ABSTRACT 4

Procedural and Late Outcomes of Percutaneous Patent Foramen Ovale Closure in 1000 Patients: A Single-Center Experience
American Journal of Cardiology 2005; 96 (suppl7):49

Sherman G Sorensen1, Peter J Casterella1, Steven C Horton1, Ali K Choucair2, Laurie Raleigh3, Heather Aguilar3, K Wes McKnight3, 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;3Utah 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), migraine 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)), pericardial 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.