Effect of Left Atrial Appendage Occlusion on Stroke Risk in Atrial Fibrillation Patients Undergoing Cardiac Surgery
Study design
Multicenter, randomized trial
Population
- Number of patients studied: 4770
- Inclusion criteria: Participants with atrial fibrillation and a CHA2DS2-VASc score of at least 2, scheduled to undergo cardiac surgery for another indication
- Exclusion criteria: Not specified
Interventions
- Experimental group: Occlusion of the left atrial appendage during cardiac surgery
- Control group: No occlusion of the left atrial appendage during cardiac surgery
Primary outcome: Occurrence of ischemic stroke (including transient ischemic attack with positive neuroimaging) or systemic embolism
NNT value = 45.45
Secondary/ Safety Outcomes
| Outcome | Occlusion group | No-occlusion group | Hazard ratio (95% CI) |
|---|---|---|---|
| Ischemic stroke | 109 (4.6%) | 164 (6.9%) | 0.66 (0.52 to 0.84) |
| Death | 538 (22.6%) | 537 (22.5%) | 1.00 (0.89 to 1.13) |
| Hospitalization for heart failure | 183 (7.7%) | 162 (6.8%) | 1.13 (0.92 to 1.40) |
| Major bleeding or myocardial infarction | Similar incidence in both groups | Similar incidence in both groups |
Issues and biases
Lack of information about the relative efficacy of left atrial appendage occlusion compared to oral anticoagulation. Findings apply primarily to surgical occlusion performed as a concomitant procedure, not to stand-alone surgical or endovascular occlusion. Cannot determine whether all surgical closure methods are comparable, and occlusion sustainability was not examined.
Conclusion
Among participants with atrial fibrillation who had undergone cardiac surgery, most of whom continued to receive ongoing antithrombotic therapy, the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it.
Whitlock, R. P., Belley-Cote, E. P., Paparella, D., Healey, J. S., Brady, K., Sharma, M., Reents, W., Budera, P., Baddour, A. J., Fila, P., Devereaux, P. J., Bogachev-Prokophiev, A., Boening, A., Teoh, K. H. T., Tagarakis, G. I., Slaughter, M. S., Royse, A. G., McGuinness, S., … Connolly, S. J. (2021). Left atrial appendage occlusion during cardiac surgery to prevent stroke. New England Journal of Medicine, 384(22), 2081-2091.