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Objectives: This study examines the early and midterm safety, efficacy, and durability of mitral valve repair for primary mitral regurgitation (MR) using the ChordArt device (CoreMedic) for chordal replacement. Methods: Five patients with symptomatic severe primary degenerative MR due to isolated central posterior leaflet prolapse/flail were treated with the ChordArt device in a transseptal surgical approach and followed prospectively with periodical clinical and echocardiographic assessments for 2 years. Results: Reduction of MR immediately after the implantation of artificial chords was achieved in all patients showing no or trace MR (

The field of mitral valve disease diagnosis and management is rapidly evolving. New understanding of pathophysiology and improvements in the adoption of sophisticated multimodality imaging modalities have led to early diagnosis and to more complex treatment. The most common cause of mitral regurgitation (MR) in the western world is in the primary alteration of the valve, which leads to degenerative leaflet prolapse due to chordal elongation or rupture and annular dilatation. Untreated, significant MR has a negative impact prognosis, leading to reduction of survival. In the setting of degenerative MR, surgical repair currently represents the standard of care. Treatment of asymptomatic patients with severe MR in the Valve Center of Excellence, in which successful repair reaches more than 95% and surgical mortality less than 1%, symbolizes the direction for the next years. Transcatheter mitral valve repair with different devices, more recently the chordal replacement ones, is providing good outcomes and became a therapeutic option in high-risk patients with degenerative MR. In the future, more advances are expected from further development of interventional techniques, careful evaluation and better patient selection. This review will focus on long-term surgical outcomes of mitral valve repair with artificial chordae and on the emerging transcatheter chordal repair devices as therapeutic options for degenerative MR patients.

Purpose The pre-clinical testing of cardiovascular implants gains increasing attention due to the complexity of novel implants and new medical device regulations. It often relies on large animal experiments that are afflicted with ethical and methodical challenges. Thus, a method for simulating physiological heart motions is desired but lacking so far. Methods We developed a robotic platform that allows simulating the trajectory of any point of the heart (one at a time) in six degrees of freedom. It uses heart motion trajectories acquired from cardiac magnetic resonance imaging or accelero-meter data. The rotations of the six motors are calculated based on the input trajectory. A closed-loop controller drives the platform and a graphical user interface monitors the functioning and accuracy of the robot using encoder data. Results The robotic platform can mimic physiological heart motions from large animals and humans. It offers a spherical work envelope with a radius of 29 mm, maximum acceleration of 20 m/s2 and maximum deflection of ±19° along all axes. The absolute mean positioning error in x-, y- and z-direction is 0.21 ±0.06, 0.31 ±0.11 and 0.17 ±0.12 mm, respectively. The absolute mean orientation error around x-, y- and z-axis (roll, pitch and yaw) is 0.24 ±0.18°, 0.23 ±0.13° and 0.18 ±0.18°, respectively. Conclusion The novel robotic approach allows reproducing heart motions with high accuracy and repeatability. This may benefit the device development process and allows re-using previously acquired heart motion data repeatedly, thus avoiding animal trials.

A novel chordal system enables automated implantation of artificial mitral chords to treat mitral regurgitation (MR). This article summarizes the first-in-man initial clinical results.The CHAGALL (CHordArt system study for the treatment of mitral ReGurgitAtion due to leaflet proLapse or fLail) trial is a single arm, multicenter, prospective study to test the feasibility of this system for mitral repair. The interim clinical and echocardiographic results of the first 5 patients with a 12-month follow-up are presented.Five patients (mean age, 64 years) with severe MR received implantation of neochords with this device under cardiopulmonary bypass. Technical success was obtained in all patients. Transesophageal echocardiogram showed either no or trace residual MR (1+/4+) after repair. Survival at 30 days was 100%, and no device-related complication occurred. Reduction of MR was sustained up to 12 months.This novel chordal system is promising because it greatly facilitates the deployment of neochords to repair the mitral valve. Results at 12 months are encouraging. The device is currently under development for transcatheter approach.

A new pseudo asynchronous level crossing analogue-to-digital converter ( adc ) architecture targeted for low-power, implantable, long-term biomedical sensing applications is presented. In contrast to most of the existing asynchronous level crossing adc designs, the proposed design has no digital-to-analogue converter ( dac ) and no continuous time comparators. Instead, the proposed architecture uses an analogue memory cell and dynamic comparators. The architecture retains the signal activity dependent sampling operation by generating events only when the input signal is changing. The architecture offers the advantages of smaller chip area, energy saving and fewer analogue system components. Beside lower energy consumption the use of dynamic comparators results in a more robust performance in noise conditions. Moreover, dynamic comparators make interfacing the asynchronous level crossing system to synchronous processing blocks simpler. The proposed adc was implemented in $0.35\,{\mu }{\text{m}}$ complementary metal-oxide-semiconductor ( cmos ) technology, the hardware occupies a chip area of $0.0372\,\mathrm{mm}^2$ and operates from a supply voltage of $1.8\,{\text{V}}$ to $2.4\,{\text{V}}$ . The adc 's power consumption is as low as $0.6\,{\mu }\mathrm{W}$ with signal bandwidth from $0.05\,{\text{Hz}}$ to $1\,{\text{kHz}}$ and achieves an equivalent number of bits ( enob ) of up to 8 bits.

