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Background: Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications., Methods: We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting., Results: Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001)., Conclusions: The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.)., (Copyright © 2023 Massachusetts Medical Society.)

The Apple Watch is capable of recording single-lead electrocardiograms (ECGs). To incorporate such devices in routine medical care, the reliability of such devices to obtain precordial leads needs to be validated. The purpose of this study was to assess the feasibility and reliability of a smartwatch (SW) to obtain precordial leads compared to standard ECGs. We included 100 participants (62 male, aged 62.8 ± 13.1 years) with sinus rhythm and recorded a standard 12-lead ECG and the precordial leads with the Apple Watch. The ECGs were quantitively compared. A total of 98 patients were able to record precordial leads without assistance. A strong correlation was observed between the amplitude of the standard and SW-ECGs' waves, in terms of P waves, QRS-complexes, and T waves (all p -values < 0.01). A significant correlation was observed between the two methods regarding the duration of the ECG waves (all p -values < 0.01). Assessment of polarity showed a significant and a strong concordance between the ECGs' waves in all six leads (91-100%, all p -values < 0.001). In conclusion, 98% of patients were able to record precordial leads using a SW without assistance. The SW is feasible and reliable for obtaining valid precordial-lead ECG recordings as a validated alternative to a standard ECG.

Introduction: The European CRT Survey II was introduced to offer insights into CRT implantation practice in Europe. We compared the national data from the participating German centres with that of the other European countries with regard to differences in patient selection, implant results, and initial properties., Methods and Results: 11,088 patients were enrolled in 288 centres from 42 countries between 2015 and 2017. Of these, 675 (6.1%) were included in 17 centres in Germany. Patients from Germany were older, had more comorbidities and more symptoms of heart failure (HF) than patients from other European countries. There were no differences with regard to HF aetiology and guideline-directed medical treatment was overall well implemented. There was a high use of CRT in patients with atrial fibrillation, even higher in German patients. CRT was most often applied due to HF with wide QRS complex (class I recommendation) but with relatively higher frequency in Germany due to HF with primary indication for an implantable cardioverter-defibrillator (class IIb) or a pacemaker with expected pacing dependency (class I). The overall implant success rate was high with some differences in the implant procedure. The use of remote monitoring was lower in Germany., Conclusion: This analysis from the European CRT Survey II overall shows good guideline adherence, high implantation success and a low rate of complications in daily practice. There are some regional differences in baseline characteristics, CRT indication, and procedural aspects. The use of remote monitoring in Germany lags behind other European countries.

The specification of standard operating procedures (SOPs) is a basic requirement for a successful implementation of telemonitoring with implanted cardiac devices and with external measuring devices in patients with heart failure, cardiac arrhytmia or increased risk of sudden cardiac death. The following article summarizes the possibilities of telemonitoring from a technical and organizational point of view and descibes basic requirements on SOPs. these basic requirements should be further specified and anchored in the organizational structure of the individual telemonitoring concept. Moreover, they should de understood as a basic guideline fpr the actions of telemonitoring center (TMC) employees.

