S3 Guideline "Smoking and Tobacco Dependence: Screening, Diagnosis, and Treatment" - Short Version.

INTRODUCTION: In addition to the prevention of tobacco consumption, the establishment and assurance of high-quality treatment for harmful use and dependence on tobacco products remains an important health-related task in Germany. Regular updating of the Association of the Scientific Medical Societies (AWMF) S3 guideline "Smoking and Tobacco Dependence: Screening, Diagnosis, and Treatment" (Tobacco Guideline) offers a sustainable and reputable source of knowledge on smoking cessation. METHODS: Under the auspices of the German Society for Psychiatry, Psychotherapy, Psychosomatics, and Neurology (DGPPN) and the German Society for Addiction Research and Addiction Therapy (DG-Sucht), the Tobacco Guideline was revised in 2019-2020 by 63 experts, who were involved in the development process of the text, in 11 working groups. Undue influence of conflicts of interest on the guideline could be minimized through careful conflict of interest management. Delegates from 50 professional societies discussed the 80 guideline recommendations and voted online. RESULTS: In addition to recommendations for screening and diagnostics, the Tobacco Guideline takes a positive stance towards the use of low-threshold counseling and support services. If, due to the severity of the tobacco-related disorder, brief counseling, telephone counseling, or internet- or smartphone-based methods are not sufficiently effective, individual or group behavioral therapy, possibly in combination with medication, is indicated. If nicotine replacement therapy is not effective, varenicline or bupropion should be offered. Alternative strategies with a lower level of recommendation are hypnotherapy, mindfulness-based treatments, or medication with cytisine. In adolescents and pregnant women, the use of medication should be limited to well-specified exceptions and nicotine replacement. The mean agreement with the recommendations reached a value of 98%. A general overview of the treatment recommendations of the Tobacco Guideline is provided by three clinical algorithms.

OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction.

BACKGROUND: There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction. METHODS AND RESULTS: OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (n=3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (P=0.84); total mortality, 4.6% and 3.7% (P=0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (P=0.1); and revascularization in survivors, 27.6% and 29.1% (P=0.34). CONCLUSIONS: Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251134.

Cardiac Rehabilitation in German Speaking Countries of Europe-Evidence-Based Guidelines from Germany, Austria and Switzerland LLKardReha-DACH-Part 2.

BACKGROUND: Scientific guidelines have been developed to update and harmonize exercise based cardiac rehabilitation (ebCR) in German speaking countries. Key recommendations for ebCR indications have recently been published in part 1 of this journal. The present part 2 updates the evidence with respect to contents and delivery of ebCR in clinical practice, focusing on exercise training (ET), psychological interventions (PI), patient education (PE). In addition, special patients' groups and new developments, such as telemedical (Tele) or home-based ebCR, are discussed as well. METHODS: Generation of evidence and search of literature have been described in part 1. RESULTS: Well documented evidence confirms the prognostic significance of ET in patients with coronary artery disease. Positive clinical effects of ET are described in patients with congestive heart failure, heart valve surgery or intervention, adults with congenital heart disease, and peripheral arterial disease. Specific recommendations for risk stratification and adequate exercise prescription for continuous-, interval-, and strength training are given in detail. PI when added to ebCR did not show significant positive effects in general. There was a positive trend towards reduction in depressive symptoms for "distress management" and "lifestyle changes". PE is able to increase patients' knowledge and motivation, as well as behavior changes, regarding physical activity, dietary habits, and smoking cessation. The evidence for distinct ebCR programs in special patients' groups is less clear. Studies on Tele-CR predominantly included low-risk patients. Hence, it is questionable, whether clinical results derived from studies in conventional ebCR may be transferred to Tele-CR. CONCLUSIONS: ET is the cornerstone of ebCR. Additional PI should be included, adjusted to the needs of the individual patient. PE is able to promote patients self-management, empowerment, and motivation. Diversity-sensitive structures should be established to interact with the needs of special patient groups and gender issues. Tele-CR should be further investigated as a valuable tool to implement ebCR more widely and effectively.

Cardiovascular prevention in clinical practice (ESC and German guidelines 2007).

Preventive efforts should be guided by the patient's global cardiovascular (CV) risk. A risk stratification should be done in every person > age 35 with more than a single risk factor. Recommendations for improved lifestyle are applicable to all persons with CV risk factors: smoking cessation, daily exercise, normal body mass index, Mediterranean diet, blood pressure < 140 mmHg systolic, and LDL cholesterol < 130 mg/dl are beneficial. If the 10-year risk is > or = 20% for CV events or > or = 5% for CV death, additional drug interventions are usually necessary: acetylsalicylic acid 100 mg daily, statins to lower LDL cholesterol to < 100 mg/dl or, in diabetics with coronary artery disease, to < 70 mg/dl, blood pressure should be < 130 mmHg systolic, e.g., in patients with diabetes or renal disease. After bare-metal stent implantation clopidogrel should be given for > or = 4 weeks and after drug-eluting stents for > or = 6 months. In patients after myocardial infarction with an ejection fraction of < 40%, ACE inhibitors and beta-blocker should be started. Influenza vaccination improves prognosis in high-risk patients.

