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Aims To evaluate the effectiveness and safety of dronedarone compared with other commonly used antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrences. Methods and results An international observational cohort study in Germany, Spain, Italy, and the USA enrolling patients with AF receiving AAD therapy. Patients with New York Heart Association (NYHA) Class IV heart failure were excluded. Participants were followed for up to 18 months, regardless of discontinuation or subsequent AAD switches. Atrial fibrillation recurrence was captured by hospitalization, emergency room visit, or electrocardiogram-based documentation of AF. Confounding bias was controlled for in the analysis of AF recurrence using multivariate models of 19 variables for adjustment. A total of 1009 participants [mean age 67.2 (10.8) years, male to female ratio 1.3] were recruited from 170 centres, 693 (69%) of which were from across Europe and the remaining 316 (31%) from the USA. At the time of enrolment, participants were taking dronedarone (51%) or other AADs (49%) [flecainide or propafenone (42%), sotalol (11%), and amiodarone (47%)]. No significant differences in the risk of first confirmed AF recurrence with dronedarone vs. other AADs [crude hazard ratio (HR) 1.10 (95% confidence interval 0.85–1.42); adjusted HR 1.16 (0.87–1.55)] were found, irrespective of whether univariate or multivariate models were used. Reported safety events were in accordance with the known safety profile of dronedarone. Conclusion In this population of patients from either Europe or the USA receiving dronedarone or another AAD, the effectiveness of dronedarone was comparable to that observed for other AADs in preventing first AF recurrence.

Thromboembolism is the most serious complication of AF, and oral anticoagulation is the mainstay therapy. Current guidelines place all AF types together in terms of anticoagulation with the major determinants being associated comorbidities translated into risk marker. Among patients in large clinical trials, those with non-paroxysmal AF appear to be at higher risk of stroke than those with paroxysmal AF. Higher complexity of the AF pattern is also associated with higher risk of mortality. Moreover, continuous monitoring of AF through cardiac implantable devices provided us with the concept of ‘AF burden’. Usually, the larger the AF burden, the higher the risk of stroke; however, the relationship is not well characterised with respect to the threshold value above which the risk increases. The picture is more complex than it appears: AF and underlying disorders must act synergically respecting the magnitude of its own characteristics, which are the amount of time a patient stays in AF and the severity of associated comorbidities.

Non-vitamin K oral anticoagulants (NOACs) are the first choice for prophylaxis of cardioembolism in patients with non-valvular atrial fibrillation (AF) who are anticoagulant-naïve, as well as the preferable anticoagulation strategy in those who are on vitamin K antagonists (VKAs), but with a low time in therapeutic range (TTR). Nonetheless, there are many good reasons to consider switching from VKAs to NOACs also when TTR is >70%. From the pharmacological standpoint, anticoagulation with VKAs may remain erratic even in those patients who have high TTR values, owing to the mode of action of this drug class. Furthermore, experimental data suggest that, unlike VKAs, NOACs favorably modulate the effects of factor Xa and thrombin in the cardiovascular system through the protease-activated receptor family. Clinically, the most striking advantage provided by NOACs over VKAs, irrespective of the TTR, is the substantially lower risk of intracranial hemorrhage. NOACs have also been associated with less deterioration of renal function as compared with VKAs and may confer protection against cardiovascular events not strictly related to AF, especially the acute complications of peripheral artery disease. In this narrative review, we discuss the evidence according to which it is warranted to systematically substitute NOACs for VKAs for the prevention of AF-related stroke and systemic embolism.

Aims A prolonged PR interval is known to be associated with increased mortality and a higher risk of developing atrial fibrillation (AF). We tested the hypothesis that cardiac resynchronization therapy (CRT) is superior to conventional dual-chamber pacing with algorithms for right ventricular pacing avoidance (DDD-VPA) in preserving systolic and diastolic function and in preventing new-onset AF in patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220 ms). Methods and results We randomly assigned 82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220 ms to CRT or to DDD-VPA. On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291). The E to A mitral wave amplitude ratio was higher in the CRT arm (1.3 ± 1.3 vs. 0.8 ± 0.4, P = 0.046) and the E wave deceleration time was longer (262 ± 83 ms vs. 205 ± 51 ms, P = 0.027). Left atrial volume was smaller in the CRT arm (64 ± 17 mL vs. 84 ± 25 mL, P = 0.035). Moreover, the functional class was lower in CRT patients (1.4 ± 0.6 vs. 1.8 ± 0.5, P = 0.010). During follow-up, CRT was associated with a lower risk of new-onset AF [hazard ratio = 0.37 (0.13–0.98), P = 0.046]. Conclusion Cardiac resynchronization therapy proved superior to DDD-VPA in terms of better diastolic function, less left atrial enlargement and lower risk of new-onset AF, at 12 months. These data need to be confirmed in a larger trial with longer follow-up. Clinical trial registration URL: http://clinicaltrials.gov/ Identifier: NCT02150538

Aims Per standard of care, dual-chamber pacemakers are programmed in DDDR mode with fixed atrioventricular (AV) delay or with long AV delay to minimize ventricular pacing. We aimed to evaluate whether the PR interval may be a specific criterion of choice between standard DDDR, to preserve AV synchrony in long PR patients, and managed ventricular pacing (MVP), to avoid ventricular desynchronization imposed by right ventricle apical pacing, in short PR patients. Methods and results In the MINERVA trial, 1166 patients were randomized to Control DDDR, MVP, or atrial anti-tachycardia pacing plus MVP (DDDRP + MVP). We evaluated the interaction of PR interval with pacing mode by comparing the risk of atrial fibrillation (AF) longer than 7 consecutive days as a function of PR interval. Out of 906 patients with available data, the median PR interval was 180 ms. The PR interval was found to significantly (P = 0.012) interact with pacing mode for AF incidence: the risk of AF > 7 days was lower [hazard ratio (HR) 0.58, 95% confidence interval (95% CI) 0.34-0.99; P = 0.047] in patients with short PR (shorter than median PR) if programmed in MVP mode compared with DDDR mode and it was lower (HR 0.65, 95% CI 0.43-0.99; P = 0.049) in patients with long PR (equal to or longer than median PR) if programmed in DDDR mode compared with MVP. Conclusion Our data show that PR interval may be used as a selection criterion to identify the optimal physiological pacing mode. Persistent AF incidence was lower in short PR patients treated by right ventricular pacing minimization and in long PR patients treated by standard dual-chamber pacing.

Aims We developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators. Methods and results The SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 [95% confidence interval (CI): 0.83–0.95] with 2.73 odds ratio (CI 1.98–3.78) for first HF hospitalization per unitary increase of index value (P Conclusion With the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year.