Aims: Cardiovascular magnetic resonance (CMR) imaging has long been a contraindication for patients with a cardiac implantable electronic device (CIED). Recent studies support the feasibility and safety for non-thoracic magnetic resonance imaging, but data for CMR are sparse. The aim of the current study was to determine the safety in patients with magnetic resonance (MR)-conditional or non-MR-conditional CIED and to develop a best practice approach., Methods and Results: All patients with a CIED undergoing CMR imaging (1.5 T) between April 2014 and April 2017 were included in the study. Devices were programmed according to the standardized protocol directly before and after the CMR examination. Follow-up interrogation was performed 6 months after CMR examination. Results were compared with a large, reference cohort of CIED patients not undergoing any MR examination. A total of 200 consecutive patients with a CIED (non-MR-conditional, n = 103) were included in the study. Directly after CMR imaging, one device failure (0.5%, battery status = end of service) was noted necessitating premature generator replacement. In three patients (2%) of pacemaker/implantable cardioverter-defibrillator (ICD) carriers a sustained ventricular tachycardia (VT) occurred during CMR imaging. Ten ICD showed a decrease in battery capacity immediately after CMR. Overall, the reference cohort showed comparable changes of CIED function during follow-up., Conclusion: With adherence to a standardized protocol and established exclusion criteria CMR imaging could safely be performed in patients with a CIED. The potential risks of device malfunction necessitate the presence of a device trained individual during the entire CMR examination. If there is a history of VT storm the attendance of an experienced cardiologist, should be mandatory., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Clinicians accept that there are many unknowns when we make diagnostic and therapeutic decisions. Acceptance of uncertainty is essential for the pursuit of the profession: bedside decisions must often be made on the basis of incomplete evidence. Over the years, physicians sometimes even do not realize anymore which the fundamental gaps in our knowledge are. As clinical scientists, however, we have to halt and consider what we do not know yet, and how we can move forward addressing those unknowns. The European Heart Rhythm Association (EHRA) believes that scanning the field of arrhythmia / cardiac electrophysiology to identify knowledge gaps which are not yet the subject of organized research, should be undertaken on a regular basis. Such a review (White Paper) should concentrate on research which is feasible, realistic, and clinically relevant, and should not deal with futuristic aspirations. It fits with the EHRA mission that these White Papers should be shared on a global basis in order to foster collaborative and needed research which will ultimately lead to better care for our patients. The present EHRA White Paper summarizes knowledge gaps in the management of atrial fibrillation, ventricular tachycardia/sudden death and heart failure., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Aims: The objective of this study was to verify acute safety, performance, and usage of a novel ultra-high density mapping system in patients undergoing ablation procedure in a real-world clinical setting., Methods and Results: The TRUE HD study enrolled patients undergoing catheter ablation with mapping for all arrhythmias (excluding de novo atrial fibrillation) who were followed for 1 month. Safety was determined by collecting all serious adverse events and adverse events associated with the study devices. Performance was determined as the composite of: ability to map the arrhythmia/substrate, complete the ablation applications, arrhythmia termination (where applicable), and ablation validation. Use of mapping system in the ablation validation workflow was also evaluated. Among the 519 patients who underwent a complete (504) or attempted (15) procedure, 21 (4%) serious ablation-related complications were collected, with 3 (0.57%) potentially related to the mapping catheter. Four hundred and twenty treated patients resulted in a successful procedure confirmed by arrhythmia-specific validation techniques (83.3%; 95% confidence interval: 79.8-86.5%). A total of 1419 electroanatomical maps were created with a median acquisition time of 9:23 min per map. Of these, 372 maps in 222 (44%) patients were collected for ablation validation purposes. Following validation mapping, 162/222 (73%) patients required additional ablation., Conclusion: In the TRUE HD study mapping was associated with rates of acute success and complications consistent with previously published reports. Importantly, a low percentage of events (0.57%) was attributed to the mapping catheter. When performed, validation mapping was useful for identifying additional targets for ablation in the majority of patients., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Sudden cardiac death (SCD) is a leading cause of death. The advent of the implantable cardioverter‑defibrillator (ICD) has revolutionized prevention of SCD in high‑risk patients with underlying cardiac diseases. However, several challenges remain. Identification of patients at risk who should receive an ICD is suboptimal, and the sole criterion applied in clinical practice is a severely reduced left ventricular ejection fraction despite the fact that SCD occurs mostly in patients with preserved or mildly reduced ejection fraction. Additionally, the majority of patients that do receive the ICD will not benefit from the device at the end. Therefore, improved risk stratification approaches to guide selection of patients for ICD implantation are definitely needed. There are several novel features and developments in the field with the subcutaneous defibrillator being probably the most important one and having the potential to substantially influence clinical practice. The role of catheter ablation of ventricular tachycardia, and particularly the potential to abolish the need for ICD implantation at least in selected patient groups, should be further defined. Internists and general practitioners play a significant role in the management of ICD patients, from identification of candidates for ICD implantation to early detection and appropriate treatment of complications.

Background: Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical routine. Left atrial (LA) electro-anatomical remodelling in AF patients indicates disease progression and is associated with poor therapeutic success. PR interval prolongation is associated with an increased risk for AF, however, the association between LA remodelling measured as low voltage areas (LVA) during catheter ablation and PR interval is unknown. The aim of this study was to investigate the association between PR interval prolongation and LVA in AF patients., Methods: We studied 103 patients (62±12 years, 59% males, 34% persistent AF) undergoing first AF catheter ablation and presenting with sinus rhythm. PR interval prolongation was defined as PR >200ms and analysed in resting ECG before intervention. LVA were determined using high-density maps and defined as <0.5 mV., Results: There were 24 patients (23%) with PR interval prolongation and 18 patients (17%) with LVA. There were significant correlations between PR prolongation with LVA, CHA2DS2-VASc score and eGFR (r2 = 0.230, 0.216, and 0.307, all p<0.05). PR interval prolongation (OR 3.450, p = 0.024), persistent AF (OR 5.391, p = 0.002), and LA size (OR 1.117, p = 0.018) were significant predictors for LVA, while age (OR 1.072, p = 0.005), LVA (OR 3.450 p = 0.024) and eGFR (OR 0.962, p = 0.004) were associated with PR interval prolongation., Conclusions: Beside persistent AF and LA size, PR interval prolongation might be useful for the prediction of electro-anatomical substrate in AF patients. Larger studies are needed to confirm these results., Competing Interests: The authors have declared that no competing interests exist.

Current guidelines recommendations, based on the results of primary sudden cardiac death prevention trials, use the left ventricular ejection fraction (LVEF) as a sole criterion for the indication of implantable cardioverter defibrillator therapy for primary prevention purposes. In this article, we review the sensitivity and specificity of LVEF for predicting arrhythmic vs. non-arrhythmic cardiac death and examine existing evidence on the use of electrophysiology testing for risk stratification of ischaemic patients with reduced left ventricular function.

