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).

[Necrotizing esophagitis by stress-cardiomyopathy with right ventricular insufficiency]. / Nekrotisierende Ösophagitis bei Stresskardiomyopathie mit Rechtsherzversagen.

Acute necrotizing esophagitis ("black esophagus") is defined as complete necrosis of the esophageal mucosa, which typically affects the entire circumference. We report a case of a healthy 62-year-old woman, who became hemodynamically unstable due to stress cardiomyopathy with acute right heart failure. Transfusion-dependent anemia occurred 24 h later and an upper gastrointestinal endoscopy revealed a black discoloured mucosa of the distal esophagus. After hemodynamic stabilization and treatment with proton pump inhibitors and sucralfate, complete healing of the esophageal mucosa was achieved.

[ICD therapy in the primary prevention of sudden cardiac death: Risk stratification and patient selection]. / ICD-Therapie zur Primärprävention des plötzlichen Herztodes : Risikostratifikation und Patientenselektion.

Without the concept of primary prevention of sudden cardiac death, therapy with implantable defibrillators would not have reached the current distribution and clinical importance. Most of the scientific evidence of the concept is based on clinical studies from 1996-2005. More than 75 % of all defibrillator implantations are currently indicated as primary prevention. Implantable converter-defibrillator (ICD) therapy in the primary prevention of sudden cardiac death was incorporated into scientific guidelines starting in 1998. The historical development of the indications for ICD therapy in the primary prevention of sudden cardiac death is presented, reflecting major results of controlled, randomized clinical studies and guideline discussions.

Variations of heart rate variability parameters prior to the onset of ventricular tachyarrhythmia and sinus tachycardia in ICD patients. Results from the heart rate variability analysis with automated ICDs (HAWAI) registry.

The HAWAI registry evaluated the role of heart rate variability in predicting the occurrence of ventricular tachycardia and fibrillation (VT/VF) and sinus tachycardia in patients with an implantable cardioverter-defibrillator (45 patients with 155 RR recordings). A significant decrease of the mean value of all RR intervals (MeanNN) was observed in the period starting 20 and 40 min prior to VT/VF and sinus tachycardia, respectively. The standard deviation of RR intervals (SDNN) and the power at low frequency (LF) were the only parameters with significant changes prior to VT/VF. For sinus tachycardia, the root mean square of successive differences of all successive RR intervals (r-MSSD) and the power at low and high frequency (HF) decreased, whereas SDNN and the power at very low frequency increased. Comparison of RR recordings preceding VT/VF and sinus tachycardia revealed significant differences of the MeanNN, SDNN, r-MSSD, LF and HF. Based on a classification and regression tree analysis, MeanNN, SDNN and r-MSSD showed a sensitivity of 94.4% and a specificity of 50.6% as predictors of VT/VF. Our results suggest that the temporal changes in heart rate before an arrhythmic event can be used to predict the occurrence of VT/VF. These parameters may be used to optimize pacing therapies designed to prevent VT/VF recurrences as well as for improving device-based discriminators for VT/VF and sinus tachycardia.

[A rare cause of syncope in a patient treated with the TASH procedure]. / Seltene Ursache einer Synkope bei einem Patienten nach TASH-Behandlung.

In patients with hypertrophic cardiomyopathy (HOCM), the decision for an implantable cardioverter-defibrillator (ICD) depends highly on the exact identification of the etiology of syncope. In this article, the case of a patient with HOCM and syncope is reported. Invasive pressure measurement was used to diagnose a typical case of cough syncope as the cause of the syncope.

Diastolic filling pattern and left ventricular diameter predict response and prognosis after cardiac resynchronisation therapy.

