Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes.

BACKGROUND: Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known. METHODS: We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding. RESULTS: The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year). CONCLUSIONS: Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).

His Bundle Pacing: Predicting Mortality and Major Complications in Mid-Term Follow-Up.

Introduction: His bundle pacing (HBP) is suitable for 80% of patients with any indication for permanent pacemaker implantation, with a clinical benefit compared to right ventricular pacing (RVP). Although complications and mortality related to RVP are widely reported in the literature, data on HBP are limited. This study aimed to analyze HBP complications and outcomes in the short-term (up to 30 days) and long-term (up to the following 24 months) follow-up (F/U). Materials and Methods: The study includes 373 patients aged ≥ 18, enrolled from October 2015 to May 2019 in a single-center HBP prospective registry conducted in the Department of Electrocardiology, Upper Silesian Medical Centre of the Medical University of Silesia in Katowice, Poland. Mortality and HBP complications were used as end-points: during hospitalization and up to 30 days (short-term F/U), and for each F/U point-six months, 12 months, and 24 months after the procedure (long-term F/U). Results: Successful HBP was achieved in 252 patients (68%), with an increasing success rate during consecutive years: 57% in 2015-2016 and 73% in 2017-2019. Complications were found in 8.4% of patients (21/252) in short-term F/U and 5.8% (13/224), 5.5% (11/201), and 6.9% (12/174) at six months, 12 months, and 24 months, respectively. There were no deaths during the first 30 days. However, 26 patients (10.3%) died within 24 months. A left ventricular ejection fraction (LVEF) ≤ 34% was the only independent predictor of all-cause mortality or any major complication in the 24-month F/U. Conclusions: This single-center study reported a low risk of mortality and complications associated with HBP at the short-term F/U. However, during the long-term F/U, we observed a higher but acceptable risk of major complications, with a lower LVEF being an independent predictor of the composite end-point of all-cause mortality or any major complication.

Do we differ in terms of indications and demographics in cardiac resynchronisation recipients in Poland? Insights from the European CRT Survey II Registry.

BACKGROUND: Multiple randomised clinical trials have proven that cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with congestive heart failure and is recommended for such patients as per the European Society of Cardiology guidelines. AIM: In this paper we compare the indications and demographics in cardiac resynchronisation recipients in Poland and other European countries. METHODS: In 2015 and 2016, physicians from 42 European countries participated in the second edition of the European Cardiac Resynchronisation Therapy Survey. For 14 months, 288 implanting centres gathered data regarding demography, indications, implanting methods, and guidance compatibility from 11,088 patients receiving CRT. RESULTS: The survey revealed that a vast group of patients were eligible for CRT implantation (although some of them with rela-tively weak guidance recommendations) and showed essential variety in clinical practice when national data were benchmarked. CONCLUSIONS: The population of CRT recipients in Poland and other European countries did not differ in terms of demographic and clinical characteristics. In most cases, indications for CRT were in accordance with the guidelines; however some devices were implanted in patients beyond the guideline recommendations. For these procedures, the decision regarding CRT im-plantation relies mainly on the physicians' experience.