Prospective European survey on atrial fibrillation ablation: clinical characteristics of patients and ablation strategies used in different countries.

BACKGROUND: Atrial fibrillation (AF) ablation is widely adopted. Our aim was to conduct a prospective multicenter survey to verify patients' characteristics, approaches, and technologies adopted across Europe. METHODS AND RESULTS: A total of 35 centers in 12 countries actively participated in the study and 940 patients (median age 60 years) were enrolled. AF was paroxysmal, persistent, and long-lasting persistent in 52.4%, 36%, and 11.6% of patients, respectively; 95.5% of patients were symptomatic and 91.4% were refractory to antiarrhythmic therapy. Redo procedures were performed in 20.9%. Pulmonary vein isolation (PVI) emerged as the cornerstone of ablative therapy and has been performed in 98.7% of procedures, with confirmation of PVI in 92.9% of cases. The ablation of nonparoxysmal AF was not generally limited to isolating the PVs and several adjunctive approaches are adopted, particularly in the case of long-lasting persistent AF. Linear lesions or elimination of complex fractionated atrial electrograms were more frequently added. Circular mapping catheters and imaging techniques were seen to be used in about two-thirds of cases. Radiofrequency energy was delivered through open irrigated catheters in 68% of cases. CONCLUSIONS: European centers are largely following the recommendations of the guidelines and the expert consensus documents for AF ablation. AF ablation is mainly performed in relatively young patients with symptomatic drug refractory AF and no or minimal heart disease. Patients with paroxysmal AF are the most frequently treated with a quite uniform ablative approach across Europe. A less standardized approach was observed in nonparoxysmal AF patients.

Quality of life in patients with atrial fibrillation: how to assess it and how to improve it.

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.

Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study.

AIMS: The Effectiveness and Cost of ICD follow-up Schedule with Telecardiology (ECOST) trial evaluated prospectively the economic impact of long-term remote monitoring (RM) of implantable cardioverter defibrillators (ICDs). METHODS AND RESULTS: The analysis included 310 patients randomly assigned to RM (active group) vs. ambulatory follow-ups (control group). Patients in the active group were seen once a year unless the system reported an event mandating an ambulatory visit, while patients in the control group were seen in the ambulatory department every 6 months. The costs of each follow-up strategy were compared, using the actual billing documents issued by the French health insurance system, including costs of (i) (a) ICD-related ambulatory visits and transportation, (b) other ambulatory visits, (c) cardiovascular treatments and procedures, and (ii) hospitalizations for the management of cardiovascular events. The ICD and RM system costs were calculated on the basis of the device remaining longevity at the end of the study. The characteristics of the study groups were similar. Over a follow-up of 27 months, the mean non-hospital costs per patient-year were €1695 ± 1131 in the active, vs. €1952 ± 1023 in the control group (P = 0.04), a €257 difference mainly due to device management. The hospitalization costs per patient-year were €2829 ± 6382 and €3549 ± 9714 in the active and control groups, respectively (P = 0.46). Adding the ICD to the non-hospital costs, the savings were €494 (P = 0.005) or, when the monitoring system was included, €315 (P = 0.05) per patient-year. CONCLUSION: From the French health insurance perspective, the remote management of ICD patients is cost saving. CLINICAL TRIALS REGISTRATION: NCT00989417, www.clinicaltrials.gov.

A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.

AIMS: The ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD). METHODS AND RESULTS: The trial's primary objective was to randomly compare the proportions of patients experiencing ≥ 1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sample of 433 patients. The 221 patients assigned to the active group were seen once a year, unless HM reported an ICD dysfunction or a clinical event requiring an ambulatory visit, while the 212 patients in the control group underwent ambulatory visits every 6 months. The characteristics of the study groups were similar. Over a follow-up of 24.2 months, 38.5% of patients in the active and 41.5% in the control group experienced ≥ 1 MAE (P < 0.05 for non-inferiority). The overall number of shocks delivered was significantly lower in the active (n = 193) than in the control (n = 657) group (P < 0.05) and the proportion of patients who received inappropriate shocks was 52% lower in the active (n = 11) than in the control (n = 22) group (P < 0.05). At the end of the follow-up, the battery longevity was longer in the active group because of a lower number of capacitor charges (499 vs. 2081). CONCLUSION: Our observations indicate that long-term HM of ICD is at least as safe as standard ambulatory follow-ups with respect to a broad spectrum of MAE. It also lowered significantly the number of appropriate and inappropriate shocks delivered, and spared the device battery. Clinical trials registration NCT00989417.