OBJECTIVE: To investigate predisposing factors for cardiac resynchronisation therapy (CRT) response. DESIGN: Single-centre study. SETTING: University hospital in Germany. PATIENTS: 122 consecutive patients with heart failure (mean (SD) age 65 (11) years; ischaemic/non-ischaemic 41%/55%; New York Heart Association (NYHA) class 3.1 (0.3); left ventricular ejection fraction 24.4 (8.1)%; QRS width 170 (32) ms, quality of life (QoL) 43.5 (19.2)) with an indication for CRT and demonstrated left ventricular dyssynchrony by echocardiography including tissue Doppler imaging. INTERVENTIONS: Besides laboratory testing of clinical variables, results of ECG, echocardiography including tissue Doppler imaging, invasive haemodynamics, measures of QoL and of exercise capacity were obtained before CRT implantation and during follow-up. MAIN OUTCOME MEASURE: Responders were predefined as patients with improvement by one or more NYHA functional class or reduction of left ventricular end-systolic volume by 10% or more during follow-up. Mean (SD) follow-up was 418 (350) days. RESULTS: Overall, 70.5% of patients responded to CRT. Responders had a significantly improved survival compared with non-responders (96.2% vs 45.5%, log-rank p<0.001). On univariate analysis, left ventricular end-diastolic diameter, left ventricular end-systolic diameter (LVESD), E/A ratio, a restrictive filling pattern, mean pulmonary artery pressure, pulmonary capillary pressure, N-terminal pro-brain natriuretic peptide and Vo(2)max were significant predictors of outcome. On multivariate analyses, LVESD (p = 0.009; F = 7.83), pulmonary capillary pressure (p = 0.015, F = 6.61) and a restrictive filling pattern (p = 0.026, F = 5.707) remained significant predictors of response. CONCLUSIONS: Despite treatment according to present guidelines nearly 30% of patients had no benefit from CRT treatment in a clinical setting. On multivariate analyses, patients with an increased left ventricular end-systolic diameter and concomitant diastolic dysfunction had a significantly worse outcome.

Transvenous ICD implantation after artificial tricuspid valve replacement. A new approach placing a transvenous ICD lead in the mid cardiac vein of the coronary sinus.

Implantation of a transvenous device in patients with a tricuspid valve replacement or a complex congenital heart disease with no access to the right ventricle represents problems. The lack of access to the right ventricle might preclude transvenous placement of a defibrillation lead at ICD implantation. A young patient (21 years) with a history of severe chest trauma with rupture of the tricuspid valve as well as the right coronary artery and consecutive inferior myocardial infarction was initially treated with tricuspid valve replacement (St Jude Medical artificial prosthesis, 33 mm) and a bypass graft to the right coronary artery. Four years later, the patient was admitted with a hemodynamically not tolerated ventricular tachycardia (VT: CL 250 ms, LBBB, left axis). The VT could be reproduced during electrophysiological testing. An ICD was implanted subpectorally in combination with a transvenous active fixation ICD lead. The transvenous ICD lead was placed via a guiding catheter into a coronary sinus branch (middle cardiac vein). Acceptable pacing and sensing values could be obtained. The defibrillation threshold was 25 J. In conclusion transvenous ICD lead implantation into a side branch of the coronary sinus in combination with a pectorally implanted "active can" ICD device seems to be an alternative approach. This approach may avoid implantation of additional subcutaneous defibrillation leads or even thoracotomy for ICD implantation.

[Cardiac resynchronization therapy and arrhythmias]. / Kardiale Resynchronisationstherapie und Arrhythmien.

Cardiac resynchronization therapy (CRT) is now considered an established therapy for patients with chronic heart failure in the presence of a wide QRS complex. Though proarrhythmic effects have been described in a few cases, CRT did not increase the frequency of ventricular tachyarrhythmias in prospective studies. In patients on CRT therapy, persistent atrial fibrillation sometimes converts back to sinus rhythm, possibly dependent on the duration of atrial fibrillation.

Stroke volume and mitral annular velocities. Insights from tissue Doppler imaging.

The aim of this study was to assess the impact of stroke volume (SV) on mitral annular velocities derived from tissue Doppler imaging (TDI). To this end, conventional echocardiographic variables and TDI derived mitral annular velocities (S', E', A') were obtained in 14 patients (pts) with increased SV (due to primary mitral (n=12) (ISV group)), in 41 pts with reduced SV (due to ischemic (n=27) or dilated cardiomyopathy (n=9) or hypertensive heart disease (n=5) (RSV group)) and 29 asymptomatic controls with normal SV (CON group). Systolic (S') and early diastolic (E') mitral annular velocities were elevated in the ISV group in the comparison to the CON group, but were significantly reduced in the RSV group. Late diastolic annular velocities (A') did not differ between the ISV and the CON group, but were lowest in the RSV group. On simple linear regression analysis, SV was significantly related to S' (r=0.74, p<0.001), to E' (r=0.74, p<0.001) and to A' (r=0.43, p<0.01). On multiple regression analysis, SV was a stronger independent predictor of S' and E' than conventional systolic or diastolic echocardiographic variables. Thus, stroke volume has a significant impact on TDI derived systolic (S') and early diastolic (E') mitral annular velocities. This should be considered, when TDI is used in the evaluation of LV performance or in the estimation of filling pressures.

