Expert review of medical devices · 2022
Effect of congestive heart failure on safety and efficacy of left atrial appendage closure in patients with non-valvular atrial fibrillation.
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Zhao Mingzhong, Hou Cody R, Bai Jianlin, Post Felix, Walsleben Jens, Herold Nora, Yu Juan, Zhang Zufeng, Yu Jiangtao
Аннотация
OBJECTIVES: To evaluate the influence of congestive heart failure (CHF) on safety and efficacy of left atrial appendage closure (LAAC) in non-valvular atrial fibrillation (NVAF) patients.
METHODS: A total of 401 patients who consecutively underwent LAAC with Watchman and LAmbre devices were divided into CHF (85 cases) and non-CHF (316 cases) groups. Comparisons between groups were performed against data.
RESULTS: No significant differences were found in implantation success and periprocedural complication rates between the two groups. During a mean 2.2 years of follow-up, the incidence rate of thromboembolism, major bleeding, device-related thrombus, and non-cardiovascular death was comparable. However, patients with CHF had significantly increased risk of all-cause death (P = 0.015), cardiovascular death (P = 0.014), and combined efficacy endpoints (P = 0.02). After performing propensity score matching, the risk of all-cause death (P = 0.01), cardiovascular death (P = 0.01), and combined efficacy endpoints (P = 0.006) was still higher. The logistic regression analyses identified CHF (OR: 3.642, 95% CI: 1.296-10.232, P = 0.014) as an independent predictor of cardiovascular death.
CONCLUSIONS: Implantation of atrial appendage occluder is effective and safe in NVAF patients with CHF. The increased risk of mortality and combined efficacy endpoints in patients with CHF versus non-CHF after LAAC may be associated with the high risk of CHF itself.
METHODS: A total of 401 patients who consecutively underwent LAAC with Watchman and LAmbre devices were divided into CHF (85 cases) and non-CHF (316 cases) groups. Comparisons between groups were performed against data.
RESULTS: No significant differences were found in implantation success and periprocedural complication rates between the two groups. During a mean 2.2 years of follow-up, the incidence rate of thromboembolism, major bleeding, device-related thrombus, and non-cardiovascular death was comparable. However, patients with CHF had significantly increased risk of all-cause death (P = 0.015), cardiovascular death (P = 0.014), and combined efficacy endpoints (P = 0.02). After performing propensity score matching, the risk of all-cause death (P = 0.01), cardiovascular death (P = 0.01), and combined efficacy endpoints (P = 0.006) was still higher. The logistic regression analyses identified CHF (OR: 3.642, 95% CI: 1.296-10.232, P = 0.014) as an independent predictor of cardiovascular death.
CONCLUSIONS: Implantation of atrial appendage occluder is effective and safe in NVAF patients with CHF. The increased risk of mortality and combined efficacy endpoints in patients with CHF versus non-CHF after LAAC may be associated with the high risk of CHF itself.