Remote control improves quality of life in elderly pacemaker patients versus standard ambulatory-based follow-up.

BACKGROUND: Health-related quality of life (HRQoL) improves shortly after pacemaker (PM) implantation. No studies have investigated the HRQoL trend for elderly patients with a remote device monitoring follow-up system. METHODS: Using EuroQol-5D Questionnaire and the PM-specific Assessment of Quality of Life and Related Events Questionnaire, HRQoL was measured at baseline and then repeatedly during the 6 months following PM implantation in a cohort of 42 consecutive patients. Twenty-five patients were followed-up with standard outpatient visits, while 17 used a remote monitoring system. RESULTS: Aquarel scores were significantly higher in patients with remote device monitoring system regarding chest discomfort and arrhythmia subscales the first month after PM implant and remained stable until 6 months. Remote monitoring affected the rate of HRQoL improvement in the first 3 months after pacemaker implantation more than ambulatory follow-up. CONCLUSIONS: Remote device monitoring has a significant impact on HRQoL in pacemaker patients, increasing its levels up to 6 months after implant.

Differences in attitude, education, and knowledge about oral anticoagulation therapy among patients with atrial fibrillation in Europe: result of a self-assessment patient survey conducted by the European Heart Rhythm Association.

The purpose of this patient survey was to analyse the knowledge about blood thinning medications relative to gender, age, education, and region of residence in patients with atrial fibrillation (AF). A total of 1147 patients with AF [mean age 66 ± 13 years, 529 (45%) women] from eight European countries responded to this survey. Most patients understood that the indication for anticoagulation therapy was to 'thin the blood', but 8.1% responded that the purpose of the medication was to treat the arrhythmia. Patients with college or university grades reported less frequent deviations from their target INR range compared with those without schooling (2.8% vs. 5.1%, P < 0.05). The awareness of anticoagulation-related risk of bleedings was lowest in patients without schooling (38.5%) and highest in those with college and university education (57.0%), P < 0.05. The same pattern was also observed regarding patient's awareness of non-vitamin K antagonist oral anticoagulants (NOACs): 56.5% of the patients with university education and only 20.5% of those without schooling (P < 0.05) knew about NOACs, indicating that information about new anticoagulation therapies remains well below the target. Bleeding events were statistically less frequent in patients on NOACs compared with vitamin K antagonists. The education level and patients' knowledge have a direct influence on the global management of the anticoagulation.

Right Ventricular Strain and Dyssynchrony Assessment in Arrhythmogenic Right Ventricular Cardiomyopathy: Cardiac Magnetic Resonance Feature-Tracking Study.

BACKGROUND: Analysis of right ventricular (RV) regional dysfunction by cardiac magnetic resonance (CMR) imaging in arrhythmogenic RV cardiomyopathy (ARVC) may be inadequate because of the complex contraction pattern of the RV. Aim of this study was to determine the use of RV strain and dyssynchrony assessment in ARVC using feature-tracking CMR analysis. METHODS AND RESULTS: Thirty-two consecutive patients with ARVC referred to CMR imaging were included. Thirty-two patients with idiopathic RV outflow tract arrhythmias and 32 control subjects, matched for age and sex to the ARVC group, were included for comparison purpose. CMR imaging was performed to assess biventricular function; feature-tracking analysis was applied to the cine CMR images to assess regional and global longitudinal, circumferential, and radial RV strains and RV dyssynchrony (defined as the SD of the time-to-peak strain of the RV segments). RV global longitudinal strain (-17±5% versus -26±6% versus -29±6%; P<0.001), global circumferential strain (-9±4% versus -12±4% versus -13±5%; P=0.001), and global radial strain (18 [12-26]% versus 22 [15-32]% versus 27 [20-39]%; P=0.015) were significantly lower and SD of the time-to-peak RV strain in all 3 directions were significantly higher among patients with ARVC compared with patients with RV outflow tract arrhythmias and controls. RV global longitudinal strain >-23.2%, SD of the time-to-peak RV longitudinal strain >113.1 ms, and SD of the time-to-peak RV circumferential strain >177.1 ms allowed correct identification of 88%, 75%, and 63% of ARVC patients with no or only minor CMR criteria for ARVC diagnosis. CONCLUSIONS: Strain analysis by feature-tracking CMR helps to objectively quantify global and regional RV dysfunction and RV dyssynchrony in patients with ARVC and provides incremental value over conventional cine CMR imaging.

Determinants of geographic variations in implantation of cardiac defibrillators in the European Society of Cardiology member countries--data from the European Heart Rhythm Association White Book.