QRS duration: a simple marker for predicting cardiac mortality in ICD patients with heart failure.

BACKGROUND: Patients resuscitated from ventricular tachyarrhythmias benefit from implantable cardioverter-defibrillators (ICDs) as opposed to medical treatment. Patients with increased QRS duration receiving an ICD in the presence of heart failure are at greatest risk of cardiac death and benefit most from ICD therapy. OBJECTIVE: To determine whether an increased QRS duration predicts cardiac mortality in ICD recipients. DESIGN: Consecutive patients with heart failure in New York Heart Association functional class III were grouped according to QRS duration (< 150 ms, n = 139, group 1; v > or = 150 ms, n = 26, group 2) and followed up for (mean (SD)) 23 (20) months. PATIENTS: 165 patients were studied (80% men, 20% women); 73% had coronary artery disease and 18% had dilated cardiomyopathy. Their mean age was 62 (10) years and mean ejection fraction (EF) was 33 (14)%. They presented either with ventricular tachycardia (VT) or ventricular fibrillation (VF). MAIN OUTCOME MEASURES: Overall and cardiac mortality; recurrence rates of VT, fast VT, or VF. RESULTS: Mean left ventricular EF did not differ between group 1 (33 (13)%) and group 2 (31 (15)%). Forty patients died (34 cardiac deaths). There was no difference in survival between patients with EF > 35% and < or = 35%. Cardiac mortality was significantly higher in group 2 than in group 1 (31.3% at 12 months and 46.6% at 24 months, v 9.5% at 12 months and 18.2% at 24 months, respectively; p = 0.04). The recurrence rate of VT was similar in both groups. CONCLUSIONS: Within subgroups at highest risk of cardiac death, QRS duration-a simple non-invasive index-predicts outcome in ICD recipients in the presence of heart failure.

Defibrillation efficacy comparing a subcutaneous array electrode versus an "active can" implantable cardioverter defibrillator and a subcutaneous array electrode in addition to an "active can" implantable cardioverter defibrillator: results from active can versus array trials I and II.

INTRODUCTION: Placement of implantable cardioverter defibrillators (ICDs) has been simplified by using the shell of a pectorally implanted ICD as a defibrillation electrode in combination with an endocardial right ventricular defibrillation lead. However, a sufficiently low defibrillation threshold (DFT) cannot be obtained in a few patients. Therefore, alternative approaches were systematically tested in the Active Can versus Array Trial (ACAT). METHODS AND RESULTS: In the first of two prospective randomized studies, the DFT of a subcutaneous left dorsolateral array anode introduced from a pectoral incision was compared to that of a standard active can anode in 68 patients. Intraoperatively, the DFT was determined twice in each patient using either the active can or, in patients with a subcutaneous array lead, once with all three fingers and once omitting the middle finger of the array. The second prospective randomized study included 40 patients. DFT also was determined twice in each patient using an active can in a left pectoral position as anode alone and combined with a left dorsolateral array electrode with two fingers. In ACAT I, stored energy at DFT decreased from 13.1+/-7.7 J (active can) to 9.6+/-6.1 J (three-finger array lead) (P = 0.04), impedance decreased from 53+/-8 ohms to 40+/-6 ohms (P < 0.0001). Omitting the middle finger of the array lead, stored energy at DFT increased by 0.9 J (P = 0.47) and impedance by 2 ohm (P < 0.0001). In ACAT II, DFT and impedance using an active can device were significantly lower when a two-finger array lead was added that decreased stored energy at DFT from 10.1+/-5.2 J to 6.9+/-3.9 J (P = 0.001) and impedance from 56+/-5 1 to 42+/-5 l (P < 0.0001). CONCLUSION: In combination with a right ventricular defibrillation electrode, a left pectoral subcutaneous array lead improves defibrillation efficacy if used instead of, or in addition to, a left pectoral active can ICD device. Implantation of the array lead can be simplified by using two instead of three fingers, without a significant loss of defibrillation efficacy.

Implantation of a dual chamber pacing and sensing single pass defibrillation lead.