Ischemic stroke associated with left cardiac catheterization: the importance of modifiable and non-modifiable risk factors.

BACKGROUND: Stroke associated with left cardiac catheterization is a devastating complication, and its incidence has not changed over the decades. We investigated the incidence, in-hospital outcomes and the modifiable and non-modifiable risk factors for periprocedural ischemic stroke. METHODS: Our retrospective cohort study included all patients experiencing periprocedural ischemic stroke among the 24,500 patients who underwent left cardiac catheterization between January 2003 and October 2010. The case group was compared with a group of control patients randomly selected among those who underwent the procedure during this period. RESULTS: Ischemic cerebrovascular events attested by brain imaging occurred in 37 patients (0.15% of procedures), transient ischemic attack occurred in 9 cases, and persistent neurological deficit occurred in 28 cases. Patients who developed strokes were more likely to be older and were more often female with a greater prevalence of comorbidities. Emergency and longer procedures were more frequent in patients in the case group who had more coronary complications. A multivariate analysis identified diabetes mellitus (adjusted odds ratio (OR) 4.2; 95% CI 1.8-9.9; P < .001), chronic renal dysfunction (OR 2.4; 95% CI 1.1-5.4; P < .001), known cerebrovascular disease (OR 5.1; 95% CI 2.3-11.5; P < .001), emergency procedure (OR 3.1; 95% CI 1.4-9.2; P < .01) and recent congestive heart failure (OR 6.1; 95% CI 2.9-13; P < .001) as independent predictors for stroke. The independent modifiable predictive factors were represented by left ventricular angiography (OR 7.5; 95% CI 2.7-21; P < .001), and low operator volume (OR 3.1; 95% CI 1.3-7.4; P < .01). CONCLUSION: Limiting the performance of left cardiac catheterization to high volume operators and avoiding unnecessary left ventricular angiography may reduce periprocedural ischemic stroke.

Personalized management of atrial fibrillation: Proceedings from the fourth Atrial Fibrillation competence NETwork/European Heart Rhythm Association consensus conference.

The management of atrial fibrillation (AF) has seen marked changes in past years, with the introduction of new oral anticoagulants, new antiarrhythmic drugs, and the emergence of catheter ablation as a common intervention for rhythm control. Furthermore, new technologies enhance our ability to detect AF. Most clinical management decisions in AF patients can be based on validated parameters that encompass type of presentation, clinical factors, electrocardiogram analysis, and cardiac imaging. Despite these advances, patients with AF are still at increased risk for death, stroke, heart failure, and hospitalizations. During the fourth Atrial Fibrillation competence NETwork/European Heart Rhythm Association (AFNET/EHRA) consensus conference, we identified the following opportunities to personalize management of AF in a better manner with a view to improve outcomes by integrating atrial morphology and damage, brain imaging, information on genetic predisposition, systemic or local inflammation, and markers for cardiac strain. Each of these promising avenues requires validation in the context of existing risk factors in patients. More importantly, a new taxonomy of AF may be needed based on the pathophysiological type of AF to allow personalized management of AF to come to full fruition. Continued translational research efforts are needed to personalize management of this prevalent disease in a better manner. All the efforts are expected to improve the management of patients with AF based on personalized therapy.

Efficacy and safety of celivarone, with amiodarone as calibrator, in patients with an implantable cardioverter-defibrillator for prevention of implantable cardioverter-defibrillator interventions or death: the ALPHEE study.

