Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI) : Joint Consensus Document of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V. (ALKK) and cooperating Cardiac Surgery Departments.

Indications for TF-TAVI (transfemoral transcatheter aortic valve implantation) are rapidly changing according to increasing evidence from randomized controlled trials. Present trials document the non-inferiority or even superiority of TF-TAVI in intermediate-risk patients (STS-Score 4-8%) as well as in low-risk patients (STS-Score < 4%). However, risk scores exhibit limitations and, as a single criterion, are unable to establish an appropriate indication of TF-TAVI vs transapical TAVI vs SAVR (surgical aortic valve replacement). The ESC (European Society of Cardiology)/EACTS (European Association for Cardio-Thoracic Surgery) guidelines 2017 and the German DGK (Deutsche Gesellschaft für Kardiologie)/DGTHG (Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie) commentary 2018 offer a framework for the selection of the best therapeutic method, but the individual decision is left to the discretion of the heart teams. An interdisciplinary TAVI consensus group of interventional cardiologists of the ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte e.V.) and cardiac surgeons has developed a detailed consensus on the indications for TF-TAVI to provide an up-to-date, evidence-based, comprehensive decision matrix for daily practice. The matrix of indication criteria includes age, risk scores, contraindications against SAVR (e.g., porcelain aorta), cardiovascular criteria pro TAVI, additional criteria pro TAVI (e.g., frailty, comorbidities, organ dysfunction), contraindications against TAVI (e.g., endocarditis) and cardiovascular criteria pro SAVR (e.g., bicuspid valve anatomy). This interdisciplinary consensus may provide orientation to heart teams for individual TAVI-indication decisions. Future adaptations according to evolving medical evidence are to be expected. Interdisciplinary consensus on indications for transfemoral transcatheter aortic valve implantation (TF-TAVI).

[Constellations of findings and derived treatment interventions in telemedical monitoring of patients with heart failure, cardiac arrhythmia or increased risk for sudden cardiac death : Recommendations of the working group 33 telemonitoring of the German Cardiac Society]. / Befundkonstellation und abgeleitete Behandlungsinterventionen bei telemedizinisch überwachten Patienten mit Herzinsuffizienz, Herzrhythmusstörungen oder erhöhtem Risiko für den plötzlichen Herztod : Empfehlungen der Arbeitsgruppe 33 Telemonitoring der Deutschen Gesellschaft für Kardiologie, Herz- und Kreislaufforschung e. V.

The specification of standard operating procedures (SOPs) is a basic requirement for a successful implementation of telemonitoring with implanted cardiac devices and with external measuring devices in patients with heart failure, cardiac arrhytmia or increased risk of sudden cardiac death. The following article summarizes the possibilities of telemonitoring from a technical and organizational point of view and descibes basic requirements on SOPs. these basic requirements should be further specified and anchored in the organizational structure of the individual telemonitoring concept. Moreover, they should de understood as a basic guideline fpr the actions of telemonitoring center (TMC) employees.

[Position paper telemonitoring : From the Nucleus Members of the AG33 Telemonitoring of the DGK and associated members]. / Positionspapier Telemonitoring : Von den Nukleusmitgliedern der AG33 Telemonitoring in der DGK und assoziierten Mitgliedern.

The position paper of the working group 33/Telemonitoring in the German Society for Cardiology e. V. (DGK) discusses the importance of digital solutions in the German health care system and highlights the application possibilities and potentials of telemonitoring in the treatment of patients with cardiac diseases. In addition to telemonitoring of acute ischaemic diseases, acute coronary syndrome and acute cardiac arrhythmias, telemonitoring of chronic cardiac diseases is discussed. Chronic diseases, such as chronic heart failure, are age-associated and present society with the great challenge of providing high-quality, yet cost-efficient care to an increasing number of patients in the future. Telemonitoring offers an opportunity to meet this challenge. However, the introduction of telemonitoring and the associated changes for patients, doctors and other service providers must be accompanied by measures to ensure the acceptance of telemonitoring and the secure handling of sensitive data as well as the quality of telemonitoring services.

[Basic structural features of a cardiac telemedicine center for patients with heart failure and implanted devices, cardiac arrhythmias, and increased risk of sudden cardiac death : Recommendations of the working group 33 Telemonitoring of the German Cardiac Society]. / Grundlegende Strukturmerkmale eines kardiologischen Telemedizinzentrums für Patienten mit Herzinsuffizienz und implantierten Devices, Herzrhythmusstörungen und erhöhtem Risiko für den plötzlichen Herztod : Empfehlungen der Arbeitsgruppe 33 Telemonitoring in der Deutschen Gesellschaft für Kardiologie, Herz- und Kreislaufforschung e. V.