Dual-chamber ICDs are increasingly used to avoid inappropriate shocks due to supraventricular tachycardias. Additionally, many ICD patients will probably benefit from dual chamber pacing. The purpose of this pilot study was to evaluate the intraoperative performance and short-term follow-up of an innovative single pass right ventricular defibrillation lead capable of bipolar sensing and pacing in the right atrium and ventricle. Implantation of this single pass right ventricular defibrillation lead was successful in all 13 patients (age 63 +/- 8 years; LVEF 0.44 +/- 0.16; New York Heart Association [NYHA] 2.4 +/- 0.4, previous open heart surgery in all patients). The operation time was 79 +/- 29 minutes, the fluoroscopy time 4.7 +/- 3.1 minutes. No perioperative complications occurred. The intraoperative atrial sensing was 1.7 +/- 0.5 mV, the atrial pacing threshold product was 0.20 +/- 0.14 V/ms (range 0.03-0.50 V/ms). The defibrillation threshold was 8.8 +/- 2.7 J. At prehospital discharge and at 1-month and 3-month follow-up, atrial sensing was 1.9 +/- 0.9, 2.1 +/- 0.5, and 2.7 +/- 0.6 mV, respectively, (P = NS, P < 0.05, P < 0.05 to implant, respectively), the mean atrial threshold product 0.79, 1.65, and 1.29 V/ms, respectively. In two patients, an intermittent exit block occurred in different body postures. All spontaneous and induced ventricular arrhythmias were detected and terminated appropriately. Thus, in a highly selected patient group, atrial and ventricular sensing and pacing with a single lead is possible under consideration of an atrial pacing dysfunction in 17% of patients.

Antitachycardia pacing for rapid VT during ICD charging: a method to prevent ICD shocks.

In patients with ICDs, rapid VTs are usually treated with shocks. It is unknown, if antitachycardia pacing (ATP) delivered once for rapid VT during capacitor charging can avoid painful shocks without increasing the risk of syncope. In patients in whom rapid monomorphic VT (cycle length 300-220 ms) could be reproducibly induced during predischarge ICD testing, the success of cardioversion (defibrillation threshold plus 10 J) and a single ATP attempt (burst with 8 or 16 stimuli) was compared using a randomized crossover study design. Consciousness of the patients was checked by the signal from a button constantly pushed by the patient. In 20 patients (ejection fraction 0.50 +/- 0.19) rapid VTs (253 +/- 26 ms) were reproducibly induced. A single burst successfully terminated 11 (55%) of 20 rapid VTs, 6 episodes could not be terminated with a single burst pacing and 3 VTs accelerated. Rapid VTs not terminated by ATP were significantly faster than those that could be terminated (246 vs 258 ms, P = 0.026). Cardioversion (19 +/- 3 J) terminated the VTs in all cases. No patient suffered syncope during rapid VTs. A single ATP may terminate rapid VT with cycle lengths < 300 ms in 55% of patients without increasing the risk of syncope. Therefore, in rapid VTs one attempt of ATP may be suitable as an additional therapy option during ICD capacitor charging to avoid painful shocks without compromise of safety. Thus, future ICDs should implement the option of ATP during charging of capacitors.

Nonthoracotomy implantable cardioverter defibrillator placement in children: use of subcutaneous array leads and abdominally placed implantable cardioverter defibrillators in children.

INTRODUCTION: The need to access the right ventricle might preclude transvenous placement of a defibrillation lead at implantable cardioverter defibrillator (ICD) placement, especially in small children or children with complex congenital heart defects. We investigated a subcutaneous array lead in addition to an abdominally placed "active can" ICD device in two children to avoid a thoracotomy. METHODS AND RESULTS: The first child (age 12 years, 138 cm, 41 kg) had transposition of the great arteries with a subsequent surgical intra-atrial correction by the Mustard technique. The second child (age 14 years, 161 cm, 54 kg) had a single atrium and a single ventricle, d-transposition of the aorta, and atresia of the main pulmonary artery with a surgical anastomosis between the aorta and the right pulmonary artery by the Cooley technique. The defibrillation threshold was 18 J and <20 J at initial implantation and at generator replacement in the first patient and 20 J in the second patient. During follow-up of 6 years and 1 month, respectively, no ICD-related complications occurred. CONCLUSION: In children in whom endocardial, right ventricular placement of a defibrillation lead is precluded, defibrillation is possible and safe between an abdominally placed "active can" ICD device and a subcutaneous array lead. This approach may avoid a thoracotomy in children with no possibility for transvenous ICD placement.

Long-term anticoagulation with recombinant hirudin in a patient on left ventricular assist device support.

We report on a 24 year old man with a Novacor left ventricular assist device (LVAD) who underwent long-term treatment with intravenous recombinant hirudin due to a heparin induced thrombocytopenia (HIT II) after suffering from an ischemic stroke.