BACKGROUND: Celivarone is a new antiarrhythmic agent developed for the treatment of ventricular arrhythmias. This study investigated the efficacy and safety of celivarone in preventing implantable cardioverter-defibrillator (ICD) interventions or death. METHODS AND RESULTS: Celivarone (50, 100, or 300 mg/d) was assessed compared with placebo in this randomized, double-blind, placebo-controlled, parallel-group study. Amiodarone (200 mg/d after loading dose of 600 mg/d for 10 days) was used as a calibrator. A total of 486 patients with a left ventricular ejection fraction ≤40% and at least 1 ICD intervention for ventricular tachycardia or ventricular fibrillation in the previous month or ICD implantation in the previous month for documented ventricular tachycardia/ventricular fibrillation were randomized. Median treatment duration was 9 months. The primary efficacy end point was occurrence of ventricular tachycardia/ventricular fibrillation-triggered ICD interventions (shocks or antitachycardia pacing) or sudden death. The proportion of patients experiencing an appropriate ICD intervention or sudden death was 61.5% in the placebo group; 67.0%, 58.8%, and 54.9% in the celivarone 50-, 100-, and 300-mg groups, respectively; and 45.3% in the amiodarone group. Hazard ratios versus placebo for the primary end point ranged from 0.860 for celivarone 300 mg to 1.199 for celivarone 50 mg. None of the comparisons versus placebo were statistically significant. Celivarone had an acceptable safety profile. CONCLUSIONS: Celivarone was not effective for the prevention of ICD interventions or sudden death. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00993382.

Celivarone for maintenance of sinus rhythm and conversion of atrial fibrillation/flutter.

INTRODUCTION: Celivarone, a new noniodinated benzofuran derivative pharmacologically related to dronedarone and amiodarone, has been shown to have antiarrhythmic properties at a molecular level. The purpose of the 2 trials presented here (MAIA and CORYFEE) was to assess celivarone efficacy in the maintenance of sinus rhythm postcardioversion and for the conversion of atrial fibrillation (AF)/atrial flutter (AFL). METHODS AND RESULTS: In the MAIA trial, 673 patients with AF/AFL recently converted to sinus rhythm were randomly assigned to receive 50, 100, 200, or 300 mg once-daily dosing of celivarone; 200 mg daily of amiodarone preceded by a loading dose of 600 mg for 10 days; or placebo. At 3 months' follow up, no significant difference was observed in time to AF/AFL relapse among the various celivarone groups and placebo. However, fewer symptomatic AF/AFL recurrences were observed in the lower-dose celivarone groups (26.6% for celivarone 50 mg [P = 0.022] and 25.2% for celivarone 100 mg [P = 0.018] vs 40.5% for placebo at 90 days). Fewer adverse events were observed with the use of celivarone and placebo than amiodarone. In the CORYFEE study, 150 patients with AF/AFL were randomly assigned to once-daily celivarone dosing of 300 or 600 mg, or placebo, for a 2-day treatment period. There was no significant difference in the rate of spontaneous conversion to sinus rhythm between the treatment and control groups. CONCLUSIONS: In these studies, celivarone does not appear to be efficacious in the maintenance of sinus rhythm in AF/AFL patients or for the conversion of AF/AFL patients.

Safety and efficacy of programming a high number of antitachycardia pacing attempts for fast ventricular tachycardia: a prospective study.

AIMS: Little is known about the optimal number of antitachycardia pacing (ATP) attempts to programme in the fast ventricular tachycardia (FVT) zone. We sought to analyse the long-term efficacy and safety of programming a high number of ATP attempts for FVTs. METHODS AND RESULTS: All patients receiving an implantable cardioverter/defibrillator (ICD) for coronary artery disease or dilated cardiomyopathy for primary and secondary prevention between 2000 and 2009 were prospectively included. Implantable cardioverter/defibrillators were programmed to deliver 10 ATP attempts for FVT cycle lengths (CLs) of 250-300 ms (200-240 b.p.m.) before shock delivery (5 bursts, then 5 ramps; 8-10 extrastimuli at 81-88% FVT CL; minimal pacing CL 180 ms). Among 770 patients included and followed for 40.6 ± 25.6 months, 137 (17.8%) experienced a total of 1839 FVTs, 1713 of which were ATP-terminated (unadjusted efficacy = 93.1%, adjusted = 81.7%), 106 ATP-accelerated (5.8%), and 20 ATP-resistant (1.1%). The majority of FVT episodes were successfully treated by one or two attempts (98.3%). However, patient-based analysis showed that 17 (12.4%), 8 (5.8%), and 5 patients (2.1%) had at least one episode treated by three or more, four or more, and five or more ATP attempts. The benefit of this strategy was reduced after five attempts. The majority of FVT episodes was asymptomatic and diagnosed at device interrogation during follow-up: syncope and pre-syncope occurred in only 0.2 and 0.4% of episodes, respectively. CONCLUSION: Programming a high number of ATP attempts (up to five ATP attempts) in the FVT zone is both safe and efficient and could prevent shocks in numerous ICD recipients.

