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Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections. This article is simultaneously published also in Eur J Cardiothorac Surg. (https://doi.org/10.1093/ejcts/ezz296) and European Heart Journal (https://doi.org/10.1093/eurheartj/ehaa010). Minor differences in style may appear in each publication, but the article is substantially the same in each journal.

Background Magnetic resonance imaging (MRI) in patients with cardiac pacing devices has become available despite previously being considered absolutely contraindicated. However, most institutional safety protocols have included several limitations on patient selection, leaving MRI unavailable for many patients. Purpose To evaluate the first 1000 MRI examinations conducted on patients with cardiac pacing devices at Helsinki University Hospital for any potential safety hazards and also to evaluate the long-term functionality of the safety protocol in "real-life" clinical practice. Material and Methods A total of 1000 clinically indicated MRI scans were performed with a 1.5-T MRI scanner according to the safety protocol. The following information was collected from the electronic medical record (EMR): patients' date of birth; sex; pacing device generator model; date of MRI scan; date of the latest pacing device generator implantation; and the body region scanned. The EMR of these patients was checked and especially searched for any pacing device related safety hazards or adverse outcomes during or after the MRI scan. Results Only one potentially dangerous adverse event was noted in our study group. In addition, patients with abandoned leads, temporary pacing devices, and newly implanted pacing device generators were scanned successfully and safely. Conclusion MRI scans can be performed safely in patients with cardiac pacing devices if the dedicated safety protocol is followed.

Contains fulltext : 237469.pdf (Publisher’s version ) (Open Access) BACKGROUND: Pyridoxine monotherapy in PDE-ALDH7A1 often results in adequate seizure control, but neurodevelopmental outcome varies. Detailed long-term neurological outcome is unknown. Here we present the cognitive and neurological features of the Dutch PDE-ALDH7A1 cohort. METHODS: Neurological outcome was assessed in 24 patients (age 1-26 years); classified as normal, complex minor neurological dysfunction (complex MND) or abnormal. Intelligence quotient (IQ) was derived from standardized IQ tests with five severity levels of intellectual disability (ID). MRI's and treatments were assessed. RESULTS: Ten patients (42%) showed unremarkable neurological examination, 11 (46%) complex MND, and 3 (12%) cerebral palsy (CP). Minor coordination problems were identified in 17 (71%), fine motor disability in 11 (46%), posture/muscle tone deviancies in 11 (46%) and abnormal reflexes in 8 (33%). Six patients (25%) had an IQ > 85, 7 (29%) borderline, 7 (29%) mild, 3 (13%) moderate, and 1 severe ID. Cerebral ventriculomegaly on MRI was progressive in 11. Three patients showed normal neurologic exam, IQ, and MRI. Eleven patients were treated with pyridoxine only and 13 by additional lysine reduction therapy (LRT). LRT started at age

The relationship between developmental milestone achievement in infancy and later cognitive function and mental health is well established, but underlying biochemical mechanisms are poorly described. Our study aims to discover pathways connected to motor milestone achievement during infancy by using untargeted plasma metabolomic profiles from 571 six-month-old children in connection with age of motor milestones achievement (Denver Developmental Index) in the Copenhagen Prospective Studies on Asthma in Childhood 2010 (COPSAC2010) mother&ndash, child cohort. We used univariate regression models and multivariate modelling (Partial Least Squares Discriminant Analysis: PLS-DA) to examine the associations and the VDAART (Vitamin D Antenatal Asthma Reduction Trial) cohort for validation. The univariate analyses showed 62 metabolites associated with gross-motor milestone achievement (p &lt, 0.05) as well as the PLS-DA significantly differentiated between slow and fast milestone achievers (AUC = 0.87, p = 0.01). Higher levels of tyramine-O-sulfate in the tyrosine pathway were found in the late achievers in COPSAC (p = 0.0002) and in VDAART (p = 0.02). Furthermore, we observed that slow achievers were characterized by higher levels of fatty acids and products of fatty acids metabolism including acyl carnitines. Finally, we also observed changes in the lysine, histidine, glutamate, creatine and tryptophan pathways. Observing these metabolic changes in relation to gross-motor milestones in the first year of life, may be of importance for later cognitive function and mental health.

