Abstract 18349: Long-term Results Comparing Recurrent Neurological Event Rates of Three Different Devices for Percutaneous PFO-Closure

Background: Percutaneous patent foramen ovale (PFO)-closure for secondary stroke prevention is discussed controversially, and long-term data comparing different closure devices are very limited. Methods: This is a prospective trial comparing procedural complications and long-term results after PFO closure in 660 patients with cryptogenic stroke randomized to three different closure devices (Amplatzer, CardioSEAL-STARflex and Helex occluder, 220 patients per group). The primary endpoint was defined as recurrent cerebral ischemia (stroke, TIA or Amaurosis fugax) or death from neurological cause during 5 year follow-up (including periprocedural events). Results: The primary endpoint occured in 25 patients (3.8%; 10 TIAs, 12 strokes and 3 cases of cerebral death). Compared with the Amplatzer (1.4%; 2 strokes, 1 cerebral death), significantly more events (p=0.02) occurred in the CardioSEAL-STARflex group (6%; 6 TIAs, 6 strokes, 1 cerebral death). The event rate in the Helex group was 4% (4 TIAs, 4 stroke, 1 cerebral death). The procedure was complicated by pericardial tamponade requiring surgery in 1 patient (Amplatzer device) and device embolization in 3 patients (all Helex devices). Device-associated thrombus formation was detected in 12 cases (11 CardioSEAL-STARflex, 1 Helex, 0 Amplatzer; p<0.0001), of which 2 required surgery. Complete closure after single device implantation was more common with the Amplatzer device than with the CardioSEAL-STARflex or Helex occluders. Conclusions: The periprocedural and long-term neurological event rates are low regardless of the device used. The recurrent neurological event rate was significantly higher after CardioSEAL-STARflex than after Amplatzer or Helex implantation. This has important implications regarding the interpretation of trials comparing PFO closure to medical management.