TL;DR: An update of the 2010 ESC Guidelines for the management of atrial fibrillation with the special contribution of the European Heart Rhythm Association is developed.
Abstract: 2012 focused update of the ESC Guidelines for the management of atrial fibrillation : an update of the 2010 ESC Guidelines for the management of atrial fibrillation: developed with the special contribution of the European Heart Rhythm Association
TL;DR: This 2012 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a Task Force, convened by the Heart Rhythm Society, the European Heart Rhythm Association, and the European Cardiac Arrhythmia Society and charged with defining the indications, techniques, and outcomes of this procedure.
Abstract: During the past decade, catheter ablation of atrial fibrillation (AF) has evolved rapidly from an investigational procedure to its current status as a commonly performed ablation procedure in many major hospitals throughout the world. Surgical ablation of AF, using either standard or minimally invasive techniques, is also performed in many major hospitals throughout the world.
In 2007, an initial Consensus Statement on Catheter and Surgical AF Ablation was developed as a joint effort of the Heart Rhythm Society, the European Heart Rhythm Association, and the European Cardiac Arrhythmia Society.1 The 2007 document was also developed in collaboration with the Society of Thoracic Surgeons and the American College of Cardiology. Since the publication of the 2007 document, there has been much learned about AF ablation, and the indications for these procedures have changed. Therefore the purpose of this 2012 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a Task Force, convened by the Heart Rhythm Society, the European Heart Rhythm Association, and the European Cardiac Arrhythmia Society and charged with defining the indications, techniques, and outcomes of this procedure. Included within this document are recommendations pertinent to the design of clinical trials in the field of AF ablation, including definitions relevant to this topic.
This statement summarizes the opinion of the Task Force members based on an extensive literature review as well as their own experience. It is directed to all health care professionals who are involved in the care of patients with AF, particularly those who are undergoing, or are being considered for, catheter or surgical ablation procedures for AF. This statement is not intended to recommend or promote catheter ablation of AF. Rather the ultimate judgment regarding care of a particular patient …
TL;DR: This 2012 Consensus Statement is a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a Task Force, convened by the Heart Rhythm Society, the European Heart Rhythm Association, and the European Cardiac Arrhythmia Society and charged with defining the indications, techniques, and outcomes of this procedure.
Abstract: During the past decade, catheter ablation of atrial fibrillation (AF) has evolved rapidly from an investigational procedure to its current status as a commonly performed ablation procedure in many major hospitals throughout the world. Surgical ablation of AF, using either standard or minimally invasive techniques, is also performed in many major hospitals throughout the world.
In 2007, an initial Consensus Statement on Catheter and Surgical AF Ablation was developed as a joint effort of the Heart Rhythm Society, the European Heart Rhythm Association, and the European Cardiac Arrhythmia Society.1 The 2007 document was also developed in collaboration with the Society of Thoracic Surgeons and the American College of Cardiology. Since the publication of the 2007 document, there has been much learned about AF ablation, and the indications for these procedures have changed. Therefore the purpose of this 2012 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a Task Force, convened by the Heart Rhythm Society, the European Heart Rhythm Association, and the European Cardiac Arrhythmia Society and charged with defining the indications, techniques, and outcomes of this procedure. Included within this document are recommendations pertinent to the design of clinical trials in the field of AF ablation, including definitions relevant to this topic.
This statement summarizes the opinion of the Task Force members based on an extensive literature review as well as their own experience. It is directed to all health care professionals who are involved in the care of patients with AF, particularly those who are undergoing, or are being considered for, catheter or surgical ablation procedures for AF. This statement is not intended to recommend or promote catheter ablation of AF. Rather the ultimate judgment regarding care of a particular patient …
TL;DR: The mechanistic interaction between predisposing factors and the electrophysiological mechanisms resulting in POAF and their therapeutic implications are discussed and show that POAF is ‘multi-factorial’.
Abstract: Post-operative atrial fibrillation (POAF) is one of the most frequent complications of cardiac surgery and an important predictor of patient morbidity as well as of prolonged hospitalization. It significantly increases costs for hospitalization. Insights into the pathophysiological factors causing POAF have been provided by both experimental and clinical investigations and show that POAF is 'multi-factorial'. Facilitating factors in the mechanism of the arrhythmia can be classified as acute factors caused by the surgical intervention and chronic factors related to structural heart disease and ageing of the heart. Furthermore, some proarrhythmic mechanisms specifically occur in the setting of POAF. For example, inflammation and beta-adrenergic activation have been shown to play a prominent role in POAF, while these mechanisms are less important in non-surgical AF. More recently, it has been shown that atrial fibrosis and the presence of an electrophysiological substrate capable of maintaining AF also promote the arrhythmia, indicating that POAF has some proarrhythmic mechanisms in common with other forms of AF. The clinical setting of POAF offers numerous opportunities to study its mechanisms. During cardiac surgery, biopsies can be taken and detailed electrophysiological measurements can be performed. Furthermore, the specific time course of POAF, with the delayed onset and the transient character of the arrhythmia, also provides important insight into its mechanisms. This review discusses the mechanistic interaction between predisposing factors and the electrophysiological mechanisms resulting in POAF and their therapeutic implications.
TL;DR: The proceedings of the 3rd Atrial Fibrillation NETwork (AFNET)/European Heart Rhythm Association (EHRA) consensus conference that convened over 60 scientists and representatives from industry to jointly discuss emerging therapeutic and diagnostic improvements to achieve better management of AF patients are described.
