrhythmia.Conclusion: In patients with STEMI, SDB was significantly associated with disturbed cardiac repolarization before and after PCI, independent of known risk factors. These findings suggest that SDB may contribute to the risk of developing malignant ventricular arrhythmia. [ABSTRACT FROM AUTHOR]

Objective: During an acute myocardial infarction, patients often use denial as a coping mechanism which may provide positive mood regulating effects but may also prolong prehospital delay time (PHD). However, empirical evidences are still sparse.Methods: This cross-sectional study included 533 ST-elevated myocardial infarction (STEMI) patients from the Munich Examination of Delay in Patients Experiencing Acute Myocardial Infarction (MEDEA) study. Data on sociodemographic, clinical and psycho-behavioral characteristics were collected at bedside. The outcome was assessed using the Cardiac Denial of Impact Scale (CDIS) with the median split as cutoff point. A total of 206 (41.8%) STEMI patients were thus classified as deniers.Results: Deniers were less likely to suffer from major depression (p=0.04), anxiety (p=0.01) and suboptimal well-being (p=0.01) compared to non-deniers during the last six months prior to STEMI. During STEMI, they were less likely to perceive severe pain strength (p=0.04) and racing heart (p=0.02). Male deniers were also less likely to perceive shortness of breath (p=0.03) and vomiting (p=0.01). Denial was not associated with overall delay time. However, in the time window of 3 to 24h, denial accounted for roughly 40min extra delay (356 vs. 316.5min p=0.02 n=196).Conclusions: Denial not only contributes to less suffering from acute heart related symptoms and negative affectivity but also leads to a clinically significant delay in the prevalent group. [ABSTRACT FROM AUTHOR]

Objective: We aimed to assess whether patients' knowledge about acute myocardial infarction (AMI) has an impact on the prehospital delay-time.Methods: This investigation was based on 486 AMI patients who participated in the cross-sectional Munich-Examination-of-Delay-in-Patients-Experiencing-Acute-Myocardial-Infarction (MEDEA) study. A modified German-version of the ACS-Response-Index Questionnaire was used. Multivariate logistic-regression models were used to identify factors associated with knowledge-level as well as the impact of knowledge-level on delay-time.Results: High AMI-knowledge shortened median delay-time in men (168[92-509] vs. 276[117-1519] mins, p=0.0069), and in women (189[101-601] vs. 262[107-951]mins, p=0.34). Almost half-of-patients (n=284,58%) demonstrated high AMI-knowledge. High-knowledge were independently associated with male-gender (OR=1.47[1.17-1.85]) and General-Practitioner as a knowledge-source (OR=1.42[1.14-1.77]). Old-age (OR=0.87[0.86-0.89]) and previous AMI-history/stent-placement (OR=0.65[0.46-0.93]) were significantly associated with lower-knowledge. Although the majority (476,98%) correctly recognized at least one AMI-symptom, 69(14.2%) patients correctly identified all AMI-symptoms. Additionally, one-in-three believed that heart-attack is always accompanied with severe chest-pain. Elderly-patients and women were more likely to be less-knowledgeable about atypical-symptoms (p=0.006), present with atypical AMI-presentation (p<0.001) and subsequently experience protracted delay-times (p<0.001).Conclusions: Knowledge of AMI-symptoms remains to be substandard, especially knowledge of atypical-symptoms. Knowledge is essential to reduce delay-times, but it is not a panacea, since it is not sufficient alone to optimize prehospital delay-times. [ABSTRACT FROM AUTHOR]

