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Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections. This article is simultaneously published also in Eur J Cardiothorac Surg. (https://doi.org/10.1093/ejcts/ezz296) and European Heart Journal (https://doi.org/10.1093/eurheartj/ehaa010). Minor differences in style may appear in each publication, but the article is substantially the same in each journal.

These are the clinical practice guidelines of the European Society of Cardiology on cardiac pacing and cardiac resynchronization therapy, from 2021.

Clinicians accept that there are many unknowns when we make diagnostic and therapeutic decisions. Acceptance of uncertainty is essential for the pursuit of the profession: bedside decisions must often be made on the basis of incomplete evidence. Over the years, physicians sometimes even do not realize anymore which the fundamental gaps in our knowledge are. As clinical scientists, however, we have to halt and consider what we do not know yet, and how we can move forward addressing those unknowns. The European Heart Rhythm Association (EHRA) believes that scanning the field of arrhythmia / cardiac electrophysiology to identify knowledge gaps which are not yet the subject of organized research, should be undertaken on a regular basis. Such a review (White Paper) should concentrate on research which is feasible, realistic, and clinically relevant, and should not deal with futuristic aspirations. It fits with the EHRA mission that these White Papers should be shared on a global basis in order to foster collaborative and needed research which will ultimately lead to better care for our patients. The present EHRA White Paper summarizes knowledge gaps in the management of atrial fibrillation, ventricular tachycardia/sudden death and heart failure.

Aims Cardiac resynchronization therapy defibrillators (CRT-D) are able to monitor various parameters that may be combined by an automatic algorithm to provide a heart failure risk status (HFRS). We sought to validate the HFRS for stratifying patient risk, evaluate its association with heart failure (HF) symptoms, and investigate its utility for triage of automatic alerts. Methods and results Data from 722 patients included in the MORE-CARE trial were analysed in a post hoc analysis. A high HFRS was associated with a significantly increased risk of admission over the next 30 days with a relative risk for cardiovascular hospitalization (CVH) of 4.5 (95% CI: 3.1-6.6, P < 0.001), of HF hospitalization of 6.3 (95% CI: 3.9-10.2, P < 0.001) and of non-HF related CVH of 3.5 (95% CI: 2.0-6.9, P < 0.001). The negative predictive value of low or medium HFRS for these admissions was >= 98%. A high HFRS was associated with an increased risk of HF symptoms. Of all the automatic remote monitoring alerts generated during the study, only 10% had a high HFRS. Conclusion The HFRS is able to risk-stratify CRT-D patients, which is potentially useful for managing automatic remote monitoring alerts, by focusing attention on the minority of high-risk patients.

The previous Core Curriculum for the General Cardiologist defined a model for cardiology training in Europe and it has been adopted as the standard for regulating training, for access to the specialty (certification), and for revalidation in several countries.1 During the last 5 years we have witnessed profound changes in cardiological practice. The work of both hospital and independent cardiologists has been better integrated with that of general practitioners. It has taken into account the requirements of national authorities, re-imbursement organizations, and hospital administrations. Cardiologists face changing patient expectations. General cardiologists, interventional …

Relevant for various areas of human genetics, Y-chromosomal short tandem repeats (Y-STRs) are commonly used for testing close paternal relationships among individuals and populations, and for male lineage identification. However, even the widely used 17-loci Yfiler set cannot resolve individuals and populations completely. Here, 52 centers generated quality-controlled data of 13 rapidly mutating (RM) Y-STRs in 14,644 related and unrelated males from 111 worldwide populations. Strikingly, >99% of the 12,272 unrelated males were completely individualized. Haplotype diversity was extremely high (global: 0.9999985, regional: 0.99836–0.9999988). Haplotype sharing between populations was almost absent except for six (0.05%) of the 12,156 haplotypes. Haplotype sharing within populations was generally rare (0.8% nonunique haplotypes), significantly lower in urban (0.9%) than rural (2.1%) and highest in endogamous groups (14.3%). Analysis of molecular variance revealed 99.98% of variation within populations, 0.018% among populations within groups, and 0.002% among groups. Of the 2,372 newly and 156 previously typed male relative pairs, 29% were differentiated including 27% of the 2,378 father–son pairs. Relative to Yfiler, haplotype diversity was increased in 86% of the populations tested and overall male relative differentiation was raised by 23.5%. Our study demonstrates the value of RMY-STRs in identifying and separating unrelated and related males and provides a reference database. ispartof: Human Mutation vol:35 issue:8 pages:1021-1032 status: published