Aims Patients with permanently increased risk of sudden cardiac death (SCD) can be protected by implantable cardioverter defibrillators (ICD). If an ICD must be removed due to infection, for example, immediate reimplantation might not be possible or indicated. The wearable cardioverter defibrillator (WCD) is an established, safe and effective solution to protect patients from SCD during this high‐risk bridging period. Very few economic evaluations on WCD use are currently available. Methods We conducted a systematic review to evaluate the available evidence of WCD in patients undergoing ICD explant/lead extraction. Additionally, a decision model was developed to compare use and costs of the WCD with standard therapy (in‐hospital stay). For this purpose, a cost‐minimization analysis was conducted, and complemented by a one‐way sensitivity analysis. Results In the base case scenario, the WCD was less expensive compared to standard therapy. The cost‐minimization analysis showed a cost reduction of €1782 per patient using the WCD. If costs of standard care were changed, cost savings associated with the WCD varied from €3500 to €0, assuming costs for standard care of €6800 to €3600. Conclusion After ICD explantation, patients can be safely and effectively protected from SCD after hospital discharge through WCD utilization. Furthermore, the use of a WCD for this patient group is cost saving when compared to standard therapy.

AIM: Adherence to guidelines was not homogeneous in Europe, according to the survey on cardiac resynchronization therapy conducted in 2008-2009. The aim of our study was to compare the results in the Italian and European cohorts of the Second European Cardiac Resynchronization Therapy Survey. METHODS: Patients' characteristics, procedural data and follow-up were collected. Italian records were compared with European countries. RESULTS: Italian hospitals enrolled 526 patients. The italian cohort was older (71.6 ± 9.5 vs. 68.4 ± 10.8; P II 47.2 vs. 59.6%; P

The frequency of premature atrial complexes (PACs) has been related with atrial fibrillation (AF) occurrence and adverse prognosis. Research objective was to evaluate whether temporal patterns of PACs are directly associated with AF onset in pacemaker patients with continuous monitoring of the atrial rhythm. Overall, 193 pacemaker patients (49% female, 72 ± 9 years old), enrolled in a national registry, were analyzed. Frequency of daily PACs was measured in a 14-day initial observation period, during which patients were in sinus rhythm. In the following period, temporal occurrence and frequency of daily PACs and eventual onset of AF were derived by pacemaker diagnostics. In the run-in period, median PACs frequency was 614 PACs/day (interquartile range 70–3056). Subsequently, in a median follow-up of 6 months, AF occurred in 109 patients, in particular in 37/96 (38.5%) patients with a PAC rate

Background Professional guidelines are based on the best available evidence. However, patients treated in clinical practice may differ from those included in reference trials. Objective The aim of this study was to evaluate the effects of cardiac resynchronization therapy (CRT) in a large population of patients implanted with a CRT device stratified in accordance with the 2016 European heart failure (HF) guidelines. Methods We collected data on 930 consecutive patients from the Cardiac Resynchronization Therapy MOdular REgistry. The primary end point was a composite of death and HF hospitalization. Results Five hundred sixty-three (60.5%) patients met class I indications, 145 (15.6%) class IIa, 108 (11.6%) class IIb, and 114 (12.3%) class III. After a median follow-up of 1001 days, 120 (14.7%) patients who had an indication to CRT had died and 71 (8.7%) had been hospitalized for HF. The time to the end point was longer in patients with a class I indication (hazard ratio 0.55; 95% confidence interval 0.39–0.76; P = .0001). After 12 months, left ventricular (LV) end-systolic volume had decreased by ≥15% in 61.5% (320/520) of patients whereas in 57.5% (389/676) of patients the absolute LV ejection fraction improvement was ≥5%. Adherence to class I was also associated with an absolute LV ejection fraction increase of >5% (P = .0142) and an LV end-systolic volume decrease of ≥15% (P = .0055). Conclusion In our population, ∼60% of patients underwent implantation according to the 2016 European HF guidelines class I indication. Adherence to class I was associated with a lower death and HF hospitalization rates and better LV reverse remodeling.

Background Atrial tachyarrhythmias (AT/AF) have been associated with an increased risk of mortality, morbidity and ischemic stroke. Up to now, single chamber ICD diagnostics was not able to detect AT/AF, therefore the incidence of new onset AT/AF in patients with single chamber ICD is not known. Objective To evaluate incidence and predictors of AT/AF occurrence in patients with dual-chamber ICD with no pacing indications and no history of AT/AF that strictly mimic single chamber ICD recipient. Methods & results Consecutive dual-chamber ICD patients were prospectively followed by 47 Italian cardiologic centers in an observational research. Clinical and device data were reviewed by expert cardiologists to assess AT/AF occurrence. Multivariate regression analysis evaluated the risk of new-onset AT/AF and its association with patients' baseline characteristics and with CHADS 2 score. 428 (13.4% female, 64years old) patients were followed for a median observation period of 31months. AT/AF episodes occurred in 160 (37.4%) patients when considering at least 5min duration, in 95 (22.2%) for AT/AF ≥6h, in 47 (11.0%) for AT/AF ≥1day, in 29 (6.8%) for AT/AF ≥7days. Patients with CHADS 2 ≥2, who comprised 36% of the whole population, showed higher incidence of AT/AF ≥6h compared with patients with CHADS 2 p =0.011). Conclusions Our observations in a population of dual-chamber ICD patients with no pacing indications and no history of AT/AF, who strictly mimic single–chamber ICD recipients, highlight that AT/AF episodes occurred in the 37.5% of the population and CHADS 2 score is predictive of new-onset AT/AF.

Atrial fibrillation is the most common sustained arrhythmia encountered in primary care practice and represents a significant burden on the health care system with a higher than expected hospitalization rate from the emergency department. The first goal of therapy is to assess the patient's symptoms and hemodynamic status. There are multiple acute management strategies for atrial fibrillation including heart rate control, immediate direct-current cardioversion, or pharmacologic cardioversion. Given the variety of approaches to acute atrial fibrillation, it is often difficult to consistently provide cost-effectiveness care. The likelihood of spontaneous conversion of acute atrial fibrillation to sinus rhythm is reported to be really high. Although active cardioversion of recent-onset atrial fibrillation is generally considered to be safe, the question arises of whether the strategy of immediate treatment for a condition that is likely to resolve spontaneously is acceptable for hemodynamically stable patients. Based on published data, non-managed acute treatment of atrial fibrillation appears to be cost-saving. The observation of a patient with recent-onset atrial fibrillation in a dedicated unit within the emergency department reduces the need for acute cardioversion in almost two-thirds of the patients, and reduces the median length of stay, without negatively affecting long-term outcome, thus reducing the related health care costs. However, to let these results broadly applicable, defined treatment algorithms and access to prompt follow-up are needed, which may not be practical in all settings.

Efficacy and safety of dronedarone was shown in the ATHENA trial for paroxysmal or persistent atrial fibrillation (AF) patients. Further trials revealed safety concerns in patients with heart failure and permanent AF. This review summarizes insights from recent real-world studies and meta-analyses, including reports on efficacy, with focus on liver safety, mortality risk in patients with paroxysmal/persistent AF, and interactions of dronedarone with direct oral anticoagulants. Reports of rapidly progressing liver failure in dronedarone-prescribed patients in 2011 led to regulatory cautions about potential liver toxicity. Recent real-world evidence suggests dronedarone liver safety profile is similar to other antiarrhythmics and liver toxicity could be equally common with many Class III antiarrhythmics. Dronedarone safety concerns (increased mortality in patients with permanent AF) were raised based on randomized controlled trials (RCT) (ANDROMEDA and PALLAS), but comedication with digoxin may have increased the mortality rates in PALLAS, considering the dronedarone–digoxin pharmacokinetic (PK) interaction. Real-world data on apixaban–dronedarone interactions and edoxaban RCT observations suggest no significant safety risks for these drug combinations. Median trough plasma concentrations of dabigatran 110 mg during concomitant use with dronedarone are at acceptable levels, while PK data on the rivaroxaban–dronedarone interaction are unavailable. In RCTs and real-world studies, dronedarone significantly reduces AF burden and cardiovascular hospitalizations, and demonstrates a low risk for proarrhythmia in patients with paroxysmal or persistent AF. The concerns on liver safety must be balanced against the significant reduction in hospitalizations in patients with non-permanent AF and low risk for proarrhythmias following dronedarone treatment.

