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).

Impact of mapping points in high-density mapping of the left atrium.

PURPOSE: Currently, high-density mapping techniques are being discussed for more precise voltage mapping, lesion validation after pulmonary vein isolation (PVI) and superior left atrial tachycardia (LAT) mapping. However, the quality of high-density maps varies according to different mapping systems, multipolar catheter (MPC) types and numbers of mapping points. The aim of this study was to evaluate the impact of different numbers of mapping points in high-density mapping on validity. METHODS: From February 2016 to August 2018, 154 patients with previous PVI ablation and recurrent atrial fibrillation (AF) or left atrial tachycardia (LAT) were mapped by Orion™ multipolar catheter and Rhythmia HDx™ mapping system at our centre. Of those, 90 maps from 25 patients [11 male patients/14 female patients; age 76 ± 12 years] with 8000 to 16,000 mapping points in the primary map were collected. All maps were evaluated offline by two independent and blinded electrophysiologists regarding the following issues: (1) Is PVI observable in all veins? (2) Does voltage map cover the whole left atrium? (3) Does activation map display one or more isthmuses? The 90 maps consist of 30 maps with deactivated 24 of 64 electrodes of MPC with < 1000 mapping points (A), 30 maps with deactivated 16 of 64 electrodes of MPC and 2000 to 6000 mapping points (B) and 30 primary maps with 8000 to 16,000 mapping points (C). RESULTS: For (A), only in one map (3.3%), for (B) in 20 maps (66.7%, p < 0.05) and for (C) in 24 maps (80%) both investigators agreed with evaluable PVI in all veins. Investigators were able to assess whether the voltage map covered the whole left atrium and the same low voltage areas in (A) in 0 maps, in (B) in 16 maps (53%, p < 0.05) and in (C) in 23 maps (77%, p < 0.05). Also, investigators were able to locate the same critical isthmuses in the activation maps in (A) in 0 maps, in (B) in 2 maps (7%) and in (C) in 20 maps (67%, p < 0.05). CONCLUSIONS: In order to achieve comparable high-density maps which are verified by independent investigators, a minimum of 2000 to 6000 mapping points are required in the majority of voltage maps to evaluate PVI and low voltage areas. To define the critical isthmuses in activations maps, 8000 mapping points or more might be necessary. High-density maps with more than 8000 points increase the interrater reliability.

[Septicemia and endocarditis with multiple implants : CIED, TAVI, MK clip and LAA occluders]. / Septikämie und Endokarditis bei multiplen Implantaten : CIED, TAVI, MK Clip und LAA-Okkluder.

Infective endocarditis (IE) as well as septicemia in patients with implanted cardiac devices are severe diseases and diagnosis is often delayed due to a variety of misleading symptoms. Imaging with transesophageal echocardiography (TEE) and also microbiology play a key role in both the diagnosis and management. They are also useful for the prognostic assessment of patients with IE, for follow-up during treatment, during extraction of the implant and after surgery. In addition to antibiotic treatment, removal of the implant is also necessary, at least if vegetation is detected. Not only the removal of the implant but also the underlying cardiac disease, the frequently occurring severe cardiac insufficiency, the advanced age and the not uncommon high degree of fragility of the patients mean that decision making for treatment and management as well as renewed implantation after completion of treatment are a challenge. The optimal treatment is only possible with a close cooperation between various specialist disciplines and should therefore be carried out in experienced centers.

[Leadless endocardial ultrasound based left ventricular stimulation : WISE CRT System: alternative to conventional methods]. / Sondenlose endokardiale linksventrikuläre Stimulation : WiSE™ CRT-System: Alternative zu herkömmlichen Verfahren.

There are still several limitations in delivering cardiac resynchronisation therapy (CRT). After 6 months, 20-40% of patients fail to have clinical benefit due to various reasons. Endocardial stimulation rather than conventional epicardial pacing has been shown to be more physiological, improves electrical stimulation of the left ventricle (LV), has less dispersion of electrical activity and results in better resynchronisation. The WiSE™ CRT System ("Wireless stimulation endocardial system"; EBR Systems, Sunnyvale, CA, USA) provides an option for wireless, LV endocardial pacing triggered by a conventional right ventricular pacing spike from a co-implant. The feasibility of the WiSE™ CRT System has been successfully demonstrated in a population of failed cardiac resynchronisation patients with either failed implantation of a conventional system, nonresponse to conventional therapy or upgrade from pacemaker or defibrillator, where a conventional system was not an option. The WiSE™ CRT System is an innovative technology with promising safety, performance and preliminary efficacy.

Evaluation of wireless stimulation of the endocardium, WiSE, technology for treatment heart failure.

