Therapy duration and improvement of ventricular function in de novo heart failure: the Heart Failure Optimization study.

BACKGROUND AND AIMS: In patients with de novo heart failure with reduced ejection fraction (HFrEF), improvement of left ventricular ejection fraction (LVEF) is expected to occur when started on guideline-recommended medical therapy. However, improvement may not be completed within 90 days. METHODS: Patients with HFrEF and LVEF ≤ 35% prescribed a wearable cardioverter-defibrillator between 2017 and 2022 from 68 sites were enrolled, starting with a registry phase for 3 months and followed by a study phase up to 1 year. The primary endpoints were LVEF improvement > 35% between Days 90 and 180 following guideline-recommended medical therapy initiation and the percentage of target dose reached at Days 90 and 180. RESULTS: A total of 598 patients with de novo HFrEF [59 years (interquartile range 51-68), 27% female] entered the study phase. During the first 180 days, a significant increase in dosage of beta-blockers, renin-angiotensin system inhibitors, and mineralocorticoid receptor antagonists was observed (P < .001). At Day 90, 46% [95% confidence interval (CI) 41%-50%] of study phase patients had LVEF improvement > 35%; 46% (95% CI 40%-52%) of those with persistently low LVEF at Day 90 had LVEF improvement > 35% by Day 180, increasing the total rate of improvement > 35% to 68% (95% CI 63%-72%). In 392 patients followed for 360 days, improvement > 35% was observed in 77% (95% CI 72%-81%) of the patients. Until Day 90, sustained ventricular tachyarrhythmias were observed in 24 wearable cardioverter-defibrillator carriers (1.8%). After 90 days, no sustained ventricular tachyarrhythmia occurred in wearable cardioverter-defibrillator carriers. CONCLUSIONS: Continuous optimization of guideline-recommended medical therapy for at least 180 days in HFrEF is associated with additional LVEF improvement > 35%, allowing for better decision-making regarding preventive implantable cardioverter-defibrillator therapy.

Transfemoral aortic valve implantation: procedural hospital volume and mortality in Germany.

AIMS: Studies assessing transfemoral transcatheter aortic valve implantation (TF-TAVI) showed lower rates of in-hospital mortality at high-volume hospitals and minimum caseloads were recommended to assure quality standards. METHODS AND RESULTS: All patients in the German mandatory quality assurance registry with elective or urgent TF-TAVI procedures in 2018 and 2019 at 81 and 82 hospitals, respectively, were analysed. Observed in-hospital mortality was adjusted to expected mortality by the German AKL-KATH score (O/E) as well as by the EuroScore II (O/E2). Hospital volume and O/E were correlated by regression analyses and volume quartiles. 18 763 patients (age: 81.1 ± 1.0 years, mean EuroSCORE II: 6.9 ± 1.8%) and 22 137 patients (mean age: 80.7 ± 3.5 years, mean EuroSCORE II: 6.5 ± 1.6%) were analysed in 2018 and 2019, respectively. The average observed in-hospital mortality was 2.57 ± 1.83% and 2.36 ± 1.60%, respectively. Unadjusted in-hospital mortality was significantly inversely related to hospital volume by linear regression in both years. After risk adjustment, the association between hospital volume and O/E was statistically significant in 2019 (R2 = 0.049; P = 0.046), but not in 2018 (R2 = 0.027; P = 0.14). The variance of O/E explained by the number of cases in 2019 was low (4.9%). Differences in O/E outcome between the first and the fourth quartile were not statistically significant in both years (1.10 ± 1.02 vs. 0.82 ± 0.46; P = 0.26 in 2018; 1.16 0 .97 vs. 0.74 ± 0.39; P = 0.084 in 2019). Any chosen volume cut-off could not precisely differentiate between hospitals with not acceptable quality (>95th percentile O/E of all hospitals) and those with acceptable (O/E ≤95th percentile) or above-average (O/E < 1) quality. For example, in 2019 a cut-off value of 150 would only exclude one of two hospitals with not acceptable quality, while 20 hospitals with acceptable or above-average quality (25% of all hospitals) would be excluded. CONCLUSION: The association between hospital volume and in-hospital mortality in patients undergoing elective TF-TAVI in Germany in 2018 and 2019 was weak and not consistent throughout various analytical approaches, indicating no clinical relevance of hospital volume for the outcome. However, these data were derived from a healthcare system with restricted access to hospitals to perform TAVI and overall high TAVI volumes. Instead of the unprecise surrogate hospital volume, the quality of hospitals performing TF-TAVI should be directly assessed by real achieved risk-adjusted mortality.

Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole.

AIMS: To allow timely initiation of anticoagulation therapy for the prevention of stroke, the European guidelines on atrial fibrillation (AF) recommend remote monitoring (RM) of device-detected atrial high-rate episodes (AHREs) and progression of arrhythmia duration along pre-specified strata (6 min…<1 h, 1 h…<24 h, ≥ 24 h). We used the MATRIX registry data to assess the capability of a single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (DX ICD system) to follow this recommendation in patients with standard indication for single-chamber ICD. METHODS AND RESULTS: In 1841 DX ICD patients with daily automatic RM transmissions, electrograms of first device-detected AHREs per patient in each duration stratum were adjudicated, and the corresponding positive predictive values (PPVs) for the detections to be true atrial arrhythmia were calculated. Moreover, the incidence and progression of new-onset AF was assessed in 1451 patients with no AF history. A total of 610 AHREs ≥6 min were adjudicated. The PPV was 95.1% (271 of 285) for episodes 6min…<1 h, 99.6% (253/254) for episodes 1 h…<24 h, 100% (71/71) for episodes ≥24 h, or 97.5% for all episodes (595/610). The incidence of new-onset AF was 8.2% (119/1451), and in 31.1% of them (37/119), new-onset AF progressed to a higher duration stratum. Nearly 80% of new-onset AF patients had high CHA2DS2-VASc stroke risk, and 70% were not on anticoagulation therapy. Age was the only significant predictor of new-onset AF. CONCLUSION: A 99.7% detection accuracy for AHRE ≥1 h in patients with DX ICD systems in combination with daily RM allows a reliable guideline-recommended screening for subclinical AF and monitoring of AF-duration progression.

Healthcare provision of transcatheter aortic valve implantation in Germany.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) for aortic stenosis in older patients is the standard of care with a well-established supply density in Germany. In the near future, healthcare reform is planned that may affect TAVI capacities. Therefore, it is important to know how political regulations may interfere with access to services and what the need for TAVI will be in the future, based on demographic trends. METHODS: The number of TAVI procedures (DRG F98A +F98) and the in-hospital main diagnoses of aortic stenosis (ICD I35) in 2021 were analyzed at the level of county or federal state based on anonymized data from hospital reports, according to § 21 of the German hospital reimbursement law. The number of TAVI and aortic stenosis cases was projected for 2035 based on data from the German Federal Statistical Office on demographic developments. With quality assurance data from hospitals in 2019 and a route planner, the travel time to the next hospital performing TAVI (OPS 5­35a.0) was calculated, and the consequence of a politically suggested minimum volume cut-off was analyzed. RESULTS: In 2021, a total of 26,506 TAVI procedures were reported with a mean number of TAVI per 100,000 inhabitants of 32 (range between federal states from 25 to 42). Among the 66,045 diagnoses of aortic stenosis, there was a variation per 100,000 inhabitants from 64 to 108 (mean 79) between federal states. Compared to 2021, an additional 8748 (+13%) diagnoses of aortic stenosis and an increase of 4673 (+18%) TAVI procedures is to be expected in 2035. In 2019, 57% of German citizens could reach a TAVI hospital within 30 min and 91% within 60 min of driving time by car (mean time to hospital 31 min). Applying a minimum number of 150 TAVI/hospital per year would increase the driving time to hospital from 33 to 52 min in Saxony-Anhalt and instantly remove six out of eight hospitals from service in Hesse. CONCLUSION: Regulation of TAVI services by minimum volume numbers would arbitrarily interfere with access to services, in contradiction to the medical service assurance tasks of federal state governments. These issues should be considered in the upcoming healthcare system reform.

