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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.)

Background: The "sequential ablation" strategy for persistent AF is aimed at progressive organization of AF until the rhythm converts to sinus rhythm or atrial tachycardia (AT). During ablation of an AT, apparently seamless transitions from one organized AT to another occur. The purpose of our study was to quantify the occurrence and the mechanism of this transition., Methods and Results: Twenty-nine of 90 patients undergoing ablation for persistent AF had multiple AT during the procedure and constitute the study group. Thirty-nine direct transitions from one AT to another during ablation were observed classified in four types: type I (79.4%), i.e., a direct transition of a faster to a slower tachycardia without significant intervening pause; type II (7.69%)--transition after intervening ectopy or longer pause; type III (10.26%)--A slower AT accelerated; type IV (2.56%)--alteration of activation sequence but with no change on CL., Conclusions: Transition to a second AT occurs frequently in the midst of ablation of AT in persistent AF patients. This transition occurs most commonly abruptly within the range of a single cycle length of the original AT. This is best explained by a continuation of AT that was "present" simultaneously with the pretransition tachycardia, being "entrained" (for a reentrant tachycardia) or "overdriven" for an automatic focal tachycardia. The presence of multiple tachycardia mechanisms active simultaneously would be consistent with the eclectic pathophysiology of persistent AF., (© 2010 Wiley Periodicals, Inc.)

Purpose: We postulated that amplitude of fibrillatory (F)-wave in patients with persistent AF would correlate with clinical characteristics and outcome in patients undergoing catheter ablation for AF., Method: Maximal and mean amplitude of F-waves were measured in V1 and lead II in 90 patients prior to ablation for persistent AF. F-wave amplitudes were correlated to clinical, echocardiographic variables, and outcome., Results: F-wave > or = 0.1 mV in lead II and V1 was correlated with younger age and shorter AF history, and in lead II only was correlated with a smaller left atrium. Higher F-wave amplitude at baseline predicted AF termination during ablation. Maximal amplitude of > or = 0.07 mV predicted AF termination by ablation with 82%/79% sensitivity and 68%/73% specificity in V1/lead II respectively. An association between F-wave amplitude and AF recurrence was observed. Forty-three percent of patients with mean f wave amplitude <0.05 in lead V1 had AF recurrence compared to 12% of those with F-wave > or = 0.05 (p = 0.004)., Conclusion: Longer AF duration, older age and larger LA size are associated with fine AF amplitude. High F-wave amplitude predicts procedural termination of arrhyhmia in patients with persistent AF and freedom from AF upon follow-up.

Purpose: We measured the proportion of intravascular leads, which can be extracted by simple traction versus with newer techniques, and examined the overall safety and success rate of lead extractions., Methods: Between January 2005 and December 2007, 311 consecutive patients (mean age = 70 +/- 14 years, 79% men) underwent extractions of 250 atrial, 318 ventricular, and 22 coronary sinus leads, in the surgical facilities of two experienced medical centers, under general anesthesia, at a mean of 7.2 +/- 5.1 years (range 0.1-27.0) after lead implantation. Infection was the indication for extraction in 67.5% of cases. Complementary techniques were used when simple extraction with a locking stylet was unsuccessful., Results: Simple traction, with or without a locking stylet, allowed the complete removal in 27.0% (95% confidence interval [CI] 22.1-31.9) of patients. A mechanical sheath, laser sheath, and/or lasso catheter were used in the remaining patients. The overall extraction success rate was 89.7% (95% CI 86.3-93.1). There was one procedure-related death (0.3%; 95% CI 0.0-1.0). Among five other deaths occurring within 10 days after the procedure, four were due to septic shock. Duration of lead implantation was the strongest independent predictor of major adverse events (P = 0.002) and incomplete lead extraction (P = 0.005)., Conclusion: In contrast with simple traction, advanced techniques allowed the complete extraction of nearly 90% of leads. In experienced hands and with surgical back-up, these techniques were safe. Patients presenting with infected implanted cardiac devices suffered a high rate of major adverse despite complete extraction of the lead(s).

Aims: The OEDIPE trial examined the safety and efficacy of an abbreviated hospitalization after implantation or replacement of dual-chamber pacemakers (PM) using a telecardiology-based ambulatory surveillance programme., Methods and Results: Patients were randomly assigned to (i) an active group, discharged from the hospital 24 h after a first PM implant or 4-6 h after replacement, and followed for 4 weeks with Home-Monitoring (HM), or (ii) a control group followed for 4 weeks according to usual medical practices. The primary objective was to confirm that the proportion of patients who experienced one or more major adverse events (MAE) was not higher in the active than in the control group. The study included 379 patients. At least one treatment-related MAE was observed in 9.2% of patients (n = 17) assigned to the active group vs. 13.3% of patients (n = 26) in the control group (P = 0.21), a 4.1% absolute risk reduction (95% CI -2.2 to 10.4; P = 0.98). By study design, the mean hospitalization duration was 34% shorter in the active than in the control group (P < 0.001), and HM facilitated the early detection of technical issues and detectable clinical anomalies., Conclusion: Early discharge with HM after PM implantation or replacement was safe and facilitated the monitoring of patients in the month following the procedure.