Showing up channels for postinfarct ventricular tachycardia ablation.

The number of scar-related ventricular tachycardia (VT) ablation procedures is increasing worldwide. This is certainly due to the ever growing number of patients implanted with an implantable cardioverter defibrillator in whom an ablation procedure may be required to better control the ventricular arrhythmia burden, but is also likely related to our better understanding of the arrhythmias mechanisms as well as the improvement of the mapping techniques during the last 15 years. Most VTs, especially those arising after myocardial infarction, depend on a critical isthmus. Defining precisely the critical isthmus of postinfarct VT may be challenging, particularly when the arrhythmia is poorly tolerated. In the literature, there are extensive data concerning the value of conventional electrophysiological techniques, especially entrainment mapping in association with postpacing interval measurements, regarding the identification of postinfarct VT isthmuses. There are, however, other--sometimes emerging--approaches to image critical postinfarct VT channels. We have summarized these, reviewing data from the published literature as well as our own experience.

Twenty-five years in the making: flecainide is safe and effective for the management of atrial fibrillation.

Atrial fibrillation (AF) is the most common arrhythmia in clinical practise and its prevalence is increasing. Over the last 25 years, flecainide has been used extensively worldwide, and its capacity to reduce AF symptoms and provide long-term restoration of sinus rhythm (SR) has been well documented. The increased mortality seen in patients treated with flecainide in the Cardiac Arrhythmia Suppression Trial (CAST) study, published in 1991, still deters many clinicians from using flecainide, denying many new AF patients a valuable treatment option. There is now a body of evidence that clearly demonstrates that flecainide has a favourable safety profile in AF patients without significant left ventricular disease or coronary heart disease. As a result of this evidence, flecainide is now recommended as one of the first-line treatment options for restoring and maintaining SR in patients with AF under current treatment guidelines. The objective of this article is to review the literature pertaining to the pharmacological characteristics, safety and efficacy of flecainide, and to place this drug in the context of current therapeutic management strategies for AF.

Rationale and current perspective for early rhythm control therapy in atrial fibrillation.

Atrial fibrillation (AF) is the most common sustained arrhythmia and an important source for mortality and morbidity on a population level. Despite the clear association between AF and death, stroke, and other cardiovascular events, there is no evidence that rhythm control treatment improves outcome in AF patients. The poor outcome of rhythm control relates to the severity of the atrial substrate for AF not only due to the underlying atrial remodelling process but also due to the poor efficacy and adverse events of the currently available ion-channel antiarrhythmic drugs and ablation techniques. Data suggest, however, an association between sinus rhythm maintenance and improved survival. Hypothetically, sinus rhythm may also lead to a lower risk of stroke and heart failure. The presence of AF, thus, seems one of the modifiable factors associated with death and cardiovascular morbidity in AF patients. Patients with a short history of AF and the underlying heart disease have not been studied before. It is fair to assume that abolishment of AF in these patients is more successful and possibly also safer, which could translate into a prognostic benefit of early rhythm control therapy. Several trials are now investigating whether aggressive early rhythm control therapy can reduce cardiovascular morbidity and mortality and increase maintenance of sinus rhythm. In the present paper we describe the background of these studies and provide some information on their design.

Recall alerts in implantable cardioverter-defibrillator recipients: implications for patients and physicians.

BACKGROUNDS: Implantable cardioverter-defibrillator (ICD) malfunctions sometimes need recall. Despite the increasing number of device implantation, ICD recalls and advisories' impacts have been little studied. The aim of this study was to determine the rate of ICD generator advisory in our center and to examine its clinical and financial implication. METHODS: We analyzed weekly Food and Drug Administration (FDA) Enforcement Reports issued between January 2000 and December 2008 to identify all advisories involving ICD generators and leads. We performed a retrospective analysis of all implanted patients affected by an advisory in our Cardiology department. RESULTS: During the 8 years of the study period, 13 advisories were issued for generators and one for leads, leading to a total number of 278 of 1,051 (26.4%) device with recall alerts, divided into 196 generator failures and 82 lead failures. Premature generator replacement was performed in 11 patients, whereas nine patients underwent lead replacement. There was no major complications attributable to advisory device replacement, and minor complications occurred only in one patient (lead extraction failure). Recalls accounted for 593 extra outpatient visits with a mean number of 2.20 ± 2.19 per patient. The total estimated cost of the device advisories in our population was 334,528 €. CONCLUSIONS: ICD recalls and safety alerts frequently occur in ICD recipients and tend to increase in number and rate. Although potentially serious, they do not appear to be associated with substantial complications. Financial implications are important.