Anamnese: Ein 36-jahriger Mann mit PR3-ANCA positive Granulomatosis mit Polyangiitis stellt sich mit Thoraxschmerzen auf der Notfallstation vor. Im Rahmen seiner Grunderkrankung wurde er regelmasig mit Rituximab therapiert. Zuletzt wurde die Rituximab-Infusion am Vortag verabreicht. Untersuchung: Das EKG zeigt ausgepragte ST-Hebungen in V1-V4. Diagnose, Therapie und Verlauf: Es wird ein akuter Vorderwandinfarkt diagnostiziert und der Patient fur eine perkutane transluminale Koronarangioplastie vorbereitet. Wahrend der Patient in das Herzkatheterlabor transportiert wird, kommt es zu einem Kreislaufstillstand bei Kammerflimmern. Nach erfolgreicher elektromechanischer Reanimation kann in der Herzkatheteruntersuchung keine relevante Koronarstenose nachgewiesen werden. Wegen des Verdachts auf einen Koronarspasmus des Ramus interventricularis anterior wird die medikamentose Therapie mit einem Kalziumantagonisten erweitert. In sekundarpraventiver Absicht wird ein Einkammer- Kardioverter-Defibrillator implantiert. Folgerung: Das akute Koronarsyndrom ist eine mogliche Nebenwirkung einer Rituximab-Therapie. Im dargestellten Fall kann ein Zusammenhang zwischen der am Vortag verabreichten Rituximab-Infusion und dem kardialen Ereignis nicht ausgeschlossen werden.

A 59-year-old male patient without the history of heart disease was referred for coronary angiography due to typical chest pain and signs of myocardial ischemia during exercise stress test. On admission, the patient was in sinus rhythm. After successful PCI, the patient was enrolled in a study to investigate esophageal long-term electrocardiography (eECG) comprising simultaneous rhythm monitoring with surface and esophageal leads during 16 h. The surface ECG (sECG) was recorded using a two-channel Holter ECG recorder with a sampling frequency of 1,024 Hz allowing continuous rhythm monitoring for 7 days (Lifecard CF, Spacelabs Healthcare, USA). The eECG was recorded using an esophageal ECG electrode (Esosoft 6S, FIAB, Italy) connected to a dedicated two-channel eECG recorder—a proprietary development—with a sampling frequency of 512 Hz. We registered two bipolar channels (interelectrode spacings of 60 and 15 mm). The eECG was well tolerated; the patient reported only a slight pharyngeal foreign body feeling without any impact on his common daily activities such as eating, talking and sleeping. The sECG was analyzed using an automatic beat classifier system (Pathfinder, Spacelabs Healthcare, USA). The software correctly detected five atrial premature beats (APB’s) but no other atrial arrhythmias. In the eECG, we unmasked another 40 APB’s, as well as 178 episodes with atrial ectopic rhythm [mean duration ± SD 25 ± 31 beats (Fig. 1)]. This report illustrates the limited sensitivity of surface long-term ECG for atrial rhythm disorders. For the sECG, software-based automatic classification of atrial arrhythmias is accomplished by calculating the ratio of the R–Rinterval to be classified and the preceding R–R-interval(s). This quotient is then compared to a coupling interval threshold, e.g., the Pathfinder software uses by default 66 % of the preceding R–R-interval duration. The number of detected atrial arrhythmias strongly depends on this threshold: atrial ectopic beats are only identifiable if they are premature enough as compared to this threshold. The sECG uses R–R-intervals as surrogate markers of the true atrial activity, while morphologic features of atrial signals are not considered. The lack of a direct classifier for atrial arrhythmias is a major limitation of sECG monitoring in cases without evident change in R–R cycle duration. Moreover, reliable detection of atrial arrhythmias is of increasing importance for risk stratification, because it has been shown that excessive supraventricular ectopic activity [1] as well as atrial premature beats [2–4] are associated with an increased risk of stroke and atrial fibrillation. Esophageal electrocardiography may provide an elegant way out by offering excellent atrial signals that additionally allow waveform analysis for the direct and reliable classification of atrial rhythm. Lead movements due to eating or respiration can confound esophageal electrocardiography. We exclude that the morphologic changes are caused by such artifacts for the ClinicalTrials.gov Identifier: NCT01436344.

Detection of arrhythmic atrial beats in surface ECGs can be challenging when they are masked by the R or T wave, or do not affect the RR-interval. Here, we present a solution using a high-resolution esophageal long-term ECG that offers a detailed view on the atrial electrical activity. The recorded ECG shows atrial ectopic beats with long coupling intervals, which can only be successfully classified using additional morphology criteria. Esophageal high-resolution ECGs provide this information, whereas surface long-term ECGs show poor atrial signal quality. This new method is a promising tool for the long-term rhythm monitoring with software-based automatic classification of atrial beats.