Introduction: A patent foramen ovale (PFO) is located at the anterior and superior part of the anatomical interatrial septum, the area that is targeted during transseptal puncture. This study sought to investigate the impact of accessing the left atrium via a PFO on paroxysmal AF ablation., Methods: From March 2004, 203 patients (55 +/- 11 years) underwent catheter ablation for paroxysmal AF (80 +/- 71 months), with the endpoint being electrical isolation of all pulmonary veins (PV) and AF noninducibility. The presence of a PFO was determined by both transesophageal echocardiography and catheter probing. Procedural difficulty was evaluated by radiofrequency (RF), procedural, and fluoroscopic durations. Clinical follow-up was also investigated., Results: A PFO was detected in 27 patients (13%) by transesophageal echocardiography and in 22 additional patients (total 49 patients, 24%), by catheter probing (P < 0.001). A PFO was associated with longer total RF applications (57 +/- 19 vs 51 +/- 18 min, P = 0.04) and RF applications to isolate the PVs (42 +/- 16 vs 35 +/- 12 min, P = 0.001). Procedural and fluoroscopic times were unaffected. Seventy-three patients (36%) required a second procedure; there was no difference in the number of PV reconnections (1.3 vs 1.8 veins, P = NS). After a mean follow-up of 19 +/- 9 months, 194/203 patients (96%) were free of AF, with no difference in patients in whom a PFO had been used., Conclusion: Although isolation of PVs is longer, overall procedural duration and success is not affected when using a PFO compared with a transseptal puncture. The presence of a PFO is underestimated by transesophageal echocardiography with brachial injection when compared with catheter probing.

Unlabelled: Women with Brugada Syndrome., Introduction: Spontaneous type-1 ECG has been recognized as a risk factor for sudden cardiac death (SCD) in Brugada syndrome (BrS), but studied populations predominantly consisted of men. We sought to investigate whether a spontaneous type-1 ECG pattern was also associated in women with severely symptomatic BrS. Other known risk factors were also examined for gender specificity., Methods: Patients with severely symptomatic BrS, defined as resuscitated SCD and/or appropriate implantable cardioverter-defibrillator (ICD) shock, were included from 11 European centers. Clinical data, investigation of family history, 12-lead ECG, and results of electrophysiological study (EPS) were collected. The average follow-up was 4 +/- 3 years., Results: Fifty-eight patients fulfilled the inclusion criteria (mean age 47 +/- 11 years, 8 women). Thirty-six men (72%) but only two women (25%) had a spontaneous type-1 ECG at baseline (P = 0.02). Maximal ST elevation before or after drug challenge was 3.7 +/- 1.3 mm in men versus 2.4 +/- 0.7 mm in women (P = 0.007). The proportion of patients with a family history of SCD or an SCN5A mutation was not significantly different between both groups. Of those patients with high-risk BrS who underwent EPS, 76%(12/25) of men and 50%(2/4) of women had a positive study., Conclusion: In contrast to men, most women with BrS and resuscitated SCD or appropriate ICD shock do not have a spontaneous type-1 ECG pattern. In addition, the degree of ST elevation is less pronounced in women than men. While women represent a lower-risk group overall, risk factors established from a predominantly male population may not be helpful in identifying high-risk females.

RF ablation for paroxysmal atrial fibrillation (PAF) is a curative treatment, which when successful, eliminates the need to take antiarrhythmic drugs, be anticoagulated, and have recurrent physician visits or hospital admissions. The authors performed a retrospective cost comparison of RF ablation versus drug therapy for PAF. The study population consisted of 118 consecutive patients with symptomatic, drug refractory PAF who underwent 1.52 +/- 0.71 RF ablation procedures (range 1-4) for PAF. During a follow-up of 32 +/- 15 weeks, 85 (72%) patients remained free of clinical recurrence in absence of antiarrhythmic drugs. The cost of RF ablation was calculated in the year 2001 euros on the basis of resource use. The mean cost of pharmacologic treatment prior to ablation was 1,590 euros/patient per year. The initial cost of RF ablation for PAF was 4,715 euros, then 445 euros/year. After 5 years, the cost of RF ablation was below that of ongoing medical management, and continued to diverge thereafter. RF catheter ablation may be a cost-effective alternative to long-term drug therapy in patients with symptomatic, drug refractory PAF.

Evaluating the cost of coronary artery disease is difficult because it must take into account not only the cost of the disease process itself, but also that of prevention and research. 1. The cost of the disease process itself may be assessed by: a) an analytical study of the real cost of diagnostic and therapeutic procedures; b) a synthetic study of the procedures according to the clinical forms of the disease. Although this task is simple for a given patient, extrapolation of the results to a whole group of patients is more aleatory; c) an epidemiological study of the different forms of coronary artery disease: although global data is available the absence of a coronary artery disease register makes this a difficult problem; d) an evaluation of the socio-professional repercussions of coronary artery disease with integration of the cost and loss in gross national product. 2 The cost of prevention can be assessed by taking the following factors into consideration: a) cost of individual primary prevention which poses the problems of check-up examinations; b) cost of community primary prevention; c) cost of research including fundamental research on the atheromatous process and myocardial ischemia plus clinical research such as secondary prevention enquiries. In conclusion, it appears that: --it is difficult to determine the cost of coronary artery disease without a specialist register; --the cost of coronary artery disease should be considered from positive (source of economic activity) and negative points of view (socio-professional repercussions); --a reduction in the cost of coronary artery disease requires a deeper understanding of the disease, better prophylaxis and socio-professional rehabilitation, and improved organisation of exciting health structures.