Incidental extracardiac findings in cardiac computed tomography performed before radiofrequency ablation of atrial fibrillation.

BACKGROUND: Radiofrequency ablation has became a validated therapeutic technique for symptomatic drug refractory atrial fibrillation (AF). Cardiac computed tomography (CT) is used to evaluate left atrial (LA) anatomy in order to improve AF ablation. The analysis of noncardiac structures during cardiac CT may identify clinically significant incidental findings (IFs). The objective of this study was to determine the prevalence of IF in patients undergoing AF catheter ablation. METHODS: Between February 2008 and March 2010, all patients planned for a first procedure of AF or LA tachycardia (LAT) ablation underwent a cardiac CT scan and were retrospectively included in this study. Extracardiac IFs were considered to be present if an abnormality was identified without previous clinical suspicion or known disease. RESULTS: Two hundred and fifty patients (55.2 ± 9.6 years of age, 82.4% men) were enrolled (133 paroxysmal, 43 persistent, 58 permanent AF, and 16 LAT). Fifty-eight patients (23.2%) had a total of 76 IFs. Patients with IF were significantly older (59.5 ± 8.2 vs 53.8 ± 9.7 years old, P < 0.001). No relationship existed between the type of arrhythmia and IF existence. The majority of IFs were pulmonary (50%), with 15.8% of pulmonary emphysema. Two cases of lung cancer and of pulmonary fibrosis, 15 mediastinal adenopathies, and three congenital coronary arteries anomalies were found. CONCLUSIONS: Cardiac CT scan is a useful tool to evaluate LA morphology before AF ablation. However, as a considerable prevalence of IF was found in our study, extracardiac structures should be routinely analyzed to detect unknown conditions, which could require specific management.

Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter.

BACKGROUND: Amiodarone is effective in maintaining sinus rhythm in atrial fibrillation but is associated with potentially serious toxic effects. Dronedarone is a new antiarrhythmic agent pharmacologically related to amiodarone but developed to reduce the risk of side effects. METHODS: In two identical multicenter, double-blind, randomized trials, one conducted in Europe (ClinicalTrials.gov number, NCT00259428 [ClinicalTrials.gov] ) and one conducted in the United States, Canada, Australia, South Africa, and Argentina (termed the non-European trial, NCT00259376 [ClinicalTrials.gov] ), we evaluated the efficacy of dronedarone, with 828 patients receiving 400 mg of the drug twice daily and 409 patients receiving placebo. Rhythm was monitored transtelephonically on days 2, 3, and 5; at 3, 5, 7, and 10 months; during recurrence of arrhythmia; and at nine scheduled visits during a 12-month period. The primary end point was the time to the first recurrence of atrial fibrillation or flutter. RESULTS: In the European trial, the median times to the recurrence of arrhythmia were 41 days in the placebo group and 96 days in the dronedarone group (P=0.01). The corresponding durations in the non-European trial were 59 and 158 days (P=0.002). At the recurrence of arrhythmia in the European trial, the mean (+/-SD) ventricular rate was 117.5+/-29.1 beats per minute in the placebo group and 102.3+/-24.7 beats per minute in the dronedarone group (P<0.001); the corresponding rates in the non-European trial were 116.6+/-31.9 and 104.6+/-27.1 beats per minute (P<0.001). Rates of pulmonary toxic effects and of thyroid and liver dysfunction were not significantly increased in the dronedarone group. CONCLUSIONS: Dronedarone was significantly more effective than placebo in maintaining sinus rhythm and in reducing the ventricular rate during recurrence of arrhythmia.

An international survey of physician and patient understanding, perception, and attitudes to atrial fibrillation and its contribution to cardiovascular disease morbidity and mortality.