Objective : cardiac pacemakers require regular medical follow-ups to ensure proper functioning. However, device replacements due to battery depletion are common and account for ∼25% of all implantation procedures. Furthermore, conventional pacemakers require pacemaker leads which are prone to fractures, dislocations or isolation defects. The ensuing surgical interventions increase risks for the patients and costs that need to be avoided. Methods : in this study, we present a method to harvest energy from endocardial heart motions. We developed a novel generator, which converts the heart's mechanical into electrical energy by electromagnetic induction. A mathematical model has been introduced to identify design parameters strongly related to the energy conversion efficiency of heart motions and fit the geometrical constraints for a miniaturized transcatheter deployable device. The implemented final design was tested on the bench and in vivo . Results : the mathematical model proved an accurate method to estimate the harvested energy. For three previously recorded heart motions, the model predicted a mean output power of 14.5, 41.9, and 16.9 μW. During an animal experiment, the implanted device harvested a mean output power of 0.78 and 1.7 μW at a heart rate of 84 and 160 bpm, respectively. Conclusion: harvesting kinetic energy from endocardial motions seems feasible. Implanted at an energetically favorable location, such systems might become a welcome alternative to extend the lifetime of cardiac implantable electronic device. Significance : the presented endocardial energy harvesting concept has the potential to turn pacemakers into battery- and leadless systems and thereby eliminate two major drawbacks of contemporary systems.

Zusammenfassung. Herzschrittmacher sind die therapeutischen Grundpfeiler bradykarder Herzrhythmusstörungen. Moderne Schrittmacher sind zuverlässig und bieten eine Vielzahl an Möglichkeiten zur patientenspezifischen Therapie. Schrittmacherwechsel aufgrund von Batterieerschöpfung sind allerdings häufig (~25 % aller Implantationen) und können Komplikationen nach sich ziehen. Batterielose Herzschrittmacher wären wünschenswert um die Anzahl der Schrittmacherwechsel zu minimieren. Ein solches Gerät müsste seine Energie im Körper selbst mittels eines speziellen Generators gewinnen. Dieser Generator könnte beispielsweise aus subkutan implantierten Solarzellen bestehen, welche die kleine Menge Licht, die in unseren Körper eindringt, in elektrische Energie umwandeln. Alternativ könnte der Blutfluss mittels kleiner intravaskulärer Turbinen als Energiequelle genutzt werden. Ein dritter Ansatz verfolgt die direkte Umwandlung eines Teils der mechanischen Energie der Ventrikelkontraktion in elektrische Energie, wozu ein spezielles mechanisches Uhrwerk auf das Myokard aufgebracht wird. Alle diese Ansätze wurden in ersten in vivo Studien erfolgreich getestet. Speziell erfolgsversprechend für die Zukunft scheinen miniaturisierte Generatoren, welche katheterbasiert intraventrikulär implantiert werden können und somit gleichzeitig erlauben, auf Schrittmacherelektroden zu verzichten – eine andere Achillesferse gegenwärtiger Schrittmacher.

Active electronic implants are powered by primary batteries, which induces the necessity of implant replacement after battery depletion. This causes repeated interventions in a patients’ life, which bears the risk of complications and is costly. By using energy harvesting devices to power the implant, device replacements may be avoided and the device size may be reduced dramatically. Recently, several groups presented prototypes of implants powered by subcutaneous solar cells. However, data about the expected real-life power output of subcutaneously implanted solar cells was lacking so far. In this study, we report the first real-life validation data of energy harvesting by subcutaneous solar cells. Portable light measurement devices that feature solar cells (cell area = 3.6 cm2) and continuously measure a subcutaneous solar cell’s output power were built. The measurement devices were worn by volunteers in their daily routine in summer, autumn and winter. In addition to the measured output power, influences such as season, weather and human activity were analyzed. The obtained mean power over the whole study period was 67 µW (=19 µW cm−2), which is sufficient to power e.g. a cardiac pacemaker.

Engineers are confronted with the energy demand of active medical implants in patients with increasing life expectancy. Scavenging energy from the patient’s body is envisioned as an alternative to conventional power sources. Joining in this effort towards human-powered implants, we propose an innovative concept that combines the deformation of an artery resulting from the arterial pressure pulse with a transduction mechanism based on magneto-hydrodynamics. To overcome certain limitations of a preliminary analytical study on this topic, we demonstrate here a more accurate model of our generator by implementing a three-dimensional multiphysics finite element method (FEM) simulation combining solid mechanics, fluid mechanics, electric and magnetic fields as well as the corresponding couplings. This simulation is used to optimize the generator with respect to several design parameters. A first validation is obtained by comparing the results of the FEM simulation with those of the analytical approach adopted in our previous study. With an expected overall conversion efficiency of 20% and an average output power of 30 μW, our generator outperforms previous devices based on arterial wall deformation by more than two orders of magnitude. Most importantly, our generator provides sufficient power to supply a cardiac pacemaker.

Replacement intervals of implantable medical devices are commonly dictated by battery life. Therefore, intracorporeal energy harvesting has the potential to reduce the number of surgical interventions by extending the life cycle of active devices. Given the accumulated experience with intravascular devices such as stents, heart valves, and cardiac assist devices, the idea to harvest a small fraction of the hydraulic energy available in the cardiovascular circulation is revisited. The aim of this article is to explore the technical feasibility of harvesting 1 mW electric power using a miniature hydrodynamic turbine powered by about 1% of the cardiac output flow in a peripheral artery. To this end, numerical modelling of the fluid mechanics and experimental verification of the overall performance of a 1:1 scale friction turbine are performed in vitro. The numerical flow model is validated for a range of turbine configurations and flow conditions (up to 250 mL/min) in terms of hydromechanic efficiency; up to 15% could be achieved with the nonoptimized configurations of the study. Although this article does not entail the clinical feasibility of intravascular turbines in terms of hemocompatibility and impact on the circulatory system, the numerical model does provide first estimates of the mechanical shear forces relevant to blood trauma and platelet activation. It is concluded that the time-integrated shear stress exposure is significantly lower than in cardiac assist devices due to lower flow velocities and predominantly laminar flow.