Objectives The aim of the study was to confirm the value of the VALID‐cardiac resynchronization therapy (CRT) risk score in predicting outcome and to assess its association with clinical response (CR) in an unselected real‐world CRT population. Methods and Results The present analysis comprised all consecutive CRT patients (pts) enrolled in the CRT‐MORE registry from 2011 to 2013. Pts were stratified into five groups (quintiles 1‐5) according to the VALID‐CRT risk predictor index applied to the CRT‐MORE population. In the analysis of clinical outcome, adverse events comprised death from any cause and non‐fatal heart failure (HF) events requiring hospitalization. CR at 12‐month follow‐up was also assessed. We enrolled 905 pts. During a median follow‐up of 1005 [627‐1361] days, 134 patients died, and 79 had at least one HF hospitalization. At 12 months, 69% of pts displayed an improvement in their CR. The mean VALID‐CRT risk score derived from the CRT‐MOdular Registry (MORE) population was 0.317, ranging from −0.419 in Q1 to 2.59 in Q5. The risk‐stratification algorithm was able to predict total mortality after CRT (survival ranging from 93%‐Q1 to 77%‐Q5; hazards ratio [HR] = 1.42, 95% confidence interval [CI]: 1.25‐1.61, P

Background Because 20% to 40% of patients undergoing cardiac resynchronization therapy (CRT) do not respond to it, identification of potential factors predicting response is a relevant research topic. Hypothesis There is a possible association between right ventricular function and response to CRT. Methods We analyzed 227 patients from the Cardiac Resynchronization Therapy Modular Registry (CRT-MORE) who received CRT according to current guidelines from March to December 2013. Response to therapy was defined as a decrease of ≥15% in left ventricular end-systolic volume (LVESV) at 6 months. Results The tricuspid annular plane systolic excursion (TAPSE) value that best predicted improvement in LVESV (sensitivity 68%, specificity 54%) was 17 mm. Stratifying patients according to TAPSE, LVESV decreased ≥15% in 78% of patients with TAPSE >17 mm (vs 59% in patients with TAPSE ≤17 mm; P = 0.006). At multivariate analysis, TAPSE >17 mm was independently associated with LVESV improvement (odds ratio: 1.97, 95% confidence interval: 1.03-3.80, P 17 mm vs 55% in patients with TAPSE

Atrial fibrillation (AF) is a relevant cardiovascular condition that is more prevalent in the elderly patients aged over 65 years. AF, with abnormal rate and rhythm can cause symptoms directly or indirectly by exacerbating other frequently coexisting cardiac conditions such as valvular heart disease, hypertension, ischemic cardiomyopathy, dilated cardiomyopathy, and hypertrophic cardiomyopathy. Evidence suggests that aging-related cardiovascular changes predispose to the elderly to AF. Current therapeutic options such as antiarrhythmic drugs have not been extensively evaluated in the elderly population. Emerging pharmacological and non-pharmacological treatment options for the management of AF, such as dronedarone or catheter ablation, are of particular interest in the elderly. The present paper reviews the pathophysiology, diagnosis, and the management of AF in the elderly patient.

Background: The subcutaneous implantable cardioverter defibrillator (S-ICD) is a relatively novel alternative to the transvenous ICD for the treatment of life-threatening ventricular arrhythmias, and is currently used in the clinical practice of several centers. The aim of this analysis was to describe current Italian practice regarding S-ICD implantation and its evolution over the years. Methods: We analyzed 607 consecutive patients (78% male, 48 ± 16 years) who underwent S-ICD implantation in 39 Italian centers from 2013 to 2017. Results: Structural cardiomyopathy was present in 78% of patients and 30% of patients received their device for secondary prevention. The proportion of patients with dilated cardiomyopathy and with left ventricular ejection fraction ≤35% increased from ≤2014 to 2017 (from 38% to 58%, from 33% to 53%, respectively; both p < 0.05). Almost all procedures (97%) were performed in electrophysiology laboratories. Over the last 4 years, the 2-incision implantation technique has been widely adopted, with sub- or inter-muscular positioning of the generator, under local anesthesia or deep sedation (≤2014 versus 2017: all p < 0.001). Defibrillation testing was performed in 81% of patients. Shock energy of ≤65 J was successful in 93.9% of patients and the overall cardioversion success rate at ≤80 J was 99.8%. Conclusions: Our analysis confirmed that the S-ICD continues to be preferentially used in specific patients (younger, less frequently with dilated cardiomyopathy and low ejection fraction.). Nonetheless, we noted a trend toward the wider use of S-ICD in patients with dilated cardiomyopathy and systolic dysfunction over the years. Novel approaches have been adopted while the acute efficacy of the system has remained stably high.

Background:\ud \ud Cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure and is strongly recommended for such patients by guidelines. A European Society of Cardiology (ESC) CRT survey conducted in 2008–2009 showed considerable variation in guideline adherence and large individual, national and regional differences in patient selection, implantation practice and follow-up. Accordingly, two ESC associations, the European Heart Rhythm Association and the Heart Failure Association, designed a second prospective survey to describe contemporary clinical practice regarding CRT.\ud Methods and results:\ud \ud A survey of the clinical practice of CRT-P and CRT-D implantation was conducted from October 2015 to December 2016 in 42 ESC member countries. Implanting centres provided information about their hospital and CRT service and were asked to complete a web-based case report form collecting information on patient characteristics, investigations, implantation procedures and complications during the index hospitalisation. The 11 088 patients enrolled represented 11% of the total number of expected implantations in participating countries during the survey period; 32% of patients were aged ≥75 years, 28% of procedures were upgrades from a permanent pacemaker or implantable cardioverter-defibrillator and 30% were CRT-P rather than CRT-D. Most patients (88%) had a QRS duration ≥130 ms, 73% had left bundle branch block and 26% were in atrial fibrillation at the time of implantation. Large geographical variations in clinical practice were observed.\ud Conclusion:\ud \ud CRT Survey II provides a valuable source of information on contemporary clinical practice with respect to CRT implantation in a large sample of ESC member states. The survey permits assessment of guideline adherence and demonstrates variations in patient selection, management, implantation procedure and follow-up strategy.

