Initial Experience With High-Risk Patients Excluded From Clinical Trials: Safety of Short-Term Anticoagulation After...

Area of Science:

• Cardiology
• Medical Devices
• Stroke Prevention

Background:

• Left atrial appendage closure devices offer an alternative to oral anticoagulation for stroke prevention in atrial fibrillation.
• Patients typically require short-term oral anticoagulation post-implantation to prevent device thrombosis.
• Limited data exists on the safety of this strategy in patients with a history of major bleeding events.

Purpose of the Study:

• To evaluate the safety of WATCHMAN device implantation and subsequent short-term oral anticoagulation in patients with a history of major bleeding.
• To assess the risk of recurrent spontaneous major bleeding in this high-risk patient population.

Main Methods:

• A retrospective review of 20 consecutive patients with a history of spontaneous major bleeding on oral anticoagulation who underwent WATCHMAN implantation.
• Patients were evaluated by a multidisciplinary Atrial Fibrillation Stroke Prevention Center for device and antithrombotic therapy candidacy.
• The primary outcome was the incidence of spontaneous major bleeding during short-term postprocedural oral anticoagulation.

Main Results:

• The study included 20 patients with high stroke risk (CHA2DS2-VASc score 5) and bleeding risk (HAS-BLED score 5).
• Previous major bleeding events included gastrointestinal bleeding, intracranial bleeding, hemopericardium, and hemarthrosis.
• No patients experienced spontaneous major bleeding during the post-implantation oral anticoagulation period. One patient had a subdural hematoma after a fall, managed conservatively.

Conclusions:

• Careful multidisciplinary evaluation enables safe implantation of left atrial appendage closure devices.
• A short course of oral anticoagulation following WATCHMAN implantation is associated with a low risk of recurrent major bleeding in patients with prior bleeding history.