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Aims: To describe obstetric/neonatal and cardiac outcomes for a cohort of women carrying implantable cardioverter-defibrillators (ICDs) during pregnancy., Methods and Results: All women in routine follow-up at our institution for ICD implantation who became pregnant between 2006 and 2013 were included in this study. All ICDs were pre-pectoral devices with bipolar endocardial leads. Obstetric/neonatal and cardiac outcomes were assessed during pregnancy and post-partum. Twenty pregnancies were conceived by 12 women carrying ICD devices, 14 of which resulted in live births and none in maternal death. Seven of these women had structural cardiomyopathies and five had channelopathies. No device-related complications were recorded. Twelve shocks (nine transthoracic and three from ICDs) were experienced during pregnancy by two women, one of whom miscarried shortly afterwards at 4 weeks gestation. One stillbirth, three miscarriages and one termination were recorded for women with long QT syndrome, repaired tetralogy of Fallot and repaired Laubry-Pezzi syndrome, respectively. Intrauterine growth restriction, low birth weight, and neonatal hypoglycaemia were recorded in four, three, and five pregnancies, respectively., Conclusions: Pregnancy had no effect on ICD operation and no evidence was found to link ICD carriage with adverse pregnancy outcomes, although one miscarriage may have been induced by ICD shock therapy. A worsening of cardiac condition occurs in specific cardiac diseases and β-blocker therapy should be continued for all women carrying ICDs in pregnancy as the benefits outweigh the risks of taking this medication., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

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., (© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Introduction: Inappropriate shocks remain a highly challenging complication of implantable cardioverter defibrillators (ICD). We examined whether automatic wireless remote monitoring (RM) of ICD, by providing early notifications of triggering events, lowers the incidence of inappropriate shocks., Methods and Results: We studied 433 patients randomly assigned to RM (n = 221; active group) versus ambulatory follow-up (n = 212; control group). Patients in the active group were seen in the ambulatory department once a year, unless RM reported an event requiring an earlier ambulatory visit. Patients in the control group were seen in the ambulatory department every 6 months. The occurrence of first and further inappropriate shocks, and their causes in each group were compared. The characteristics of the study groups, including pharmaceutical regimens, were similar. Over a follow-up of 27 months, 5.0% of patients in the active group received ≥1 inappropriate shocks versus 10.4% in the control group (P = 0.03). A total of 28 inappropriate shocks were delivered in the active versus 283 in the control group. Shocks were triggered by supraventricular tachyarrhythmias (SVTA) in 48.5%, noise oversensing in 21.2%, T wave oversensing in 15.2%, and lead dysfunction in 15.2% of patients. The numbers of inappropriate shocks delivered per patient, triggered by SVTA and by lead dysfunction, were 74% and 98% lower, respectively, in the active than in the control group., Conclusion: RM was highly effective in the long-term prevention of inappropriate ICD shocks., (© 2014 Wiley Periodicals, Inc.)

Aims: Limited data are available on long-term prognosis or causes-of-death analysis among survivors of acute myocardial infarction (MI) according to whether or not they developed ventricular fibrillation (VF) during the acute stage of MI., Methods and Results: Among 3670 MI patients hospitalized in France in 2005 and enrolled in this prospective follow-up cohort study, we assessed in-hospital mortality and 5-year cause of death among those who survived to hospital discharge, according to whether they developed VF (116 cases) or not, during the acute stage. 94.5% of patients had complete follow-up at 5 years. In-hospital mortality was significantly higher among VF patients (adjusted OR 7.38, 95% CI 4.27-12.75, P < 0.001). Among 3463 survivors at hospital discharge, 1024 died during a mean follow-up of 52 ± 2 months. The overall survival rate at 5 years was 74.4% (95% CI 72.8-76.0). In Cox multivariate analysis, occurrence of VF during the acute phase of MI was not associated with an increased mortality at 5 years (HR 0.78, 95% CI 0.38-1.58, P = 0.21). The distribution of causes of death at 5 years did not statistically differ according to the presence or absence of VF, especially for sudden cardiac death (13.1% in VF group vs.12.9% in non-VF group), despite a very low rate of implantation of cardioverter defibrillator in both groups (Overall rate 1.2%)., Conclusion: Patients developing VF in the setting of acute MI are at higher risk of in-hospital mortality. However, VF is not associated with a higher long-term all-cause or sudden cardiac death mortality.

Objectives: To describe the management of patients with atrial fibrillation (AF) and to study consistency with guidelines on management of AF., Patients and Methods: Observational study on a random sample of cardiologists from a French national database. Each cardiologist had to recruit the first five patients meeting inclusion criteria (patients diagnosed with AF between January 2004 and one month before inclusion and accepting the collection of their medical data)., Results: Between December 2006 and January 2207, 1789 patients aged 71 on average have been recruited by 481 cardiologists. Fifty-one percent were diagnosed with paroxysmal, 15% with persistent and 33% with permanent AF. Restoration of sinus rhythm was preferred in forms considered as paroxysmal or persistent forms whereas control of the ventricular rate was more frequent in AF considered as permanent. Overall, therapeutic guidelines are applied in practice, despite a frequent use of amiodarone in patients with no associated heart disease. Prevention of thromboembolism was observed in 88% of the patients., Conclusions: FACTUEL is the biggest observational study on AF ever conducted in France. The therapeutic strategies used by the cardiologists are consistent with the objectives of preventing thromboembolism and controlling heart rhythm and/or rate. In most cases, the treatment used is consistent with the therapeutic guidelines.