INTRODUCTION: There are several unsolved limitations in delivering cardiac resynchronization therapy. 30-40% of patients fail to have any clinical benefit after 6 months caused by different reasons. AREAS COVERED: Endocardial stimulation rather than conventional epicardial pacing has been shown to: be more physiologically, improve electrical stimulation of the left ventricular, give less dispersion of repolarisation and result in better resynchronization. The Wireless Cardiac Stimulation in Left Ventricle, WiCS-LV, system provides an option for wireless, left ventricular endocardial pacing triggered from a conventional right ventricular pacing spike from a co-implant. Expert commentary: The feasibility of the WiCS-LV system has been successfully demonstrated in a population of failed cardiac resynchronization patients, either failed implantation procedure of a conventional system, non-responder to conventional therapy or upgrade from pacemaker or defibrillator, where a conventional system was not an option. WiCS-LV is innovative technology with promising safety, performance and preliminary efficacy.

[Implantable hemodynamic monitoring devices]. / Implantierbare hämodynamische Monitorsysteme.

Heart failure is one of the most frequent diagnoses in hospital admissions in Germany. In the majority of these admissions acute decompensation of an already existing chronic heart failure is responsible. New mostly wireless and remote strategies for monitoring, titration, adaptation and optimization are the focus for improvement of the treatment of heart failure patients and the poor prognosis. The implantation of hemodynamic monitoring devices follows the hypothesis that significant changes in hemodynamic parameters occur before the occurrence of acute decompensation requiring readmission. Three different hemodynamic monitoring devices have so far been investigated in clinical trials employing right ventricular pressure, left atrial pressure and pulmonary artery pressure monitoring. Only one of these systems, the CardioMENS™ HF monitoring system, demonstrated a significant reduction of hospitalization due to heart failure over 6 months in the CHAMPION trial. The systematic adaptation of medication in the CHAMPION trial significantly differed from the usual care of the control arm over 6 months. This direct day to day management of diuretics is currently under intensive investigation; however, further studies demonstrating a positive effect on mortality are needed before translation of this approach into guidelines. Without this evidence a further implementation of pressure monitoring into currently used devices and justification of the substantial technical and personnel demands are not warranted.

Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system.

The interventional treatment of mitral valve regurgitation by the MitraClip procedure has grown rapidly in Germany and Europe during the past years. The MitraClip procedure has the potential to treat high-risk patients with secondary mitral valve regurgitation and poor left ventricular function. Furthermore, patients with primary mitral valve regurgitation may be treated successfully by the MitraClip procedure in case of high surgical risk or in very old patients. At the same time it has been emphasised that the MitraClip interventional treatment is still at an early stage of clinical development. The largest clinical experience with the MitraClip procedure so far is probably present in some German cardiovascular centers, which here summarise their recommendations on the current indications and procedural steps of the MitraClip treatment. These recommendations of the AGIK and ALKK may present a basis for future development.

A neonate with a meningomyelocele complicated by Aeromonas caviae ventriculoperitoneal shunt infection.

We report on a newborn girl with a Aeromonas caviae shunt infection and meningitis after insertion of a ventriculoperitoneal shunt and surgical repair of a meningomyelocele in one procedure. This pathogen has never been reported, related to ventriculoperitoneal shunt infections. Beside the need for surgical revision of the shunt because of shunt obstruction and septa formation in the ventricles, the clinical outcome was good with intravenous cefotaxime therapy.

[Recommendations of the Working Group of Arrhythmias of the German Society of Cardiology on the approach to patients with Riata® and Riata ST® leads (St. Jude Medical). Nucleus of the Working Group of Arrhythmias of the German Society of Cardiology]. / Empfehlungen der Deutschen Gesellschaft für Kardiologie (Arbeitsgruppe Rhythmologie) zum Umgang mit Patienten mit ICD-Elektroden Riata® und Riata ST® der Firma St. Jude Medical. Nucleus der AG Rhythmologie der Deutschen Gesellschaft für Kardiologie.

Riata® and Riata ST® implantable cardioverter defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA) show an increased incidence of insulation defects, particularly "inside-out" lead fracture where inner, separately insulated cables penetrate through the surrounding silicone of the lead body. The exact incidence of Riata® lead problems is not clear and seems to range between 2-4% per year in the first 5 years after implantation according to new registry data. We recommend beyond a detailed information the following care of patients with Riata® and Riata ST® leads: 1) Activation of automatic ICD alerts, 2) remote monitoring with automatic daily alerts whenever possible, 3) monthly ICD controls in patients at high risk (pacemaker dependency, history of ventricular tachyarrhythmias) and high or moderate lead-related risk (8F, 7F single coil), 3-monthly controls in moderate patient and lead-related risk, 3 to 6-monthly controls in low patient and lead-related risk (no bradycardia, no history of ventricular tachyarrhythmia). Every ICD control should include meticulous analysis of oversensing artifacts in stored electrograms (EGMs) of sustained and non-sustained ventricular tachyarrhythmias and registration of EGMs during provocation testing (pectoral muscle activity, arm movements). If electrical abnormalities are observed, reoperation with addition of a new ICD lead is recommended; lead extraction only if indicated according to current guidelines. Fluoroscopy should only be performed if electrical abnormalities are found by an experienced electrophysiologist and a high frame rate and resolution. Management of fluoroscopic abnormalities in the absence of electrical abnormalities is not clear. Therefore, routine fluoroscopy of patients with Riata® leads without electrical abnormalities is not recommended.

