Several left atrial appendage (LAA) closure devices have been developed for patients
with atrial fibrillation (AF) seeking an alternative to long-term oral anticoagulation
(OAC). PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in
Patients With Atrial Fibrillation) was the first multicenter randomized controlled
trial (RCT) comparing LAA closure device vs OAC with warfarin. Primary safety events
were statistically more frequent in the device group (7.4% vs 4.4%). At mean follow-up
of 3.8 years, LAA closure device showed superiority for the primary efficacy endpoint
(ie, composite of stroke, cardiovascular death, and systemic embolism), with a 34%
relative risk reduction in total mortality.
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However, with the available data this device requires a short period of OAC and dual
antiplatelet therapy (DAPT). The optimal treatment option for patients with AF who
survive an intracranial hemorrhage (ICH) remains unknown. OAC reintroduction after
these events has been associated with a significant reduction in ischemic stroke and
all-cause mortality rates based on observational retrospective data.
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References
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- 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
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- Left atrial appendage closure device implantation in patients with prior intracranial hemorrhage.Heart Rhythm. 2019; 16: 663-668
- Assessment of device-related thrombus and associated clinical outcomes with the WATCHMAN Left Atrial Appendage Closure Device for Embolic Protection in Patients With Atrial Fibrillation (from the PROTECT-AF trial).Am J Cardiol. 2016; 117: 1127-1134
- Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry.Circulation. 2011; 123: 417-424
- Device-related thrombosis after percutaneous left atrial appendage occlusion for atrial fibrillation.J Am Coll Cardiol. 2018; 71: 1528-1536
- The Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO) trial.Am Heart J. 2017; 189: 68-74
- 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
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Article info
Publication history
Published online: January 14, 2019
Footnotes
Dr Di Biase is a consultant for Biosense Webster and Stereotaxis and has received speaker honoraria/travel expenses from Biosense Webster, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Biotronik, Pfizer and Bristol Meyers Squibb. Dr. Natale is a consultant for Biosense Webster, Stereotaxis, and St Jude Medical.
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© 2019 Heart Rhythm Society. All rights reserved.
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- Left atrial appendage closure device implantation in patients with prior intracranial hemorrhageHeart RhythmVol. 16Issue 5
- PreviewThe Watchman device (Boston Scientific), used for left atrial appendage closure (LAAC), was approved for stroke prevention in patients with atrial fibrillation (AF) and an appropriate rationale to avoid long-term oral anticoagulation. Patients with AF and prior intracranial hemorrhage (ICH) were excluded from clinical trials because of perceived risks of perioperative anticoagulation.
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