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Introduction Reliable detection and monitoring of atrial fibrillation (AF) is essential for accurate clinical decision making, which can now be done continuously with the introduction of implantable cardiac monitors (ICM) The DETECT AF study evaluated the performance of the Confirm DM2102 ICM (St. Jude Medical, St. Paul, MN, USA) to accurately detect and monitor AF. Methods Ninety patients previously implanted with the ICM and with either suspected or known paroxysmal AF were enrolled at 12 centers in Germany and The Netherlands. At least 2 weeks after ICM implant, patients wore a Holter monitor for 4 days, while the ICM monitored for AF episodes lasting at least 2 minutes. Holter monitor data was analyzed by a blinded, independent core laboratory and compared to the ICM AF detections. Patient and episode sensitivity (SE), specificity (SP), positive predictive value (PPV) and negative predictive (NPV) were calculated using standard analysis and a generalized estimation equation method where appropriate. Results A total of 79/90 subjects (61% male, 65.7 ± 9.6 years old) were included in the analysis, totaling 6894 hours of Holter monitoring. Using a per patient analysis SE was 100%, PPV was 64.0%, SP was 85.7% and NPV was 100%. Using a per episode analysis, SE was 94.0% and PPV was 64.0%. With an AF duration analysis, the SE was 83.9%, PPV was 97.3%, SP was 99.4% with a NPV of 98.5%. Conclusion The SJM Confirm DM2102 can accurately and repeatedly detect paroxysmal AF episodes of at least 2 minutes in length. This article is protected by copyright. All rights reserved

Aims Multiple trials have shown that implantable cardioverter defibrillators (ICDs) prolong survival in secondary and primary prevention populations. However, in spite of the efficacy of these devices in terminating life-threatening arrhythmias, total mortality remains high. Methods and results We evaluated 1703 patients (mean age: 67±12 years, 82% male) with conventional ICD indications, who were enrolled and followed between 2001 and 2004 at 128 US centres. Patients were followed for up to a year, and vital status was obtained for 1655 patients (97%, median follow-up: 377 days). There were 183 deaths within 1 year of ICD implantation (1-year mortality rate: 16%). Predictors of mortality included a history of atrial fibrillation (AF, P < 0.0001), diabetes ( P = 0.0001), failure to use cholesterol-lowering medications ( P < 0.001), use of digitalis and derivatives ( P < 0.0001), use of diuretics ( P < 0.0001), low body mass index (BMI, P < 0.0001), increasing age ( P < 0.0001), low left ventricular ejection fraction ( P < 0.0001), low activity hours ( P < 0.0001), elevated resting heart rate ( P = 0.014), low mean arterial pressure (MAP, P = 0.007), and poor functional status (New York Heart Association class, P < 0.0001). In multivariate modelling, AF ( P ≤ 0.001), diabetes ( P = 0.004), BMI ( P = 0.001), MAP ( P = 0.040), and functional class ( P = 0.006) predicted mortality. Conclusion In this population undergoing ICD implantation, poor functional status, low MAP, diabetes, low BMI, and AF were strongly associated with death within a year.

The Silent Atrial Fibrillation Detection With Stored EGMs (SAFE) registry is the first prospective study to characterize the incidence, duration, and predictors of atrial high-rate episodes (AHREs) in patients without previous clinically diagnosed atrial fibrillation after dual-chamber pacemaker implantation. Patients underwent in-clinic device interrogation at 2 weeks and then 3, 6, and 12 months after implantation. An AHRE was defined as an atrial tachyarrhythmia with an atrial rateor =180 beats/min lastingor =5 minutes. During the first month after pacemaker implantation, AHREs were identified in 68 patients (4.6%). Thirty-four of these patients (50%) did not have AHREs beyond the first month after implantation; these patients were older than those who continued to have AHREs (79 +/- 9 vs 74 +/- 12 years, p = 0.05). Within the first 6 months after pacemaker implantation, 150 patients (10%) experienced a total of 455 AHREs, of which only 28 (6%) prompted clinical visits. The 6-month freedom from an AHRE was 82%. Overall, 75% of patients with AHREs had multiple episodes; most AHREs lasted 5 to 60 minutes. In conclusion, 6 months after dual-chamber pacemaker implantation, 10% of patients experiencedor =1 AHRE, usually lasting 5 to 60 minutes. Some patients had AHREs only within the first 30 days after implantation, suggesting the possibility of transient atrial proarrhythmia related to lead insertion.

This study compared a two‐layer (Coban™ 2 Layer) and a four‐layer (Profore™) compression bandage system in venous leg ulcer patients. Participants (n = 81) were enrolled into an 8‐week, randomised, open‐label, ten‐centre, crossover clinical trial. The primary endpoint was bandage slippage measured at each dressing change. Secondary endpoints included wound healing, health‐related quality of life (HRQoL) and patient preference. Mean slippage estimated from a mixed analysis of variance model (697 visits) was 2·48 cm for the two‐layer system and 4·17 cm for the four‐layer system (P

Atrial Pacing in Heart Failure. Introduction: Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population. This trial was designed to evaluate the effect of atrial support pacing among heart failure patients receiving a CRT defibrillator. Methods and Results: PEGASUS CRT was a multicenter, 3-arm, randomized study. At 6 weeks, patients were randomized to DDD mode at a lower rate of 40 bpm (DDD-40; control arm), or one of the following 2 treatment arms: DDD-70, or DDDR-40. The primary endpoint was a clinical composite endpoint that included all-cause mortality, heart failure events, NYHA functional class, and patient global self-assessment. Subjects were classified as improved, unchanged, or worsened at 12 months. There were 1,433 patients randomized, of whom 66% were male, mean age was 67 ± 11 years, and mean left ventricular ejection fraction was 23 ± 7%. The average follow-up time was 10.5 ± 3.5 months and 1,309 patients contributed to the primary endpoint. No significant differences were observed in the composite endpoint between either of the 2 treatment arms compared to the control arm (P>0.05 for both comparisons). Additionally, there were no differences among the groups in mortality or heart failure events. Conclusion: In advanced heart failure patients treated with CRT, atrial support pacing did not improve clinical outcomes compared to atrial tracking. However, atrial pacing did not adversely affect mortality or heart failure events. (J Cardiovasc Electrophysiol, Vol. 23, pp. 1317-1325, December 2012)