WATCHMAN implantation in patients with a history of atrial fibrillation and intracranial hemorrhage

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WATCHMAN implantation in patients with a history of atrial fibrillation and intracranial hemorrhage William J. Hucker 1 & Joshua A. Cohen 1 & M. Edip Gurol 1 & E. Kevin Heist 1 & Carola Gianni 2 & Jennifer Galvin 1 & Donita Atkins 3 & Sudha Bommana 3 & Luigi Di Biase 4 & Jeremy Ruskin 1 & Sanghamitra Mohanty 2 & Rodney Horton 2 & Dhanunjaya Lakkireddy 3 & Andrea Natale 2 & Moussa Mansour 1 Received: 7 July 2019 / Accepted: 27 November 2019 # Springer Science+Business Media, LLC, part of Springer Nature 2019

Abstract Purpose Use of oral anticoagulation (OAC) in patients with a history of intracranial hemorrhage (ICH) is often considered high risk as OAC-related ICH is associated with high mortality rates. Left atrial appendage closure with a WATCHMAN device is an alternative management strategy to OAC to decrease thrombotic risk in atrial fibrillation patients; however use of OAC followed by dual antiplatelet therapy (DAPT) or DAPT therapy alone is required for 6 months post-procedurally. In this study, we examined the safety of WATCHMAN implantation followed by 6 months of anti-thrombotic therapy in patients with a history of ICH. Methods This is a retrospective analysis of 63 patients with a history of ICH prior to WATCHMAN implantation (Group I) and 95 patients without a history of ICH who underwent WATCHMAN placement (Group II). The primary outcome was death, stroke, or major bleeding within 6 months of WATCHMAN placement. Results The average CHA2DS2-VASc of Group I was 4.9 ± 1.7 vs 4.7 ± 1.4 for Group II (p = 0.34). The most common type of ICH in Group I was an intracerebral hemorrhage (57%). The median time between ICH and WATCHMAN implantation in Group I patients was 212 days. A total of 19% of Group I patients were managed with DAPT alone post-procedurally vs. 3% in Group II (p < 0.001). Similar to 89% of Group II (p = 0.19), 95% of Group I patients were free of the primary outcome at 6 months. No Group I patients had recurrent ICH within 6 months after WATCHMAN implantation. Conclusion In a retrospective, multicenter series of patients with a history of ICH prior to WATCHMAN implantation, WATCHMAN placement was performed safely with 6-month outcomes that were similar to patients without a history of ICH, encompassing the time during which a patient with a history of ICH would need antithrombotic therapy to facilitate WATCHMAN placement. Keywords Left atrial appendage closure . Intracranial hemorrhage . Atrial fibrillation . WATCHMAN

Abbreviations ACT Activated clotting time AF Atrial fibrillation DAPT Dual antiplatelet therapy

* Moussa Mansour [email protected] 1

Corrigan Minehan Heart Center, Massachusetts General Hospital, 55 Fruit Street GRB 109, Boston, MA 02114, USA

2

Texas Cardiac Arrhythmia Institute, St. David’s Medical Center, Austin, TX, USA

3

Kansas City Heart Rhythm Institute, KS, Overland Park, KS 66211, USA

4

Albert Einstein College of Medicine at Montefiore Hospital, NY New York, USA

DOAC GI ICH IRB LAA LAAC OAC TEE CAA

Direct oral anticoagulant Gastrointestinal Intracrania