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Background Atrial fibrillation (AF) is common in patients with cardiac implantable electronic devices (CIED) and has been associated with an increased stroke risk. The aim of our project was to assess the clinical value of a web-based application, Discovery Link AFinder, in improving AF detection in CIED patients. Methods and Results Seven Italian hospitals performed an observational study consisting of four phases. During phase 1, expert nurses and cardiologists prospectively followed-up CIED patients via in-hospital examinations and remote monitoring, and classified clinically relevant events, particularly AF occurrence. During phase 2, Discovery Link AFinder was exploited to identify patients who had suffered AF in the previous 12 months through the systematic scanning of device data remote transmissions. Phases 3 and 4 were repetitions of phases 1 and 2, respectively, and were implemented 6 months after the previous phases. A total of 472 consecutive patients were included in phase 1; AF occurred in 170 patients, 61 of whom were identified as new AF patients. Evidence of AF during this phase prompted prescription of oral anticoagulation (OAC) therapy in 30 patients. In phase 2, AFinder uncovered new AF, unidentified in phase 1, in 54 patients and prompted implementation of OAC therapy in 11 patients. During phase 3, 30 new AF patients were identified by means of remote monitoring, while during phase 4, a further three AF patients were identified by AFinder only. Conclusions The AFinder web-based software, applied on top of standard in-hospital and remote monitoring, improved AF detection and enabled OAC treatment to be undertaken. [ABSTRACT FROM AUTHOR] more...

Background: Dual-chamber (DDD) pacing has generally been regarded as “physiologic pacing” and therefore expected to be superior to ventricular pacing. Major randomized trials have so far failed to demonstrate significant reductions in the incidences of mortality, stroke, and heart failure. It has been shown that unnecessary ventricular pacing in patients with sinus node dysfunction or only intermittent atrioventricular block is associated with ventricular desynchronization and increased risk of atrial tachyarrhythmias (ATA). Methods: The MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure (MINERVA) study is a prospective, multi-center, randomized, international, single-blind, controlled trial designed to determine whether physiologic pacing through the managed ventricular pacing (MVP) algorithm combined with preventive atrial pacing (PAP) and atrial antitachycardia pacing (ATP) is superior to standard DDD pacing in terms of 2-year reduction in death, permanent ATA, and cardiovascular hospitalizations. Patients with standard class I or II indications for permanent DDD pacing and history of ATA will receive a Medtronic EnRhythm implantable pacemaker (Medtronic, Minneapolis, MN). After a 1-month run-in period, patients will be randomized in a 1:1:1 manner to the DDD (control group, all OFF), the DDDRP (MVP + PAP + ATP ON), and the MVP group (only MVP ON). Up to 1,300 patients will be included in approximately 70 centers in Europe, the Middle East, and Asia. Conclusions: The MINERVA study will make an important contribution to the management of patients with paroxysmal ATA and accepted indications for dual-chamber pacemaker implantation by determining whether physiologic pacing combined with PAP and ATP is superior to standard DDD pacing in terms of reduction of mortality, incidence of permanent ATA, and cardiovascular hospitalizations. [Copyright &y& Elsevier] more...

Background: The aim of this study was to compare time-domain and morphological descriptors of paced and spontaneous P wave in patients prone to atrial fibrillation (AF). Methods: Nineteen patients (nine women, aged 72 ± 10 years) affected by paroxysmal AF and implanted with dual-chamber pacemakers (PM) were studied. Two 5-minute recordings were performed during spontaneous and paced rhythm. Electrocardiogram (ECG) signals were acquired using a 32-lead mapping system. Patients were grouped into two classes: no previous AF and previous AF groups, according to the number of AF episodes in the 6 months before the analysis. Results and Conclusion: During atrial pacing P wave appeared prolonged and morphologically more complex with respect to sinus rhythm. We also found that in patients at lower risk for AF, the atrial pacing changes the atrial activation to a greater extent than in patients at higher risk for AF. Finally, all time-domain and morphological descriptors of the P wave except one succeed in discriminating “no previous AF” and “previous AF” patients in spontaneous rhythm, while no significant differences have been observed during pacing for any parameters. [ABSTRACT FROM AUTHOR] more...