Abstract: While management of atrial fibrillation (AF) patients is improved by guideline-conform application of anticoagulant therapy, rate control, rhythm control, and therapy of accompanying heart disease, the morbidity and mortality associated with AF remain unacceptably high. This paper describes the proceedings of the 3rd Atrial Fibrillation NETwork (AFNET)/European Heart Rhythm Association (EHRA) consensus conference that convened over 60 scientists and representatives from industry to jointly discuss emerging therapeutic and diagnostic improvements to achieve better management of AF patients. The paper covers four chapters: (i) risk factors and risk markers for AF; (ii) pathophysiological classification of AF; (iii) relevance of monitored AF duration for AF-related outcomes; and (iv) perspectives and needs for implementing better antithrombotic therapy. Relevant published literature for each section is covered, and suggestions for the improvement of management in each area are put forward. Combined, the propositions formulate a perspective to implement comprehensive management in AF.
TL;DR: WhileRCTs suggest that LVEF is higher with RVNA than with RVA pacing, there remains a need for large RCTs to compare the safety and efficacy of RVNA and R VA pacing.
Abstract: Aims Previous studies have suggested that right ventricular apical (RVA) pacing may have deleterious effects on left ventricular function. Whether right ventricular non-apical (RVNA) pacing offers a better alternative to RVA pacing is unclear. We aimed to conduct a systematic review and meta-analysis of randomized-controlled trials (RCTs) in order to compare the mid- and long-term effects of RVA and RVNA pacing.
Methods and results We systematically searched the Cochrane library, EMBASE, and MEDLINE databases for RCTs comparing RVA with RVNA pacing over >2 months follow-up. Data were pooled using random-effects models. Fourteen RCTs met our inclusion criteria involving 754 patients. Compared with subjects randomized to RVA pacing, those randomized to RVNA pacing had greater left ventricular ejection fractions (LVEF) at the end of follow-up [13 RCTs: weighted mean difference (WMD) 4.27%, 95% confidence interval (CI) 1.15%, 7.40%]. RVNA had a better LVEF at the end of follow-up in RCTs with follow-up ≥12 months (WMD 7.53%, 95% CI 2.79%, 12.27%), those with <12 months of follow-up (WMD 1.95%, 95% CI 0.17%, 3.72%), and those conducted in patients with baseline LVEF ≤40–45% (WMD 3.71%, 95% CI 0.72%, 6.70%); no significant difference was observed in RCTs of patients whose baseline LVEF was preserved. Randomized-controlled trials provided inconclusive results with respect to exercise capacity, functional class, quality of life, and survival.
Conclusions While RCTs suggest that LVEF is higher with RVNA than with RVA pacing, there remains a need for large RCTs to compare the safety and efficacy of RVNA and RVA pacing.
TL;DR: The present document focuses on the rising burden and the increasing complexity of techniques of lead extraction with an emphasis on the critical issues of training, accreditation, and documentation of results.
Abstract: ### Introduction
The European Heart Rhythm Association charged the present writing committee with the task of producing a consensus document on training and accreditation for transvenous extraction of chronically implanted pacing and defibrillator leads.1,2 The core curriculum for the European Heart Rhythm Specialist includes implantation of heart rhythm devices but does not specifically mandate learning and accreditation for extraction techniques.3 The lack of such recommendations is related to the limited number of extractions available for training purposes and attaining competency. The present document focuses on the rising burden and the increasing complexity of techniques of lead extraction with an emphasis on the critical issues of training, accreditation, and documentation of results. There is also an educational component felt necessary to include by the Task Force in view of the specialized and emerging nature of this field. Where appropriate, a European perspective is presented and paediatric aspects are treated separately. The aim is to complement two recently published documents, one from the Heart Rhythm Society (HRS)4 on facilities, training, indications, and management of transvenous lead extraction and the other from the American Heart Association on device-related infections.5 The indications for lead extraction have not changed since these publications and are therefore not covered in this present document.
### Need for lead extraction/removal—a European perspective
Due to improving recognition of clinical need and wider indications, the implant rate of Cardiovascular Implantable Electronic Devices (CIED) continues to rise in most countries.6,7 The number of leads per patient is increasing with cardiac resynchronisation therapy–pacemaker/defibrillator, upgrades and a higher proportion of dual vs. single-chamber devices. As life expectancy has risen, so have the number of generator and lead changes despite advances in technology. Product advisories are inevitable despite overall improvements in reliability and have led to surges in extraction.8–10
Currently, infection accounts …
TL;DR: In this article, the authors systematically review all available studies describing the efficacy of β-blocker therapy for prevention of arrhythmic events in Catecholaminergic polymorphic ventricular tachycardia.
Abstract: Catecholaminergic polymorphic ventricular tachycardia (CPVT) is an inherited arrhythmia syndrome characterized by bidirectional or polymorphic ventricular arrhythmias under conditions of increased sympathetic activity in young patients with structurally normal hearts. Patients with CPVT are at high risk of developing life-threatening ventricular arrhythmias when untreated. A wide variety of arrhythmic event rates on conventional therapy, with β-blockers as the cornerstone, has been reported. Here, we systematically review all available studies describing the efficacy of β-blocker therapy for prevention of arrhythmic events in CPVT. Because of heterogeneity between the studies, a random-effects meta-analysis model was used to assess the efficacy of β-blocker therapy in preventing any arrhythmic event [syncope, aborted cardiac arrest (ACA), and sudden cardiac death (SCD)], near-fatal arrhythmic events (ACA and SCD), and fatal arrhythmic events. Eleven studies including 403 patients, of whom 354 (88%) had a β-blocker prescribed, were identified. Mean follow-up ranged from 20 months to 8 years. Estimated 8-year arrhythmic, near-fatal, and fatal event rates were 37.2% [95% confidence interval (CI): 16.6-57.7], 15.3% (95% CI: 7.4-23.3), and 6.4% (95% CI: 3.2-9.6), respectively. In addition, we review the recent developments in alternate chronic treatment options for CPVT patients, including calcium channel blockers, flecainide, left cardiac sympathetic denervation, and implantable cardioverter defibrillators. A new treatment strategy is proposed, including a stepwise addition of the alternate treatment options to β-blockers in patients who do not respond sufficiently to this first-line therapy. Finally, future developments in chronic treatment options and acute treatment options of ventricular arrhythmias are discussed.
