Key result
Amulet LAAC linked to ~293% higher periprocedural complication risk vs Watchman despite comparable long-term outcomes.
Why the study?
Data reporting a head-to-head comparison between the Amulet and Watchman left atrial appendage closure devices are scarce.
Does the Amulet LAAC device improve safety and efficacy compared to the Watchman LAAC device in patients undergoing left atrial appendage closure?
Observational (n=226)
No
Does the Amulet LAAC device improve safety and efficacy compared to the Watchman LAAC device in patients undergoing left atrial appendage closure?
Absolute Event Rate: 10.6% vs 2.7%
p-value: p=0.029
In a real-world matched cohort, the Amulet LAAC device was associated with higher periprocedural complications compared to Watchman, though long-term safety and efficacy were comparable.
May support Watchman preference to reduce periprocedural complications; leaves open long-term device equivalence in randomized cohorts.
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.
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Saad et al. (2021) conducted an observational in Non-valvular atrial fibrillation (n=226). Amulet LAAC device vs. Watchman LAAC device was evaluated on Periprocedural complications (p=0.029). The Amulet LAAC device was associated with a significantly higher rate of periprocedural complications compared to the Watchman device (10.6% vs 2.7%, p=0.029), though long-term outcomes were comparable.
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