Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience

Abstract

Background Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. The aim of this study was to compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry. Methods Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during long-term follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death). Results After matching the patients for age (±5 years), gender, CHA2DS2Vasc score (±1) and HASBLED score (±1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During long-term follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively). Conclusion Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On long-term follow-up, both devices showed comparable efficacy and safety.

Safety and efficacy of the Amplatzer Amulet and Watchman 2.5 for left atrial appendage occlusion: A systematic review and meta‐analysis

“…A total of 2926 patients from seven studies (Table 2) 12,[15][16][17][18][19][20] underwent LAAO, with a total of 1508 patients in the Watchman 2.5 group and 1418 patients in the Amplatzer Amulet group included in the meta-analysis (Figure 1 and Table 2). Seven total studies, including TA B L E 1 Quality assessment of included studies by NOS…”

“…Lakkireddy 2021, 12 Saad 2021, 20 and Radinovic 2021 19 which scored 8 points on the Newcastle-Ottawa Scale (Table 1), and Mansour 2021, 18 Chen 2019, 15 Fastner 2018, 16 and Kefer 2018 17 scored 7 points on the Newcastle-Ottawa Scale (Table 1), indicating good quality. A descriptive comparison of the baseline characteristics and follow-up durations is shown in Table 2.…”

“…Of the seven studies reviewed, one randomized controlled trial and six cohort studies directly compared the safety and efficacy of the Amplatzer Amulet and the Watchman 2.5 device. 12,[15][16][17][18][19][20] Nevertheless, these studies were limited in their sample size; so, we conducted a meta-analysis of studies that directly compared the Amplatzer Amulet and Watchman 2.5 devices, emphasizing on efficacy and safety outcomes. 21 Additionally, we review their latest technological advances.…”

Sex Differences in Efficacy and Safety After Left Atrial Appendage Closure: A 4.3-Year Follow-Up Analysis

“…Saad et al also reported that periprocedural complications were higher in ACP device than in Watchman device. But the efficacy and safety between Watchman and ACP devices were comparable during the long-time follow-up (median follow-up durations of Watchman and ACP devices were 238 and 160 days, respectively) ( 17 ). The efficacy and safety were also comparable between Watchman and ACP devices during our long-term follow-up, but procedure-related complications were comparable between Watchman and ACP devices in our center ( Supplementary Figure 1 ).…”

Combined MitraClip and Left Atrial Appendage Occlusion: Is It Still a Utopia?

“…For ACP and its second-generation, Amulet, multiple retrospective and prospective registries have reported successful device implantation in 95–100% of patients, with a low rate of major periprocedural adverse events. A recently published, industry-initiated, large, randomized, multi-center, trial (Amulet IDE trial), evaluating the safety and effectiveness of the Amulet occluder compared with the Watchman™ device, has shown that the Amulet occluder was non-inferior to safety and effectiveness of stroke prevention compared with the Watchman device ( 34 ). In light of the results of these trials, ESC guidelines suggest LAA closure, for stroke prevention, in patients with AF and contraindications for long-term anticoagulant treatment, e.g., intracranial bleeding without a reversible cause (class of recommendation IIb, level of evidence B) ( 35 ).…”