TL;DR: This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use of implantable pacemakers, implantable cardioverter-defibrillators, devices for cardiac resynchronization therapy (CRT), loop recorders, and haemodynamic monitoring devices.
Abstract: We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices (CIEDs) with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), devices for cardiac resynchronization therapy (CRT) (both, with and without defibrillation properties), loop recorders, and haemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology (ISHNE) and the European Heart Rhythm Association (EHRA) combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.
TL;DR: Dilated LA significantly increases the risk of AF recurrence after single CPVI after single circumferential pulmonary vein isolation and the potential mechanism is explored.
Abstract: Aims Left atrial (LA) enlargement is associated with atrial fibrillation (AF). However, it is controversial whether dilated atrium can predict post-ablation AF recurrence. We undertook a systematic review and meta-analysis to analyse the association between LA diameter and AF recurrence after single circumferential pulmonary vein isolation (CPVI) and explore the potential mechanism.
Methods and results Electronic databases and bibliographies of retrieved studies were searched. The anteroposterior diameters of LA were available in all included studies, which were measured at end-systole by M-mode transthoracic echocardiography. Subgroup analysis was conducted based on the duration of follow-up. Weighted mean difference (WMD) and 95% confidence interval (CI) were calculated using random-effect or fixed-effect model, depending on statistical heterogeneity. Twenty-two studies with a total of 3750 individuals met the inclusion criteria. The summary WMD of LA diameter between patients with and without recurrence was 1.87 mm (95% CI 1.26–2.48, P < 0.001). Meta-regression analysis of the 22 studies indicated that study design, duration of follow-up, and measurement of asymptomatic recurrences were significant sources of heterogeneity. Sensitivity analysis suggested that the difference in LA diameter between patients with and without recurrences persisted regardless of the duration of follow-up.
Conclusion Dilated LA significantly increases the risk of AF recurrence after single CPVI. This is especially applicable to the patients with long-term follow-up.
TL;DR: Vernakalant modestly slowed AFL and ventricular response rates, and was well tolerated, but did not restore sinus rhythm in patients with AFL.
Abstract: Vernakalant is a novel, relatively atrial-selective antiarrhythmic agent for conversion of atrial fibrillation (AF) to sinus rhythm. This study examined the safety and efficacy of vernakalant in converting atrial flutter (AFL) to sinus rhythm. This was a phase 2/3, randomized, double-blind, placebo-controlled trial. Adults with AFL received either a 10 min infusion of 3.0 mg/kg vernakalant (n 39) or placebo (n 15). If AFL or AF persisted at the end of a 15 min observation period, a second 10 min infusion of 2.0 mg/kg vernakalant or placebo was administered. The primary efficacy outcome was the proportion of patients who had treatment-induced conversion of AFL to sinus rhythm for a minimum duration of 1 min within 90 min after the start of the first infusion. No patient in the placebo group met the primary outcome. Only one patient receiving vernakalant (1 of 39, 3) converted to sinus rhythm. A reduced mean absolute ventricular response rate occurred within 50 min in patients receiving vernakalant (mean change from baseline 8.2 b.p.m.) vs. patients receiving placebo (0.2 b.p.m.) (P 0.037). A post-hoc analysis revealed that vernakalant increased AFL cycle length by an average of 55 ms, whereas the AFL cycle length was unchanged in the placebo group (P 0.001). There was no occurrence of 1 : 1 atrio-ventricular conduction. Dysgeusia and sneezing were the most common treatment-related adverse events, consistent with previous reports. Vernakalant did not restore sinus rhythm in patients with AFL. Vernakalant modestly slowed AFL and ventricular response rates, and was well tolerated. (Less)
TL;DR: Frontal QRS-T angle ≥ 100° increases the risk of arrhythmic death, this being mainly the result of an altered T-wave axis.
Abstract: Aims Spatial QRS-T angle measured from a 12-lead electrocardiogram (ECG) has been shown to predict cardiac mortality. However, there is a paucity of studies on the prognostic significance of frontal QRS-T angle, which is more readily available from the standard 12-lead ECG. The purpose of the present study was to investigate the importance of wide frontal QRS-T angle, QRS-axis, and T-wave axis as cardiac risk predictors in general population.
Methods and results We evaluated the 12-lead ECGs of 10 957 Finnish middle-aged subjects from the general population recorded between 1966 and 1972, and followed them for 30 ± 11 years. QRS-T angle 0 to 90°, QRS-axis −30 to 90°, and T-wave axis 0 to 90° were considered normal. The primary endpoint was death from arrhythmia, and the secondary endpoints were all-cause mortality and non-arrhythmic cardiac mortality. QRS-T angle ≥100° was present in 2.0% of the subjects, and it was associated with an increased risk of sudden arrhythmic death [relative risk (RR) 2.26; 95% confidence interval (CI) 1.59–3.21; P < 0.001) and all-cause mortality (RR 1.57; CI 1.34–1.84; P < 0.001), but not with non-arrhythmic cardiac mortality (RR 1.34; CI 0.93–1.92; P = 0.13). The prognostic significance of wide QRS-T angle was mainly due to abnormal T-wave axis, which predicted death from arrhythmia (RR 2.13; CI 1.63–2.79; P < 0.001), all-cause mortality (RR 1.39; 1.24–1.55; P < 0.001), and non-arrhythmic cardiac death (RR 1.87; CI 1.50–2.34; P < 0.001).
Conclusion Frontal QRS-T angle ≥100° increases the risk of arrhythmic death, this being mainly the result of an altered T-wave axis.
