A comparison of postprocedural anticoagulation in high-risk patients undergoing WATCHMAN device implantation.


Journal

Pacing and clinical electrophysiology : PACE
ISSN: 1540-8159
Titre abrégé: Pacing Clin Electrophysiol
Pays: United States
ID NLM: 7803944

Informations de publication

Date de publication:
10 2019
Historique:
received: 01 02 2019
revised: 28 06 2019
accepted: 25 07 2019
pubmed: 4 9 2019
medline: 25 8 2020
entrez: 4 9 2019
Statut: ppublish

Résumé

Left atrial appendage closure (LAAC) is an alternative to long-term anticoagulation for thromboembolic protection in patients with atrial fibrillation (AF) and high bleeding risk. Short-term Warfarin use following LAAC is well-studied, while data pertaining to novel oral anticoagulant (NOAC) use in this setting is less robust. Specifically, data regarding the safety and efficacy of postprocedural NOAC use in high-risk patients is lacking. To compare the safety and efficacy of Warfarin and NOAC use in a high-risk patient population undergoing LAAC with the WATCHMAN device. From November 2015 to October 2017, 97 patients underwent LAAC with the WATCHMAN device. All patients were discussed at a multidisciplinary meeting prior to device implantation. Longitudinal data were collected and analyzed for a composite endpoint of stroke and death at 8 months, and major bleeding at 3 and 6 months. Among the 90 patients included in the safety and efficacy analysis, 43 were prescribed Warfarin and 47 were prescribed NOACs. Baseline characteristics were comparable between study groups. There were no procedural complications and no significant differences in the incidence of death and stroke at 8 months or major bleeding at 3 and 6 months. For patients with AF at high risk of both thromboembolic and hemorrhagic events, NOACs as compared to Warfarin, seem to be safe and effective for short-term anticoagulation following LAAC with the WATCHMAN device. Further validation in large randomized controlled trials is required.

Sections du résumé

BACKGROUND
Left atrial appendage closure (LAAC) is an alternative to long-term anticoagulation for thromboembolic protection in patients with atrial fibrillation (AF) and high bleeding risk. Short-term Warfarin use following LAAC is well-studied, while data pertaining to novel oral anticoagulant (NOAC) use in this setting is less robust. Specifically, data regarding the safety and efficacy of postprocedural NOAC use in high-risk patients is lacking.
OBJECTIVE
To compare the safety and efficacy of Warfarin and NOAC use in a high-risk patient population undergoing LAAC with the WATCHMAN device.
METHODS
From November 2015 to October 2017, 97 patients underwent LAAC with the WATCHMAN device. All patients were discussed at a multidisciplinary meeting prior to device implantation. Longitudinal data were collected and analyzed for a composite endpoint of stroke and death at 8 months, and major bleeding at 3 and 6 months.
RESULTS
Among the 90 patients included in the safety and efficacy analysis, 43 were prescribed Warfarin and 47 were prescribed NOACs. Baseline characteristics were comparable between study groups. There were no procedural complications and no significant differences in the incidence of death and stroke at 8 months or major bleeding at 3 and 6 months.
CONCLUSION
For patients with AF at high risk of both thromboembolic and hemorrhagic events, NOACs as compared to Warfarin, seem to be safe and effective for short-term anticoagulation following LAAC with the WATCHMAN device. Further validation in large randomized controlled trials is required.

Identifiants

pubmed: 31479160
doi: 10.1111/pace.13796
doi:

Substances chimiques

Anticoagulants 0
Warfarin 5Q7ZVV76EI

Types de publication

Comparative Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1304-1309

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2019 Wiley Periodicals, Inc.

Références

Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: A randomised non-inferiority trial. Lancet. 2009;374:534-542.
Holmes DR, Jr Kar S, Price MJ, et al. Prospective randomized evaluation of the WATCHMAN left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial. J Am Coll Cardiol. 2014;64:1-12.
Holmes DR, Jr Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: A patient-level meta-analysis. J Am Coll Cardiol. 2015;65:2614-2623.
Reddy VY, Doshi SK, Kar S, et al. 5-year outcomes after left atrial appendage closure: From the PREVAIL and PROTECT AF trials. J Am Coll Cardiol. 2017;70:2964-2975.
Schwartz RS, Holmes DR, Van Tassel RA, et al. Left atrial appendage obliteration: Mechanisms of healing and intracardiac integration. Cardiovasc Interv. 2010;3:870-877.
Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37:2893-2962.
January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association task force on practice guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014;64:e1-76.
Boersma LV, Ince H, Kische S, et al. Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-year follow-up outcome data of the EWOLUTION trial. Heart Rhythm. 2017;14:1302-1308.
Reddy VY, Mobius-Winkler S, Miller MA, et al. Left atrial appendage closure with the WATCHMAN device in patients with a contraindication for oral anticoagulation: The ASAP study (ASA plavix feasibility study with WATCHMAN left atrial appendage closure technology). J Am Coll Cardiol. 2013;61:2551-2556.
Barakat AF, Hussein AA, Saliba WI, et al. Initial experience with high-risk patients excluded from clinical trials: Safety of short-term anticoagulation after left atrial appendage closure device. Circ Arrhythm Electrophysiol. 2016;9:e004004.
Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost. 2010;8:202-204.
Enomoto Y, Gadiyaram VK, Gianni C, et al. Use of non-warfarin oral anticoagulants instead of warfarin during left atrial appendage closure with the WATCHMAN device. Heart Rhythm. 2017;14:19-24.
Dukkipati SR, Kar S, Holmes DR, et al. Device-related thrombus after left atrial appendage closure: Incidence, predictors, and outcomes. Circulation. 2018;138:874-885.

Auteurs

Joshua A Cohen (JA)

Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.

E Kevin Heist (EK)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Jennifer Galvin (J)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Hang Lee (H)

Massachusetts General Hospital, Biostatistics Center, Boston, Massachusetts.

Matthew Johnson (M)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Michael Fitzsimons (M)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Kathryn Slattery (K)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Brian Ghoshhajra (B)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Rahul Sakhuja (R)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Grace Ha (G)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Margaux Forsch (M)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Linsheng Shi (L)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Jacqueline Danik (J)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Jacob Dal-Bianco (J)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Danita Sanborn (D)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Judy Hung (J)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Jeremy Ruskin (J)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

M Edip Gurol (ME)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

Moussa Mansour (M)

Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.

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