Surgical left atrial appendage occlusion will be evaluated in a planned 4150-patient trial to determine its efficacy in reducing one-year embolism events and cardiovascular mortality.
RCT (n=4,150)
single-blinded
1:1
Sí
Does surgical left atrial appendage occlusion reduce the composite of ischemic stroke/TIA, systemic arterial embolism, and cardiovascular mortality in patients with valvular diseases undergoing cardiovascular surgeries?
This study protocol outlines a two-part trial (prospective cohort and RCT) to evaluate the efficacy of surgical left atrial appendage occlusion for stroke prevention in patients with valvular heart disease undergoing cardiac surgery.
Background: As increasing evidence showed the efficacy of percutaneous left atrial appendage (LAA) occlusion in reducing the stroke risks in patients with non-valvular atrial fibrillation(AF), we design this study to quantify the effect of surgical LAA occlusion (SLAAO) for patients with valvular diseases and with or without AF. Methods: The current study will be implemented in two parts: Part 1 (AF study) is a prospective longitudinal study with a plan to consecutively register 2032 patients diagnosed with valvular diseases and AF and receiving cardiovascular surgeries. SLAAO will be performed at the individual surgeon’s preference. We centrally conducted a one-year follow-up on stroke, systemic arterial embolism, and all-cause mortality. Part 2 (non AF study) is a single-blinded, multicenter, randomized controlled trial with the purpose to evaluate the efficacy of SLAAO to reduce one-year embolism events in patients with valvular diseases, without AF, and receiving cardiovascular surgeries. 2118 patients will be randomized 1:1 to the intervention or control arm using a central randomization system. Results: The primary outcome is a composition of newly occurred ischemic stroke/transient ischemic attack (TIA) with positive neuroimaging or systemic arterial embolism, and cardiovascular mortality during one-year follow-up. Conclusion: The trial is designed to evaluate the efficacy of SLAAO to reduce embolism events one year after mitral or aortic surgeries, and this paper presents the prospective study protocol. It provides details of patient randomization, follow-up, methods of analysis of the material, and publication plan.
Yuan et al. (Tue,) conducted a rct in Valvular diseases with or without atrial fibrillation (n=4,150). Surgical left atrial appendage occlusion (SLAAO) vs. Control arm (no SLAAO) was evaluated on Composition of newly occurred ischemic stroke/transient ischemic attack (TIA) with positive neuroimaging or systemic arterial embolism, and cardiovascular mortality. Surgical left atrial appendage occlusion will be evaluated in a planned 4150-patient trial to determine its efficacy in reducing one-year embolism events and cardiovascular mortality.