From the Guidelines
A Watchman device is indicated for patients with non-valvular atrial fibrillation who have an increased risk of stroke and are poor candidates for long-term oral anticoagulation due to bleeding propensity, poor drug tolerance, or adherence issues, as supported by the 2019 AHA/ACC/HRS guideline update 1.
Key Considerations
- The device is suitable for patients with a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥3, as specified by the Centers for Medicare & Medicaid Services (CMS) 1.
- Patients should be deemed suitable for anticoagulation and have a period of periprocedural anticoagulation, according to the current FDA labeling 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, which demonstrated significantly fewer hemorrhagic strokes in the device group, but an increase in ischemic strokes that was not significant when periprocedural events were excluded 1.
Patient Selection and Management
- Before implantation, patients typically require a transesophageal echocardiogram to ensure their left atrial appendage anatomy is suitable for the device.
- Following implantation, patients usually require a short course of anticoagulation (about 45 days) followed by dual antiplatelet therapy with aspirin and clopidogrel for 6 months, then lifelong aspirin therapy.
- The Watchman works by physically occluding the left atrial appendage, which is the source of more than 90% of stroke-causing blood clots in non-valvular atrial fibrillation, thereby reducing stroke risk without the need for lifelong anticoagulation.
Important Differences in Approval
- There are important differences in wording between the FDA approval and the CMS approval, with the FDA restricting the device to patients suitable for long-term warfarin and the CMS stating it is an option for patients suitable for short-term warfarin but deemed unable to take long-term oral anticoagulation 1.
From the Research
Indications for Watchman Device
The Watchman device is indicated for patients with non-valvular atrial fibrillation (AF) who are at high risk of stroke and have contraindications to long-term oral anticoagulation therapy 2, 3, 4, 5.
- Patients with a history of hemorrhagic or bleeding tendencies are considered eligible for the Watchman device 3.
- The device is also suitable for patients with a high CHADS₂ score, indicating an increased risk of stroke 3, 4.
- Additionally, patients who are ineligible for warfarin therapy due to various reasons, such as increased risk of bleeding, can be considered for the Watchman device 3, 5.
Patient Selection
The selection of patients for the Watchman device involves assessing their risk of stroke and bleeding 4.
- Patients with a high risk of stroke, as indicated by a high CHA₂DS₂-VASc score, may benefit from the Watchman device 3, 4.
- The device may also be considered for patients who have experienced a stroke or transient ischemic attack while on oral anticoagulation therapy 2, 4.
Clinical Evidence
Numerous studies have demonstrated the safety and efficacy of the Watchman device in reducing the risk of stroke in patients with non-valvular AF 2, 3, 4, 5.
- The PROTECT AF trial showed that the Watchman device was non-inferior to warfarin therapy in reducing the risk of stroke 3.
- The ASAP study demonstrated that the Watchman device can be safely implanted without the need for warfarin transition 3.
- Other studies have also reported favorable outcomes with the Watchman device, including a reduced risk of ischemic stroke and systemic embolism 4, 5.