AIMS: Sudden cardiac death (SCD) is a major health concern in developed countries. Many studies have demonstrated the efficacy of implantable cardioverter defibrillator (ICD) therapy in the prevention of SCD and total mortality reduction. However, the high individual costs and the reimbursement policy may limit widespread ICD utilization. METHODS AND RESULTS: This study analyzed the temporal and the geographical trends of the ICD implantation rate. Data were gathered from two editions of the European Heart Rhythm Association (EHRA) White Books published in 2008 and 2009. The analysis revealed significant differences in the rates of ICD implantation per million capita between the countries, but the median implantations was constantly increasing. The number of ICD implantations correlated with gross domestic product (GDP), GDP per capita, expenditure on health, life expectancy, and the number of implanting centres. CONCLUSION: There are great number of differences in the ICD-implanting rates between EHRA member countries, consequent to the increase in the number of ICD implantations. The ICD implantation rates are related to national economic status and healthcare expenses.

Tracing the European course of cardiac resynchronization therapy from 2006 to 2008.

Cardiac resynchronization therapy (CRT) is a highly efficient treatment modality for patients with severe congestive heart failure and intraventricular dyssynchrony. However, the high individual cost and technical complexity of the implantation may limit its widespread utilization. The European Heart Rhythm Association (EHRA) launched a project to assess treatment of arrhythmias in all European Society of Cardiology member countries in order to have a platform for a progressive harmonization of arrhythmia treatment. As a result, two EHRA White Books have been published in 2008 and 2009 based on governmental, insurance, and professional society data. Our aim was to analyse the local differences in the utilization of CRT, based on these surveys. A total of 41 countries provided enough data to analyse years 2006-2008. Significant differences were found in the overall number of implantations and the growth rate between 2006 and 2008. Other contributing factors include local reimbursement of CRT, the existence of national guidelines, and a high number of conventional implantable cardioverter-defibrillator implantations, while GDP or healthcare spending has less effect. Focusing on improving these factors may increase the availability of CRT in countries where it is currently underutilized.

[Permanent atrial fibrillation and heart failure: radiofrequency ablation of atrioventricular junction and cardiac resynchronization therapy: review of the literature and of the new techniques for echocardiographic assessment]. / Fibrillazione atriale permanente e scompenso cardiaco: ablazione a radiofrequenza della giunzione atrioventricolare e terapia di resincronizzazione cardiaca. Revisione della letteratura e delle nuove tecniche di valutazione ecocardiografica.

Radiofrequency ablation of atrioventricular junction plus pacing therapy ("ablate and pace") is an effective non-pharmacological therapy in patients with medically refractory permanent atrial fibrillation and heart failure. However, the chronic right ventricular pacing may result in regional wall motion abnormalities and adverse hemodynamic effects. These findings imply that patients with permanent atrial fibrillation who undergo "ablate and pace" may benefit from cardiac resynchronization therapy. The review of both observational and randomized studies suggests an important role of biventricular pacing combined with atrioventricular junction ablation only in patients with severe reduction of left ventricular ejection fraction and advanced heart failure. In all other patients with permanent atrial fibrillation, the comparison of conventional right ventricular pacing with respect to cardiac resynchronization therapy showed conflicting results. The assessment of cardiac dyssynchrony by means of new echocardiographic technology, including three-dimensional analysis, may improve the selection of the best pacing modality in patients undergoing "ablate and pace" for drug refractory permanent atrial fibrillation.

Temporal variability of atrial fibrillation in pacemaker recipients for bradycardia: implications for crossover designed trials, study sample size, and identification of responder patients by means of arrhythmia burden.

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.

Primary prevention of sudden cardiac death: can we afford the cost of cardioverter-defibrillators? Data from the Search-MI Registry-Italian sub-study.

BACKGROUND: Large randomized trials show that in appropriately selected patients with left ventricular dysfunction, implantable cardioverter-defibrillators (ICDs) can improve overall survival at 2-5 years. Since direct implementation of the criteria used in the MADIT II and SCD-HeFT will lead to a marked rise in ICD implants, there is a growing fear that increased use of ICDs may cause a dramatic burden to health care systems. The ICD has traditionally been seen as an expensive form of treatment, which is difficult to accept at the first look. This is mainly due to the nonlinear character of the ICD investment, characterized by high initial expenditure, followed by a deferred pay-off in terms of clinical benefits. Cost-effectiveness analysis may help provide a different perspective on the problem of ICD cost, as may estimation of the daily cost of ICD treatment, assuming a time horizon of 5-7 years--a particularly interesting subject for further registry studies. METHODS AND RESULTS: Based on real expenditure data from 2002 to 2005, as recorded in the Search-MI Registry-Italian Sub-study of patients implanted on MADIT II indications, we estimated the daily costs associated with the device and leads. Over a 5-7 year time horizon, the average daily cost was estimated to be euro 4.60-euro 6.70. Translation of these figures into U.S. market conditions suggests a daily cost of around $7.90-$11.40. CONCLUSIONS: These findings appear useful to help evaluate the affordability of ICD in comparison with other therapeutic options in a context of limited available economic resources.