ABSTRACT 2

Safety and Efficacy of a Transeptal Technique for Percutaneous Patent Foramen
Ovale Closure   TCT 2003; 1:286

Peter J. Casterella, Andrew T Coletti, Peter Chatelain, Marsha McIntosh, Laurie Raleigh,
Sherman G. Sorensen (procedural physician),  Salt Lake City Utah

Bachground: Patent Foramen Ovale ( PFO ) is associated with cerebrovascular accidents (CVA) and transient ischemic attacks (TIA) via paradoxical embolization. Percutaneous closure devices have expanded PFO treatment options. Long tunnel lengths are associated with sub-optimal device position with standard device deployment. We evaluated outcomes using a transeptal PFO closure technique for long tunnel lengths.

Methods: Between 9/2001 and 2/2003, 386 PFO closure procedures (133 transeptal) were performed in our institution. Procedural variables evaluated were: procedural success, device size (mm), tunnel length (mm), presence of intra-atrial aneurysm (IAS), and residual shunt. Follow-up variables evaluated included: major adverse events (CVA / TIA, device thrombus or infection, device removal), persistent shunt, device mal-apposition, and minor neurologic events (symptoms without CVA/TIA).

Results: Device deployed included CardioSeal™(116/133, 87%), and Amplatzer™ (17?133, 13%). Procedural success rate was 100% with no occurrence of CVA or pericardial tamponade. Mean± SD device size and tunnel length were 31.5±3.7 mm and 13.9±5.2 mm respectively. IAS aneurysm and residual shunt were present in 34/133 (26%) and 53/133 (40%) of patients respectively. Follow-up was available in 87/133 (65%) of patients at 4.3±2,9 months.  Major adverse events occurred in 5/87 (5.7%) including 2 CVA (minor without residual), 1 device infection requiring removal, and 2 thrombi on device. Device mal-apposition occurred in 1 patient, but did not require device removal. Minor neurological events occurred in 6/87 (6.9%) of patients. Residual shunt decreased by 40% and was present in 21/87 (24%) of patients at follow-up.

Conclusions: Transeptal PFO closure is associated with: better device positioning in patients with long tunnel lengths, a high success rate with low risk of procedural complications, larger device sizes and higher incidence of residual shunt. Further investigation is required to determine technique, device, and pharmacologic modifications that will improve the safety and efficacy of percutaneous PFO closure.