The purpose of this European Heart Rhythm Association (EHRA) survey is to provide an overview of the current use of leadless pacemakers (LLPM) across a broad range of European centres. An online questionnaire was sent to centres participating in the EHRA Electrophysiology Research Network. Questions dealt with standards of care and policies used for patient management, indications, and techniques of implantation of LLPM. In total, 52 centres participated in the survey. Most (86%) reported using LLPM, although 82% of these centres implanted < 30 LLPM devices during the last 12 months. Non-availability (36%), lack of reimbursement (55%), and cost of the device (91%) were factors limiting the use of LLPM. The most commonly reported indications for LLPM were permanent atrial fibrillation (83%), a history of complicated conventional pacemaker (87%), or an anticipated difficult vascular access (91%). Implantation of LLPM is perceived as an easy-to-do and safe procedure by most implanters (64%), while difficult or risky in 28%, and comparable to conventional pacemakers by only a few (8%). Local vascular complications were the most frequently reported major problems (28%), but a significant number of respondents (36%) have never encountered any issue after LLPM implantation. Although cost and reimbursement issues strongly influence the use of LLPM, most respondents (72%) anticipate a significant increase in device utilization within next 2 years.

This paper deals with the intrasystem electromagnetic interference (EMI) in a pacemaker equipped with a wireless power transfer (WPT) charging system. The WPT application to pacemakers is very new, and no results are yet published on possible EMI effects produced by the WPT coil currents in the pacemaker pacing leads. To this aim, an efficient and original co-simulation circuit/field method is proposed to predict the induced voltages on a pacing lead. In the numerical calculation, the pacemaker with WPT secondary coil and a pacing lead is implanted in a sophisticated human body model. The numerical results are validated by measurements showing a good agreement. The proposed approach would be a useful tool for pacemaker EMI compliance tests and safety assessment evaluations.

Background: Kidney transplant recipients (KTRs) with “operational tolerance” (OT) maintain a functioning graft without immunosuppressive (IS) drugs, thus avoiding treatment complications. Nevertheless, IS drugs can influence gene-expression signatures aiming to identify OT among treated KTRs. Methods: We compared five published signatures of OT in peripheral blood samples from 18 tolerant, 183 stable, and 34 chronic rejector KTRs, using gene-expression levels with and without adjustment for IS drugs and regularised logistic regression. Findings: IS drugs explained up to 50% of the variability in gene-expression and 20–30% of the variability in the probability of OT predicted by signatures without drug adjustment. We present a parsimonious consensus gene-set to identify OT, derived from joint analysis of IS-drug-adjusted expression of five published signature gene-sets. This signature, including CD40, CTLA4, HSD11B1, IGKV4–1, MZB1, NR3C2, and RAB40C genes, showed an area under the curve 0⋅92 (95% confidence interval 0⋅88–0⋅94) in cross-validation and 0⋅97 (0⋅93–1⋅00) in six months follow-up samples. Interpretation: We advocate including adjustment for IS drug therapy in the development stage of gene-expression signatures of OT to reduce the risk of capturing features of treatment, which could be lost following IS drug minimisation or withdrawal. Our signature, however, would require further validation in an independent dataset and a biomarker-led trial. Funding: FP7-HEALTH-2012-INNOVATION-1 [305147:BIO-DrIM] (SC,IR-M,PM,DSt); MRC [G0801537/ID:88245] (MPH-F); MRC [MR/J006742/1] (IR-M); Guy's&StThomas’ Charity [R080530]&[R090782]; CONICYT-Bicentennial-Becas-Chile (EN-L); EU:FP7/2007–2013 [HEALTH-F5–2010–260687: The ONE Study] (MPH-F); Czech Ministry of Health [NV19–06–00031] (OV); NIHR-BRC Guy's&StThomas' NHS Foundation Trust and KCL (SC); UK Clinical Research Networks [portfolio:7521].

Purpose: Implantable cardioverter defibrillators (ICDs) can treat life-threatening tachyarrhythmia with high-voltage shocks. The aims were to compare the efficacy of single and dual coil shock vectors in modern ICDs and to identify predictors of shock failure. Methods: This is a single-center paired randomized study including 216 patients with mixed indications and ICDs from four manufacturers. All patients underwent two implant defibrillation tests using single and dual coil vectors with the test order randomized. Tested shock energy differed slightly between manufacturers because of differences in device programmability: first shock approximately 15 J below maximal output—if failed, second shock approximately 10 J below maximal output—if failed, third shock at maximal output. Results: First shock success rate was 399/432 (92.4%). Comparing single and dual coil vectors, no differences were seen in first shock efficacy (91.7% vs. 93.1%, P = 0.629) or lowest tested succesfully stored energy (27.2 J vs. 27.1 J, P = 0.620). All successive internal shocks failed in 4/432 (0.9%) of inductions requiring external rescue shocks to restore circulation. Multivariate predictors of first shock failure were QRS duration (relative risk 0.81 per 10 ms, P = 0.001), amiodarone treatment (relative risk 3.30, P = 0.003), and body height (relative risk 1.70 per 10 cm, P = 0.019). Conclusions: Implant defibrillation testing of modern intravenous ICD systems demonstrates high shock efficacy with no difference between single and dual coil vectors.