Heart failure is one of the most common diseases. It is associated with high morbidity and mortality. Since heart failure is age-associated, the number of patients with heart failure is constantly increasing. At the same time, the imbalance between the need for treatment and the provision of care is growing. Telemonitoring/telemedicine offers patients in rural or remote areas access to high-quality health care and enables fast access to specialists. The working group 33 Telemonitoring of the German Cardiac Society describes the characteristics and possible applications of telemonitoring/telemedicine in the treatment of patients with heart failure. Furthermore, quality criteria for cardiological telemedicine centres are defined. In addition to the personnel structure of a telemedicine centre and the competencies of employees, requirements for the technical infrastructure and the management of incoming data and alarms are described.

[The telemedical service centre as an essential element of the conceptual approach for telemonitoring of cardiac patients : Requirements on the service, quality, and technical realization of telemonitoring]. / Das Telemedizinische Zentrum als essenzieller Baustein konzeptioneller Ansätze zum Telemonitoring kardialer Patienten : Anforderungen an Leistungen, Qualität und technische Umsetzung von Telemonitoring.

Telemonitoring as part of a treatment strategy supports and facilitates the monitoring, disease management and education of patients with heart failure and cardiac arrhythmias. Therefore, telemonitoring affects quality and success of the therapy. Thus, meeting the needs of the patients and of the involved health care professionals is important for the success of the telemonitoring service. Moreover, a high quality of the service has to be ensured. The following article describes several configuration options for telemonitoring services considering technical as well as quality- and service-related aspects.

The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis.

Background The increasing prevalence of severe aortic valve defects correlates with the increase of life expectancy. For decades, surgical aortic valve replacement (AVR), under the use of extracorporeal circulation, has been the gold standard for treatment of severe aortic valve diseases. In Germany ~12,000 patients receive isolated aortic valve surgery per year. For some time, percutaneous balloon valvuloplasty has been used as a palliative therapeutic option for very few patients. Currently, alternatives for the established surgical procedures such as transcatheter aortic valve implantation (TAVI) have become available, but there are only limited data from randomized studies or low-volume registries concerning long-time outcome. In Germany, the implementation of this new technology into hospital care increased rapidly in the past few years. Therefore, the German Aortic Valve Registry (GARY) was founded in July 2010 including all available therapeutic options and providing data from a large quantity of patients.Methods The GARY is assembled as a complete survey for all invasive therapies in patients with relevant aortic valve diseases. It evaluates the new therapeutic options and compares them to surgical AVR. The model for data acquisition is based on three data sources: source I, the mandatory German database for external performance measurement; source II, a specific registry dataset; and source III, a follow-up data sheet (generated by phone interview). Various procedures will be compared concerning observed complications, mortality, and quality of life up to 5 years after the initial procedure. Furthermore, the registry will enable a compilation of evidence-based indication criteria and, in addition, also a comparison of all approved operative procedures, such as Ross or David procedures, and the use of different mechanical or biological aortic valve prostheses.Results Since the launch of data acquisition in July 2010, almost all institutions performing aortic valve procedures in Germany joined the registry. By now, 91 sites which perform TAVI in Germany participate and more than 15,000 datasets are already in the registry.Conclusion The implementation of new or innovative medical therapies needs supervision under the conditions of a well-structured scientific project. Up to now relevant data for implementation of TAVI and long-term results are missing. In contrast to randomized controlled trials, GARY is a prospective, controlled, 5-year observational multicenter registry, and a real world investigation with only one exclusion criterion, the absence of patients' written consent.

[Aortic valve stenosis: transcatheter aortic valve implantation (TAVI) ­ transarterial or transapical approach]. / Aortenklappenstenosen: Kathetergestützte Aortenklappenimplantation (TAVI) ­ transarterieller oder transapikaler Zugang.

