Dr. med, Ph.D., DMSc
Lars Peter Riber
Department of Cardiothoracic and Vascular Surgery, OUH
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 01.09.2023 | |
| Slut | 31.08.2023 | |
Surgical left atrial appendage closure with and without postoperative anticoagulant therapy in patients with atrial fibrillation undergoing cardiac surgery
Short summary
The purpose of this study is to determine if patients with atrial fibrillation who have undergone surgical closure of the left atrial appendage can discontinue their anticoagulant treatment. Patients who have previously undergone surgical close, will be included and randomized, to either continue or discontinue their anticoagulant treatment, and the risk of stroke, systemic embolism and major bleeding with and without treatment will be evaluated.
Rationale
The risk of stroke is increased five times in patients with fibrillation, and current guidelines recommend anticoagulant treatment to most patients with atrial fibrillation. Among patients who are treated with anticoagulants, each year about 1-2% of patients experience life threatening or invalidating bleeding (e.g., cerebral hemorrhage or gastrointestinal bleedings), while up to 20% or patients experience any type of bleeding (e.g., nosebleeds). The increased risk of bleeding is tolerated since the treatment results in a substantial reduction in the risk of stroke. In patients with atrial fibrillation, who have undergone cardiac surgery, the left atrial appendage is surgically closed. After this procedure, the risk of stroke is considerably reduced, and therefore it is questionable if the continued use of anticoagulants is justified in these patients. Current guidelines, however, still recommend anticoagulant treatment, as it has never been investigated if it is safe to discontinue anticoagulants in these patients. An alternative to anticoagulants, which permanently reduces the risk of stoke and systemic embolism, without the life-long risk of hemorrhage, could change the way patients with atrial fibrillation are treated. This study might impact guidelines for treatment of atrial fibrillation and might also cause a reduction in unnecessary life-threatening and invalidating bleedings as well as minor, but frustrating bleedings in thousands of patients worldwide.
Description of the cohort
The cohort will consist of patients with atrial fibrillation, who have undergone surgical left atrial appendage closure in addition to any cardiac surgical procedure from January 2010 to April 2023.
Data and biological material
Data from patient journals, Data from national registries, questionnaire data