Intramyocardial Inflammation after COVID-19 Vaccination: An Endomyocardial Biopsy-Proven Case Series.

Myocarditis in response to COVID-19 vaccination has been reported since early 2021. In particular, young male individuals have been identified to exhibit an increased risk of myocardial inflammation following the administration of mRNA-based vaccines. Even though the first epidemiological analyses and numerous case reports investigated potential relationships, endomyocardial biopsy (EMB)-proven cases are limited. Here, we present a comprehensive histopathological analysis of EMBs from 15 patients with reduced ejection fraction (LVEF = 30 (14-39)%) and the clinical suspicion of myocarditis following vaccination with Comirnaty® (Pfizer-BioNTech) (n = 11), Vaxzevria® (AstraZenica) (n = 2) and Janssen® (Johnson & Johnson) (n = 2). Immunohistochemical EMB analyses reveal myocardial inflammation in 14 of 15 patients, with the histopathological diagnosis of active myocarditis according the Dallas criteria (n = 2), severe giant cell myocarditis (n = 2) and inflammatory cardiomyopathy (n = 10). Importantly, infectious causes have been excluded in all patients. The SARS-CoV-2 spike protein has been detected sparsely on cardiomyocytes of nine patients, and differential analysis of inflammatory markers such as CD4+ and CD8+ T cells suggests that the inflammatory response triggered by the vaccine may be of autoimmunological origin. Although a definitive causal relationship between COVID-19 vaccination and the occurrence of myocardial inflammation cannot be demonstrated in this study, data suggest a temporal connection. The expression of SARS-CoV-2 spike protein within the heart and the dominance of CD4+ lymphocytic infiltrates indicate an autoimmunological response to the vaccination.

Increased Quality of Life Among Newly Diagnosed Patients With Heart Failure With Reduced Ejection Fraction in the Months After Initiation of Guideline-Directed Medical Therapy and Wearable Cardioverter Defibrillator Prescription.

BACKGROUND: The patient experience of heart failure involves a multi-impact symptom response with functional limitations, psychological changes, and significant treatment burden. OBJECTIVE: The aim of this study was to examine the change in patient-reported outcomes in newly diagnosed patients with heart failure and reduced ejection fraction (HFrEF) prescribed a wearable cardioverter defibrillator. METHODS: Adults hospitalized for new-onset heart failure, due to ischemic or nonischemic cardiomyopathy, and prescribed a wearable cardioverter defibrillator within 10 days post discharge were approached for inclusion. Participants completed the Kansas City Cardiomyopathy Questionnaire at 3 time points: baseline, day 90, and day 180. RESULTS: A total of 210 patients (26% female) were included. All Kansas City Cardiomyopathy Questionnaire subscales (physical limitation, symptom frequency, quality of life, and social limitation) showed improvement from baseline to day 90 (all Ps < .001). Only quality of life continued to improve from day 90 to day 180 (P < .001). By day 90, nearly 70% of patients showed an improvement in quality of life (67.9%, n = 91), and by day 180, more than 80% (82.8%, n = 111) reported a net improvement. Five patients (3.7%) reported a net decrease, and 18 patients (13.4%) had no net change in quality of life during the 180-day period. CONCLUSION: Patient-reported quality of life improved significantly among patients newly diagnosed with HFrEF and prescribed a wearable cardioverter defibrillator. These results suggest that pursuing guideline-directed medical therapy for HFrEF, while being protected by the wearable cardioverter defibrillator, is likely to provide symptom relief and improve quality of life.

The wearable cardioverter-defibrillator: current technology and evolving indications.

The wearable cardioverter-defibrillator has been available for over a decade and now is frequently prescribed for patients deemed at high arrhythmic risk in whom the underlying pathology is potentially reversible or who are awaiting an implantable cardioverter-defibrillator. The use of the wearable cardioverter-defibrillator is included in the new 2015 ESC guidelines for the management of ventricular arrhythmias and prevention of sudden cardiac death. The present review provides insight into the current technology and an overview of this approach.

