BACKGROUND: Percutaneous patent foramen ovale (PFO) closure is indicated for recurrent cryptogenic stroke occurring on anticoagulant therapy. Few patients meet this criterion, and the safety of this procedure when performed infrequently is unclear. METHODS: Fifty-two patients with cryptogenic stroke (66%) or transient ischemic attack (34%) undergoing PFO closure from June 2001 to December 2004 were analyzed. CardioSEAL, Amplatzer or Cardia Star devices were used. Patients were discharged on aspirin, clopidogrel or (at the discretion of the neurologist) coumadin for 6 months. RESULTS: The study population was young (mean age 51 years) and included 25 males (48%). Seventeen patients (34%) had atrial septal aneurysms. Balloon-stretched PFO size ranged from 6 to 25 mm. Deployment success was 100%; mild residual shunting persisted in 10 patients (19%) at hospital discharge. Mean length of stay was 1 day. Predischarge complications included bleeding in 4 patients and arrhythmia in 3 patients. At 28-month follow up, 4 patients reported spells of uncertain etiology and 1 had paroxysmal atrial fibrillation. There were no transient ischemic attacks or strokes. One patient died of renal failure and sepsis unrelated to PFO closure. CONCLUSION: Low-volume PFO closure (15 per year) can be performed safely and effectively in a moderate-volume interventional laboratory with good short-term clinical results.
BACKGROUND: Percutaneous patent foramen ovale (PFO) closure is indicated for recurrent cryptogenic stroke occurring on anticoagulant therapy. Few patients meet this criterion, and the safety of this procedure when performed infrequently is unclear. METHODS: Fifty-two patients with cryptogenic stroke (66%) or transient ischemic attack (34%) undergoing PFO closure from June 2001 to December 2004 were analyzed. CardioSEAL, Amplatzer or Cardia Star devices were used. Patients were discharged on aspirin, clopidogrel or (at the discretion of the neurologist) coumadin for 6 months. RESULTS: The study population was young (mean age 51 years) and included 25 males (48%). Seventeen patients (34%) had atrial septal aneurysms. Balloon-stretched PFO size ranged from 6 to 25 mm. Deployment success was 100%; mild residual shunting persisted in 10 patients (19%) at hospital discharge. Mean length of stay was 1 day. Predischarge complications included bleeding in 4 patients and arrhythmia in 3 patients. At 28-month follow up, 4 patients reported spells of uncertain etiology and 1 had paroxysmal atrial fibrillation. There were no transient ischemic attacks or strokes. One patient died of renal failure and sepsis unrelated to PFO closure. CONCLUSION: Low-volume PFO closure (15 per year) can be performed safely and effectively in a moderate-volume interventional laboratory with good short-term clinical results.