EU-CaRE study: Could exercise-based cardiac telerehabilitation also be cost-effective in elderly?

BACKGROUND: The role of cardiac rehabilitation (CR) is well established in the secondary prevention of ischemic heart disease. Unfortunately, the participation rates across Europe remain low, especially in elderly. The EU-CaRE RCT investigated the effectiveness of a home-based mobile CR programme in elderly patients that were not willing to participate in centre-based CR. The initial study concluded that a 6-month home-based mobile CR programme was safe and beneficial in improving VO2peak when compared with no CR. OBJECTIVE: To assess whether a 6-month guided mobile CR programme is a cost-effective therapy for elderly patients who decline participation in CR. METHODS: Patients were enrolled in a multicentre randomised clinical trial from November 11, 2015, to January 3, 2018, and follow-up was completed on January 17, 2019, in a secondary care system with 6 cardiac institutions across 5 European countries. A total of 179 patients who declined participation in centre-based CR and met the inclusion criteria consented to participate in the European Study on Effectiveness and Sustainability of Current Cardiac Rehabilitation Programs in the Elderly trial. The data of patients (n = 17) that were lost in follow-up were excluded from this analysis. The intervention (n = 79) consisted of 6 months of mobile CR programme with telemonitoring, and coaching based on motivational interviewing to stimulate patients to reach exercise goals. Control patients did not receive any form of CR throughout the study period. The costs considered for the cost-effectiveness analysis of the RCT are direct costs 1) of the mobile CR programme, and 2) of the care utilisation recorded during the observation time from randomisation to the end of the study. Costs and outcomes (utilities) were compared by calculation of the incremental cost-effectiveness ratio. RESULTS: The healthcare utilisation costs (P = 0.802) were not significantly different between the two groups. However, the total costs were significantly higher in the intervention group (P = 0.040). The incremental cost-effectiveness ratio for the primary endpoint VO2peak at 6 months was €1085 per 1-unit [ml/kg/min] improvement in change VO2peak and at 12 months it was €1103 per 1 unit [ml/kg/min] improvement in change VO2peak. Big differences in the incremental cost-effectiveness ratios for the primary endpoint VO2peak at 6 months and 12 months were present between the adherent participants and the non-adherent participants. CONCLUSION: From a health-economic point of view the home-based mobile CR programme is an effective and cost-effective alternative for elderly cardiac patients who are not willing to participate in a regular rehabilitation programme to improve cardiorespiratory fitness. The change of QoL between the mobile CR was similar for both groups. Adherence to the mobile CR programme plays a significant role in the cost-effectiveness of the intervention. Future research should focus on the determinants of adherence, on increasing the adherence of patients and the implementation of comprehensive home-based mobile CR programmes in standard care.

[Short version of the 2nd edition of the German-Austrian S3 guidelines "Cardiogenic shock complicating myocardial infarction-Diagnosis, monitoring and treatment"]. / Kurzversion der 2. Auflage der deutsch-österreichischen S3-Leitlinie "Infarkt-bedingter Kardiogener Schock ­ Diagnose, Monitoring und Therapie".

BACKGROUND: The present guidelines ( http://leitlinien.net ) focus exclusively on cardiogenic shock due to myocardial infarction (infarction-related cardiogenic shock, ICS). The cardiological/cardiac surgical and the intensive care medicine strategies dealt with in these guidelines are essential to the successful treatment and survival of patients with ICS; however, both European and American guidelines on myocardial infarction and heart failure and also position papers on cardiogenic shock focused mainly on cardiological aspects. METHODS: Evidence on the diagnosis, monitoring and treatment of ICS was collected and recommendations compiled in a nominal group process by delegates of the German Cardiac Society (DGK), the German Society for Medical Intensive Care Medicine and Emergency Medicine (DGIIN), the German Society for Thoracic and Cardiovascular Surgery (DGTHG), the German Society for Anaesthesiology and Intensive Care Medicine (DGAI), the Austrian Society for Internal and General Intensive Care Medicine (ÖGIAIM), the Austrian Cardiology Society (ÖKG), the German Society for Prevention and Rehabilitation of Cardiovascular Diseases (DGPR) and the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI), under the auspices of the Working Group of the Association of Medical Scientific Societies in Germany (AWMF). If only poor evidence on ICS was available, general study results on intensive care patients were inspected and presented in order to enable analogue conclusions. RESULTS: A total of 95 recommendations, including 2 statements were compiled and based on these 7 algorithms with defined instructions on the course of treatment.

[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.