Computational analysis has become ubiquitous within the heliophysics community. However, community standards for peer-review of codes and analysis have lagged behind these developments. This absence has contributed to the reproducibility crisis, where inadequate analysis descriptions and loss of scientific data have made scientific studies difficult or impossible to replicate. The heliophysics community has responded to this challenge by expressing a desire for a more open, collaborative set of analysis tools. This article summarizes the current state of these efforts and presents an overview of many of the existing Python heliophysics tools. It also outlines the challenges facing community members who are working towards the goal of an open, collaborative, Python heliophysics toolkit and presents guidelines that can ease the transition from individualistic data analysis practices to an accountable, communalistic environment., Comment: Published in JGR

Background Mitochondrial damage leading to oxidant stress may play an important role in the pathogenesis of airflow obstruction and emphysema. NLPR3 inflammasome can be activated by mitochondrial ROS (mtROS) and other stimuli. We examined the importance of mtROS and NLRP3 inflammasome and their interactions in multiple ozone-induced lung inflammation and emphysema. Methods C57/BL6 mice were exposed to ozone (2.5 ppm, 3 h) or filtered air twice a week over 6 weeks. MitoTEMPO (20 mg/kg), an inhibitor of mtROS, and VX765 (100 mg/kg), an inhibitor of caspase-1 activity, were administered by intraperitoneal or intragastric injection respectively 1 h prior to each ozone exposure for 6 weeks. Results Ozone-exposed mice had increased bronchoalveolar lavage (BAL) total cells and levels of IL-1β, KC and IL-6, augmented lung tissue inflammation scores, enhanced oxidative stress with higher serum 8-OHdG concentrations, emphysema with greater mean linear intercept (Lm), airway remodeling with increased airway smooth muscle mass and airflow limitation as indicated by a reduction in the ratio of forced expiratory volume at 25 and 50 milliseconds to forced vital capacity (FEV25/FVC, FEV50/FVC). Both MitoTEMPO and VX765 reduced lung inflammation scores, cytokine levels, oxidative stress and increased mitochondrial fission proteins. VX765 also attenuated emphysema, airway remodeling and airflow limitation. MitoTEMPO inhibited the increased expression of mitochondrial complex II and IV and of NLPR3 while VX765 inhibited the expression and activity of NLRP3 and caspase-1 pathway in the lung. Conclusions Both mtROS and NLRP3 inflammasome play a role in ozone-induced lung inflammation while only NLRP3 is involved in ozone-induced emphysema. Electronic supplementary material The online version of this article (10.1186/s12931-018-0931-8) contains supplementary material, which is available to authorized users.

In recent years an extension of devices longevity has been obtained for implantable cardioverter-defibrillators (ICDs), including ICDs for cardiac resynchronization therapy (CRT-D) through improved battery chemistry and device technology and this implies important clinical benefits (reduced need for device replacements and associated complications, particularly infections), as well as economic benefits, in line with patient preferences and needs. From a clinical point of view, the availability of this improvement in technology allows to better tune the choice of the device to be implanted, taking into account that the reasons supporting the value of an extended device longevity as a clinical priority may differ according to the clinical setting (purely electrical diseases or left ventricular dysfunction/heart failure, respectively). From an economic point of view, extension of device longevity may have an important impact in reducing long-term costs of device therapy, with substantial daily savings in favour of devices with extended longevity, up to 30%, depending on clinical scenarios. In studies based on projections, an extension of device longevity allowed to calculate that the cost per day of ICDs may be substantially reduced, and this allows to overcome the frequent perception of ICD and CRT-D devices as treatments with unaffordable costs and to overturn the misconception that up-front costs are the only metric with which to value device treatments. In view of its clinical and economic value, device longevity should be a determining factor in device choice by physicians and healthcare commissioners and should be appropriately considered and valued in comparative tenders. Sin financiación 5.047 JCR (2018) Q1, 30/136 Cardiac & Cardiovascular Systems 2.612 SJR (2018) Q1, 27/365 Cardiology and Cardiovascular Medicine, 7/108 Physiology (medical) No data IDR 2018 UEM