Comparison of infection and complication rates associated with transvenous vs. subcutaneous defibrillators in patients with stage 4 chronic kidney disease: a multicenter long-term retrospective follow-up.

Background: Patients with progressive chronic kidney disease (CKD) are at higher risk of infections and complications from cardiac implantable electronic devices (CIED). In patients with a primary or secondary prophylactic indication, implantable cardiac defibrillators (ICD) can prevent sudden cardiac deaths (SCD). We retrospectively compared transvenous-ICD (TV-ICD) and intermuscularly implanted subcutaneous-ICD (S-ICD) associated infections and complication rates together with hospitalizations in recipients with stage 4 kidney disease. Methods: We retrospectively analyzed 70 patients from six German centers with stage 4 CKD who received either a prophylactic TV-ICD with a single right ventricular lead, 49 patients, or a S-ICD, 21 patients. Follow-Ups (FU) were performed bi-annually. Results: The TV-ICD patients were significantly older. This group had more patients with a history of atrial arrhythmias and more were prescribed anti-arrhythmic medication compared with the S-ICD group. There were no significant differences for other baseline characteristics. The median and interquartile range of FU durations were 55.2 (57.6-69.3) months. During FU, patients with a TV-ICD system experienced significantly more device associated infections (n = 8, 16.3% vs. n = 0; p < 0.05), device-associated complications (n = 13, 26.5% vs. n = 1, 4.8%; p < 0.05) and device associated hospitalizations (n = 10, 20.4% vs. n = 1, 4.8%; p < 0.05). Conclusion: In this long-term FU of patients with stage 4 CKD and an indication for a prophylactic ICD, the S-ICD was associated with significantly fewer device associated infections, complications and hospitalizations compared with TV-ICDs.

Home Monitoring technology and integrated follow-up care of ICD patients.

OBJECTIVE: Increasing utilization rates of implantable cardioverter-defibrillators (ICDs) tend to overburden follow-up resources at the implanting electrophysiological centres (ECs). Remote monitoring technology allows physicians from different institutions to simultaneously review ICD data of shared patients. We studied if an integrated follow-up care involving ECs and general cardiologists (GCs) may reduce the frequency of in-office follow-ups at ECs by using remote monitoring data to identify routine checks that may be conducted at GCs. METHODS AND RESULTS: The analysis included 109 patients (aged 63 +/- 11 years, 84.4% male) followed for a cumulative study duration of 155 patient-years. The patients underwent 436 in-office controls after hospital discharge: 143 (33%) at two ECs and 293 (67%) at two GCs (each cooperating with one EC). The mean duration of in-office follow-up sessions was 13.7 min (EC) and 10.3 min (GC). The average distance between patients' homes and follow-up sites was 31.6 km (EC) vs. 16.2 km (GC). Investigators considered a follow-up to be of'high or medium'importance in 78% (EC) vs. 45% (GC) of all in-office follow-ups. At one EC, the integrated follow-up care concept appeared highly successful, with 97% of follow-ups transferred to the corresponding GC and, on average, 103.8 km shorter patient trips per follow-up. CONCLUSIONS: Integrated follow-up care guided by remote monitoring allows to direct the more significant follow-ups towards ECs and routine follow-ups towards GCs.This concept may contribute to the needed adaptations of the health-care system to the rising numbers of patients with implanted devices.

Potential role of telemedical service centers in managing remote monitoring data transmitted daily by cardiac implantable electronic devices: results of the early detection of cardiovascular events in device patients with heart failure (detecT-Pilot) study.