Heart failure is a leading cause of hospitalization and a significant medical burden in our society. Implantable medical devices are nowadays established therapies in heart failure patients that not only provide cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillators (ICDs) therapy but are also able to continuously and remotely monitor diagnostic information of various physiologic parameters. The value of combining individual diagnostic variables to predict worsening of heart failure is still largely unclear but could eventually become a valuable tool towards a better heart failure management.SELENE HF (Selection of potential predictors of worsening Heart Failure) is an observational, multicentre study designed to prospectively collect follow-up and home monitoring data trends from a population of individuals with ICDs with or without resynchronization therapy (CRT-D), to document heart failure hospitalizations and deaths and to correlate these events with Home Monitoring data in order to identify the combination with the greatest sensitivity and specificity in predicting heart failure events.The purpose of this study is to describe the design of the study focusing on the Heart Failure Predicting model and statistical approach that will be used to analyse the data.The results of the SELENE HF study could help to select and define potential predictors of worsening heart failure in patients with remotely monitored ICD or CRT-D devices.ClinicalTrials.gov Identifier NCT01836510.

BACKGROUND: Pacing in the right ventricle can cause a variety of detrimental effects, including atrial tachyarrhythmias (AT/AF).OBJECTIVE: To evaluate incidence and predictors of persistent AT/AF in patients with long term exposure to ventricular pacing.METHODS: In a multi-center international trial, 605 patients (75±11 years, 240 females), referred for replacement of an implanted pacemaker or cardioverter defibrillator (ICD), with history of high percentage (>40%) ventricular pacing, were randomly allocated to standard dual-chamber pacing or Managed Ventricular Pacing (MVP), a pacing modality which minimizes ventricular pacing. Main end point of this secondary analysis of the PreFER MVP randomized study was persistent AT/AF, defined as ≥7 consecutive days with AT/AF or AT/AF interrupted by atrial cardioversion or AT/AF present during 2 consecutive follow-up visits.RESULTS: Persistent AT/AF was observed in 71 patients (11.7%) after 2 years of follow-up. At multivariable Cox regression analysis, prior AT/AF (hazard ratio (HR)=2.85, 95% confidence intervals (CI)=1.20-6.22, p=0.017) and ventricular pacing percentage, estimated in the first 3 months, ≥10% (HR=3.24, CI=1.13-9.31, p=0.029) resulted as independent predictors for persistent AT/AF. MVP was associated with persistent AT/AF risk (HR=3.41, CI=1.10-10.6, p=0.024) in the subgroup of patients with a baseline long PR interval (PR>230 ms), but not in the whole population.CONCLUSION: In pacemaker and ICD replacement patients, high percentage of ventricular pacing is associated with higher risk of persistent AT/AF. The use of algorithms which minimize right ventricular pacing may benefit patients with normal spontaneous AV conduction but should be evaluated with caution in patients with long PR interval.CLINICAL TRIAL REGISTRATION: URL http://www.clinicaltrials.gov. Identifier: NCT00293241.

Atrial tachycardia (AT) and atrial fibrillation (AF) are common in pacemaker patients and are associated with bad prognoses.The purpose of this study was to evaluate atrial antitachycardia pacing impact on AT/AF-induced atrial remodeling, measured by early recurrence of AT/AF (ERAF) and by change in left atrial diameter (LAD), and to evaluate the impact of AT/AF duration on ERAF incidence.Pacemaker patients were randomized to dual-chamber pacing (Control DDDR: 385 patients), managed ventricular pacing (MVP: 398 patients), or atrial antitachycardia pacing plus MVP (DDDRP+MVP: 383 patients). LAD change, estimated by echocardiography, was considered significant if the relative difference between baseline and 24-month measurements was10%.At median follow-up of 34 months, ERAF incidence was significantly lower in the DDDRP+MVP arm for all AT/AF durations, in particular, ERAF followed AT/AF longer than 3 hours in 53% cases in Control DDDR, in 51% cases in MVP, and in 39% cases in DDDRP+MVP (P.001 vs other groups). ERAF incidence showed a U-shaped pattern when evaluated as a function of previous AT/AF duration, decreasing for durations from 5 minutes to 12 hours and increasing for longer durations. Among patients with significant LAD change, the proportion of patients with a reduction in LAD was 35% in Control DDDR, 37% in MVP, and 70% in DDDRP+MVP (P.05 vs other groups).Our data suggest that atrial electrical remodeling becomes important after about 12 hours of continuous arrhythmia. Compared to DDDR or MVP, DDDRP+MVP reduces ERAF and favors LAD reduction, suggesting that atrial antitachycardia pacing may reverse electrical and mechanical remodeling.

Among atrial tachyarrhythmias (AT), atrial fibrillation (AF) is the most common sustained arrhythmia. Many patients with AT have no symptoms during brief or even extended periods of the arrhythmia, making detection in patients at risk for stroke challenging. Subclinical atrial tachyarrhythmia and asymptomatic or silent atrial tachyarrhythmia often precede the development of clinical AF. Clinical AF and subclinical atrial fibrillation (SCAF) are associated with an increased risk of thromboembolism. Indeed, in many cases, SCAF is discovered only after complications such as ischaemic stroke or congestive heart failure have occurred

Introduction The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers. Material and methods The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables. Discussion This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID: NCT01647490 ). Trial registration Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov : NCT01647490 .

Atrial fibrillation (AF) is the most frequent cardiac rhythm disorder and presents a considerable public health burden that is likely to increase in the next decades due to the ageing population. Current management strategies focus on the heart rate and rhythm control, thromboembolism prevention, and treatment of underlying diseases. The concept of quality of life (QoL) has gained significant importance in recent years as an outcome measure in AF studies evaluating therapeutic interventions and as a relevant component of a comprehensive treatment plan. Quality of life is impaired in the majority of patients with AF, and both rate and rhythm control strategies show significant improvement in QoL measures in highly symptomatic patients. This article reviews generic and specialized instruments for measuring QoL in the context of AF, discusses their applications and limitations to integration in clinical practice, and addresses the potential of early therapy for improving QoL outcomes. The development and validation of new QoL assessment tools will have a central role in the advancement of therapies and treatment guidelines for AF.

CRT Patient Characteristics and Outcomes. Introduction: The characteristics and outcomes of patients who undergo cardiac resynchronization therapy (CRT) device implantation in current clinical practice may differ from those of reference trial populations. Study objectives were to assess 2-year outcomes in a population implanted with a CRT plus defibrillator device in accordance with the standard of care and to evaluate any independent association between clinical variables and outcome. Methods and Results: A total of 406 patients enrolled at 35 centers in Italy were followed up prospectively for 2 years. All patient management decisions were left to the treating physician's discretion, in accordance with clinical practice. ACTION-HF patients had a better baseline clinical status than patients enrolled in the COMPANION study: shorter HF history (1 vs 3.5 years, P

