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.

Cierre de orejuela izquierda en pacientes mayores de 85 años: seguridad y eficacia del registro EWOLUTION / Left atrial appendage occlusion in patients older than 85 years. Safety and efficacy in the EWOLUTION registry

INTRODUCCIÓN Y OBJETIVOS: Los pacientes ancianos con fibrilación auricular están en mayor riesgo de eventos cardioembólicos y hemorragia mayor que los más jóvenes. El cierre de la orejuela izquierda (COI) podría ser una opción atractiva para estos pacientes, pero hay pocos datos sobre los resultados del COI de pacientes de 85 o más años. El objetivo del presente estudio es evaluar la seguridad y la eficacia del COI de pacientes de 85 o más años. MÉTODOS: Se analizó a 1.025 pacientes incluidos en el registro EWOLUTION que se habían sometido al COI, se identificó a 84 de edad ≥ 85 años y se los comparó con el grupo de menos edad. RESULTADOS: Los pacientes de 85 o más años tenían mayores riesgos estimados de accidente cerebrovascular y de hemorragias que los pacientes más jóvenes (edad ≥ 85 frente a <85 años: CHA2DS2-VASc, 5,2+/-1,2 frente a 4,4+/-1,6; p <0,0001; HAS-BLED, 2,7+/-1,1 frente a 2,3+/-1,2; p = 0,003). Las tasas de éxito del procedimiento fueron altas y similares en ambos grupos (el 98,8 frente al 98,5%; p = 0,99). No hubo diferencias en las tasas de eventos adversos relacionados con el dispositivo o el procedimiento a los 7 días (el 2,6 frente al 3,1%; p = 0,80). A pesar del mayor riesgo basal de accidente cerebrovascular, en el seguimiento no hubo diferencias entre los grupos en la tasa de ictus anualizada (0,8 frente a 1,3/100 pacientes-año; p = 0,649). CONCLUSIONES: El COI de los pacientes de edad ≥ 85 años es seguro y eficaz a pesar del alto riesgo de eventos embólicos y hemorrágicos de estos pacientes. El COI puede ser una alternativa razonable a la anticoagulación oral para estos pacientes

INTRODUCTION AND OBJECTIVES: Elderly patients with atrial fibrillation are at greater risk of both cardioembolic events and major bleeding than younger patients. Left atrial appendage occlusion (LAAO) could be an attractive alternative for these patients, but there are limited data on outcomes with LAAO in patients ≥ 85 years old. The aim of the present study was to assess the safety and efficacy of LAAO in patients ≥ 85 years old. METHODS: A total of 1025 patients included in the EWOLUTION registry who underwent LAAO were analyzed and 84 patients ≥ 85 years old were identified and compared with the younger cohort. RESULTS: Patients ≥ 85 years old had higher estimated stroke and hemorrhagic risks than younger patients (CHA2DS2-VASc: 5.2+/-1.2 vs 4.4+/-1.6, P <.0001; HAS-BLED: 2.7+/-1.1 vs 2.3+/-1.2; P=.003; ≥ 85 years vs <85 years). Procedural success was high and similar in both groups (98.8% vs 98.5%; P=.99). There were no differences in 7-day device- or procedure-related adverse event rates (2.6% in ≥ 85 years vs 3.1% in <85 years; P=.80). Despite the higher baseline stroke risk, there was no difference at follow-up between the groups in the annualized stroke rate (0.8/100 patient-years in ≥ 85 years vs 1.3/100 patient-years in <85 years; P=.649). CONCLUSIONS: LAAO in patients ≥ 85 years is safe and effective even though these patients are at high risk for embolic and hemorrhagic events. LAAO may be a reasonable alternative to oral anticoagulation in these patients