Congenital Zika virus (ZIKV) syndrome may cause fetal microcephaly in -1% of affected newborns. Here, we investigate whether the majority of clinically inapparent newborns might suffer from long-term health impairments not readily visible at birth. Infection of immunocompetent pregnant mice with high-dose ZIKV caused severe offspring phenotypes, such as fetal death, as expected. By contrast, low-dose (LD) maternal ZIKV infection resulted in reduced fetal birth weight but no other obvious phenotypes. Male offspring born to LD ZIKV-infected mothers had increased testosterone (TST) levels and were less likely to survive in utero infection compared to their female littermates. Males also presented an increased number of immature neurons in apical and basal hippocampal dendrites, while female offspring had immature neurons in basal dendrites only. Moreover, male offspring with high but not very high (storm) TST levels were more likely to suffer from learning and memory impairments compared to females. Future studies are required to understand the impact of TST on neuropathological and neurocognitive impairments in later life. In summary, increased sex-specific vigilance is required in countries with high ZIKV prevalence, where impaired neurodevelopment may be camouflaged by a healthy appearance at birth.

Background: ST segment depression (STD) and T wave inversion (TWI) are typical electrocardiographic (ECG) findings in non-ST elevation myocardial infarction (NSTEMI). In ST elevation myocardial infarction, ST changes represent transmural ischemia. The pathophysiological mechanisms of the ECG changes in NSTEMI are unclear. Purpose: We studied the associations between ECG and the echocardiographic findings in NSTEMI patients. Methods: Twenty patients with acute NSTEMI were recruited during their hospital stay. A comprehensive echocardiography study was performed. The findings were compared with blinded ECG analyses. Results: Nine (45%) patients had STD, and 16 (85%) patients had TWI. In multivariable analysis, STD was independently associated with a lower global early diastolic strain rate (beta=-5.061, p=0.033). TWI was independently associated with lower circumferential strain (beta=0.132, p =0.032). Conclusions: The typical ECG changes in NSTEMI patients were associated with subtle echocardiographic changes. STD was related to changes in diastolic function, and TWI was associated with systolic deterioration. (C) 2017 Elsevier Inc. All rights reserved.

Super-resolution fluorescence imaging techniques allow optical imaging of specimens beyond the diffraction limit of light. Super-resolution optical fluctuation imaging (SOFI) relies on computational analysis of stochastic blinking events to obtain a super-resolved image. As with some other super-resolution methods, this strong dependency on computational analysis can make it difficult to gauge how well the resulting images reflect the underlying sample structure. We herein report SOFIevaluator, an unbiased and parameter-free algorithm for calculating a set of metrics that describes the quality of super-resolution fluorescence imaging data for SOFI. We additionally demonstrate how SOFIevaluator can be used to identify fluorescent proteins that perform well for SOFI imaging under different imaging conditions. shorttitle: SOFIevaluator urldate: 2020-01-14 file: Submitted Version:/Users/peter/Zotero/storage/LTTQBTXF/Moeyaert et al. - 2020 - SOFIevaluator a strategy for the quantitative qua.pdf:application/pdf ispartof: Biomedical Optics Express vol:11 issue:2 pages:636-648 ispartof: location:United States status: published

We studied the presence of benign infantile epilepsy (BIE), paroxysmal kinesigenic dyskinesia (PKD), and PKD with infantile convulsions (PKD/IC) in patients with a 16p11.2 deletion including PRRT2 or with a PRRT2 loss-of-function sequence variant. Index patients were recruited from seven Dutch university hospitals. The presence of BIE, PKD and PKD/IC was retrospectively evaluated using questionnaires and medical records. We included 33 patients with a 16p11.2 deletion: three (9%) had BIE, none had PKD or PKD/IC. Twelve patients had a PRRT2 sequence variant: BIE was present in four (p = 0.069), PKD in six (p

