Postapproval Community Hospital Experience in the United
States with Left Atrial Appendage Closure Device (Watchman)
Koroush Khalighi, MD,*
,
† Munish Sharma, MD,‡ Rohit Masih, MD,‡ and
Vadim Levin, MD†
Background: To review the procedural safety and postimplantation complications
of Watchman device implanted at 2 community hospitals for primary prevention
of systemic embolization in patients with nonvalvular atrial fibrillation (NVAF)
who were not candidates for long-term oral anticoagulation (OAC). Methods: This
was a retrospective case series of 48 patients carried out in 2 community hospitals
in the United States. Patients with NVAF who had a CHADS2 higher than 2 or
CHADS2VASc2 (congestive heart failure, hypertension, age ≥75 years, diabetes mel-
litus, prior stroke or transient ischemic attack [TIA] or thromboembolism, vascular
disease, age 65-74 years, and female gender) score of 3 or higher and were not
candidates for long-term OAC. These patients were selected for implantation of
Watchman device. They were followed up at 45 days, 6 months, 9 months, and 12
months after implantation of Watchman device to assess for complications involving
the device and to determine if anticoagulation could be discontinued at the 45 days
follow-up. They were monitored for any systemic thromboembolism while off
anticoagulation. Results: The success rate of device implantation was 98% (48 of 49).
Only a single patient could not get Watchman implantation because of unfavorable
left atrial appendage anatomy. Access-related and device implantation-related com-
plications were zero (0%). At 45 days follow-up and end of follow-up duration, the
rate of thrombus formation on the Watchman device was 4% (2 of 48). One patient
had TIA after warfarin discontinuation. Conclusion: With improved procedural
technique and well-trained operators, Watchman implantation is feasible in a com-
munity hospital also. Key Words: Nonvalvular atrial fibrillation—left atrial appendage
closure device—Watchman device—stroke prevention—community hospital.
© 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.
Background
Atrial fibrillation (AF) is the most common cardiac ar-
rhythmia with estimated number of individuals in 2010
being 33.5 million worldwide.
1
In the United States, the
estimated prevalence of AF is about 3.03 million, with
projected prevalence by 2050 to be around 7.56 million.
2
One of the most devastating complications of AF is stroke.
AF increases the risk of stroke 5-fold; this risk is not ho-
mogeneous and changes cumulatively with the presence
of stroke risk factors. In some patients, stroke can be the
first manifestation of the AF. About 30% cryptogenic strokes
have silent AF.
3
Since 2010, 4 new medications have been approved by
U.S. Food and Drug Administration (US-FDA) for stroke
prevention in patients with nonvalvular AF (NVAF). These
drugs are dabigatran, rivaroxaban, apixaban, and edoxaban.
In spite of the significant advancement in the pharma-
cological therapy, around 32% of patients who have
indications for anticoagulation therapy based on CHADS2
and CHA2DS2VASc (congestive heart failure, hypertension,
age ≥75 years, diabetes mellitus, prior stroke or tran-
sient ischemic attack [TIA] or thromboembolism, vascular
From the *Drexel University College of Medicine, Philadelphia,
Pennsylvania; †Department of Cardiology, Easton Hospital, Easton,
Pennsylvania; and ‡Department of Internal Medicine, Easton Hos-
pital, Easton, Pennsylvania.
Received January 20, 2018; revision received May 5, 2018; accepted
May 15, 2018.
Address correspondence to Munish Sharma, Easton Hospital, 250 s
21 Street, Easton, PA. E-mail: munishs1@hotmail.com.
1052-3057/$ - see front matter
© 2018 National Stroke Association. Published by Elsevier Inc. All
rights reserved.
https://doi.org/10.1016/j.jstrokecerebrovasdis.2018.05.016
ARTICLE IN PRESS
Journal of Stroke and Cerebrovascular Diseases, Vol. ■■, No. ■■ (■■), 2018: pp ■■–■■ 1