Left Atrial Appendage Closure as an Alternative to Oral Anticoagulation After Ablation for Atrial Fibrillation

Experts from the UPMC Heart and Vascular Institute in Central Pa. recently published results of the OPTION clinical trial in the New England Journal of Medicine. This trial investigated the use of left atrial appendage closure as an alternative to anticoagulation following ablation for atrial fibrillation. UPMC Harrisburg was one of the 10 leading centers for the OPTION trial.

The OPTION trial was a multicenter, randomized trial that involved 1600 patients with atrial fibrillation who had an elevated score on the CHA₂DS₂-VASc scale – a measurement of risk of stroke in patients with atrial fibrillation – and who had undergone catheter ablation. Participants were randomly assigned to undergo left atrial appendage closure with Watchman device or receive oral coagulation. 803 patients were assigned to undergo left atrial appendage closure, and 797 were assigned to receive anticoagulant therapy.

The primary end points of the study were non-procedure-related major bleeding or clinically relevant nonmajor bleeding and death from any cause, stroke, or systemic embolism at 36 months. The secondary end point was major bleeding, including procedure-related bleeding through 36 months.

Conclusion of Findings

The trial found that left atrial appendage closure resulted in a lower incidence of bleeding than oral anticoagulation after ablation. Additionally, left atrial appendage closure was noninferior to oral anticoagulation regarding the primary end point of death from any cause, stroke, or systemic embolism at 36 months. The incidence of death was similar between the two groups, and no deaths were found to be related to the device.

In this trial, left atrial appendage closure with Watchman device proved to be a safe alternative to oral anticoagulation for atrial fibrillation patients following ablation. Among patients at moderate to high risk for stroke who underwent ablation for atrial fibrillation, left atrial appendage closure was associated with lower risk of non-procedure-related major or clinically relevant nonmajor bleeding than oral anticoagulation.

"OPTION trial provides additional randomized data that underscores safety and efficacy of left atrial appendage closure with Watchman device for stroke prevention in atrial fibrillation. Data shows that concomitant catheter ablation and left atrial appendage closure is safe. Although findings of OPTION trial can't be generalized to all the patients with atrial fibrillation, it definitely paves the path forward,” says Chinmay Patel, MD, the site Principal Investigator at UPMC Harrisburg.  

Reference

Wazni, O. M., Saliba, W. I., Nair, D. G., Marijon, E., Schmidt, B., Hounshell, T., Ebelt, H., Skurk, C., Oza, S., Patel, C., Kanagasundram, A., Sadhu, A., Sundaram, S., Osorio, J., Mark, G., Gupta, M., DeLurgio, D. B., Olson, J., Nielsen-Kudsk, J. E., … Reddy, V. Y. (2024). Left atrial appendage closure after ablation for atrial fibrillation. New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa2408308