JACC: CLINICAL ELECTROPHYSIOLOGY
2, 2017
2017 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
PUBLISHED BY ELSEVIER
Letters
TO THE EDITOR
Device-Related Thrombus
Formation With the
Amplatzer Amulet
LAA Device
Optimal Implantation Optimal Results
In March 2015, the U.S. Food and Drug Administration
approved left atrial appendage (LAA) occlusion with
the Watchman device (Boston Scientic Corp., Marl-
borough, Massachusetts) to reduce stroke risk in
patients with nonvalvular atrial brillation. Outside
the United States, the Amplatzer Amulet device (St.
Jude Medical, St. Paul, Minnesota) is also available for
percutaneous LAA closure. The Amulet device is
designed to plug the LAA distally with the lobe and to
place the larger disk against the LAA ostiumat the
level of the limbus between the LAA and pulmonary
veinto obtain complete sealing (1). Compared with
the older generation Amplatzer Cardiac Plug device,
the Amulet device has a recessed central end-screw,
increased lobe length and sizes, a longer waist, and
larger disk diameters (1). Directions for use of the
Amulet recommend double antiplatelet therapy
([DAPT]; aspirin and clopidogrel) for 3 months fol-
lowed by aspirin monotherapy (1).
In a recent article, Sedaghat et al. (2) evaluated
Amulet device performance with a follow-up trans-
esophageal echocardiogram in 24 patients (mean
follow-up of 11.0  8.2 weeks). Device-related
thrombosis (DRT) occurred in 16.7% of patients
(n 4 of 24); 3 of the patients were still on DAPT and
1 was on clopidogrel monotherapy (2). Patients with
DRT had a lower left ventricular ejection fraction,
larger LA, greater spontaneous echocardiogram
contrast, and lower peak LAA emptying velocity as
compared to those without DRT. In addition, 3 pa-
tients with DRT had a history of LAA thrombus, and
all of them had incomplete coverage of the limbus by
the Amulet disk. In the accompanying editorial, De
Lurgio questions the efcacy of the Amulet device
quoting the disturbingly high incidence of DRT and
raises concerns on the post-procedural antith-
rombotic management with only DAPT.
VOL. 3, NO.
ISSN 2405-500X/$36.00
Following these reports, we evaluated the incidence
of DRT in 64 successive Amulet implants at our insti-
tution. In our practice, all patients implanted with the
Amulet device receive DAPT for 3 months followed by
aspirin lifelong with a routine cardiac computed to-
mography follow-up at 3 months to assess for DRT and
complete LAA sealing. The mean age was 75 years with
a mean CHADSVASc (Congestive Heart Failure,
Hypertension, Age 65 to 74, Diabetes Mellitus, Stro-
ke/Transient Ischemic Attack/Thromboembolism,
Vascular Disease, Sex) score of 3.4. At 3 months, the
DRT rate was 3.1% (n 2 of 64) in our patient cohort. In
those 2 cases with DRT, the Amulet disk did not cover
the limbus and thrombi were observed within the
untrabeculated part of the LAA ostium between the
uncovered portion of the limbus and the Amulet disk.
This Amulet DRT rate of 3.1% is lower than the
reported DRT rate of 16.7% by Sedaghat et al. (2). This
result is also consistent with a large report (N 1,047)
by Tzikas et al. (3), describing an Amplatzer Cardiac
Plug DRT incidence of 4.4% in the 63% of patients
that received follow-up transesophageal echo. With
the Watchman device, DRT is reported to occur in
4.0% to 5.7% of patients (4)in addition to differ-
ences in device design, patients in the PROTECT AF
(Watchman Left Atrial Appendage System for Embolic
Protection in Patients With Atrial Fibrillation) trial
also received oral anticoagulation for 45 days
following a Watchman implantation (5).
In conclusion, complete sealing of the LAA ostium
with the Amulet disk should be targeted by means of
optimal device sizing and implantation technique, as
in both series thrombi were found between the
Amulet disk and the uncovered portion of the limbus.
These observations strongly suggest that failure of
the pacier principle and creation of a cul-de-sac
may act as a nidus for thrombi and increase throm-
bogenicity. Maybe a more individualized post-
procedural antithrombotic regimen should be
considered, as those patients with a reduced left
ventricular ejection fraction, larger LA, high CHADS-
VASc score, or an Amulet disk placed deeper within
the LAA could benet from a short-term course of an
oral anticoagulant.
The Amulet device will be evaluated for safety and
efcacy in a noninferiority trial comparing this device
with the commercially available Watchman LAA
closure device in patients with nonvalvular atrial
brillation.
190 Letters to the Editor
*Fadi J. Sawaya, MD
Danny H.F. Chow, MD
Oscar Millan-Iturbe, MD
Ole De Backer, MD, PhD
*The Heart CenterRigshospitalet
Blegdamsvej 9
2100 Copenhagen
Denmark
E-mail: fjsawaya@gmail.com
http://dx.doi.org/10.1016/j.jacep.2016.11.006
Please note: Dr. De Becker is a proctor for St. Jude Medical. All other authors
have reported that they have no relationships relevant to the contents of this
paper to disclose.