TL;DR: In this article, the prevalence of atrial fibrillation on electrocardiography was established in prospectively selected groups: 3960 randomly selected from the population, aged 45; 782 with a previous diagnosis of heart failure; and 1062 with a record of myocardial infarction, hypertension, angina, or diabetes.
TL;DR: Frequent PACs predict new AF and adverse cardiovascular events, and patients with frequent PACs were more at risk than those without for the composite endpoint.
Abstract: Aims To investigate the relation between baseline frequency of premature atrial complexes (PACs) and new atrial fibrillation (AF) and adverse cardiovascular events.
Method and results Four hundred and twenty-eight patients without AF or structural heart disease undergoing 24 h electrocardiography monitoring for palpitations, dizziness, or syncope were recruited. One hundred and seven patients with number of PACs at the top quartile (i.e. >100PACs/day) were defined to have frequent PACs. After 6.1-year follow-up, 31 patients (29%) with frequent PACs developed AF compared with 29 patients (9%) with PACs ≤100/day ( P 75 years (HR: 2.3; 95% CI: 1.3–3.9; P = 0.004), and coronary artery disease (HR: 2.5; 95% CI: 1.4–4.4; P = 0.002) were independent predictors for new AF. Concerning the composite endpoint (ischaemic stroke, heart failure, and death), patients with frequent PACs were more at risk than those without (34.5 vs. 19.3%) (HR: 1.95; 95% CI: 1.37–3.50; P = 0.001). Cox regression analysis showed that age >75 years (HR: 2.2; 95% CI: 1.47–3.41; P < 0.001), coronary artery disease (HR: 2.2, 95% CI: 1.42–3.44, P < 0.001), and frequent PACs (HR: 1.6; 95% CI: 1.04–2.44; P = 0.03) were independent predictors for the secondary composite endpoint.
Conclusion Frequent PACs predict new AF and adverse cardiovascular events.
TL;DR: Cardiac implantable electronic device infection is more often monomicrobial, CoNS are most frequently isolated and S. aureus is largely the main single agent, although oxacillin resistance and quinolones resistance has increased in the last 5 years.
Abstract: Aims The aim of the study was to describe the microbiological findings of cardiac implantable electronic devices (CIEDs) infection in the 2000–2011 period at the Cardiology Unit of New Santa Chiara Hospital in Pisa (Italy).
Methods and results Removed CIED leads and pocket material were seeded on solid media and isolates tested for antimicrobial susceptibility with the Kirby Bauer method. Electrodes from 1204 patients were analysed and 854 (70.9%) tested positive. In 663 (77.6%) cases only one species was isolated, in 175 (20.5%) two species, and in 14 (1.8%) >2 species. In 116 cases material from the pocket was also cultured. The result was consistent with that from the electrodes in 69 (59%) cases. In 359 cases a blood sample was also obtained for culture. The result was consistent with that from the leads in 124 (35%) cases. A total of 1068 strains were isolated from electrodes. Gram-positive organisms were most frequently isolated (92.5% of isolates); particularly, coagulase-negative staphylococci (CoNS), mainly Staphylococcus epidermidis , in 69% of cases and Staphylococcus aureus in 13.8%, Gram-negative rods in 6.1%, yeasts in 1% and molds in 0.4%. Overall, Oxacillin resistance was 30%, in particular 33% among CoNS and 13% among S. aureus . Oxacillin resistance and quinolones resistance have increased in the period 2006–2011 with respect to the 5 years before. Seventeen percent of Enterobacteriaceae strains had a phenotype compatible with extended spectrum beta-lactamase expression.
Conclusions Culture of the leads offers the possibility of an aetiological diagnosis in the majority of cases. When material from the pocket can be obtained, the microbiological result is often consistent with that from the electrodes, while species isolated from blood cultures are often different and more likely to be the result of contamination. Cardiac implantable electronic device infection is more often monomicrobial, CoNS are most frequently isolated and S. epidermidis is largely the main single agent. Very early infections were associated with S. aureus infection. The pattern of susceptibility to antimicrobials is in general that of community-acquired infections, although oxacillin resistance and quinolones resistance has increased in the last 5 years.
TL;DR: The AFib Ablation Pilot Study provides crucial information on AF ablation in clinical practice across Europe and is relevant for further improvement of the management strategies of patients suffering from atrial fibrillation.
Abstract: The AFib Ablation Pilot Study provides crucial information on AF ablation in clinical practice across Europe. These data are relevant for further improvement of the management strategies of patients suffering from atrial fibrillation.
TL;DR: Considering the very long duration of RV stimulation in the study population, the prevalence of PiCMP was remarkably low and was associated with more pronounced intraventricular dyssynchrony.
Abstract: Aims The prevalence of pacing-induced cardiomyopathy (PiCMP) has been reported to be 9% 1 year after implantation. As long-term data are sparse, the aim of our study was to evaluate the prevalence of PiCMP in a cohort of patients with at least 15 years of right ventricular (RV) pacing.
Methods and results Inclusion criteria were RV stimulation for at least 15 years due to atrioventricular block III° and absence of structural heart disease at the time of initial implantation. All patients were examined by echocardiography and spiroergometry. Pacing-induced cardiomyopathy was pre-defined as left ventricular (LV) ejection fraction (LVEF) ≤45%, dyskinesia during RV pacing and absence of other known causes of cardiomyopathy. Twenty-six patients from our outpatient department met the inclusion criteria. Pacing-induced cardiomyopathy was diagnosed in four patients (15.4%). Echocardiography showed significant LV remodelling in PiCMP patients [LVEF 41.0 ± 4.5%, LV end-diastolic diameter (LVEDD) 54.0 ± 2.7 mm] compared with patients with preserved LVEF (LVEF 61.2 ± 5.8%, P = 0.002, LVEDD 45.6 ± 4.0 mm, P = 0.004). There were no significant differences regarding age, gender, duration of RV pacing, heart rate, interventricular mechanical delay, QRS duration or prevalence of sinus rhythm, and arterial hypertension between both groups. The longest intraventricular delay was significantly shorter in patients with preserved LVEF (65.5 ± 43.0 ms) compared with PiCMP patients (112.5 ± 15.0 ms, P = 0.043). Exercise capacity and quality of life did not differ significantly between both groups.
