Clinical efficacy and safety comparison of Watchman device versus ACP/Amulet device for percutaneous left atrial appendage closure in patients with nonvalvular atrial fibrillation: A study‐level meta‐analysis of clinical trials

Abstract

Left atrial appendage occlusion is not inferior to oral anticoagulants in the prevention of stroke in several randomized controlled trials. However, the clinical efficacy and safety comparison of the Watchman and amplatzer cardiac plug (ACP)/Amulet devices for percutaneous left atrial appendage closure (LAAC) in patients with non‐valvular atrial fibrillation was controversial. A database search was conducted using PubMed, EMBASE, Cochrane Library, and http://Clinicaltrials.gov for trials that compared Watchman device vs ACP/Amulet device. The effective outcomes were stroke and systemic embolism. Safety outcomes were all‐cause death, cardiovascular death, and major bleeding. Device‐related complications included device‐related thrombus (DRT), peri‐device leaks (PDL > 5 mm). A total of 19 articles involving 6224 patients were included in the present study. The Watchman and ACP/Amulet groups comprised 3267 and 2957 patients, respectively. No statistically significant differences were detected in the stroke (odd ratio [OR]:1.24, 95% confidence interval [CI]: 0.92−1.67, p = .17, I2 = 0), systemic embolism (OR:1.10, 95% CI: 0.51−2.35, p = .81, I2 = 0%), all‐cause death (OR:0.97, 95% CI: 0.80−1.18, p = .77, I2 = 1%), cardiogenic death (OR:0.99, 95% CI: 0.77−1.29, p = .96, I2 = 0%), major bleeding (OR:1.18, 95% CI: 0.98−1.43, p = .08, I2 = 25%). DRT (OR:1.48, 95% CI: 1.06−2.06, p = .02, I2 = 0%) and PDL > 5 mm (OR:2.57, 95% CI: 1.63−4.04, p < .0001, I2 = 0%) were significantly lower in ACP/Amulet group compared to Watchman group. The effective and safety outcomes were comparable between two groups. ACP/Amulet group had significantly lower rates of DRT and PDL > 5 mm than Watchman group.

Comparing Efficacy and Safety of Left Atrial Appendage Closure Devices: A Network Meta-Analysis of Randomized Controlled Trials

“…The findings are substantial enough to warrant individual patient meta-analysis and possibly larger-scale, long-term head-to-head trials between WATCHMAN and novel editions of Amulet. 13 Study-level differences in 1) exclusion criteria, 2) operator experience, and 3) event definitions could have meaningfully changed event rates and confounded our findings. For example, the exclusion of subjects with a prior history of major bleeding in the studies where subjects were randomized to OACs or WATCHMAN 9,10 almost certainly decreased absolute risk of death and hemorrhagic stroke within the trial, while inclusion of inexperienced operators in the Amulet-IDE trial likely increased risk of pericardial effusion.…”

“…The findings are substantial enough to warrant individual patient meta-analysis and possibly larger-scale, long-term head-to-head trials between WATCHMAN and novel editions of Amulet. 13…”

“…This is especially true for Amulet versus OAC comparisons, which are based exclusively on indirect evidence. Previous direct meta-analysis 13 compared only WATCHMAN and Amulet but 16/19 studies included were observational. Thus, it was more subject to bias, yet also did not include indirect RCT evidence and thereby lacked statistical power to properly evaluate outcomes such as death.…”

“…12 However, the differences observed in this flagship trial can be augmented by including evidence from all available studies. Previous direct meta-analysis 13 of LAAC devices combined observational and randomized evidence but still appeared underpowered to detect rarer events such as mortality. There have also been subsequent, head-to-head RCTs that may augment prior evidence.…”

Endovascular occlusion of the left atrial appendage in atrial fibrillation: modern concepts and prospects (review)

“…Варианты антитромбоцитарной терапии после эндоваскулярной окклюзии ушка левого предсердия, подобранные индивидуально в зависимости от риска тромбоза и кровотечения, связанного с устройством По данным метаанализа сообщений об имплантации устройств Watchman (n = 3267) и Amulet (n = 2957) не было обнаружено статистически значимых различий в частоте инсульта (ОР 1,24 при 95% ДИ 0,92-1,67; р = 0,17), системной эмболии (ОР 1,10 при 95% ДИ 0,51-2,35; р = 0,81), смерти от всех причин (ОР 0,97 при 95% ДИ 0,80-1,18; р = 0,77), кардиальной смерти (ОР 0,99 при 95% ДИ 0,77-1,29; р = 0,96), большого кровотечения (ОР 1,18 при 95% ДИ 0,98-1,43; р = 0,08). Однако в группе Watchman по сравнению с группой Amulet наблюдалась более высокая частота ТНУ (ОР 1,48 при 95% ДИ 1,06-2,06; р = 0,02) и затеков вокруг устройства > 5 мм (ОР 2,57 при 95% ДИ 1,63-4,04; р < 0,0001) [39].…”