[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.

[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.

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.

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).

Orality, preference behavior, and reinforcement value of nonfood object in monkeys with orbital frontal lesions.

Monkeys with orbital frontal ablation, compared with sham-operated controls, showed enhancement of oral tendencies toward nonfood items. Further, unlike the controls, they persistently performed an instrumental response for one of these nonfood items. On the other hand, the lesioned monkeys did not show altered preferences for food versus nonfood items. These findings suggest that reinforcement value and preferential ordering are dissociated by orbital frontal ablation.

[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.

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.

[Functional capacity as a criterion for patient selection--too poor or too good for CRT?]. / Die funktionelle Ausgangsleistung als Kriterium der Patientenselektion -- Zu gut oder zu schlecht für CRT?

The article analyses the status of functional tests used in patient selection for cardiac resynchronization therapy (CRT). Based on published randomized trials, the NYHA classification, the quality of life score, the 6-minute walk and the cardio-pulmonary exercise test (CPX) are reviewed. The NYHA classification is a weak and unspecific test and should be used only as a basic consideration in patient selection. The 6-minute walk test shows a wide spread of values and high dependency on patients' motivation. Patients' functional capacity is measured most objectively by the CPX test, which additionally stratifies prognosis. We conclude that functional capacity is an important criterion in patient selection for CRT. However, primary functional status is of minor importance in estimating the expected functional benefit since multiple factors influence the success of CRT.

[Indication for cardiac resynchronization therapy: Consensus 2005]. / Indikation zur kardialen Resynchronisation: Konsensus 2005.

The indication for cardiac resynchronization therapy (CRT) using biventricular pacing or ICD systems has to be highly differentiated to optimize the proportion of patients who derive significant symptomatic benefit from this therapy, on the one hand, and to avoid this invasive treatment in patients with a low probability of clinical success of CRT, on the other hand. As a consensus in 2005, it can be put forward that there is sufficient evidence for an indication for CRT from clinical studies for the following characteristics: 1) Heart failure in NYHA functional class III or IV (if cardiac recompensation to class III is at least temporarily successful), 2) left ventricular ejection fraction < or =35%, 3) QRS duration >130 ms, particularly if left bundle branch block is present, 4) sinus rhythm. In addition, available data also suggest an indication for CRT in patients with atrial fibrillation if the other criteria listed above are met. The indication for CRT is unclear in patients with other intraventricular conduction delay (particularly right bundle branch block) while patients with left bundle branch block and a QRS duration of 120-130 ms seem to benefit if echocardiographic criteria demonstrate ventricular dyssynchrony. Since a multiplicity of echocardiographic criteria of ventricular dyssynchrony exists which is neither standardized nor evaluated in large-scale randomized trials, ventricular dyssynchrony on echocardiography alone cannot be regarded as an established indication for CRT without a QRS complex > or =120 ms. Similarly, whether heart failure in functional state NYHA II should be regarded as a CRT indication is currently being investigated in the randomized RAFT and MADIT-CRT trials.

[Is standard-echocardiography sufficient for identification of responders?]. / Reicht die Standard-Echokardiographie zur Identifizierung von Respondern aus?

During recent years cardiac re-synchronization has become an important tool in the treatment of patients with signs and symptoms of heart failure and de-synchronized contraction of the heart. This article describes the pathophysiological basis of de-synchronized contraction due to left bundle branch block and the use of conventional echocardiography to unmask whether the electrical abnormality is accompanied by an asynchronous contraction in the individual patient. The altered contraction in the de-synchronized heart is analysed on different levels: atrioventricular dyssynchrony describes the disturbed mechanical coupling of the ventricles and atria, interventricular dyssynchrony describes the disturbed mechanical coupling of the left and right ventricle, and intraventricular dyssynchrony describes the uncoordinated contraction of the left ventricle. Since tissue Doppler imaging is implemented only in the top level echo machines of the respective manufacturers, this article uses parameters derived from standard echo techniques to analyse the different aspects of dyssynchrony.

[From guiding catheter to coronary sinus lead]. / Vom Führungskatheter bis zur Koronarsinus-Elektrode -- Was ist neu?