Conclusion Considering the very long duration of RV stimulation in our study population (24.6 ± 6.6 years), the prevalence of PiCMP was remarkably low. Pacing-induced cardiomyopathy was associated with more pronounced intraventricular dyssynchrony.
TL;DR: PEA-based optimization of CRT in HF patients significantly increased the proportion of patients who improved with therapy, mainly through improved NYHA class, after 1 year of follow-up.
Abstract: Aims Non-response rate to cardiac resynchronization therapy (CRT) might be decreased by optimizing device programming. The Clinical Evaluation on Advanced Resynchronization (CLEAR) study aimed to assess the effects of CRT with automatically optimized atrioventricular (AV) and interventricular (VV) delays, based on a Peak Endocardial Acceleration (PEA) signal system.
Methods and results This multicentre, single-blind study randomized patients in a 1 : 1 ratio to CRT optimized either automatically by the PEA-based system, or according to centres’ usual practices, mostly by echocardiography. Patients had heart failure (HF) New York Heart Association (NYHA) functional class III/IV, left ventricular ejection fraction (LVEF) 150 or >120 ms with mechanical dyssynchrony. Follow-up was 1 year. The primary endpoint was the proportion of patients who improved their condition at 1 year, based on a composite of all-cause death, HF hospitalizations, NYHA class, and quality of life. In all, 268 patients in sinus rhythm (63% men; mean age: 73.1 ± 9.9 years; mean NYHA: 3.0 ± 0.3; mean LVEF: 27.1 ± 8.1%; and mean QRS duration: 160.1 ± 22.0 ms) were included and 238 patients were randomized, 123 to PEA and 115 to the control group. At 1 year, 76% of patients assigned to PEA were classified as improved, vs. 62% in the control group ( P = 0.0285). The percentage of patients with improved NYHA class was significantly ( P = 0.0020) higher in the PEA group than in controls. Fatal and non-fatal adverse events were evenly distributed between the groups.
Conclusion PEA-based optimization of CRT in HF patients significantly increased the proportion of patients who improved with therapy, mainly through improved NYHA class, after 1 year of follow-up.
TL;DR: Pneumothorax treated with a chest tube remains a clinically important problem in device therapy and the cephalic vein cut-down technique should be applied whenever possible to avoid this complication.
Abstract: Aim To identify risk factors for pneumothorax treated with a chest tube after cardiac pacing device implantation in a population-based cohort.
Methods and results A nationwide cohort study was performed based on data on 28 860 patients from the Danish Pacemaker Register, which included all Danish patients who received their first pacemaker (PM) or cardiac resynchronization device from 1997 to 2008. Multiple logistic regression was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals for the association between risk factors and pneumothorax treated with a chest tube. The median age was 77 years (25th and 75th percentile: 69–84) and 55% were male ( n = 15 785). A total of 190 patients (0.66%) were treated for pneumothorax, which was more often in women [aOR 1.9 (1.4–2.6)], and in patients with age >80 years [aOR 1.4 (1.0–1.9)], a prior history of chronic obstructive pulmonary disease [aOR 3.9 (1.6–9.5)], implantation of a dual-chamber PM [aOR 1.5 (1.0–2.2)], venous access with subclavian vein puncture [aOR 7.8 (4.9–12.5)], venous access with both subclavian vein puncture and cephalic vein cut-down [aOR 5.7 (3.0–10.8)], and implantation in a non-university centre [aOR 2.1 (1.6–2.9)].
Conclusion Pneumothorax treated with a chest tube remains a clinically important problem in device therapy. The cephalic vein cut-down technique should be applied whenever possible to avoid this complication.
TL;DR: The incidence of HAVB in STEMI patients treated with pPCI has been reduced compared with reports from the thrombolytic era, however, despite this improvement high-degree AV block remains a severe prognostic marker in the p PCI era.
Abstract: Aims Primary percutaneous coronary intervention (pPCI) has replaced thrombolysis as treatment-of-choice for ST-segment elevation myocardial infarction (STEMI). However, the incidence and prognostic significance of high-degree atrioventricular block (HAVB) in STEMI patients in the pPCI era has been only sparsely investigated. The objective of this study was to assess the incidence, predictors and prognostic significance of HAVB in STEMI patients treated with pPCI.
Methods and results This study included 2073 STEMI patients treated with pPCI. The patients were identified through a hospital register and the Danish National Patient Register. Both registers were also used to establish the diagnosis of HAVB. All-cause mortality was the primary endpoint. During a median follow-up of 2.9 years [interquartile range (IQR) 1.8–4.0] 266 patients died. High-degree atrioventricular block was documented in 67 (3.2%) patients of whom 25 died. Significant independent predictors of HAVB included right coronary artery occlusion, age >65 years, female gender, hypertension, and diabetes. The adjusted mortality rate was significantly increased in patients with HAVB compared to patients without HAVB [hazard ratio = 3.14 (95% confidence interval 2.04–4.84), P < 0.001]. A landmark-analysis 30 days post-STEMI showed equal mortality rates in the two groups.
Conclusion The incidence of HAVB in STEMI patients treated with pPCI has been reduced compared with reports from the thrombolytic era. However, despite this improvement high-degree AV block remains a severe prognostic marker in the pPCI era. The mortality rate was only increased within the first 30 days. High-degree atrioventricular block patients who survived beyond this time-point thus had a prognosis equal to patients without HAVB.
TL;DR: This multicentre observational study demonstrates a significant reduction of fluoroscopy exposure using a new 3D non-fluoroscopic mapping system to guide catheter ablation of atrial fibrillation.
