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In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), the need for implantable cardioverter-defibrillator (ICD) back-up may be questionable at time of CRT-D replacement (REP) if ICD implant criteria are no longer met due to an improved left ventricular ejection fraction (LVEF) and if no major ventricular arrhythmic event (VAE) occurred during the CRT-D lifetime. The aim of our study was to assess the relevance of ICD back-up and predictors of VAE after REP in primary prevention CRT-D patients.The prospective, observational, international BioCONTINUE study investigated the rate of patients with at least 1 sustained VAE (sVAE) post-REP and searched for predictive factors of sVAE.Two hundred seventy-six patients (70 ± 10 years, 77% men, mean LVEF 40.6 ± 12.6%) were followed for 28.4 ± 10.2 months. The rate of patients with sVAE was 8.3%, 10.3%, and 21.2% at 1, 2, and 4 years post-REP. Patients without persistent ICD indication at REP still had a sVAE rate of 5.7% (95% CI 2.3-11.5%) at 2 years. In multivariate analysis, predictive factors of subsequent sVAE were (i) persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6-8.3; p = 0.003); (ii) 64-72 years of age as compared to ≥ 79 years (HR 3.7; 95% CI 1.4-9.7; p = 0.008); and (iii) ischemic heart disease (HR 4.4; 95% CI 2.1-9.3; p 0.0001).The risk of sVAE (21.2% at 4 years post-REP) depends on age, ischemic heart disease, and ICD indication at the time of REP. A non-trivial risk of sVAE remains in patients without persistent ICD indication.NCT02323503.

BackgroundFirst medical contact (FMC)-to-balloon time is associated with outcome of ST-elevation myocardial infarction (STEMI). We assessed the impact on mortality and the determinants of indirect vs. direct transfer to the cardiac catheterization laboratory (CCL).MethodsWe analyzed data from 2,206 STEMI patients consecutively included in a prospective multiregional percutaneous coronary intervention (PCI) registry. The primary endpoint was 1-year mortality. The impact of indirect admission to CCL on mortality was assessed using Cox models adjusted on FMC-to-balloon time and covariables unequally distributed between groups. A multivariable logistic regression model assessed determinants of indirect transfer.ResultsA total of 359 (16.3%) and 1847 (83.7%) were indirectly and directly admitted for PCI. Indirect admission was associated with higher risk features, different FMCs and suboptimal pre-PCI antithrombotic therapy.At 1-year follow-up, 51 (14.6%) and 137 (7.7%) were dead in the indirect and direct admission groups, respectively (adjusted-HR 1.73; 95% CI 1.22–2.45). The association of indirect admission with mortality was independent of pre-FMC and FMC characteristics. Older age, paramedics- and private physician-FMCs were independent determinants of indirect admission (adjusted-HRs 1.02 per year, 95% CI 1.003–1.03; 5.94, 95% CI 5.94 3.89–9.01; 3.41; 95% CI 1.86–6.2, respectively).ConclusionsOur study showed that, indirect admission to PCI for STEMI is associated with 1-year mortality independent of FMC to balloon time and should be considered as an indicator of quality of care. Indirect admission is associated with higher-risk features and suboptimal antithrombotic therapy. Older age, paramedics-FMC and self-presentation to a private physician were independently associated with indirect admission. Our study, supports population education especially targeting elderly, more adequately dispatched FMC and improved pre-CCL management.

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.

The objective of this study was to assess the effects ofradiofrequency energy application on implanted pacemaker functions.Radiofrequency (RF) catheter ablation may cause pacemaker dysfunction dueto electromagnetic interferences. The effects of RF on pacemaker behaviorwere studied in a series of 38 pacemakers, implanted 18 ± 26 monthsprior to a RF procedure using either a right ventricular approach (AV nodeablation, n = 35) or a left ventricular approach (left concealedaccessory pathway ablation, n = 1; VT ablation, n = 2). The38 patients (mean age 65 ± 9 years) included 20 men and 18 women.Before energy applications, the 23 different pacemaker models wereprogrammed to the VVI mode at the lowest available rate. The continuoussurface ECG was recorded throughout the procedure. Thorough testing of thedevices was performed before and after each RF delivery. Unusual pacemakerresponses occurred in 20 of the 38 cases studied (53%). The impactof RF delivery was unpredictable, and variable dysfunctions were observedat different times for a given patient or could vary for a given model.Unusual pacemaker responses included pacemaker inhibition (n = 8), untoggled backup mode (n = 3), electromagnetic interference noisemode (n = 3), temporary RF-induced pacemaker tachycardia (n =2), erratic behavior (n = 1), oversensing of RF onset and offset (n= 8), and transient loss of ventricular capture, (n = 1).Postablation, most devices automatically toggled back to fullfunctionality. The three devices in the untoggled backup mode had to bereprogrammed to obtain normal operations. At the end of the procedure,pacing thresholds remained unchanged in all but one patient, in whom theincrease in ventricular threshold was due to a nicked lead. In conclusion,implanted pacemakers frequently exhibit transient, unpredictable responsesto RF energy application. Although all pacemaker functions were restored postablation, some devices had to be reset manually. The anomalies observedduring the RF application argue for the simultaneous use of an externalpacemaker in pacing-dependent patients.