Background: Reliable burden of disease (BOD) estimates are needed to support decision making in health care.Objectives: The objective of this study was to introduce an analysis approach based on individual-level longitudinal survey data that estimates the burden of diabetes in patients with coronary heart disease in terms of quality-adjusted life-years (QALYs) lost.Methods: Data from two postal surveys (2006, N = 1022; 2010-2011, N = 716) of survivors from the KORA Myocardial Infarction Registry in Southern Germany were analyzed. Accumulated QALYs were calculated for each participant over a mean observation time of 4.1 years, considering the noninformative censoring structure of the follow-up study. Linear regression models were used to estimate the loss in (quality-unadjusted) life-years and QALYs between patients with and without diabetes, and generalized additive models were used to analyze the nonlinear association with age. The cross-sectional and longitudinal association with quality of life (QOL) and QOL change and the impact on mortality were analyzed to enhance the understanding of the observed results.Results: Diabetes was associated with a reduced QOL at baseline (cross-sectional: β = -0.069; P < 0.001), but not with a significant longitudinal QOL change. Mortality in patients with diabetes was increased (hazard ratio = 1.68; P < 0.005). This resulted in a loss of 0.14 life-years (P = 0.003) and 0.37 QALYs (P < 0.001). Results from generalized additive models indicated that the burden of diabetes is less pronounced in older subjects.Conclusions: The application of the proposed approach provides confounder-adjusted BOD estimates for the studied time horizon and can be used to compare the BOD across different chronic conditions. Curative efforts are needed to diminish the substantial diabetes-related QALY gap. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To determine if an algorithm implementing a serial high-sensitive cardiac troponin T (hs-cTnT) measurement at presentation (0h) and at 3 hours after presentation (3h) is helpful for early diagnosis of non-ST-elevation myocardial infarction (NSTEMI) in older patients. Design: Prospective observational cohort study. Setting: An emergency department (ED) of a city hospital covering a population of approximately 1 million in Germany. Participants: A total of 332 consecutive unselected patients were recruited, of whom 25 had one or more of the prespecified exclusion criteria and 1 had a missing hs-cTnT at 3h, resulting in a final population of 306 patients. Measurements: In addition to clinical examination, hs-cTnT was measured at 0h and 3h. The final diagnosis of NSTEMI was adjudicated by two independent consultants and an algorithm for rule-in and rule-out of NSTEMI was developed using classification and regression tree analysis. All patients were followed-up for cardiovascular outcome within 12 months. Results: Among 306 patients (mean age 81 ± 6 years), 38 (12%) patients had NSTEMI. Accuracy to diagnose NSTEMI was significantly higher for hs-cTnT measurements at 3h versus 0h (area under the receiver operating characteristic curve [AUC] 0.88 vs. 0.82, P = .0038) and for absolute versus relative hs-cTnT delta changes (AUC 0.89 versus 0.69, P < .001). A diagnostic algorithm using hs-cTnT values at presentation and absolute delta changes values ruled-in NSTEMI in 23% and ruled-out NSTEMI in 35% of patients. For patients neither fulfilling the rule-in nor the rule-out criteria, an observational zone was established. Cumulative 1-year survival was 79.4%, 88.5%, and 99.1% in patients classified as rule-in, observational zone, and rule-out, respectively. Conclusion: In older patients, serial hs-cTnT measurements and absolute delta-changes at 3h were valuable for early diagnosis of NSTEMI. An algorithm ruled-in NSTEMI in one quarter of patients with high risk and ruled-out NSTEMI in one-third with low risk. [Copyright &y& Elsevier]

Abstract: There is strong evidence from both animal- and in vitro-models that paraoxonase (PON1) is involved in the onset of cardiovascular disease. In humans there is no consensus on this issue and therefore we investigated the effect of PON1 genotype and activity on the incidence of coronary heart disease (CHD) and acute myocardial infarction (AMI) in a large prospective cohort of 17,357 middle-aged women. We applied a case-cohort design using the CHD (n =211) and AMI cases (n =71) and a random sample from the baseline cohort (n =1527). A weighted Cox proportional hazards model was used to estimate age- and multivariate-adjusted hazard ratios (HR) for the PON1 genetic variants (192Q>R and −107C>T) and tertiles of the PON1 arylesterase- and paraoxonase activities. Neither the PON1 genetic variants, nor the PON1 activities affected the incidence of CHD in general, but, an increased paraoxonase activity was associated with a higher risk of AMI: the second and third tertile HR were 1.31 and 2.07, respectively (P-trend=0.029, multivariate model). In the subgroup of never-smokers, paraoxonase activity was associated with an increased risk for AMI: the second and third tertile HR were 4.1 and 4.7, respectively (P-trend=0.009, multivariate model). Additionally, when compared to the lowest paraoxonase tertile in never-smokers, the highest paraoxonase tertile in current-smokers showed a 19.2-fold higher risk for AMI (95%CI: 5.3–69.5, P <0.0001, multivariate model). In conclusion, this study shows that in middle-aged women paraoxonase activity was associated with an increased risk for AMI and that the risk was modified by the effects of smoking. [Copyright &y& Elsevier]

Summary: Aim: To investigate the implementation of mild therapeutic hypothermia (MTH) after cardiac arrest into clinical practice. Methods and results: A structured evaluation questionnaire was sent to all German hospitals registered to have ICUs; 58% completed the survey. A total of 93 ICUs (24%) reported to use MTH. Of those, 93% started MTH in patients after out-of-hospital resuscitation with observed ventricular fibrillation and 72% when other initial rhythms were observed. Only a minority of ICUs initiate MTH in patients after cardiac arrest with cardiogenic shock (28%), whereas 48% regarded cardiogenic shock as a contra-indication for MTH. On average, target temperature was 33.1±0.6°C and duration of cooling 22.9±4.9h. Many centres used economically priced cold packs (82%) and cold infusions (80%) for cooling. The majority of the ICUs considered infection, hypotension and bleeding as relevant complications of hypothermia which was of therapeutic relevance in less than 25% of the cases. Conclusions: MTH is underused in German ICUs. Centres which use MTH widely follow the recommendations of ILCOR with respect to the indication and timing of cooling. In hospitals that use MTH the technique is considered to be safe and inexpensive. More efforts are needed to promote this therapeutic option and hypothermia since MTH has now been included into European advanced cardiovascular life support protocols. [Copyright &y& Elsevier]

Explores the factors influencing patients' and physicians' views on patients' vocational disability following myocardial infarction or coronary artery bypass grafting and the impact of these factors on actual re-employment of patients following cardiac rehabilitation in Germany. Relevance of medical variables to re-employment; Consequences for cardiac rehabilitation.

Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of the randomized trials (284 of 491, 58%); group II, patients not included in these trials (207 of 491, 42%). Of group II the following subgroups were defined: group IIa, patients in cardiogenic shock (20 of 491, 4.1%); group IIb, patients with a left bundle branch block (12 of 491, 2,4%); group IIc, patients with contraindications for thrombolysis (42 of 491, 8.6%); group IId, patients with a nondiagnostic first electrocardiogram (95 of 491, 19.3%); group IIe, patients with a prehospital delay of > 12 hours (72 of 491, 14.7%); group IIf, patients with an unknown prehospital delay (30 of 491, 6.1%). A comparison of groups I and II showed similar baseline characteristics but a higher clinical event rate during hospitalization was seen in group II: combined end point of death, reinfarction, heart failure equal to or greater than NYHA class III, any stroke or postinfarction angina, 26.6% versus 18%; p = 0.022. Hospital deaths were nearly twice as high in these patients, without reaching statistical significance (10.6% vs 6%; p = 0.06). The subgroups of group II showed quite different rates of clinical events. In-hospital death rates were: IIa, 40% (8 of 20); IIb, 8% (1 of 12); IIc, 12% (5 of 42); IId, 5% (5 of 95); IIe, 6% (4 of 72); and IIf, 13% (4 of 30). The incidence of the combined end point was 60% (12 of 20) in IIa, 33% (4 of 12) in IIb, 29% (12 of 42) in IIc, 16% (15 of 95) in IId, 26% (19 of 72) in IIe, and 33% (10 of 30) in IIf. Thus, in clinical practice, about half of the patients treated with pPTCA would not have been included in randomized trials comparing pPTCA with thrombolysis. These patients represent a population at higher risk for in hospital clinical events. However, they do represent very different nonhomogenous subgroups with different clinical event rates. [ABSTRACT FROM AUTHOR]

Our results show significant and independent influence of the GUSTO-1 trial on the use of recombinant tissue plasminogen activator in acute myocardial infarction in Germany. This influence started soon after the publication of the trial and was not restricted to subgroups who benefitted most from recombinant tissue plasminogen activator. [ABSTRACT FROM AUTHOR]

The Abiomed Impella 5.5 (Danvers, MA), is a newly developed axial flow trans-aortic cardiac support device mounted on a 9 Fr steering catheter with a 21 Fr pump cannula. The Impella 5.5 is intended for longer use and received in 2018 CE mark for 30 days. This study evaluates the first-in-man series from six high volume mechanical circulatory support centers in Germany after CE approval. The worldwide first 37 consecutive patients have been implanted in six German centers between March 2018 and September 2019 for post CE mark evaluation. Mean age was 59.1±11.5yearsand 35 (94.6%) were male. Main indication for Impella 5.5 implantation was ischemic cardiomyopathy and acute myocardial infarction (43%). Mean support time was 15.9± 26 days (up to 161) with a total of more than 587 patient-days on support. Average flow rate was 3.7 ± 0.7 l/min. 30 day survival was 72.9%. Survival to next therapy was 75.7%. 13 (35.1%) have been weaned from the device for native heart recovery and 14 (37.8%) have been bridged to a durable device. 13 patients (35.1%) have been mobilized to chair and 11 (29.7%) were able to walk around. There were no strokes or thrombembolic complications. 5 patients (13.5 %) had hemolysis. 9 patients (24.3%) had pump dislocations. The Impella 5.5 provides promising early outcomes for patients with acute heart failure and expends the spectrum of available devices. More implantations are needed to further evaluate performance of the device. [ABSTRACT FROM AUTHOR]

Objective To analyze the burden of institutionalizations after femoral fracture and compare it with other “catastrophic” disease entities like stroke, myocardial infarction, or pneumonia. Design/Setting/Participants Routine data of 414,000 hospitalized German patients aged 66 years and older were used to calculate institutionalization risks after femoral fracture, stroke, myocardial infarction, pneumonia or a combined group of “all other hospitalizations.” Measurements Institutionalization was defined as nursing home admission within 6 months after discharge from hospital. Age- and sex-specific incidence and incidence rates of institutionalization were calculated. To compare the risk of institutionalization between the disease entities, age-standardized rates were computed and proportional hazards models were applied. In-house mortality and mortality after discharge from hospital were also calculated. Results The risk of institutionalization increased exponentially with age in all disease entities. For example, the risk of institutionalization after femoral fracture increased from 3.6% in women aged 65 to 69 years to 34.8% in women aged 95 years and older. The highest institutionalization rates were observed in patients with stroke, followed by femoral fracture, pneumonia, and myocardial infarction. In men, the age-standardized risk of institutionalization was almost as high after femoral fracture as after stroke (7.5% vs 8.0%). In contrast to myocardial infarction and pneumonia, femoral fracture and stroke were more likely to be followed by institutionalization rather than death. Conclusion Femoral fractures result in high burden of institutionalizations. Prevention of falls, diagnosis and treatment of osteoporosis, and high-quality rehabilitation are challenges to tackle the burden of institutionalization in these patients in the future. [ABSTRACT FROM AUTHOR]