Efficacy and Safety of Left Atrial Appendage Closure With WATCHMAN in Japanese Nonvalvular Atrial Fibrillation Patients ― Final 2-Year Follow-up Outcome Data From the SALUTE Trial ―
View Full Paper
Ask AI
Bookmark
Share
Key result
WATCHMAN device achieves 100% effective LAAC in Japanese patients with NVAF.
- n=42
Why the study?
The study was conducted to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure device for stroke prevention in patients with nonvalvular atrial fibrillation in Japan.
Does left atrial appendage closure with the WATCHMAN device safely and effectively prevent stroke in Japanese patients with nonvalvular atrial fibrillation?
Population
42 Japanese patients with NVAF
Comparison
WATCHMAN left atrial appendage closure without a comparator arm
Design
Prospective, multicenter, single-arm trial
Follow-up
2-Year
Authors
Discussion
Loading...
Member takes
Implication
Supports WATCHMAN LAAC feasibility in Japanese NVAF patients; leaves open need for randomized efficacy data versus anticoagulation.
Structured PICO
Does left atrial appendage closure with the WATCHMAN device safely and effectively prevent stroke in Japanese patients with nonvalvular atrial fibrillation?
P
Population
42 Japanese patients with nonvalvular atrial fibrillation at increased risk of thromboembolism, followed for 2 years after WATCHMAN left atrial appendage closure device implantation.
I
Intervention
Left atrial appendage closure (LAAC) with the WATCHMAN device
O
Outcome
Safety and efficacy (successful implantation, effective LAAC rate, and stroke prevention)safety
The WATCHMAN LAAC device is a safe and effective nonpharmacological alternative for stroke risk reduction in Japanese patients with NVAF who are unsuitable for lifelong anticoagulation.
Limitations
- Single-arm clinical trial design without direct comparison to standard medication therapy (warfarin or direct oral anticoagulants).
- Device implanters were proctored by very experienced operators, which may have contributed to the low complication rate and high effective closure rate.
- Small sample size requires corroboration by real-world registries in Japan.
Cite This Study
Aonuma et al. (2020) studied Nonvalvular atrial fibrillation (NVAF) (n=42). WATCHMAN left atrial appendage closure (LAAC) device was evaluated on Effective LAAC rate (peri-device flow ≤5 mm) at 45 days. The WATCHMAN left atrial appendage closure device achieved a 100% effective closure rate at 45 days to 12 months in Japanese patients with nonvalvular atrial fibrillation, exceeding the 94.0% performance goal.
Topics
View Full Paper
Ask AI
Bookmark
Share