Amplatzer Amulet LAA Occluder Trial (Amulet IDE); NCT02879448.
REFERENCES
1. Tzikas A, Gafoor S, Meerkin D, et al. Left atrial appendage occlusion with the
AMPLATZER Amulet device: an expert consensus step-by-step approach.
EuroIntervention 2016;11:151221.
2. Sedaghat A, Schrickel J, Andri R, Schueler R, Nickenig G, Hammerstingl C.
Thrombus formation after left atrial appendage occlusion with the Amplatzer
Amulet device. J Am Coll Cardiol EP 2017;3:715.
3. Tzikas A, Shakir S, Gafoor S, et al. Left atrial appendage occlusion for stroke
prevention in atrial brillation: multicenter experience with the Amplatzer
cardiac plug. EuroIntervention 2016;11:11709.
4. Holmes DR Jr., Doshi SK, Kar S, et al. Left atrial appendage closure as an
alternative to warfarin for stroke prevention in atrial brillation: a patient-
level meta-analysis. J Am Coll Cardiol 2015;65:261423.
5. Main ML, Fan D, Reddy VY, et al. 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;117:112734.
REPLY: Device-Related Thrombus Formation
With the Amplatzer Amulet LAA Device
Optimal Implantation Optimal Results
We read the letter to the editor by Dr. Sawaya and
colleagues with great interest. The authors raised
some concerns with respect to our recently published
ndings, and we are happy to comment on their
ndings. Dr. Sawaya and colleagues report their ex-
periences in a cohort of patients, which underwent left
atrial appendage occlusion (LAAo) with the Amplatzer
Amulet device (St. Jude Medical, St. Paul, Minnesota).
Interestingly, this group reports a signicantly lower
rate of device-related thrombi (DRT) (3.1%) as
compared to the observed rate in our analysis.
Furthermore, we acknowledge that in most analyses
the reported incidence of DRT after LAAo is below
10%. These differences depend on important clinical
aspects concerning patient selection and the
applied method of DRT imaging. First, according to
our experience the rate of LA thrombi and DRT is
relevantly inuenced by clinical factors such as
increased CHA 2DS 2-VASc (Congestive heart failure,
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 2, 2017
FEBRUARY 2017:18993
Hypertension, Age $75 years, Diabetes mellitus, Prior
stroke or transient ischemic attack or thromboembo-
lism, Vascular disease, Age 65 to 74 years, Sex) score
and hemodynamic parameters of LA hemostasis. In
our cohort we included patients at high thromboem-
bolic risk with relevantly altered LA hemodynamics
increasing the risk of DRT. In this context we would
be interested in more detailed information on de-
mographic and echocardiographic characteristics of
the cohort reported by Dr. Sawaya and colleagues.
Second, Dr. Sawaya and colleagues used computed
tomography (CT) angiography for the assessment of
DRT. Although CT imaging is an accepted diagnostic
tool to exclude left atrial thrombi (1,2) in selected pa-
tient cohorts, there is little evidence on its ability to
evaluate DRT after LAAo. The comparability of CT
imaging with transesophageal echocardiography has
not been investigated yet and in our experience DRT is
relevantly underestimated by the use of CT. Finally,
we agree with Dr. Sawaya and colleagues, that optimal
device implantation, especially when using the
Amplatzer Amulet device is of high importance to
avoid DRT. This matter has been emphasized in a
recently published consensus document (3). However,
in clinical practice, complex LAA morphology, each
individuals pulmonary vein anatomy, or difcult
transseptal access may prohibit optimal device posi-
tioning. Therefore, individualized post-procedural
anticoagulation regimens should be considered in
patients with high embolic risk, or when complete
pacication of the LAA is not possible due to specic
procedural aspects. Unfortunately, there are no
evidence-based recommendations on post-LAAo
anticoagulation treatment (4). Interestingly, reported
incidences of DRT with the Watchman device (Boston
Scientic, Marlborough, Massachusetts) appear to be
lower (5), which might be due to the mandatory course
of oral anticoagulant after Watchman implantation.
This emphasizes the unmet clinical need for prospec-
tive studies identifying the optimal post-LAAo treat-
ment with different occluder devices.
Alexander Sedaghat, MD
*Christoph Hammerstingl, MD
*Department of Cardiology
Heart Center Bonn
University of Bonn
Sigmund-Freud-Strasse 25
53105 Bonn
Germany
E-mail: christoph.hammerstingl@ukb.uni-bonn.de
http://dx.doi.org/10.1016/j.jacep.2017.01.001
Please note: The authors have reported that they have no relationships relevant
to the contents of this paper to disclose.