Professional Documents
Culture Documents
2, 2017
PUBLISHED BY ELSEVIER
Letters
TO THE EDITOR 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
Device-Related Thrombus
aspirin lifelong with a routine cardiac computed to-
Formation With the mography follow-up at 3 months to assess for DRT and
complete LAA sealing. The mean age was 75 years with
Amplatzer Amulet
a mean CHADSVASc (Congestive Heart Failure,
LAA Device Hypertension, Age 65 to 74, Diabetes Mellitus, Stro-
ke/Transient Ischemic Attack/Thromboembolism,
Optimal Implantation Optimal Results
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
In March 2015, the U.S. Food and Drug Administration those 2 cases with DRT, the Amulet disk did not cover
approved left atrial appendage (LAA) occlusion with the limbus and thrombi were observed within the
the Watchman device (Boston Scientic Corp., Marl- untrabeculated part of the LAA ostium between the
borough, Massachusetts) to reduce stroke risk in uncovered portion of the limbus and the Amulet disk.
patients with nonvalvular atrial brillation. Outside This Amulet DRT rate of 3.1% is lower than the
the United States, the Amplatzer Amulet device (St. reported DRT rate of 16.7% by Sedaghat et al. (2). This
Jude Medical, St. Paul, Minnesota) is also available for result is also consistent with a large report (N 1,047)
percutaneous LAA closure. The Amulet device is by Tzikas et al. (3), describing an Amplatzer Cardiac
designed to plug the LAA distally with the lobe and to Plug DRT incidence of 4.4% in the 63% of patients
place the larger disk against the LAA ostiumat the that received follow-up transesophageal echo. With
level of the limbus between the LAA and pulmonary the Watchman device, DRT is reported to occur in
veinto obtain complete sealing (1). Compared with 4.0% to 5.7% of patients (4)in addition to differ-
the older generation Amplatzer Cardiac Plug device, ences in device design, patients in the PROTECT AF
the Amulet device has a recessed central end-screw, (Watchman Left Atrial Appendage System for Embolic
increased lobe length and sizes, a longer waist, and Protection in Patients With Atrial Fibrillation) trial
larger disk diameters (1). Directions for use of the also received oral anticoagulation for 45 days
Amulet recommend double antiplatelet therapy following a Watchman implantation (5).
([DAPT]; aspirin and clopidogrel) for 3 months fol- In conclusion, complete sealing of the LAA ostium
lowed by aspirin monotherapy (1). with the Amulet disk should be targeted by means of
In a recent article, Sedaghat et al. (2) evaluated optimal device sizing and implantation technique, as
Amulet device performance with a follow-up trans- in both series thrombi were found between the
esophageal echocardiogram in 24 patients (mean Amulet disk and the uncovered portion of the limbus.
follow-up of 11.0 8.2 weeks). Device-related These observations strongly suggest that failure of
thrombosis (DRT) occurred in 16.7% of patients the pacier principle and creation of a cul-de-sac
(n 4 of 24); 3 of the patients were still on DAPT and may act as a nidus for thrombi and increase throm-
1 was on clopidogrel monotherapy (2). Patients with bogenicity. Maybe a more individualized post-
DRT had a lower left ventricular ejection fraction, procedural antithrombotic regimen should be
larger LA, greater spontaneous echocardiogram considered, as those patients with a reduced left
contrast, and lower peak LAA emptying velocity as ventricular ejection fraction, larger LA, high CHADS-
compared to those without DRT. In addition, 3 pa- VASc score, or an Amulet disk placed deeper within
tients with DRT had a history of LAA thrombus, and the LAA could benet from a short-term course of an
all of them had incomplete coverage of the limbus by oral anticoagulant.
the Amulet disk. In the accompanying editorial, De The Amulet device will be evaluated for safety and
Lurgio questions the efcacy of the Amulet device efcacy in a noninferiority trial comparing this device
quoting the disturbingly high incidence of DRT and with the commercially available Watchman LAA
raises concerns on the post-procedural antith- closure device in patients with nonvalvular atrial
rombotic management with only DAPT. brillation.
190 Letters to the Editor JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 3, NO. 2, 2017
FEBRUARY 2017:18993