Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial

Background Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Objective EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry. Methods A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice. Results The baseline CHA 2 DS 2 -VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen ( P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related. Conclusion LAA closure with the WATCHMAN device has a high implant and sealing success. This method of stroke risk reduction appears to be safe and effective with an ischemic stroke rate as low as 1.1%, even though 73% of patients had a contraindication to and were not using oral anticoagulation

Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial

Aims: Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. Methods and results: The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan–Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0–18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03–1.08, per year increase], heart failure (HR 1.73, CI: 1.24–2.41), vascular disease (HR 1.47, CI: 1.05–2.05), valvular disease (HR 1.63, CI: 1.15–2.33), abnormal liver function (HR 1.80, CI: 1.02–3.17), and abnormal renal function (HR 1.58, CI: 1.10–2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. Conclusion: One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. Clinical trial registration: The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282

The OPTI-MIND study: A prospective, observational study of pacemaker patients according to pacing modality and primary indications

Aims The OPTI-MIND study aims to collect 2-year clinical outcomes of pacemaker patients in real-world clinical practice, overall and according to patient characteristics and pacemaker settings. Methods and results The present analysis of the OPTI-MIND study describes the programmed device settings after discharge from the pacemaker implant. The objective was to determine whether these settings fit recent guidelines for device-programmed physiological pacing based on the preservation of atrioventricular synchrony, avoiding unnecessary pacing, ensuring rate increase during exercise or preventing neurally mediated symptoms. A total of 1740 patients were enroled at 68 centres worldwide. Baseline patient characteristics and device programming settings are available in 1674 of 1740 patients (96%). Guidelines to ensure physiological pacing were followed in 41% of patients: in patients with sinus node disease (SND), and without atrioventricular block (AVB), device programming could have led to unnecessary right ventricular pacing in 38% of patients. In SND patients with chronotropic incompetence, assisted rate increase during exercise was not programmed in 42% of patients. In 11% of patients with AVB, atrioventricular (AV) synchrony was not pursued; the main drivers being advanced age and history of atrial fibrillation. Patients with both SND and AVB were generally programmed physiologically (87%). Conclusion The present analysis showed that frequent deviations occurred when comparing the device settings at discharge from the pacemaker implant in clinical practice to the available guidelines on pacing mode selection. Analysis of 2-year outcomes in the OPTI-MIND study will provide an insight into whether specific physiological settings could improve the quality of pacing with a positive effect on patient outcome. \ua9 2014 Published on behalf of the European Society of Cardiology. All rights reserved