[Cardiac resynchronisation therapy : new data and technical developments]. / Kardiale Resynchronisationstherapie : Neue Daten und technische Entwicklungen.

Cardiac resynchronisation therapy (CRT) has opened up new perspectives over the past 10 years for highly symptomatic patients with severe systolic heart failure. The present article analyses and comments on recent publications which have lead to an expansion of the indication to patients with mild symptoms of heart failure, and which resulted in the modification of current European guidelines in 2010. The data available from narrow QRS complex studies are critically examined. Furthermore, the latest technical innovations in the field of CRT, which have helped to ease the implantation procedure and achieve higher success rates, are presented. Finally, new wireless ultrasound technology to stimulate the left ventricle, currently in an early clinical phase of evaluation, is presented as a potential alternative in the future.

[Improving left ventricular contraction by stimulation during the absolute refractory period. Cardiac contractility modulation]. / Verbesserung der linksventrikulären Kontraktilität durch Stimulation in der absoluten Refraktärperiode. Kardiale Kontraktilitätsmodulation.

Cardiac contractility modulating (CCM) signals are nonexcitatory signals applied during the absolute refractory period and have been shown to enhance the strength of left ventricular contraction in studies performed in animals and humans with heart failure. In patients with congestive heart failure, improvement of exercise tolerance and quality of life have been shown. Recent studies from myocardial biopsies demonstrate that CCM treatment normalizes expression of many genes that are abnormally expressed in heart failure, including proteins involved with calcium cycling. These findings suggest that CCM might be an alternative or even additional electrical treatment option for patients with heart failure and normal QRS duration delivered by a pacemaker, e.g., a rechargeable device without any antibradycardiac or antitachycardiac function.

[Role of imaging in cardiac resynchronization therapy]. / Rolle der Bildgebung bei der kardialen Resynchronisationstherapie.

Several multicenter randomized clinical trials have established cardiac resynchronization as a safe and effective way to treat heart failure patients. This is reflected in the Focus Update of the European guidelines that describes a class IA indication in patients with NYHA class II-IV heart failure with LVEF≤35% and QRS≥120 ms (NYHA III/IV) or ≥150 ms (NYHA II). If applied in clinical practice, this patient selection results in ineffective treatment in about one third of patients implanted. Since the pathophysiological basis of the disease, a disorganized electromechanical function in patients with left bundle branch block (LBBB), is amenable to analysis with imaging methods, imaging has always played an important role in patient selection. None of the parameters used proved to be reliable for the prediction of cardiac resynchronization therapy success in the multicenter PROSPECT trial. Following the publication of PROSPECT in 2008, several new studies using echocardiography and cardiac magnetic resonance imaging were published. New publications are evaluated and analyzed in the context of earlier ones.

Early replication in pulmonary B cells after infection with Marek's disease herpesvirus by the respiratory route.

Abstract Natural infection with Marek's disease virus occurs through the respiratory mucosa after chickens inhale dander shed from infected chickens. The early events in the lung following exposure to the feather and squamous epithelial cell debris containing the viral particles remain unclear. In order to elucidate the virological and immunological consequences of MDV infection for the respiratory tract, chickens were infected by intratracheal administration of infective dander. Differences between susceptible and resistant chickens were immediately apparent, with delayed viral replication and earlier onset of interferon (IFN)-gamma production in the latter. CD4(+) and CD8(+) T cells surrounded infected cells in the lung. Although viral replication was evident in macrophages, pulmonary B cells were the main target cell type in susceptible chickens following intratracheal infection with MDV. In accordance, depletion of B cells curtailed viremia and substantially affected pathogenesis in susceptible chickens. Together the data described here demonstrate the role of pulmonary B cells as the primary and predominant target cells and their importance for MDV pathogenesis.

[Optimal electrode placement. What to consider during implantation of a biventricular pacemaker?]. / Optimale Elektrodenposition. Was ist bei der Implantation biventrikulärer Schrittmacher zu beachten?

Since the introduction of transvenous left ventricular lead systems nearly a decade ago, resynchronization therapy has gained widespread acceptance and has become a growing field in heart failure therapy. Due to the increasing numbers of implanting centers and physicians, the need for adequate education is increasing. This article describes and illustrates the anatomical background, the technical opportunities and pitfalls, which have to be overcome, to achieve an implanting success rate of 95% to 98%, as can be achieved by well-trained physicians under optimal conditions.

