HEARTLINE HSM Genoa Cardiology Meeting - Aristea

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Primary Safety Endpoint included:
• Device embolization requiring retrieval;
• Pericardial effusion requiring intervention;
• Cranial bleeds and gastrointestinal bleeds;
• Any bleed that requires ≥ 2uPRBC;
Eighty-seven percent of implanted subjects were able to cease warfarin at days and the
rate further increased at later time points; reasons for remaining on warfarin therapy after
-days were observation of ow in the LAA (n = 0), physician order (n = 1 ), other
reasons (n = 9).
As far as safety endpoints are concerned events in device group were classied as
ischemic stroke: they were all periprocedural and extended hospitalization by 7 days; three
events were related to air embolism; one hemorrhagic stroke in device group vs 6 in control
group were adjudicated. By note, device events occurred 1 days post implant while patient
was on warfarin and /6 stroke events in control group patients resulted in death.
In conclusion, in AF patients who were candidates for warfarin therapy, device closure of
the LAA using the Watchman device (Atritech, Plymouth, MN) was associated with a
reduction in hemorrhagic stroke risk vs warfarin, and all-cause stroke and all-cause
mortality outcomes were noninferior to warfarin. 10
Safety events, particularly pericardial effusion, were more common in the device group, but
these have decreased over time with procedural modications and enhanced training, the
researchers noted.
Indications
Currently, when to close LAA?
Patients with:
• Permanent atrial brillation
• High risk of stroke
And with:
• Contraindication to warfarin
• High risk of bleeding with OAC
• Difcult to maintain INR within the therapeutic range
• Poor compliance
• Difculty to manage the patient because of logistic problems
AMPLATZER ® Cardiac Plug (AGA Medical Corporation)
The AMPLATZER Cardiac Plug (ACP; Figure 2) is a transcatheter self-expanding device
constructed from a nitinol mesh and polyester patch, ACP consists of a lobe and a disc
connected by a central waist.
The ACP is available in 8 sizes: 16, 18, 20, 22, 2 , 26, 28, and 0 mm.