Laurence Guédon-Moreau

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 trials 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.

Contributions of remote monitoring to the follow-up of implantable cardioverter–defibrillator leads under advisory

Aims Automatic daily transmission of data from implantable cardioverter–defibrillators (ICDs) enables the remote monitoring of device status and leads function. We report on a 2-year experience with remote monitoring in 40 recipients of high-voltage ICD leads, prone to fracture and under advisory since October 2007. Methods and results The ICDs were remotely monitored as well as systematically interrogated in the ambulatory department every 3 months. The patients were also seen in case of abnormal lead impedance, or other manifestations consistent with lead dysfunction. Over a mean follow-up of 22 ± 4 months after ICD implantation, four lead dysfunctions were suspected because of remotely transmitted oversensing of noise artifacts, abrupt rise in pacing impedance, or both. A lead fracture needing lead replacement was confirmed in three patients (7.5%), two of them before any inappropriate therapy and one after the delivery of three inappropriate shocks. No lead failure was observed in the remaining 36 patients, either at the time of ambulatory visits or during remote monitoring. Conclusion Remote monitoring allowed the early and reliable detection of ICD leads failure without requiring any patient intervention.

Absolute contraindications in relation to potential drug interactions in outpatient prescriptions: analysis of the first five million prescriptions in 1999.

ObjectivesAdverse drug interactions increase morbidity and mortality. To prevent these, situations leading to adverse prescriptions must be clarified. This study quantifies and analyses prescriptions with potential adverse drug interactions in primary health care in the north of France over a 3-month period.MethodsAll prescriptions administered between 1 January and 31 March 1999 were analysed to identify potential interactions amongst drugs appearing on the same prescription sheet. The regional French healthcare database was compiled to further classify contra-indications.ResultsThere were 5,358,374 prescriptions administered to 44% of the overall population of the Nord-Pas de Calais area (1,754,372 patients/3,990,167 general population). There were 14,390 prescriptions classified as either absolute (26%) or relative contraindications (74%). Nine drug categories accounted for most of the absolute contraindications: dopaminergic antiparkinsonians, neuroleptic agents, migraine treatments (such as ergot alkaloids, sumatriptan and other triptan derivatives), prokinetic drugs (cisapride), antibacterial drugs (macrolides), antifungals (imidazoles), antiarrhythmics, betablockers and analgesics (opioids and floctafenine). In 54% of patients exposed, the incurred risk was either QT prolongation/Torsade de Pointes or antagonism of dopaminergic antiparkinson agents with dopamine receptor antagonists prescribed as antipsychotic agents.ConclusionsAmong a non-selected population of ambulatory outpatients, the number of quarterly prescriptions with contra-indications with potentially harmful drug interaction was 27 in 10,000 prescriptions. This would extrapolate to nearly 200,000 contra-indications on the same-prescription sheets in France in the first quarter of 1999.

Decreased Delivery of Inappropriate Shocks Achieved by Remote Monitoring of ICD: A Substudy of the ECOST Trial

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.

SINGLE CENTER EXPERIENCE WITH FEMORAL EXTRACTION OF PERMANENT ENDOCARDIAL PACING LEADS

Between March 1995 and June 1997, 128 leads were extracted from the hearts of 28 women and 50 men, 69 ± 15 years of age (mean ± SD, range 22–92 years). The indications for the procedure were: Accufix lead in 18 patients (14%), dysfunction or incompatibility with ICD in 16 (12%), endocarditis on the lead in 41 (32%), pulse generator pocket infection in 28 (22%), and pulse generator and/or lead erosion in 25 patients (19%). The extraction was performed with a snare (lasso), via a femoral vein as a first approach in 116 leads, and as an alternate approach, after extraction from the original site of implantation had failed, in 12 leads. The leads had been implanted for 62 ± 48 months (range 1–205 months). A Cook sheath was used in 7, and a femoral approach traction in 20 instances. Of the 128 leads, 122 (95%) were completely extracted, and 2 (2%) were partially extracted (the distal electrode remaining attached to the myocardium), and 4 (3%) could not be removed. Four complications occurred: 2 tears of the tricuspid valve without clinical consequences, one separation of the leads distal electrode which migrated into the hypogastric vein, and one hemorrhage at the femoral puncture site. There was no death or serious complication caused by lead extraction in this series.

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

Impact of the control of symptomatic paroxysmal atrial fibrillation on health-related quality of life.

Aims Patients with atrial fibrillation (AF) consider the related symptoms disruptive to their quality of life (QoL). This study aimed to evaluate the impact of the control of symptomatic paroxysmal AF (PAF) on QoL. Methods and results Patients with symptomatic PAF were treated for 48 weeks with open-label flecainide acetate controlled release (Flec CR). Quality of life was assessed by SF-36 and Atrial Fibrillation Severity Scale scores at baseline, Week 12 (W12), W24, and W48. Of the 229 treated patients, 217 were analysed for QoL (123 with controlled and 94 with uncontrolled symptomatic PAF at inclusion). The controlled group had a similar or better QoL (SF-36) at baseline compared with a reference population (significantly better for: physical functioning, bodily pain, and physical component). The uncontrolled group had an inferior QoL (significantly worse for: role physical, general health, vitality, role emotional, social functioning, mental health, and mental component). When treated with Flec CR, the controlled group baseline QoL scores were maintained and the uncontrolled group scores were improved to a level comparable to the controlled group scores. Safety findings reflect the known clinical safety profile of flecainide acetate. Conclusion In this study, patients with uncontrolled symptomatic PAF at baseline had an inferior QoL to those with controlled symptomatic PAF. Following treatment with controlled-release flecainide acetate, their QoL improved to a level comparable to controlled patients.

