Closure of patent foramen ovale for paradoxical emboli: Intermediate-term risk of recurrent neurological events following transcatheter device placement

OBJECTIVES We report the largest and the longest follow-up to date of patie nts who underwent transcatheter patent foramen ovale (PFO) closure for para doxical embolism. BACKGROUND Closure of a PFO has been proposed as an alternative to anticoag ulation in patients with presumed paradoxical emboli. METHODS Data were collected for patients following PFO closure with the Cla mshell, CardioSEAL or Buttoned Devices at two institutions. There were 63 p atients (46 +/- 18 years) with a follow-up of 2.6 +/- 2.4 years. Fifty-four (86%) had effective closure of the foramen ovale (trivial or no residual s hunt by echocardiography) while seven (11%) had mild and two (3%) had moder ate residual shunting. RESULTS There were four deaths (leukemia, pulmonary embolism, sepsis follow ing a hip fracture and lung cancer). There were four recurrent embolic neur ological events following device placement: one stroke and three transient events. The stroke occurred in a 56-year-old patient six months following d evice placement. A follow-up transesophageal echocardiogram showed a well s eated device without residual shunting. Two of the four events were associa ted with suboptimal device performance tone patient had a significant resid ual shunt and a second patient had a "friction lesion" in the left atrial w all associated with a displaced fractured device arm). The risk of recurren t stroke or transient neurological evens following device placement was 3.2 % per year for all patients. CONCLUSION Transcatheter closure of PFO is an alternative therapy for parad oxical emboli in selected patients. Improved device performance may reduce the risk of recurrent neurological events. Further studies are needed to id entify patients most likely to benefit from this intervention. CT Am Coil C ardiol 2000;35:1311-6) (C) 2000 by the American College of Cardiology.