Coronary computed tomography angiography (CCTA) in patients with suspected stable coronary artery disease (CAD): diagnostic impact and clinical consequences in the German Cardiac CT Registry depending on stress test results.

To evaluate diagnostic impact of clinical use of coronary computed tomography angiography (CCTA) in patients with suspected stable coronary artery disease (CAD) and its consequences in daily practice for patient management, depending on stress test results in daily practice. Between 2009 and 2014 of a total population of 1352 patients of the German Cardiac Computed Tomography (CT) Registry who had previously undergone stress tests, CCTA visualizations were carried out on the coronary arteries with suspected stable CAD. Patients were divided into three groups according to stress test results: Group 1 with inconclusive (n = 178, 13.2%), Group 2 with ischemia in stress test (n = 372, 27.5%) and Group 3 without ischemia in stress test (n = 802, 59.3%). The test of preference was the stress electrocardiogram (ECG), which was performed more frequently in patients without ischemia in stress test as compared to those with ischemia (96.3% vs. 93.0%, p = 0.015). The incidence of detected obstructive CAD was lower in patients with suggested ischemia in stress test as compared to patients with inconclusive results (14.1% vs. 21.1%, p = 0.037). There was no difference in the incidence of an obstructive CAD in patients with and without ischemia in stress test (14.1% vs. 15.8%, p = 0.440). CCTA is a reliable, non-invasive option for ruling-out obstructive CAD irrespective of the stress test result.

Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study.

Trial design Prospective randomized multicentre interventional study. Methods Individual cardiovascular risk assessment in Ford Company, Germany employees ( n = 4.196), using the European Society of Cardiology-Systematic Coronary Risk Evaluation (ESC-SCORE) for classification into three risk groups. Subjects assigned to ESC high-risk group (ESC-SCORE ≥ 5%), without a history of cardiovascular disease were eligible for randomization to a multimodal 15-week intervention programme (INT) or to usual care and followed up for 36 months. Objectives Evaluation of the long-term effects of a risk-adjusted multimodal intervention in high-risk subjects. Primary endpoint: reduction of ESC-SCORE in INT versus usual care. Secondary endpoints: composite of fatal and non-fatal cardiovascular events and time to first cardiovascular event. STATISTICAL ANALYSIS: intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT ( n = 224) or to usual care ( n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.).

[Return to work after cardiologic rehabilitation]. / Berufliche Wiedereingliederung nach kardiologischer Rehabilitation.

OBJECTIVES: The objectives of the present study were to determine prospectively return to work and its predictors in patients after cardiac rehabilitation. METHODS: Patients were enrolled at admission to inpatient cardiac rehabilitation centres (n = 18). Primary indications for admission were myocardial infarction, coronary artery bypass grafting or percutaneous transluminal coronary angioplasty. RESULTS: We included 2441 consecutive patients (1907 men, mean age: 60 +/- 10 years; 534 women, mean age: 65 +/- 10 years). A total of 43% of all patients had been actively employed before the event. Of these patients, 65% had returned to work six months and 67% 12 months after cardiac rehabilitation. Successful return to work after 12 months was significantly predicted by younger age, non-manual work, self-employment, a higher physical and mental quality of life, and a better exercise ECG result. CONCLUSION: Return to work is predicted by sociodemographic factors, quality of life, and the exercise ECG at the rehabilitation centre. The determination of early predictors for return to work may aid to identify patients particularly at risk for failure to return to work.

Short-term comprehensive cardiac rehabilitation after AMI is associated with reduced 1-year mortality: results from the OMEGA study.