Asystolic cardiac arrest during head-up tilt test: incidence and therapeutic implications.

Occasionally, the cardioinhibitory response may be profond during tilt induced syncope. Whether this response is associated with more severe symptoms or predicts a poor response to pharmacotherapy remains controversial. The aim of this study was to characterize patients with vasovagally mediated asystole occurring during head‐up tilt test and to evaluate the respective interests of sequential pacing and β‐blockers to treat them. We performed 60° tilt testing in 179 consecutive patients with unexplained syncope (91 women and 88 men, age 36.6 ± 20.1 years). Asystole was defined as a ventricular pause > 5 seconds. All patients with tilt induced asystole received therapy with either β‐blockers or sequential pacing, the efficacy of which was evaluated with serial tilt tests. Of 77 patients with positive tilt test, 10 developed syncope related to asystole (mean duration 11.9 ± 4.9 s), 2 with spontaneous recovery, and 8 with seizures needing a brief cardiopulmonary resuscitation. When compared with patients without asystole, asystolic patients had more severe symptoms (seizures: 6/10 vs 9/67, P = 0.05, injury: 9/10 vs 27/67, P = 0.0048). In the first six patients in whom cardiac pacing was considered, syncope or presyncope still occurred despite atrioventricular pacing at 45 beats/min. Five of these 6 patients, as well as the remaining 4 asystolic patients, were tilted with β‐biockers: 3 patients became tilt‐negative; 3 were significantly improved; and 3 did not respond. During follow‐up (mean 22.7 ± 11.7 months) with every patient taking β‐blockers and seven having a permanent pacemaker, no syncopal recurrence was observed. Tilt‐induced asystole that may require resuscitative maneuvers occurs especially in patients with a history of seizures or injury. Therapy with β‐blockers is often effective to prevent induction of syncope as well as recurrences.

Recurrent unexplained syncope may have a cerebral origin: Report of 10 cases of arrhythmogenic epilepsy

BACKGROUND Despite thorough investigation, approximately 15-20% of syncope cases remain unexplained. An underrecognized cause of syncope may occur when partial epileptic discharges profoundly disrupt normal cardiac rhythm, including cardiac asystole, the so-called arrhythmogenic epilepsy (AE). AIM To report initial results of observations of AE in patients with recurrent, unexplained, traumatic and/or convulsive syncope. METHODS Ten patients aged 49+/-20 years (median 49.5 years; nine women) underwent complete cardiological (including ambulatory Holter electrocardiogram (ECG), echocardiography and head-up tilt test [plus electrophysiology in four patients]) and neurological (including standard electroencephalogram [EEG], computed tomography [CT] and magnetic resonance imaging scan [MRI]) assessments. RESULTS After initial evaluation, neurocardiogenic syncope was suspected in six patients with tilt-induced hypotension+/-bradycardia. Further evaluation (prolonged inpatient video-EEG/ECG monitoring) was undertaken because of non-diagnostic syncope or uncertainty about the diagnosis of neurocardiogenic syncope. While monitored in the neurophysiology lab, a syncopal episode similar to the spontaneous episodes recurred in all 10 patients. Cardiac asystole preceded by partial seizure of temporal onset was documented in nine patients; a second-degree atrioventricular (AV) block with a cardiac rhythm of 30 beats per minute preceded by partial seizure of temporal onset was noted in one patient. Eight patients were treated successfully with antiepileptic drugs; two were refractory to antiepileptic therapy and required pacemaker implantation. No patient had recurrent syncope during a median follow-up of 102.5 months (mean 82.2+/-42; range 16-128 months). CONCLUSIONS In patients with recurrent, unexplained, traumatic and/or convulsive syncope, AE should be considered as a possible aetiology.

Temporal analysis of heart rate variability as a predictor of post traumatic stress disorder in road traffic accidents survivors

BACKGROUND Road Traffic Accidents (RTA) are most probably the leading cause of post traumatic stress disorder (PTSD) in developed countries. The autonomic nervous system (ANS) disturbances, due to psychological trauma, are part of the pathophysiology of PTSD. The aim of the present study was to determine whether early heart rate variability (HRV) measurement, a biomarker of the ANS function, could act as a predictor of PTSD development after a RTA. METHODS We prospectively investigated 35 survivors of RTA with both physical injury and psychological trauma. HRV data were obtained from 24-h Holter ECG monitoring, which was performed on the second day after the accident. Time domain analysis was applied to the inter-beat (RR) interval time series to calculate the various parameters of HRV. PTSD status was assessed 2 and 6 months after RTA. RESULTS There was a global diminution of HRV measurements in the PTSD group at both 2 and 6 months. The variability index was the best predictor of PTSD with the area under the receiveroperating curve for discriminating PTSD at 6 months at 0.92 (95% CI: 0.785; 1.046). A cut-off at 2.19% yielded a sensitivity of 85.7% and a specificity of 81.8% for PTSD. Positive and negative predictive values were respectively 75% and 90%. However, initial heart rate (HR) data were relevant at 2 months but not at 6 months. CONCLUSION RTA survivors exhibiting lower parasympathetic modulation of HR, indexed by temporal analysis of HRV, are more susceptible to developing PTSD as a short and long-term outcome.