Abstract: Aims Catheter ablation of atrial fibrillation (AF) focuses on pulmonary vein (PV) ablation with or without additional atrial substrate modification. These procedures require significant fluoroscopy exposure. A new 3D non-fluoroscopic navigation system (CARTO® 3 System, Biosense Webster, CA, USA) that allows precise location visualization of diagnostic and ablation catheters was evaluated for its impact on fluoroscopic exposure during AF ablation procedures.
Methods and results Two groups of patients were treated by our centres for drug refractory AF. One group was treated using the new CARTO® 3 system to guide catheter ablation (Group A, 117 patients). The other group was treated using the CARTO® XP system (Biosense Webster) 3 months previously (Group B, 123 patients). For both groups, circumferential PV ostia ablation was performed; PV isolation was validated using a circular catheter placed at each ostium. There was no difference in any clinical characteristics (age, sex, AF type, left atrium diameter and volume, and heart disease) among the two study groups. The mean number of PVs identified and isolated per patient was similar in both groups, as were the mean procedural duration and radiofrequency time. However, mean fluoroscopic time was significantly reduced in Group A (15.9±12.3 min) as compared with Group B (26±15.1 min) ( P < 0.001).
Conclusion This multicentre observational study demonstrates a significant reduction of fluoroscopy exposure using a new 3D non-fluoroscopic mapping system to guide AF catheter ablation.
TL;DR: The occurrence of syncope displayed an age distribution with important gender-specific differences and higher incidence rates than previously reported, and significant association between cardiovascular comorbidity and pharmacotherapy and the risk ofsyncope was found.
Abstract: Aims Syncope is a common cause for hospitalization and may be related to comorbidity and concurrent medication. The objective of this study was to determine the incidence, comorbidity, and pharmacotherapy in a nationwide cohort of patients hospitalized with syncope.
Methods and results An observational study including patients with the diagnosis of syncope identified from the Danish National Patient Register in the period 1997–2009. All patients were matched on sex and age with five controls from the Danish population. We estimated the incidence of syncope and the association with comorbidities and pharmacotherapy by conditional logistic regression analyses. We identified 127 508 patients with a first-time diagnosis of syncope [median age 65 years (interquartile range 49–81), 52.6% female]. The age distribution of the patients showed three peaks around 20, 60, and 80 years of age with the third peak occurring 5–7 years earlier in males. Cardiovascular disease and cardiovascular drug therapy was present in 28 and 48% of the patients, respectively. We found significant association between cardiovascular disease and the risk of admission for syncope increasing with younger age; age 0–29 years [odds ratio (OR) = 5.8, confidence interval (CI): 5.2–6.4), age 30–49 (OR = 4.4, CI: 4.2–4.6), age 50–79 (OR = 2.9, CI: 2.8–3.0), and age above 80 (OR = 2.0, CI: 1.9–2.0). Cardiovascular pharmacotherapy associated with age and risk of syncope was similar.
Conclusion In a nationwide cohort of patients hospitalized for first syncope we found significant association between cardiovascular comorbidity and pharmacotherapy and the risk of syncope. The occurrence of syncope displayed an age distribution with important gender-specific differences and higher incidence rates than previously reported.
TL;DR: It is found that all five algorithms/criteria had rather moderate ACC, and that the newer methods were not more accurate than the classic Brugada algorithm, suggesting that the value of a diagnosis may differ depending on the method used.
Abstract: Aims To compare the sensitivity (SN), specificity (SP), and diagnostic accuracy (ACC) for ventricular tachycardia (VT) diagnosis of five electrocardiographic methods for wide QRS-complex tachycardia (WCT) differentiation, specifically the Brugada, Bayesian, Griffith, and aVR algorithms, and the lead II R-wave-peak-time (RWPT) criterion.
Methods and results We retrospectively analysed 260 WCTs from 204 patients with proven diagnoses. The SN, SP, ACC, and likelihood ratios (LRs) were determined for the five methods. Of the 260 tracings, there were 159 VTs and 101 supraventricular tachycardias. All five methods were found to have a similar ACC although the RWPT had a lower ACC than the Brugada algorithm (68.8 vs. 77.5%, P = 0.04). The RWPT had lower (60%) SN than the Brugada (89.0%), Griffith (94.2%), and Bayesian (89%) algorithms ( P < 0.001). The Griffith algorithm showed lower (39.8%) SP than the RWPT (82.7%), Brugada (59.2%), and Bayesian (52.0%) algorithms ( P < 0.05). The positive LRs for a VT diagnosis for the RWPT criterion and the Brugada, Bayesian, aVR, and Griffith algorithms were 3.46, 2.18, 1.86, 1.67, and 1.56, respectively.
Conclusion The present study is the first independent ‘head-to-head’ comparison of several WCT differentiation methods. We found that all five algorithms/criteria had rather moderate ACC, and that the newer methods were not more accurate than the classic Brugada algorithm. However, the algorithms/criteria differed significantly in terms of SN, SP, and LR, suggesting that the value of a diagnosis may differ depending on the method used.
TL;DR: In patients with short-lasting AF, early AF recurrence seemed to be associated with inflammation as represented by IL-6, suggesting that treatment aimed against inflammation may preventEarly AF recurrences, which can improve rhythm control outcome.
Abstract: Aims Outcome of rhythm control in atrial fibrillation (AF) is still poor due to various mechanisms involved in the initiation and perpetuation of AF. Differences in timing of AF recurrence may depend on different types of mechanisms. The aim of this study was to assess the mechanisms involved in early AF recurrence in patients with short-lasting AF.