Background: In acute coronary syndrome (ACS), ST-segment elevation (STE), often associated with a completely occluded culprit artery, is an important ECG criterion for primary percutaneous coronary intervention (PCI). However, several studies showed that in ACS a completely occluded culprit artery can also occur with a non-ST-elevation (NSTE) ECG. In order to elucidate reasons for this discrepancy we examined ST injury vector orientation and magnitude in ACS patients with and without STE, all admitted for primary PCI and having a completely occluded culprit artery.Methods: We studied the ECGs of 300 ACS patients (214/86 STE/NSTE; 228/72 single/multivessel disease) who had a completely occluded culprit artery during angiography prior to primary PCI. The J+60 injury vector orientation and magnitude were computed from Frank XYZ leads derived from the 10-s standard 12-lead ECG.Results: Demographic and anthropomorphic characteristics of the STE and NSTE patients did not differ. STE patients had a higher rate of right coronary artery occlusions, and a lower rate of left circumflex occlusions than NSTE patients (43 vs. 31%, and 13 vs. 22%, respectively; P Conclusion: STE criteria favor certain injury vector directions and larger injury vector magnitudes. Obviously, several ACS patients with complete culprit artery occlusions requiring primary PCI do not fulfill these criteria. Our study suggests that STE NSTE-based ACS stratification needs further enhancement. (C) 2014 Elsevier Inc. All rights reserved.

Introduction: To establish an up-to-date and comprehensive set of normal values for the clinically current measurements in the adult ECG, covering all ages for both sexes.Methods: The study population included 13,354 individuals, taken from four population studies in The Netherlands, ranging in age from 16 to 90 years (55% men) and cardiologically healthy by commonly accepted criteria. Standard 12-lead ECGs were available for all participants. The ECGs were processed by a well-validated computer program. Normal limits were taken as the 2nd and 98th percentiles of the measurement distribution per age group.Results: Our study corroborates many findings of previous studies, but also provides more differentiated results, in particular for the older age groups. Age trends were apparent for the QTc interval, QRS axis, and indices of left ventricular hypertrophy. Amplitudes in the left precordial leads showed a substantial increase in the older age groups for women, but not for men. Sex-dependent differences were apparent for most ECG parameters. All results are available on the Website www.normalecg.org, both in tabular and in graphical format.Conclusions: We determined age- and sex-dependent normal values of the adult ECG. Our study distinguishes itself from other studies by the large size of the study population, comprising both sexes, the broad range of ages, and the exhaustive set of measurements. Our results emphasize that most diagnostic ECG criteria should be age- and sex-specific. (C) 2014 Elsevier Inc. All rights reserved.

The implantation of cardiac pacemakers has become a well-established therapy for conduction disorders and sinus node dysfunction. In many countries pacemaker registries have been initiated in order to collect information on patient characteristics, trends in numbers and the types of pacemakers used, to identify problematic devices, and for safety monitoring. For this utilisation study the Central Pacemaker Patients Registration (CPPR) from the Netherlands Pacemaker Registry Foundation (CPPR-SPRN) containing data collected for more than 20 years was used. During this period nearly 97,000 first pacemakers were implanted. Analyses show an increase in the rate of implanted devices. The change in pacemaker type from VVI to DDD, followed by biventricular stimulation, is reflected by the number of simultaneously implanted leads, which is partly a consequence of cardiac resynchronisation therapy. Our data demonstrate that indications for implantation and type of pacemaker are comparable with other European countries.