AIMS: Atrial fibrillation (AF) is not always perceived as a serious health threat, but is the most common sustained arrhythmia, with a major impact on morbidity, mortality, and patient quality of life (QoL). A survey was undertaken to examine the level of understanding, perception, and attitudes of the cardiovascular risks associated with AF. METHODS AND RESULTS: The AF AWARE group (an international coalition of organizations with an interest in AF) conducted an international quantitative survey in 11 countries in 2009, to investigate patients' (n = 825) and cardiologists' (n = 810) perceptions of AF, preferences for communicating information on AF and burden of AF. Both patients and physicians considered AF life-threatening (55 and 43%, respectively). Physicians were more concerned about the risk of stroke and hospitalizations than patients, whereas patients were most concerned about death risk. One in four patients felt unable to explain AF and >33% were worried or fearful about their disease. Many physicians (51%) wanted more patient information with >60% viewing available information as poor/difficult to find. Hospital specialists and GPs were identified as key information sources for patients. Most patients (83%) reported symptoms, yet 75% claimed to be satisfied with AF therapies. Atrial fibrillation patients, often with associated diseases, made an average of nine visits per year to their doctors, who consider AF difficult and time consuming to manage. Patients and physicians rated the QoL impact of AF as moderate to high. CONCLUSIONS: A comprehensive international patient and professional information and support programme on AF is needed to improve management and consequently health outcomes.

Delayed rhythm control of atrial fibrillation may be a cause of failure to prevent recurrences: reasons for change to active antiarrhythmic treatment at the time of the first detected episode.

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.

Automatic home monitoring of implantable cardioverter defibrillators.

AIMS: With the expanding indications for implantable cardioverter defibrillator (ICD) and reports of unexpected ICD failures, home monitoring (HM) was proposed to decrease follow-up workload and increase patient safety. Home monitoring implantable cardioverter defibrillators offer wireless, everyday transfer of ICD status and therapy data to a central HM Service Center, which notifies the attending physician of relevant HM events. We evaluated functionality and safety of HM ICDs. METHODS AND RESULTS: A total of 260 patients with HM ICDs were monitored for a mean of 10 +/- 5 months. Time to HM events [medical (ventricular tachycardia/ventricular fibrillation) and technical (ICD system integrity)] since ICD implantation and since the latest in-clinic follow-up was analysed. Mean number of HM events per 100 patients per day was calculated, without and with a 2-day blanking period for re-notifying the same type of event. About 41.2% of the patients had HM events (38.1% medical, 0.8% technical, and 2.3% both types). Probability of any HM event after 1.5 years was 0.50 (95% confidence interval: 0.42-0.58). More than 60% of new HM event types occurred within the first month after follow-up. A mean of 0.86 event notifications was received per 100 patients per day or 0.45 with the 2-day blanking period. CONCLUSION: Home monitoring is feasible and associated with an early detection of medical and technical events.

Nonischemic dilated cardiomyopathy: results of noninvasive and invasive evaluation in 310 patients and clinical significance of bundle branch block.

BACKGROUND: The survival of patients with idiopathic dilated cardiomyopathy (IDCM) at III and IV stages of New York Heart Association (NYHA) is decreased in those with a bundle branch block (BBB) compared to those without BBB. Less is known on the prognosis of patients at earlier stages of NYHA and who had a left BBB (LBBB) or right BBB (RBBB). We sought to evaluate the prevalence and the clinical significance of LBBB or RBBB in patients with IDCM and classes I and II of NYHA. METHODS: Clinical data, noninvasive, and invasive studies were consecutively collected in 310 patients, with IDCM, followed up to 4.8+/-3.7 years. RESULTS: Seventy-six patients (25%) had LBBB, 21 (7%) had RBBB, and 212 had no BBB. Patients with BBB were older than other patients (P < 0.009). Left ventricular ejection fraction (LVEF) was lower in LBBB than in RBBB and other patients (P < 0.05). Syncope was more frequent in BBB than in absence (P < 0.05). Incidence of spontaneous ventricular tachycardia (VT) and atrial fibrillation, VT induction, total cardiac events, and sudden death were similar in the presence or absence of BBB. Deaths by heart failure and heart transplantations tended to be more frequent in BBB than in absence. CONCLUSIONS: LBBB was present in 25% of patients with IDCM; RBBB was rare. Patients with BBB were older and had more frequent syncope than patients without BBB; LVEF was lower in LBBB than in RBBB or in absence of BBB. BBB did not increase the risk of spontaneous VT, VT induction, or sudden death, and tended to increase deaths by heart failure and the indications of heart transplantation.