Objectives The purpose of this analysis was to evaluate the correlation between atrial tachycardia (AT) or atrial fibrillation (AF) and clinical outcomes in heart failure (HF) patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D). Background In HF patients, AT and AF have high prevalence and are associated with compromised hemodynamic function. Methods Forty-four Italian cardiological centers followed up 1,193 patients who received a CRT-D according to current guidelines for advanced HF, New York Heart Association functional class ≥II, left ventricular ejection fraction ≤35%, and QRS complex ≥120 ms. All patients were in sinus rhythm at implant. Results During a median follow-up period of 13 months, AT/AF >10 min occurred in 361 of 1,193 (30%) patients. The composite end point (deaths or HF hospitalizations) occurred in 174 of 1,193 (14.6%). Multivariate time-dependent Cox regression analyses showed that composite end point risk was higher among patients with device-detected AT/AF (hazard ratio [HR]: 2.16, p = 0.032), New York Heart Association functional class III or IV compared with II (HR: 2.09, p = 0.002), and absence of beta-blockers (HR: 1.36, p = 0.036). Furthermore, the composite end point risk was inversely associated with left ventricular ejection fraction (HR: 1.04, p = 0.045), increasing by a factor of 4% for each 1% decrease in left ventricular ejection fraction. Conclusions In HF patients with CRT-D, device-detected AT/AF is associated with a worse prognosis. Continuous device diagnostics monitoring and Web-based alerts may inform the physician of AT/AF occurrences and identify patients at risk of cardiac deterioration or patients with suboptimal rate or rhythm control. (Italian ClinicalService Project; NCT01007474 )

Background Pill-in-the-pocket treatment should be prescribed only if the administration of a loading oral dose of flecainide or propafenone has been proved safe in hospital, since major adverse effects have been reported in 5% of patients during in-hospital treatment. However, in emergency rooms, the oral administration of these drugs for the conversion of atrial fibrillation (AF) is very rarely used because it is time consuming. Objective To investigate whether tolerance to intravenous administration of flecainide or propafenone might predict the safety of pill-in-the-pocket treatment—the out-of-hospital self-administration of these drugs after the onset of palpitations—in patients with AF of recent onset. Methods One hundred and twenty-two patients with AF of recent onset who were successfully treated (conversion of AF within 2 h without major adverse effects) in hospital with intravenous flecainide or propafenone were discharged on pill-in-the-pocket treatment. Results During a mean follow-up of 11±4 months, 79 patients self-treated 213 arrhythmic episodes; treatment was successful in 201 episodes (94%). Major adverse events occurred in five patients (6%) and in four (5%) of these during the first oral treatment (one syncope, two presyncope, one sinus arrest). No patient reported symptoms attributable to bradyarrhythmia or hypotension during the self-treatment of arrhythmic recurrences when the first oral treatment was not accompanied by any major adverse effects. The study was prematurely terminated because of the high incidence of major adverse effects during the first out-of-hospital treatment. Conclusion The patient9s tolerance of intravenous administration of flecainide or propafenone does not seem to predict adverse effects during out-of-hospital self-administration of these drugs.

Atrial fibrillation (AF) is associated with impaired functional capacity and quality of life and significant morbidity and mortality. The current management approach fails to maintain stable sinus rhythm (SR) in the majority of patients. For many years, guidelines have recommended antiarrhythmic treatment of a first AF episode only if the AF is poorly tolerated, a position that has been reinforced by studies showing no mortality or morbidity advantage of rhythm control over rate control. During the last decade, research has shown mechanisms of self-perpetuation of AF based on electrophysiological and structural remodelling induced by AF itself. There is mounting evidence that 'lone' AF is because of a host of factors, some of which may be easily treatable, such as hypertension, sleep apnoea, and obesity, thus allowing secondary prevention at the time of the first episode of AF. According to these concepts, lack of early intervention could be one of the reasons for long-term failure of maintenance of SR. In this position paper, we propose testing the working hypothesis that if an SR maintenance strategy is selected, treatment of AF should commence at the first-detected episode and should be based on a double strategy of SR restoration and aggressive treatment of associated conditions that promote atrial remodelling.

Background: Most clinical trials that have tested pacing therapies to prevent and treat atrial tachyarrhythmias (AT) have chosen endpoints such as AT frequency or burden (defined as percentage of time a patient is in AT), but failed to show unequivocal evidence of a clinical impact. Aim: The aim of our multicenter prospective observational study was to measure the variability of AT burden and estimate its impact on study outcomes. Methods and Results: Two hundred and fifty patients indicated for permanent pacing and suffering from AT (age 71 ± 9 years; 47.2% male) received a dual-chamber pacemaker. AT burden was measured in two consecutive, 2-month observation periods; the Monte Carlo method was then applied to simulate findings of a crossover design study. We simulated several models of therapy impact, each model being characterized by the percentage of responder patients and the percentage reduction in AT burden. To show a significant impact of AT therapies in a sample of 250 patients in whom 100, 75, or 50% would be theoretical responders to therapies, AT burden reduction should be at least 27, 32, or 57%, respectively. Temporal fluctuations in AT burden were so high that about 60% of patients would falsely appear as responders or nonresponders in a crossover study, regardless of AT burden reduction. Conclusions: In patients paced for bradycardia and suffering from AT, high intrapatient variability in AT burden was measured. Various models of therapy impact showed that, in crossover trials of AT therapies, time-related fluctuations in AT burden negatively impact on sample sizes and impair the ability to identify patients as responders or nonresponders.

Accurate selection of patients with left bundle branch block (LBBB) may help increasing response to cardiac resynchronization therapy (CRT). There is no agreement on LBBB definition. The aim of the study was to investigate the prevalence of 'true-LBBB' according to Strauss in patients undergoing CRT.The study population included 414 consecutive patients (71.9% men; mean age 69.7 ± 9.6 years), who underwent CRT according to 2010 European Society of Cardiology (ESC) guidelines. Patients were classified into three groups: traditional LBBB according to American Heart Association, LBBB according to Strauss and intraventricular conduction delay (IVCD). Subsequently, they were re-classified into classes of recommendations, according to the current 2013 ESC Guidelines. Traditional LBBB was recorded in 229 patients (55%), an LBBB according to Strauss in 153 (37%) and an IVCD in 32 (8%). Patients with an LBBB according to Strauss showed a significantly more prolonged QRS duration (P 0.001), greater baseline end-systolic and end-diastolic volumes (P = 0.011 and P = 0.013, respectively) compared with those with IVCD. The prevalence of mid-QRS notching in at least two contiguous leads was 100% in LBBB according to Strauss; 24% in traditional LBBB and 21.9% in IVCD (P 0.001). At multivariate analysis, PR interval less than 200 ms and QRS of at least 150 ms were independent predictors of mid-QRS notching [odds ratio (OR) 1.78; 95% confidence interval (95% CI) 1.10-2.88; P = 0.02 and OR 2.88; 95% CI 1.80-4.62;P 0.0001]. Applying stricter criteria for LBBB according to Strauss, a significant reduction in Class I recommendation and an increase in Class II was observed (90.1 vs. 37%; P 0.0001 and 9.9 vs. 63%; P 0.0001).Applying stricter criteria, only 37% of patients undergoing CRT showed a true-LBBB according to Strauss. Accurate identification of true-LBBB may have a potential additional value in better selecting patients.