RésuméBien que les indications d’implantation de pacemaker présentent de nombreuses similitudes entre enfants et adultes, il existe plusieurs particularités dans la population pédiatrique justifiant une approche spécifique. Le bloc auriculo-ventriculaire congénital, le bloc auriculo-ventriculaire postopératoire, la dysfonction sinusale, le syndrome bradycardietachycardie, le syndrome du QT long congénital et la resynchronisation biventriculaire constituent les principales indications d’implantation en pédiatrie. La caractéristique propre des jeunes patients est qu’ils seront stimulés sur une durée prolongée, impliquant : 1) une réflexion parfois difficile concernant la décision d’implanter un dispositif définitif de stimulation, d’autant qu’en l’absence d’études cliniques randomisées menées en pédiatrie, les recommandations émanant des sociétés savantes sont pour la plupart basées sur des consensus ; 2) une fois la décision prise d’implanter un stimulateur cardiaque, la question de la voie d’abord est également essentielle. L’implantation d’un pacemaker peut être réalisée chez l’enfant par voie endocardique ou épicardique avec un faible taux de complication à court et moyen terme. Cependant, les complications à plus long terme, moins étudiées, pourraient s’avérer plus problématiques. L’effet d’une stimulation prolongée durant toute une vie sur un site ventriculaire suboptimal ou même délétère pourrait avoir été sous-évalué. De même, les enfants sont exposés à un risque plus important de complications tardives en rapport avec leur matériel de stimulation.Dans cette revue, nous proposons la description des principales indications de stimulation cardiaque en pédiatrie, discutons de l’intérêt et des limites des différentes voies d’abord et essayons d’envisager les futurs progrès qui pourraient permettre une véritable révolution dans la discipline.SummaryAlthough the general indications for pacemaker implantation in children and adolescents are similar to those in adults, there are several important considerations in young patients. Congenital atrioventricular block, surgical or acquired atrioventricular block, sinus node dysfunction, bradycardia - tachycardia syndrome, long QT syndrome and cardiac resynchronization therapy are the main indications for pacing in the paediatric population. One of the peculiar characteristics in young patients is the long duration of pacing, which involves: difficult reflection regarding the indications for and timing of pacing therapy (all the more so given that the absence of randomized clinical trials of cardiac pacing conducted in the paediatric population, which means that the level of evidence for most recommendations is based on consensus); and the choice between endocardial and epicardial approaches. Indeed, children can now undergo implantation of epicardial or endocardial pacing systems with low rates of short- and mid-term compl ications. However, despite no clear demonstration in the literature because of the absence of studies with life-long follow-up, long-term complications may impact on the life expectancy of these patients. Lifelong pacing effects on a suboptimal or detrimental ventricular site may have been underestimated. Moreover, children are prone to a higher incidence of longterm adverse events because of the pacing device. In this review, we present the pacing indications and recommendations in the paediatric population, we discuss the benefits and limitations of epicardial and endocardial approaches and we examine whether new cardiac stimulation techniques might enable an absolute revolution in pacing therapy.

International audience; SummaryBackgroundDespite the increased number of implantable cardioverter defibrillator (ICD) recipients and the frequent need for device upgrading and/or occurrence of lead malfunction, the optimal approach to managing abandoned leads remains debated. Aims To determine the rate and type of complications related to either abandoned or extracted ICD leads. Methods Patients with abandoned or extracted leads were identified retrospectively. Patient medical records were reviewed to assess long-term lead or device malfunction, defibrillation test values before and after lead abandonment or extraction, and appropriateness of delivered shocks and subsequent surgical procedures related to devices or leads. Results A total of 58 ICD patients with 47 extracted and 34 abandoned leads were identified. After a mean follow-up of 3.2 ± 2.6 years, the defibrillation test was not affected by either abandoned or extracted leads (23.4 ± 6.6 J vs 25.4 ± 4.9 J, respectively; P = 0.24). There were no differences in the number of ICD-related surgical procedures after extracting versus abandoning leads (22% vs 12%, respectively; P = 0.3) or in the thromboembolic event rate (7.7% vs 6.3%; P = 0.83). During follow-up, no differences in the occurrence of major complications or appropriate/inappropriate shocks were observed between patients with or without abandoned leads. Conclusion We observed no difference in rates of immediate or medium-term complications between extracting versus abandoning leads. Lead abandonment remains an alternative and safe option when extraction does not appear mandatory according to the age of the leads or experience of the operating centre.

Objectives The aim of this study was to assess the relationship between initial ST-segment deviation and final QRS complex changes related to the posterolateral left ventricular wall in patients with acute inferior myocardial infarction receiving reperfusion therapy. The secondary aim was to determine if this relationship is stronger for patients who present early in the ischemia/infarction process in comparison with patients who present late. Methods The ST-segment depression in the leads V 1 , V2, and −V6 were measured in the electrocardiograph (ECG) just before initiation of myocardial reperfusion. These leads were chosen because they represent the posterolateral wall in the Selvester score. In addition, the Anderson-Wilkins acuteness score was calculated in the admission ECG. Selvester criteria related to the posterolateral wall were identified in the ECG performed before hospital discharge to assess final infarct size. Results Fifty-six patients were included in this study. No significant relationship was found between the sum of initial ST-segment depression in the leads V 1 , V 2 , and −V 6 , and final infarct size in the posterolateral left ventricular wall for the total study population ( r = 0.19, P = .16). Patients were subgrouped by Anderson-Wilkins acuteness score of less than 3 vs 3 or more. In those with a low acuteness score, the amount of ST-segment depression had no relationship with final infarct size ( r = −0.16, P = .41). However, the correlation was statistically significant for those with a high acuteness score ( r = 0.42, P = .04). Conclusion The initial ST-segment depression in leads V 1 , V 2 , and −V 6 can predict ECG-estimated amount of infarction in the posterolateral left ventricular wall in patients with acute inferior myocardial infarction receiving reperfusion therapy, but only in those who present early in the ischemia/infarction process.