[Dermatosurgery in the age of novel oral anticoagulants/direct oral anticoagulants]. / Dermatochirurgie im Zeitalter der neuen oralen Antikoagulanzien/direkten oralen Antikoagulanzien.

Current guidelines generally recommend continuation of blood thinning drugs in dermatologic surgery and the previously used "bridging" with subcutaneous or intravenous heparin is obsolete. While the guidelines are increasingly implemented in daily practice, there is still uncertainty concerning the use of the novel direct oral anticoagulants (NOAC = DOAC). In this review, we analyze current developments and formulate concise recommendations for continuation during skin surgery under consideration of individual risk.

Editor's Choice - Frailty and the management of patients with acute cardiovascular disease: A position paper from the Acute Cardiovascular Care Association.

Frailty is increasingly seen among patients with acute cardiovascular disease. A combination of an ageing population, improved disease survival, treatable long-term conditions as well as a greater recognition of the syndrome has accelerated the prevalence of frailty in the modern world. Yet, this has not been matched by an expansion of research. National and international bodies have identified acute cardiovascular disease in the frail as a priority area for care and an entity that requires careful clinical decisions, but there remains a paucity of guidance on treatment efficacy and safety, and how to manage this complex group. This position paper from the Acute Cardiovascular Care Association presents the latest evidence about frailty and the management of frail patients with acute cardiovascular disease, and suggests avenues for future research.

[Management of different cardiovascular risk factors with a combination tablet (polypill)]. / Management verschiedener kardiovaskulärer Risikofaktoren mit einem Kombinationspräparat ("Polypill").

BACKGROUND: The multifactorial origin of cardiovascular diseases has led to polypharmacy in primary and secondary prophylaxis with evidence-based medications, such as statins, antihypertensive drugs and platelet aggregation inhibitors. The number of prescribed drugs correlates inversely to adherence and can lead to treatment failure. Fixed-dose combination drugs (polypills) could increase the medication adherence of patients, reduce risks and prevent cardiovascular events. METHODS: This review is based on publications that were retrieved from Medline (via PubMed) and The Cochrane Library. The clinical database ClinicalTrials.gov. was also considered. RESULTS: In the studies on primary prevention conducted to date, fixed-dose combinations showed a superior control of risk factors, e.g. hypertension and low-density lipoprotein (LDL) cholesterol compared to placebo and at least non-inferiority compared to usual care. In secondary prevention, the effect of the polypill is mostly on the reduction of blood pressure and LDL cholesterol in non-adherent patients; however, evidence that fixed-drug combinations reduce cardiovascular morbidity and mortality compared to standard therapy is lacking. CONCLUSION: The polypill can be considered as an alternative to polypharmacy after a risk-benefit assessment, especially in non-adherent patients. Ongoing studies are investigating the effect of the polypill on cardiovascular events. Current polypills are limited by the lack of sufficient dosages of the individual components to avoid overtreatment and undertreatment at the individual treatment level.

[Immediate multivessel PCI in patients with ACS : Is less more?] / Sofortige Mehrgefäß-PCI bei Patienten mit ACS : Ist weniger mehr?

Approximately 50 % of hemodynamically stable patients with ST-segment elevation myocardial infarction (STEMI) and up to 80 % of patients with infarction-related cardiogenic shock have multivessel coronary artery disease. The optimal revascularization strategy in these patients has still not been defined. Following successful percutaneous coronary intervention (PCI) of the culprit lesion, immediate PCI of all additional lesions or staged PCI, after invasive or non-invasive proof of ischemia or conservative therapy can be considered. Randomized studies have demonstrated a clinical benefit of immediate or staged multivessel PCI compared to a conservative approach. So far there are no randomized studies available comparing immediate versus staged PCI. The data regarding the optimal strategy in patients with cardiogenic shock show low concordance. The currently running CULPRIT shock study will help to define the optimal strategy in shock patients. This manuscript summarizes the current knowledge and data and provides recommendations for the clinical practice.

[Bleeding in patients receiving dual antiplatelet therapy after acute coronary syndrome - significance, prevention and interdisciplinary management]. / Interdisziplinäres Management von Blutungen unter dualer antithrombozytärer Therapie nach akutem Koronarsyndrom.

