ABSTRACT 6

Late Failure of Percutaneous PFO Closure: Mechanisms of Failure and Treatment Options  
American Journal of Cardiology 2005: 96 (sippl 7) :90

Sherman G Sorensen1, James W Long2, Steven C Horton1, Peter J Casterella1, Laurie Raleigh3, Heather Aguilar3, Donald L Lappé1, 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: Percutaneous catheter closure of patent foramen ovale (PFO) is an increasingly accepted treatment option for stroke prevention that has good procedural safety and early results. However, late results due to device failure are unknown. Differences of device design, device materials, implantation technique, healing effect, or PFO morphologic features may influence long-term outcomes.

METHODS: From 2001-2005, 950 PFO closure procedures were performed with 261 CardioSEAL® (CS) and 689 Amplatzer® PFO (AMP) devices. Implant imaging used transesophageal echocardiography in 430 patients (pts) and intra-cardiac echocardiography in 520 pts. In our early experience with the CS device, pts with long PFO tunnel (> 10 mm) and large PFO with atrial septal aneurysm (ASA) were usually treated by the transeptal technique. Eleven (1.0%) pts (3 AMP, 8 CS) required evaluation and treatment for persistent or late failure of PFO closure (range: 9-26 months post closure). Evaluation of these pts was prompted by transient ischemic attack (TIA) in 4 pts, recurrent complex migraine (migraine with TIA symptoms) in 3 pts, and persistent severe shunt in 4 pts.

RESULTS: There were 3 AMP pts that had severe persistent shunting. All had ASA, long tunnel, and closure with a 35 mm AMP device. Catheter treatment was not feasible and all were treated medically without event. Of the 8 CS pts, 5 developed progressive shunt worsening from implant to symptom presentation. All CS failure patients were closed by the transeptal technique, had a tunnel of 15-27 mm, had an ASA, and received a large device (40 mm= 4 pts, 33 mm= 4 pts). Device retraction and arm splay was defined by echocardiography in all and by surgical removal in 4 pts. There were 4 pts treated by second device placement (second device: AMP PFO= 2 pts, AMP SO= 2 pts).

CONCLUSIONS: We conclude that 1) Late PFO closure failure is uncommon and is multi-factorial; 2) Healing retraction is related to transeptal placement and device type, but is treatable by second device placement; 3) AMP failure due to non incorporation is difficult to treat percutaneously; and 4) Complex PFO morphology may be better treated with devices resulting in better defect filling and device apposition.