Aims: To prospectively determine evaluability of routine cardiovascular magnetic resonance (CMR) diagnostic modules in a referral population of implanted rhythm device all-comers, and to establish a device-dependent CMR imaging strategy to achieve optimal image quality., Methods and Results: One hundred and twenty-eight patients with cardiac implantable electronic devices [insertable cardiac monitoring system, n = 14; implantable loop-recorder, n = 21; pacemaker, n = 31; implantable cardioverter-defibrillator (ICD), n = 50; and cardiac resynchronization therapy defibrillator (CRT-D), n = 12] underwent clinically indicated CMR at 1.5 T. CMR protocols were tailored to the clinical indication and consisted of cine, perfusion, T1-/T2-weighted, late-gadolinium enhancement (LGE), 3D angiographic, and post-contrast cine spoiled gradient echo (SGE) scans. Image quality was determined using a 4-grade visual score per myocardial segment. Segmental evaluability was strongly influenced by device type and location with the highest proportion of non-diagnostic images encountered in the presence of ICD/CRT-D systems. Cine steady-state free-precession (SSFP) imaging was found to be mostly non-diagnostic in ICD/CRT-D patients, but a significant improvement of image quality was demonstrated when using SGE sequences with a further incremental improvement post-contrast resulting in an overall four-fold higher likelihood of achieving good image quality. LGE scans were found to be non-diagnostic in about one-third of left-ventricular segments of ICD/CRT-D patients but were artefact-free in > 94% for all other device types., Conclusion: Device type and location constitute the main independent predictors of CMR image quality and thus, need to be considered during protocol adaptation. Most notably, post-contrast SGE cine imaging proved superior to conventionally used SSFP sequences. Thus, following the proposed device-dependent CMR imaging strategy, diagnostic image quality can be achieved in the majority of device patients.

Arrhythmia recurrences after catheter ablation of atrial fibrillation (AF) cause intensive treatment costs. Left atrial electro-anatomical remodeling measured as low voltage areas (LVA) during catheter ablation indicates advanced disease stage and is associated with poor ablation success. The aim of this study was to analyze the prediction of LVA and arrhythmia recurrences using APPLE, DR-FLASH and MB-LATER scores. APPLE, DR-FLASH scores were calculated at baseline and MB-LATER at 3 months post-ablation in AF patients undergoing first catheter ablation. LVA was determined using high-density maps and defined as <0.5 mV. Early (ERAF, <3 months) and late (LRAF, 3-12 months) were analyzed during follow-up. The study population included 241 patients (age 64 ± 11 years, 59% males, 59% persistent AF, 27% LVA, 27% LRAF). LVA were significantly associated with recurrences (OR 2.081, p = 0.026). While on univariable analysis, all scores were significantly associated with LVA, on multivariable analysis only APPLE (OR 1.789, p < 0.001) and DR-FLASH (OR 2.144, p < 0.001) remained significant predictors. However, MB-LATER (OR 1.445, p = 0.034) and ERAF (OR 5.078, p < 0.001) remained associated with LRAF on the multivariable analysis. These results were validated in a subgroup of 873 patients (age 61 ± 10, 63% males, 39% persistent AF, 34% LRAF, 27% LVA) from The Leipzig Heart Center AF Ablation Registry. All scores were significantly associated with recurrences. However, ERAF was the most powerful predictor for later rhythm outcomes. Summarizing, a clinical score useful for prediction for both LVA and rhythm outcomes in AF patients remains a clinical unmet need.

Aims: Dual coil (DC) electrodes are preferred to single coil (SC) electrodes because of an assumed higher shock efficacy. However, DC-electrodes may be associated with an increased difficulty and risk of lead extraction. We aimed to compare SC- and DC-electrodes with respect to the first shock efficacy (FSE) after implantable cardioverter defibrillator (ICD) implantation., Methods and Results: One thousand and seventy-seven patients of the NORDIC ICD trial were randomly assigned to first time ICD implantation with or without defibrillation (DF) testing. The electrode configuration was determined before randomization. One thousand and sixty-seven patients eventually received an ICD, 516 (48.4%) with a SC- and 551 (51.6%) with a DC-electrode. DC-electrodes were preferentially selected in older patients, renal failure, atrial fibrillation, dual chamber, Cardiac Resynchronization Therapy (CRT) devices, angiotensin-converting-enzyme (ACE) inhibitors/angiotensin (AT) receptor blockers and without Sotalol. However, the preference of the investigational site was dominant over clinical parameters. The DF energy at the final electrode position was higher in SC-electrodes (adjusted difference +1.15 J; P = 0.005; only patients tested). Less patients with DC-electrodes required intra-operative system reconfiguration (adjusted difference -3.9; P = 0.046; only patients tested). Using mixed logistic regression, the FSE was 92.6% in SC- and 97.8% in DC-electrodes (adjusted odds ratio 4.3 (95% confidence interval [1.9, 9.8]; P < 0.001))., Conclusion: Dual coil-electrode selection mainly depends on the preference of the investigational site and seems to be preferred in older patients, renal failure, atrial fibrillation, dual chamber, and CRT devices. Patients with DC-electrodes required less intraoperative system reconfigurations. Dual coil-electrodes provided a substantially higher FSE during follow-up. Mortality rates were not significantly different in patients with DC- and SC-electrodes.

