AI Article Synopsis

  • The trial focuses on the effectiveness of surgical left atrial appendage (LAA) closure during open-heart surgery to prevent strokes in patients with varying CHADS-VASc scores and atrial fibrillation (AF) status.
  • It involves a randomized, multicenter design, enrolling 1500 adult patients and comparing outcomes of LAA closure versus standard care over a two-year follow-up period.
  • The study aims to provide high-level evidence to guide future guidelines on LAA closure and ensure transparency in its statistical analyses.

Article Abstract

Background: Surgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHADS-VASc score and preoperative atrial fibrillation or flutter (AF) status-the current trial attempts to provide such evidence.

Methods: The study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHADS-VASc score will be enrolled. The primary exclusion criteria are planned LAA closure, planned AF ablation, or ongoing endocarditis. Before randomization, a three-step stratification process will sort patients by site, surgery type, and preoperative or expected oral anticoagulation treatment. Patients will undergo balanced randomization (1:1) to LAA closure on top of the planned cardiac surgery or standard care. Block sizes vary from 8 to 16. Neurologists blinded to randomization will adjudicate the primary outcome of stroke, including transient ischemic attack (TIA). The secondary outcomes include a composite outcome of stroke, including TIA, and silent cerebral infarcts, an outcome of ischemic stroke, including TIA, and a composite outcome of stroke and all-cause mortality. LAA closure is expected to provide a 60% relative risk reduction. In total, 1500 patients will be randomized and followed for 2 years.

Discussion: The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases.

Trial Registration: Clinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318 .

Protocol Version: https://doi.org/10.1016/j.ahj.2023.06.003 .

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11092018PMC
http://dx.doi.org/10.1186/s13063-024-08122-9DOI Listing

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(1) Background: Cerebral magnetic resonance imaging has reported new cerebral ischemic lesions after left atrial appendage (LAA) closure in about one- third of patients. Stroke occurs predominantly periprocedurally. This study evaluated the characteristics of embolized debris captured by the SENTINEL cerebral embolic protection system in patients undergoing LAA closure; (2) Methods: Sixty filters of 30 consecutive patients undergoing LAA closure with the WATCHMAN FLX device were collected and captured debris was analyzed by histopathology and histomorphometry.

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