Driejaarsuitkomsten van linker hartoorsluiting met of zonder ablatie: RECORD-studie

BACKGROUND AND AIMS: The long-term impact of left atrial appendage occlusion (LAAO) plus ablation for atrial fibrillation remains controversial. The present study aims to compare the three-year clinical outcomes of LAAO patients with or without one-staged ablation. METHODS: The RECORD study (NCT03917563) was a prospective registry conducted in 39 participating sites in China between 1st April 2019 and 31st October 2020, which consecutively enrolled 3,082 patients who successfully received the WATCHMAN LAAO device. The current study compared patients who received LAAO only to patients who underwent LAAO plus ablation. A 1:1 propensity score matching was performed to attenuate confounding. The primary outcome was a composite endpoint of cardiovascular death, stroke, and systemic embolism at three-year. RESULTS: 1,633/2,928 (55.8%) patients received LAAO only and 1,295/2,928 (44.2%) received LAAO plus ablation. After propensity score matching, 1,016/2,032 (50.0%) were in the LAAO group and 1,016/2,032 (50.0%) in the LAAO plus ablation group. The mean±SD age was 68.8±9.3 years, with 815 (40.1%) participants being female. The mean±SD CHA2DS2-VASc and HAS-BLED scores at baseline were 3.9±1.8 and 2.4±1.1, respectively. At three-year, compared to LAAO only, LAAO plus ablation was associated with a lower risk of cardiovascular death, stroke, systemic embolism (6.9%vs.10.4%, HRPSM:0.66, 95%CI:0.49-0.89, p=0.007), which was driven mainly by the lower risk of cardiovascular death (3.7%vs.7.3%, HRPSM:0.50, 95%CI:0.34-0.74, p=0.001). No significant between-group differences were noted for BARC-defined bleeding. CONCLUSION: LAAO plus ablation was associated with a lower risk of a composite of cardiovascular death, stroke, and systemic embolism than LAAO only at three-year. However, given the observational nature of the current study, the results should be considered as hypothesis-generating only.