Relevant for various areas of human genetics, Y-chromosomal short tandem repeats (Y-STRs) are commonly used for testing close paternal relationships among individuals and populations, and for male lineage identification. However, even the widely used 17-loci Yfiler set cannot resolve individuals and populations completely. Here, 52 centers generated quality-controlled data of 13 rapidly mutating (RM) Y-STRs in 14,644 related and unrelated males from 111 worldwide populations. Strikingly, >99% of the 12,272 unrelated males were completely individualized. Haplotype diversity was extremely high (global: 0.9999985, regional: 0.99836-0.9999988). Haplotype sharing between populations was almost absent except for six (0.05%) of the 12,156 haplotypes. Haplotype sharing within populations was generally rare (0.8% nonunique haplotypes), significantly lower in urban (0.9%) than rural (2.1%) and highest in endogamous groups (14.3%). Analysis of molecular variance revealed 99.98% of variation within populations, 0.018% among populations within groups, and 0.002% among groups. Of the 2,372 newly and 156 previously typed male relative pairs, 29% were differentiated including 27% of the 2,378 father-son pairs. Relative to Yfiler, haplotype diversity was increased in 86% of the populations tested and overall male relative differentiation was raised by 23.5%. Our study demonstrates the value of RMY-STRs in identifying and separating unrelated and related males and provides a reference database. Published 2014 Wiley Periodicals, Inc.**

Catheter ablation (CA) has emerged as an increasingly popular treatment option for selected patients with atrial fibrillation (AF) because drugs are frequently limited by side effects and poor effectiveness. However, very little data is available regarding outcomes of CA of AF beyond 5 years. Guidelines' recommendations are not clear regarding long-term oral anticoagulation (OAC) after 2 years. We assessed thromboembolic events (TE) and AF ablation outcomes at very long-term follow-up (5 years) after CA. During a mean follow-up of 9 years after CA, 68% patients were in stable sinus rhythm without anti-arrhythmic drugs and the TE event rate was 0.41 per 100 patients/year. Our data suggests that patients post ablation with a high risk for stroke (CHA2DS2-VASc ≥ 2) should however continue OAC treatment.

Aims To define the clinical characteristics and long-term clinical outcomes of a large cohort of patients with idiopathic ventricular fibrillation (IVF) and normal 12-lead electrocardiograms (ECGs). Methods and results Patients with ventricular fibrillation as the presenting rhythm, normal baseline, and follow-up ECGs with no signs of cardiac channelopathy including early repolarization or atrioventricular conduction abnormalities, and without structural heart disease were included in a registry. A total of 245 patients (median age: 38 years; males 59%) were recruited from 25 centres. An implantable cardioverter-defibrillator (ICD) was implanted in 226 patients (92%), while 18 patients (8%) were treated with drug therapy only. Over a median follow-up of 63 months (interquartile range: 25–110 months), 12 patients died (5%); in four of them (1.6%) the lethal event was of cardiac origin. Patients treated with antiarrhythmic drugs only had a higher rate of cardiovascular death compared to patients who received an ICD (16% vs. 0.4%, P = 0.001). Fifty-two patients (21%) experienced an arrhythmic recurrence. Age ≤16 years at the time of the first ventricular arrhythmia was the only predictor of arrhythmic recurrence on multivariable analysis [hazard ratio (HR) 0.41, 95% confidence interval (CI) 0.18–0.92; P = 0.03]. Conclusion Patients with IVF and persistently normal ECGs frequently have arrhythmic recurrences, but a good prognosis when treated with an ICD. Children are a category of IVF patients at higher risk of arrhythmic recurrences.