Aims: Cardiac magnetic resonance (CMR) imaging in patients with implanted cardiac devices is often limited by device-related imaging artefacts. Limitations can potentially be overcome by employing a broadband late gadolinium enhancement (LGE)-CMR imaging technique. The purpose of this study was to investigate the relationship between implanted cardiac devices and the optimal frequency offset on broadband LGE-CMR imaging to increase the artefact-free visibility of myocardial segments., Methods and Results: A phantom study was performed to characterize magnetic field disturbances related to 15 different cardiac devices. This was complemented by B0 and B1+ imaging of three different device types in four healthy volunteers. Findings were validated in 28 patients with an indication for arrhythmogenic substrate characterization before catheter ablation. In the phantom study, the placement of a PM, implantable cardioverter-defibrillator (ICD) or CRT-D generator led to a significant impairment of the radiofrequency field. B0 mapping in phantom and volunteers showed the highest off-resonance maximum with CRT-D systems with the maximum off-resonance significantly decreasing for ICD or PM systems, respectively. In all patients, with conventional LGE imaging 73.1% (61.5-92.3%) of LV segments were free of device-related artefacts, while with the broadband LGE technique, a significant increase of artefact-free segments was achieved [96.4% (85.7-100%); P = 0.00008]., Conclusion: Using a modified broadband sequence for LGE imaging significantly increased the number of artefact-free myocardial segments thereby leading to improved diagnostic value of the CMR exam. Since the occurrence and extent of hyperintensity artefacts are closely related to the individual device, more studies are warranted to evaluate if the results can be extrapolated to other devices and manufacturers.

Background: A new implantable cardiac monitor (BioMonitor, Biotronik) with a continuous remote monitoring option was prospectively implanted in patients with suspected arrhythmias or for therapy control after atrial fibrillation (AF) ablation. A three-lead ECG detection was intended to make the implantation more independent of the implantation site and the electrical heart axis. Because noise is a frequent problem in implantable cardiac monitors, an active noise detection algorithm was implemented. The aim of the trial was to evaluate the clinical performance of the device., Methods: The device performance was evaluated in a prospective nonrandomized multicenter study with a follow-up of 12 months. Study endpoints were device-related serious adverse events at 3 months, appropriate QRS detection in direct comparison with synchronized Holter ECG recordings, sensitivity and positive predictive value of arrhythmia detection in comparison with Holter ECG and independent of it, and noise burden during the entire follow-up period., Results: The implantation was successful in all 152 patients. Two device-related serious adverse events (pocket infections) occurred by 3 months. The mean QRS amplitude of 0.3 ± 0.2 mV at implantation remained stable over 12 months. QRS sensing performance indicated little over- and undersensing in most patients. More than 80 % of the patients had more than 22 h of noise-free monitoring per day., Conclusion: BioMonitor effectively detects patients with bradycardia, tachycardia, AF, or asystole. Active noise detection seems to reduce the transmission of meaningless data without diminishing the positive predictive value of the device.

Aims: The aim of this analysis was to provide comprehensive information on invasive cardiac arrhythmia therapies in the European Society of Cardiology (ESC) area over the past 10 years., Methods and Results: The European Heart Rhythm Association (EHRA) has collected data on invasive arrhythmia therapies since 2008. This year 53 of the 56 ESC member countries provided data for the EHRA White Book. Here we present updated data on procedure rates together with information on demographics, economy, vital statistics, local healthcare systems and training activities. Considerable heterogeneity in the access to invasive arrhythmia therapies still exists across the five geographical ESC regions. In 2016, the device implantation rates per million population were 3-6 times higher in the Western region than in the non-European and Eastern ESC member countries. Catheter ablation activity was highest in the Western countries followed by the Northern and Southern areas. In the non-European countries, atrial fibrillation ablation rate was more than tenfold lower than in the European countries. On the other hand, the growth rate over the past ten years was highest in the non-European and Eastern countries. In some Eastern European countries with relative low gross domestic product the procedure rates exceeded the average values., Conclusion: It was encouraging to note that during the past decade the growth in invasive arrhythmia therapies was greatest in the areas historically with relatively low activity. Nevertheless, there is substantial disparity and continued efforts are needed to improve harmonization of cardiac arrhythmia therapies in the ESC area., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

Ventricle myocardial extensions (VMEs) from the right ventricular outflow tract to the pulmonary artery (PA) serve as arrhythmogenic foci for idiopathic ventricular arrhythmias (VAs). Although an autopsy study revealed the heterogeneity of the VME, only the electrocardiographic features of PA-VAs arising from septal VMEs have been discussed. Here, we describe a case of idiopathic PA-VAs conducting over a VME accompanied by unique ventricle activation patterns, which contributed to the appearance of an S wave in the inferior limb leads despite an arrythmogenic focus in the outflow tract., (© 2016 Wiley Periodicals, Inc.)

