Safety of percutaneous left atrial appendage closure with the Amplatzer cardiac plug in patients with atrial fibrillation and contraindications to anticoagulation.

OBJECTIVE: To evaluate the safety of percutaneous left atrial appendage (LAA) closure with the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (AF) who are not eligible for oral anticoagulation with warfarin.

BACKGROUND: Anticoagulation is the treatment of choice for prevention of strokes in patients with AF, but some patients have contraindications to anticoagulation.

METHODS: A total of 60 patients with a CHA2 DS2 -VASc score of at least 1 and contraindications to warfarin who underwent percutaneous LAA closure with the ACP were included. Stroke risk assessment was performed with the CHADS2 and CHA2 DS2 -VASc score and the bleeding risk was calculated with the HAS-BLED-score. Follow-up included office visits, telephone inquiries, and mail contact.

RESULTS: Mean CHADS2 -, CHA2 DS2 -VASc-, and HAS-BLED scores were 2.6 (± 1.4), 4.3 (± 1.7), and 3.3 (± 1.0), respectively. Twenty-five percent had a history of previous bleeding without oral anticoagulation and 63.3% while receiving oral anticoagulation. In 36.7% other contraindications to warfarin were present. Procedural success was achieved in 95%. Mean follow-up time was 1.8 (1.0-2.8) years. The estimated annual stroke risk based on the CHADS2 -score was 5.8%. The estimated annual bleeding risk on warfarin based on the HAS-BLED score was 3.7%. During follow-up, the annual incidence of stroke was 0%. Major bleeding complications occurred in 1.9% annually.

CONCLUSIONS: Percutaneous LAA closure with the ACP in patients with contraindications to oral anticoagulation is safe. The stroke and bleeding risk after percutaneous LAA closure is lower than predicted by conventional risk scores.