Methods and results Patients with short-lasting persistent AF undergoing rhythm control ( n = 100) were included. Markers of mechanisms involved in the initiation and perpetuation of AF were assessed, including clinical factors, echocardiographic parameters, and biomarkers. Primary endpoint was early AF recurrence (recurrence <1 month). Secondary endpoint was progression to permanent AF. Median total AF history was short: 4.2 months. Early AF recurrences occurred in 30 patients (30%) after a median of 6 (inter-quartile range 2–14) days. Baseline log2 interleukin (IL)-6 [adjusted hazard ratio (HR) 1.3, 95% confidence interval (CI) 1.0–1.7, P = 0.02] and present or previous smoking (adjusted HR 3.6, 95% CI 1.2–10.9, P = 0.03) were independently associated with early AF recurrence, suggesting that inflammation played an important role in early recurrences. Atrial fibrillation became permanent in 29 patients (29%). Baseline transforming growth factor-β1, left ventricular ejection fraction, and early AF recurrence were independently associated with progression to permanent AF.
Conclusion In patients with short-lasting AF, early AF recurrence seemed to be associated with inflammation as represented by IL-6. Treatment aimed against inflammation may therefore prevent early AF recurrences, which can improve rhythm control outcome.
TL;DR: There is emerging evidence that pacing from the RV septum is associated with a shorter duration of activation, improved haemodynamics, and less LV remodelling, and all implanters should adopt RV sePTal pacing to minimize the potential of harm to patients.
Abstract: Transvenous pacing has revolutionized the management of patients with potentially life-threatening bradycardias and at its most basic level ensures rate support to maintain cardiac output. However, we have known for at least a decade that pacing from the right ventricle (RV) apex can induce left ventricle (LV) dysfunction, atrial fibrillation, heart failure, and maybe an increased mortality. Although pacemaker manufacturers have developed successful pacing algorithms designed to minimize unnecessary ventricular pacing, it cannot be avoided in a substantial proportion of pacemaker-dependent patients. Just as there is undoubted evidence that RV apical pacing is injurious, there is emerging evidence that pacing from the RV septum is associated with a shorter duration of activation, improved haemodynamics, and less LV remodelling. The move from traditional RV apical pacing to RV septal pacing requires a change in mindset for many practitioners. The anatomical landmarks and electrocardiograph features of RV septal pacing are well described and easily recognized. While active fixation is required to place the lead on the septum, shaped stylets are now available to assist the implanter. In addition, concerns about the stability and longevity of steroid-eluting active fixation leads have proven to be unfounded. We therefore encourage all implanters to adopt RV septal pacing to minimize the potential of harm to their patients.
TL;DR: The new quadripolar electrode LV lead provides more programming options to address common problems faced when managing CRT patients, and Physicians were able to use the increased programming Options to manage threshold changes and PNS.
Abstract: Aims Cardiac resynchronization therapy (CRT) is sometimes complicated by elevated pacing thresholds and phrenic nerve stimulation (PNS), both of which may require that the coronary sinus lead be repositioned. The purpose of this study was to evaluate the performance of a novel quadripolar electrode lead and cardiac resynchronization therapy-defibrillator (CRT-D) device that enables electrical repositioning, potentially obviating a lead reposition procedure.
Methods and results Patients indicated for CRT were enrolled and received a quadripolar electrode lead and CRT-D device (Quartet®model 1458Q and Promote Q®; St Jude Medical, Sylmar, CA, USA). Electrical data, and the presence of PNS during pacing from each left ventricular (LV) configuration, were documented at pre-hospital discharge and at 1 month. Seventy-five patients were enrolled and 71 were successfully implanted with a Quartet®lead. Electrical measurements were stable over the follow-up period. Ninety-seven per cent (64 of 66) of patients had one or more programmable configurations with a threshold <2.5 V and no PNS vs. 86% (57 of 66) if only conventional bipolar configurations were considered. Physicians were able to use the increased programming options to manage threshold changes and PNS.
Conclusion The new quadripolar electrode LV lead provides more programming options to address common problems faced when managing CRT patients. Electrical measurements from new vectors are comparable with conventional configurations. Furthermore, 11% of patients in the study suffered PNS on all conventional bipolar vectors.
TL;DR: Investigation of electrocardiogram parameters found presence of J wave or fQRS in the inferior leads predicted higher risk of SCD in DCM and ICM patients and might serve as independent predictors forSCD in patients with CHF.
Abstract: Aims To investigate the relationship between electrocardiogram (ECG) parameters [J wave, fragmented QRS (fQRS), QTc, the peak-to-end interval of T wave (Tp–Te)], and sudden cardiac death (SCD) in chronic heart failure (CHF).
Methods and results The ECGs of 1570 CHF patients, 572 cases with dilated cardiomyopathy (DCM) and 998 cases with ischaemic cardiomyopathy (ICM) were analysed with the endpoint being an SCD or non-SCD (NSCD). During a median follow-up period of 36 months (0.40–65 months), 438 (27.89%) patients died, of which 158 (35.84%) were SCD. Overall, the occurrence of J wave, fQRS, and long Tp–Te were greater in SCD patients than that of NSCD patients (all P < 0.01). For DCM cases, more SCD patients had J waves observed in the inferior leads than that in the NSCD group (26.78 vs. 13.07%, P <0.001). However, ICM cases with SCD did have more fQRS in the inferior leads than that with NSCD (42.16 vs. 26.67%, P = 0.01). After adjusting for other risk factors, Cox regression analysis revealed that presence of J wave or fQRS in the inferior leads predicted a higher risk for SCD in DCM [hazard ratio (HR), 4.095; 95% confidence interval (CI), 2.132–7.863] and ICM (HR, 2.714; 95% CI, 1.809–4.072) patients. A left ventricular ejection fraction ≤30% also predicted SCD and NSCD in DCM and ICM patients. In contrast, the predictive value of QTc and Tp–Te for SCD was not significant.
Conclusions Presence of J wave or fQRS in the inferior leads predicted higher risk of SCD in DCM and ICM patients and might serve as independent predictors for SCD in patients with CHF.
