Left atrial appendage occlusion for patients with valvular diseases: a
prospective study design
Abstract
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.