Aims: The aim of this analysis was to provide comprehensive information on the access to and use of cardiac implantable electronic device (CIED) and catheter ablation therapy in the European Society of Cardiology (ESC) area., Methods and Results: The European Heart Rhythm Association (EHRA) has been collecting descriptive and quantitative data on invasive arrhythmia therapies since 2008. This year 50 of the 56 ESC member countries provided data for the EHRA White Book. Up-to-date information on procedure rates for the last 5 years together with information on demographics, economy, vital statistics, local healthcare systems, and training activities is presented for each country and the 5 geographical ESC regions. Our analysis indicated that considerable heterogeneity in the access to arrhythmia therapies still exists across the ESC area. In 2015, the CIED implantation rates per million population were highest in the Western followed by the Southern and Northern European countries. The catheter ablation activity was largest in the Western followed by the Northern and Southern areas. Overall, the procedure rates were 3-10 times higher in the European than in the non-European ESC countries. Economic resources were not the only driver for utilization of arrhythmia therapies as in some Eastern European countries with relative low gross domestic product the procedure rates exceeded the average values., Conclusion: These data will help the healthcare professionals and stakeholders to identify and to understand in more depth the trends, disparities, and gaps in cardiac arrhythmia care and thereby promote harmonization of cardiac arrhythmias therapies in the ESC area., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Competing Interests: Potential Conflict of Interest J.S. has received consultant and/or speaker fees from Amgen, Astra-Zeneca, Atricure, Bayer, Biosense Webster, Biotronik, Boehringer-Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cook Medical, Daiichi Sankyo, Medtronic, Pfizer, Sanofi-Aventis, Sorin, St Jude Medical, and Zoll. J.S. is co-director von CorXL. He reports grant support through his institution from Bayer Healthcare, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and St Jude Medical. G.H. has received research grants from Biotronik, Boston Scientific, and St Jude Medical through the University Leipzig/Heart Center. P.J. reports consultancy honoraria and lecture fees from Biosense Webster, St. Jude Medical, and Boston Scientific; he reports stock options for Cardio Insight.

Introduction: Recently, an automatic, high-resolution mapping system has been presented to accurately and quickly identify right atrial geometry and activation patterns in animals, but human data are lacking. This study aims to assess the clinical feasibility and accuracy of high-density electroanatomical mapping of various RA arrhythmias., Methods and Results: Electroanatomical maps of the RA (35 partial and 24 complete) were created in 23 patients using a novel mini-basket catheter with 64 electrodes and automatic electrogram annotation. Median acquisition time was 6:43 minutes (0:39-23:05 minutes) with shorter times for partial (4.03 ± 4.13 minutes) than for complete maps (9.41 ± 4.92 minutes). During mapping 3,236 (710-16,306) data points were automatically annotated without manual correction. Maps obtained during sinus rhythm created geometry consistent with CT imaging and demonstrated activation originating at the middle to superior crista terminalis, while maps during CS pacing showed right atrial activation beginning at the infero-septal region. Activation patterns were consistent with cavotricuspid isthmus-dependent atrial flutter (n = 4), complex reentry tachycardia (n = 1), or ectopic atrial tachycardia (n = 2). His bundle and fractionated potentials in the slow pathway region were automatically detected in all patients. Ablation of the cavotricuspid isthmus (n = 9), the atrio-ventricular node (n = 2), atrial ectopy (n = 2), and the slow pathway (n = 3) was successfully and safely performed., Conclusions: RA mapping with this automatic high-density mapping system is fast, feasible, and safe. It is possible to reproducibly identify propagation of atrial activation during sinus rhythm, various tachycardias, and also complex reentrant arrhythmias., (© 2015 Wiley Periodicals, Inc.)

Aims: The aim was to provide comprehensive information on the use of cardiac implantable electronic device (CIED) and catheter ablation therapy in the European Society of Cardiology (ESC) area., Methods and Results: The European Heart Rhythm Association (EHRA) has collected data on use of invasive arrhythmia managements since 2008. Fifty-one of the 56 ESC member countries provided data for the EHRA White Book 2015. This analysis is based on the current and previous editions of the EHRA White Book. Up-to-date information on procedure rates for the last 5 years together with information on economic resources, reimbursement systems, and training requirements are presented for each country and the five geographical ESC regions. In 2014, the CIED implantation rates per million population were highest in the Western followed by the Southern and Northern European countries. The catheter ablation activity was largest in the Western followed by the Northern and Southern areas. Altogether the procedure rates were lowest in the Eastern European and in the non-European ESC countries. In the European ESC countries, the procedure rates were 3-10 times higher than in the non-European ESC countries. However, in some countries with a relatively low gross domestic product the procedure rates exceeded the average values indicating that utilization of arrhythmia therapies was not driven merely by the economic factors., Conclusion: This analysis indicates that considerable heterogeneity in the availability and utilization of arrhythmia therapies still exist across the ESC area. The data will hopefully aid in directing future activities and promote harmonization of cardiac arrhythmia care in the ESC countries., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

This review looks back at important and clinically relevant new developments in the fields of invasive electrophysiology and device therapy in 2014. Many findings do not only apply to pure electrophysiologists, but also to every clinical cardiologist’s practice. The authors have extracted the key findings of studies with potential guideline impact and put those into a clinical perspective. Looking back at the achievements of 2014 may instil enthusiasm for further scientific endeavours in the years to come!

It has now been more than a quarter of a century since modulation of the sympathetic nervous system was proposed for the treatment of cardiac arrhythmias of different origins. But it has also been some time since some of the early surgical attempts have been abandoned. With the development of ablation techniques, however, new approaches and targets have been recently introduced that have revolutionized our way of thinking about sympathetic modulation. Renal nerve ablation technology is now being successfully used for the treatment of resistant hypertension, but the indication spectrum might broaden and new therapeutic options might arise in the near future. This review focuses on the possible impact of renal sympathetic system modulation on cardiac arrhythmias, the current evidence supporting this approach, and the ongoing trials of this method in electrophysiological laboratories. We will discuss the potential roles that sympathetic modulation may play in the future., (© 2014 Wiley Periodicals, Inc.)

