Key result
Surgical LAAO will be evaluated for reducing one-year embolism and CV mortality during valvular surgery.
Why the study?
The efficacy of surgical left atrial appendage occlusion (SLAAO) to reduce embolism events in patients with valvular diseases, with or without atrial fibrillation, was not established.
Does surgical left atrial appendage occlusion reduce embolism events and cardiovascular mortality in patients with valvular diseases undergoing cardiovascular surgeries?
Does surgical left atrial appendage occlusion reduce embolism events and cardiovascular mortality in patients with valvular diseases undergoing cardiovascular surgeries?
This study protocol outlines a two-part trial to evaluate the efficacy of surgical left atrial appendage occlusion in reducing long-term embolism events in patients with valvular diseases undergoing cardiac surgery, both with and without atrial fibrillation.
Large RCT will test surgical LAAO efficacy during valvular surgery; extends observational data with first definitive randomized evidence.
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.
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Yuan et al. (2021) studied Valvular heart diseases with or without atrial fibrillation (n=4,150). Surgical left atrial appendage occlusion (SLAAO) vs. No surgical left atrial appendage occlusion was evaluated on Composite of newly occurred ischemic stroke/transient ischemic attack (TIA) or systemic arterial embolism, and cardiovascular mortality. Surgical left atrial appendage occlusion will be evaluated for its efficacy in reducing one-year embolism events and cardiovascular mortality in a planned study of 4,150 patients undergoing valvular surgeries.
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