The calcified aortic stenosis is the dominating valve disease. Patients affected are most common elderly people in the 8 (th) or 9 (th) decade of their life who often show associated comorbidities like reduced left ventricular function, impaired renal function, pulmonary hypertension, and further diseases (Diabetes mellitus, stroke, COPD). In many cases perioperative morbidity and mortality are too high for surgical valve replacement and up to 30 % of patients are rejected. Nevertheless, prognosis of aortic stenosis is worse if the typical symptoms like dyspnea on exertion, syncope, and angina occur. The transcatheter aortic valve implantation is a new method treating this particular group of patients. The aortic valve bioprothesis consists of a balloon-expandable stent or a self-expandable frame, in which a valve of bovine or porcine pericardium is incorporated. The implantation is performed by retrograde access via the femoral or subclavian artery; the balloon-expandable prosthesis can also be implanted by transapical approach. Recently, the PARTNER trial and other studies demonstrate a high implantation success rate and better survival in comparison to standard therapy but exhibit also cerebral vascular and peripheral vascular complications. A further reduction of the available delivery systems and new types of valves which are under experimental tests and clinical evaluation contribute to this development.

[Telemedicine--ready for use in the cardiological field?]. / Telemedizin in der Kardiologie. Welche Anwendungen sind reif für die klinische Praxis?

The changes in the demographic structure, the increasing multi-morbidity in connection with a rise in the number of chronic illnesses and the absence of an effective coordination of the different levels of health care services with its discontinuous processes and redundancies will increase the economic burdens in the health care system. The latest developments and appropriate logistic premises nowadays offer a realistic basis for implementing telemonitoring as a central service and information tool as well as an instrument controlling the information- and data-flow between patient, hospital and medical practitioner.

Randomized comparison of effects of suture-based and collagen-based vascular closure devices on post-procedural leg perfusion.

BACKGROUND: Vascular closure devices (VCD) are well established to facilitate hemostasis after cardiac catheterization procedures. However, impairment of flow due to the reduction of femoral artery diameter remains a major concern. The present study aims to evaluate leg perfusion before and after application of collagen- and suture-based vascular closure devices. METHODS: A total of 366 patients (age: 64.3 years+/-10.7, male: 71.3%) were randomized to receive femoral access site closure with either a collagen-based closure device (group A) (n=214) or a suture-mediated device (group B) (n=152), immediately following coronary catheterization procedures. In all patients, the ankle-brachial-index (ABI) was measured before and the day after closure device application. RESULTS: In group A, mean ABI at baseline was 1.09+/-0.2, in group B 1.11+/-0.2. In both groups, there was a significant, albeit clinically not relevant, reduction in post-procedural ABI (group A: 1.04+/-0.2, p<0.01 vs baseline, group B: 1.06+/-0.2, p<0.01 vs baseline). DeltaABI was not different between both VCD groups (p=0.55). In patients with peripheral vascular disease (PVD), neither the Angioseal device (mean ABI at baseline 0.76+/-0.1) nor the Perclose-device (mean ABI at baseline 0.79+/-0.1) induced a remarkable impairment of leg perfusion (Angioseal: 0.77+/-0.1, p=0.9 vs baseline, Perclose: 0.78+/-0.1, p=1.0 vs baseline). Clinically, no aggravation of claudication was observed in the PVD patient group. CONCLUSION: Both vascular closure devices are not associated with clinically relevant reduction in ABI. There was no difference between the two groups with respect to the level of flow impairment. Both devices may be safely used in patients with reduced ABI.

Prevalence of the metabolic syndrome in German women with polycystic ovary syndrome.

The aim of our study was to evaluate the prevalence of the metabolic syndrome (MBS) according to the current International Diabetes Federation definition in German PCOS women. Four hundred and eleven PCOS patients (age 28+/-6.3 years) and 82 controls (age 28+/-7.5 years) were evaluated for anthropometric and metabolic parameters by physical examination, blood testing and a personal interview including family history. A subgroup analysis of controls with BMI-matched PCOS women (BMI 22.9+/-2.8 kg/m (2)) was performed to detect PCOS specific differences in metabolic variables between the groups. The MBS was found in 33.8% of PCOS women compared to 7.3% in the control group. Parameters of insulin resistance, lipid-and glucose metabolism, mean values of all criteria of the MBS as well as the prevalence of the MBS were significantly different between the entire PCOS cohort and controls, but did not differ between BMI-matched PCOS women and controls. In addition, the prevalence of the MBS increased with age. Moreover, in PCOS women an increase in BMI and insulin resistance was accompanied by a further significant increase in the severity of clinical and biochemical hyperandrogenism. In PCOS women, while one out of three PCOS women had the MBS, the presence of metabolic abnormalities did not appear to be associated with PCOS per se, but rather correlated with age and the degree of obesity.