Is the Watchman (Left Atrial Appendage Closure) device safe?

From the Guidelines

The Watchman device is generally considered safe for patients with atrial fibrillation who need an alternative to blood thinners, as evidenced by the most recent guidelines and studies, including the 2021 guideline for the prevention of stroke in patients with stroke and transient ischemic attack 1.

Key Points to Consider

• The Watchman device has been approved by the FDA and has shown a good safety profile in clinical trials and real-world use, with a significant reduction in the risk of hemorrhagic strokes compared to warfarin 1.
• The procedure involves a one-time minimally invasive surgery to implant the device in the left atrial appendage of the heart, where most stroke-causing blood clots form in atrial fibrillation patients.
• While all surgical procedures carry some risks, the Watchman's complications are relatively rare and include bleeding, infection, device migration, blood clots, or stroke during or after the procedure.
• Most patients can discontinue blood thinners 45 days after implantation following confirmation that the device is properly sealed.
• The safety of the Watchman is enhanced by the fact that it addresses the root cause of stroke risk in atrial fibrillation by physically blocking the left atrial appendage, providing a mechanical rather than pharmaceutical solution to prevent blood clots.

Important Considerations

• Patients should discuss their specific risk factors with their cardiologist to determine if the Watchman is the right choice for their situation, as the procedure is not appropriate for everyone.
• The 2021 guideline for the prevention of stroke in patients with stroke and transient ischemic attack recommends considering percutaneous closure of the left atrial appendage with the Watchman device for patients with stroke or TIA in the setting of nonvalvular AF who have contraindications for lifelong anticoagulation but can tolerate at least 45 days of anticoagulation 1.
• The Watchman device has been compared to warfarin in several studies, including the PROTECT AF and PREVAIL trials, which demonstrated its efficacy and safety in reducing the risk of stroke and systemic embolism 1.

From the Research

Safety of the Watchman Device

The safety of the Watchman device for left atrial appendage occlusion has been evaluated in several studies.

• The device has been shown to be non-inferior to warfarin therapy in preventing ischemic stroke/systemic thromboembolism, with lower rates of hemorrhagic stroke, bleeding, and death 2.
• A focused review of the literature found that Watchman device implantation is effective and safe in high-risk patients with non-valvular atrial fibrillation contraindicated to oral anticoagulants 3.
• Another study found that the Watchman device has a role in selected settings, with a randomized controlled trial demonstrating its noninferiority to warfarin and suggesting an advantage in terms of functional outcome for patients 4.
• However, the procedural risk associated with device implantation remains substantial, although improving device design and increasing operator experience may decrease this risk in the future 4.
• A review of left atrial appendage occlusion and ligation devices found that the evidence for long-term efficacy and safety of percutaneous LAA closure is insufficient to recommend this approach to all patients, except those in whom long-term oral anticoagulation is contraindicated 5.

Efficacy and Safety in Specific Patient Populations

• The Watchman device has been found to be effective and safe in patients with contraindications to oral anticoagulation therapy 3, 6.
• The device provides an option for patients with atrial fibrillation who are at risk of stroke and have contraindications for anticoagulation 6.
• The role of LAA occlusion and ligation in patients who undergo successful catheter ablation of atrial fibrillation is less clear, and further studies are needed to address the long-term safety and efficacy of this approach 5.