Clinical efficacy and safety of Watchman occluders vs. ACP/Amulet occluders in patients with non-valvular atrial fibrillation: a patient-pooled meta-analysis of clinical trials

  AIM  To compare the clinical efficacy of Watchman occluders vs. ACP/Amulet occluders in patients with non-valvular atrial fibrillation (nVAF). METHODS Included in this analysis were nVAF patients who were not suitable for oral anticoagulant therapy, or did not tolerate a log-time anticoagulant therapy, or had high risk of stroke, or were bleeding. Two researchers independently screened the literature, submitted the data and cross-checked them. In case of differences, the third researcher would assist to make the judgment. RevMan5.4 was used for Meta analysis. As the outcome indicator was a binary variable, odds ratio (OR) was used as the effect indicator and point valuation/95%CI was given for each indicator. With P > 0.05 and I² < 0.5, the fixed effect model was used for Meta analysis. The primary endpoint was the incidence of all-cause death, cardiovascular death and stroke. Secondary endpoints were perioperative and in-hospital complications (including pericardial effusion, cardiac tamponade and loss of occlude dislodgement). The safety endpoints were device-related thrombus (DRT), residual complications ≥5 mm and bleeding events within follow-up.

  RESULTS  A total of 8 articles and 1821 patients were included in this study. Eight hundred and ninety-six patients were in the Watchman group and 925 patients were in the ACP/Amulet group. The all-cause death in the Watchman group was 10.7%, lower than that in the ACP/Amulet group (OR:0.74, CI 95% CI: 0.55 -- 0.99, P =0.04, I²=0%). There was no difference in the incidence of cardiovascular death and total stroke, pericardial effusion, cardiac tamponade and occluder dislodgement. The incidence of residual leakage (≥5 mm) in the Watchman group was 1.8% higher than that in the ACP/Amulet group (OR: 2.64, CI 95% CI: 1.09 -- 6.41, P =0.03, I²=0%). No differences were observed in the incidence of bleeding and device-related thrombosis.

  CONCLUSION  The all-cause death in Watchman group is lower than that in ACP/Amulet group. The incidence of perioperative and in-hospital complications is similar and both of the two devices are safe.