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The Medtronic CareLink allows remote implantable device follow-up. In this first European experience with CareLink, we assessed the ease of use of the system, the acceptance, and satisfaction of patients and clinicians. Methods: Patients implanted with biventricular defibrillators for more than 6 months received the CareLink monitor and were trained to perform home device interrogation and transmission. Patient and clinician experience and preference were evaluated through specific questionnaires. Results: Sixty-seven patients were enrolled and were able to perform data transmissions during the 3-month study duration. The overall duration of interrogation procedure was 7 ± 5 minutes, and frequently the procedure did not require the assistance of a caregiver. Patients reported a general preference for remote versus in-clinic follow-up and described a sense of reassurance created by the remote monitoring capability. In the centers, the review procedure was successful; its mean duration was 5 ± 2 minutes per transmission and the users indicated that the access and navigation of the review website were easy. At the end of the evaluation, the data available for remote review were judged complete and adequate to provide almost the same standard of care as that offered in traditional in-clinic visit. In general, the remote monitoring was seen as a potential tool to improve the clinical management of patients with device. Conclusions: The ease of use, satisfaction, and acceptance of the CareLink Network in European clinical practice appears elevated both for patients and for clinicians. [ABSTRACT FROM AUTHOR]

Aim: Cardiac resynchronization therapy (CRT) is an effective therapy for patients with reduced systolic function and enlarged QRS. Recently, some Authors have demonstrated that the presence of positive antinuclear antibodies (ANAs) may play a role in the development of heart failure in a population of patients implanted with PM., Methods: We investigated the effect of positive ANAs in 90 patients (mean age 71±8 years) implanted with a CRT device in our Centre between May 2010 and June 2013. To assess for immunologic contribution to CRT outcome, patients were divided into positive and negative ANAs (ANA +, ANA -), considering as positive patients with an ANAs dilution > 1:80. The primary endpoint was constituted by a combined endpoint of death or first hospitalization for heart failure; secondary endpoints were constituted by: 1) incidence of first hospitalization for heart failure; and 2) total cause mortality., Results: After a mean follow-up of 1200 days, primary endpoint occurred in 11 patients (30%) of ANA+ group and in 8 patients (15.1%) of ANA-group. The significant difference is due to difference in heart failure events (27% vs. 11.3%, P<0.05), whilst difference in total mortality did not reach statistical significance (10.8% vs. 3.8%)., Conclusion: Immune status seems to play a role in patients with congestive heart failure. If this immunological alteration is a determinant or a consequence of heart failure remains unclear.

Background: Inflammation may play a significant role in the pathogenesis of atrial fibrillation (AF)., Objectives: To examine the roles of three systemic inflammatory markers in predicting recurrent AF., Methods: The association between the plasma concentrations of high-sensitivity C reactive protein (hsCRP), interleukin-6 (IL-6) and pentraxin-3 (PTX3) with echocardiographic parameters and with the time to first recurrence of AF was tested in 382 patients with a history of AF but in sinus rhythm at randomisation, enrolled in the GISSI-AF biohumoral study., Results: Baseline PTX3 was related to left atrial, but not to left ventricular chamber volume. During one year of follow-up, 204 patients (53.1%) had a recurrent AF. There were no significant differences in baseline median [Q1-Q3] plasma concentrations of IL-6, hsCRP and PTX3 among patients with (2.11 [1.47-3.74] pg/ml, 3.30 [1.40-6.80] mg/l and 4.66 [3.27-6.97] ng/ml, respectively) or without recurrent AF (2.09 [1.37-2.90] pg/ml, p=0.182; 3.00 [1.10-6.20] mg/l, p=0.333; 5.09 [3.22-7.98] ng/ml, p=0.637). At 6 and 12 months follow-up, AF patients had significantly higher concentrations of IL-6 and PTX3 than those in sinus rhythm, and those with most recent episodes of AF had higher hsCRP. Baseline levels of IL-6, hsCRP or PTX3 were not significantly associated with a higher risk of recurrence of AF., Conclusion: In patients with a history of AF, but without significant left ventricular dysfunction or heart failure, inflammatory biomarkers may be raised but are, at best, weak predictors of the risk for first recurrence of AF.