BACKGROUND: The prognostic effect of early, comprehensive short-term cardiac rehabilitation on top of current, guideline-adjusted treatment of acute myocardial infarction has not sufficiently been evaluated. DESIGN: Prospective cohort study. METHODS: Within the OMEGA study population, the clinical course of 3560 patients still alive 3 months after acute myocardial infarction were evaluated by comparing patients who had attended to cardiac rehabilitation (70.6%) with those who did not. Total mortality and major adverse cerebrovascular and cardiovascular events, as well as non-fatal events, were evaluated within the time period of 4-12 months after hospital admission for acute myocardial infarction. The effect of cardiac rehabilitation on clinical events was estimated by using the propensity score method to adjust for confounding parameters in multivariate analysis. RESULTS: Patients participating in cardiac rehabilitation were younger, more often had acute revascularization, less often experienced non-ST-elevation myocardial infarction, and less often had a history of diabetes or cardiovascular events. Total mortality (OR 0.46, 95% CI 0.27-0.77) and major adverse cerebrovascular and cardiovascular events (OR 0.53, 95% CI 0.38-0.75) were significantly lower in the rehabilitation group. Subgroup analysis including major clinical characteristics also revealed significantly reduced rates of total death and major adverse cerebrovascular and cardiovascular events in the rehabilitation group. CONCLUSIONS: Attendance to early, comprehensive short-term cardiac rehabilitation programmes on top of current guideline-adjusted treatment of acute myocardial infarction is associated with a significantly improved 1-year prognosis.

Is it worth offering cardiovascular disease prevention to the elderly?

The question whether prevention in the elderly or in the old is still worthwhile arises frequently in clinical practice. The life expectancy (LE) of elderly persons is often underestimated and ranges for a 65-year-old European person from 17 to 23 years and for an 80-year-old from 8 and 11 years. In the elderly patients with cardiovascular disease, preventive measures are of great benefit. Smoking cessation results in substantial gains in LE and is more effective than most other interventions. Lipid lowering with statins is cost effective and the intensity of low-density lipoprotein cholesterol lowering correlates with the risk reduction of cardiac events and stroke without increasing the risk of cancer. A quality-adjusted life year costs US $ 18,800, less than the costs of a nursing home for 1 year. Exercise training decreases cardiovascular events and improves quality of life. The benefits of the Mediterranean diet are based on a small randomized trial, which is supplemented by a large observational database. A reduction in all-cause, cardiovascular disease, and cancer mortality is highly likely. Blood pressure lowering reduces stroke and all-cause mortality above the age of 80; however, the target blood pressure should be around 150/80 mmHg or slightly lower. Annual vaccination against influenza is one of the most cost-effective methods to prolong life and should not be forgotten in patients with cardiovascular disease above the age of 65. Thus a number of options are available to add quality-adjusted life years in the elderly by adhering to the general guidelines for cardiovascular prevention.

Effects of 1-year treatment with highly purified omega-3 fatty acids on depression after myocardial infarction: results from the OMEGA trial.

OBJECTIVE: The effects of supplementation of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on prevalence and severity of depression were evaluated in patients after a myocardial infarction. METHOD: A cross-sectional evaluation (posttest-only design) within the prospective, randomized, controlled, multicenter OMEGA trial was performed in patients after myocardial infarction at 12 months' follow-up (N = 2,081; age, mean = 64 years; men, 76.7%; women, 21.8%) from April 2005 to June 2007. Patients received supplementation with ethyl esters 90 (460-mg EPA and 380-mg DHA) or placebo for 12 months. Depression was assessed with the Beck Depression Inventory-II (BDI-II); a BDI-II cutoff score of ≥ 14 was used as diagnosis of depression. RESULTS: When the total population was evaluated, no effects of EPA/DHA supplementation on depressive symptoms according to BDI-II score (mean [SD]) could be demonstrated: EPA/DHA (n = 1,046), 7.1 (6.9); placebo (n = 1,035), 7.1 (7.0); P = .7. The post hoc analyses of depressed patients with and without antidepressants revealed a tendency toward an antidepressant effect in patients with EPA/DHA supplementation as monotherapy: EPA/DHA (n = 125), 19.4 (5.8); placebo (n = 113), 19.9 (5.1); P = .07. However, in depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants, a clinically relevant antidepressant effect was demonstrated: EPA/DHA (n = 33), 20.9 (7.1); placebo (n = 29), 24.9 (8.5); P < .05. CONCLUSIONS: EPA/DHA supplementation in the total sample of patients after myocardial infarction had no effect on depressive symptoms. The clinically relevant antidepressant effect in the subgroup of depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants that was revealed in the post hoc analysis might provide a basis for a controlled, prospective trial of omega-3 augmentation of antidepressants in patients after myocardial infarction. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00251134.

Predictors of 1-year mortality in patients with contemporary guideline-adherent therapy after acute myocardial infarction: results from the OMEGA study.