Is there a need for routine testing of ICD defibrillation capacity? Results from more than 1000 studies.

AIMS: Benefits and complications of postoperative implantable cardioverter-defibrillator tests are controversial matters. This study sought to assess the necessity of defibrillation function tests after implantation. METHODS AND RESULTS: We retrospectively analysed 1007 implantable cardioverter-defibrillator tests in 587 systems and 556 patients. Nine hundred and thirty implantable cardioverter-defibrillator tests (89.4%) were routinely performed. Seventy-one tests (7%) were performed after a change in the antiarrhythmic drug regimen and six tests (0.60%) because of a suspected dysfunction of the implantable cardioverter-defibrillator. During routine tests, four systems (0.4%) failed to defibrillate the patient. However, in all but one test, abnormalities of the system had been observed before the test. After the addition of antiarrhythmic drugs, two of 71 implantable cardioverter-defibrillator systems (2.8%) failed to defibrillate the patient. One of six systems tested due to a suspected dysfunction failed to defibrillate the patient. During 16 tests (1.6%), complications occurred. CONCLUSIONS: Our experience demonstrates that postoperative tests of the defibrillation function of implantable cardioverter-defibrillators rarely reveal dysfunctions. As testing is unpleasant for the patient and not free of complications, tests might be restricted to those patients in whom a dysfunction is suspected and to those patients in whom class I or class III antiarrhythmic drugs have been added to the antiarrhythmic drug regimen.

Fractally coated defibrillation electrodes: is an improvement in defibrillation threshold possible?

AIMS: In patients with implantable cardioverter-defibrillators (ICD), the goals of lowering the defibrillation threshold (DFT) can be achieved by means of higher defibrillation safety margins, more rapid charging of capacitors, improved battery longevity, implying smaller devices. Whether an increase in the electrically active surface of ICD leads by fractal coating results in decreased DFTs is unknown. METHODS AND RESULTS: In this prospective randomized cross-over study the defibrillation efficacy of a novel right ventricular endocardial defibrillation electrode fractally coated with iridium was compared with an uncoated but otherwise identical electrode in 30 patients undergoing ICD implantation. In each patient, DFT testing was performed twice according to a binary search protocol introducing the two different electrodes in a random order. The mean DFT was 8.4 +/- 4.1 J with the fractally coated lead and 9.6 +/- 3.6 J using the uncoated lead. The improvement of 1.2 J was statistically not significant (P = 0.11). No differences were observed between the patients with an improved DFT (n =12) and those with an unchanged or worsened DFT (n = 18) concerning age, underlying cardiac disease, NYHA class, or left ventricular ejection fraction, respectively. CONCLUSION: Increasing the electrical surface of defibrillation leads by fractal coating does not lead to a substantial clinically relevant reduction in defibrillation thresholds. Defibrillation impedance is not influenced by the increased electrical surface of the defibrillation lead.

Metallothionein: localization in human transplant endomyocardium, relation to cytokines and allograft function.

BACKGROUND: The aim of this study was to investigate the role of metallothionein in cardiac transplants in relation to cytokines and allograft function. Recent studies have revealed an association of allograft dysfunction with elevated proinflammatory cytokines independent of cellular rejection. In animal experiments, cytokines induced overexpression of metallothionein, a low-molecular-weight protein implicated in cellular stress response. METHODS: In 105 consecutive biopsies from 15 patients during the first 3 months after heart transplantation, metallothionein expression was investigated immunohistochemically. Its relation to serum interleukin-6, tumor necrosis factor-alpha, interleukin-2 (IL-2), soluble interleukin-2 receptor rejection, and echocardiographic parameters was determined. Forty-three biopsies of 12 patients with idiopathic ventricular tachycardia served as controls. RESULTS: Metallothionein expression was demonstrated in small vessels, cardiomyocytes, fibrocytes, and interstitial round cells. A positive relation between interleukin-6 levels and the number of metallothionein-positive small vessels (p < 0.028) was observed. Patients with lower serum IL-2 levels showed significantly higher numbers of metallothionein-positive small vessels (p < 0.043). Grafts with prolonged ischemic time (>150 minutes) showed a significantly higher myocardial metallothionein score (p < 0.021). Metallothionein expression was associated with lower fractional shortening, larger left ventricular end-systolic diameter, and lower mean arterial pressure but not with acute cellular rejection. CONCLUSIONS: Metallothionein expression is associated with elevated interleukin-6 and decreased interleukin-2 serum levels and left ventricular allograft dysfunction in the absence of rejection.