Background The implantation strategy appears to play a pivotal role in determining response to cardiac resynchronization therapy (CRT). Objective The aim of our study was to determine the association between anatomic and electrical interlead distance and clinical outcome after CRT implantation. Methods We included 216 first-time CRT recipients with left bundle branch block and sinus rhythm. On implantation, the electrical interlead distance (EID), defined as the time interval between spontaneous peak R waves detected at the right ventricular (RV) and left ventricular (LV) pacing sites, was measured. The anatomic distance between the RV and LV lead tips was determined on chest radiographs. Results The mean EID was 74 ± 41 ms, and the mean horizontal corrected interlead distance (HCID) was 125 ± 73 mm. After 12 months, 87 patients (40%) displayed an improvement in their clinical composite score. The cutoff values that best predicted an improved clinical status were as follows: 84 ms for EID (area under the curve 0.59; confidence interval [CI] 0.52-0.66; P =.026) and 90 mm for HCID (area under the curve 0.62; CI 0.55-0.69; P =.004). On multivariate analysis, only EID >84 ms (hazard ratio 0.36; CI 0.14-0.89; P =.028) and HCID >90 mm (hazard ratio 0.45; CI 0.23-0.90; P =.025) were significantly associated with the composite endpoint of death or cardiovascular hospitalization. In particular, the presence of both conditions (EID

Background DOACs are increasingly used in patients with NVAF. Information on efficacy and safety of these compounds in patients undergoing electrical or pharmacological cardioversion is limited. Thus, we performed a systematic review and a meta-analysis of the literature to address this issue. Methods Randomized controlled trials comparing the efficacy and safety of DOACs and VKAs in patients with NVAF were systematically searched in Medline, Web of Science, Scopus, Cochrane, and EMBASE databases (up to September 2014). Pooled relative risk (RR) and the corresponding 95% confidence interval (CI) were calculated for each outcome. Results Four randomized controlled trials (3635 patients), for a total of 4517 cardioversions (2869 with DOACs and 1648 with VKAs), were included in the analysis. DOACs and VKAs appeared equally effective in the prevention of stroke/systemic embolism (0.41% vs 0.61%; RR: 0.73, 95% CI: 0.31, 1.72; P=0.48) and of post-cardiovascular death (0.52% vs 0.81%; RR: 0.73, 95% CI: 0.27, 2.03; P=0.55), with a similar risk of major bleeding complications (0.81% vs 0.60%; RR: 1.23, 95% CI: 0.55, 2.71). Heterogeneity among studies was generally absent. Furthermore, the Weighted Mean Incidence (WMI) of complications appeared very low in patients randomized to DOACs (WMI: 0.6% and 0.9% for stroke/systemic embolism and major bleeding, respectively). Conclusion Our results suggest that DOACs are at least as effective and safe as VKAs in patients with NVAF undergoing to an electrical or pharmacological cardioversion. Thus, DOACs may be considered a valid and practical alternative to VKAs.

This editorial refers to ‘Effect of cardiac resynchronization therapy and implantable cardioverter defibrillator on quality of life in patients with heart failure: a meta-analysis’ by S. Chen et al ., on page 1602 Heart failure (HF) is a syndrome that poses a substantial clinical and economic burden.1 Frequently, life-threatening ventricular arrhythmias may also accompany this condition.1 In the past, two large randomized clinical trials (RCTs), MADIT II (Multicenter Automatic Defibrillator Implantation Trial), and SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial),2,3 have demonstrated that implantable cardioverter-defibrillator (ICD) therapy produces a significant reduction in total mortality when used for primary prevention in patients at risk for sudden cardiac death. Although ICDs reduce the risk of life-threatening ventricular arrhythmias, they have no effect on ventricular structure and function, and underlying cardiomyopathy hence remains unchanged. Biventricular pacing, introduced into clinical practice in the early 1990s, has become an accepted therapeutic modality for patients with HF in addition to optimum medical therapy (OMT). This novel pacing strategy, more generally defined cardiac resynchronization therapy (CRT), restores synchronized ventricular contraction, which consequently results in an improved pumping efficiency, enhanced left ventricular filling, and a reduction in the severity of mitral regurgitation. Cardiac resynchronization therapy has substantially modified the natural history of HF, exerting its physiological impact through favourable ventricular remodelling, with a reduction in left ventricular volumes and improvement in left ventricular ejection fraction (LVEF). This in turn translates into long-term clinical benefits such as improved symptoms, and functional capacity, with a concomitant reduction in hospitalization for HF and overall mortality.4 However, whether the combination of CRT and ICD (CRT-D) would bring any additional benefit over CRT or ICD alone has been a matter of debate for a long while. In a systematic review of 4420 patients in 14 trials, McAlister …

Atrial fibrillation has a high incidence in patients wearing an implantable cardioverter defibrillator for ventricular tachyarrhythmias and may lead to palpitations, heart failure, angina, stroke and inappropriate defibrillator discharge. The aim of the study was to evaluate the efficacy of a dual chamber defibrillator with atrial antitachycardia functions in treating spontaneous atrial tachyarrhythmias.One hundred and twelve patients, 88 male, mean age 64+/-11 years, were enrolled. Seventy-six had ischaemic heart disease, 21 idiopathic dilated cardiomyopathy, nine other heart diseases, six no structural heart disease. The mean left ventricular ejection fraction was 40+/-11%. Sixty-two had prior atrial tachyarrhythmias.Follow-up lasted 11+/-9 months (range 1-42). Among 933 ventricular tachyarrhythmia episodes, 100% of ventricular fibrillation and 92% of ventricular tachycardia were successfully cardioverted. Among 414 detected sustained atrial tachyarrhythmias, 195 were classified as atrial tachycardia (47.1%), 192 as atrial fibrillation (46.4%) and 27 (6.5%) as sinus rhythm. The detection-positive predictive value was 93.5%. Therapy success rates: antitachy pacing on atrial tachycardia = 71.3% (crude estimate); 66.1% (adjusted estimate); 50 Hertz on atrial fibrillation=36.2% (crude estimate); 13.5% (adjusted estimate); atrial shock on atrial fibrillation = 62.5% (mean energy 7.8+/-14.1J). Shock efficacy was 32% when delivered energy wasor = 2 atrial defibrillation threshold at implant and 92% when2. Duration of successfully treated atrial episodes was significantly lower than that of unsuccessfully treated (6+/-26 min vs 42+/-60).Atrial antitachy pacing and shock therapies demonstrated very high efficacy in treating atrial tachyarrhythmias in defibrillator patients.

Aims Permanent atrial fibrillation develops in many patients after ablation and pacing therapy. We compared a strategy that initially allowed patients to remain in atrial fibrillation with a strategy that initially attempted to restore and maintain sinus rhythm. Methods and Results In this multicentre randomized controlled trial, 68 patients affected by severely symptomatic paroxysmal atrial fibrillation were assigned, after successful atrioventricular junction ablation and pacing treatment, to antiarrhythmic drug therapy with amiodarone, propafenone, flecainide or sotalol and were compared with 69 patients assigned, after successful AV junction ablation and pacing treatment, to no antiarrhythmic drug therapy. The patients were followed-up for 12 to 24 months (mean 16±4). The drug arm patients had a 57% reduction in the risk of developing permanent atrial fibrillation (21% vs 37%, P =0·02). Evaluation after 12 months revealed similar quality of life scores and echocardiographic parameters in the two groups, but the drug arm patients had more episodes of heart failure and hospitalizations ( P =0·05). The outcome was similar between the 40 patients who developed permanent atrial fibrillation and the 97 who did not. Conclusion Conventional antiarrhythmic therapy reduces the risk of development of permanent atrial fibrillation after ablation and pacing therapy. The present data do not support the concept that the development of permanent atrial fibrillation is related to an adverse outcome when a perfect control of heart rate is obtained by ablation and pacing. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved

Background and Purpose— In patients with atrial fibrillation (AF), stroke risk stratification schema do not consider AF parameters. The aim of the study is to assess the impact of combining risk factors with continuous AF burden monitoring. Methods— In this retrospective study 568 patients implanted with a DDDR-P pacemaker (AT-500; Medtronic) and a history of AF were continuously monitored for 1 year. Results— During follow-up, 14 patients (2.5%) had a thromboembolic event. Patients were divided into 3 groups: AF burden ≤5 minutes per day (AF-free; n=223 [39%]), AF burden >5 minutes but 2 and CHA 2 DS 2 -VASc risk scores. The discrimination ability of each risk score was evaluated performing a logistic regression analysis and calculating the corresponding C-statistic. The addition of AF burden improved C-statistics: for CHADS 2 from 0.653 ( P =0.051) to 0.713 ( P =0.007); for CHA 2 DS 2 -VASc, from 0.898 ( P P Conclusions— The CHA 2 DS 2 -VASc score had a high sensitivity to predict thromboembolism. Implementation of device data on AF presence/duration/burden has the potential to contribute to improved clinical risk stratification and should be tested prospectively.

Aims Atrial fibrillation (AF) is a common comorbidity in bradycardia patients. Advanced pacemakers feature atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), which minimizes unnecessary right ventricular pacing. We evaluated whether DDDRP and MVP might reduce mortality, morbidity, or progression to permanent AF when compared with standard dual-chamber pacing (Control DDDR). Methods and results In a randomized, parallel, single-blind, multi-centre trial we enrolled 1300 patients with bradycardia and previous atrial tachyarrhythmias, in whom a DDDRP pacemaker had recently been implanted. History of permanent AF and third-degree atrioventricular block were exclusion criteria. After a 1-month run-in period, 1166 eligible patients, aged 74 ± 9 years, 50% females, were randomized to Control DDDR, DDDRP + MVP, or MVP. Analysis was intention-to-treat. The primary outcome, i.e. the 2-year incidence of a combined endpoint composed of death, cardiovascular hospitalizations, or permanent AF, occurred in 102/385 (26.5%) Control DDDR patients, in 76/383 (19.8%) DDDRP + MVP patients [hazard ratio (HR) = 0.74, 95% confidence interval 0.55–0.99, P = 0.04 vs. Control DDDR] and in 85/398 (21.4%) MVP patients (HR = 0.89, 95% confidence interval 0.77–1.03, P = 0.125 vs. Control DDDR). When compared with Control DDDR, DDDRP + MVP reduced the risk for AF longer than 1 day (HR = 0.66, 95% CI 0.52–0.85, P < 0.001), AF longer than 7 days (HR = 0.52, 95% CI 0.36–0.73, P < 0.001), and permanent AF (HR = 0.39, 95% CI 0.21–0.75, P = 0.004). Conclusion In patients with bradycardia and atrial tachyarrhythmias, DDDRP + MVP is superior to standard dual-chamber pacing. The primary endpoint was significantly lowered through the reduction of the progression of atrial tachyarrhythmias to permanent AF. ClinicalTrials.gov Identifier NCT00262119.

AIM—To define the effect of defibrillator paddle position on technical success and dc shock energy requirements of external cardioversion of atrial fibrillation. METHODS—301 patients (mean (SD) age 62 (11) years) with stable atrial fibrillation were randomly assigned to elective external cardioversion using anterolateral paddle position (ventricular apex-right infraclavicular area; group AL (151 patients)) or anteroposterior paddle position (sternal body-angle of the left scapula; group AP (150 patients)). A step up protocol was used, delivering a 3 J/kg body weight dc shock, then a 4 J/kg shock (maximum 360 J), and finally a second 4 J/kg shock using the alternative paddle location. RESULTS—The two groups were comparable for the all clinical variables evaluated. The cumulative percentage of patients successfully converted to sinus rhythm was 58% in group AL and 67% in group AP with low energy dc shock (NS); this rose to 76% in group AL and to 87% in group AP with high energy dc shock (p = 0.013). Thirty seven patients in group AL and 19 in group AP experienced dc shock with the alternative paddle position; atrial fibrillation persisted in 10/37 in group AL and in 10/19 in group AP. Mean dc shock energy requirements were lower for group AP patients than for group AL patients, at 383 (235) v 451 (287) J, p = 0.025. Arrhythmia duration was the only factor that affected the technical success of external cardioversion (successful: 281 patients, 80 (109) days; unsuccessful: 20 patients, 193 (229) days; p 6 months: 29 of 37 (78%) v 252 of 264 (95%); p = 0.0001. CONCLUSIONS—An anteroposterior defibrillator paddle position is superior to an anterolateral location with regard to technical success in external cardioversion of stable atrial fibrillation, and permits lower dc shock energy requirements. Arrhythmia duration is the only clinical variable that can limit the restoration of sinus rhythm. Keywords: atrial fibrillation; cardioversion; electric countershock

A population of 123 patients with recent-onset (< 72 hours) atrial fibrillation (AF) without heart failure was randomly treated with propafenone (PFN) intravenously (i.v.) (2 mg/kg bolus followed by 0.0078 mg/kg/min infusion) or in a single oral dose (o.s.) (600 mg), or with placebo (PLA) (phase 1). If AF persisted 8 hours later, patients on active drugs received the alternative formulation (crossover), and patients receiving PLA remained on PLA (phase 2). A 24-hour Holter monitoring was performed and conversion to sinus rhythm (SR) at 1, 4, and 8 hours of each phase was used as the criterion of efficacy. Conversion to SR occurred within 1 hour in 48% of patients with i.v.-PFN, 15% with o.s.-PFN, and in 17% with PLA (both P < 0.05 vs i.v.-PFN). Oral PFN was superior to PLA at 4 hours (71% vs 33%, P = 0.001) and 8 hours (78% vs 48%, P < 0.01), and 1 at 8 hours also superior to i.v.-PFN (53%, P < 0.03). The mean conversion time within 4 hours was shorter with i.v.-PFN (25 +/- 15') than with o.s.-PFN (167 +/- 166', P < 0.001) or with PLA (156 +/- 107', P < 0.001). The rates of conversion to SR with i.v.-PFN after o.s.-PFN failure were comparable to PLA at any observation time, whereas nonresponders to i.v.-PFN who received o.s.-PFN had significantly higher conversion rates than with placebo at both 4 hours (65% vs 19%) and 8 hours (76% vs 24%; both P < 0.045). Neither serious adverse effects nor episodes of regular tachycardia with 1:1 AV conduction were noted. PFN administered intravenously or in a single oral loading dose was safe and efficacious in converting recent-onset AF to SR. The rates of conversion were different with different routes of administration: i.v.-PFN was superior to o.s.-PFN over a short observation period, while the overall efficacy of o.s.-PFN was superior at 8 hours.