OBJECTIVE: Implantable cardioverter-defibrillators (ICDs) alone or combined with cardiac resynchronization therapy (CRT-Ds) featuring automatic home monitoring (HM) function can be monitored remotely on a daily basis. Different ways of implementing HM into clinical routines are possible, with efficient patient management being the main objective. In this study, a concept using a telemedical service center (TmSC) to manage HM data was developed and investigated regarding patients' satisfaction, physicians' satisfaction, and alert filtering. SUBJECTS AND METHODS: Fifty-five ICD or CRT-D patients with symptomatic heart failure were enrolled. The TmSC received HM data, identified "actionable parameters" (APs) by following protocol-defined procedures, conducted structured patient interviews, and forwarded selected APs to the respective follow-up clinic. Satisfaction of patients and physicians with the TmSC was evaluated at the end of the study by purpose-designed questionnaires. RESULTS: During a mean follow-up of 402±200 days, 3,831 APs were identified and analyzed at the TmSC (5.28 per patient-month). Most APs were triggered by a pilot detection algorithm for worsening heart failure (2.80 per patient-month), followed by atrial tachyarrhythmia episodes (1.10 per patient-month) and ventricular pacing issues (0.87 per patient-month). The TmSC forwarded 682 APs (18% of all APs) to 10 study sites. Approximately 65% of physicians and patients deemed the TmSC improved patient care. CONCLUSIONS: The TmSC-based management concept was well accepted and appreciated by the majority of physicians and patients. It may be helpful in gaining symptomatic information on top of automatic HM data and in supporting smaller clinics in the follow-up of their device patients.

Structural components for the development of a heart failure network.

Diagnosis and treatment of heart failure (HF) is challenging, and development of specialized HF networks is mandatory to warrant broad access to guideline directed therapies for patients. Numerous national cardiovascular societies recommend a three-level association of health care providers. This comprises tertiary academic centres, specialized HF clinics and specialized general cardiologists to cover the large spectrum of HF severity and entities. Although this idea of a multi-level care is widely accepted, optimal approach to build and implement a HF network service needs further definition. The core principle is that of network healthcare facilities that also consider regional peculiarities and that implements academic standards, quality indicators (QIs), interdisciplinarity and reimbursement strategies. These determinants of trans-sectoral healthcare need to be embedded in a network that provides sustainability and that incorporates QIs to objectify the efficacy of specific measures. The basis of a HF-network should be a certification system of the respective national HF association to warrant guideline standards and to prevent development of regional hierarchies or dependencies between members. This nationwide framework needs to be complemented by a federal system of regional networks, which also takes local demands into account. These regional units should incorporate digital communication and interaction pathways, structured educational programmes, certified telehealth concepts and follow-up algorithms to meet the requirements of sustainability and efficacy. We here summarize different components of HF networks and introduce the structure and development philosophy of the RUHR-HF-network that constitutes the first certified HF-clinics-network in the Ruhr area-the largest metropolitan area in Germany.

Single beta-blocker or combined amiodarone therapy in implantable cardioverter-defibrillator and cardiac resynchronization therapy-defibrillator patients: Insights from the German DEVICE registry.

BACKGROUND: Because of its antiarrhythmic potency and due to the lack of alternatives, amiodarone is often used for antiarrhythmic therapy in patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator systems. To date, robust data on the safety and clinical benefit of amiodarone therapy in these patients are missing. OBJECTIVE: The purpose of this study was to assess the periprocedural and postprocedural outcomes of combined therapy with beta-blockers plus amiodarone compared to treatment with single beta-blockers in the "real-life" cohort of ICD recipients of the German DEVICE registry. METHODS: A total of 4499 patients who underwent ICD implantation, revision, or upgrade in 49 centers participating in the German DEVICE registry were enrolled from March 2007 to February 2014. RESULTS: Amiodarone had no significant effect on the success of defibrillation testing. Early implantation-associated complications were similar between the groups. However, 1-year overall mortality was significantly higher in the beta-blocker plus amiodarone cohort (adjusted hazard ratio 2.09; P <.001). Interestingly, among the surviving patients, amiodarone was not associated with a significantly reduced risk of ICD discharges or syncopal events. Furthermore, the occurrence of ventricular tachycardia (VT) storm or incessant VTs and the number of patients scheduled for intracardiac ablation did not differ among both groups, whereas the rate of rehospitalization was lower in the cohort with only beta-blockers. CONCLUSIONS: Although amiodarone has no adverse effect on the success of defibrillation testing, our data suggest an increased all-cause mortality under amiodarone therapy, especially in the subgroups of patients with sinus rhythm or severely reduced left ventricular function. In surviving patients, rates of arrhythmic events were comparable.

