Left Atrial Appendage Closure after Ablation for Atrial Fibrillation

"BACKGROUND

Oral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but data regarding its use after atrial fibrillation ablation are lacking.

METHODS

We conducted an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated CHA₂DS₂-VASc score (≥2 in men and ≥3 in women) and underwent catheter ablation. Patients were assigned to undergo left atrial appendage closure (device group) or receive oral anticoagulation (anticoagulation group). The primary safety end point was non-procedure-related major or clinically relevant nonmajor bleeding at 36 months. The primary efficacy end point was a composite of death from any cause, stroke, or systemic embolism.

RESULTS

At 36 months, the primary safety end point occurred in 8.5% of the device group versus 18.1% in the anticoagulation group (P<0.001 for superiority). The primary efficacy end point occurred in 5.3% and 5.8%, respectively (P<0.001 for noninferiority). Device-related complications occurred in 23 patients.

CONCLUSIONS

Left atrial appendage closure reduced bleeding risk compared with oral anticoagulation and was noninferior for preventing stroke, systemic embolism, or death in patients post-ablation. (Funded by Boston Scientific; OPTION ClinicalTrials.gov number, NCT03795298.)"

"BACKGROUND

Oral anticoagulation is recommended after ablation for atrial fibrillation among patients at high risk for stroke. Left atrial appendage closure is a mechanical alternative to anticoagulation, but data regarding its use after atrial fibrillation ablation are lacking.

METHODS

We conducted an international randomized trial involving 1600 patients with atrial fibrillation who had an elevated CHA₂DS₂-VASc score (≥2 in men and ≥3 in women) and underwent catheter ablation. Patients were assigned to undergo left atrial appendage closure (device group) or receive oral anticoagulation (anticoagulation group). The primary safety end point was non-procedure-related major or clinically relevant nonmajor bleeding at 36 months. The primary efficacy end point was a composite of death from any cause, stroke, or systemic embolism.

RESULTS

At 36 months, the primary safety end point occurred in 8.5% of the device group versus 18.1% in the anticoagulation group (P<0.001 for superiority). The primary efficacy end point occurred in 5.3% and 5.8%, respectively (P<0.001 for noninferiority). Device-related complications occurred in 23 patients.

CONCLUSIONS

Left atrial appendage closure reduced bleeding risk compared with oral anticoagulation and was noninferior for preventing stroke, systemic embolism, or death in patients post-ablation. (Funded by Boston Scientific; OPTION ClinicalTrials.gov number, NCT03795298.)"