TL;DR: The hypothesis that reversible tissue injury contributes to PV isolation that may be acute but not necessarily durable is supported.
Abstract: Aims Temporary, ablation-mediated effects such as oedema may cause reversible pulmonary vein (PV) isolation. To investigate this, point-by-point circumferential ablation was performed to achieve acute electrical PV isolation with an incomplete circumferential ablation line. Then, the impact of this intentional ‘visual gap’ (ViG) on the conduction properties of the ablation lesion set was assessed with adenosine and pacing manoeuvres.
Methods and results Twenty-eight patients undergoing ablation for paroxysmal ( n = 20) or persistent atrial fibrillation ( n = 8) were included. Pulmonary vein (PV) ablation was performed around ipsilateral vein pairs. Once acute isolation was achieved, ablation was halted and the presence and size of the ViG were calculated. The ViG electrophysiological properties were tested with pace capture along the ViG at 10 mA/2 ms, and assessment for dormant PV conduction with adenosine. Despite electrical isolation, a ViG was present in 75% ( n = 42/56) of vein pairs (21 of 28 left PVs and 21 of 28 right PVs). There was no difference in the ViG size between the left and right PVs (22.1 ± 14.2 and 17.3 ± 11.3 mm, P > 0.05). Dormant PV connections were revealed by adenosine in more than a quarter ( n = 12/42) of acutely isolated PV pairs, of which the majority were dependent on conduction through the ViG.
Conclusions Electrical PV isolation can usually be achieved without complete circumferential ablation. However, more than a quarter of these ‘isolated’ PVs exhibit dormant conduction—predominantly via the un-ablated ‘ViGs’ in the ablation lesion set. These findings support the hypothesis that reversible tissue injury contributes to PV isolation that may be acute but not necessarily durable.
TL;DR: In this registry analysis, patients with CRT had similarly high short-term survival to those in controlled trials, and this favourable prognosis was sustained over the long term.
Abstract: Aims Cardiac resynchronization therapy (CRT) improves prognosis in patients with moderate-to-severe heart failure, reduced left ventricular ejection fraction, and wide QRS complexes. However, CRT may be under-utilized in women and data on long-term follow-up are still scarce. The aim was to investigate long-term mortality and hospitalization and prognostic impact of gender after CRT.
Methods and results Data on 619 consecutive patients (19% women) that received CRT at a single centre between 1998 and 2008 were collected from electronic medical records and national death and hospitalization registries up to 2010. The primary endpoint was death of any cause and the secondary endpoint was combined death of any cause or heart failure hospitalization. Over a mean follow-up of 1320 ± 786 days, 215 (35%) patients reached the primary endpoint and 437 (71%) the secondary endpoint. Overall, 1-, 5-, and 10-year survivals were 91, 63, and 39%, respectively. Female gender was the only independent predictor of all-cause mortality; hazard ratio (HR) 0.44 [95% confidence interval (CI), 0.21–0.90; P = 0.025]. Women also had a trend towards lower risk for the secondary endpoint, HR 0.68 (95% CI, 0.45–1.04; P = 0.072).
Conclusion In this registry analysis, patients with CRT had similarly high short-term survival to those in controlled trials, and this favourable prognosis was sustained over the long term.Women had lower all-cause mortality than men.
TL;DR: Sedation with 2% propofol infusion sedation administered by cardiologists without assisted ventilation is safe, effective, and practical for use in AF ablation without serious or residual complications.
Abstract: Aims Patients can expect a cure from atrial fibrillation (AF) with ablation. Procedural safety and success depend on patient comfort, compliance, and immobility. This is difficult to achieve with benzodiazepine and opiate boluses that are the mainstay of current practice. We sought to determine the safety and efficacy of propofol infusion sedation administered to patients without assisted ventilation for AF ablation.
Methods and results Procedural data from 1000 consecutive patients undergoing AF ablation were analysed. Sedation with 2% propofol was used in all procedures without assisted ventilation and was administered, monitored, and controlled by electrophysiologists. Primary outcome measures were adverse sedative affects including (i) respiratory depression (SpO2 20 s) and (ii) persistent hypotension [systolic blood pressure (SBP)<90 mmHg at minimum sedation level]. Secondary endpoints included full recovery within 60 min and procedural complications. Of 1000 ablations, 506 ablations were performed for persistent and 494 for paroxysmal AF. Average patient age was 60.1 ± 11.3 years (72.3% male). Propofol was commenced in all patients at a mean infusion rate of 18.5 ± 4.8 mL/h with a mean baseline SBP of 140.3 ± 19.9 mmHg. Mean procedure time was 148.7 ± 57.7 min. Adverse sedative effects necessitating cessation of propofol and switch to midazolam bolus sedation occurred in 15.6% of patients (13.6% due to persistent hypotension, 1.9% due to respiratory depression, and 0.1% due to hypersalivation). Patients who had persistent hypotension were older (62.9 ± 11.2 vs. 60.0 ± 11.4 years, P = 0.011) and more likely to be female (39.5 vs. 23.7%, P < 0.001) than those who tolerated propofol. Patient age correlated to maximum blood pressure drop with propofol ( R 2= 0.101, P < 0.001) and inversely correlated to mean propofol infusion rate ( R 2= 0.066, P < 0.001). No procedures were abandoned due to adverse effects of sedation. All patients recovered within 60 min. Serious procedural complications, unrelated to sedation, occurred in 0.5%, all of whom had pericardial tamponade successfully treated with percutaneous pericardiocentesis.
Conclusions Sedation with 2% propofol infusion administered by cardiologists without assisted ventilation is safe, effective, and practical for use in AF ablation without serious or residual complications. In this setting, persistent hypotension is the most common acute adverse effect requiring cessation of propofol in ∼14%.