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

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

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.

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Abbreviations

ACT:

Activated clotting time

AF:

Atrial fibrillation

DAPT:

Dual antiplatelet therapy

DOAC:

Direct oral anticoagulant

GI:

Gastrointestinal

ICH:

Intracranial hemorrhage

IRB:

Institutional Review Board

LAA:

Left atrial appendage

LAAC:

Left atrial appendage closure

OAC:

Oral anticoagulation

TEE:

Trans-esophageal echo

CAA:

Cerebral amyloid angiopathy

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Authors and Affiliations

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

    William J. Hucker, Joshua A. Cohen, M. Edip Gurol, E. Kevin Heist, Jennifer Galvin, Jeremy Ruskin & Moussa Mansour

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

    Carola Gianni, Sanghamitra Mohanty, Rodney Horton & Andrea Natale

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

    Donita Atkins, Sudha Bommana & Dhanunjaya Lakkireddy

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

    Luigi Di Biase

Authors
  1. William J. Hucker
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  2. Joshua A. Cohen
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  3. M. Edip Gurol
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  13. Dhanunjaya Lakkireddy
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  15. Moussa Mansour
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Corresponding author

Correspondence to Moussa Mansour.

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Conflict of interest

EK Heist is a consultant at Boston Scientific, Abbott. Research Grants: Boston Scientific, Abbott. L DiBiase is a consultant at Biosense Webster, Stereotaxis and speaker honoraria/travel support at Biosense Webster, Abbott, Boston Scientific, Medtronic, Biotronik, Pfizer, Bristol-Myers Squibb. R Horton is a consultant at Biosense-Webster, Boston Scientific, Abbott. Research grants were received from Biosense-Webster, Boston Scientific, Abbott. D Lakkireddy is a consultant at Biosense-Webster, Boston Scientific, Abbott, Sentre Heart. Research grants were received from Biosense-Webster, Boston Scientific, Abbott, Sentre Heart. A Natale is a consultant at Biosense-Webster, Boston Scientific, Abbott, Medtronic. Research grants were received from Biosense-Webster, Boston Scientific, Abbott.

M Mansour is a consultant at Biosense-Webster, Boston Scientific, Abbott, Medtronic, Johnson and Johnson, Janssen, Philips, Novartis, Sentre Heart. Research grants were received from Biosense-Webster, Boston Scientific, Abbott, Pfizer, Boehringer Ingelheim, Sentre Heart, Johnson and Johnson, Medtronic. He has an equity from EPS Solutions, New Pace Ltd. The other authors declare that they have no conflicts of interest.

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Hucker, W.J., Cohen, J.A., Gurol, M.E. et al. WATCHMAN implantation in patients with a history of atrial fibrillation and intracranial hemorrhage. J Interv Card Electrophysiol 59, 415–421 (2020). https://doi.org/10.1007/s10840-019-00678-w

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  • DOI: https://doi.org/10.1007/s10840-019-00678-w

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