What are the indications for a Watchman device in a patient with atrial fibrillation (AF), hypertension, diabetes, and heart failure, with a high risk of stroke and bleeding?

Watchman Device Indications

The Watchman device may be considered for percutaneous left atrial appendage occlusion in this patient with atrial fibrillation, high stroke risk (given hypertension, diabetes, and heart failure), and high bleeding risk, but only if they have absolute contraindications to all oral anticoagulants and can tolerate at least 45 days of post-procedural anticoagulation. 1

Primary Indication

• Oral anticoagulation (preferably a direct oral anticoagulant or warfarin with INR 2.0-3.0) remains the first-line therapy for stroke prevention in atrial fibrillation patients, even those with high bleeding risk. 2
• The Watchman device is a Class IIb recommendation (may be considered) specifically for patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation—not simply high bleeding risk. 1

Patient Selection Algorithm

Step 1: Assess Stroke Risk

• This patient has multiple CHA₂DS₂-VASc risk factors (hypertension, diabetes, heart failure), placing them at high stroke risk. 1
• CMS requires CHADS₂ score ≥2 or CHA₂DS₂-VASc score ≥3 for device consideration. 1

Step 2: Determine Anticoagulation Eligibility

• First, attempt oral anticoagulation with a DOAC or warfarin. 2
• The device should only be considered if the patient has absolute contraindications to all oral anticoagulants (not relative contraindications or patient preference). 3
• Common absolute contraindications include history of life-threatening bleeding, hemorrhagic tendencies, or documented inability to tolerate any anticoagulant. 4

Step 3: Assess Periprocedural Anticoagulation Tolerance

• Critical caveat: The patient must be able to tolerate at least 45 days of post-procedural anticoagulation (warfarin or DOAC) plus aspirin. 1, 5
• This creates a paradox—patients who cannot tolerate any anticoagulation are not ideal candidates despite having contraindications to long-term therapy. 3
• If the patient cannot tolerate even short-term anticoagulation, dual antiplatelet therapy (DAPT) alone has been used in real-world practice, though this was not part of the original trial protocols. 1, 4

Evidence Supporting the Device

• The PROTECT AF and PREVAIL trials demonstrated non-inferiority to warfarin for the composite endpoint of stroke, systemic embolism, and cardiovascular death. 1
• Hemorrhagic stroke risk is significantly lower with the Watchman device compared to long-term warfarin (RR 0.09; 95% CI 0-0.45). 5
• However, there was an initial increase in ischemic strokes in the device group, though this difference was not significant when periprocedural events were excluded. 1

Important Limitations and Risks

Procedural Complications

• Serious periprocedural complications occur in approximately 6-7% of cases, including pericardial effusion requiring drainage (5%), device embolization, and procedure-related stroke. 1, 2
• A learning curve exists, with higher complication rates in early cases at each center. 3

Device-Related Thrombus

• Device-related thrombus formation occurs in up to 7.2% per year and is associated with increased ischemic stroke risk. 5
• Risk factors include non-paroxysmal AF (OR 1.90-2.24), renal insufficiency (OR 4.02), history of TIA/stroke (OR 2.31), and deep device implantation >10 mm from pulmonary vein limbus (OR 2.41). 2, 5

Lack of DOAC Comparison

• No randomized trials have compared the Watchman device to modern DOACs, which have better safety profiles than warfarin. 3
• All pivotal trials used warfarin as the comparator, making the device's relative benefit in the current era uncertain. 1

Post-Implantation Requirements

Mandatory Anticoagulation Protocol

• Phase 1 (0-45 days): Warfarin (INR 2.0-3.0) or DOAC plus aspirin 81-162 mg daily. 5
• Phase 2 (45 days to 6 months): Dual antiplatelet therapy with aspirin plus clopidogrel. 5
• Phase 3 (>6 months): Aspirin alone indefinitely. 5

Surveillance Requirements

• Transesophageal echocardiography (TEE) is mandatory at 45 days and 1 year post-implantation to evaluate for device-related thrombus and peridevice leak before discontinuing anticoagulation. 2, 5
• Any peridevice leak, regardless of size, is associated with increased thromboembolism risk. 2, 5

Regulatory Considerations

• FDA approval specifies patients must be deemed suitable for short-term warfarin and can tolerate at least 45 days of post-procedural anticoagulation. 5
• CMS approval differs slightly, stating the device is for patients suitable for short-term warfarin but unable to take long-term oral anticoagulation. 1

Clinical Decision Framework for This Patient

Given this patient has AF with hypertension, diabetes, heart failure, and high stroke and bleeding risk:

1. First-line: Attempt a DOAC (preferred over warfarin due to lower bleeding risk). 2
2. If absolute contraindication to all DOACs and warfarin exists: Consider Watchman device if patient can tolerate 45 days of post-procedural anticoagulation. 1, 2
3. If patient cannot tolerate even short-term anticoagulation: Device use becomes controversial; DAPT-only regimens have been used but lack robust evidence. 4
4. Ensure patient understands: 6-7% procedural complication risk, need for TEE surveillance, and lifelong aspirin therapy. 2, 5