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Amplatzer Amulet device associated with lower stroke or TIA rates than Watchman FLXAmplatzer Amulet Shows Lower Stroke Risk Than Watchman FLX Device

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Key Takeaway
Note that Amplatzer Amulet is associated with lower stroke or TIA rates than Watchman FLX in patients undergoing LAAO.

This meta-analysis evaluated the comparative outcomes of the Amplatzer Amulet and Watchman FLX devices in patients with atrial fibrillation undergoing percutaneous left atrial appendage occlusion (LAAO) for high bleeding risk. The analysis pooled data from five studies involving 1316 patients.

The primary finding indicates that the Amplatzer Amulet was associated with lower rates of stroke or transient ischemic attack (TIA) compared to the Watchman FLX, with a reported RR of 2.31 (95% CI 1.02-5.25; p = 0.04). Regarding secondary outcomes, no statistically significant differences were observed between the two devices for peridevice leak (RR 1.57; 95% CI 0.86-2.89; p = 0.14), device-related thrombus (RR 2.01; 95% CI 0.87-4.68; p = 0.10), or pericardial effusion (RR 1.00; 95% CI 0.17-5.96; p = 1.00).

The results suggest that the Amplatzer Amulet may offer a lower risk of stroke or TIA in this specific patient population. However, clinicians should note that these findings are based on pooled risk ratios from five studies and do not provide data on other safety metrics like tolerability or discontinuation rates.

How this fits prior evidence

This meta-analysis addresses the clinical choice between two specific LAAO devices for patients with high bleeding risk. While previous coverage noted that discontinuing oral anticoagulants after ablation raises stroke risk in high-risk patients, this finding specifically compares the efficacy of Amplatzer Amulet versus Watchman FLX in reducing stroke or TIA rates during LAAO procedures.

Researchers analyzed data from 1,316 patients with atrial fibrillation who underwent a procedure called percutaneous left atrial appendage occlusion (LAAO). This procedure is often used for patients at high risk of bleeding. The study specifically compared two different devices: the Watchman FLX and the Amplatzer Amulet.

The analysis found that the Amplatzer Amulet was associated with lower rates of stroke or transient ischemic attack (TIA) when compared to the Watchman FLX device. However, there were no significant differences found between the two devices regarding other safety measures, such as peridevice leaks, device-related thrombus, or pericardial effusion.

Because this is a meta-analysis based on pooled data from five studies, it shows an association rather than a direct cause. While the results suggest one device may have a lower risk of stroke, patients should discuss these specific findings with their doctors to determine which option is best for their individual health needs.

What this means for you:
The Amplatzer Amulet was associated with lower stroke rates than the Watchman FLX in this meta-analysis.

Common questions

What is the main difference between these two heart devices?

The primary finding in this study was that the Amplatzer Amulet was associated with lower rates of stroke or transient ischemic attack (TIA) compared to the Watchman FLX. Other factors, such as peridevice leaks and device-related thrombus, showed no significant differences between the two devices.

Who is eligible for these procedures?

These specific devices were studied in patients with atrial fibrillation who are at high risk of bleeding. The study included a total of 1,316 patients to compare the outcomes of the Watchman FLX and Amplatzer Amulet.

Are there any safety concerns regarding these devices?

The study found no significant differences between the Watchman and Amplatzer devices regarding peridevice leaks, device-related thrombus, or pericardial effusion. You should talk to your doctor about which device is safest for your specific medical history.

Study Details

Study typeMeta analysis
Sample sizen = 1,316
EvidenceLevel 1
PublishedAug 2026
View Original Abstract ↓
BACKGROUND: The comparative safety and efficacy of Watchman FLX (Boston Scientific, Marlborough, MA, USA) and Amplatzer Amulet (Abbott, Abbott Park, IL, USA) devices for left atrial appendage occlusion (LAAO) remain unclear. OBJECTIVE: To compare Watchman FLX and Amplatzer Amulet devices for LAAO. METHODS: We systematically searched PubMed, Embase, and Cochrane Library for studies comparing Watchman FLX versus Amulet in patients with atrial fibrillation (AF) undergoing percutaneous LAAO. We applied a random-effects model to pool risk ratios (RR) with corresponding 95 % confidence intervals (CI) for binary endpoints. RESULTS: We included five studies comprising 1316 patients with AF undergoing LAAO for high bleeding risk. A total of 629 (47.8 %) patients underwent LAAO with Watchman FLX. Amulet was associated with lower rates of stroke or transient ischemic attack (TIA) (RR 2.31; 95 % CI 1.02-5.25; p = 0.04; I = 0 %), but no differences were observed in terms of peridevice leak (RR 1.57; 95 % CI 0.86-2.89; p = 0.14; I = 0 %) between Watchman and Amulet devices. Additionally, no differences were found in terms of device-related thrombus (RR 2.01; 95 % CI 0.87-4.68; p = 0.10; I = 0 %), or pericardial effusion (RR 1.00; 95 % CI 0.17-5.96; p = 1.00; I = 59.7 %) between both groups. CONCLUSION: This meta-analysis indicates a lower risk of stroke or TIA with Amulet compared to Watchman FLX.
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