Despite novel left ventricular (LV) lead technologies, phrenic nerve stimulation (PNS) remains an adverse effect observed in many patients with cardiac resynchronization therapy (CRT). Beyond anatomic repositioning, modern CRT devices allow avoidance of PNS also by software-based adaption of the pacing configuration. The Electronic Repositioning With Acuity and Easytrak Leads study evaluated the incidence of PNS in a CRT population and examined how often LV lead relocation can be avoided by “electronic repositioning” (ER). Patients who had an indication for implantation of a first CRT defibrillator with the option of ER were enrolled. Primary endpoint was the efficiency of ER determined by the frequency of PNS with the standard pacing configuration (LV tip to RV coil) avoidable by ER. PNS and pacing parameters were evaluated during implant, predischarge, and first routine follow-up (FU) using four different pacing configurations available by ER. In total, 292 patients were enrolled and provided with a transvenous LV lead (82.2 % male, 65.5 ± 9.2 years old). The majority of the population was in NYHA III (84.2 %) with a LV ejection fraction of 25.3 ± 6.8 % and mean QRS width of 155 ± 27 ms, ischemic cardiomyopathy was present in 43.6 %. Median FU was 116 days. In the standard pacing configuration, PNS was inducible in 19.0/25.6/24.6 % at implant/predischarge/FU, respectively, resulting in 32.2 % of the patients presenting at least once with PNS. The safety margin for the standard pacing configuration between LV and PNS threshold was

International audience; AIMS: Inappropriate therapy delivered by implantable cardioverter defibrillators (ICDs) remains a challenge. The OPERA registry measured the times to, and studied the determinants of, first appropriate (FAT) and inappropriate (FIT) therapies delivered by single-, dual- and triple-chamber [cardiac resynchronization therapy defibrillator (CRT-D)] ICD. METHODS AND RESULTS: We entered 636 patients (mean age = 62.0 ± 13.5 years; 88% men) in the registry, of whom 251 received single-, 238 dual-, and 147 triple-chamber ICD, for primary (30.5%) or secondary (69.5%) indications. We measured times to FAT and FIT as a function of multiple clinical characteristics, examined the effects of various algorithm components on the likelihood of FAT and FIT delivery, and searched for predictors of FAT and FIT. Over 22.8 ± 8.8 months of observation, 184 patients (28.9%) received FAT and 70 (11.0%) received FIT. Ventricular tachycardia (VT) was the trigger of 88% of FAT, and supraventricular tachycardia was the trigger of 91% of FIT. The median times to FIT (90 days; range 49-258) and FAT (171 days; 50-363) were similar. The rate of FAT was higher (P

Purpose: Chronic right ventricular pacing (VP) has been linked to deleterious effect on cardiac function. This registry was designed to quantify the efficacy of Intrinsic Rhythm Support algorithm (IRS Plus), aimed to minimize VP.MethodsPatients (pts) were prospectively included 1 to 3 months after PM implantation and had IRS Plus set on. Device statistics were collected after 6 months of FU.ResultsPreliminary results have been obtained in 158 pts (mean age 78±9 years, 55% male). Median VP% was 3.9 in pts with SND vs 25.3 in pts presenting an impaired AV conduction (p = 0.024). The median VP% was 4.2 in pts with normal baseline PR interval vs 39.5 in pts with prolonged (>200 ms) PR interval (p

Objective Automatic algorithms in pacemakers (PM) allow continuous adaptation of settings to patients’ clinical conditions. Some are dedicated to pacing and others to sensing. One of the objectives of BELUGA on-going, international, prospective registry was to evaluate the use of automatic algorithms available in Insignia™ PM in current medical practice. Methods The percentage (%) of activation of atrio-ventricular search hysteresis algorithm (AVSH), dynamic AV delay (DynAVD), automatic atrial/ventricular sensing (AAS/AVS), ventricular automatic capture (VAC) and the % of use of automatic ventricular threshold test during patients assessment (AVT) are reported at enrolment (Enrol), 3-6 months (FU1) and 9-12 months (FU2) in patients with dual chamber PM (pts). Results Up to now 804 pts were enrolled and followed during 9.5±3.9 months (age 76±9 years, 57% male, PR interval 196±34 ms, 40% sinus node dysfunction, 27% bradycardia/tachycardia syndrome, 10% 1°AV block, 33% paroxysmal 2° or 3° AV block). PM programming was left to the discretion of the investigator. Atrial and ventricular automatic sensing algorithms were used in less than half of the pts without any increase over the time. During follow-up, ventricular automatic capture algorithm and ventricular automatic threshold test were increasingly used (p Parameter AAS on (%) AVS on (%) VAC on (%) AVT (%) AVSH on (%) DynAVD on (%) Enrol 46 40 69 64 85 97 FU1 45 39 74 68 87 97 FU2 46 40 76 71 87 97 p (Enrol vs FU2) ns ns ns ns Conclusion Intermediate results of this study show that automatic algorithms were currently used by the investigators when directly dedicated to right ventricular pacing. However, automatic algorithms dedicated to sensing appeared to be less used in daily medical practice.

