Control/Tracking Number: 05-A-1239-CRF
Activity: Abstracts
Current Date/Time: 6/9/2005 3:19:33 PM
Procedural and Late Outcomes of Percutaneous Foramen
Ovale Closure in 1000 Patients: A Single-Center Experience
Sherman G Sorensen1, Peter J Casterella1,
Steven C Horton1Ali K Choucair2, Laurie
Raleigh3, Heather A Aguilar3, K Wes
Knight3, Donald L Lappé1, Heidi
Thomas2, Joseph B Muhlestein2
1Utah Heart Clinic and LDS Hospital Cardiology,
Salt Lake City, UT;2LDS Hospital Cardiology, Salt
Lake City, UT;3 Utah Heart Clinic, Salt Lake City,
UT
BACKGROUND: Patent foramen ovale (PFO) closure has
evolved in recent years with significant changes in risk stratification,
imaging methods, anti-platelet regimens, and device design.
This study evaluates immediate and long-term outcomes of PFO
closure with 3 different devices.
METHODS: Review of PFO closures were made
through outpatient records, telephone (>1 year post procedure),
catheterization laboratory and hospital database. Risk stratification
for recurrent stroke was defined from established criteria:
multiple MRI (MMRI), septal aneurysm (ASA), migrane headache
(MHA), and high shunt (HS). Serious adverse events (SAE) for
procedure and late outcomes: device related death (DRD), cerebrovascular
accident (CVA) with/without residual deficit, transient ischemic
attack (TIA), device related failure (DRF) (embolization,
dislodgement, device removal, second device placement, device
thrombus (T), or device infection (SBE)), pericardinal effusion
(PE) with/without tamponade, and other cardiac sequelae (OCS).
The annualized incidence of recurrent CVA was compared to
reported historical incidence of 3.8% per year.
RESULTS: From 2001-2005, 1000 PFO closures
were performed: Cardioseal® (CS) 261 (26%), Amplatzer
PFO® (AMP) 689 (69%), and Amplatzer SO® 50 (5%). Most
AMP patients (638) had program risk stratification: MMRI 77%,
ASA 43%, MHA 36%, HS 91%. Procedural SAE were uncommon: access
site bleeding (8), transfusion (7), CVA without residual (1),
device failure (1), and esophageal perforation (1). Total
SAE occurrence: DRD=1 (CVA + T), CVA=9 (0.9%; CS=5, AMP=4
(residual deficit=0)), TIA=32 (3.2% CS=20 AMP=12), PE=3 (0.3%
AMP=3 (0 tamponade)), T=3 (0.3% CS=3), SBE=2 (0.2% CS=2),
DRF with removal=5 (0.5%; CS=4, AMP=1), DRF with second device=4
(0.4% CS=4), OCS=23 (2.3% (atrial arrhythmias)). Annualized
relative risk of CVA compared to historical controls=0.15
(p=0.01).
CONCLUSIONS: Catheter-based PFO closure performed in a structured,
risk stratified program setting is associated with a high
immediate success rate and a low incidence of late complications
in patients followed for 2.5 (range 1-4) years. Complications
may be related to procedural experience and device design.
Author Disclosure Block: S.G. Sorensen, None.
Category (Complete): Congenital Heart Disease
Presentation Format (Complete): Oral
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