Long-term electrocardiography (ECG) featuring adequate atrial and ventricular signal quality is highly desirable. Routinely used surface leads are limited in atrial signal sensitivity and recording capability impeding complete ECG delineation, i.e. in the presence of supraventricular arrhythmias. Long-term esophageal ECG might overcome these limitations but requires a dedicated lead system and recorder design. To this end, we analysed multiple-lead esophageal ECGs with respect to signal quality by describing the ECG waves as a function of the insertion level, interelectrode distance, electrode shape and amplifier's input range. The results derived from clinical data show that two bipolar esophageal leads, an atrial lead with short (15 mm) interelectrode distance and a ventricular lead with long (80 mm) interelectrode distance provide non-inferior ventricular signal strength and superior atrial signal strength compared to standard surface lead II. High atrial signal slope in particular is observed with the atrial esophageal lead. The proposed esophageal lead system in combination with an increased recorder input range of ±20 mV minimizes signal loss due to excessive electrode motion typically observed in esophageal ECGs. The design proposal might help to standardize long-term esophageal ECG registrations and facilitate novel ECG classification systems based on the independent detection of ventricular and atrial electrical activity.

Background Ischemia monitoring cannot always be performed by 12-lead ECG. Hence, the individual performance of the ECG leads is crucial. No experimental data on the ECG's specificity for transient ischemia exist. Methods In 45 patients a 19-lead ECG was registered during a 1-minute balloon occlusion of a coronary artery (left anterior descending artery [LAD], right coronary artery [RCA] or left circumflex artery [LCX]). ST-segment shifts and sensitivity/specificity of the leads were measured. Results During LAD occlusion, V3 showed maximal ST-segment elevation (0.26 mV [IQR 0.16–0.33 mV], p = 0.001) and sensitivity/specificity (88% and 80%). During RCA occlusion, III showed maximal ST-elevation (0.2 mV [IQR 0.09–0.26 mV], p = 0.004), aVF had the best sensitivity/specificity (85% and 68%). During LCX occlusion, V6 showed maximal ST-segment elevation (0.04 mV [IQR 0.02–0.14 mV], p = 0.005), and sensitivity/specificity was (31%/92%) but could be improved (63%/72%) using an optimized cut-off for ischemia. Conclusion V3, aVF and V6 show the best performance to detect transient ischemia.

ObjectiveWave intensity analysis is a method that allows separating pulse waves into components generated proximally and in the periphery of arterial trees, as well as characterising them as accelerating or decelerating. The early diastolic suction wave (eaDSW) is one of the most prominent wave events in the coronaries. The aim of this study was to determine whether (1) microvascular dilatation directly influences its energy, (2) stenosis severity can be assessed proximal to stenoses, (3) distal pulse wave entrapment exists in the presence of stenoses and (4) coronary collaterals influence wave entrapment.MethodsIn 43 coronary artery disease patients, Doppler flow velocity and pressure measurements were performed in a proximal coronary segment at rest, in a distal segment at rest, during adenosine-induced hyperaemia and during balloon occlusion. Wave energies were calculated as the area under the wave intensity curves.ResultsThe eaDSW energy showed a significant increase during hyperaemia, but did not differ between proximal and distal segments. There was no significant correlation between eaDSW energy and coronary stenosis severity. Pulse wave entrapment could not be observed consistently in the distal segments. Consequently, the effect of coronary collaterals on pulse wave entrapment could not be studied.ConclusionsMicrovascular dilation in the coronary circulation increases distal eaDSW energy. However, it does not show any diagnostically useful variation between measurement sites, various stenosis degrees and amount of collateral flow. The assessment eaDSW and its reflections were not useful for the quantification of coronary stenosis severity or the collateral circulation in clinical practice.

Objective To evaluate the effect of heart rate reduction by ivabradine on coronary collateral function in patients with chronic stable coronary artery disease (CAD). Methods This was a prospective randomised placebo-controlled monocentre trial in a university hospital setting. 46 patients with chronic stable CAD received placebo (n=23) or ivabradine (n=23) for the duration of 6 months. The main outcome measure was collateral flow index (CFI) as obtained during a 1 min coronary artery balloon occlusion at study inclusion (baseline) and at the 6-month follow-up examination. CFI is the ratio between simultaneously recorded mean coronary occlusive pressure divided by mean aortic pressure both subtracted by mean central venous pressure. Results During follow-up, heart rate changed by +0.2±7.8 beats/min in the placebo group, and by –8.1±11.6 beats/min in the ivabradine group (p=0.0089). In the placebo group, CFI decreased from 0.140±0.097 at baseline to 0.109±0.067 at follow-up (p=0.12); it increased from 0.107±0.077 at baseline to 0.152±0.090 at follow-up in the ivabradine group (p=0.0461). The difference in CFI between the 6-month follow-up and baseline examination amounted to −0.031±0.090 in the placebo group and to +0.040±0.094 in the ivabradine group (p=0.0113). Conclusions Heart rate reduction by ivabradine appears to have a positive effect on coronary collateral function in patients with chronic stable CAD. ClinicalTrials.gov Identifier: NCT01039389.