Biventricular pacing system implantation is a challenging procedure. The first-choice technique to initiate left ventricular pacing consists of a transvenous approach via the coronary sinus (CS) tributaries. Different techniques to achieve CS access using dedicated guiding catheters and left ventricular leads are described. New developments in catheter and lead technology are presented. The most common procedure-related complications are reported.

[Three-dimensional vectorcardiography to predict CRT-responder]. / Dreidimensionale Vektorkardiographie zur CRT-Responderbestimmung.

Cardiac resynchronization therapy (CRT) is an accepted treatment for congestive heart failure (NYHA III-IV), but a substantial number of patients show no response to therapy. LBB, QRS width and echocardiographic measurements are parameters for indication, but they are not valid to predict hemodynamic response. A new method based on vector ECG analysis can deliver additional information, such as: parts or areas with late excitation, and with slow or fast depolarization speed. Electrical excitation is a prerequisite for contraction; this leads to the hypothesis that areas with late electrical activation will contract later. Algorithms for analysis of the vector ECG (determination of the vector -- time, area and speed) may help to identify responders and non-responders.

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.

Transvenous biventricular defibrillation halves energy requirements in patients.

BACKGROUND: Defibrillation thresholds (DFT) with standard implantable cardioverter-defibrillator leads in the right ventricle (RV) may be determined by weak shock field intensity in the myocardium of the left ventricle (LV). Adding a shocking electrode in a coronary vein on the middle of the LV free wall, thereby establishing biventricular defibrillation, substantially reduced defibrillation requirements in animals. We investigated the feasibility of this approach in 24 patients receiving an implantable cardioverter-defibrillator using a prototype over-the-wire temporary LV defibrillation lead. METHODS AND RESULTS: The LV lead was inserted through the coronary sinus, using a guide catheter and guidewire, into a posterior or lateral coronary vein whose location was determined by retrograde venography. Paired DFT testing compared a standard system (RV to superior vena cava plus can emulator [SVC+Can], 60% tilt biphasic shock) to a system including the LV lead. The biventricular system was tested with a dual-shock waveform (20% tilt monophasic shock from LV-->SVC+Can, then 60% tilt biphasic shock from RV-->SVC+Can). Twenty patients completed DFT testing. Venography and LV lead insertion time was 46+/-40 minutes. The biventricular system reduced mean DFT by 45% (8.9+/-1.1 J versus 4.9+/-0.5 J, P<0.001). Twelve patients (60%) had a standard system DFT >/=8 J, and the biventricular system gave a lower DFT in all patients. There were no adverse events related to the use of the LV lead, which was removed after testing. CONCLUSIONS: Internal defibrillation using a transvenously inserted LV lead is feasible, produces significantly lower DFTs, and seems safe under the conditions tested. Biventricular defibrillation may be a useful option for reducing DFTs or could be added to an LV pacing lead for heart failure.

Effect of resynchronization therapy stimulation site on the systolic function of heart failure patients.

BACKGROUND: Cardiac resynchronization therapy (CRT) improves systolic function in heart failure patients with ventricular conduction delay by stimulating the left ventricle (LV) or both ventricles (biventricular, BV). Optimal LV site selection is of major clinical interest for CRT device implantation; however, the dependence of hemodynamics on LV stimulation site has not been established. Thus, the objective of this study was to compare the hemodynamic response to CRT for 2 LV coronary vein sites: the free wall and anterior wall. Methods and Results- A total of 30 patients (mean NYHA class, 2.7; mean QRS interval, 152 ms; mean PR interval, 194 ms) enrolled in the PATH-CHF-II trial were studied. CRT was administered with LV and BV stimulation in VDD mode at 4 AV delays. LV stimulation was at the lateral free wall or anterior wall, whereas right ventricular stimulation was fixed near the apex. LV+dP/dt(max) and aortic pulse pressure changes from baseline during CRT were compared for LV sites. Free wall sites with LV and BV stimulation yielded significantly larger LV+dP/dt(max) (14% versus 6%, P<0.001 for LV; 12% versus 5%, P<0.001 for BV) and pulse pressure (8% versus 4%, P<0.001 for LV; 9% versus 5%, P<0.001 for BV) compared with anterior sites. In one third of patients, CRT at free wall sites increased LV+dP/dt(max), whereas it decreased at anterior sites over most AV delays. CONCLUSION: CRT with LV free wall stimulation produced significantly better LV systolic performance compared with anterior stimulation. Further studies are warranted to prove the clinical superiority of the LV free wall as a site for long-term CRT.