Background: Atrial fibrillation (AF) induces loss of atrial contribution, heart rate irregularity, and fast ventricular rate. Objectives: The objectives of the study were to accurately measure AF incidence and to investigate the mutual temporal patterns of AF and heart failure (HF) in patients indicated to cardiac resynchronization therapy. Methods: Four hundred ten consecutive patients (70% male, age 69 ± 11) with advanced HF (NYHA = 3.0 ± 0.6), low ejection fraction (EF = 27 ± 9%), and ventricular conduction delay (QRS = 165 ± 29 ms) received a biventricular pacemaker. Enrolled patients were divided into two groups: G1 = 249 patients with no AF history, G2 = 161 patients with history of paroxysmal/persistent AF. Results: In a median follow-up of 13 months, AF episodes longer than 5 minutes occurred in 105 of 249 (42.2%) G1 patients and 76 of 161 (47.2%) G2 patients, while AF episodes longer than one day occurred in 14 of 249 (5.6%) G1 patients and in 36 of 161 (22.4%) G2 patients. Device diagnostics monitored daily values of patient activity, night heart rate (NHR), and heart rate variability (HRV). Comparing 30-day periods before AF onset and during persistent AF, significant (P < 0.0001) changes were observed in patient activity, which decreased from 221 ± 13 to 162 ± 12 minutes, and in NHR, which increased from 68 ± 3 to 94 ± 7 bpm. HRV significantly decreased (from 75 ± 5 ms before AF onset to 60 ± 6 ms after AF termination). NHR during AF was significantly (P < 0.01) and inversely correlated (R2= 0.73) with activity, with a significant lower activity associated with NHR ≥ 88 bpm. Conclusion: AF is frequent in HF patients. Persistent AF is associated with statistically significant decrease in patient activity and HRV and NHR increase. [ABSTRACT FROM AUTHOR] more...

Background: Atrial fibrillation (AF) is a common problem in pacemaker patients. We conducted a prospective observational study in patients paced for bradycardia with associated paroxysmal or persistent AF, to determine whether P-wave duration may stratify patients at higher risk for AF recurrences and AF-related hospitalizations. The patients were evaluated for the prevalence, cause, and predictors of hospitalization. Methods: We studied 660 consecutive patients (50% male, 72 ± 9 years) who received a dual-chamber pacemaker. Median value of baseline P-wave duration was equal to 100 ms (25%–75% quartile range equal to 80–120 ms). We used this cut-off to divide the patients into group A (P ≤ 100 ms), composed of 385 (58.3%) patients, and group B (P>100 ms), composed of 275 (41.7%) patients. Results: In a median follow-up of 19 months, 173 patients were hospitalized for all causes, 130 for cardiovascular causes, and 85 for AF-related hospitalizations. Multivariate logistic analysis showed that P-wave duration >100 ms identified patients at higher risk (OR = 1.6, 95% confidence interval (1.1–2.8), P = 0.044) for AF-related hospitalizations. Patients in group B (P > 100 ms) more frequently suffered AF-related hospitalizations (16.4% vs 10.4%, P = 0.02) and underwent more frequent cardioversions (14.5% vs 9.1%, P = 0.029) compared with group A (P ≤ 100 ms). Conclusions: P-wave duration may define the risk of persistent AF requiring cardioversion or AF-related hospitalization in patients with a pacemaker for bradycardia with associated paroxysmal or persistent AF. [ABSTRACT FROM AUTHOR] more...

Background: In sinus node disease (SND) atrial tachyarrhythmias (ATs) may frequently occur, after implant of a pacemaker for bradycardia, and are to be managed by rate or rhythm control. Methods: We evaluated ventricular heart rate (HR) during AT, AT-related symptoms and hospitalizations in 333 patients who received DDDRP pacemakers for SND. Results: In days with 24 hours of AT, mean daily HR during AT was >80, 90, 100, 110, and 120 beats per minute (bpm) in 191 (57%), 114 (34%), 55 (16%), 23 (7%), and 11 (3%) patients, respectively. The proportion of patients with a mean daily HR >80 bpm during AT despite the use of rate control agents was 28% among patients treated with calcium-channel blockers, 43% with digoxin, 49% with a combination of agents, 54% with amiodarone, 64% with sotalol, and 69% with β blockers. Patients with HR >100 bpm experienced a higher prevalence of both AT-related hospitalizations and cardiovascular hospitalizations than those with HR ≤100 bpm (36% vs 21%, P = .013; 42% vs 28%, P = .003) and a significantly higher number of AT-related symptoms (1.8 ± 0.9 vs 1.4 ± 1.0, P = .008). Conclusions: Limited attention has been dedicated to rate control in patients with pacemaker. This is the first study to evaluate the prevalence and implications of inappropriate rate control in patients with pacemaker. We found that in a substantial proportion of patients with SND who have recurrent ATs despite pacing, mean daily HR during AT is high and that these patients present increased hospitalizations and more symptoms, thus suggesting the need to improve rate control. [Copyright &y& Elsevier] more...