[Upgrading to biventricular pacing: indications and procedural challenges]. / Upgrade konventioneller Schrittmacher und Defibrillatoren auf biventrikuläre Systeme: Indikationen und technische Besonderheiten bei der Implantation.

Upgrading RV pacing systems to biventricular resynchronization modalities is a promising option for paced patients with worsening heart failure. The potentially favorable effect of upgrading has been demonstrated in several, non-randomized trials. Selection of eligible patients and technical aspects of the procedure are described. The most common procedure-related complications are reported.

[Role of right heart failure in cardiac resynchronization]. / Rolle der Rechtsherzinsuffizienz im Rahmen der kardialen Resynchronisationstherapie.

During recent years cardiac resynchronization has become an important tool in the treatment of patients with signs and symptoms of heart failure and desynchronized contraction of the left ventricle. Among patients with heart failure, right ventricular involvement can occur because the underlying disease affects both ventricles or because the reduction of left ventricular function impairs the right ventricular function by altered coupling and increased right ventricular afterload. Irrespective of the underlying cause the reduction of right ventricular function confers an adverse prognosis that is further aggravated by the presence of pulmonary hypertension. The present article describes the relevance of reduced right ventricular function for the clinical syndrome of heart failure, the role of right ventricular resynchronization in patients with predominant right heart failure and the possible effects of left ventricular resynchronization on a preexisting impairment of right ventricular function.

[CRT in atrial fibrillation--methodical and apparatus options in decision-making]. / CRT bei Vorhofflimmern. Methodische und apparative Optionen zur Entscheidungsfindung.

Heart failure and atrial fibrillation often coexist, especially with increasing degree of heart failure severity. Under this constellation, the advantage of cardiac resynchronization therapy (CRT) is still under discussion and displayed as an unresolved problem in the guidelines for cardiac stimulation and resynchronization. If ventricular desynchronization can be documented and response to CRT can be expected, the challenge is to interoperatively seek the best left ventricular electrode position and to postoperatively optimize the device in order to achieve the best therapy performance. This situation encourages the development of individualized methods and to utilize innovative apparatus features in order to consolidate individual decisions and to optimize CRT in heart failure with atrial fibrillation.

[Improving left ventricular contractility by stimulation during the absolute refractory period--cardiac contractility modulation (CCM)]. / Verbesserung der linksventrikulären Kontraktilität durch Stimulation in der absoluten Refraktärperiode--Cardiac Contractility Modulation (CCM).

Cardiac contractility modulation (CCM) is a treatment option for patients with systolic ventricular dysfunction, independent of QRS duration, moderate to severe systolic heart failure and symptoms despite optimal medical therapy. In contrast to cardiac resynchronization therapy (CRT) which has been an established therapy in patients with wide QRS and ventricular asynchrony, CCM can enhance cardiac contractility in patients independent of QRS duration. Whereas inotropic drugs increase oxygen demand, CCM works without additional myocardial oxygen need and without reference to asynchrony. Non-excitatory signals applied during the absolute refractory period have been shown to enhance the strength of left ventricular contraction in animals and humans with heart failure probably due to normalization of myocardial gene expression. Several multicenter studies have demonstrated safety and efficacy of CCM in patients with medically refractory heart failure. We describe the specific technical aspects and conditions in clinical application of CCM.

Bifocal versus unifocal right atrial pacing under plasma level controlled sotalol to prevent atrial fibrillation in patients with symptomatic sinus bradycardia and paroxysmal atrial fibrillation.

AIMS: Bifocal right atrial pacing (BP) has been reported to increase arrhythmia-free intervals in patients with paroxysmal atrial fibrillation (PAF) under antiarrhythmic drugs. This study compares AF burden with unifocal pacing (UP) vs BP under sotalol. METHODS: In 19 patients with PAF a DDDR pacemaker with right atrial lateral and CS ostial leads was implanted. Sotalol was initiated. After a 3 month back-up pacing period patients were randomized to continuous UP or BP for 3 months and crossed over for 3 more months. Primary endpoint was AF burden. Secondary endpoints included number of episodes, time to first recurrence and safety of BP. RESULTS: The intention to treat analysis revealed 12.4% AF during back-up, 6.2% during UP and BP (p=0.91 UP vs BP, p=0.08 back-up vs UP and p=0.07 back-up vs BP). Per protocol analysis showed no advantage of either pacing mode (UP 4.8% and BP 5.4% AF, p=0.64). Overdrive pacing reduced AF burden to 6.2 vs 8.8% during back-up (p=0.09). Septal lead dislodgement occurred in 3 patients. CONCLUSION: Atrial pacing tends to reduce AF burden in patients with PAF under sotalol. An incremental effect of BP vs UP cannot be confirmed. BP may be complicated by elevated lead dislodgement rates.