Remote monitoring of implantable-cardioverter defibrillators: results from the Reliability of IEGM Online Interpretation (RIONI) study.

AIMS: Intracardiac electrograms (IEGMs) recorded by implantable cardioverter-defibrillators (ICDs) are essential for arrhythmia diagnosis and ICD therapy assessment. Short IEGM snapshots showing 3-10 s before arrhythmia detection were added to the Biotronik Home Monitoring system in 2005 as the first-generation IEGM Online. The RIONI study tested the primary hypothesis that experts' ratings regarding the appropriateness of ICD therapy based on IEGM Online and on standard 30 s IEGM differ in <10% of arrhythmia events. METHODS AND RESULTS: A total of 619 ICD patients were enrolled and followed for 1 year. According to a predefined procedure, 210 events recorded by the ICDs were selected for evaluation. Three expert board members rated the appropriateness of ICD therapy and classified the underlying arrhythmia using coded IEGM Online and standard IEGM to avoid bias. The average duration of IEGM Online was 4.4±1.5 s. According to standard IEGM, the underlying arrhythmia was ventricular in 135 episodes (64.3%), supraventricular in 53 episodes (25.2%), oversensing in 17 episodes (8.1%), and uncertain in 5 episodes (2.4%). The expert board's rating diverged between determinable IEGM Online tracings and standard IEGM in 4.6% of episodes regarding the appropriateness of ICD therapy (95% CI up to 8.0%) and in 6.6% of episodes regarding arrhythmia classification (95% CI up to 10.5%). CONCLUSION: By enabling accurate evaluation of the appropriateness of ICD therapy and the underlying arrhythmia, the first-generation IEGM Online provided a clinically effective basis for timely interventions and for optimized patient management schemes, which was comparable with current IEGM recordings.

[An implantable loop recorder after survived sudden cardiac death? : Uncommon case from daily practice]. / Ein implantierbarer Loop-Rekorder nach überlebtem plötzlichem Herztod? : Ungewöhnliches Fallbeispiel aus dem kardiologischen Alltag.

A 58-year-old woman fainted on the ward a few days after an emergency appendectomy. Due to recurrent loss of consciousness, immediate resuscitation was started and a ventricular torsades de pointes tachycardia was documented. Further diagnostic procedures did not reveal any underlying cardiac disease or channelopathy and different potential causes were ruled out. For optimal diagnostic accuracy in a situation where a reversible/preventable cause might have been present, a loop recorder was implanted for continuous ECG monitoring of the patient.

[The wearable cardioverter defibrillator as diagnostic tool : Case report from remote monitoring daily practice]. / Der Wearable Kardioverter-Defibrillator als Diagnostikum : Fallbeispiel aus dem telemedizinischen Alltag.

Telemedical care can point out new applications of already established therapeutics such as a wearable cardioverter-defibrillator (WCD) and improve the quality of care for chronically ill patients with heart failure through improved management of data derived from this device. The current case report describes the clinical course of a 71-year-old man, who was treated with a WCD in accordance with the current guidelines until a final decision was made about ICD implantation, after acute cardiac decompensation and lately diagnosed severe decrease of left ventricular function in the context of ischaemic cardiomyopathy. The data collected by the WCD were evaluated in a structured way via a telemedicine centre (TMC) and recurrence of the previously known paroxysmal atrial fibrillation (AF) was discovered. This made it possible to treat the paroxysmal AF, before cardiac decompensation happened again by adjusting the medication and early initiation of pulmonary vein isolation (PVI). This case exemplifies the usefulness of structured telemedical intervention, which makes it possible to meaningfully supplement established concepts of patient care, improve existing concepts and significantly improve patient care.