Real-time magnetic resonance imaging (MRI) combines the advantages of excellent soft-tissue characterization in a true 3D anatomical and functional model with the possibility of lesion and gap visualization without the need of any radiation. Therefore, real-time MRI presents a particularly attractive imaging technology to guide electrophysiology studies and catheter ablation procedures. This article aims to provide an overview on current routine clinical application of MRI in the setting of interventional electrophysiology. Furthermore, development of real-time MRI guided electrophysiology studies and first experiences with MRI guided catheter ablation procedures are depicted. In this context advantages, challenges and limitations of real-time MRI guided catheter ablation as well as future perspectives are discussed.

Aims: The rapidly increasing number of patients with implantable cardioverter-defibrillators (ICD) places a large burden on follow-up providers. This study investigated the possibility of longer in-office follow-up intervals in primary prevention ICD patients under remote monitoring with automatic daily data transmissions from the implant memory., Methods and Results: Conducted in 155 ICD recipients with MADIT II indications, the study compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (SF-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals in the period between 3 and 27 months after implantation. Remote monitoring (Biotronik Home Monitoring) was used equally in all patients. In contrast to previous clinical studies, no calendar-based remote data checks were performed between scheduled in-office visits. Compared with the 3-month follow-up interval, the 12-month interval resulted in a minor increase in the number of unscheduled follow-ups (0.64 vs. 0.27 per patient-year; P = 0.03) and in a major reduction in the total number of in-office ICD follow-ups (1.60 vs. 3.85 per patient-year; P < 0.001). No significant difference was found in mortality, hospitalization rate, or hospitalization length during the 2-year observation period, but more patients were lost to follow-up in the 12-month group (10 vs. 3; P = 0.04). The SF-36 scores favoured the 12-month intervals in the domains 'social functioning' and 'mental health'., Conclusion: In prophylactic ICD recipients under automatic daily remote monitoring, the extension of the 3-month in-office follow-up interval to 12 months appeared to safely reduce the ICD follow-up burden during 27 months after implantation., Clinicaltrialsgov Identifier: NCT00401466 (http://www.clinicaltrials.gov/ct2/show/NCT00401466).

Exercise-related palpitations, vertigo, and syncope may be caused by benign etiologies but can also herald life-threatening arrhythmias. The precise diagnosis of these findings is therefore essential and potentially life saving but often is a challenge for sports physicians and cardiologists. Leadless, ambulatory HR monitors with chest strap transmitters have been designed to steer exercise intensity in athletes with a baseline sinus rhythm. However, they also can capture arrhythmias. Presented here are three cases of varying arrhythmias: atrial fibrillation, atrioventricular nodal reentrant tachycardia, and ectopic atrial tachycardia that demonstrate the utility of HR monitors designed for athletic purposes in facilitating the diagnosis of arrhythmias and guiding appropriate treatment.

Aims: Magnetic resonance imaging (MRI) in the context of electrophysiology (EP) studies facilitates visualization of complex three-dimensional anatomy and the underlying arrhythmogenic substrate, real-time passive visualization of catheters, atrial and ventricular function and complications, as well as lesion visualization during the ablation without radiation. In the following we report on our first experience of a real-time MRI-guided EP study demonstrating current possibilities and drawbacks., Methods and Results: Five consecutive patients (one male, four female; mean age 66 ± 11 years) with symptomatic arrhythmias, three patients with highly symptomatic typical atrial flutter, presented to our hospital for isthmus ablation, one patient for an EP study and one for slow pathway ablation in atrioventricular node re-entry tachychardia. The four ablations were performed successfully in a conventional EP laboratory and complete bidirectional isthmus block was confirmed in three patients with atrial flutter. After the procedure in the EP laboratory all five patients were transferred to a 1.5 T whole-body MRI scanner (Intera) for a diagnostic EP procedure. Two MRI compatible steerable diagnostic/ablation catheters (Vision) were inserted via the femoral sheaths and manipulated by an experienced electrophysiologist using a commercially available interactive real-time steady-state free precession sequence (repetition time = 3 ms, echo time = 1 ms, flip angle = 35°, slice thickness = 10 mm, frame rate = 8/s). All catheters could be placed successfully in the right atrium and ventricle, confirmed by intracardiac electrograms, using passive catheter tracking. Furthermore, simple programmed stimulation maneuvers were performed. During and after the procedure, no adverse effects were observed in any patients., Conclusion: To our knowledge, this is the first series of patients with real-time MRI-guided placement of multiple catheters with subsequent performance of stimulation maneuvers. Besides the mentioned benefits, this technology still encounters several limitations, which have to be solved before application in a routine clinical setting. Challenges arise from delineation of precise surface electrocardiogram recordings in the MRI setting along with intracardiac electrograms, easier handling and visualization of catheters, facilitation of immediate defibrillation in the MRI setting and implementation of an active catheter tracking system.