Prognostic studies after acute myocardial infarction (AMI) have mainly been performed in the prethrombolytic era. Despite the fact that modern management of AMI has reduced mortality rates, the occurrence of malignant ventricular arrhythmias in the late phase of AMI remains an important issue. We prospectively studied 244 consecutive patients (97 treated with thrombolytics) who survived a first AMI. All patients underwent time domain signal-averaged electrocardiography (vector magnitude: measurements of total QRS duration, terminal low [40 microV] amplitude signal duration, and root-mean-square voltage of the last 40 ms of the QRS complex), Holter electrocardiographic monitoring, and cardiac catheterization. Late life-threatening ventricular arrhythmias were recorded. Eighteen arrhythmic events occurred during a mean follow-up period of 57 +/- 18 months. Three independent factors were associated with a higher risk of arrhythmic events: (1) left ventricular ejection fraction (odds ratio 1.9/0.10 decrease), (2) terminal low-amplitude signal duration (odds ratio 1.5/5 ms increase), and (3) absence of thrombolytic therapy (odds ratio 3.9). Low-amplitude signal duration sensitivity for sudden cardiac death was low (30%). Left ventricular ejection fraction had the highest positive predictive value for sudden cardiac death (10%). Thus, thrombolysis decreases both the incidence of ventricular tachycardia and sudden cardiac death with a higher reopening rate of the infarct-related vessel. Signal averaging predicts the occurrence of ventricular tachycardia and an impaired left ventricular ejection fraction predicts the occurrence of sudden cardiac death.

Summary Background Much attention is being paid to the education of and provision of medical information to patients, to optimize their understanding and acceptance of their disease. Aims To ascertain the impact of educating recent recipients of an implantable cardioverter defibrillator (ICD) on their perception and acceptance of a home monitoring (HM) system. Methods Questionnaire 1, completed one month after ICD implantation, was designed to assess: the quality of patient preparation for HM; patient comprehension of HM; and patient anxiety experienced during its installation. The comprehension questions were assigned a score of –2 for an incorrect answer, +1 for a correct answer and 0 for neither (total score ranging from –40 to +20). Questionnaire 2, completed six months after ICD implantation, assessed patient acceptance of and anxiety about HM. Results The registry included 571 patients (mean age 63.9 ± 12.8 years; 83% men; 76% of ICDs implanted for primary prevention) followed by HM for 6.2 ± 1.2 months. Questionnaire 1 was completed by 430 (75.3%) patients and questionnaire 2 by 398 (69.7%) patients. Younger patients had a better comprehension of HM than older patients. High-quality training conditions improved the comprehension score, and a positive association was observed between anxiety and acceptance levels and the comprehension score. The 80 ± 20% mean data transmission rate (days of transmission/days of follow-up ratio) was unrelated to the comprehension scores. Conclusion A clear understanding was associated with a higher acceptance of HM, although it was unrelated to the data transmission rate.

We followed-up 244 consecutive patients (210 men, mean age 56 ± 9 yrs) who survived the acute phase (alive after day 7) of a first anterior (N = 102) or inferior (N = 142) myocardial infarction (MI) with a mean follow-up (FU) delay of 57 ± 18 months. In the acute phase, 97/244 patients (40%) received a thrombolytic therapy. Within the second and third week after admission, all patients underwent a Holter ECG monitoring graded by the Lown classification, a signal averaged electrocardiogram (SAECG) and a coronary angiography. Three parameters were measured by SAECG (predictor system, 40 Hz high-pass filter): total QRS duration (QRSd), root mean square voltage of the last 40 ms (RMS) and duration of the terminal low (l40 uV) amplitude signal (LAS). The number of diseased vessels as well as the infarct related artery (IRA) patency was evaluated by TIMI grading (TIMI 2 or 3 = patent) and left ventricular ejection fraction (LVEF) was measured angiographically. Cox proportional hazards model was used for the statistical analysis. Results We observed 18 arrhythmic events (AE): 10 sudden cardiac death and 8 ventricular tachycardia during the FU period. Statistical analysis identified 3 independent factors predictive of the occurence of an AE: 1) LVEF, with a risk multiplied by 1.9 for each 0.10 decrease in the LVEF value, 2) LAS, with a risk multiplied by 1.3 for each 5 ms increase in LAS value and 3) absence of thrombolysis, with a risk multiplied by 3.9. Conclusions After MI in the thrombolytic era the Holter ECG monitoring and the results of the coronary angiography do not predict the risk of an AE. LVEF, SAECG and absence of thrombolysis are the 3 independent predictors of such a risk.