Purpose: The aim of the present study is to evaluate if remote monitoring with the CareLink Network may improve clinical management of tachyarrhythmias and heart failure episodes in patients treated with biventricular defibrillators (CRT-D)., Methods: Patients implanted with CRT-D for more than 6 months received the CareLink monitor and were trained to perform device interrogation. At-home transmissions were scheduled at 2 weeks, 1 and 2 months after training, with a final in-office visit after 3 months., Results: Sixty-seven patients performed 264 data transmissions. Twenty-three unscheduled data transmissions were requested by the centers after patient contact. Ventricular tachyarrhythmias were reported in nine patients during 16 data reviews. Thirteen data reviews (81%) were performed remotely via CareLink transmissions (nine scheduled and four unscheduled), in seven patients. Of these events, in two cases (15%) in-hospital visits were requested, while in 11 (85%) no action was needed and no additional in-clinic visits were scheduled. During the study period, in 20/28 (71%) intra-thoracic impedance alerts, the patients remotely transmitted their device data. After remote data review, in ten cases drug therapy was adjusted by phone and in four cases no action was needed and the patient reassured. In six episodes an in-hospital extra visit was scheduled. On the whole, in 14 cases (70%), the patient could be managed remotely avoiding a visit to the hospital., Conclusions: Our study showed that remote follow-up is an efficient method to manage tachyarrhythmias and heart failure episodes in CRT-D patients. Early reaction to clinical events may improve overall patient care.

Objective: The receptor for advanced glycation end products (RAGE) is a cell surface receptor whose signaling pathway has been implicated in atherogenesis. RAGE has an endogenous secretory receptor form, called soluble RAGE (sRAGE), that could exert antiatherogenic effects by acting as a decoy. We sought to determine whether a decreased plasma level of sRAGE could be independently associated with the prevalence of coronary artery disease (CAD) in nondiabetic men., Methods and Results: Plasma levels of sRAGE were determined in 328 nondiabetic male patients with angiographically proved CAD and in 328 age-matched healthy controls. The concentration of sRAGE in plasma was significantly lower (P<0.0001) in CAD cases [median (interquartile range): 966 (658-1372) pg/mL] than in control subjects [1335 (936-1954) pg/mL]. In logistic regression analysis, the multivariate-adjusted odds ratio for the presence of CAD was 6.719 (95% confidence interval, 3.773 to 11.964; P<0.0001) when the lowest quartile of the sRAGE level was compared with the highest quartile., Conclusions: Our findings indicate that low levels of sRAGE in plasma are independently associated with the presence of CAD in nondiabetic men and suggest that sRAGE is one of the clinically important molecules associated with atherosclerosis.

Background: We have recently reported that homozygosity for the minor A-allele of RAGE (receptor for advanced glycation end products) -374T/A polymorphism may exert a protective effect toward the development of angiographic coronary artery disease (CAD). Here we focused on the putative involvement of this functional RAGE polymorphism on the severity of coronary atherosclerosis as assessed by angiography., Methods: In a total of 234 consecutive Caucasian patients with angiographically proven CAD, the severity of coronary atherosclerosis was assessed by the number of diseased vessels (greater than 50% stenosis). Genotyping for the -374T/A variant was performed by means of PCR-RFLPs., Results: The mean number of diseased vessels was significantly lower in patients with the AA genotype (1.47+/-0.68) than in those with the AT or TT genotype (1.88+/-0.82, p=0.029). After confounding variables were controlled for, the number of diseased vessels remained significantly different in the AA genotype carriers from that in the AT or TT carriers (p=0.041, ANCOVA)., Conclusions: Our data suggest that the RAGE -374T/A polymorphism is one of the likely candidate determinants for the genetic variance of disease phenotype in coronary atherosclerosis.