For secondary prevention of acute coronary syndrome, guidelines recommend dual antiplatelet therapy with acetylsalicylic acid and a P2Y12 receptor antagonist such as clopidogrel, prasugrel or ticagrelor for a period of 12 months. Premature discontinuation of dual antiplatelet therapy is associated with an increased risk of ischaemic events. However, antiplatelet therapy is also associated with an increased risk of bleeding that should not be under- or overestimated. To ensure an optimal care of patients receiving dual antiplatelet therapy after an acute coronary syndrome, an interdisciplinary group of experienced experts in the fields of cardiology, cardiac surgery, gastroenterology, anaesthesiology, intensive care and haemostaseology gathered bleeding-related information and developed recommendations relevant to daily clinical practice. These include the significance of bleeding events in the course of treatment, measures for bleeding prevention and the adequate care of patients with bleedings.

[Atrial fibrillation in Germany: A prospective cost of illness study]. / Vorhofflimmern in Deutschland--eine prospektive Krankheitskostenstudie.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in clinical practice and associated with a high risk of stroke, heart failure and hospitalization. This study examines the indication-specific costs of illness of AF patients in Germany. METHODS: The study was conducted nationwide with 54 general practitioners and internists, as well as 12 practicing cardiologists. The observational period per patient was one year. Costs were calculated from the perspective of the German statutory health insurance. The study collected the annual direct indication-specific costs and additional patient relevant outcomes. RESULTS: Indication-specific services of 361 patients (age: 75, male: 55%) documented by general practitioners and internists cause average costs of 582 € per patient. The highest cost are caused by hospitalization (289 €), followed by outpatient treatment costs (151 €) and costs of anticoagulation with 52 € per patient. Additional consulting of a cardiologist (115 patients) causes average costs of 81 €. Assuming that a patient with AF is treated once a year by a resident cardiologist, the average annual cost amounted to 664 €. CONCLUSION: The results of this prospectively cost of illness analysis for AF patients under real life conditions in Germany indicate a high socio-economic burden of AF.

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.

Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany.

BACKGROUND: Representative data on the current management of patients with acute coronary syndromes (ACS) are of high interest. The EPICOR registry aimed to prospectively collect such real-life data with particular focus on antithrombotic drug utilization and outcomes. METHODS: As part of the international prospective EPICOR registry, 29 hospitals in Germany documented 296 patients with ST-elevation myocardial infarction (STEMI)-ACS and 333 with unstable angina or non-STEMI (NSTEMI)-ACS surviving the hospital phase. The statistical analysis was performed in a descriptive manner. The ClinicalTrials.gov identifier is NCT01171404. RESULTS: The mean age of patients was 62 ± 13 years, and 77.4 % were men. Treatment with antithrombotic agents was initiated in the prehospital phase in 50.7 % of STEMI and 33.3 % of NSTEMI patients. During the hospital stay (median 7.0 days), cardiac catheterization was performed in 97.6 %, percutaneous coronary intervention in 85.6 %, thrombolysis in 4.6 %, and coronary bypass surgery in 2.7 % patients. The use of acetylic salicylic acid (ASA) was reported in 95.6 % vs. 96.1 %, clopidogrel in 60.8 % vs. 73.0 %, prasugrel in 45.6 % vs. 22.5 %, any GP IIb/IIIa inhibitor in 52.4 % vs. 18.9 % [any dual combination of ASA+(clopidogrel/prasugrel)in 94.0 vs. 91.0 %], statins in 94.6 % vs. 92.2 %, beta blockers in 96.3 % vs. 94.6 %, and ACE-I/ARB in 91.6 % vs. 87.7 % of STEMI vs. NSTEMI patients, respectively. Combined use of the five drug classes recommended in the guidelines-ASA, P2Y12 antagonists, statin, beta blocker, and ACE-I/ARB-was reported in 81.1 % vs. 69.4 % of STEMI vs. NSTEMI patients, respectively. CONCLUSION: In Germany a high proportion of patients with ACS are treated according to current guidelines, receiving primary revascularization as well as antithrombotic drugs and other agents for prevention of secondary events; associated bleeding complications were less frequent as compared with published registries.

[Antithrombotic therapy and atrial fibrillation. Dual or triple therapy after acute coronary syndrome and stent?]. / Anithrombotische Therapie und Vorhofflimmern. Duale oder Triple-Therapie nach akutem Koronarsyndrom und Stent?

Current guidelines recommend dual antiplatelet therapy preferably with prasugrel or ticagrelor for 12 months in patients after acute coronary syndrome with stent implantation. Problems occur in patients with a need for oral anticoagulation, such as patients with atrial fibrillation. In these patients a combination of oral anticoagulation and platelet inhibitors is necessary. Antithrombotic combination therapy is known to increase bleeding complications. In a small randomized trial the combination of a vitamin K antagonist (VKA) and clopidogrel decreased bleeding compared to triple therapy with VKA, clopidogrel and aspirin. The new oral anticoagulants have consistently been shown to decrease bleeding complications compared to VKAs regardless of additional antiplatelet therapy. Because of the lack of randomized trials the individual decision about the intensity and duration of antithrombotic combination therapy should be based on the bleeding and ischemic risk in the individual patient. However, in most patients in addition to oral anticoagulation, antiplatelet monotherapy preferably with clopidogrel seems necessary only for 3-6 months.