Investigation of coronary venous anatomy by retrograde venography in patients with malignant ventricular tachycardia.

BACKGROUND: The coronary venous system is increasingly used for left ventricular or biventricular pacing in patients with severe heart failure. The present study investigated the structure of the coronary veins in patients presenting with structural heart disease and malignant ventricular tachyarrhythmias. The availability of veins for possible lead placement was assessed. METHODS AND RESULTS: The number, relative size, and location of coronary veins were evaluated by retrograde venography in 129 patients undergoing cardioverter-defibrillator implantation. Detailed x-ray image analysis was performed in 86 patients, for whom optimal coronary sinus occlusion and vein visualization was achieved. The anterior interventricular vein and the middle cardiac vein were visible in 85 (99%) of 86 patients and in 86 (100%) of 86 patients, respectively. Between these 2 veins, at least 1 additional prominent vein was visible in 85 (99%) of 86 patients. Just 1 vein was present in 44 (51%) of 86 patients. Two veins were observed in 40 (46%) of 86 patients, and >2 veins were visualized in 2 (2%) of 86 patients. Venous anatomy allowed positioning of a 0.014-in guidewire in a coronary vein in 115 (93%) of 124 patients. CONCLUSIONS: The presence, diameter, angulation, and tortuosity of veins as visualized by retrograde venography determine their acceptability for the placement of a lead in a predetermined location. Despite the considerable variability of the coronary venous system among patients, a lateral vessel for lead introduction was available in 82%, and a posterior or lateral vessel was available in 99% of individuals within a patient population that could potentially benefit from a lead on the left ventricle.

[Effect of cardiac resynchronization therapy (CRT) on exercise tolerance, functional capacity and quality of life in patients with congestive heart failure]. / Effekt der Cardialen Resynchronisationstherapie (CRT) auf die Belastbarkeit und Lebensqualität bei Herzinsuffizienzpatienten.

This review article summarizes the effect of cardiac resynchronization therapy (CRT) on exercise tolerance, functional capacity and quality of life, as it has been shown in previous randomized controlled trials. Based on these data we carefully have to reconsider the initial goals of this therapy. An early prophylactic implantation is not justified today. Especially patient selection has to be performed with more care in the future using new methods for detection of cardiac asynchrony to avoid a mismatch between implant numbers and real functional benefit.

Effect of stimuli in right hemispace on left-sided neglect in a line cancellation task.

Twenty-seven patients with right cerebral infarcts resulting in left-sided neglect in a line cancellation task were also tested for line cancellation when the lines were confined to the left half of sheets. All but one patient (whose neglect in the former condition was minimal) were still impaired in the latter condition, a finding that indicates that hyperattraction to test stimuli in the unneglected (right) hemispace was not the crucial factor preventing them from completing the standard version of the cancellation task, although it may have played some role. The results are consistent with the conclusion that hyperattention to stimuli in the unneglected hemifield, and possibly to stimuli in the unneglected hemispace, together with other factors, could account for the patients' impairment in line cancellation.

Spatial attentional shifts: implications for the role of polysensory mechanisms.

Simple reaction times to lateralized visual (Experiment 1) or auditory (Experiment 2) targets were studied in normal subjects. The targets were preceded by a visual or auditory cue located on the same (valid cue), or opposite (invalid cue) side as the subsequent target, or on both sides (neutral cue), with one of four cue target intervals. The validity of visual and auditory cues influenced the speed of response to the visual target but not to the auditory target. It is hypothesized that cross-modal cueing of spatial position works only with modalities for which a movement (e.g. saccade) leads to improved sensory analysis.