AIMS Recent data have demonstrated the feasibility of therapeutic induction of coronary collateral growth (arteriogenesis); however, mechanisms of action of such therapeutic collateral stimulation in humans are unknown. The aim of this study was to evaluate potential mechanisms, especially the involvement of arteriogenesis-relevant genes. METHODS AND RESULTS A total of 52 patients were randomized into two groups: subcutaneous G-CSF (10 μg/kg; n=26) or placebo (n=26). Before and after this 2-week treatment, collateral-flow index (CFI) was determined by simultaneous measurement of mean aortic, distal coronary occlusive and central venous pressure. CD34+ endothelial progenitor cells (EPC) and monocytes were quantified before, during and after treatment; gene-expression analysis of monocytes was performed with real-time polymerase chain reaction (RT-PCR). G-CSF lead to a significant increase of EPC and monocytes (4.8 and 2.6 fold, p < 0.05); for both cell types, the extent of increase correlated with CFI increase (r=0.23 and 0.14, p < 0.05). G-CSF also induced a change in gene expression of pro-and anti-arteriogenic genes in monocytes. Among nine assessed genes, three were found to be differentially regulated (IL8, JAK2, and PNPLa4; p < 0.05). CONCLUSIONS The mechanism of induction of collateral growth by G-CSF is related to an increase of EPC and of peripheral monocytes. It also leads to a change toward a pro-arteriogenic gene expression in peripheral monocytes.

Energy harvesting devices are widely discussed as an alternative power source for todays active implantable medical devices. Repeated battery replacement procedures can be avoided by extending the implants life span, which is the goal of energy harvesting concepts. This reduces the risk of complications for the patient and may even reduce device size. The continuous and powerful contractions of a human heart ideally qualify as a battery substitute. In particular, devices in close proximity to the heart such as pacemakers, defibrillators or bio signal (ECG) recorders would benefit from this alternative energy source. The clockwork of an automatic wristwatch was used to transform the hearts kinetic energy into electrical energy. In order to qualify as a continuous energy supply for the consuming device, the mechanism needs to demonstrate its harvesting capability under various conditions. Several in-vivo recorded heart motions were used as input of a mathematical model to optimize the clockworks original conversion efficiency with respect to myocardial contractions. The resulting design was implemented and tested during in-vitro and in-vivo experiments, which demonstrated the superior sensitivity of the new design for all tested heart motions.

Active medical implants play a crucial role in cardiovascular medicine. Their task is to monitor and treat patients with minimal side effects. Furthermore, they are expected to operate autonomously over a long period of time. However, the most common electrical implants, cardiac pacemakers—as all other electrical implants—run on an internal battery that needs to be replaced before its end of life. Typical pacemaker battery life cycles are in the range of 8–10 years1; however, they strongly depend on the device type and usage.

A 36-year-old man with a history of PR3-ANCA positive granulomatosis with polyangiitis presented with chest pain at the emergency department. Due to his underlying disease, he was treated with Rituximab in regular intervals. The last Rituximab infusion was admitted one day before presentation.The ECG showed marked ST elevation in V1-V4.After the diagnosis of an acute anterior myocardial infarction, the patient was prepared for acute percutaneous coronary intervention. During transport to the cardiac catheterization laboratory, he suffered a cardiac arrest due to ventricular fibrillation. After successful resuscitation, the cardiac catheterization showed no evidence of relevant coronary stenosis. Because of suspected coronary spasm of left anterior descending artery the therapy was extended with a calcium channel blocker. A single chamber cardiac defibrillator was implanted for secondary prevention.Acute coronary syndrome is a possible side effect of rituximab therapy. The reported case emphasizes a correlation between Rituximab therapy and cardiac event.

Borderline personality disorder (BPD) and major depressive disorder (MDD) pose a significant burden to the German health care system in terms of direct and indirect costs. The aim of this study was to determine the incremental costs that arise due to the treatment of patients with BPD, in relation to MDD patients adjusted for gender and age. Insured persons who suffered from BPD (F60.3; N = 6599) or MDD (F32, F33; N = 26,396) in the year 2010 were identified from the German Health Risk Institute research database. To estimate the costs resulting from disorder-specific health care service utilization and the mean total costs per patient for the health care system, we analyzed anonymized claims data of individuals with BPD and matched individuals with MDD. The costs resulting from disorder-specific health care service utilization 1 year after index diagnosis amounted to 8508 EUR for BPD and 8281 EUR for MDD per patient utilizing services. With mean total annual costs per patient of 4636 EUR versus 2020 EUR 1 year preceding index diagnosis, 7478 EUR versus 3638 EUR in the year after index diagnosis, and 11,817 EUR versus 6058 EUR 2 years after index diagnosis, BPD patients incurred markedly higher costs. Since the treatment of BPD causes incremental costs for the German health care system compared to the treatment of MDD, and since both conditions are associated with a high level of suffering, there is a need for establishing adequate and early treatment of these mental disorders.