Conventional fluoroscopy is the main technology for intracardiac device tracking in interventional cardiovascular procedures. For therapy delivery it carries the advantage of being able to instantaneously localize the device and its spatial relationship with respect to the moving target organ. However, besides the associated X-ray exposure, fluoroscopy only provides 2D orientation. For treatment of complex cardiac anatomies and substrates such as in interventional electrophysiology, 3-D mapping technologies have been introduced to facilitate spatial, anatomic, and electrical orientation. A new technological platform (MediGuide(™)) offers the option to continuously display the catheter tip on a prerecorded cine-loop allowing better anatomic understanding of the underlying substrate. We describe our initial experience using the system with diagnostic catheters only and the first procedures with the MediGuide(™) equipped ablation catheter (available since May 2012). We could show a significant decrease of fluoroscopy time in all types of procedures with comparable procedure times. No increase in complication rates was observed.

Background: Electrophysiologic characteristics, mapping strategies, and acute success rates of radiofrequency catheter ablation of atriofascicular accessory pathways are well described. However, data on long-term prognosis and predictors for freedom from arrhythmias are lacking., Objective: To report our 20-year single-center experience on ablation of atriofascicular fibers., Method: Between 1992 and 2010, 34 patients with atriofascicular accessory pathways underwent catheter ablation at our institution because of symptomatic antidromic atrioventricular reentrant tachycardias. Radiofrequency procedures were retrospectively analyzed, and patients were followed for recurrences of tachyarrhythmias. Electrocardiograms (before and after ablation and at follow-up) were analyzed for each patient., Results: Successful catheter ablation of the atriofascicular fiber was achieved in 23 (68%) patients. Mechanical block during mapping occurred in 3 (9%) patients, and in 2 of them ablation was performed at the site of mechanical block. Mere modification of conduction properties of the pathway without complete block was achieved in 5 patients (15%). Fast pathway ablation was performed in 2 (6%) of the patients ablated in the early 1990s. During follow-up of 9.3 ± 5.5 years, 24 patients (71%) remained free of tachyarrhythmias, 7 reported significant improvement, and 3 (9%) had no change in symptoms after ablation. Long-term success was identical between patients from the first (1992-1999) and second (2000-2010) decade (12 of 17 [71%] vs 12 of 17 [71%]). It was 87% in those with complete block of the atriofascicular fiber while all patients with mechanical block during mapping reported recurrences. Fast pathway ablation was complicated by complete atrioventricular block in 1 patient, who required pacemaker implantation 18 years after ablation owing to loss of conduction properties of the atriofascicular fiber over the years. On analyzing patients with preexcitation before ablation (n = 16; 47%), we found that the PR interval after ablation was significantly longer only in those without recurrence (162 ± 21 ms vs 134 ± 21 ms; P = .042). None of the other analyzed electrocardiographic parameters, including PR, QRS duration, and preexcitation, had prognostic impact., Conclusion: Acute success of complete ablation of atriofascicular pathways is associated with excellent long-term success (87%). Mere modification of conduction properties of atriofascicular fibers or ablation at the sites of mechanical block are less promising end points of ablation with high recurrence rates. Technical innovations during decades may not further improve long-term outcome in these patients., (Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this multicenter study was to evaluate the device- and procedure-related safety of a novel force-sensing radiofrequency (RF) ablation catheter capable of measuring the real-time contact force (CF) and to present CF data and its possible implications on patient safety., Background: The clinical outcome of RF ablation for the treatment of cardiac arrhythmias may be affected by the CF between the catheter tip and the tissue. Insufficient CF may result in an ineffective lesion, whereas excessive CF may result in complications., Methods: Seventy-seven patients (43 with right-sided supraventricular tachycardia [SVT] and 34 with atrial fibrillation [AF]) received percutaneous ablation with the novel studied catheter. The CF applied and safety events related to the procedure were reported., Results: CF values at mapping ranged from 8 ± 8 to 60 ± 35 g and from 12 ± 10 to 39 ± 29 g in the SVT group and the LA group, respectively, showing a significant interinvestigator variability (P < .0001). High transient CFs (>100 g) were noted in 27 patients (79%) of the LA group. One device-related complication (tamponade, 3%) occurred in the AF group., Conclusions: Catheter ablation using real-time CF technology is safe for the treatment of SVT and AF. High CFs may occur during catheter manipulation and not just during ablation, suggesting that measuring CF may provide additional useful information to the operator for safe catheter manipulation. In the future, CF-sensing catheters may also increase the effectiveness of RF ablations by allowing better control of the RF lesion size., (Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

In the last decade, catheter ablation (CA) became a viable therapeutic approach for symptomatic patients with atrial fibrillation (AF) non-responsive to antiarrhythmic drugs (AAD). The economic analysis of CA is complex due to the presence of several confounding factors, such as the pattern of AF (paroxysmal AF, persistent or long-term persistent AF), the patient population (age, presence/absence of underlying structural heart disease, comorbidities, etc.), the different techniques for ablation (with impact on complexity and cost of the procedure, as well as on efficacy and safety), and the learning curve and experience of an individual centre (with impact on efficacy and cost effectiveness). At present, CA appears to be cost effective mainly in patients with paroxysmal AF who are refractory to AADs, especially if the success of the procedure and, thus, the benefit in quality of life remains >5 years, with a low complication rate. More data are needed on cost effectiveness of CA of persistent and long-term persistent AF or of AF associated with heart failure. Atrial fibrillation ablation is unlikely to be cost effective for patients who have preserved quality of life despite their AF or for patients whose quality of life is not expected to improve substantially despite elimination of AF (e.g. patients with poor quality of life mainly due to other health problems). These observations may help in the selection of candidates for AF ablation.

