From the Guidelines
The primary purpose of a Watchman device is to reduce stroke risk in patients with non-valvular atrial fibrillation who cannot tolerate long-term anticoagulation therapy by permanently sealing off the left atrial appendage (LAA) of the heart. The device works by preventing blood clots from forming in the LAA and potentially traveling to the brain, causing a stroke. According to the most recent and highest quality study 1, the Watchman device has been compared with warfarin in patients with AF at increased risk of stroke in two RCTs: the PROTECT AF and the PREVAIL trials. A meta-analysis combining data from these two trials and their registries demonstrated that patients receiving the device had significantly fewer hemorrhagic strokes than did those receiving warfarin, but there was an increase in ischemic strokes in the device group. However, when periprocedural events were excluded, the difference in ischemic strokes was not significant. The device provides a mechanical solution for stroke prevention rather than relying on daily medication, making it particularly valuable for patients who experience bleeding complications from anticoagulants or have difficulty maintaining a consistent medication regimen. Some key points to consider when using the Watchman device include:
- The device is implanted during a one-time minimally invasive procedure that typically takes about an hour under general anesthesia.
- After implantation, patients usually take blood thinners for a short period (about 45 days) until the device becomes fully incorporated into the heart tissue.
- The Centers for Medicare & Medicaid Services (CMS) specify that patients should have a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥3 to be considered for the device.
- The current FDA labeling specifies that patients should be deemed suitable for anticoagulation and, in particular, a period of periprocedural anticoagulation. As stated in the 2019 AHA/ACC/HRS focused update 1, oral anticoagulation remains the preferred therapy for stroke prevention for most patients with AF and elevated stroke risk, but the Watchman device provides an alternative for patients who are poor candidates for long-term oral anticoagulation.
From the Research
Purpose of a Watchman Device
The Watchman device is a percutaneous left atrial appendage closure device used for stroke prevention in patients with atrial fibrillation (AF) [ 2, 3, 4, 5, 6 ].
- The device is designed to prevent thrombus formation in the left atrial appendage (LAA), which is the main source of thrombus formation in AF patients [ 2, 3, 4, 5 ].
- The Watchman device offers an alternative to oral anticoagulation (OAC) for patients with non-valvular AF who are at high risk of bleeding or have contraindications to anticoagulation [ 2, 3, 4, 5, 6 ].
- The device has been shown to be safe and effective in preventing ischemic stroke and systemic thromboembolism, with lower rates of hemorrhagic stroke, bleeding, and death compared to warfarin therapy [ 3 ].
Clinical Evidence
Clinical trials and studies have demonstrated the efficacy and safety of the Watchman device for stroke prevention in AF patients [ 2, 3, 4, 5, 6 ].
- The device has been approved by the FDA for use in patients with non-valvular AF who are at high risk of stroke and have contraindications to anticoagulation [ 4 ].
- Patient selection for Watchman device implantation is crucial, with typical candidates including those with prior intracranial bleeding or recurrent serious bleeding who are not eligible for long-term OAC [ 5 ].