Purpose Paroxysmal atrial fibrillation (PAF) often remains undiagnosed. Long-term surface ECG is used for screening, but has limitations. Esophageal ECG (eECG) allows recording high quality atrial signals, which were used to identify markers for PAF. Methods In 50 patients (25 patients with PAF; 25 controls) an eECG and surface ECG was recorded simultaneously. Partially A-V blocked atrial runs (PBARs) were quantified, atrial signal duration in eECG was measured. Results eECG revealed 1.8‰ of atrial premature beats in patients with known PAF to be PBARs with a median duration of 853 ms (interquartile range (IQR) 813-1836 ms) and a median atrial cycle length of 366 ms (IQR 282-432 ms). Even during a short recording duration of 2.1 h (IQR 1.2–17.2 h), PBARs occurred in 20% of PAF patients but not in controls (p = 0.05). Left atrial signal duration was predictive for PAF (72% sensitivity, 80% specificity). Conclusions eECG reveals partially blocked atrial runs and prolonged left atrial signal duration – two novel surrogate markers for PAF.

Objective Surgical treatment of mitral leaflet prolapse using artificial neochordae shows excellent outcomes. Upcoming devices attempt the same treatment in a minimally invasive way but target the left ventricular apex as an anchoring point, rather than the tip of the corresponding papillary muscle. In this study, cine cardiac magnetic resonance imaging was used to compare these 2 different anchoring positions and their dynamic relationship with the mitral leaflets. Methods Eleven healthy volunteers (mean age, 31 years; 6 female; mean ejection fraction, 62%) were examined by cardiac magnetic resonance imaging (3 Tesla, cine steady free precession technique with retrospective gating), whereby dedicated software enabled assessment of the physiologic distances among 3 anchoring sites (anterior papillary muscle, posterior papillary muscle, and apex) and the plane of the mitral annulus at the level of leaflet coaptation. These distances were measured in systole and diastole, and the performance of virtual neochordae was analyzed for the 3 potential anchoring sites. Results Length difference between systole and diastole for the 3 measured distances were 0.19 ± 0.11 cm (5.9% ± 3.4%) for the anterior papillary muscle, 0.19 ± 0.09 cm (6.7% ± 3.6%) for the posterior papillary muscle, and 1.52 ± 0.18 cm (17.8% ± 2.8%) for the left ventricular apex ( P = .001). Virtual neochordae between the leaflet and the left ventricular apex were first adjusted in systole to achieve leaflet coaptation. Leaflet tear in diastole can only be avoided if the width of the attached leaflet is larger than the systole–diastole length difference. On the other hand, if virtual neochordae are adjusted in diastole to avoid leaflet tear, residual leaflet prolapse during systole can result. Because the systole–diastole length difference for papillary muscle anchored chordae is smaller than for apical chordae by a factor 10, there is a strongly reduced risk of prolapse or tearing and the leaflet width is unimportant. Furthermore, if the neochordae attached to the anterior mitral leaflet uses the apex as a distal anchoring site, the angle α between the aortic valve plane and this mitral leaflet is significantly reduced in diastole and therefore increases the risk of systolic anterior motion. Conclusions Anchoring of neochordae at the papillary muscles, thereby mimicking the real anatomy, should be preferred over the left ventricular apex. Further analysis of dilated hearts and papillary muscle displacement is necessary to include the whole spectrum of pathologies.

Iatrogenic free wall cardiac perforation is a rare but serious complication encountered during percutaneous cardiac procedures, which usually leads to tamponade and death. Septal occluder devices have been developed for sealing intracardiac shunts but may be also used in this emergency setting.We report a small series of five consecutive cases of iatrogenic heart perforations that were treated with implantation of Amplatzer Septal Occluders (ASO). In the first case, iatrogenic left ventricle (LV) perforation occurred during LV biopsy and could be closed up with a 4 mm ASO. In the second case, a 4 mm ASO was used for sealing of a right atrial perforation allocated to Port-a-Cath dislodgment. The third case happened during transseptal puncture for implantation of a TandemHeart bVAD device in a patient suffering cardiogenic shock and was treated by implantation of a 5 mm ASO. The fourth patient was transferred to our facilities for percutaneous closure of an acute post-infarct VSD after anteroseptal myocardial infarction. This procedure was complicated by perforation of the posterolateral free wall and led to the deployment of 12 mm ASO. The last patient suffered from free LV wall perforation during investigation of a severe aortic stenosis and was treated by implantation of 4 mm ASO. All patients were alive after 24 hrs but the last patient died during the in-hospital stay of a right ventricular infarction complicated by multiple organ failure.Percutaneous device occlusion of iatrogenic heart perforation seems to be a safe and efficient method to treat iatrogenic heart perforation. In order to perform this elegant method, it is however imperative not to prematurely withdraw the perforating catheter to maintain access to the hole for closure.

Introduction: Diagnosing arrhythmias by conventional Holter-ECG can be cumbersome because of artifacts, skin irritation and poor P-waves. In contrast, esophageal electrocardiography (eECG) is promising due to the anatomic relationship of the esophagus to the atria and its favorable bioelectric properties. Methods used: In an ambulant setting, we recorded eECGs from 10 volunteers with a novel, highly-miniaturized eECG recorder that is worn discretely behind the ear (1.5×1.8×5cm, 22grams). The device continuously records two eECG leads during 3 days with 500Hz sampling frequency and 24-bit resolution. Results: Mean ± SD recording time was 21.7±19.6 hours (max. 60 hours). Test persons were not limited in daily activities (e.g. eating, speaking) and only complained mild discomfort during probe insertion, which subsided later on. During 99.8% of time, the recorder acquired signals appropriate for further analysis. In unfiltered data, QRS complexes and P-waves were identifiable during >98% of time. P waves had higher amplitudes as compared to surface ECG (0.71 ± 0.42mV vs. 0.16 ± 0.03mV, p = 0.004). No complications occurred. Conclusion: Ambulatory eECG recording is safe, well tolerated and promising due to excellent P-wave detection, overcoming some limitations of conventional Holter ECG.