Aims Cardiac implantable electronic device (CIED) infection rates are increasing. Worldwide compliance and disparities to published guidelines for the prevention, diagnosis and management of these conditions are not well elucidated. The purpose of this survey, therefore, was to clarify these issues through an inquiry to arrhythmia-related associations and societies worldwide. Methods and results A questionnaire comprising 15 questions related to CIED infections was distributed among members of seven arrhythmia societies worldwide. A total of 234 centres in 62 countries reported implantation rates of which 159 (68.0%) performed more than 200 device implantations per year and 14 (6.0%) performed fewer than 50 implantations per year. The reported rates of CIED infections for 2017 were ≤2% in 78.7% of the centres, while the infection rates exceeded 5% in 7.8% of the centres. Preventive measures for CIED infection differed from published recommendations and varied among different regions mainly in terms of pocket irrigation and administering post-operative antimicrobial therapy the use of which was reported by 39.9% and 44% of the respondents, respectively. Antibacterial envelopes were used by 37.7% of the respondents in selected circumstances. In terms of pocket infection management, 62% of the respondents applied complete system removal as an initial step. Diagnostic pocket needle aspiration and pocket surgical debridement were reported by 15.8% and 11.8% of centres, respectively. Conclusion Clinical practices for prevention and management of CIED do not fully comply with current recommendations and demonstrate considerable regional disparities. Further education and programmes for improved implementation of guidelines are mandatory.

For kinship testing, it is important to consider the issue of genetic linkage when evaluating data from closely positioned short tandem repeat (STR) loci. The aim of our study was to assess the impact of ignoring vs. accounting for linkage on likelihood ratio (LR) values in kinship analyses. We took linkage into account by incorporating the recombination frequency into LR calculations and studied the effect of linkage between D5S818 and CSF1PO in the pedigree scenario "full siblings vs. unrelated" for 65 pairs of full siblings and 65 pairs of unrelated persons. For the marker pair vWA and D12S391, we evaluated 46 cases of kinship testing from our institute and compared the approach of incorporating the recombination frequency into LR calculations with the alternative option of dealing with linkage by including only one of two closely positioned loci in a kinship analysis.

As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diagnosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the implementation of CIEDs in the 'real world' through a variable spectrum of practices. These may range from the situation where reimbursement may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a transparent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.

Background Predicting response to cardiac resynchronization therapy (CRT) remains a challenge. We evaluated the role of baseline QRS pattern to predict response in terms of improvement in biventricular ejection fraction (EF). Methods Consecutive patients (pts) undergoing CRT implantation underwent radionuclide angiography at baseline and at mid-term follow-up. The relationship between baseline QRS pattern and mechanical dyssynchrony using phase analysis was evaluated. Changes in left and right ventricular EF (LVEF and RVEF) were analyzed with regard to baseline QRS pattern. Results We enrolled 56 pts, 32 with left bundle branch block (LBBB), 4 with right bundle branch block (RBBB) and 20 with non-specific intraventricular conduction disturbance (IVCD). A total of 48 pts completed follow-up. LBBB pts had significantly greater improvement in LVEF compared to RBBB or non-specific IVCD pts (+9.6 ± 10.9% vs. +2.6 ± 7.6%, p = 0.003). Response (defined as ≥ 5% increase in LVEF) was observed in 68% of LBBB vs. 24% of non-specific IVCD pts (p = 0.006). None of the RBBB pts were responders. RVEF was significantly improved in LBBB (+5.0 ± 9.0%, p = 0.007), but not in non-specific IVCD and RBBB pts (+0.4 ± 5.8%, p = 0.76). At multivariate analysis, LBBB was the only predictor of LVEF response (OR, 7.45; 95% CI 1.80-30.94; p = 0.006), but not QRS duration or extent of mechanical dyssynchrony. Conclusions Presence of a LBBB is a marker of a positive response to CRT in terms of biventricular improvement. Pts with non-LBBB pattern show significantly less benefit from CRT than those with LBBB.

Background With the advent of remote monitoring, current models of implantable cardioverter defibrillators (ICDs) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload, atrial fibrillation and device integrity issues. Timely treatment of these events has the potential to improve patient outcome, but this has not as yet been proven. Methods The MORE-CARE study is a multicenter randomized controlled trial evaluating the efficacy of advanced device diagnostics and remote monitoring in improving the outcome of patients with biventricular ICDs. Up to 1720 patients with a standard indication for a biventricular ICD will be randomized to standard in-office follow-up, or to a remote monitoring strategy using the CareLink network and involving automatic alerts for lung fluid overload, atrial fibrillation, and device integrity issues. The first phase aims at evaluating the delay between an alert event, and clinical action to the event. The second phase of the study will evaluate whether the remote monitoring strategy results in a significant reduction of a combined end point of total mortality or cardiovascular and device-related hospitalization. The duration of the study will be event-driven due to its sequential design. Conclusion MORE-CARE will evaluate the efficacy of remote monitoring for improving patient outcome in patients implanted with a biventricular ICD.