Implantation of cardioverter-defibrillators in patients with limited venous access due to recurrent infections, thrombosis, or congenital anomalies can be challenging. For this subset of patients, we performed a video-assisted thoracoscopic intrapericardial implantation using standard shock electrodes and epicardial leads. The pulse generator was placed in pectoral or subcostal position. All pacing and sensing parameters and defibrillation thresholds were satisfactory and stable in time. No major complications were reported. Our limited experience suggests that this technique is a potential alternative in patients where endocardial implantation should be avoided. (C) 2014 by The Society of Thoracic Surgeons

Aims An estimated 10 000–15 000 pacemaker and implantable cardioverter–defibrillator (ICD) leads are extracted annually worldwide using specialized tools that disrupt encapsulating fibrous tissue. Additional information is needed regarding the safety of the devices that have been approved for lead extraction. The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than published data suggest, and whether procedural safety precautions are effective. Methods and results We searched the US Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database from 1995 to 2008 using the search terms ‘lead extraction and death’ and ‘lead extraction and injury’. Additional product specific searches were performed for the terms ‘death’ and ‘injury’. Between 1995 and 2008, 57 deaths and 48 serious cardiovascular injuries associated with device-assisted lead extraction were reported to the FDA. Owing to underreporting, the FDA database does not contain all adverse events that occurred during this period. Of the 105 events, 27 deaths and 13 injuries occurred in 2007–2008. During these 2 years, 23 deaths were linked with excimer laser or mechanical dilator sheath extractions. The majority of deaths and injuries involved ICD leads, and most were caused by lacerations of the right atrium, superior vena cava, or innominate vein. Overall, 62 patients underwent emergency surgical repair of myocardial perforations and venous lacerations and 35 (56%) survived. Conclusion These findings suggest that device-assisted lead extraction is a high-risk procedure and that serious complications including death may not be mitigated by emergency surgery. However, skilled standby cardiothoracic surgery is essential when performing pacemaker and ICD lead extractions. Although the incidence of these complications is unknown, the results of our study imply that device-assisted lead extractions should be performed by highly qualified physicians and their teams in specialized centres.

BACKGROUND: The best choice of defibrillator lead in patients with routine implantable cardioverter-defibrillator (ICD) is not settled. Traditionally, most physicians prefer dual-coil leads but the use of single-coil leads is increasing.OBJECTIVE: The purpose of this study was to compare clinical outcomes in patients with single- and dual-coil leads.METHODS: All 4769 Danish patients 18 years or older with first-time ICD implants from 2007 to 2011 were included from the Danish Pacemaker and ICD Register. Defibrillator leads were 38.9% single-coil leads and 61.1% dual-coil leads. The primary end point was all-cause mortality. Secondary end points were lowest successful energy at implant defibrillation testing, first shock failure in spontaneous arrhythmias, structural lead failure, and lead extraction outcomes.RESULTS: Single-coil leads were associated with lower all-cause mortality with an adjusted hazard ratio of 0.85 (95% confidence interval 0.73-0.99; P = .04). This finding was robust in a supplementary propensity score-matched analysis. However, dual-coil leads were used in patients with slightly higher preimplant morbidity, making residual confounding by indication the most likely explanation for the observed association between lead type and mortality. The lowest successful defibrillation energy was higher using single-coil leads (23.2 ± 4.3 J vs 22.1 ± 3.9 J; P < .001). No significant differences were observed for other secondary end points showing high shock efficacies and low rates of lead failures and extraction complications.CONCLUSION: Shock efficacy is high for modern ICD systems. The choice between single-coil and dual-coil defibrillator leads is unlikely to have a clinically significant impact on patient outcomes in routine ICD implants.