Unprotected left main (ULM) coronary artery disease is encountered in 3%-10% of coronary angiograms and is associated with high mortality. The survival of patients with ULM disease presenting with acute coronary syndromes (ACS) depends on different variables and is lowest in those with cardiogenic shock (CS). The aim of the present study was to estimate the impact of baseline characteristics on the subsequent clinical outcome in patients treated by percutaneous coronary intervention (PCI) of ULM for ACS.One hundred and thirty-four patients were retrieved from our database and followed by phone or physician visit. Patients were classified into two groups according to their presentation (CS/STEMI group: patients presenting with CS or ST-elevation myocardial infarction; NSTEMI/UA group: patients with non-STEMI or unstable angina). Data collected were baseline characteristics, procedural information, and clinical outcome. The primary endpoint was all-cause mortality at 6-month follow-up. The secondary end point was a composite of cardiac death, myocardial infarction, and any repeat revascularisation, i.e., major adverse cardiac events (MACE). Kaplan-Meier curves were computed for survival. Logistic regression determined that hypercholesterolaemia (OR 6.22, p=0.03), high pre-procedural TIMI score (OR 3.89, p=0.01), preserved left ventricular ejection fraction (OR 1.07, p=0.01) and LM as culprit lesion (OR 8.57, p=0.01) protected against development of CS. Primary outcome occurred in 44% of patients in the CS/STEMI group compared to 6% in the NSTEMI/UA group (p0.001). MACE were observed in 30 patients (48%) of the CS/STEMI group and in 12 patients (19%) of the NSTEMI/UA group (p=0.001).Acute coronary syndrome due to critical ULM stenosis is associated with high mortality even after successful PCI. Patients presenting with CS or STEMI are at particular risk.

Background— Long-term comparative data of first-generation drug-eluting stents are scarce. We investigated clinical and angiographic outcomes of sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) at 5 years as part of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) LATE study. Methods and Results— A total of 1012 patients were randomly assigned to SES or PES. Repeat angiography was completed in 444 of 1012 patients (43.8%) at 5 years. Major adverse cardiac events occurred in 19.7% of SES- and 21.4% of PES-treated patients (hazard ratio, 0.89; 95% confidence interval, 0.68 to 1.17; P =0.39) at 5 years. There were no differences between SES and PES in terms of cardiac death (5.8% versus 5.7%; P =0.35), myocardial infarction (6.6% versus 6.9%; P =0.51), and target lesion revascularization (13.1% versus 15.1%; P =0.29). Between 1 and 5 years, the annual rate of target lesion revascularization was 2.0% (95% confidence interval, 1.4% to 2.6%) for SES and 1.4% (95% confidence interval, 0.9% to 2.0%) for PES. Among patients undergoing paired angiography at 8 months and 5 years, delayed lumen loss amounted to 0.37±0.73 mm for SES and 0.29±0.59 mm for PES ( P =0.32). The overall rate of definite stent thrombosis was 4.6% for SES and 4.1% for PES ( P =0.74), and very late definite stent thrombosis occurred at an annual rate of 0.65% (95% confidence interval, 0.40% to 0.90%). Conclusions— Long-term follow-up of first-generation drug-eluting stents shows no significant differences in clinical and angiographic outcomes between SES and PES. The continuous increase in late lumen loss in conjunction with the ongoing risk of very late stent thrombosis suggests that vascular healing remains incomplete up to 5 years after implantation of first-generation drug-eluting stents. Clinical Trial Registration— http://www.clinicaltrials.gov . Unique identifier: NCT00297661.

Objectives This study sought to compare the efficacy of passive stent coating with titanium-nitride-oxide (TiNO) with drug-eluting stents releasing zotarolimus (ZES) (Endeavor, Medtronic, Minneapolis, Minnesota). Background Stent coating with TiNO has been shown to reduce restenosis compared with bare-metal stents in experimental and clinical studies. Methods In an assessor-blind noninferiority study, 302 patients undergoing percutaneous coronary intervention were randomized to treatment with TiNO or ZES. The primary endpoint was in-stent late loss at 6 to 8 months, and analysis was by intention to treat. Results Both groups were well balanced with respect to baseline clinical and angiographic characteristics. The TiNO group failed to reach the pre-specified noninferiority margin for the primary endpoint (in-stent late loss: 0.64 ± 0.61 mm vs. 0.47 ± 0.48 mm, difference: 0.16, upper 1-sided 95% confidence interval [CI]: 0.26; pnoninferiority = 0.54), and subsequent superiority testing was in favor of ZES (psuperiority = 0.02). In-segment binary restenosis was lower with ZES (11.1%) than with TiNO (20.5%; psuperiority = 0.04). A stratified analysis of the primary endpoint found particularly pronounced differences between stents among diabetic versus nondiabetic patients (0.90 ± 0.69 mm vs. 0.39 ± 0.38 mm; pinteraction = 0.04). Clinical outcomes showed a similar rate of death (0.7% vs. 0.7%; p = 1.00), myocardial infarction (5.3% vs. 6.7%; p = 0.60), and major adverse cardiac events (21.1% vs. 18.0%, hazard ratio: 1.19, 95% CI: 0.71 to 2.00; p = 0.50) at 1 year. There were no differences in rates of definite or probable stent thrombosis (0.7% vs. 0%; p = 0.51) at 1 year. Conclusions Compared with TiNO, ZES was superior with regard to late loss and binary restenosis. The concept of passive stent coating with TiNO remains inferior to drug-eluting stent technology in reducing restenosis. ([TIDE] Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent: NCT00492908 )