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.

Interventional treatment and outcome in elderly patients with stable coronary artery disease. Results from the German ALKK registry.

BACKGROUND: The number of elderly and very elderly patients undergoing percutaneous coronary interventions (PCI) is increasing. We therefore analyzed data from the German ALKK registry (Arbeitsgemeinschaft Leitende Krankenhausärzte; Working Group of Hospital Cardiologists) to determine differences in procedural features, antithrombotic treatment, and in-hospital outcome in patients with coronary artery disease (CAD) according to age in a large series of patients. METHODS AND RESULTS: The present analysis was based on the data of 35,534 consecutive patients undergoing elective PCI who were enrolled in the ALKK registry. Of these 27,145 (76.4 %) were younger than 75 years, 7,645 (21.5 %) were aged between 75 and 84 years, and 744 (2.1 %) patients were older than 85 years. Mean age was 68.5 years (60.9-74.5 years), and 25,784 patients (72.6 %) were male. Overall intraprocedural events were very low (1.1 %) and there was no significant difference between the three age groups [< 75 years (1.1 %); 75-< 85 years (1.2 %); ≥ 85 years (0.5 %) (p = not significant)]. Rates of in-hospital death, stroke and transient ischemic attack (TIA), as well as the combined endpoint in-hospital major adverse cardiac and cerebrovascular events (MACCE) were also very low (0.6 % vs. 0.9 % vs. 0.9 %; p < 0.001) but significantly higher in elderly patients with no further increase in the very elderly patient group. CONCLUSION: We found no differences in this registry in intraprocedural complications during elective PCI between younger and elderly patients. Although in-hospital MACCE were somewhat higher in the elderly, the overall event rate was low and thus elderly patients should not be deprived from this therapy because of age alone.

Prospective 'real world' registry for the use of the 'PCB only' strategy in small vessel de novo lesions.

BACKGROUND: This prospective registry assessed the safety and efficacy of paclitaxel coated balloon (PCB) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions without additional stenting. The use of PCBs in small vessels seems to be associated with favourable outcomes; however, prospective data for the use of PCBs without stenting are limited. METHODS: The SeQuent Please Small Vessel 'PCB only' Registry was an international, prospective, multicentre registry enrolling patients with de novo lesions of small reference diameters (≥ 2.0 mm, ≤ 2.75 mm). The primary end point was clinically driven target lesion revascularisation (TLR) at 9 months. Secondary end points were acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) (death, myocardial infarction, or TLR), and the occurrence of definite lesion and vessel thrombosis. RESULTS: A total of 479 patients (66.1 ± 10.9 years, 36.7% diabetics) were enrolled, 105 (23.5%) with an acute coronary syndrome, 41 (9.2%) with ST elevation myocardial infarction (STEMI), and 60 (14.8%) with non-STEMI. The initial procedural success rate was 99.0%; 27 patients (6%) needed additional bare metal stent implantation. TLR at 9.4±1.7 months occurred in 14 patients (3.6%), while three patients (0.6%) had vessel thrombosis in non-target lesions. There was no cardiac death or coronary artery bypass graft surgery. CONCLUSIONS: To date, this is the largest prospective study with PCBs in small vessel de novo lesions in unselected patients. Rates of TLR and MACE were low, suggesting the use of PCBs may be an attractive alternative treatment option to drug eluting stents in small vessels.

[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.

[Current status of transcatheter aortic valve implantation (TAVI) for patients with severe symptomatic aortic stenosis]. / Perkutane Aortenklappenimplantation (TAVI) zur Behandlung schwerer symptomatischer Aortenklappenstenosen: aktueller Stand.

Percutaneous trans-catheter aortic valve implantation (TAVI) has been established as an alternative to surgical valve replacement in surgical high-risk patients. TAVI is also considered the treatment of choice for symptomatic with severe aortic stenosis who are judged to be in-operable. In current practice in Germany more than one third of all aortic valve replacement interventions are performed as a TAVI procedure. It is of crucial importance that proper selection of patients as well as the treatment modality is performed by a so called "heart team", consisting of at least a cardiologist and a cardiac surgeon.