Will a Watchman procedure allow a patient to stop taking anticoagulation (blood thinner) medication?

Watchman Procedure and Anticoagulation Discontinuation

The Watchman device allows most patients to eventually stop oral anticoagulation, but only after a mandatory period of post-procedural anticoagulation lasting 45 days to 6 months, depending on the regimen used. 1

FDA-Approved Indication and Patient Selection

The Watchman device is FDA-approved specifically for patients with atrial fibrillation who:

• Are at increased stroke risk (CHADS₂ ≥2 or CHA₂DS₂-VASc ≥3) 1
• Are deemed suitable for warfarin therapy 1
• Have an appropriate rationale to seek a nonpharmacological alternative to warfarin 1

Percutaneous LAA occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation (Class IIb, Level B-NR). 1

Mandatory Post-Procedural Anticoagulation Protocol

Standard FDA-Labeled Regimen

The device requires a structured anticoagulation protocol that cannot be bypassed: 2

1. Days 1-45: Warfarin (target INR 2-3) plus aspirin 81-325 mg daily 2
2. Day 45 TEE assessment: If minimal peri-device flow (≤5mm) and no device-related thrombus detected 2
3. Days 45-180 (6 months): Aspirin plus clopidogrel 75 mg daily 2
4. After 6 months: Aspirin indefinitely 2

Alternative Regimens in Real-World Practice

For patients with absolute contraindications to oral anticoagulation, dual antiplatelet therapy (DAPT) alone for 6 months followed by aspirin indefinitely may be feasible, though this represents off-label use. 2, 3 The EWOLUTION registry demonstrated that 60.3% of patients received DAPT post-implantation with low rates of device thrombus (2.6%), stroke (0.4%), and major bleeding (2.6%). 3

Direct oral anticoagulants (DOACs) have been used as alternatives to warfarin, with the EWOLUTION data showing NOAC therapy had numerically the lowest bleeding rates without increased device thrombus or stroke. 3 However, a critical caveat: low-dose dabigatran (110 mg twice daily) showed significantly higher device-related thrombosis rates (15.8% vs 2.2%, p=0.03) compared to warfarin, despite lower bleeding rates. 4

Critical Timeline: When Anticoagulation Can Be Stopped

Oral anticoagulation cannot be discontinued immediately after device implantation. The minimum mandatory period is 45 days, contingent on TEE confirmation of proper device endothelialization. 2 Complete freedom from all antithrombotic therapy (including aspirin) typically occurs at 6 months post-implantation at the earliest. 2

Device-Related Thrombosis Risk

Device-related thrombosis remains a concern during the endothelialization period:

• Overall incidence: 2.6-3.7% in registry data 3, 5
• Risk is highest in the first 45 days before complete endothelialization 2
• Not correlated with specific drug regimen in EWOLUTION (p=0.14) 5
• Low-dose DOACs may increase this risk substantially 4

Long-Term Outcomes After Anticoagulation Cessation

Once the post-procedural anticoagulation period is completed and patients transition to aspirin alone or off all therapy:

• Ischemic stroke rate: 1.1% annually (84% relative risk reduction vs historical data) 5
• This benefit persists even in the 73% of patients deemed unsuitable for long-term oral anticoagulation 5
• Major bleeding rate: 2.6% annually, predominantly non-procedure related 5

Common Pitfalls to Avoid

Do not discontinue anticoagulation before the 45-day TEE assessment, as premature cessation increases device-related thrombosis risk before complete endothelialization. 2

Do not assume the device allows immediate anticoagulation cessation—patients must be willing and able to tolerate at least 45 days of post-procedural anticoagulation. 1 The FDA labeling specifically requires patients be "suitable for warfarin" and able to tolerate periprocedural anticoagulation. 1

Avoid using low-dose DOACs (particularly dabigatran 110 mg twice daily) for post-procedural anticoagulation, as this significantly increases device-related thrombosis risk. 4

Clinical Context: CMS vs FDA Approval Differences

An important distinction exists between regulatory approvals: 1

• FDA approval: Restricted to patients suitable for long-term warfarin with appropriate rationale to seek alternatives 1
• CMS approval: Covers patients suitable for short-term warfarin but deemed unable to take long-term oral anticoagulation 1

This discrepancy reflects evolving real-world experience with the device in patients who have absolute contraindications to long-term anticoagulation, though such use remains outside the strict FDA-labeled indication. 1