Background
The 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.
Objective
The purpose of this study was to study the efficacy and safety of LAAC using Watchman
in patients with AF and prior ICH.
Methods
In a multidisciplinary AF/stroke prevention clinic, 38 consecutive patients with AF
and prior ICH underwent Watchman implantation. Patients were enrolled in a prospectively
maintained data registry.
Results
Patients’ mean CHA2DS2-VASc score was 5.0 ± 1.3 and HAS-BLED score 4.2 ± 1.0. Prior ICH events were intraparenchymal
(60%), subdural (24%), or subarachnoid bleeds (16%). The median event-to-implantation
time was 637 days (minimum 60). Watchman was implanted in all patients with no procedural
complications. All patients completed 45 days of anticoagulation with warfarin (55%),
apixaban (37%), or dabigatran (8%). Transesophageal echocardiograms at 45 days showed
no peridevice leak, and 1 patient had a small filamentous echodensity on device that
resolved with anticoagulation. While undergoing anticoagulation, none of the patients
developed recurrent ICH. Minor bleeding occurred in 1 patient (trauma-related lower
extremity hematoma at 19 days postimplantation). At 13.4 months (quartiles 8–19) of
follow-up, there were no strokes, ICH, or deaths.
Conclusion
AF patients with prior ICH tolerated short-term anticoagulation for the purpose of
Watchman implantation. LAAC with attendant short-term anticoagulation seems to be
both safe and effective in this patient population.
Keywords
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Article info
Publication history
Published online: December 02, 2018
Footnotes
Funding sources: None. Drs Wazni, Saliba, and Kanj are advisory board consultants for BSC.
Identification
Copyright
© 2018 Heart Rhythm Society. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Left atrial appendage closure device implantation in patients with atrial fibrillation and prior intracranial hemorrhage: “No man left behind”Heart RhythmVol. 16Issue 5
- PreviewSeveral 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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