The aim of this survey was to describe the different strategies regarding the management of malfunctioning and recalled pacemaker and defibrillator leads across Europe. A questionnaire has been designed to assess the current practice and physician's approach to the management of leads which are faulty, unnecessary, and/or recalled. Responses to the questionnaire were received from 34 hospitals-members of the European Heart Rhythm Association (EHRA) electrophysiology (EP) research network. The survey involved both very high and low volume implanting centres, with 85% of the responding centres performing lead extraction. The survey provides a panoramic view of operator's decision making in the field of malfunctioning, recalled, and redundant leads and outlines a common point of view on lead abandonment and factors influencing the decision about lead extraction. The main factors strongly influencing the decision making were patient's age (59%), the presence of the damaged leads (44%), and the lead dwelling time (44%). Regarding the lead abandonment, the main concern (61%) was the potential greater difficulty associated with lead extraction in the future. High volume extracting centres showed a greater propensity to removing the malfunctioning or recalled leads compared with low volume or non-extracting centres. This EP Wire survey gives a snapshot of the operators' approaches and options regarding redundant, malfunctioning, and recalled lead management and may form the basis for future prospective research on this topic.

BACKGROUND: The St Jude Medical Riata lead advisory was issued owing to insulation failures. The impact of this advisory on patients' well-being is unknown.OBJECTIVES: The objectives of this study were to describe the acute impact of the Riata advisory on patients' well-being and psychological functioning and to examine changes over time.METHODS: Patients with active Riata leads completed standardized and validated patient-reported outcomes (PROs) in connection with a nationwide fluoroscopic screening with 12-month follow-up. They were matched (1:1) on age, sex, and implant indication with nonadvisory controls for baseline comparisons. Cohen's effect size d was used to determine the clinical relevance of the estimated adjusted mean differences (small, d = 0.20; moderate, d = 0.50; large, d ≥ 0.80).RESULTS: Of all Riata patients, 86% (256 of 299) completed baseline PROs and 70% (210 of 299) follow-up PROs. Riata patients reported poorer device acceptance (d = -0.28; P = .001) and increased device-related concerns (d = 0.29; P < .001) as compared with matched nonadvisory controls. There were no differences in symptoms of depression (d = 0.13; P = .13). Female sex was an independent predictor of a high advisory impact on general well-being as assessed with a purpose-designed question (odds ratio 2.24; P = .04). Device-related concerns decreased over time (d = -0.17; P = .002), but no changes were seen for other PROs.CONCLUSION: The Riata advisory is associated with a persistent small reduction in device acceptance and a small increase in device-related concerns with minimal improvement over time. Female sex is a predictor of a high negative advisory impact on general well-being. A need for counseling may arise in vulnerable subsets of patients.

Impact of Recalls on ICD Utilization. Introduction: The study was designed to evaluate the feasibility and performance of right ventricular (RV) mid-septal versus apical implantable defibrillator (ICD) lead placement. Methods and Results: SEPTAL is a randomized, noninferiority trial, which randomly assigned patients to implantation of ICD leads in the RV mid-septum versus apex, with a primary objective of comparing the implant success rate of implant at each site, based on strict electrical predefined criteria. We also compared the (1) pacing lead characteristics, (2) rates of appropriate and inappropriate ICD therapies, and (3) all-cause mortality between the 2 sites at 1 year. The trial enrolled 215 patients (mean age = 59.7 ± 12.4 years, mean LVEF = 34.0 ± 14.2%, 84.2% men), of whom 148 (68.8%) presented with ischemic heart disease. The ICD indication was primary prevention in 117 patients (54.4%). The lead was successfully implanted in 96/107 patients (89.7%) assigned to the RV mid-septum, and in 99/108 (91.7%) assigned to the apex (ns). The 1-year rate of lead-related adverse events was similar in both groups. A total of 8 first inappropriate ICD therapies (7.9%) were delivered in the RV mid-septal group, versus 8 (7.8%) in the apical group (ns), while first appropriate therapies were delivered to 22 (21.4%) and 24 patients (23.8%), respectively (ns). All-cause mortality was 7.9% in the RV mid-septal versus 2.9% in the RV apical group (ns). Conclusion: This study confirmed the technical feasibility and noninferior performance of ICD leads implanted in the RV mid-septum versus the apex. (J Cardiovasc Electrophysiol, Vol. 23, pp. 853-860, August 2012)

In the modern implanting era with progressive expanding indications to resynchronization therapy, upgrading procedure is a relatively common event. Persistent left superior vena cava (PLSVC), the most common venous abnormality, may exacerbate technical difficulties. We describe the procedure of upgrading from a dual chamber pacemaker to resynchronization/defibrillation system with a total of 4 leads through a PLSVC entering a dilated coronary sinus (CS) never described before. The case report, in addition to the description of a unique technical approach, raises a lot of clinical questions about how many leads we can introduce in such a venous structure and inside CS without hemodynamic impact on venous drainage potentially leading to life-threatening situations.