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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http://dx.doi.org/10.1186/s13063-024-08122-9 | DOI Listing |
Cureus
December 2024
Internal Medicine, Mercy Health St. Vincent Medical Center, Toledo, USA.
We present a case of spontaneous hemorrhage in an emphysematous bulla, complicated by anticoagulation. Bullous emphysema is a well-recognized complication of chronic obstructive pulmonary disease (COPD), and a rare manifestation is hemorrhage into preexisting pulmonary bullae. A 69-year-old male patient presented to the emergency department with hemoptysis, shortness of breath, and productive cough.
View Article and Find Full Text PDFEur Heart J
January 2025
Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Largo A. Gemelli, 8, 00136 Rome, Italy.
Heart Rhythm
January 2025
Cardioangiologisches Centrum Bethanien, AGAPLESION Markus Krankenhaus, Academic Teaching Hospital of the Goethe University, Frankfurt, Germany.
J Cardiovasc Dev Dis
December 2024
German Heart Centre Munich, 80636 Munich, Germany.
(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.
View Article and Find Full Text PDFJACC Cardiovasc Interv
December 2024
William Beaumont University Hospital, Corewell Health East, Royal Oak, Michigan, USA. Electronic address:
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