Do implantable loop recorders impact the survival of patients with recurrent unexplained syncope?

Aim: This study compares the outcomes of patients who receive an implantable loop recorder (ILR) for unexplained syncope to a control group without the diagnostic device in German claims data. Methods and materials: Patients with ILR were matched to a control group based on prior syncope events, age, gender and Charlson Comorbidity index (CCI). Survival, syncope hospitalizations, treatment and costs were compared. Results/conclusion: Four hundred and twelve ILR patients were matched with controls, mean age was 68, mean CCI was 2.7, 42% females. ILR patients lived on average 1.2 years longer than patients in the control group. Twenty-five percent of ILR patients received a therapeutic device compared with 5% in the control group. ILRs might help to diagnose and treat patients with positive impact on survival.

[Artificial intelligence in cardiology : Relevance, current applications, and future developments]. / Künstliche Intelligenz in der Kardiologie : Relevanz, aktuelle Anwendungen und nächste Schritte.

Big data and applications of artificial intelligence (AI), such as machine learning or deep learning, will enrich healthcare in the future and become increasingly important. Among other things, they have the potential to avoid unnecessary examinations as well as diagnostic and therapeutic errors. They could enable improved, early and accelerated decision-making. In the article, the authors provide an overview of current AI-based applications in cardiology. The examples describe innovative solutions for risk assessment, diagnosis and therapy support up to patient self-management. Big data and AI serve as a basis for efficient, predictive, preventive and personalised medicine. However, the examples also show that research is needed to further develop the solutions for the benefit of the patient and the medical profession, to demonstrate the effectiveness and benefits in health care and to establish legal and ethical standards.

[Position paper on required competencies of nonphysician employees in telemedicine centers]. / Positionspapier zum Anforderungsprofil von nichtärztlichen Assistenzkräften in Telemedizinzentren.

The non-physician employees in telemedicine centers (TMC) play a decisive role in the care and treatment of patients with heart failure. For this reason, a holistic profile consisting of professional and methodological as well as social and personal competences is necessary, which should be built up or promoted in corresponding training concepts. This position paper underlines the urgency of appropriate and standardized further training of non-physician employees for quality assurance in TMCs and summarizes the requirements for the additional qualification of a telemedical assistant across the board.

Protected risk stratification with the wearable cardioverter-defibrillator: results from the WEARIT-II-EUROPE registry.

BACKGROUND: The prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death. METHODS AND RESULTS: 781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription (p < 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown. CONCLUSIONS: Mortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation.

Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial.

AIMS: Implantable cardioverter defibrillators (ICD) can prevent sudden cardiac death by delivering high-energy shocks in patients at risk of life-threatening ventricular tachyarrhythmias. Patients may be anxious about receiving inappropriate shocks in case of device or lead system malfunction, or about failing to receive needed therapy for the same reason. New devices include programmable vibrating patient notifiers (PN), which, by warning patients of a possible device dysfunction, might lower device-related anxiety. PAtient NOtifier feature for Reduction of Anxiety: a Multicentre ICD study (PANORAMIC) is a multicentre, randomized, clinical trial designed to examine the effects of the awareness of an active vibrating alert system on device-related anxiety. METHODS: The trial will randomly assign 356 patients in a 1:1 design to a control group (PN OFF) vs. a treatment group (PN ON). Patients will be followed for 12 months, with visits scheduled at 6 and 12 months. During clinical follow-up visits, the ICD will be interrogated, and all patients will complete the Hospital Anxiety and Depression Scale and a device-related anxiety questionnaire. The sensitivity and specificity of PN, the effect of personality on anxiety, using the Type D scale (DS14), the number of delivered appropriate and inappropriate ICD therapies, changes in anxiety related to the delivery of appropriate or inappropriate shocks, crossovers from the assigned group, the number of hospitalizations, and the mortality rate will also be assessed. ClinicalTrials.gov Identifier: NCT00559559.