Objective: The purpose of this large multicenter study was to evaluate the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence of adverse events (AEs)., Background: A recent concern has been the performance of cardiac defibrillator leads. There have been conflicting reports regarding the rate of lead perforation and other AEs., Methods: Medical records from patients implanted from 6-1-2001 to 11-27-2007 with the St. Jude Medical Riata family of RV leads at 23 US (N = 12,969) and 5 German (N = 2,418) centers were reviewed for chronic lead-related AEs. These included perforation, dislodgment, conductor fracture and insulation damage. The mean follow-up period was 18.0 months. AEs were defined as those that required Riata lead revision, extraction, or replacement., Results: The incidence of lead AEs was <1% for each AE type. Perforation occurred in 0.38%, dislodgement in 0.93%, conductor fracture in 0.18%, and insulation damage in 0.21% of patients studied., Conclusions: During the follow-up of the 15,387 patients with Riata leads, the incidence of AEs which included perforation, dislodgement, conductor fraction and insulation damage was low and within the range of what is considered clinically acceptable.

Accurate understanding and visualization of the mechanisms of cardiac arrhythmias originating from a complex 3D substrate are a prerequisite for successful treatment of such disorders. Nonfluoroscopic cardiac mapping systems are designed to provide the required spatial anatomical information in combination with local electrical information. During recent years, the EnSite system, with its EnSite NavX navigation and visualization technology, and CARTO have evolved as the main representatives. EnSite Velocity is the latest released platform of the EnSite NavX technology. It represents an open system enabling 3D visualization of multiple intracardiac catheters from different manufacturers. Fusion algorithms and respiratory compensation allow for model-guided therapy with real-time nonfluoroscopic visualization of intracardiac catheters within registered 3D CT/MRI images.

Aims: Catheter ablation is a treatment of first choice for many arrhythmias. Data in geriatric patients are still limited, mostly focusing on single arrhythmia types. The aim of the study was to investigate characteristics of contemporary ablation therapy in the very elderly, focusing on patient characteristics, arrhythmia spectrum, and outcome in a large cohort., Methods and Results: We studied 131 consecutive patients aged 80 and older (mean age 83 +/- 3) undergoing ablation for any indication from 1998 until 2004. Sixty-eight patients (52%) had structural heart disease. Most common indications were typical atrial flutter (54%), atrioventricular nodal re-entrant tachycardia (AVNRT) (22%), and atrial fibrillation (AF) (18%). Patients with structural heart disease had more often atrial flutter (72 vs. 35%, P < 0.001) and less AVNRT (7 vs. 38%, P < 0.001) than those without structural heart disease. In almost all patients with AF, ventricular rate control was achieved by elimination of atrioventricular conduction and pacemaker implantation. Success rate exceeded 97% for all ablation types. There was one major complication (0.8%), a stroke after isthmus ablation., Conclusion: Almost half of the very elderly patients undergoing ablation have structural heart disease. Indications have changed significantly in recent years, typical atrial flutter is nowadays the predominant indication. The arrhythmia spectrum differs significantly between patients with and without structural heart disease. Regardless of the presence or absence of structural heart disease, success is excellent. Catheter ablation is an excellent therapy option for geriatric patients with arrhythmias.

Aims: The experience of using radiofrequency ablation (RFA) for the treatment of arrhythmias in children and adolescents is still limited. This study aimed to review the most recent results of RF ablation in children and adolescents in a highly experienced centre with access to both conventional techniques and non-fluoroscopic electroanatomic mapping (CARTO)., Methods and Results: A total of 154 consecutive patients younger than 19 years treated with RFA during the period 2000-04 were included. Numbers (%) or median (quartiles) are reported. Age was 15 (12-17) years, 70 (45%) were males. Five patients (3%) had congenital heart disease. RFA was successful in 147/154 patients (95%). Arrhythmia recurrence occurred in 11 patients (7%). Procedure time was 55 (35-90) min and fluoroscopy time was 8.8 (4-19) min. Number of RF applications was 4 (2-10) and number of RF applications >20 s was 2 (1-7). One patient (0.7%) had complicating high-grade atrioventricular block. CARTO was used in 18 RF ablation procedures (11%) performed in 15 patients., Conclusion: RF ablation can be undertaken in children and adolescents with a high success rate, few recurrences and complications, very short procedure times, and acceptable fluoroscopy times. Non-fluoroscopic electroanatomic mapping is helpful in selected patients.

This article discusses recent changes in antiarrhythmic therapy, with a focus on nonpharmacologic therapy (electrode catheter ablation, implantable cardioverter-defibrillators [ICDs]), and puts them into perspective for the coming years. The treatment of supraventricular tachycardias and tachycardia involving accessory pathways is likely to remain the domain of catheter ablation. With promising new techniques under investigation, the spectrum of arrhythmias that can be cured will probably be expanded. Treatment of life-threatening ventricular arrhythmias is likely to remain the domain of the ICD in the foreseeable future. With the safety net of the ICD in place, new antiarrhythmic drugs or other forms of antiarrhythmic therapy can be developed and tested.