A population of 283 patients with recent onset (< 72 hours) AF, without heart failure, who received a single 450- or 600-mg oral dose of propafenone, or digoxin 1 mg, or placebo for conversion to sinus rhythm (SR), was studied to determine whether a routine admission to the hospital for drug administration is justified. Previous bradyarrhythmias or sick sinus syndrome (SSS), and concomitant use of antiarrhythmic drugs were exclusion criteria. None of the 283 patients studied experienced VT or VF and none of them needed implantation of a temporary pacemaker. Periods of atrial tachyarrhythmias with regularization of atrial waves and 1:1 AV conduction were observed in only two cases, both receiving placebo. No predictor of proarrhythmia was found among the clinical variables considered (age, etiology, arrhythmia duration, atrial dimension, and blood potassium). No serious hemodynamic adverse effects were noted in either group. The rates of conversion to SR after 4 hours were: 80 (57%) of 141 patients who received propafenone and 35 (25%) of 142 patients who received digoxin or placebo (P < 0.001). Acute oral treatment with propafenone is simple and effective for the conversion of recent onset AF to SR in patients without clinical signs of heart failure. The routine admission of these patients to the hospital is not necessary. Home-based administration of oral propafenone to a selected group of patients could significantly increase the cost effectiveness of this treatment.

BackgroundThere’s scarce evidence about cardiovascular events (CV) in patients with hospitalization for acute heart failure (HF) and no indication for immediate device implant. ObjectiveThe CARdiac RhYthm monitorING after acute decompensatiON for Heart Failure study was designed to assess the incidence of prespecified clinical and arrhythmic events in this patient population. MethodsIn this pilot study, 18 patients (12 (67%) male; age 72±10; 16 (89%) NYHA II-III), who were hospitalized for HF with low left ventricular ejection fraction (LVEF) (

Background— Atrial fibrillation (AF) is a well-established risk factor for stroke and thromboembolism and is a frequent comorbid arrhythmia in patients with implantable cardioverter-defibrillators (ICDs). The Anticoagulation Use Evaluation and Life Threatening Events Sentinels (ANGELS) of AF project was a medical care program aimed at supporting adherence to oral anticoagulation (OAC) guidelines for thromboprophylaxis through the use of ICD AF diagnostics. Methods and Results— Fifty Italian cardiology clinics followed 3438 patients with ICDs. In a subgroup of 15 centers (the ANGELS of AF centers), cardiologists attending to follow-up visits were supplied with specific reports describing stroke risk factors and risk scores (American College of Chest Physicians and CHADS 2 [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack]), AF occurrence and duration, and current antithrombotic therapy for patients with AF, especially those with a CHADS 2 score >0 and not on OAC therapy. The remaining centers represented a control group of patients as a comparison of OAC use. In the ANGELS of AF centers, 709 (36%) patients had AF described either in their clinical history (n=426 [22%]) or as new-onset AF (n=257 [14%]). Among 683 (96%) patients with CHADS2 score >0, 209 (30.6%) were not taking an OAC. Appropriate OAC therapy was prescribed in 10% (22/209) of patients after evaluation of ANGELS of AF reports. The percentage of patients on OAC therapy, as indicated by guidelines, increased during follow-up from 46.1% at baseline, to 69.4% at the stroke risk evaluation phase, to up to 72.6% at the end of the observation period. In control centers, corresponding figures were 46.9% at baseline and 56.8% at the end of the observation period ( P Conclusions— The ANGELS of AF project demonstrates the possibility to improve OAC use in accordance with available guidelines for stroke risk reduction in AF by supplying attending physicians with reports about patients risk factors and AF information from continuous ICD monitoring. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01007474.

The incidence of fast atrial tachycardias with regular ventricular rhythm was assessed in a population of 243 patients with recent onset (72 hours) atrial fibrillation (AF), without heart failure, randomly treated with single loading oral dose of propafenone (600 mg), flecainide (300 mg), digoxin (1 mg), or placebo for acute conversion to sinus rhythm (SR). Fast atrial arrhythmias developed in 14 (6%) patients: 6/92 treated with propafenone, 3/34 treated with flecainide, 1/25 treated with digoxin, and 4/92 who received placebo (P = NS). Heart rate175 beats/min with 1:1 AV conduction ensued in 4 cases: 2 treated with flecainide and 2 treated with placebo; in the other cases 2:1 AV conduction was observed. Widening of QRS during regular tachycardia was observed in 4 patients; 3 who received propafenone and 1 who received flecainide. Conversion to SR within 4 hours was achieved in 55/92 (60%) patients treated with propafenone, 20/34 (59%) patients treated with flecainide, 7/25 (28%) patients treated with digoxin, and 19/92 (20%) treated with placebo (P0.001 propafenone vs placebo and flecainide vs placebo; P0.05 propafenone vs digoxin and flecainide vs digoxin). Periods of regular tachycardia are expected in recent onset AF and may not necessarily represent a proarrhythmic effect of Class 1C drugs, rather than mark the transition from AF to SR. Class 1C agents are probably responsible for widening of the QRS complex seen during these tachycardias. Propafenone and flecainide appear equally effective in converting recent onset AF.

Background— The role of pacing sites and atrial electrophysiology on the progression of atrial fibrillation (AF) to the permanent form in patients with sinus node dysfunction (SND) has never been investigated. The aim of the study was to investigate the relationship between atrial electrophysiology and the efficacy of atrial pacing at the low interatrial septum (IAS) or at the right atrial appendage (RAA) to prevent persistent/permanent AF in patients with SND. Methods and Results— The Electrophysiology-Guided Pacing Site Selection (EPASS) Study was a prospective, controlled, randomized study. Atrial refractoriness, basal and incremental conduction times from the RAA to the coronary sinus ostium were measured before implantation, and the difference (ΔCTos) was calculated. Patients with ΔCTos ≥50 ms (study group) and those with ΔCTos P =0.047). Conclusions— In patients with SND and intra-atrial conduction delay, low IAS pacing was superior to RAA pacing in preventing progression to persistent or permanent AF. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00239226.

Background Heart failure(HF) and atrial fibrillation(AF) frequently coexist in the same patient and are associated with increased mortality and frequent hospitalizations. As the concomitance of AF and HF is often associated with a poor prognosis, the prompt treatment of AF in HF patients may significantly improve outcome. Methods/design Recent implantable cardiac resynchronization (CRT) devices allow electrical therapies to treat AF automatically. TRADE-HF (trial registration: NCT00345592; http://www.clinicaltrials.gov) is a prospective, randomized, double arm study aimed at demonstrating the efficacy of an automatic, device-based therapy for treatment of atrial tachycardia and fibrillation(AT/AF) in patients indicated for CRT. The study compares automatic electrical therapy to a traditional more usual treatment of AT/AF: the goal is to demonstrate a reduction in a combined endpoint of unplanned hospitalizations for cardiac reasons, death from cardiovascular causes or permanent AF when using automatic atrial therapy as compared to the traditional approach involving hospitalization for symptoms and in-hospital treatment of AT/AF. Discussion CRT pacemaker with the additional ability to convert AF as well as ventricular arrhythmias may play a simultaneous role in rhythm control and HF treatment. The value of the systematic implantation of CRT ICDs with the capacity to deliver atrial therapy in HF patients at risk of AF has not yet been explored. The TRADE-HF study will assess in CRT patients whether a strategy based on automatic management of atrial arrhythmias might be a valuable option to reduce the number of hospital admission and to reduce the progression the arrhythmia to a permanent form. Trial registration NCT00345592