Long-term experience and outcomes with transcatheter closure of patent foramen ovale.

OBJECTIVES: This study sought to examine the frequency of indications for and the immediate and long-term clinical outcomes of transcatheter closure of patent foramen ovale (PFO). BACKGROUND: Transcatheter PFO closure is commonly performed for several indications, including cryptogenic stroke, despite conflicting data regarding the efficacy of this intervention. METHODS: We report the outcomes of 800 consecutive patients (52% male, 50 ± 14 years of age) who underwent PFO closure at our institution after multidisciplinary evaluation over a 16-year period. RESULTS: Indications for closure included cryptogenic cerebrovascular event (94%), hypoxemia (2%), peripheral embolism (3%), and migraine headaches (2%). Procedural success was 99% with effective closure obtained in 93% of patients. At a mean follow-up of 42.7 ± 33.4 months, 21 patients suffered a recurrent ischemic neurologic event (12 strokes, and 9 transient ischemic attacks) for an incidence rate of 0.79 events per 100 person-years and freedom from recurrent events of 91.6% at 10 years. There was no device-based difference in the rate of recurrent ischemic neurologic events (p = 0.82). Only Eustachian valve prominence (hazard ratio: 9.04; 95% confidence interval: 2.07 to 39.44; p = 0.0034) was associated with recurrent neurologic events. CONCLUSIONS: Transcatheter PFO closure is safe and feasible in patients with several clinical indications. The long-term efficacy of this intervention in patients with paradoxical embolism appears superb in this observational study. Carefully selected patients with features suggestive of paradoxical embolism are the most likely to benefit from PFO closure and should be the focus of future investigation.

Management of residual shunts after initial percutaneous patent foramen ovale closure: a single center experience with immediate and long-term follow-up.

BACKGROUND: Moderate-to-large residual shunts following percutaneous patent foramen ovale (PFO) closure are clinically important and associated with recurrent neuroembolic events. However, their management has not been clearly established in clinical practice. We report our experience in patients of these patients with a prior history of cryptogenic stroke and/or transient ischemic attack (TIA). METHODS: All patients undergoing percutaneous PFO closure were routinely screened at six-months for residual shunts using transthoracic 2D echocardiography with antecubital administration of agitated saline contrast and color flow Doppler. Patients with evidence of moderate-to-large residual shunts were selected to undergo reintervention with shunt closure. Post-reintervention follow-up was performed at 24-hr, 30 days, and every six months thereafter. Clinical predictors of the moderate-to-large residual shunts, and the feasibility, safety and long-term efficacy of percutaneous residual shunt closure using a second device implant were examined. RESULTS: Between 1995 and 2007, a total of 424 patients underwent PFO closure. Of these, 5% (21/424) had moderate-to-large residual shunts. Baseline characteristics among patients with moderate-to-large residual shunts and those with only none or small defects (n = 403) were similar. Multivariate analysis identified the 24-hr postprocedure shunt as the only independent predictor of residual shunting at six months. Of the 21 study patients with moderate-to-large residual shunt (mean age, 47 +/- 14), one underwent successful elective surgical repair, while the remaining 20 underwent transcatheter closure using a second device. The technique was successful in 95% (19/20), and all but one patient had complete shunt closure at six months of their percutaneous reintervention. We report no deaths, recurrent strokes or TIAs during the long-term mean follow-up period of 2.9 years. CONCLUSIONS: Our study suggests that in patients with moderate-to-large residual PFO shunts, percutaneous reintervention using a second device implant is safe and effective.