• JACC Cardiovasc Interv · Nov 2013

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

    • Ignacio Inglessis, Sammy Elmariah, Pablo A Rengifo-Moreno, Ronan Margey, Caitlin O'Callaghan, Ignacio Cruz-Gonzalez, Suzanne Baron, Praveen Mehrotra, Timothy C Tan, Judy Hung, Zareh N Demirjian, Ferdinando S Buonanno, MingMing Ning, Scott B Silverman, Roberto J Cubeddu, Eugene Pomerantsev, Robert M Schainfeld, G William Dec, and Igor F Palacios.
    • Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard, Medical School, Boston, Massachusetts.
    • JACC Cardiovasc Interv. 2013 Nov 1;6(11):1176-83.

    ObjectivesThis 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).BackgroundTranscatheter PFO closure is commonly performed for several indications, including cryptogenic stroke, despite conflicting data regarding the efficacy of this intervention.MethodsWe 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.ResultsIndications 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.ConclusionsTranscatheter 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.Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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