BACKGROUND: Predictors of long-term mortality after discharge after acute myocardial infarction (AMI) are well characterized. However, these established risk factors are based on data almost exclusively derived from older studies without consistent use of revascularization therapy and adjunctive therapy with statins, platelet inhibitors, beta-blockers and ACE inhibitors/ARBs. We therefore sought to investigate predictors of 1-year mortality in survivors of AMI treated with contemporary guideline-adherent therapy. METHODS AND RESULTS: We performed a retrospective analysis of 3,782 patients surviving acute ST-elevation and non ST-elevation myocardial infarction who were enrolled in the prospective, randomized, double-blind, controlled OMEGA trial with 104 German centers. The primary objective of the OMEGA study was to determine the effect of highly purified omega-3 fatty acid ethyl esters-90 on the rate of sudden cardiac death in patients surviving AMI and receiving current guideline-adherent treatment within the 1-year of follow-up. 80.8 % of the patients received early revascularization therapy. At discharge, 94.2 % of the patients received beta-blocker, 90.4 % ACE inhibitor/angiotensin receptor blocker, 94.3 % statin, 95.4 % aspirin and 88.4 % clopidogrel. During the 1-year follow-up 139 patients (3.7 %) died. Multivariate logistic regression analysis revealed the following independent predictors of 1-year mortality in decreasing order of importance: ejection fraction <45 % [odds ratio (OR) 2.28, 95 % confidence interval (CI) 1.53-3.41], age ≥70 years (OR 2.17, 95 % CI 1.42-3.32), no acute revascularization (OR 2.02, 95 % CI 1.33-3.08), prior stroke/transient ischemic attack (OR 1.90, 95 % CI 1.09-3.30), peripheral arterial disease (OR 1.86, 95 % CI 1.12-3.10), heart rate >85/min (OR 1.82, 95 % CI 1.23-2.71), chronic obstructive lung disease (OR 1.77, 95 % CI 1.01-3.10) and HDL cholesterol <40 mg/dl (OR 1.75, 95 % CI 1.15-2.67). CONCLUSIONS: In patients surviving AMI and treated with contemporary guideline-adherent therapy, 1-year mortality was low. Nevertheless, traditional risk factors such as ejection fraction <45 %, older age, no acute revascularization and comorbidities were the strongest predictors of long-term mortality supporting the findings from previous studies.

Usefulness of heart rate to predict one-year mortality in patients with atrial fibrillation and acute myocardial infarction (from the OMEGA trial).

In the setting of acute myocardial infarction and sinus rhythm, the heart rate (HR) has been demonstrated to correlate closely with mortality. In patients presenting with acute myocardial infarction and atrial fibrillation (AF) on admission, however, the prognostic relevance of the HR has not yet been systematically addressed. A post hoc subgroup analysis of the data from the OMEGA trial was conducted to analyze whether the admission HR determines the 1-year mortality in patients presenting with AF in the setting of acute myocardial infarction. Of 3,851 patients enrolled in the OMEGA study, 211 (6%) presented with AF on admission. This subgroup was dichotomized according to the admission HR (cutoff 95 beats/min). Multiple regression analysis revealed that an admission HR of ≥95 beats/min independently determined the 1-year mortality in patients with AF (odds ratio 4.69, 95% confidence interval 1.47 to 15.01; p = 0.01). In conclusion, this is the first study demonstrating that a high HR (≥95 beats/min) on admission in patients with AF and acute myocardial infarction is associated with an almost fivefold mortality risk.

Smoking restrictions and hospitalization for acute coronary events in Germany.

AIMS: To study the effects of smoking restrictions in Germany on coronary syndromes and their associated costs. METHODS AND RESULTS: All German states implemented laws partially restricting smoking in the public and hospitality sectors between August 2007 and July 2008. We conducted a before-and-after study to examine trends for the hospitalization rate for angina pectoris and acute myocardial infarction (AMI) for an insurance cohort of 3,700,384 individuals 30 years and older. Outcome measures were hospitalization rates for coronary syndromes, and hospitalization costs. Mean age of the cohort was 56 years, and two-thirds were female. Some 2.2 and 1.1% persons were hospitalized for angina pectoris and AMI, respectively, during the study period from January 2004 through December 2008. Law implementation was associated with a 13.3% (95% confidence interval 8.2, 18.4) decline in angina pectoris and an 8.6% (5.0, 12.2) decline in AMI after 1 year. Hospitalization costs also decreased significantly for the two conditions-9.6% (2.5, 16.6) for angina pectoris and 20.1% (16.0, 24.2) for AMI at 1 year following law implementation. Assuming the law caused the observed declines, it prevented 1,880 hospitalizations and saved 7.7 million Euros in costs for this cohort during the year following law implementation. CONCLUSIONS: Partial smoking restrictions in Germany were followed by reductions in hospitalization for angina pectoris and AMI, declines that continued through 1 year following these laws and resulted in substantial cost savings. Strengthening the laws could further reduce morbidity and costs from acute coronary syndromes in Germany.