Background: Most clinical trials that have tested pacing therapies to prevent and treat atrial tachyarrhythmias (AT) have chosen endpoints such as AT frequency or burden (defined as percentage of time a patient is in AT), but failed to show unequivocal evidence of a clinical impact. Aim: The aim of our multicenter prospective observational study was to measure the variability of AT burden and estimate its impact on study outcomes. Methods and Results: Two hundred and fifty patients indicated for permanent pacing and suffering from AT (age 71 ± 9 years; 47.2% male) received a dual-chamber pacemaker. AT burden was measured in two consecutive, 2-month observation periods; the Monte Carlo method was then applied to simulate findings of a crossover design study. We simulated several models of therapy impact, each model being characterized by the percentage of responder patients and the percentage reduction in AT burden. To show a significant impact of AT therapies in a sample of 250 patients in whom 100, 75, or 50% would be theoretical responders to therapies, AT burden reduction should be at least 27, 32, or 57%, respectively. Temporal fluctuations in AT burden were so high that about 60% of patients would falsely appear as responders or nonresponders in a crossover study, regardless of AT burden reduction. Conclusions: In patients paced for bradycardia and suffering from AT, high intrapatient variability in AT burden was measured. Various models of therapy impact showed that, in crossover trials of AT therapies, time-related fluctuations in AT burden negatively impact on sample sizes and impair the ability to identify patients as responders or nonresponders. [ABSTRACT FROM AUTHOR] more...

INAMA, G.,et al.: Far-Field R Wave Oversensing in Dual Chamber Pacemakers Designed for Atrial Arrhythmia Management: Effect of Pacing Site and Lead Tip to Ring Distance. The aim of the study was to determine the incidence and practical implications of far-field R wave oversensing (FFRWO) and its association with pacing site and lead tip to ring spacing (TTRS) in implantable devices designed to diagnose and treat atrial tachyarrhythmias and programmed with a fixed and short postventricular blanking period. The study included 395 patients who were implanted with a DDDRP pacemaker and prospectively followed. At implant and follow-up visits FFRWO was assessed by analyzing lead electrical measures and atrial tachyarrhythmic episodes collected in the device diagnostics. During a median follow-up of 12 months 11 (2.8%) of 395 patients showed a clinically significant FFRWO that induced inappropriate detection or pacemaker malfunctioning. The atrial pacing site of these 11 patients was right atrium appendage (RAA) for 3 patients, representing 1.1% of 254 RAA patients, coronary sinus ostium (CSO) for 7 patients, representing 7.4% of 94 CSO patients (P<0.005 vs RAA), and lateral wall (LW) for 1 (2.9%) of 34 LW patients. The minimal value of the FFRWO to P wave ratio, measured at implant, associated with a clinically significant FFRWO was 0.6; therefore, a value of 0.5 was used as a cutoff to identify patients at risk of undesirable device behavior induced by FFRWO: there were 11 (9.6%) of 114 of RAA patients with short (≤ 10 mm) TTRS, 22 (18.8%) of 117 of RAA patients with long (≥ 17 mm) TTRS (P<0.05 vs short TTRS), 21 (30.6%) of 64 of CSO patients short TTRS (P<0.001 vs RAA patients with short TTRS) and 3 (30%) of 10 of CSO patients with long TTRS. The analysis showed that, despite the short postventricular blanking time, FFRWO inducing undesired functioning in AT500 pacemakers is infrequent (2.8% of patients). Compared to RAA, the CSO lead position was more frequently associated with FFRWO.TTRS<10 mm was associated with lower risk of clinically significant FFRWO in RAA.(PACE 2004; 27:1221–1230) [ABSTRACT FROM AUTHOR] more...

Atrial Tachyarrhythmia Recurrence Temporal Patterns. Introduction: New-generation pacemakers allow continuous atrial tachyarrhythmia (AT) monitoring that provides accurate information about AT type, frequency, burden, and temporary evolution. Methods and Results: We performed a prospective multicenter study to describe AT temporal patterns in patients with sinus bradycardia and AT. Two hundred forty patients (123 men; age 71 ± 8 years) were implanted with a DDDRP pacemaker (model AT500, Medtronic Inc.). All patients were followed for 13 months. The first-month stabilization period of all patients was discarded from analysis. Seventy percent of patients had AT recurrences. Mean time to first AT recurrence (48.2 days, 95% confidence interval [CI] 37.0–59.5 days) was significantly longer than the time between first and second AT episode (10.3 days, 95% CI 6.7–13.9 days, P < 0.01). A minority of patients had a uniform time distribution of AT recurrences: <25% of patients had AT episodes in more than 6 of the 12 months considered in the study. The probability density function of consecutive sinus rhythm days between AT episodes was calculated for each of 40 patients who experienced >25 AT episodes and fitted by power law and exponential functions. The best fit was obtained by power law function in 60% of patients, by exponential function in 10%, and the two models gave comparable results in 30% of patients. Conclusion: In our population of patients with a history of sinus bradycardia and AT who were implanted with a new device equipped with atrial pacing therapies, 30% did not experience AT recurrences in the 12-month study period. Analysis of interevent time showed that in 60% of patients AT recurrences do not follow a uniform or random distribution. These findings bring into question the use of cross-over design and time to first AT recurrence as a clinical outcome in trials for AT therapy in this patient population. (J Cardiovasc Electrophysiol, Vol. 15, pp. 44-51, January 2004) [ABSTRACT FROM AUTHOR] more...