Background: The Prospective Evaluation of Pacemaker Lead Endocarditis study is a multicenter, prospective survey of the incidence and risk factors of infectious complications after implantation of pacemakers and cardioverter-defibrillators., Methods and Results: Between January 1, 2000, and December 31, 2000, 6319 consecutive recipients of implantable systems were enrolled at 44 medical centers and followed up for 12 months. All infectious complications were recorded, and their occurrence was related to the baseline demographic, clinical, and procedural characteristics. Among 5866 pacing systems, 3789 included 2 and 117 had >2 leads; among 453 implantable cardioverter-defibrillators, 178 were dual-lead systems. A total of 4461 de novo implantations occurred and 1858 pulse generator or lead replacements. Reinterventions were performed before hospital discharge in 101 patients. Single- and multiple-variable logistic regression analyses were performed to identify risk factors; adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. At 12 months, device-related infections were reported in 42 patients (0.68%; 95% CI, 0.47 to 0.89). The occurrence of infection was positively correlated with fever within 24 hours before the implantation procedure (aOR, 5.83; 95% CI, 2.00 to 16.98), use of temporary pacing before the implantation procedure (aOR, 2.46; 95% CI, 1.09 to 5.13), and early reinterventions (aOR, 15.04; 95% CI, 6.7 to 33.73). Implantation of a new system (aOR, 0.46; 95% CI, 0.24 to 0.87) and antibiotic prophylaxis (aOR, 0.4; 95% CI, 0.18 to 0.86) were negatively correlated with risk of infection., Conclusions: This study identified several factors of risk of device infection and confirmed the efficacy of antibiotic prophylaxis in recipients of new or replacement pacemakers or implantable cardioverter-defibrillators.

Unlabelled: Implantable defibrillator is the recognized treatment of sudden cardiac death. Miniaturization of the devices allows implantation in children., Methods: This multicentric retrospective study analyzed data of 33 children aged 18 years and less who were implanted from 1990 to 2005., Results: Age of patients are 10 to 18 years, 20 patients were implanted after a resuscitation of sudden death, 10 after a syncope, 2 after a ventricular tachycardia and 1 in a prophylactic way. Tachycardias on primary electrical disease are most frequent (46%). Hypertrophic cardiomyopathy accounts for 22%, DAVD for 14%, congenital cardiopathies for 12%. Seventeen patients received appropriate shocks and 14 patients had inappropriate shocks. There were two unexplained deaths. Five leads fractures and two device infections were noted., Conclusion: Implantable defibrillator is an effective treatment for children high-risk of sudden death. Occurrence of inappropriate shocks due to sinusal tachycardia, infections and leads fractures are frequent.

Background: Congenital long QT syndrome (LQTS) is a well-defined clinical entity associated with a high mortality among untreated patients. Tissue Doppler (TD) echocardiography that has been recently introduced, facilitates wall motion analysis. Therefore, to further characterize myocardial velocity abnormalities associated with LQTS, using TD and conventional echocardiography, we compared control subjects and LQTS patients., Methods and Results: Ten patients with mild LQTS and 14 control subjects were examined with standard and TD echocardiography. We studied myocardial velocities in basal and mid-segments of the septal, lateral, inferior and anterior walls. Peak velocity and time intervals were measured in each segment. We confirmed previously described M-mode abnormalities, demonstrated by an increase of the wall thickening time index. TD analysis demonstrated increased systolic and diastolic peak velocities for all segments in LQTS patients. Regional isovolumic relaxation time and systolic velocity half time (VHT) were significantly longer in LQTS group associated with a prolonged late systolic phase, resulting in a plateau morphology., Conclusion: We demonstrated that TD allows the characterization of myocardial velocity abnormalities in LQTS patients. TD measurements could become part of the routine clinical evaluation for patients potentially affected by the LQTS as a new phenotypic marker.

The epidemiology of paroxysmal atrial fibrillation (PAF) is poorly known because of the difficulties in setting up trials to study this condition. Its biannual incidence is about 2 per thousand. Its prevalence is 1 to 2% in a population of over 65 years of age. Paroxysmal atrial fibrillation is often asymptomatic. An initial episode of atrial fibrillation may remain a single event in a number of cases. Isolated paroxysmal atrial fibrillation progresses to permanent atrial fibrillation in about 20% of cases, usually if there is underlying cardiac disease. Rheumatic valve disease, cardiac failure, hypertension, previous myocardial infarction and cerebrovascular accidents are often associated with paroxysmal atrial fibrillation. Embolic complications are rare if paroxysmal atrial fibrillation is isolated.

The lack of specificity of VT detection is a significant shortcoming of current ICDs. In a French multicenter study, 18 patients underwent implantation of the Defender 9001 (ELA Medical), an ICD utilizing dual chamber pacing and arrhythmia detection. Over a mean follow-up period of 7.1 +/- 4.5 months, 176 tachycardia episodes recorded in the device memory were analyzed, and physician diagnosis was compared with that by the device. All 122 VT/VF episodes were correctly diagnosed, as were 51 of 53 supraventricular tachyarrhythmias. Two episodes of AF with rapid regular ventricular rates were treated as VT, and a third episode, treated as VT, could not be diagnosed with certainty. A dual chamber pacemaker defibrillator offers improved diagnostic specificity without loss of sensitivity, in addition to the hemodynamic benefit of dual chamber pacing.