Author + information
- Received June 1, 2013
- Accepted June 21, 2013
- Published online November 1, 2013.
- Ignacio Inglessis, MD∗,
- Sammy Elmariah, MD, MPH∗,
- Pablo A. Rengifo-Moreno, MD∗,
- Ronan Margey, MD∗,
- Caitlin O'Callaghan, NP∗,
- Ignacio Cruz-Gonzalez, MD, PhD∗,†,
- Suzanne Baron, MD∗,
- Praveen Mehrotra, MD∗,
- Timothy C. Tan, MD, PhD∗,
- Judy Hung, MD∗,
- Zareh N. Demirjian, MD‡,
- Ferdinando S. Buonanno, MD§,
- MingMing Ning, MD§,
- Scott B. Silverman, MD§,
- Roberto J. Cubeddu, MD∗,‖,
- Eugene Pomerantsev, MD, PhD∗,
- Robert M. Schainfeld, DO∗,
- G. William Dec Jr., MD∗ and
- Igor F. Palacios, MD∗∗ ()
- ∗Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard, Medical School, Boston, Massachusetts
- †Cardiology Division, University Hospital of Salamanca, Salamanca, Spain
- ‡Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
- §Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
- ‖Division of Cardiology, Aventura Medical Center, Miami, Florida
- ↵∗Reprint requests and correspondence:
Dr. Igor F. Palacios, Massachusetts General Hospital, 55 Fruit Street, GRB 800, Boston, Massachusetts 02114.
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.
Dr. Buonanno is an investigator in the PREMIUM migraine trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Inglessis and Elmariah contributed equally to the manuscript. Dr. Demirjian is deceased.
- Received June 1, 2013.
- Accepted June 21, 2013.
- American College of Cardiology Foundation