Objectives This study sought to compare the unrestricted use of everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary intervention. Background It is unclear whether there are differences in safety and efficacy between EES and SES during long-term follow-up. Methods Using propensity score matching, clinical outcome was compared among 1,342 propensity score–matched pairs of patients treated with EES and SES. The primary outcome was a composite of death, MI, and target vessel revascularization. Results The median follow-up was 1.5 years with a maximum of 3 years. The primary outcome occurred in 14.9% of EES- and 18.0% of SES-treated patients up to 3 years (hazard ratio [HR]: 0.83, 95% confidence interval [CI]: 0.68 to 1.00, p = 0.056). All-cause mortality (6.0% vs. 6.5%, HR: 0.92, 95% CI: 0.68 to 1.25, p = 0.59) was similar, risks of myocardial infarction (MI) (3.3% vs. 5.0%, HR: 0.62, 95% CI: 0.42 to 0.92, p = 0.017), and target vessel revascularization (7.0% vs. 9.6%, HR: 0.75, 95% CI: 0.57 to 0.99, p = 0.039) were lower with EES than SES. Definite stent thrombosis (ST) (HR: 0.30, 95% CI: 0.12 to 0.75, p = 0.01) was less frequent among patients treated with EES. The reduced rate of MI with EES was explained in part by the lower risk of definite ST and the corresponding decrease in events associated with ST (HR: 0.25, 95% CI: 0.08 to 0.75, p = 0.013). Conclusions The unrestricted use of EES appears to be associated with improved clinical long-term outcome compared with SES. Differences in favor of EES are driven in part by a lower risk of MI associated with ST.

Background: Coronary collaterals protect myocardium jeopardized by coronary artery disease (CAD). Promotion of collateral circulation is desirable before myocardial damage occurs. Therefore, determinants of collateral preformation in patients without CAD should be elucidated. Methods: In 106 patients undergoing coronary angiography who were free of coronary stenoses, a total of 39 clinical test variables were collected. The coronary collateral flow index (CFI) was measured. Stepwise multiple linear regression analysis was performed after choosing a restricted number of candidates emerging from univariate testing. Separate multiple regression analyses were performed in patients with and without beta-blocker therapy. Results: Nine parameters were found to be possible determinants of CFI by univariate analysis: arterial hypertension (aHT), dyslipidemia, statins, diuretics, age, height, heart rate (HR), pulse pressure amplitude, and left ventricular end-diastolic pressure (LVEDP). After multiple regression analysis, a low HR, absence of aHT, and elevated LVEDP were significantly related to CFI (F = 5.31, p = 0.002, adjusted r2 = 0.12). In patients without beta-blockers, a low HR and absence of aHT were independent predictors of CFI (F = 8.03, p < 0.001, n = 50, adjusted r2 = 0.30). Conclusions: A low HR and absence of aHT are both related to collateral preformation in humans. We suppose that bradycardia favors fluid shear stress in coronary arteries, thus triggering collateral growth.

Background Although rare, iatrogenic left main coronary artery (LM) dissection is a feared complication of coronary catheterization. Its incidence, optimal therapeutic management, and prognosis remain largely unknown. The aim of the present study was to estimate the incidence, characterize the population at risk, depict the initial management, and evaluate the long-term prognosis of iatrogenic LM dissection. Methods Thirty-eight patients who fulfilled the National Heart, Lung, and Blood Institute diagnostic criteria for iatrogenic LM dissection were retrieved from our database and followed up by telephone or physician visit. The primary end point was freedom from major adverse cardiac events (MACE) at 5 years. Results The overall incidence of iatrogenic LM dissection during the study period was 0.07% (38/51,452 patients) and almost twice as common with percutaneous coronary intervention than coronary angiography. From 38 patients, 1 (3%) patient died before any therapeutic attempt was performed, 6 (16%) patients were treated conservatively, and 31 (82%) patients underwent stent implantation and/or coronary artery bypass grafting (CABG). In-hospital outcome was favorable irrespective of the therapeutic strategy. During the 5-year follow-up, among 31 patients who underwent revascularization treatment by stenting or CABG, one patient died in each group from a cardiac cause, and MACE were observed in 12 patients (39%). Kaplan-Meier cumulative survival estimates showed no significant difference between different revascularization treatment strategies. Conclusions Iatrogenic LM dissection is a rare complication of cardiac catheterization procedures with favorable early and long-term outcome when recognized timely and managed properly.