Category (Complete): Congenital Heart Disease
Presentation Format (Complete): Oral
Control/Tracking Number: 05-A-1248-CRF
Activity: Abstracts
Current Date/Time: 6/9/2005 3:22:08 PM
Use of the Amplatzer® SO Device for Percutaneous
Patent Foramen Ovale Closure: Tunnel Reduction Technique and
Initial Outcomes
Sherman G Sorensen1, Peter J Casterella1,
Brian K Whisenant1, Laurie Raleigh2,
Heather Aguilar2, K Wes McKnight2, Donald
L Lappé1, Joseph B Muhlestein3
1Utah Heart Clinic and LDS Hospital Cardiology,
Salt Lake City, UT;2Utah Heart Clinic, Salt Lake
City, UT;3LDS Hospital Cardiology, Salt Lake City,
UT
BACKGROUND: Patent foramen ovale (PFO) closure
is commonly performed using devices with a thin, central,
connecting pin design. Specific PFO anatomic features may
result in sub-optimal defect closure using such devices. The
Amplatzer® SO device, PMA approved for atrial septal defect
closure, has less design features which may result in better
PFO closure due to tunnel occlusion, less free device overlap,
and greater tissue contact. The current study evaluates the
initial outcomes of PFO closure using the Amplatzer® SO
device.
METHODS: A review of 50 consecutive patients
undergoing PFO closure at our institution was made. All patients
presented with recurrent neurologic events and had a PFO with
> = 2 additional risk factors for recurrent stroke. PFO
tunnel reduction was performed using a contrast inflated pulmonary
capilary wedge catheter balloon pulled back against the septum
to stretch and collapse the tunnel to the level of the septum
secundum. A 24 mm sizing balloon was then used to size the
defect, define resolution of the tunnel length and further
reduce the tunnel, and to define displacement of left atrial
entry orifice. Amplatzer SO devices were placed by standard
method.
RESULTS: Procedural success without complications
was 100%. Device sizes ranged from 6-20mm. Following PFO closure,
2 patients had residual trace shunting by intra-cardiac echo
assessment with agitated saline injection. Following balloon
pull-back technique, 15 (30%) of the patients had a residual
tunnel length of > 9mm. Following sizing balloon inflation
beyond stop-flow pressure, 14 of these 15 patients showed
further decrease in tunnel length to < = 5mm. Device implantation
in these patients with long tunnel lengths did not result
in dislodgement, device instability, or mal-apposition.
CONCLUSION: This feasibility study of the
use of the Amplatzer® SO device for PFO closure demonstrated
a high (100%) procedural success rate without major complications.
Further evaluation of the Amplatzer® SO device will assist
in defining its role in PFO closure. These initial results
suggest that this device may be a reasonable alternative to
current PFO devices in selected anatomic variations.
Author Disclosure Block: S.G. Sorensen, None.
Category (Complete): Congenital Heart Disease
Presentation Format (Complete): Oral
Keywords (Complete): Shunt closure: ASD,
PFO, etc ; Congenital Heart Disease
Status: Complete
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